STEERING VACCINES THROUGH THE UK SYSTEM - WHAT FACTORS INFLUENCE THE LIKELIHOOD OF POSITIVE AND NEGATIVE RECOMMENDATIONS?
Author(s)
Hill CA1, Mockler C2, Balman E1
1MAP BioPharma Limited, Cambridge, UK, 2Portcullis Public Affairs, London, UK
Presentation Documents
OBJECTIVES: Vaccines are one of the greatest triumphs of healthcare innovation. They have saved millions of lives, prevented destructive chronic illnesses and eased pressures on health services across the globe. However, it is surprisingly difficult for manufacturers trying to navigate the UK government system. We provide an outline of the route to potential reimbursement, using recent examples, and guidance based on lessons learned. METHODS: Published UK articles, The Health and Social Care Act 2012 and government and industry records were scrutinised and summarised into an outline of the process to make vaccines available. Examples of vaccines, the challenges they have faced and potential solutions to those challenges were examined. RESULTS: Once a licence has been obtained, usually through the European Medicines Agency, the Joint Committee on Vaccination and Immunisation (JCVI), makes recommendations to the Department of Health (DH). The JCVI covers all UK countries (subject to potential devolution of powers to Scotland). The JCVI is considering allowing industry to attend Committee meetings, which would be a huge step forward for such a secretive body. There is no scoping phase, limited stakeholder engagement; recommendations are not made public and their rationale not given, and there is no appeal element to the process. The DH agrees the price of each vaccine, which in a recent example took around a year, with input from NHS England (NHSE) and Public Health England (PHE). PHE is then responsible for implementation and procurement through its Health Protection Directorate. To draw together this process, the NHSE and DH jointly convene a Senior Oversight Committee, chaired by NHSE. CONCLUSIONS: Companies proposing to bring vaccines to market need to pay special attention, well in advance, to navigating this complicated structure. This is needed to achieve a satisfactory price, which rewards R&D and other costs, within a reasonable period.
Conference/Value in Health Info
2015-11, ISPOR Europe 2015, Milan, Italy
Value in Health, Vol. 18, No. 7 (November 2015)
Code
PIN101
Topic
Health Policy & Regulatory, Health Technology Assessment
Topic Subcategory
Decision & Deliberative Processes, Pricing Policy & Schemes, Reimbursement & Access Policy
Disease
Infectious Disease (non-vaccine)