The hurdles

Ten things we need to know about the Single National Formulary

It’s been over a year since the announcement of the Single National Formulary (SNF). No question – this is a really big one for pharma, and at my new company, Life Science Access Academy, we’re getting lots of queries about it.

There have been some announcements, directions of travel and timelines in the midst, and in some therapy areas the shape is becoming clearer. But at the moment this feels like a slightly scary area with many questions unanswered. Article idea: list them, so we can all feel apprehensive about the same things, together!

The basic premise of the SNF announced in the 10-Year Health Plan last summer had many backers in industry. Okay, many sceptics too – but the broad idea of replacing England’s multitude of bureaucratic, duplicative and postcode-variable local market access systems seemed a good one. It had been challenging and annoying much of pharma for years.

Why should a medicine recommended nationally by NICE then encounter a new series of local hurdles before reaching patients?

More than a year on, however, it’s becoming clear that the SNF could be much more significant, and complicated, than simply replacing lots of local formularies with one national one.

It could influence where medicines sit within treatment pathways, how quickly innovation is adopted, how the NHS extracts value from established medicines and, ultimately, how pharma approaches market access.

So, what do we know – and what still needs answering?

1. Is the SNF definitely happening?

For real. The SNF has moved a long way from a paragraph in the 10-Year Health Plan.

In July, NHS England set out a phased implementation programme. Half of England’s 26 ICBs are expected to adopt standardised national formulary categories by December 2026, with the remainder following by July 2027.

The first digital SNF product is scheduled for July 2027, initially covering between eight and 12 therapy areas. Further areas will then be added through to 2030.

So July 2027 is not a cliff edge on which local formularies suddenly disappear. This is a multi-year transition. But companies shouldn’t interpret that as permission to wait. Decisions about how the system works are being taken now.

2. Is it more than a big list of medicines?

Oh yes. The word formulary risks underselling what is being built.

NHS England describes the SNF as a single evidence-based source of prescribing guidance, delivered as a digital product and integrated into clinical workflows.

That means common classifications, common recommendations and potentially decision support appearing at the point at which clinicians prescribe. This matters. A PDF sitting on an NHS intranet can be ignored. Guidance built into prescribing infrastructure has much greater potential to influence behaviour.

What will the SNF say about your medicine when a clinician is deciding what to prescribe?

3. What therapy areas will be first?

We know NHS England has selected four therapy areas for phase one: chronic heart failure; adult type 2 diabetes; ophthalmology, and asthma.

These aren’t random choices. They combine large populations and substantial service burden with prescribing variation, complex pathways and opportunities for innovation.

They also provide very different tests of the SNF model. Diabetes contains multiple established and innovative treatment classes. Asthma raises questions about medicines, devices, patient preference and environmental impact. Ophthalmology provides an environment where biosimilars, acquisition cost and treatment capacity already interact.

For companies operating in these areas, this will be business critical to engage with. For others, the interesting question is what lessons from these first four areas will subsequently be applied elsewhere.

4. Will ‘sequencing’ become the most important word in market access?

Could well do. The original 10-Year Health Plan said products would be sequenced according to clinical and cost-effectiveness, with clinicians encouraged to use highly ranked products while retaining clinical autonomy within NICE guidance.

That distinction is crucial.

Current formularies answer ‘Can this medicine be prescribed?’ The SNF will be more: ‘Which of these medicines should I try first?’

Imagine three NICE-recommended treatments for the same patient population. All three could appear on the SNF while one receives more favourable positioning because the national assessment considers it to represent better clinical and economic value.

Suddenly, formulary inclusion isn’t the prize. Where you are sequenced may well be the prize. For manufacturers, that raises obvious questions about the evidence that will inform sequencing, the weight attached to cost and how differences between patient populations will be reflected. The sequencing criteria, basically. I have some ideas on what these might be for the right price.

5. Are we removing local barriers to create one enormous national barrier?

Maybe. This is perhaps the great paradox of the SNF.

For years, industry has complained, often reasonably, that a positive NICE recommendation doesn’t guarantee consistent adoption. Companies can find themselves fighting variations of the same market-access battle repeatedly around England.

Remove those layers and an innovative medicine could theoretically move much more quickly from NICE recommendation to national availability.

That’s the enormous opportunity, but look at the risk. Today, an unfavourable decision in one local system can potentially be offset by success elsewhere. What happens if a medicine receives unfavourable positioning nationally?

A reform intended to remove dozens of local barriers must be designed carefully enough not to create one big national barrier instead.

