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Archive for the ‘Health’ Category

Navigating party priorities: health policy in the political landscape

With Party Conference Season now behind us, we have (some) more clarity on the health priorities of the two major political parties. Now that both the Labour and Conservatives have established their positions, what does this mean for organisations seeking to engage on the commitments made by both sides, as competing priorities divide attention?

In this analysis we show how healthcare organisations can amplify their policy objectives with Government and the Opposition through shared ambitions, as Westminster gears up for a general election.

Prevention is the name of the game

Your policy positions need to align to the prevention agenda.

While political championing of prevention is not new, one of the clear shifts for both parties this year was the central focus on public health and prevention.

For the Conservative Party this is a significant change in direction, fronted by the smoking ban announcement made by Rishi Sunak on the final day of conference; arguably, what could be one of the most significant public health interventions of recent decades. This is perhaps not surprising, given it is unlikely that the Government will have met many of its 2019 health manifesto commitments by the general election and hence a desire to show real change.

For Labour, Wes Streeting’s ‘shift from treatment to prevention’ was reiterated throughout conference. Unlike the Conservatives’ approach of bold policy to demonstrate change, Labour’s position is focused on long-term planning. However, despite talk of 10-year strategies and the shift towards community-centric care, many were left questioning the practicalities of implementation including the rebalancing of investments and community staffing.

Crafting effective policy asks

Your policy asks must focus on levers that can enact change and drive impact.

While ambitious reforms may capture attention, policy teams in Government and the Opposition are facing competing priorities with limited resources.

Wes Streeting has reiterated this distinction, favouring detail and evidence over ‘pledge card policies’. This is especially important to bear in mind when engaging with Labour. Also, while Streeting may have presented his overarching goals in Labour’s Health Mission, his shadow ministers are still getting to grips with the intricate details of their briefs.

It is nuanced and well-articulated policies that will hold weight for Labour and the Conservatives in the run-up to the general election. This means an opportunity to engage constructively by offering expertise, insights, and data that can inform policy decisions. Organisations should invest in refining their precise policy asks that address the current real-world challenges, and where possible, costed roadmaps for implementation.

In it for the long haul

Focus on policy proposals that can unlock cash or productivity

What is abundantly clear is that both parties are positioning their priorities as long-term commitments and ambitions.

For both, this is in part necessity – with reluctance to commit to any new policy proposals for fear they could be held up as uncosted. The other part is about positioning, with parties wanting to be seen as the safe bet for the future. This pivot will arguably be harder to pull off for the Conservatives who have been at the helm for more than a decade. For Labour, it may suggest short term inertia if elected, with fiscal restraint likely to remain front and centre in the first 12-18 months.

For organisations looking to engage with the health policy agenda is greater scrutiny on the financial implications of policy proposals. Political and policy prioritisation is likely to be focused on interventions that can either unlock cash or create an immediate and measurable impact on productivity to unlock capacity in other parts of the system. Engagement should focus on being explicit about where these savings can be made.

About WA Communications

WA Communications is an integrated strategic communications and public affairs consultancy. Our specialist health practice supports clients across a diverse range of diseases at the intersection of policy, government affairs and communications, to achieve their strategic objectives.

If you would like to discuss how we can help your key areas of focus, contact Giulia Corsi at giuliacorsi@wacomms.co.uk.

Our analysis of the Labour Party’s health policy thinking draws Next Left – WA’s recently published Guide to Engaging with the Labour Party – which explores the people, processes and politics shaping the development of Labour’s next election manifesto, and how businesses in every sector can engage with the party’s plans.

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Five key takeaways: Engaging with ICS priorities panel session

WA was delighted to host a panel session with Dr Layla McCay, Director of Policy and NHS Confederation and Mike Bell, Chair of NHS South West London integrated care board (ICB) and WA Health Senior Adviser.  

At the session, WA’s Head of Health, Dean Sowman, explored Layla and Mike’s perspectives on how the life sciences industry can meaningfully engage with, and play a role in delivering integrated care systems (ICS) priorities. 

In light of a 30% cut to operating budgets and industrial action absorbing the bandwidth of executive teams, ICSs are currently heavily focused on short-term operational priorities. We have outlined five key factors to engage effectively against this backdrop:   

1. ICSs are delaying some action until the general election 

Whilst both the Labour and Conservative parties have communicated support and optimism for ICSs, the reality is that political uncertainty and operational pressures mean that many ICBs have little bandwidth to implement their ICB led five-year joint forward plan.  

Instead, ICSs are increasingly deferring important decisions until there is a stable administration which can ensure the preservation of essential funding and objectives. The overarching concern is that the exact vision of ICS working to respond to local population needs will be overshadowed by national pressures.    

Whilst this is a considerable challenge, the take home message for organisations looking to engage is the importance of timing the hope is that following the winter period, which is a particularly politically sensitive time, ICSs will have greater bandwidth to begin to implement their strategies.  

2. There’s no shortcut to engaging with all ICSs, and no one-size fits all approach 

When looking to secure policy changes, there is currently no shortcut to speaking to all 42 ICSs. We are starting to see some ICSs coalescing or developing strategic multi-ICB structures where some ICBs lead on certain workstreams on behalf of others. This trend is likely to become more commonplace – so engagement may become more streamlined in the future.  

For now, the best route to engage with multiple ICSs comes through existing forums, including NHS Confederation’s ICS network and NHSE’s Academic Health Science Networks (AHSN) 

3. Medicines optimisation and management is a priority with positive examples needed  

One key barrier to ensuring medicines optimisation is that current financial models are created to show benefits to local service providers – some of which are not covered by ICS budgets. There needs to be an overhaul of where the service is delivered, where the money flows and where the savings are realised. While there is clarity on this being a problem – at present there is no solution.  

NHS Confederation would welcome examples of impactful collaborations between ICSs and industry as there is currently a shortfall of tangible examples.  

4. New evidence and ideas to support the delegation of specialised commissioning are welcomed  

The delegation of specialised commissioning to ICSs remains a concern. Prescribing budgets will remain with NHS England, but services deemed ready for integration will be delivered locally. There are outstanding questions as to whether individual ICSs are equipped with the right workforce and expertise, and what multi-ICB structures could be formed.  

This is especially pertinent in the case of rare diseases. Given their low prevalence in local areas, rare diseases are unlikely to be a core focus for ICSs, as evidenced by WA’s analysis which found that just five of the ICB five-year plans featured rare diseases.  

However, there is optimism that the transfer of specialised commissioning responsibilities offers the opportunity for a reset. If done right, it could ensure the repurposing of specialised commissioning budgets across the whole pathway, challenging local systems to reduce spend on tertiary services, and instead finding new ways to act earlier.  

5. Understanding where each ICS is placing strategic emphasis is critical 

Each ICS is at a different stage of maturity and there is distinct variation in size, scale and local characteristics, meaning a one-size fits all approach to engagement will not work. As a first step, understanding where you may wish to begin engagement and how to frame this in line with local priorities is essential. 

At the end of June 2023, 40 of the 42 ICBs had published their five-year joint forward plans setting out their strategic vision to tackle the health issues faced by their local population.  

To support industry, WA has undertaken an in-depth analysis of the plans to create an interactive map showing the level of priority each ICB is placing across 27 themes. Understanding the ICBs that are prioritising your areas of interest, can support you in identifying meaningful collaborations and partnerships aligned to an ICB goals. 

About WA Communications 

WA Communications is an integrated strategic communications and public affairs consultancy. Our specialist health practice supports clients across a diverse range of diseases at the intersection of policy, government affairs and communications, to achieve their strategic objectives. 

If you would like to discuss how to best work in partnership with Integrated Care Systems, and our analysis of their key areas of focus, contact Lloyd Tingley atlloydtingley@wacomms.co.uk. 

 

 

 

 

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NHS England’s medicines optimisation guidance: What are the opportunities to improve uptake of medicines at ICS level?

The NHS has been plagued by difficulty when it comes to variation in the uptake of NICE approved medicines. With the establishment of ICSs, there has been an attempt to position medicines as strategic enablers of improved patient outcomes and NHS productivity and efficiencies rather than just a clinical intervention for patients. The publication of NHS England’s medicines optimisation guidance 2023/24 last week signals a shift to create a national framework around this ambition, which NHS England (NHSE) has linked to integrated care board (ICB) priorities. Reading the guidance, the financial imperative is clear the broader goals of medicines optimisation e.g., reduced wastage, improved outcomes, and improved safety, are consistently correlated to helping systems ‘deliver financial balance’. 

However, with financial constraints placed on ICBs and the ongoing operational pressures facing staff, the root perception that medicines optimisation equates to doing more with less must be tackled first.  

NHS England’s new guidance sets out 16 national medicines optimisation opportunities for 2023/24, and signposts to best practice resources to support implementation. NHS England recommends that ICBs choose at least five medicines optimisation opportunities.  

What does Industry need to know and do following publication of this guidance?  

Here are a few of our thoughts: 

As we look to implementation, many questions remain. Will we see ICSs prioritise the same five ‘opportunities’ and what does it mean for progress in the opportunities that are not selected? How should system partners tailor their approach to targeted interventions in each ICS, each with differing local barriers? Finally, what additional strategies can help ensure that healthcare inequalities are not exacerbated? The ambition is high and must be matched by collaborative action at national, regional and local levels.  

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‘Stopping the 8am rush’ – Is the plan for recovering access to primary care an oversimplification?

