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.

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.

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.

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.

2. 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.

3. 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.

4. 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.

5. 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?

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