OBJECTIVES

The data requirements for regulatory approval of medicines and MedTech devices are markedly different. Traditionally, clinical plans of the life sciences sector have aimed at securing regulatory approval. However, payers frequently require additional data addressing value comparative to their other options to improve the health of their population. Performance based risk sharing agreements (PBRSAs) are an increasingly common way for payers to manage clinical and financial risks when such data is absent or insufficiently compelling. This research was aimed at exploring whether payer attitudes to risk sharing agreements differed between medicines and MedTech devices.

METHODS

We conducted research with payers in the US and Europe to explore attitudes and decision-making criteria regarding the necessity for PBRSAs and their willingness to enter them for medicines and MedTech devices. Additionally, we explored factors affecting the selection of the type PBRSA considered appropriate between these therapeutic approaches.

RESULTS

Threshold data requirements for reimbursement with and without a PBRSA differ between medicines and MedTech and between different classes of MedTech devices. Payers required a higher level of efficacy and safety data for class III medical devices compared to lower classes. Payers were more likely to either refuse reimbursement or require coverage only in research for MedTech devices than medicines. Additionally, payers were less likely to enter outcomes guarantee based RBRSAs for MedTech devices rather than medicines to address data uncertainties. Criteria used in PBRSA decision making included, strength of data supporting efficacy and safety, the condition, the degree of innovation, any infrastructure required, other treatment options, overall resource utilisation, sub-group data, and implementation issues.

CONCLUSIONS

Payers consider medicines and MedTech devices differently with reference to PBRSAs. Manufacturers of MedTech devices should consider PBRSAs as a part of their reimbursement strategy and proactively offer them to payers in certain situations.