Sohail Kasmani. Brand and marketing strategist in London: pharma brand management at Cipla and Alembic, now marketing strategy and AI adoption at ACTAsia. MBA, Brunel University London.
How to develop a market access strategy for a new drug in the UK
To develop a market access strategy for a new drug in the UK, you plan backwards from four decisions: the MHRA licence, the health technology assessment (NICE for England, Wales and Northern Ireland, SMC for Scotland, AWMSG for gaps in Wales), the commercial deal with NHS England, and local adoption by ICBs and trusts. Each needs evidence designed in from Phase II, not bolted on after Phase III reads out.
The numbers moved this year. From April 2026 NICE’s standard threshold rose from £20,000-£30,000 to £25,000-£35,000 per QALY gained, and the VPAG payment rate on newer medicines fell from 22.9% in 2025 to 14.5% for 2026, now capped at 15%.
This is an explainer written by a marketer, not regulatory advice.
What does the UK market access pathway for a new drug look like?
The Department of Health and Social Care publishes a surprisingly readable map, Introducing new medicines in the NHS in the UK (June 2025, updated July 2026), and most of the timings below come from it.
| Stage | Body | What it decides | Timing that matters |
|---|---|---|---|
| Horizon scanning | UK PharmaScan | What the NHS expects to arrive | Register from 3 years before UK availability or the start of Phase III |
| Development support | ILAP (MHRA, NICE, SMC, AWTTC, NHS England and others) | Innovation Passport and Target Development Profile | Before confirmatory trials start |
| Licensing | MHRA | Marketing authorisation | 210 assessment days on the national route |
| HTA for England, Wales, NI | NICE (technology appraisal or HST) | Five recommendation types, including managed access | Funding within 90 days of guidance |
| HTA for Scotland | SMC | Accepted, restricted, interim or not recommended | 18 weeks standard; boards have 90 days for formulary decisions |
| HTA gaps in Wales | AWMSG with AWTTC | Medicines NICE has not assessed or scheduled | Around 22 weeks; boards have 60 days |
| Commercial | NHS England, NICE commercial liaison team | Patient access schemes and agreements | In parallel with the appraisal |
| Rebate | VPAG | Payment on newer branded medicine sales | 14.5% in 2026, 15% cap |
| Local adoption | ICBs, trust and area prescribing committees | Formulary listing and pathway placement | From the day NICE publishes |
MHRA licensing, ILAP and the Aligned Pathway
ILAP is open in 2026. The MHRA’s ILAP guidance (January 2025, last updated 5 August 2026) covers medicines with human safety data that have not yet entered confirmatory trials: you apply for an Innovation Passport, then agree a Target Development Profile with the partners. Applications run in windows, and on 4 August 2026 the MHRA granted two passports (a biologic for liver cancer, a small molecule for dementia with Lewy bodies) and opened a window that closes on 4 November 2026.
People often confuse ILAP with the MHRA-NICE Aligned Pathway. Fiona Howard’s MHRA MedRegs post of June 2026 separates them: ILAP is early development support with Joint Scientific Advice from MHRA, NICE, AWTTC and SMC, while the Aligned Pathway comes later and syncs the licensing and NICE timelines, provided you register on UK PharmaScan at least three years before your marketing authorisation application. NICE says the pathway, fully launched on 1 April 2026, delivers decisions 3 to 6 months sooner, and its Integrated Scientific Advice costs about 25% less than the old service.
How does the NICE appraisal process work?
NICE agrees a scope (population, comparators, outcomes), the company submits its evidence and economic model, an independent External Assessment Group critiques it, and an appraisal committee meets. Draft guidance goes out for consultation before final guidance, with an appeal stage before publication. NICE aims to publish final guidance at the same time as marketing authorisation, which only happens if you started talking to it years earlier.
There are five outcomes: recommended, optimised (a narrower population than the licence), only in research, not recommended, or recommended with managed access. A positive recommendation means commissioners must begin funding no later than 90 calendar days after publication.
What are the NICE cost-effectiveness thresholds in 2026?
The standard range is now £25,000-£35,000 per QALY gained, the first rise since NICE was set up in 1999, according to The Pharmaceutical Journal. NICE’s FAQ on the change says it covers technology appraisals, including those underway, with no retrospective reviews, and NICE estimated it would allow 3-5 extra medicines a year. The House of Commons Library briefing of July 2026 links it to the UK-US pharmaceuticals deal, notes that regulations (SI 2026/202) now let ministers direct NICE on thresholds, and reports nine additional medicines approved since. The deal also commits the UK to raising spending on new medicines from 0.3% of GDP in 2026 to at least 0.6% by 2036.
