How NICE managed access works
Managed access is a time-limited arrangement in which a medicine is funded by the NHS in England while more evidence is collected to resolve uncertainty. NICE then uses that evidence to decide whether the medicine should be recommended for routine use. Every medicine in technology appraisal or highly specialised technologies guidance is considered for suitability, and the company can submit a managed access proposal to inform that assessment.[1]
Two funds pay for medicines recommended for use within managed access. The Cancer Drugs Fund (CDF), set up in 2011 and reformed in 2016, covers cancer medicines. The Innovative Medicines Fund (IMF), launched in 2022, extends the same principles to non-cancer medicines. Each has an annual budget of £340 million, ring-fenced by NHS England. For the full process, from entry to exit, read our guide to the Cancer Drugs Fund and Innovative Medicines Fund.[2]
NHS England's IMF principles set out when managed access can be recommended. The medicine must have plausible potential to be cost effective at the agreed price, the evidence must be too uncertain for routine use, the uncertainty must be significant and resolvable, and the data must be feasible to collect within a reasonable timeframe without undue burden on patients or clinicians.
The managed access agreement
The managed access agreement is made between NHS England and the company. It has two parts:
- Data collection agreement: developed with stakeholders, it sets out roles and responsibilities, the eligible population, clinical assessments, and the data to be collected and analysed. It lasts only as long as needed, up to a maximum of five years.
- Commercial access agreement: the commercial terms for NHS funding during the managed access period, which can sit alongside a patient access scheme.
Both must be signed before NICE publishes draft final guidance, and a statistical analysis plan is due within six months of the agreement starting. Oversight groups meet regularly to review data quality, progress and safety signals. At the end of data collection, or after five years if sooner, NICE updates its guidance. If routine use is not recommended, no new patients start treatment through the fund, and patients already treated continue at the company's cost.
One detail matters for later appraisals: NICE's manual states that technologies recommended with managed access are not considered established practice, so they are not used as comparators.
Scotland and Wales
The Scottish Medicines Consortium (SMC) does not run a managed access fund, but it has two routes that work in a similar way. Under the ultra-orphan pathway, for conditions with a prevalence of 1 in 50,000 or less in Scotland that meet the other criteria, a medicine is available for up to three years while further evidence is gathered, followed by a full reassessment. Interim acceptance applies to medicines with an MHRA conditional marketing authorisation, a positive EAMS scientific opinion or an ILAP place, where the medicine may offer value for money and further data are expected to address key uncertainties.
For end of life medicines and medicines for rare conditions, the company can request a Patient and Clinician Engagement (PACE) meeting, and SMC describes its output as a major factor in the decision. In Wales, NHS health boards must fund medicines recommended by NICE or the All Wales Medicines Strategy Group (AWMSG), and medicines that NICE recommends for use within the CDF have been made available to Welsh patients.
Managed entry agreements in Europe
Outside the UK, managed entry agreements fall into two broad families. Financial agreements, such as confidential discounts, cost sharing or expenditure caps, manage budget impact without changing the evidence base. Outcomes-based agreements link access or payment to data collected in practice, and are the closer equivalent of NICE managed access. The ISPOR good practices task force stresses that additional data collection is costly, so the study design must match the specific uncertainty being addressed.[3]
| Country | Mechanism | Scope | Evidence element |
|---|---|---|---|
| England | CDF and IMF managed access | Cancer (CDF) and non-cancer (IMF) medicines | Data collection agreement, up to five years, then NICE guidance update |
| Scotland | Ultra-orphan pathway; interim acceptance | Ultra-orphan medicines; conditional, EAMS or ILAP medicines | Up to three years of evidence generation, or data due under the licence, then reassessment |
| Germany | Routine practice data collection (section 35a(3b) SGB V)[4] | Conditional, exceptional circumstances and orphan approvals | Set by the G-BA, reviewed at least every 18 months |
| Belgium | Article 81 and 111 conventions | Innovative medicines with insufficient evidence or price data | Temporary reimbursement, uncertainties set by the reimbursement commission |
| Netherlands | Conditional inclusion | Orphan, conditional and exceptional medicines with unmet need | Research under a covenant, usually up to seven years |
| Italy | AIFA monitoring registries | Monitored medicines and indications | Registry data supporting cost sharing, risk sharing and payment by result |
Country notes
Germany: Under section 35a(3b) of the Fifth Book of the Social Code, the G-BA can require routine practice data collection (anwendungsbegleitende Datenerhebung) for medicines with conditional or exceptional circumstances approval and for orphan medicines. It sets the duration, methods and patient-relevant endpoints, can limit prescribing to providers who take part, and reviews the data at least every 18 months. See AMNOG dossiers.
