England’s Single National Formulary: Win-Win Reform or New Market Access Bottleneck?
“We will therefore move to a Single National Formulary (SNF) for medicines within the next 2 years. We will create a new formulary oversight board, responsible for sequencing products included in the formulary based on clinical and cost effectiveness, supported by NICE. Local prescribers (such as clinicians and pharmacists) will be encouraged to use products ranked highly in the SNF but will retain clinical autonomy as long as they prescribe in line with NICE guidance. The intention of this policy is to ensure that we can drive rapid and equitable adoption of the most clinically and cost-effective innovations.” [1]
The policy sits alongside wider plans to streamline procurement, improve adoption of innovation, reduce variation in access across the NHS as laid out in the UK Government´s Life Sciences Sector Plan published last year [2].
In principle, this should be a win-win development for all. A well-designed SNF could improve equity of access for patients, reduce duplication for the NHS, provide better value for taxpayers and create a clearer access pathway for life sciences companies.
The current system takes national level NICE recommendations and cascades them down to local formulary processes, pathways and at times, uneven implementation. The idea behind the current approach is that health care resource allocation reflects local needs. However, the downside is that it creates duplicative work for NHS teams, complexity and uncertainty for companies and “postcode lottery-like” access for patients.
If the SNF is to succeed, it will be through balancing these competing factors in its design. If the formulary is too loose, it may add little beyond NICE guidance, the British National Formulary and existing local medicines optimisation processes. If on the other hand it is too restrictive, it could create new problems: reduced clinical flexibility, national decision-making bottlenecks, supply vulnerabilities and potential barriers to prescribing the most appropriate medicine for individual patients. The SNF should therefore be viewed less as a simple formulary project and more as a policy trade-off. The key question is whether the NHS can standardise access without creating rigidity.
Go live in 2027… much uncertainty to address
The current implementation timeline looks ambitious. The Pharmaceutical Journal has reported that NHS England expects to begin testing a prototype SNF by June 2026, alongside draft national guidance for local formulary standardisation. From July 2026, decisions in therapeutic areas are expected to start being released through a “test and learn” approach with early adopter sites. Final national guidance is expected in December later this year. A digital SNF tool is then expected to launch in selected therapeutic areas in July 2027, with broader expansion towards 2030 and potential later inclusion of medical technologies. [3]
A disease-area-by-disease-area rollout is the only realistic way to do this. Trying to standardise all medicines pathways at once would be almost impossible. However, this still leaves a lot to resolve in a short period of time. It is still not clear how therapeutic areas will be prioritised, how committees will make sequencing decisions, how much clinical discretion will remain, how manufacturers will engage, how strongly local systems/ICBs will be expected to follow the SNF, or how the formulary will interact with existing NICE processes.
Sequencing: the critical market access issue for life science companies
The most important market access issue is that the SNF may not simply be a national list of medicines that can be prescribed. There has been discussion of medicines being sequenced based on clinical and cost-effectiveness. This would for example result in recommendations around which treatments should be considered first line etc. This matters because sequencing is not the same as availability. A medicine can be available, but still commercially constrained if it is positioned later in the pathway, reserved for selected patients, or placed behind a preferred alternative. NICE already assesses clinical and cost-effectiveness, but the SNF could add a further layer of national pathway positioning.
This creates an important question for pharmaceutical companies. Is the objective now simply to price to secure NICE’s recommendation, or also to price and evidence the product in a way that supports preferred formulary positioning? If the answer is both, the market access challenge becomes more difficult. The manufacturer is effectively trying to jump through multiple hoops at the same time: first NICE, then national formulary placement; each of these steps carrying significant commercial risk. This could become particularly important in crowded specialty areas such as oncology, immunology, inflammatory disease and rare disease markets where several therapies may have overlapping indications.
It is unlikely that the SNF will become a US-style payer formulary. In the announcement made in the NHS’s 10 year plan, it was stated that clinicians will still retain clinical autonomy, provided they follow NICE guidelines. Furthermore, the NHS does not usually operate through hard step edits and prior authorisation in the same way as US commercial payers. However, if the SNF starts to define preferred medicines, first-line options, later-line use or sequencing across therapeutic pathways, the practical effect could still be significant. Clinicians may be faced with having to justify why they chose not to prescribe in line with the SNF. So, the difference between guidance and restriction will matter, and so will the strength of enforcement.
Will the SNF have any impact at all?
There is also a risk of overstating the impact. A nationally set formulary only changes behaviour if local NHS organisations, clinicians and pharmacists use it and trust it. If local stakeholders feel little ownership of the process, or if enforcement is weak, the SNF could have less impact than expected. In that case, the policy could become another national framework that still requires local interpretation and local implementation. The SNF could become a major access reform, but only if it has clinical credibility, operational usefulness and clear governance. [4]
Local access challenges will remain
Local implementation will remain important whatever happens nationally. This is particularly true for advanced cancer therapies, cell and gene therapies, rare disease treatments, antibiotics and other specialist medicines. A national formulary cannot by itself create infusion capacity, genomic testing access, specialist centre readiness, homecare infrastructure, cold-chain distribution, data collection systems or trained clinical teams. For these products, formulary inclusion is only one part of access. The NHS still needs the practical ability to deliver treatment safely and consistently.
For companies, this means local access work is unlikely to disappear. It may become less focused on securing formulary acceptance and more focused on solving implementation barriers. Some local variation will also remain both inevitable and necessary. Antibiotic prescribing may need to reflect local resistance patterns, advanced therapies may need to be concentrated in accredited centres, and rare disease medicines may depend on specialist networks and long-term monitoring. Homecare and distribution models may also need to vary by geography, product availability and complexity and patient population. The SNF may reduce some local access friction, but it is unlikely to remove the need for local market access, service design and implementation support.
Now is the time to get involved and inform the SNF design
The opportunity remains substantial. If the SNF removes duplicated local processes and supports faster uptake of NICE-approved medicines, it could make a real difference to patients and to companies launching new therapies in England. It could also help the NHS make more consistent value-based decisions and reduce avoidable administrative burden. These are aims worth pursuing. The concern is not the ambition, but the execution.
For life sciences companies, the immediate implication is that SNF readiness should now become part of launch planning. Companies should assess which products in their portfolio are most exposed to national sequencing, where pricing may affect pathway position, whether their evidence package demonstrates value at pathway level rather than product level alone, and whether their supply and service models can support broader national implementation. Engagement through ABPI and other industry routes will also be important, particularly while the process remains undefined. The ABPI has already published its position on the opportunities and risks of the policy; we can expect more statements to follow once the details become clearer.[5]
In summary, the Single National Formulary could be a win-win reform for patients, the NHS, taxpayers and industry. But this will depend on getting the design trade-offs right. Too little direction and the SNF may add little. Too much restriction and it could create new barriers to access. The next year will be critical in determining whether this becomes a practical mechanism for faster and fairer medicines access, or another layer in an already complex NHS market access environment.
Contact:
If you are interested in discussing any of the issues above for your company/drug development program, please contact me through my email address dniven@nivenbiopharma.com . Feel free to also visit my website at www.nivenbiopharma.com for more information. I have no conflicts of interest in the production of this article.
Sources:
[1] Fit for the Future: 10 Year Health Plan for England, UK Government, July 2025
[2] Life Sciences Sector Plan, UK Government, July 2025
[3] NHS to start testing prototype of single national formulary in June 2026, Pharmaceutical Journal, May 2026
[4] How practical is a Single National Formulary in the real world? HSJ Advisory, 2025
[5] ABPI position on the government’s plans to develop a Single National Formulary in England, ABPI, March 2026