NICE is also adopting a new EQ-5D-5L value set, which Dalia Dawoud and colleagues at Cytel, writing in DIA Global Forum in April 2026, expect to change utility estimates and trial mapping.
How does the severity modifier work?
Since 2022 the severity modifier has replaced the old end-of-life criteria. It weights QALYs by how much health patients lose on current care compared with the general population. Edward Oliver and David Mott of the Office of Health Economics set out the cut-offs: a proportional QALY shortfall of 0.85 to 0.95 or an absolute shortfall of 12 to 18 earns a 1.2 weight, and at least 0.95 or at least 18 earns 1.7. NICE reported in September 2024 that 16 of the 19 appraisals using it were positive, including cystic fibrosis, which would never have qualified as end of life. The method is in the NICE Decision Support Unit’s TSD 23, and I’d run it yourself early rather than learn at committee that your population is less severe than your slide deck implied.
Managed access: the Cancer Drugs Fund and the Innovative Medicines Fund
When evidence is promising but immature, NICE can recommend managed access. Cancer medicines go through the Cancer Drugs Fund (in its current form since July 2016) and others through the Innovative Medicines Fund (June 2022), each with £340 million a year. IMF funding starts from draft final guidance, up to five months earlier, and the company pays for the data collection. Think of it as a timed exam you sit while patients are already on the drug, since NICE re-appraises at exit.
Scotland and Wales
The Scottish Medicines Consortium takes 18 weeks as standard, or 22-26 weeks where PACE (its patient and clinician engagement process for end-of-life and very rare conditions) or a complex patient access scheme is involved, and a complex scheme must clear the Patient Access Scheme Assessment Group before SMC will consider the medicine. AWMSG, supported by AWTTC, only appraises medicines NICE has not assessed or scheduled, and Welsh health boards have 60 days to make recommended medicines available. So a UK plan has at least two submissions and a Scottish date that will differ from England’s.
VPAG, patient access schemes and the commercial deal
VPAG (the 2024 Voluntary Scheme for Branded Medicines Pricing, Access and Growth) is the rebate most branded companies pay on NHS sales: 14.5% on newer medicines in 2026, capped at 15% from 2026 onwards, per the DHSC notice of 10 December 2025. The ABPI welcomed the fall from 22.9%, though chief executive Richard Torbett added that rates remain much higher than in similar countries. Model net revenue after the confidential discount and after VPAG, because that is the number finance asks about roughly four seconds into the meeting.
NHS England’s Commercial Framework for New Medicines describes simple patient access schemes as confidential fixed prices or percentage discounts applied at source. Complex arrangements are considered only once simple discounts are shown to be unsuitable, and are expected only for products at or below the lower end of the NICE threshold. Commercial surgeries need four weeks’ notice. With a PAS now offered almost by default, the list price in your submission is largely theatre, and everyone in the room knows it.
Local formulary and ICB adoption
A positive NICE recommendation obliges commissioners to fund. It does not oblige a consultant in a busy clinic to change what they prescribe on Tuesday. ICB formularies and trust committees still decide pathway position, shared-care arrangements and service changes (infusion chairs, diagnostics, homecare), and this is where well-appraised medicines can stall for a year.
How do you develop a market access strategy for a new drug?
When should you start?
While Phase II is still running, because that is when you can still change the Phase III comparator and endpoints. The timeline below is my planning view, built on the official dates above.
| When | Access work |
|---|---|
| Phase II (4-6 years out) | Target value profile; map the NHS pathway and comparators; decide on an ILAP application while you are still eligible |
| End of Phase II | Integrated Scientific Advice or ILAP Joint Scientific Advice; test Phase III design against NICE’s likely scope |
| Phase III start (3+ years before filing) | Register on UK PharmaScan; plan RWE; early economic model; first severity shortfall estimate |
| 18-24 months out | Stakeholder mapping; NHS clinician advisory boards; patient group engagement; draft value story |
| 12-18 months out | Final model and budget impact; PAS strategy and commercial surgery; SMC and AWMSG plans; managed access decision |
| 6-12 months out | NICE and SMC submissions; EAMS if eligible (needs at least 6 months before expected licence); MHRA pre-submission notice 3 months before filing |
| Launch to +90 days | Formulary packs; pathway and service support; account plans by ICB |
| +3 to +24 months | Uptake tracking by ICB; managed access data; evidence for new indications |
Plan evidence that NICE can use
HTA-ready design starts with a comparator that reflects NHS practice. A trial against a US standard of care leaves you building an indirect comparison, and NICE’s manual expects a network meta-analysis where technologies have not been compared in a single RCT, uncertainty included. Collect EQ-5D in the trial, and give follow-up enough length to support survival extrapolation, which is where many committee meetings are won or lost. For the gaps, the NICE real-world evidence framework (June 2022) sets out when real-world data can reduce uncertainty, including whether trial results apply to NHS patients.
