As healthcare systems across Europe confront growing cost pressures, budget holders are increasingly focused on steering resources toward high-impact interventions that deliver the best possible health outcomes at an affordable cost.
Often, uncertainty remains about the value of a newly approved treatment or medicine regarding:
There may be understandable reasons for this uncertainty. However, "missing" evidence forces healthcare decision-makers to allow commitments before full knowledge of the new medicine's value is available.
The opportunity to continue to generate evidence about a medicine's value after its introduction provides several benefits. It allows timely patient access to valuable treatments, without requiring an all-or-nothing commitment from payers. Resolving uncertainty about the value of a medicine enables more efficient use of budgets and more appropriate use of therapies, improving outcomes across a health system.
Post-launch value assessment (PVA) can provide an alternative to denial of reimbursement until all evidence gaps are filled or, on the other end of the spectrum, reimbursement without a mechanism in place to fill key evidence gaps. Tapestry Networks engaged the Post-launch Value Assessment Working Group to tackle the issue of improving value assessment and evidence generation following the introduction of new treatments.
Post-launch Value Assessment Working Group Recommendations
The final recommendations of the Post-launch Value Assessment Working Group identify how to clarify a medicine's value and maximise health outcomes. They also provide companies with a framework that supports constructive discussion with regulatory and reimbursement decision makers and addresses lingering uncertainty that can be resolved post-launch.
Post-launch Value Assessment Working Group launch meeting
The Post-launch Value Assessment Working Group (PVAWG) convened for its first meeting in London in September 2012. Participants focused on resolving issues surrounding uncertainty about the value of medicines at the time of launch and improving the tools used to gather post-launch evidence. This meeting confirmed the need for and value of a decision framework to guide post-launch value assessment decision-making.