The primary care access plan is finally here. A comprehensive plan to mull over but difficult to have a full view in the absence of the workforce plan. It is coined by DHSC as “the first step to address the access challenge ahead of longer-term reforms”, but this is not to undersell its transformative potential. Primary Care Networks (PCNs) are now fully focused on delivering this plan which spans the introduction of better phone and online systems, pharmacies supplying medicines for more conditions, and more staff and more appointments – anything else will be deprioritised.  

The plan has been widely praised as championing innovation. However, there is a feeling that the plan doesn’t duly assess the risks and benefits of what has been put forward and is perhaps an oversimplification from DHSC and NHSE.  

On a micro level, in this blog we explore the potential impact on access of changes to the role of pharmacy, the Investment and Impact Fund (IIF) and Quality and Outcomes Framework (QOF).  

Broadening the role of pharmacists presents both opportunities and risks

Pharmacy First has arguably elicited the strongest discourse and feelings both good and bad. Outwardly, a number of high-profile pharmacy leads are supportive of the initiative but there is cautiousness amongst the health sector. In conversation with David Thorne, Transformation Director at Well Up North PCN, he noted the following challenges:

1. Interoperability: It is vital that GP and pharmacy systems speak to each other, and we avoid the fragmentation that has bedevilled GP systems to date. Currently, robust systems are not in place to inform pharmacists of what medication someone is on to support their prescribing decisions ─ apart from placing faith in very early use of the NHS App. We need consistency and safe links, especially when looking to enable people to use a pharmacy distant from their GP practice.

2. Pharmacy closures:  In theory, the enhanced role of pharmacists could make primary care more accessible. However, data reports that pharmacy closures have disproportionally been in the most deprived areas of England ─ so there is a risk that positive changes to the role of pharmacists’ conflict with national priorities around health inequalities. One of the main drivers of the shortages of community pharmacists is the PCN recruitment of pharmacists to work in primary care roles.

3. Right Place, Right Role: Community Pharmacies may not be able to develop responsive clinical governance systems that adequately respond to case mix escalation, for example when superficially routine consultations escalate to issues of drug/alcohol misuse, mental health and safeguarding. How can we support pharmacists to develop the skill, time and governance systems to manage the types of conversations that GPs have?  Extensive training and public awareness will need to accompany these changes.

This is far from a done deal with negotiations on the £645 million supportive investment ongoing. Further, there will be a consultation on upholding patient safety considering greater prescribing powers for pharmacists.

Polling results conducted by WA communications in March 2023 of 1,000 members of the UK public highlight that whilst there is public support for a greater role for pharmacists, there is some way to go to building public awareness of the services pharmacists can provide.

A word of caution surrounding progressive changes to the IIF and QOF

Further details of the streamlining of IIF and QOF were announced within the plan. Redirecting £246 million of IIF funds represents a major shift with 30% to be awarded by ICBs (integrated care board), conditional on PCNs achieving agreed improvement in access and patient experience. DHSC/NHSE guidance is that access improvement plans should prioritise supporting those with the lowest patient satisfaction scores.

Local flexibility must be at the heart of the re-design of incentives, without arbitrary access quotas for certain groups such as ethnic minorities or LGBTQ+, which could lead to under-funding and deepening inequalities. It seems that DHSC/NHSE are cognisant of this, explaining that the plan is designed to move towards a “more equitable approach that will benefit all patients” and “does not call out specific cohort of patients” for that reason. This must be pulled through at an incentive level to ensure certain PCNs such as rural PCNs who may have small numbers of certain communities, are not caught out.

NHSE further announced that, through a consultation this summer, they will explore how to link QOF to key strategies such as the upcoming Major Conditions Strategy. Ultimately, ICBs new commissioning powers will mean ICBs very closely performance manage PCNs. This goes against the ‘neighbourhood’ aspect of integrated care reforms, which will only seek to become more complex as preventative care models are adopted.

As always, implementation will be the true test. The plan comes with no standardisation frameworks or action plans attached. This passes the buck to PCNs and/or ICBs to operationalise, which risks fragmentation in the absence of nationally led advice.

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The challenges that remain for tackling variation in CVD prevention in England

Cardiovascular disease (CVD) is one of the leading causes of morbidity, disability and health inequalities, affecting approximately 6% of the adult population in England.  

To provide greater understanding on the state of CVD prevention services across England, the NHS Benchmarking Network publishes an annual CVDPrevent audit report. The latest iteration is much more oriented to looking through the lens of health inequalities and regional variation in care, highlighting the significant issue of a postcode lottery in cardiovascular care across the country. This new angle of focus of putting inequalities in the spotlight in the CVDPrevent report rightfully signals that this is where the focus should be for both health system leaders and industry working in this space alike.  

The report indicates some positive highlights for example with the prescription of anticoagulation drug therapy for those with atrial fibrillation at high-risk of stroke rising to 88.9% – only 1.1 percentage point below the national ambition to reach 90% by 2029.  

However, there remains some distance to go on the road to recovery from the pandemic with hypertension services particularly lagging behind others and health inequalities and variation remaining prevalent. Notably, individuals from a Black, Asian or Minority Ethnic background were identified as being the least likely to be prescribed an appropriate drug therapy, receive monitoring, or be treated to target with similar issues present across sex, age and deprivation level.   

Alongside variation in treatment and management, there is also significant variation in local approaches to CVD prevention. Our research and analysis of ICS strategies, planning documents and data relating to CVD-prevention, has found that there is a significant level of variation present in the level of planning for CVD prevention services, as well in care and outcomes.  

It is therefore particularly welcome to see the recent prioritisation of CVD services on the national policy agenda through the intention to publish a Major Conditions Strategy later this year and more recently through the appointment of Professor John Deanfield as the first ever Government Champion for Personalised Prevention. Both developments recognise the issue of inequality and unwarranted variation in the absence of a dedicated Health Disparities White Paper.   

However, the test of any such policy is whether it can be implemented uniformly to impact change across the country and not exacerbate variation as well as whether it can truly trickle down and impact at the local place-based level. To do so these policies will need to balance national direction with a sufficient amount of autonomy to allow for population-based CVD prevention strategies, an ambition of newly formed integrated care systems.  

Although the report demonstrates that progress is being made in this hugely important disease area, it is clear to see that much work remains to be done. Promising policies with high potential are a welcome sight to see and only time will tell if they can truly make the impact they set out to achieve.  

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WA Communications roundtable with Rob Kettell

On Thursday 6 October, WA Communications convened a roundtable discussion between Rob Kettell, Director of Commercial Medicines Negotiation and Complex Transactions at NHS England, and representatives from leading pharmaceutical companies.

The session explored NHS England’s Commercial Medicines Directorate (CMD) priorities, and how companies can work in partnership with the NHS to ensure timely access to medicines for patients.

The session was timely, given the recent and further pending changes in the leadership team within the CMD, the recent launch of the innovative medicines fund (IMF), and ahead of discussions about a successor to the voluntary scheme for branded medicines pricing and access (VPAS) that runs to the end of 2023.

To start, Rob outlined his three priorities:

  1. Access: Continuing to secure rapid patient access to new treatments
  2. Uptake: Ensuring there is consistency in the use of innovative treatments that are provided on the NHS across the country.
  3. Value: Delivering value for taxpayers by striking commercial deals for new medicines that are clinically led and commercially driven, at cost effective prices

A wide-ranging discussion followed. We outline five key takeaways below:

  1. Better, earlier dialogue between the NHS, NICE and companies has helped ensure expanded and accelerated access to innovative treatments, and this can continue to develop in the future

The growth of the commercial medicines team and with it the evolution of the commercial capabilities within NHS England has allowed for earlier and greater engagement with industry. Whereas previously, dialogue between NHS England, NICE and companies could be inconsistent and limited, there are now clear and established routes for early and ongoing communication – including a formal triage function in the CMD. This has benefited both sides, and is an approach that NHS England is keen to continue to develop.

As well as supporting new approaches to individual negotiations, it has also led to more effective horizon scanning which, in turn, has helped the CMD to work with NHS colleagues to better plan for new types of medicines, or medicines in specific disease areas, which may be ready to be appraised at the same time. For example, Advanced therapy medicinal products (ATMPs) have been earmarked as a potential priority area for the coming years, building on the NHS’ track record as a leader in Europe for cell and gene therapies

It was acknowledged that this stronger approach to partnership working has been essential in overcoming some of the more difficult recent access challenges. Securing patient access to immuno-oncology treatments and combination therapies are clear examples of cracking ‘unsolvable’ challenges when all parties work together in partnership to ensure rapid access.

NHS England is now keen to work with companies to explore how to signal areas where there is demand for innovation from the system. This can give further clarity to industry on where focus may lie in the future.

  1. A focus on primary care to meet population health needs

Rapid innovation in drug development over the last ten years has led to huge breakthroughs for conditions with high unmet need like cystic fibrosis and spinal muscular atrophy. However, the focus on innovations like gene therapies and precision medicines, which are prescribed and administered in hospital settings, has not been matched by the same focus on innovation in the primary care setting, which is needed to achieve the population health ambitions of the NHS Long Term Plan.

There is now a real appetite to explore how innovative treatments that have an impact on a wider, population-based level, in areas like as cardiovascular disease, can be brought into the system.

This may require new approaches to align value and affordability among very large patient populations. There is appetite for further exploration of how industry and NHS England can work together to find access routes for more to patients in primary care – to have the most significant impact.

