Post-launch value assessment recommendations

June 2013

“Be brave to say no, be ethical to say yes. Drug companies have to accept saying no to some [evidence] requests, but they have to accept saying yes to some important ethical questions.”

—HTA leader 

Health systems are under increasing pressure throughout Europe as the ongoing fiscal crisis leads to reductions in health spending and negative consequences to patient care. In parallel, pharmaceutical manufacturers are facing increased evidence requests and the rising cost of medicine development. Since 2012, a Working Group comprising health technology assessors (HTAs) and reimbursers, medicine developers, clinicians, patient advocates, and health outcomes researchers dissatisfied with the status quo has come together to determine how best to address uncertainty regarding the value of a new medicine that remains at the time of the medicine’s launch. Please see the document below for a list of PVA Working Group participants. 

Uncertainty concerning a medicine’s value may affect decisions regarding its use and reimbursement, which in turn can delay or prevent patient access to potentially valuable treatments. 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. Working Group participants defined PVA as the process by which the value of a medicine (or medical technology) to all constituents is weighed and adjusted to reflect an evolving understanding of its benefit to patients and healthcare systems over its life cycle.