Belgium: INAMI-RIZIV concludes Article 81 and 111 conventions with companies when evidence on relative efficacy or price is insufficient for permanent reimbursement. The financial annex is confidential, and the company must address the uncertainties identified by the Commission for Reimbursement of Medicines during the convention.
Netherlands: Since October 2019, conditional inclusion has allowed orphan, conditional and exceptional medicines into the basic package while effectiveness research is carried out with clinicians, patient organisations and an independent institute. The default maximum is seven years. Zorginstituut Nederland advises and the Minister of Health, Welfare and Sport takes the final decision.
Italy: AIFA monitoring registries are a national web platform that checks prescribing appropriateness and supports managed entry agreements, including cost sharing, risk sharing, payment by result, success fee and capping.[5]
How the EU JCA interacts with managed entry
Regulation (EU) 2021/2282 has applied to new oncology medicines and advanced therapy medicinal products since 12 January 2025. Member States must give due consideration to joint clinical assessment reports, but pricing and reimbursement remain a national competence, so every managed entry agreement is still negotiated nationally. The uncertainties a JCA report records, such as immature survival data or missing comparators, are often the same ones a later data collection agreement must resolve. Planning both together avoids collecting evidence twice. See our EU JCA dossier work.
What we deliver
- Early assessment of whether a medicine is a realistic candidate for managed access or managed entry
- Managed access proposals and data collection agreement drafting, mapped to the uncertainties the committee is likely to identify
- Value of information and scenario analysis to show which uncertainties data collection can resolve
- Real-world data and registry endpoint specification, including statistical analysis plans
- Economic model updates for the exit review or reassessment (see health economic modelling)
- Outcomes-based agreement design: response definitions, data flows and payment triggers
- Cross-country evidence plans linking the JCA, NICE, SMC and European national requirements
What assessors look for
- Uncertainties that data collection can actually resolve within the period, not ones it cannot address
- Feasible data sources, such as ongoing trials or established registries, with realistic follow-up
- A plausible case for cost-effectiveness at the proposed price before managed access starts
- A clear plan for the exit review, so the final model can use the new data directly
- Limited burden on patients and clinicians
Why Evidaxia
We bring HTA experience from the assessor's side, including technical lead work at NICE, together with submission work for SMC, AWMSG and NCPE and EU JCA dossiers covering PICO scoping, indirect comparisons and network meta-analyses. For managed entry in Germany, Belgium and the Netherlands, our EU-level evidence and modelling work is built to feed national processes, and we bring that experience alongside your local market access teams. See UK HTA submissions.
References
- National Institute for Health and Care Excellence. Managed access [Internet]. London: National Institute for Health and Care Excellence; [date unknown] [cited 2026 Oct]. Available from: https://www.nice.org.uk/what-nice-does/patient-access-schemes-and-pricing-agreements/managed-access
- NHS England. Innovative Medicines Fund principles [Internet]. London: NHS England; 2022 [cited 2026 Oct]. Available from: https://www.england.nhs.uk/wp-content/uploads/2022/06/B1686-the-innovate-medicines-fund-principles-june-2022.pdf
- Garrison LP Jr, Towse A, Briggs A, de Pouvourville G, Grueger J, Mohr PE, et al. Performance-based risk-sharing arrangements: good practices for design, implementation, and evaluation: report of the ISPOR good practices for performance-based risk-sharing arrangements task force. Value Health. 2013;16(5):703-19. doi:10.1016/j.jval.2013.04.011 Available from: https://doi.org/10.1016/j.jval.2013.04.011
- Sozialgesetzbuch (SGB) Fünftes Buch (V): Gesetzliche Krankenversicherung, § 35a Bewertung des Nutzens von Arzneimitteln mit neuen Wirkstoffen [Internet]. Berlin: Bundesministerium der Justiz; [cited 2026 Oct]. Available from: https://www.gesetze-im-internet.de/sgb_5/__35a.html
- Agenzia Italiana del Farmaco (AIFA). Monitoring registries [Internet]. Rome: Agenzia Italiana del Farmaco (AIFA); [date unknown] [cited 2026 Oct]. Available from: https://www.aifa.gov.it/en/registri-farmaci-sottoposti-a-monitoraggio
Sources reviewed October 2026. Methods and procedures change; check the latest agency guidance before submission.