  1. The CMD is keen to partner with companies to boost uptake, but must be selective

It was acknowledged that progress on boosting the uptake of new medicines has been mixed.  There have been some big successes, particularly on treatments that have benefited from funding through the Cancer Drugs Fund, but also areas where potential uptake has not been realised, or has been slower than it could have been.

NHS England – including the CMD – has finite resource, and current fiscal pressures mean there is more focus than ever on achieving value. It must therefore focus this resource towards areas which are likely to have the biggest impact. This will inevitably require a degree of prioritisation on where to focus attention.

As an example, this might include working more closely with companies on targeted uptake strategies whose treatments address longstanding health inequalities, for example, as aligned with the NHS’ health inequalities CORE20PLUS5 strategy.

  1. The CMD is driven by the need to provide value to the taxpayer across all activity

There is recognition that the pricing and revenue environment in the UK is tighter than some other countries. From an NHS perspective, this provides value to the taxpayer and supports the sustainability of the NHS – while companies benefit from the NHS model where access to more than 55 million people can follow a single successful negotiation.

The NHS commercial framework for new medicines points to the complex problems that the CMD is often trying to solve by agreeing ground-breaking and world-first deals, for example the recently announced antimicrobial subscription model.

There is clearly risk involved in facilitating complex deals that go beyond a simple discount to reach a cost effective price with NICE. Therefore, more value needs to be derived from them, ideally creating a ‘win-win’ for companies, the NHS and the taxpayer.

Value is always expected to be at the cornerstone of all decisions made and can often be generated by treatments sitting at, or below, the bottom end of the NICE QALY cost-effective range. This is the value NHS England expects going into a complex negotiation.

  1. Making the UK an attractive place to launch medicines and bring in research and development investment is a continued area of focus

In recent years, the Life Sciences Vision and the UK’s Industrial Strategy have set-out ambitions to make the UK an attractive location for global pharmaceutical companies to invest in.

Maintaining and building on the opportunities of the UK’s strong skills and science base, regulatory regime, single payer system and high levels of clinical trial activity remain key features in the government’s ambitions for global life sciences leadership.

There is clearly appetite on all sides for the pharmaceutical sector to be a key industry to help deliver the government’s economic agenda. However, industry representatives expressed their views that life sciences investment in the UK could be limited due to the rigorous focus on securing value as outlined above.

While recognising the need for value, a more holistic approach to the life sciences operating environment is becoming increasingly important for industry. There are risks to these growth ambitions if industry feels squeezed on all sides. An elevated – more unified recognition of industry’s contribution would enable UK leadership teams to make a stronger case internally for further investment in the future.

In summary:

  1. Utilise NHS England’s CMD triage function and the Office for Market Access to support with early dialogue and horizon scanning
  2. NHS England would welcome ideas and support to more effectively signal demand to the sector in specific disease areas
  3. Ensure resources are used effectively by providing detailed information and positions to NICE at pre-committee stage
  4. The NHS is looking to tackle the population health challenges set out in the NHS Long Term Plan, including by utilising greater innovation in primary care
  5. Medicines that offer holistic benefits, such as addressing longstanding health inequalities, are more likely to be considered for a bespoke NHS arrangement to drive faster and comprehensive uptake

About WA Communications

WA Communications is an integrated strategic communications and public affairs consultancy. Our specialist health practice supports clients across a diverse range of diseases at the intersection of policy, government affairs and communications, to achieve their strategic objectives.

If you would like to discuss how to best work in partnership with the NHS, contact Lloyd Tingley at lloydtingley@wacomms.co.uk.

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The future of HIV/AIDs in the UK – ending HIV transmission for everyone, everywhere.

Undoubtedly, progress toward ending HIV is a major twentieth-century success story. Within our lifetimes, HIV has gone from a life-ending condition to being completely treatable and non-transmissible. It is a fact that a person living with HIV today who is on effective treatment can’t pass it on.

These significant advances in treatment mean that the vision of ending HIV transmission has become tangible. The UK has an opportunity to be a world leader in this space, and the government is committed to being the first country in the world to achieve zero new HIV infections, AIDS and HIV-related deaths in England by 2030. The current political turmoil and the new cabinet’s lack of appetite for prevention do not seem to have tainted a commitment to the effective implementation of the HIV Action Plan.

So where are we now?

HIV prevention is working. For the second year in a row, England met its 95:95:95 HIV treatment targets. The number of people diagnosed has fallen by 35% from 2014 – 2019, particularly among gay and bisexual men. In 2019 an estimated 94% of people living with HIV had been diagnosed, 98% of those diagnosed were on treatment, and 97% of those on treatment had an undetectable viral load – meaning they cannot pass on the infection.

Few countries can show this level of success but as we approach eliminating HIV transmission, we need to ensure that the most vulnerable do not fall through the gaps.

Last week I attended the 5th biannual National HIV Prevention conference. It was the first time so many health professionals, community experts, and researchers working in HIV prevention in the UK have met face to face since the pandemic.

There was palpable enthusiasm to maintain momentum and go further, faster and harder than ever before. And rightly so. Lives depend on this work. Professor Kevin Fenton asked attendees to ‘celebrate and recommit’ and stated that progress on the HIV Action Plan has been necessary but insufficient to end HIV transmissions in a UK context.

As the epidemiology of the virus evolves, what is the future of the fight against HIV?

Solely focusing on diagnosis as a measure of progress does not tell the whole story. Retention of people in care is key to managing HIV transmission. UKHSA estimates that between 15,000 and 20,000 people are living with transmissible levels of the virus in England. Delving into this a bit further reveals that only 24% of these people are undiagnosed, and over 7,000 people living with HIV in the UK have not been retained in care (lost to follow-up).

This problem, it seems, is much larger than was previously recognised. Lost to follow-up is now replacing those still undiagnosed in driving HIV morbidity and mortality.

Patients lost to follow-up are critically immunosuppressed, resulting in immense human tragedy. Speakers at the conference shared first-hand accounts of people presenting at Kings College Hospital with advanced AIDS, despite being aware of their status. This issue disproportionately affects women of black ethnicity from areas of social deprivation. As such, it represents a significant health inequality.

But in a country with universal health coverage free at the point of access, the question surely must be – why?

Reasons will differ on a case by case basis but can be broadly broken down into three key areas:

  1. Stigma kills. It prevents people from getting tested and accessing treatment because they are afraid. It interacts with homophobia, racism and transphobia and prevents people from meeting their need to thrive. It means that patients are treated differently by health care providers once their HIV status becomes known. All of these factors prevent access to care.
  2. The current cost of living crisis means that for some, attending appointments is simply unaffordable. Rocketing childcare and transport costs and the rise of zero-hours contracts coinciding with a huge NHS backlog has meant that logistically retention in care is becoming more difficult to manage.
  3. Some patients are more complex than others. People are individuals with chaotic lives and can experience mental health, mobility or drug and alcohol issues further complicating the matter. There is no baseline measure in place for treating complex HIV patients. The care you receive depends on the training of your physician.

So what can be done?

It’s about people and partnerships. Putting patients at the centre and working together to adopt a proactive approach to prevent people from falling out of care. Every part of the system has a responsibility to find solutions that work. Innovations in diagnosis (oral swabs) and treatment (long-acting injectables), or personalized care, such as offering flexible appointments at alternative venues and providing food and travel vouchers all have a role to play. The voluntary sector are well placed to provide comprehensive support in order ot allow clinicians to focus on the clinical aspects of care.

One thing is certain – offering patients a full range of choices is central to success.

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Like pulling teeth: has the government finally got to grips with dental contract reform?

More than a decade after the coalition government announced its intention to reform the dental contract in England, action may finally be on the horizon. The new Health Secretary Therese Coffey has announced her focus will be on “ABCD: Ambulances, Backlogs of routine treatment, Care, Doctors and Dentistry.” It is no secret that NHS dentistry has been facing a growing crisis, with patients across the country struggling to access treatment due to the number of dentists moving to the private sector. Coffey’s challenge is significant – stabilizing the system and restoring public and professional trust in a system that has seen a number of false starts in the quest for a new dental contract.

The current dental contract has long been criticized by dentists for its sole focus on activity, which reimburses dentists for the volume of activity ‘units’ they complete. Dentists argue that this process is overly simplistic, and prevents them from focusing on preventative treatment, as they are financially incentivized to carry out more invasive work.

To remedy this, in 2015 the coalition government announced the launch of two new prototype contracts, with the aim of reducing dependency on activity as the only means of measuring activity and allocating funding. After the timetable for reform was pushed back repeatedly for a number of years, the government announced it would abandon the protypes in March 2022 and would work to find an alternative means of reform.

Against this backdrop of long term uncertainty, NHS dentistry has struggled to recover from the disruption caused by Covid-19, and is now suffering from an accessibility crisis. Since the pandemic, many practices have been operating at full capacity with patients waiting months for an appointment. At the same time, dentists are leaving the NHS, with over 2,000 ending their NHS contracts in 2021 alone. This leaves those remaining struggling to keep pace with demand. Currently, 90% of dental practices in England are unable to take on new patients, driving patients to the private sector (where they can afford it).

In July 2022 the Johnson government announced some significant revisions to the contract, with the aim of stabilizing NHS dentistry. These changes included establishing a new minimum UDA value, which increases the amount dentists will receive for their work, funding practices to deliver more work where possible and removing some of the barriers preventing dental therapists from carrying out treatment.

