Gaps In Us And Eu Payer Policies Limit Theapeutic Options In Pain Conditions

Abstract

OBJECTIVES: Despite a shift towards consideration of pain as a focus of treatment rather than a symptom to be managed, the introduction of new products for pain has been detrimentally affected by reimbursement frameworks that are unlikely to support decisions that favour patient access. This situation exists despite public support for effective pain management, particularly within the palliative care setting. This study aims to identify the mechanisms that limit the available therapeutic options in pain management and to suggest potential alternative approaches to be considered. METHODS: The study involved interviews with 30 interviewees in the US, France, Germany and the UK, including national level HTA influencers, medical directors, influencers on hospital formularies and product use, palliative medicine consultants, anaesthesiologists and oncologists. Interviews focused on the challenges of securing a favourable reimbursement status and a commercially viable price in a pain indication, as well as the difference between treatment guidelines and clinical practice. The success (or not) of market access for 4 selected pain products was also assessed based upon a set of criteria set out in the poster. The organisational structures for delivery of pain services were also considered. RESULTS: New pain products struggle to secure uptake in both the US and EU. Countries adopting a model that attaches the achievable price level with the level of additional clinical benefit demonstrated (France, Germany) are reluctant to consider favourable assessment versus established cheap products. The absence of life extension and common existence of pain in late stage disease means countries adopting a cost-effectiveness model (UK) are methodologically unsuited to evaluation of such products. US payers are likely to place restrictive prior authorisation requirements on products while cheap options exist. CONCLUSIONS: Patient access to new pain therapies is significantly limited by reimbursement policy in the US and EU, including in instances where the product has a recognised clinical benefit.