Lump-Sum Envelopes: High Predictability for Payers (Healthcare Product Pricing Committee – CEPS) and Minor Contribution for Companies

OBJECTIVES: The possibility of regulation by lump-sum envelopes (capped total revenue amount) was introduced in the framework agreement of September 25, 2008, with the initial intention of regulating orphan drugs. Such agreements also offer the possibility of securing a prescription framework, when the fields of reimbursement is restricted or indication(s) extended in a short timeframe. The objective of this study was then to describe the contribution of fixed-price envelopes to the regulation of healthcare drugs by the CEPS.

METHODS: We focused on the drugs, which presents a reimbursement at least in one indication and a clawback agreement in particular the ones with a lump-sum envelopes. The research was conducted on the clawback payment file, held by the CEPS. Health products presenting a clawback agreement made by lump-sum envelope for 2021 and 2022 with a payback rate exceeded 80% above a specified amount were included in the analysis.

RESULTS: Of the 6,620 and 6,747 drugs respectively reimbursed (individual agreement with the Committee) in 2021 and 2022, 317 and 357 present a clawback agreement, where 84 and 95 involved a lump-sum envelope. Both years, 80% were strictly regulated (marginal rate of 100%), while 20% had a marginal payout rate of between 80% and 100%. Respectively 37% and 38% of the identified products have seen their capping reached in 2021 and 2022. This regulation concerns 14.6M€ and 17.7M€ of revenue data and allows 4.6M€ and 5.7M€ to be remitted, excluding the safeguard clause. This contribution represents 5% of the total contribution of regulated drugs for both years.

CONCLUSIONS: Lump-sum envelopes account for only a minority of clawback agreements, as they do in terms of performance and contribution. However, these agreements are tending to be more widely used and accepted by the companies. Although they are not designed to be activated, they provide both security and predictability.