The reforms have been largely well received, but some sector leaders have warned that they lack the ambition to truly solve the issues the sector faces. Nigel Edwards, Chief Executive of the Nuffield Trust has argued that ”a lack of investment and misalignment between costs and funding have made it increasingly unattractive to be an NHS dentist. The resulting exodus of dentists has fuelled growing waiting times. While more money to help high-performing dental surgeries see more NHS patients is helpful, it does not address the problem that many areas in England have little or no access to an NHS dentist.” This view is shared by the British Dental Association, which has warned that the changes will not stop the ongoing exodus of staff from NHS dentistry, or solve patient access issues.

We may have already seen some preliminary reform to the dental contract, but Coffey’s very public focus on dentistry as an issue indicates that further reform is on the horizon for the NHS dental sector, an admission of how much change is needed. It also potentially signals that dentistry, long seen as a Cinderella service in comparison to other parts of the health system, may finally be getting the recognition and attention it needs to be able to secure real and lasting change.

In the meantime, however, more dentists are likely to switch their focus to private practice, in turn driving those who can pay for dental treatment to do so. The government is unlikely to seek to alter this dynamic and is likely to instead focus on addressing the lack of NHS dentists taking on new patients to attempt to stem the accessibility crisis.

Solving the issues facing the dental sector is no mean feat, but in putting the issue so high on the political agenda, Therese Coffey has indicated that there is now a feeling of greater urgency in finding a solution to long running issues affecting the sector. Regardless of what this change looks like, demand for affordable, accessible dental care will remain extremely high, particularly for patients who are unwilling and unable to pay high prices for treatment in light of the growing cost of living crisis.

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Are women finally being heard?

Women in the UK are becoming increasingly vocal about the challenges they face in their healthcare and the unjust variation in access to services. When the Government opened their consultation to inform a Women’s Health Strategy in Spring 2021, over 110,000 respondents took the opportunity to make it known that the system does not work for them. Following years of campaigning, it comes as no surprise to women and those in the women’s health community that an overwhelming 84% of people felt their voices are simply not being heard when they seek health care.

By demonstrating an interest in women’s voices and their experiences, recognising failures in the system, and committing to developing a Women’s Health strategy, the Government has taken a positive initial step, albeit an ambitious one. There is no disease-specific focus and no target patient population, unlike other policy areas. This challenge affects 51% of our population and includes natural, life course events that women have, for many years, been told to just live with. With publication of the strategy imminent, the Government now need to demonstrate that they are willing to not only listen to women’s voices but to implement action based on what they are saying.

Women continue to face challenges when it comes to choices about their own bodies. Ongoing variation in access to abortion care, a full range of contraceptive choice, and a holistic range of menopause treatment options, all impact on women’s freedom to choose the treatments that work best for them. The Government’s commitment to prioritising the menopause in the upcoming strategy and cutting prescription costs for Hormone Replacement Therapies (HRT) in response to the Menopause Revolution campaign is hopeful. However, the Government’s initial attempt to reverse progress made in at-home abortion during the pandemic despite women citing a clear preference for this to continue, suggests more need to be done to prioritise women’s voices, choices and rights in practice.

In addition to not being heard, a fragmented system and the pandemic backlog have resulted in services that are increasingly difficult to navigate, leading to the most vulnerable falling through the cracks. Upcoming system reforms focusing on the integration of care offer opportunities to take a patient centered approach and reduce inequalities in outcomes. The Government is also expected to advocate for the establishment of ‘women’s health hubs’, which aim to enable access to all required care in a one-stop shop, in line with calls from advocates including the Primary Care Women’s Health Forum and Royal College of Obstetricians and Gynaecologists. Despite the promise of better integration locally, fragmentation is continuing at a national level. Abortion has been removed from the Women’s Health Strategy and is expected to feature in the upcoming Sexual Health Strategy. With a wider interest in health inequalities, the Government must recognise the connection between these elements of healthcare and align planning nationally to support local areas to integrate care.

Committing to a women’s health strategy is a promising step in the right direction for this Government and has offered women long overdue hope. Action in response to prominent campaigns, such as the Menopause Revolution, to change the way women can interact with the system allow us to believe that the challenges women have faced for far too long could be overcome within their lifetime.

The Government have a real opportunity to ensure women have their voices heard. To do this, they must recognise the challenges they face, capitalise on system reforms to integrate care, collaborate with the women’s health community, and most importantly, commit to funding appropriate and immediate action. In a health system and economy designed by and for men, the time for meaningful, impactful change, is now.

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Battle stations: reflections on the Government’s War on Cancer announcement

When the Conservatives were re-elected in 2019, it was on a manifesto that mentioned cancer in only two specific commitments: the expansion of the Cancer Drugs Fund and the rollout of cancer diagnostic machines across 78 hospital trusts. And yet, at the beginning of February, the Government used World Cancer Day to declare war on cancer, announcing a sweeping consultation for a new 10 Year Cancer Plan for England, designed to “radically improve” outcomes for cancer patients.

There is no doubt that the COVID-19 pandemic has had a significant impact on cancer diagnosis and care, so, despite the surprise nature of the announcement, it’s hard to oppose the Government’s decision to intervene. What isn’t clear yet is the extent to which this will be a wholesale reform backed by serious funding commitments, or a rehash of existing policies in the 2019 NHS Long Term Plan and the 2015 Cancer Strategy for England.

The announcement shows the Government’s intention of taking the reins on cancer policy, and making it political. Following months of political unrest and serious concerns about the elective care backlog, this allows the Government to set its long-term intentions. By making cancer a political priority, the Government and NHS can be held to account on the impact of reform, ensuring delivery against commitments. This is likely to be central to the purpose of the Cancer Plan and will help to give momentum to a programme of change.

It is essential that funding is adequate to achieve targets at an extremely challenging time. Patient groups, who have witnessed years of rhetoric yet insufficient progress, are cautiously optimistic, rightly concerned that years of underinvestment and understaffing will mean that however great the commitments are, the resource to achieve them will not match.

We have also witnessed this week The Treasury being more muscular on making stipulations attached to funding commitments. The tense stand-off with Department of Health and Social Care (DHSC) over the Elective Recovery Plan may indicate what’s to come with the Cancer Plan, with the Treasury not keen to loosen the purse strings for wooly ambitions.

Whether the Plan, when published, is a total reset or momentum for existing policy in a new format, the potential for real change in the diagnosis, management and treatment of cancers is certainly closer.

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NHS outsourcing to the independent sector: politicians vs the public

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Politicians signal regulatory change on the horizon for IVF clinics

After a long period of stability, IVF policy is set for a shake up as a result of new regulatory proposals made recently by the Human Fertilisation and Embryology Authority (HFEA), the industry regulator. HFEA is looking to amend the Human Fertilisation and Embryology Act 2008 in a number of areas which would affect access and treatment types.

Scrutiny of IVF clinics has been growing over the past year. In June 2021, the Competition and Markets Authority (CMA) collaborated with the HFEA to develop new guidance which allows couples to initiate legal proceedings against IVF clinics that have falsely guaranteed their success rates. Following on from this, Julia Chain, the newly appointed Chair of HFEA, has called for far reaching changes to be made to current IVF regulations, which would allow HFEA to fine clinics that mislead patients over the efficacy of their treatments, as well as widen access to treatment. Chain has also called for IVF regulatory reform to allow scientists to use embryos for research beyond the present 14-day limit.

Chain has argued that IVF policy has become outdated, with reproductive regulations no longer matching the reality of treatment provided in the UK. She has highlighted several areas of the 2008 Act as being in need of reform, including patient protection and the means of maintaining the quality of care provided for them. Chain has called for a broader range of methods for addressing poor performance, such as economic sanctions against non-compliant clinics. This would also include addressing the increasing commercialisation of the fertility sector, where 65% of treatments are self-funded and public funding is unevenly distributed, resulting in a postcode lottery.

Political awareness of the discrepancy in NHS funding for fertility procedures has been growing. Under pressure from MPs across all parties, in September 2021 the then Care Minister Helen Whately MP announced that the government had conducted an internal review of variations in coverage and was currently considering its next steps.

This additional scrutiny substantially changes the political environment affecting IVF. Government reviews, the attentions of the CMA, a new activist Chair of the HFEA, as well as increased press coverage and ongoing legal cases will all increase the need for careful political due diligence of any investments in the sector. Demand for IVF services will remain high, and indeed is three times higher than it was in 1999, but investors will need to take the political and regulatory changes on the horizon into account as they plan their strategies and make their decisions.

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WA Investor Services supports Agathos’ investment in Hunter Healthcare

WA Investor Services is proud to announce it has supported Agathos’ acquisition of Hunter Healthcare, a specialist recruiter working across the healthcare and life sciences sectors. The investment will help support Hunter’s ambitious growth plans, providing vital staffing solutions to healthcare providers and medical researchers, including developing its offer in international markets.

WA provided political due diligence to support the transaction, with its team of healthcare policy experts providing insights integral to the deal process, working closely with Agathos and other due diligence providers to deliver clarity on how ongoing structural changes to the NHS, the elective recovery and acceleration of the digital transformation agenda will affect healthcare recruitment decisions and priorities.

Commenting on the deal, WA Partner and Head of Investor Services Lizzie Wills said: “We are extremely pleased to have worked with Agathos on this deal. NHS staffing is a very high-profile issue at the moment and ensuring the NHS meets patient demand while undertaking fundamental system reform is a priority for political and NHS leaders, not least as they tackle the post-Covid backlog. As a market leading provider of political due diligence in healthcare transactions we were in an extremely strong position to support Agathos’ successful deal and we look forward to seeing the business develop over the coming years.”

