The Access to Medicines and Medical Devices All-Party Parliamentary Group (APPG) has published its report following its inquiry into the NICE methods review.
The inquiry gathered evidence from over 50 individuals and organisations across the life science sector including industry, patient organisations, clinicians, economists and the National Institute for Health and Care Excellence (NICE).
The report acknowledges the economic contribution of the life sciences industry to the UK, particularly the number of clinical trials based in the country, the companies with European headquarters sited in the UK, and the talent from around the world this attracts.
It also highlights the need for change in the light of the evolving scientific landscape, including the fast-changing world of treatment development.
The report sets out in some detail the messages and themes which ran through the evidence collected and includes reference to the fact that it was drawn to the APPG’s attention that the challenging access and funding environment in the UK may impact on whether companies can justify launching there.
The inquiry stretched beyond the NICE methods review and the recommendations are divided into those which relate to current methodologies and processes which might be adopted within the time frame of the review and longer-term systemic recommendations.
The recommendations which relate to process and methodology include:
- Reviewing the routing criteria for Highly Specialised Technology appraisal
- Enhanced patient input in the decision-making process, including the introduction of a PACE style meeting within STA for orphan treatments, where there is clear unmet need, prior to the appraisal Committee meeting
- QALY modifiers for severity and unmet need
- Interim conditional approval
- Adoption of the Treasury’s suggested discount rates
The report calls for more clarity in the governance and process of the NICE methods review and for clearer information on the timelines for each stage of the review including a calendar of touchpoints for stakeholders and disclosure of the names and organisations of those involved in the closed parts of the review.
The APPG recognises that NICE does not operate in a vacuum and is limited in the reforms it can make to the access landscape through the review.
System recommendations include:
- Research into the QALY and other methods for measuring value
- Work on the inherent value of rarity and Society’s priorities for other disease area treatments
- Reviewing the medicines budget and exploring sources of funding for new medicines including the formulation of a way to ensure that the funds rebated through the VPAS can be spent on access to cost-effective medicines
- Adaptations of NICE’s methods for changing treatment paradigms
- Clarification of the roles of NICE and NHS England in decisions about cost-effectiveness and reimbursement
- Greater support for innovative pricing arrangements
The report acknowledges that some decisions about medicines funding are inherently political and NICE does not have the mandate to make such decisions.
Read more from the All-Party Parliamentary Group’s inquiry from MAP’s previous coverage here.