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Inclusion on the list “en sus”: the importance of the place in the therapeutic strategy
As a reminder, only products whose added expected benefit (ASA, for medical devices) or added medical benefit (ASMR, for pharmaceutical…
LFSS 2025: When will the pharmaceutical products new measures be applicable?
In its decision no. 2025-875 DC issued on Friday, the Constitutional Council ruled on the conformity with the Constitution of the…
LFSS 2025: When will the medical devices new measures be applicable?
In its decision no. 2025-875 DC issued on Friday, the Constitutional Council ruled on the conformity with the Constitution of the…
Does the failure to produce the studies requested by the HAS justify the withdrawal of reimbursement for the product?
When assessing the medical benefit (SMR) and the expected benefit (SA) of a healthcare product, the French Transparency Commission (CT)…
What can we learn from the 2025 expenses and income report?
Article L. 111-11 of the French Social Security Code stipulates that the Union nationale des caisses d'assurance maladie (French National Union…
Requesting a price that is “too high” may justify the refusal of reimbursement… without negotiation!
The French Social Security Code allows ministers to refuse the reimbursement of a healthcare product if it is likely to…
Pharma package: pharmaceutical companies soon to be required to apply for medicinal product reimbursement?
The European Parliament has just adopted in first reading the "pharmaceutical package" which includes a new directive and a new…
Product paybacks: pricing agreements must be strictly interpreted (annulment of a CEPS decision)
The French Economic Committee for Health Products (CEPS) can negotiate or set paybacks on products reimbursed by the French health…
CEPS report: what the 2022 report says about delays and disputes
On January 23, 2024, the French Economic Committee for Health Products (“CEPS”) published its activity report for 2022. It describes…
Price/volume paybacks and reimbursable indications: a review of the judge’s recent rulings
As a reminder, with the aim of regulating health insurance expenditures, paybacks may be negotiated between the French Economic Committee…
LFSS 2024: When will the medical devices new measures be applicable?
In its decision no. 2023-860 DC of December 21, 2023, the Constitutional Council ruled on the conformity with the Constitution of…
LFSS 2024: When will the pharmaceutical products new measures be applicable?
In its decision no. 2023-860 DC of December 21, 2023, the Constitutional Council ruled on the conformity with the Constitution of…
LFSS 2024: new paybacks to penalise medical devices with a negative environmental impact
On December 4, 2023, the French National Assembly definitively adopted the Social Security Financing Bill (PLFSS) on final reading without voting. Article…
PLFSS 2024: a new reimbursement regime post early access
Early access makes it possible to finance treatments that are presumed to be innovative and often expensive. However, once this…
Contradictory procedure: what’s at stake in terms of market access?
Many decisions concerning the reimbursement of healthcare products must be preceded by a contradictory procedure. The aim of this procedure…
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