Hugh Costello, Investment Director at Agathos said: “WA Comms produced a comprehensive report with insightful conclusions that were well supported by desktop research and interviews with sector participants. The team was available for calls as and when required and were always a total pleasure to deal with. Ultimately, the output produced by WA was instrumental in our decision to complete our investment. I would recommend their services wholeheartedly.”

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What can we learn from the proposed NHS Standard Contract for 2021/22?

What can we learn from the proposed NHS Standard Contract for 2021/22?

NHS England has published a consultation on its proposed changes to the NHS Standard Contract for the financial year ahead. The final document will be used by Clinical Commissioning Groups and NHS England to contract for all healthcare services bar primary care. The focus of any changes often provides important insight into system priorities for the coming year and the strength of conviction behind them.

With 2021/22 set to be another uniquely testing year for the NHS, one might expect measures to mitigate the impact of COVID-19 to dominate the contract. Instead, there is a sense of defiant ambition, with clear signals for providers to push on with other key NHS and government priorities.

With this year’s consultation now live, here are four key takeaways for the year ahead:

 

1. Don’t get left behind as the NHS pushes on with system transformation

The Contract for 2021/22 shows that NHS England is not letting up in its push for system transformation. It includes several steps to establish more collaborative relationships between commissioners and providers, the most symbolic of which is the removal of financial sanctions for providers that fail to achieve national standards.

This is a significant step towards reversing the transactional, almost adversarial relationship that has proliferated between commissioners and providers over recent years, instead encouraging more collaborative system-level action to identify and address the causes of poor provider performance.

The cogs of system transformation are well and truly turning again so engagement with NHS leaders will need to focus on how to support the achievement of their newly framed outcomes in the most direct way. Additionally, the prospect of major health legislation is looming large for the first time in almost a decade, providing an important opportunity to think bigger picture.

 

2. Get serious about delivering ‘Net Zero’

In October, NHS England published its report on Delivering a ‘Net Zero’ National Health Service, which set out the interventions required to achieve just that, ‘Net Zero’. Yet, the report itself had no legal standing on which to enforce its recommendations or incentivise action.

The inclusion of stronger targets on the reduction of harmful greenhouses gases and air pollution in the proposed Standard Contract for 2021/22, and a requirement for providers to identify board-level officers accountable for delivering ‘Net Zero’ commitments, is a clear indication that NHS England is serious about driving this agenda forwards.

The NHS will increasingly expect everyone who works alongside it to demonstrate that they are also serious about reducing their environmental impact. Medicines, medical devices, services and care pathways can all be made more sustainable. Clearly communicating what you are doing in this space could start to deliver a commercial advantage as pressure builds on providers and health systems to make rapid progress.

 

3. Offer a helping hand on health inequalities

Commitments to reducing health inequalities have been somewhat of a stalwart in NHS policy over recent years. The delivery of coordinated programmes at a local level that actually move the needle have not been so common. This was brought into stark relief by the disproportionate impact of COVID-19 on people of Black, Asian and Minority Ethnic backgrounds.

To create greater accountability at a local level, it is proposed that the Contract include a requirement for each provider to identify a board-level executive responsible for overseeing their actions to address and reduce health inequalities. With broader government and public focus on health inequalities brought on by COVID-19, the pressure on these individuals to demonstrate progress will be palpable.

Those working alongside the NHS should place increasing focus on how they support providers and health systems to address health inequalities. At a time when resources are stretched, we may find that some are actually more open to industry support in delivering staff training programmes, new capacity or improvements to patient pathways, but they’ll have to be able to justify the time investment. Demonstrating how you can contribute to reducing health inequalities could help to secure support for your joint working projects.

 

4. Communicate the benefits of remote consultations and management

Following the rapid up take of video and telephone outpatient appointments during COVID-19, the NHS is now trying to cement their use into everyday clinical practice by requiring all providers to offer patients (where appropriate) a choice between remote and face-to-face consultations. The hope is that this choice will be maintained in primary care too, where uptake of remote consultations has also rocketed.

However, to truly support clinicians and patients to select remote consultations in the long-term, the NHS will need to place additional value on health technologies that support effective remote monitoring and management.

Before some slip back into old habits, the wider health sector can play a role in crystallising broad clinical support for this new way of working. Arming your field force and spokespeople with clear, real-world evidence of how your technology is reducing the need for labour intensive, face-to-face clinical interventions could provide clinicians with the confidence to continue their transformation.

 

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A viral epidemic is becoming a mental health epidemic, but does the Long Term Plan need a rethink to cope?

Just 18 months on from the launch of the NHS Long Term Plan, is it already outdated when it comes to mental health?

As the focus of health policymakers moves from coping with COVID-19 to catching-up care across all conditions, attention is increasingly turning to the mental health catastrophe we face.

The challenge is not only stark for people living with mental ill health. It also threatens the carefully-laid strategy put in place before the pandemic struck.

Improving mental health care was at the heart of the Plan, with a promise to “deliver the fastest expansion in mental health services in the NHS’s history”. The ambition to finally establish parity with physical health was supported by significant funding across acute and community support.

But COVID has moved the goalposts and cut the game time. For this reason, the NHS can’t simply pick up where it left off with the mental health aims in the Plan. Somehow now it must go much further, and faster.

The impact of COVID-19 on mental health

It is clear that the pandemic is both a cause and compounder of mental illness.

Broadly speaking there are now two groups of patients with considerable and potentially long-term needs:

Firstly, those who already had and were undergoing treatment for an existing mental illness. COVID-19 lockdown restrictions have made access to primary services, support and therapies more challenging. It is likely that this has led to relapses and more acute mental health needs.

A recent survey by Rethink Mental Illness found 80% of people living with mental illness say the crisis has made their mental health worse. Almost half surveyed have struggled to access services.

Secondly, there is a wave of new patients who have developed mental illness as a result of COVID-19 and the lockdown. Triggers are wide-ranging, including stress regarding job insecurity, grief, isolation and anxiety over the future. There are also particular concerns over the long term impact on young people.

Each group will have different needs, with a complex mix of therapies, treatments and support. But the modelling of mental health services within the Long Term Plan was not designed to cope with a spike in acute cases or for a whole wave of new ones.

Further, as the implementation of the Plan was still in its infancy when COVID struck, much of the work will have been disrupted or delayed at the least.

What does the response look like?

This emerging backlog and new wave of patients requiring care will exert a pressure on services that hasn’t been experienced before. The NHS therefore needs to rapidly reassess how to respond to the challenge.

For example, the Long Term Plan aimed to expand mental health support services for an extra 345,000 children and young people aged 0-25, including through schools and colleges. Following months of school closures and the risks faced by vulnerable children, that number will now need to be much higher and rolled out with greater urgency. This is an additional and complex challenge for headteachers facing already unprecedented difficulties as schools look to reopen.

The ambition to expand community and hospital services, including talking therapies and mental health liaison teams is also a core part of the Long Term Plan’s aims. This has been seen as a long-overdue measure to provide the appropriate level of care for hundreds of thousands more people with common or severe mental illnesses. But policymakers and the health service will have to consider what a best ‘new normal’ and staffing levels looks like to ensure services can provide the levels needed.

There are glimpses of positives. NHS England has brought forward implementation of a 24/7 crisis helpline and announced extra funding for the mental health charities at the frontline of dealing with the COVID fallout during Mental Health Awareness Week.

Yet the money attached to mental health in the LTP is now superseded by the new situation. Undoubtedly more will be needed.

A new generation of political leadership

While not all will agree with Luciana Berger or Norman Lamb’s politics, Parliament lost two of its biggest mental health champions in December. New parliamentary mental health champions are stepping forward and they have an important job to play.

Promisingly, beyond COVID, mental health is the key health issue for parliamentarians. WA’s January survey of the new parliament’s health priorities saw mental health care emerge as MPs’ top priority for additional NHS funding, with two thirds choosing it as an option. But despite growing awareness of the looming mental health crisis, there has been little political focus on what needs to happen next.

It is essential that the progress made over the past few years in mental health doesn’t fall to the wayside because of COVID. A rapid review of the Long Term Plan – with a COVID lens – backed up by sufficient funding and implementation, is needed to stop the viral health epidemic becoming a mental health epidemic.

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After COVID-19, what next for cancer services?

Thousands of cancer patients are missing. Many patients are having appointments delayed or cancelled, others simply aren’t seeking help. There is growing unease over the implications.

And so the direction from the centre is clear – getting cancer services back up to pre-pandemic levels is a top priority for the health service.

How this will be achieved remains to be seen, with many remaining unknowns around how, when and which services and standards will be brought back.

As the health system starts to piece together a path towards the new normal, we provide a recap of the key decisions made during the pandemic and some of the remaining questions that will be playing on the minds of those tasked with delivering the cancer recovery.

A pause on the 28-day faster diagnosis standard (FDS)

Due to be rolled out fully from April 1st, NHS England and Improvement cancer leads confirmed that implementation of the FDS would be put on hold indefinitely. While providers have been asked to continue sending data, they will not be expected to meet the 75% threshold and no data will be published until at least July.

Cancer providers will be anxious for further guidance over expectations when the NHS formally enters the “recovery” phase. With the need to maintain surge capacity alongside an anticipated backlog of pent-up demand for cancer services, there will be tough decisions to be made over how much leeway can be allowed for services that will undoubtedly continue to be stretched thin over the foreseeable future.