Build the value story and the economic model together
The value story is the argument in plain English: who the patients are, what care they get now, what your medicine changes and what that is worth to the NHS. The model is the same argument in numbers, and if the two drift apart the External Assessment Group will find the gap for you. I’d write a one-page narrative a medical director, a finance director and a patient group chair could each read, then check every claim has a model input behind it, including service effects an ICB feels, such as fewer admissions. An AI assistant is useful for pressure-testing, provided you only feed it non-confidential material:
You are a sceptical NICE appraisal committee member. Here is our draft value story and the main model assumptions (population, comparator, time horizon, extrapolation method, utilities). List the five assumptions you would challenge first, the evidence you would ask for, and which one would most move the ICER.
Map the stakeholders
The list runs from NICE, NHS England, SMC, AWMSG and the MHRA, through specialist societies and the consultants who write local protocols, down to ICB medicines optimisation leads and formulary committees. Patient organisations carry real weight at NICE and at SMC PACE meetings. Map each by influence and by what they need to see, and remember that all of this engagement sits under the ABPI Code, which I cover in UK pharma advertising rules.
Set the price you can defend
UK pricing is a back-calculation. Work out the net price at which the base-case ICER lands inside £25,000-£35,000 (higher with a severity weight), apply VPAG, then decide how much list price you need for international reference pricing. The confidential PAS bridges the two, and if the maths only works with a complex scheme, expect a harder conversation. I worked through similar value-based pricing trade-offs in the Axial3D pricing project.
Pull-through after launch
Track uptake by ICB and trust, find the formularies that have not listed, and work out why, which is usually a pathway or capacity problem rather than a view on the evidence. HCP communication has to stay within the licence and the Code, and the digital side is covered in how pharma engages HCPs digitally in the UK. Having worked in pharma brand management at Cipla, my view is that a brand plan which assumes access is solved tends to discover otherwise at its first quarterly review, usually while we are busy blaming the forecast, the sales force and, on a bad day, the summer holidays.
Market access strategy UK: a practical checklist
- Check ILAP eligibility and whether an application window is open.
- Register on UK PharmaScan at least three years before filing.
- Book Integrated Scientific Advice before Phase III design is locked.
- Test the Phase III comparator against current NHS practice.
- Collect EQ-5D and check the effect of the 5L value set.
- Estimate QALY shortfall with the DSU method.
- Decide early whether you will need the CDF or IMF, and cost the data collection.
- Plan SMC and AWMSG routes, including PASAG timing.
- Write the value story, then align the model to it.
- Design the PAS and book a commercial surgery with four weeks’ notice.
- Forecast net revenue after PAS and VPAG.
- Have formulary packs and ICB plans ready before guidance publishes.
How is market access different for rare disease drugs?
Ultra-rare conditions, which NICE defines as affecting 1 in 50,000 people or fewer under routing criteria revised from 1 April 2025, can go to the highly specialised technologies programme. HST uses £100,000 per QALY with flexibility up to £300,000, according to NICE’s threshold FAQ, which says NICE is not aware of plans to change it. Scotland’s ultra-orphan pathway allows up to three years of availability while data is gathered, and the IMF is another route. The harder commercial problem is usually diagnosis, because patients nobody has identified do not show up in budget impact or in sales.
Examples of successful pharma marketing campaigns focusing on rare diseases
Two UK examples I could verify, both disease awareness rather than product promotion. Meet the MPN 10, funded by Novartis UK with the charity MPN Voice, turned ten common symptoms of myeloproliferative neoplasms (a rare group of blood cancers) into ten sculptures by five UK mural artists, each with an augmented reality layer, touring from Westfield White City in London to Liverpool, Bristol and Glasgow. It was a finalist at the Communiqué Awards 2024 and the PM Society Awards 2025. It goes after the real barrier: symptoms mistaken for old age.
The second came from patient groups. A Rare Find, a comedy short narrated by Robert Webb for the Newborn Screening Collaborative (16 patient organisations covering more than 500 rare diseases), launched in November 2023 to push for wider newborn screening, pointing out that the UK screened for 9 conditions against 59 in the US, according to MLD Support Association UK. It was also a PM Society 2025 finalist. For a rare disease brand the lesson is that earlier diagnosis belongs in the access plan, and patient organisations have usually set that agenda long before we turn up with a pitch deck.
If you are planning a UK launch now, the first concrete step is to check your UK PharmaScan entry and your Phase III comparator against NICE’s likely scope this quarter, while both can still change.
FAQs
What is pharma market access in the UK?
