OBJECTIVES

The National Institute for Health and Care Excellence (NICE) published England’s first Managed Access Agreement (MAA) in 2015. A further 39 agreements have been published to date. In 2019 the Organisation for Economic Co-operation and Development (OECD) published a paper on the track record of MAAs for new medicines in OECD countries and EU member states. The paper identifies potential pitfalls and good practice concerning MAAs. We have assessed the first 5 years of NICE’s managed access programme in England against the OECD framework and identified highlights and areas for further development.

METHODS

Information was extracted from the OECD paper on key success indicators for MAAs. Four main themes were identified; (i) defining a strategy for when MAAs should be recommended, (ii) clearly defining the uncertainties in the evidence base and appropriate data collection strategies, (iii) a clear framework for MAA exits, including how evidence is handled and guidance updated, (iv) ensuring transparency of content. MAAs in England were assessed against these criteria, highlighting where good practice is employed and where development is needed.

RESULTS

Decision making criteria for cancer drug MAA recommendations are clear. There is greater flexibility in the application of criteria for non-cancer drugs. 90% of agreements outline the uncertainties. 100% of agreements outline data collection strategies. All MAAs, the committee discussion summary and the guidance review decision are published on the NICE website however commercial content is confidential.

CONCLUSIONS

NICE’s managed access programme has been designed with strategies in place to address most aspects of good practice outlined by the OECD’s paper; defining uncertainties, transparency and enabling England’s payer to make informed commissioning decisions. In partnership with the payer, NICE is enhancing the existing MAA process to ensure decision making criteria are applied consistently and mechanisms are designed to address changes in clinical practice during the evidence generation period.