Maintaining impetus on early cancer diagnosis in primary care

The re-worked primary care network (PCN) contract for 2020/21 pushed back the start date for the Early Cancer Diagnosis service specification from 1 April to 1 October, while urging PCNs to “make every possible effort” to begin work earlier if possible.

This plaintive request from the centre was no doubt made against concern over the impact of the suspension of all cancer screening programmes. Together with screening, the service specification is integral for achieving the Long-Term Plan ambition to diagnose most cancers at an early stage.

It includes considerable administrative asks of PCNs, including a rigorous review of their referral practice and targeted action to improve the uptake of cancer screening services. Whether this can feasibly be done amidst the current situation remains to be seen. With no further signals on the resumption of the cancer screening programmes, much depends on PCNs’ ability to drive progress on this front.

Accelerating the roll-out of Rapid Diagnostic Centres (RDCs)

Many RDCs across the country have continued to operate during the pandemic, and NHS England has recognised their potential to support the COVID-19 response with guaranteed funding flows as required. The pandemic has accelerated the introductions of innovative approaches to manage referrals to RDCs and avoid hospital attendances, which may well continue well beyond the current crisis. At the same time however the submission of RDC management information has been paused, as has the planned national RDC evaluation exercise.

As services begin the task of bringing referral and diagnostic activity back to pre-pandemic levels, the expectations of RDCs will be high – the challenge will be to ensure that their learnings and good practice can be shared effectively across the system.

Continuing uncertainty over shielding

Little has been said officially over whether individuals who have been advised to shield during the pandemic, many of whom are cancer patients, will be asked to continue isolating in the coming weeks and months. Reports of recent communication by text message with those on the shielding list has indicated that some individuals are being removed from the list, although nothing has been announced on the rationale behind this decision or which groups will be affected.

Cancer Alliances have reported significant falls in 2WW referrals for suspected cancer, with anecdotal reports of some patients refusing to attend for fear of infection. Any continued ambiguity in the official advice will only exacerbate the concerns of vulnerable patients and will need careful management in order to ensure that cancer patients are receiving appropriate treatment and support.

Responding to the pandemic required rapid changes to cancer services and the necessary suspension of initiatives that were just gathering momentum before the crisis hit. What’s clear is that the task of piecing cancer services back up to pre-pandemic levels is just as complex, and there is a lot of remaining uncertainty as to where and how priorities should lie.

 

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A shot in the arm for the vaccine industry? Implications of the NHS Long Term Plan for vaccine providers

Medicines manufacturers could be forgiven for feeling overlooked by the NHS Long Term Plan, with its clear focus on prevention over pills. Their colleagues in the vaccine industry may in contrast have good reason to be optimistic. Immunisation is a cornerstone of prevention, and NHS England’s ambition is clear: there will be both investment and action to increase vaccination uptake and reduce variation.

The extension of the HPV programme to adolescent boys is a strong positive signal for industry that, where the evidence is clear, investment will follow. The taxpayer funded Vaccines Manufacturing Innovation Centre announced at the end of last year is another welcome beacon to industry, indicating the importance of vaccine manufacturing capacity to UK life sciences policy.

Delve deeper however and there is the potential for impending change in vaccine policy, with mixed implications for the sector.

Vaccines are not immune – pardon the pun – to the pricing pressure being applied the pharmaceutical industry from ever-tightening drugs budgets.  While the UK has a world-leading vaccines programme, the JCVI (the industry’s equivalent to NICE) doesn’t shy from making challenging recommendations in its efforts to maximise efficiencies and value for money. Decisions with significant implications for how vaccines are funded are due to be made soon – amongst them whether the QALY threshold for reimbursement of new vaccines should be lowered, raising the bar even higher for new products to market. Vaccines already on the market are also subject to this pressure – as highlighted by the JCVI’s proposal to drop the dosing schedule for routine infant pneumococcal vaccination.

Adding to this general sense of impending change is the “fundamental review” of immunisation standards, funding, and procurement in general practice that will take place in 2019, as announced in the Long Term Plan.

While the aim is ostensibly to improve uptake and reduce variation, it seems likely that this will also consider potential efficiencies and the wider role of the NHS in providing certain vaccinations. Public Health England has already been tasked with reviewing the appropriateness of providing NHS-funded travel vaccines, and a broader review of all NHS-funded vaccinations would feel like a natural extension.

For the travel vaccine industry, scrapping NHS reimbursement would have significant implications. There is of course a risk that travellers deprived of free vaccinations will choose simply not to be immunised, rather than pay for private services. On the other hand, both manufacturers and the private travel clinic industry could stand to benefit significantly from a more level playing field, without competition from the NHS providers able to offer free vaccines as a selling point to attract travellers who then purchase additional, chargeable vaccines.

Elsewhere, any changes to the funding and procurement of GP vaccines could entail significant administrative flux for industry, with potential movement for some vaccines centrally procured by NHS England to direct ordering by practices – and vice versa.

It’s not inconceivable that NHS England may also review its centralised procurement procedures for routine immunisations, with an eye on incentivising best value for tenders.

As is evident, the potential impacts of the review on vaccine manufacturers and the broader supply industry could be substantial, for better or for worse. Questions around the scope of the review remain – prudent action at this stage would be to champion wherever possible the crucial role of vaccines in achieving the Long Term Plan’s ambitions to transform prevention and public health.

 

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Is crown use licensing a loaded threat for pharma?

The battle between NHS England and American pharmaceutical company Vertex over the cost of the revolutionary cystic fibrosis drug, Orkambi, rages on.

In the latest development, campaign groups are upping the ante, backed in Parliament by Conservative MP Bill Wiggin, by calling for the government to invoke Crown use licensing. This would take the patent for Orkambi from Vertex, allowing it to be manufactured at a lower cost as a generic medicine. Earlier this week, Shadow Health Secretary Jonathan Ashworth took up the mantle, backing the call for the patent to be removed in a direct-to-camera message to Vertex on the BBC’s Victoria Derbyshire Show.

How likely is it that this will happen? In short, not very.

The suggestion to strip a company of its exclusive patent is highly controversial. Crown use licensing has only been used in very rare occasions, such as in cases of emergencies where a patent was not available at all in the UK. It has not been used as a tool to take a drug from a company simply to supply a medicine for a cheaper rate.

While it may feel like a quick fix, it is probable that the process would be very drawn out. The government would have to compensate Vertex, legal battles would likely ensue, and it could take several years before a generic manufacturer would be able to produce the medicine.

Vertex, who have several pipeline drugs for cystic fibrosis, argue that the price of Orkambi is a return on investment for years of ongoing research and development in this sector. Stripping them of the ability to sell profitably in the United Kingdom would, they argue, be highly detrimental to cystic fibrosis patients in the long run who would not benefit from this or future innovative new medicines.

For the wider sector (who are watching the standoff closely), such a bold more would be highly provocative. It would be a damning signal to industry, who already see the UK as a relatively small market on a global scale and could risk the UK’s position as an attractive launch market. Companies may increasingly turn to markets, such as Germany, for their technology appraisal processes and launch. In short, Crown use licensing could lead many to reassess their relationship and ongoing commitment to the UK.

As a single payer, the NHS has negotiated preferential rates for decades, and it is feasible that industry would start to see the UK as a less influential and more volatile market, particularly given the existing pressures created by Brexit.

Invoking crown use licensing would, to put it briefly, appear to directly contradict the sentiment of the Accelerated Access Review and the Life Sciences Sector Deal, both of which promised faster access to innovative treatments.

Who will blink first? It is not clear. But as Vertex gears up to appear in front of the Health and Social Care Select Committee, there is little doubt that tensions need to cool if progress is going to be made.

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With pharma pricing in the spotlight, US scrutiny could lead to UK ramifications

Pharma companies and their approach to pricing are back in the political spotlight. While there are major differences between US parties on most issues, the debate on drug pricing has united them as last week top executives from seven major pharmaceutical companies were called to testify in front of Congress. A combative session lasted several hours, with industry leaders laying out their position on why innovative treatments bring the price tag they do.

President Trump has set out a blueprint on medical pricing, a key aim of which is to base US drug prices on a basket of treatment prices in other developed countries. The response from pharma executives to Trump’s proposals was largely dismissive, but it has upped the pressure on pharma companies around their approach to pricing as well as increasing public scrutiny of their approach.

The ramifications for pharma companies may also now be felt here in the UK and the timing is important.

While the UK health system is markedly different to that in the US, there is mounting political awareness at home over drug pricing. And the longer the public debate goes on, the greater the willingness of politicians to take up a challenger role on the issue will be.

Today, the UK’s Health and Social Care Select Committee is gearing up for a showdown with US pharma company Vertex – as concerns escalate over the impasse between NHS England and the company on agreeing a deal for its cystic fibrosis drug Orkambi.

NHS England state they have ‘offered the best deal in its history’ to Vertex, but you can bet that it is significantly lower than the US offer, and Vertex will be seeing this in the broad global context.

Put the US’s scrutiny over globally unequal drug prices together with the UK’s bullish approach to cutting the medicines bill, add in a dose of post-Brexit trade negotiation and a heightened political atmosphere. Medicines pricing could stay in the spotlight for some time to come. And pharmaceutical companies will be on red alert, as all moves in this political chess match points towards a squeeze in prices for manufacturers.