Pharma market access in the UK is the work of getting a licensed medicine funded and used by the NHS. It covers MHRA licensing, NICE, SMC and AWMSG appraisals, the commercial deal with NHS England including patient access schemes, VPAG rebates, and local adoption by ICBs and trust formularies.
How long does a NICE technology appraisal take?
NICE aims to publish final guidance at the same time as marketing authorisation. That depends on registering on UK PharmaScan at least three years before filing and using the MHRA-NICE Aligned Pathway, which NICE says delivers decisions 3 to 6 months sooner. Once guidance is positive, the NHS in England must begin funding within 90 days.
What is the NICE threshold per QALY in 2026?
From April 2026 the standard NICE threshold for technology appraisals is £25,000 to £35,000 per QALY gained, up from £20,000 to £30,000. Highly specialised technologies for ultra-rare conditions use a separate threshold of £100,000 per QALY, with flexibility up to £300,000.
What is the VPAG payment rate for 2026?
The VPAG headline payment rate on eligible sales of newer branded medicines is 14.5% for 2026, down from 22.9% in 2025, according to DHSC and the ABPI. From 2026 the rate is capped at 15%, a commitment linked to the UK-US pharmaceuticals deal, and a replacement scheme is due by 1 January 2029.
Do I need a separate submission for Scotland?
Yes. NICE guidance covers England, Wales and Northern Ireland, but Scotland uses the Scottish Medicines Consortium. A standard SMC assessment takes 18 weeks, or 22 to 26 weeks with PACE or a complex patient access scheme, which must clear PASAG first. Scottish health boards then have 90 days to make formulary decisions.
Sources
- Department of Health and Social Care, Introducing new medicines in the NHS in the UK: pathway, 23 June 2025, updated 24 July 2026.
- NICE, Changes to NICE’s cost-effectiveness thresholds confirmed, 1 December 2025.
- NICE, Changes to NICE’s cost-effectiveness thresholds (FAQ), accessed September 2026.
- House of Commons Library, What is the UK-US pharmaceuticals deal?, 23 July 2026.
- The Pharmaceutical Journal, NICE cost-effectiveness thresholds increased as UK strikes trade deal with United States, December 2025.
- Department of Health and Social Care, The 2024 voluntary scheme for branded medicines pricing, access and growth: payment percentage for 2026, 10 December 2025.
- ABPI, VPAG payment rate for newer medicines will be 14.5% in 2026, 10 December 2025.
- MHRA, Innovative Licensing and Access Pathway (ILAP), 30 January 2025, updated 5 August 2026.
- MHRA, The Innovative Licensing and Access Pathway grants Innovation Passports to investigational products for cancer and dementia, 4 August 2026.
- MHRA MedRegs blog (Fiona Howard), The ILAP and the Aligned Pathway: what’s the difference?, 24 June 2026.
- NICE, MHRA-NICE pathway opens for business: everything you need to know to get started, April 2026.
- NICE, UK licensing and technology appraisals, accessed September 2026.
- NICE, NICE technology appraisal guidance, accessed September 2026.
- NICE, Compliance with NICE-approved medicines or treatments, accessed September 2026.
- DIA Global Forum (Dalia Dawoud, Angie Raad, Ben Rousseau and Wyatt Gotbetter, Cytel), NICE methods changes: what, when, why, and the expected impact on patient access to medicines, April 2026.
- Office of Health Economics (Edward Oliver and David Mott), NICE’s severity modifier: a step in the right direction, but still a long way to go, 23 March 2022.
- NICE, NICE Board says new method allowing greater weight to be given to severe diseases is working, 25 September 2024.
- NICE Decision Support Unit, University of Sheffield, Calculating severity shortfall for NICE evaluations (TSD 23), accessed September 2026.
- NHS England, Innovative Medicines Fund, accessed September 2026.
- NHS England, Cancer Drugs Fund, accessed September 2026.
- NHS England, NHS Commercial Framework for New Medicines, accessed September 2026.
- Scottish Medicines Consortium, Making a submission, accessed September 2026.
- All Wales Therapeutics and Toxicology Centre, How medicines are approved for use in NHS Wales, accessed September 2026.
- NICE, Changes approved to the routing criteria for highly specialised technologies, March 2025.
- NICE, NICE real-world evidence framework, 23 June 2022.
- NICE, NICE health technology evaluations: the manual, evidence chapter, accessed September 2026.
- Novartis UK, Meet the MPN 10, accessed September 2026.
- Communiqué Awards, Meet the MPN 10 (finalist), 2024.
- PM Society, PM Society Awards 2025: Disease and/or Health Awareness: Public or Patients, 2025.
- MLD Support Association UK, A Rare Find: comedy short wants to create conversation around newborn screening, 22 November 2023.
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