Written by Angeliki Meletsi, Analyst Email: [email protected]
The time taken to get access and reimbursement for new drugs is a key area of concern that most healthcare bodies are constantly trying to improve. We look at two varied approaches – France’s temporary reimbursement scheme and Canada’s time-limited recommendation – that are being currently experimented which may well improve access and reimbursement for innovative drugs.
France’s Temporary Reimbursement Scheme
The temporary reimbursement scheme, included in France’s 2024 social security funding bill (PLFSS), aims to address the transition period between the end of exceptional funding and regular reimbursement for expensive hospital drugs, preventing products from being left without coverage1. The conditions for eligibility for the temporary reimbursement scheme are that the drug is only used in hospitals, it is not on the special reimbursement list, and it has been evaluated by France’s Transparency Committee (TC) with a therapeutic value rating that meets certain criteria2. The price of the drug during the temporary reimbursement period will be based on the lowest price in similar European markets3. In the absence of a European set price, the price of the drug during the temporary reimbursement period will be based on the first price set by the pharmaceutical company during the early access program (AAP), with a discount applied. The discount will be determined by a decree, taking into account various elements such as the deadline for companies to submit the required data to the TC. The following situations can put a stop or end the temporary reimbursement period:
- When the drug is added to the special reimbursement list (liste en sus)
- When the health technology assessment (HTA) evaluation does not allow reimbursement
- If the marketing authorisation is withdrawn
- If the drug is struck from the hospital reimbursement list
- If the reimbursement period lasts longer than a set period (no longer than 36 months)2
According to the PLFSS impact analysis, the temporary reimbursement scheme would have covered seven drugs in 2022 and 2023, resulting in additional costs of €39 million for the first year, €43 million for the second, and €32 million for the third. The scheme is projected to increase health insurance spending by €20 million each following year2.
CADTH’s Time-Limited Recommendation
Time-limited reimbursement recommendation, a recently introduced process by the Canadian Agency for Drugs and Technologies in Health (CADTH), aims to provide earlier access to promising new treatments for severe, rare, or debilitating diseases in Canada4. This scheme will publicly fund a drug or drug regimen for a certain period of time based on evidence from clinical trials and the manufacturer’s commitment to conduct additional studies to verify the clinical benefit. To be eligible for a time-limited reimbursement, a drug must have a Notice of Compliance with Conditions (NOC/c) from Health Canada, indicating approval to market the drug with the condition that the manufacturer will undertake additional studies to verify the clinical benefit4,5. Additionally, the study completion date should not exceed three years from the targeted expert committee meeting date5. The drug should also have evidence-generation plans to address any gaps identified by CADTH’s expert committee and a reassessment commitment from the drug sponsor. The alignment of CADTH’s procedures for time-limited recommendation with Health Canada’s NOC/c policy aims to ensure parallel HTA and regulatory pathways4.
Both France’s temporary reimbursement and CADTH’s time-limited recommendations are anticipated to establish more favourable access terms for manufacturers aiming to launch new drugs for serious or life-threatening diseases in Canada and France, potentially leading to prioritisation of these markets.
P4A has been and will continue to stay updated on any changes to the PRMA landscape in France and Canada, to best advise our clients on how to react, plan, and adapt to the evolving environment. Contact us to learn more about our services to support with determining ideal access pathways, and to remain up-to-date in an ever-changing space.