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NICE’s HTA methodology to undergo long anticipated review

At a recent meeting of the All-Party Parliamentary Group (APPG) on Access to Medicines and Medical Devices, NICE’s Chief Executive, Sir Andrew Dillon discussed the long anticipated NICE methods review. Here are five key takeaways:

  1. Explicit recognition of NICE’s role in the wider system

NICE has always stated that it is accountable to the Department of Health and Social Care (DHSC) but independent from government. Whilst Sir Andrew looked to reaffirm this, he was clear that NICE has to work within the wider system – there is clearly no point in creating a system that works for NICE and industry if the DHSC and NHS England can’t or won’t deliver it. The NHS’ restructuring over the past decade, including the creation of bodies such as NHS England, has reduced the autonomy and ease at which NICE can make decisions. NICE will have to collaborate more closely with these bodies to receive buy-in from across the healthcare system.

As a result, the first set of discussions will be within the health system rather than external, with the initial scope of the methodology review determined by the DHSC, NHS England and NICE.

  1. There will be a need to balance industry views

Meindert Boysen, Director of the Centre for Health Technology Evaluation (CHTA) at NICE, confirmed that the Working Committee tasked with setting the scope of this methodology review will initially only invite representatives from the Association of British Pharmaceutical Industry (ABPI).

This decision raised some questions from industry partners who felt the ABPI may not be able to represent all views. Some industry representatives may not appreciate being unable to influence to scope of the methodology in its early stages. Boysen was quick to stress that following the initial working group, there will be technical groups looking at specific topics, involving representations from a whole range of the pharma industry.

It is likely that NICE will also continue to face pressure from other industry representatives, such as the Ethical Medicines Industry Group (EMIG), as it pushes for a say on the scope of the methodology earlier on in the process.

  1. Is this what long grass looks like?

NICE has not yet set an anticipated date for the completion of this methodology review, and it is likely to be a complex and consultative task. For NHS England and government, there is a distinct upside to having an extended review which keeps everyone occupied in a holding pattern – putting off difficult decisions until further down the line. While the review was certainly positively received, many regard it as long overdue given the rapid advancements in medical technology over the last decade.

  1. Clear focus on highly specialised technologies

Unsurprisingly, there were many questions around the system for appraising treatments for rare diseases.  Sir Andrew recognised that this is clearly an area in need of consideration and stressed that one of the key things the review will look at is the criteria used to put products in the highly specialised treatment programme.

A holistic look at the challenge of how to balance limited resource with costly treatments for very small patient populations will be welcome, but Sir Andrew made it clear that there were no easy answers.

  1. APPG launches its own call for written evidence

Anne Marie Morris MP, Chair of the APPG, has launched a call for written evidence on NICE’s review of its methods for appraising treatments for use on the NHS. The consultation document offers industry representatives an alternative route to have their say on the methods review. However, the APPG are only accepting submissions until 29 April 2019. It will therefore it will be important for industry partners to determine the key messages and requests they want to highlight to the APPG, before it submits its findings to the CHTA.

So what next?

Appraisal and access routes have developed somewhat organically over time. For example, there are now around 10 access routes in the medicines process so a streamlining and sharpening of processes is vital.

While the review will seek to address challenges currently faced, this is also an exciting opportunity for NICE to have a longer-term vision and prepare for the future. As innovation in treatments accelerates at pace, will we now see a genuine consideration of new access models such as value-based or variable pricing across multiple indications? Or will the risk of undermining ‘a QALY is a QALY is a QALY?’ win the day?

 

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The future is female: how women’s health got technical

The #MeToo and Time’s Up movements have created (and been a direct response to) some of the biggest headlines of 2018. They have created a renewed focus on many of the lingering inequalities women continue to face in the workplace, as members of society (both in the UK and elsewhere) and in the eyes of the law –  a study by the Fawcett Society in January 2018 found that the UK system continues to fail women, and called for fundamental reform to increase access to justice and offer additional protections against harassment.

Despite ongoing challenges, ever greater numbers of women from all walks of life are continuing to step into formal and informal political arenas, with a record number of women elected in the US Midterms, sparking comparisons with ‘the year of the woman’ in 1992.

Against this political and societal backdrop, $400 million has been funnelled into femtech startups.

The term “femtech” was coined in late 2016, when Ida Tin, the founder of menstrual tracking app Clue, came up with the word to describe a sector that had started to quietly gather momentum. The femtech industry, made up of largely female led start-ups focusing on women’s health and wellbeing, has developed as a result of the desire among women to seek out alternatives to hormone-derived contraceptives and has expanded to include tech specifically catering to all aspect of women’s health, including post-natal care and female specific medical conditions. Consumers are increasingly demanding a major point of difference between medical options available to them, for example in contraceptives, where all conventional options are hormone derived, rather than offering non-hormone-based options. Start-ups are increasingly filling the gap that conventional pharma companies have yet to fill, creating apps and devices for women that range from daily monitoring of reproductive cycles to new treatments for chronic long term medical conditions based on technology, rather than pharmaceuticals.

The negative impact a lack of diversity (not only gender-based) in boardrooms has on business success is well-documented. A report by Grant Thornton found that a lack of diversity means companies fail to challenge their own assumptions and bring new ideas to the table. This is having a particular effect on the ability of the femtech industry to expand. There remains a disparity between the amount male-oriented health companies can raise, and the amount female-oriented companies can expect to raise. Ro and Hims, both specialists in male specific conditions, raised over $170 million between them this year, nearly half the amount raised by an entire industry of femtech leaders. This has been partially attributed to the makeup of the boardrooms femtech leadership pitch to, with femtech leaders stating that the disproportionately high concentration of men in the investment community make their products ‘unrelatable’, leading to ‘uncomfortable’ pitches that hamper sector growth.

Market analysts Frost & Sullivan have forecast femtech will be worth $50 billion by 2025 – a rapid expansion for an industry currently made up of 200 start-ups scattered around the globe. They found that women are 75 per cent more likely to use digital tools for health than men and that working age women spend 29 per cent more per capita on health than men of the same age. Given these figures, the opportunities are clear, however, currently just 10 per cent of global investment goes to female-led start-ups.

From a political perspective, much of the drive for women to take charge of their own health has been helped along by the re-politicisation of reproductive health and women’s rights. The election of President Trump in America is frequently cited as a galvanising moment for women globally, who have become concerned by his tendency to insult women he disagrees with and brag about sexual assault prior to his election. Additionally, while in office, Trump has become known for his promotion of anti-choice judges and politicians.

Battles to normalise women’s issues have taken place in Parliament too. In 2015, Stella Creasy MP made headlines for forcing Conservative MP Sir Bill Cash to say the word “tampon” in a parliamentary debate. The image of a young, female MP persuading a middle aged male Conservative to talk directly about the ‘taboo’ subject of women’s health and menstruation was something of a milestone in a parliamentary system not known for moving with the times. Creasy made headlines again in October 2018 when, following a referendum in the Republic of Ireland in favour of ending the ban on abortion, she and fellow MP Conor McGinn successfully passed a series of symbolic amendments to the Northern Ireland Bill in Parliament forcing the Northern Ireland secretary, Karen Bradley, “to issue guidance” to explain how officials can continue to enforce the ban. Given the issue is a devolved one, the real-world ramifications are likely to be limited, but as a symbolic gesture it was a powerful one –  it became an embarrassing subject for the UK government, given their confidence and supply agreement with the DUP, who are stridently anti-abortion. The DUP is unlikely to change its opposition to ending the ban on abortion, but they are increasingly isolated on the issue, with their view seen as increasingly unacceptable across all mainstream parties.

As more femtech products show that new ways of approaching female health are not only possible, but popular, investors will become aware of their growth potential and transformative effect on the health market. Elvie, a femtech start up that manufactures pelvic trainers, has just entered into a contract with the NHS that has the potential to save the NHS over £400 per female patient annually.

It hasn’t all been plain sailing for femtech companies, particularly those dealing with female contraception. In August 2018 an advert for Natural Cycles, one of the most high profile contraceptive apps, was banned by the Advertising Standards Authority after it found that their claim to be “highly accurate” at preventing unwanted pregnancies was misleading. Such headlines have caused some reputational damage for the fledgling industry, raising doubts about the viability of non-hormonal contraceptives, which remain a significant focus for femtech businesses. However, wider enthusiasm for alternatives to conventional contraception and medical treatments remains high, proving the continuing consumer enthusiasm for femtech.

Against this backdrop, femtech has the potential to make it far easier for women to take control of their own health. The consumer market is ready and willing to pay for innovative new options, as opposed to just dealing with the pain and side effects that are often dismissed as being ‘part and parcel’ of being a woman. As investors who benefitted from the consumer interest in men’s health over the last decade can attest, the personalisation of female healthcare holds benefits for both consumers and investors.

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Investing in fertility with IVF

The in vitro fertilisation (IVF) sector has been catching investors’ attention for some time, with growth accelerating due to demographic trends, a market which looks ready for consolidation and stretched NHS budgets increasing the amount of lucrative private work available. But with promising commercial indicators for the market are there any political, policy, or regulatory risks investors in the sector should watch out for?

Accelerating sector growth

Change may be coming in the way the NHS commissions IVF providers. NHS England is working to develop a benchmark price to inform what CCGs should pay for IVF. This is aimed at reducing the significant variation in pricing across the country but may also lead to a reduction in the average price paid. Commissioning guidance aimed at improving adherence to the NICE guidance was also promised by NHS England in the face of concerns over variation in commissioning across CCGs. However, rather than an NHS England-led review, this is now being primarily driven by NHS Commissioners, the national member organisation for CCGs, suggesting that it has been de-prioritised for national focus.

