Regulation and reimbursement – Two sides of the same coin?
16-17th January 2008, Surrey, UK
Background
The topic for this Workshop, held in Surrey, UK, January 2008, was a departure from the subjects that the CMR International Institute for Regulatory Science has addressed in the past. Previous Workshops have focussed on regulatory requirements, strategies and best practices before, during and after the approval of new medicines but not on the all-important and question: The medicine is approved but will anyone pay for it?
Recommendations from earlier Workshops have, however, pointed to the need to address the R&D implications of the various types of post-authorisation evaluation upon which decisions are made on the reimbursement, pricing and availability of new medicines: The so-called ‘fourth hurdle’. For the purpose of the Workshop (and this report) Health Technology Assessment: (HTA) is the term used for the assessments made by government and insurance reimbursement agencies, HMOs, hospital formulary committees and other bodies representing the ‘payers’ for health care and medicines.
In preparation for the Workshop, the Institute conducted a brief survey among its member companies to investigate current perceptions and future views on the ways in which reimbursement considerations are driving and shaping development decisions
Key themes
The presentations and general discussion at the Workshop highlighted four main themes:
- Organisation: Regulatory authorisation (Licensing) and reimbursement are operationally and conceptually distinct activities with different legal frameworks and operations. There is an obvious degree of overlap but the two activities are likely to remain separate for the foreseeable future. A structure is needed that recognises the potential for separate but related programmes of work.
- Dialogue between regulatory agencies and industry during product development is well established but there is little or no history of prelaunch dialogue between HTA bodies and companies. Whilst it would be premature to look for tripartite pre-launch discussions on individual products, a mechanism or forum is needed to bring all stakeholders together to clarify some of the major issues and potential conflicts, in the interests of patient access to new therapies.
- Conditionality: There is experience, in product authorisation, of the concept of ‘conditional’ licensing and there is a continuum within which licensing conditions can be revisited and changed. The type of ‘conditional authorisation’ that enables products to reach the market earlier will not, however, help patients if third party payers will not purchase or reimburse such products. Inflexible pricing decisions, made prematurely, however, present an equal barrier to the innovator and the concept of ‘conditionality’ needs to be applied to reimbursement to allow pricing to be ‘staged’ after launch, with possibilities for funding to be withdrawn or for prices to rise as the true value of the product is recognised.
- Harmonisation: There appears to be scope to bring about greater uniformity in the methodology and assessment criteria used by HTA bodies but it may be difficult, in the near future, to move towards a common approach to decisions and decision-making in view of the heterogeneous nature of health care and political systems.