6. What’s the deal about the SNF finding money for innovation?

In theory this sounds good, and the SNF should also be viewed alongside the government’s wider medicines strategy.

The Life Sciences Sector Plan explicitly couples faster access to innovation with rapid uptake of generics and biosimilars, allowing cash savings to be reinvested in newer medicines. The government has subsequently committed to doubling spending on new medicines as a proportion of GDP from 0.3% in 2026 to 0.6% by 2036.

NHS England now explicitly places the SNF alongside both ambitions: faster adoption of innovative medicines and continued rapid uptake of generics and biosimilars.

This suggests something bigger than formulary tidying and more like a medicines life cycle: extract greater value from established treatments, create headroom and accelerate clinically and cost-effective innovation. Exactly how the SNF will balance those objectives will matter enormously to industry, and again, we don’t really know how this will work yet. Or if it will.

7. How can a national formulary create identical local NHS services?

It can’t, and perhaps the hardest problem for the SNF to solve will be implementation.

Imagine the SNF identifies an innovative medicine as nationally preferred. One ICB has the diagnostics, specialist workforce – infusion teams for example – prescribing capacity and pathway required to use it. Another doesn’t.

Both technically have ‘access’ but patients would not necessarily experience the same access.

This is why the abolition of formulary variation cannot by itself abolish the postcode lottery. NHS England appears alive to this problem: its plans already reference pathway transformation, service readiness and moving care from hospital into community settings. So take note: implementation, implementation, implementation.

For pharma, this suggests that local market access may need a different conversation, moving from ‘Will you put our product on formulary?’ towards ‘What needs to change here so eligible patients actually receive it?’

8. Does the ABPI like the idea?

The ABPI’s position is revealing. It’s made positive noises but is increasingly interested in the small print.

It welcomes the ambition to accelerate equitable adoption and sees the potential to dismantle duplicated local decision-making.

But its March 2026 position paper also contains some clear red lines.

The SNF should not weaken the NICE funding mandate, create another access bottleneck, reinterpret NICE guidance, restrict clinical autonomy or become principally a cost-containment mechanism.

The ABPI also argues that sequencing must have strong clinical justification and warns that overly restrictive recommendations could reduce treatment choice and potentially affect supply resilience.

In other words, it’s a yes, provided the SNF removes an access hurdle rather than inventing a new one. And it isn’t clear if that condition will be met, yet.

9. How will this process work and can we appeal?

We now know considerably more about implementation than we did a year ago. But much of great consequence is unresolved.

A national formulary committee will provide clinical and professional oversight and work with NICE to translate national evidence into formulary recommendations.

But precisely how will individual recommendations be made? How will therapy-area expertise feed into them? What evidence can manufacturers submit? How transparent will the deliberations be? Who exactly will be on the decision boards and why? How will patient organisations participate? How frequently will recommendations change as prices, evidence and competitors change?

And perhaps most importantly: what happens if a company believes the SNF has got its medicine wrong?

At present, there is no clearly published SNF manufacturer appeal mechanism comparable to NICE’s established processes. As national recommendations acquire greater influence, the transparency and contestability of the decisions behind them will become increasingly important.

10. What should pharma be asking about the SNF?

What it means for its portfolio. This is ultimately where the conversation needs to move.

The generic question – ‘What is the Single National Formulary?’ – is rapidly becoming less interesting than the specific ones.

Where are our medicines currently positioned across local formularies? Which of those positions might we gain or lose under nationalisation? Who are our principal competitors within the emerging national pathway? What evidence will determine sequencing? Where might price, outcomes, pathway costs, patient preference or service capacity alter our position?

And if local formulary decision-making diminishes, which NHS stakeholders become more important – and what should market access and field teams actually be doing differently?

There will not be one answer for pharma. A manufacturer of an innovative specialist medicine faces a very different SNF from a company selling an established branded medicine, biosimilar, inhaler or diabetes treatment.

Ultimately…

Companies will need to translate this national policy into therapy-area, portfolio and product-level consequences.

The Single National Formulary was originally presented as a way of removing bureaucracy and postcode variation. Twelve months later, its potential significance looks much greater.

Done well, it could finally close part of the stubborn gap between NICE approval and real-world adoption, releasing NHS resources while getting effective innovation to patients faster. Done badly, it could simply move market-access barriers from local committees to the national stage.

The architecture is being built now. For life sciences, the time to understand where its medicines might fit into it is before the decisions are made, not afterwards.