The emotional investment of patients, and the few other options available to those with fertility issues, mean IVF patients are considered particularly vulnerable and the issue is likely to stay active in discussions around pricing and NHS availability.

Scrutiny of “added extras”

There has been criticism from public figures, such as Labour’s Lord Winston, a fertility expert, who have verbally attacked some private clinics for allegedly exaggerating the chances of patients achieving a successful pregnancy as a result of IVF cycles. Added extras, which some clinics offer, such as endometrial scratches, embryo glue, and immune therapy, have come under particular scrutiny, with Lord Winston saying there is little evidence for their efficacy.

In other areas such as dentistry, government has sought to encourage competition by requiring clinics to publish detailed price lists and supporting the creation of comparison websites, so patients can more easily research service levels and affordability. Media commentators have suggested similar measures could be taken forward for IVF as part of government’s consumer rights agenda.

Though there is scope for some regulatory disruption, many of the other trends are positive. The sector, which contains many small operators, looks ripe for consolidation and scaling and there has been some investment from private equity already. Nexxus Iberia and Capzanine acquired a 35 per cent stake in the largest European fertility network, Eva Fertility, this year; Mobeus Equity Partners provided growth capital to Bourn Hall, the first IVF clinic in the world, in 2014; and Create Fertility, a low-cost provider, received backing from Livingbridge Capital in 2013. The UK’s largest private fertility clinic group, CARE Fertility has been wholly owned by Bowmark Capital since 2012.

The UK market varies in scale and ownership. In 2017 there were 132 licensed clinics and laboratories in the UK of differing types. Some performed 4,200 cycles of IVF treatment whilst the smallest provided fewer than 100. Most (34 per cent) are privately owned, many of which are part of groups owning clinics across the country. 29 per cent of clinics are run by an NHS/private partnership where self-funded patients can access services through NHS institutions. NHS-only services make up just 22 per cent of all clinics.

“Patchy service” within NHS

One driver of demand is the increasing restriction in IVF availability on the NHS. NICE guidelines for England, which must be considered by Clinical Commissioning Groups (CCGs) but not necessarily adhered to, specify that women aged under 40 should be offered three cycles of IVF treatment and those aged 40 to 42 should have access to one cycle.

However, the Human Fertilisation and Embryology Authority (HFEA), the sector regulator, has noted that the trend is for CCGs to “reduce the number of treatment cycles they fund”, resulting in “patchy service”. This has been corroborated by Fertility Fairness, the campaign for access to fertility treatment, which has published an audit showing the treatment CCGs offer across the UK. Just 12 per cent of CCGs now follow NICE guidance, down from 24 per cent in 2013. Seven CCGs offer no IVF at all, while many are introducing new criteria to restrict treatment such as: changing the definition of an “IVF cycle”; lowering the upper age limit for treatment to 35; restricting treatment based on Body Mass Index; and stopping` treatment based on past relationships.

Falling fertility

Another factor is reduced fertility and delayed parenthood. According to the HFEA, 32 per cent of heterosexual couples in the UK experience unexplained infertility, with the primary treatment being IVF. This high rate of infertility can partly be explained by the increase in the average age women have their first child – up from 27.2 years in 2005 to 28.6 in 2015. In 2014, 52 per cent of all live births in the UK were to mothers aged 30 and over (with 67 per cent of fathers over 30).

Declining male fertility is also a key factor causing an increase in IVF usage. Sperm counts of men in western countries have more than halved in the past 40 years and are falling by an average of 1.4 per cent per year. Male infertility, for which there is no treatment, is the main reason for people pursuing IVF and therefore its growth will continue to drive demand.

To ensure investors can take advantage of these trends towards growth, they must navigate their way around the increased attention on IVF access and pricing and mitigate potential regulatory hurdles. They must pay close attention to stakeholders commenting on the sector and carefully consider how their companies will operate and sell to patients.

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What does Hancock’s ‘tech revolution’ mean for health-tech and AI?

Given his well-publicised love of all things tech and digital, it comes as no surprise that Matt Hancock’s main priority as Health Secretary will be to overhaul technology in the NHS. Steeped in his family’s software company before entering politics, and driver of a much-praised digital government and economic strategies he seems, on paper, the ideal candidate for ushering in the ‘tech revolution’.

But Hancock will be equally aware of the challenge ahead, and that the dreaded fax machine has outlived many a Health Secretary. So, will his ambitious plans lead to a tech revolution in the NHS, or will the fax machine outlive him?

Last week Hancock unveiled “The future of healthcare: our vision for digital, data and technology in health and care” introducing minimum technical standards to ensure interoperability and upgradability in the NHS. Any system that fails to meet these new standards will be ‘phased out’, and any providers who do not adhere to the new principles will see their contracts terminated. No deadline for this phasing out has yet been given.

The DHSC also reaffirmed its commitment to delivering upon the AI and Data Grand Challenge set out in the Industrial Strategy to ‘use data, AI and innovation to transform the prevention, early diagnosis and treatment of diseases’. Just last month, health minister Lord O’Shaughnessy announced a ten point ‘code of conduct’ for AI intelligence and other data-driven technologies that encourages companies to protect patient data and seeks to ensure that only the best technologies are used by the NHS.

Under the changes, the use of ‘off-the-shelf’ technologies is encouraged, and CCGs and trusts will be free to buy whatever technology they need – so long as it is compliant with the principles. The DHSC said that “this should encourage competition on user experience and better tools for everyone”.

So far, so positive for healthtech and AI companies – especially for those who can meet the new standards. For new and emerging companies, that is unlikely to be a problem – it is older, more dated and less interoperable companies that are likely to suffer under the changes.

This is, of course, not the first time that a Health Minister has sought to upgrade NHS IT and tech. The doomed NHS National Programme for IT cost the tax payer nearly £10 billion before it was scrapped in 2013, one of a string of failed tech reforms.

Hancock is well aware of these failures and of the pressure to make his reforms succeed where the others did not. A key difference between the new changes and the previous attempts is the cost – so far, funding has been limited. Investment in the plans is unlikely to come out of the £20 billion announced earlier this year, and it is improbable that there will be any tech funding announced in next week’s Autumn Budget. In August, Hancock unveiled just £450 million of funding for new technology across the NHS. Alan Woodward, visiting Professor of Cyber Security at Surrey University pointed out that the funding would likely not go far in reality, saying: “Think about it per head, and what it could actually do”. The NHS spent £157 million on simply upgrading its systems to Windows 10.

This time around, reforms are less of a top-down, funded programme and more about making the market more accessible for new providers. Companies will need to show their worth and make a case for how their technology can make a substantial difference to the individual trusts. With the NHS endlessly battling its debts, a company that can highlight how its software can help to save money in the long-term will be an attractive prospect.

NHS trusts can also provide immense non-monetary value to tech companies. The NHS trove of patient data is often cited as one of its most valuable assets, and healthtech and AI companies are keen to access it to further develop technological solutions and diagnostic programmes. Partnerships like that of Google’s DeepMind and Moorfields Eye Hospital have enabled the development of software proven to be as accurate as world-leading eye experts in detecting over 50 different eye diseases.  The DHSC highlights DeepMind in its policy paper and describes it as technology that has “the potential to transform the way professionals carry out eye tests.”.

Moorfields is not paying DeepMind anything, but DeepMind is benefitting enormously from the partnership – through harvesting the patient data, it is designing and building diagnostic AI programmes that have the future potential to be adopted around the world.

With the DHSC increasingly cognisant of the importance of safe-guarding patient data, it is important for companies like DeepMind to provide reassurance they are adhering to the new guidelines. Whilst the lack of funding might initially seem discouraging for the healthtech and AI industry, there remain significant benefits and opportunities to working with the NHS and an ever more accessible environment to doing so. If companies create a compelling case for their value, efficiency and safety and if commissioners are receptive to change, the long-held dream of a technologically advanced NHS may just be realised.

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WA’s Digital Health Map: Understanding the digital landscape in health

For years, the pace of change in digital health has outstripped government and NHS policy. But the landscape is changing rapidly. With digital being the bedrock of Matt Hancock’s health vision, a long-term plan for health in place and a growing digital architecture to support innovation, for industry there’s never been a better time than now to shape the digital revolution.

Against this background, WA Health held a senior-level industry roundtable meeting with Richard Sloggett, Special Advisor to Health Secretary Matt Hancock, and Anna King, Commercial Director at Health Innovation Network. Discussions focused on why the time is ripe for industry involvement, and how to navigate the complexities.

The meeting was largely positive, with a clear enthusiasm from attendees about the potential role industry can play in leading this growing, fast paced and important agenda. It was argued that there are now more opportunities and stronger political backing than in the past, so there’s a real chance to make the UK the best place globally to ‘do digital’.

But with multiple policies and organisations (some dating back to the Coalition Government) involved in the agenda, there is much confusion about how and who to engage with. And the landscape grows ever more complex; with Digital Innovation Hubs, Local Health and Care Record Exemplars (LHCRES), Academic Health Science Networks, The Health Tech Advisory Board and the Data Guardian to name just a few.

And of course, July 2019 will see the launch of NHSX – the new unit tasked with driving forward and aligning the digital transformation of health and social care.

The organic nature in which these systems have developed means there is sometimes overlap, and change will take time.

To help you navigate this system, WA Health has developed a new Digital Health Map, designed to give some order to the complexity. You can access the Digital Health Map via the link below.

We’d love to talk to anyone seeking to engage with the system on digital health and innovation, so please do get in touch at deansowman@wacomms.eprefix.com.

WA’s Digital Health Map

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