Innovative drugs manufactured in France will match highest price on European Market
The French state-industry drug framework agreement stipulates that innovative products manufactured in the country can have the same initial price as the highest one applied in Germany, the UK, Italy, or Spain.
The new 2021-24 framework agreement signed on Friday 5th March between France’s healthcare products committee CEPS and French pharma body Leem includes a measure encouraging the reshoring to France of innovative products which have an additional therapeutic value rating of I (major) to III (moderate).
In cases where “the main manufacturing” stages are based in France, “the public prices cannot be lower than one of the prices in place on four comparable European markets”. If these prices are not known, CEPS will sign an agreement with the pharma company “setting the public price at the level requested by the pharmaceutical company and stipulating the agreement-based conditions of its revision”.
For a drug with a low additional therapeutic value rating (ASMR IV), the guarantee of a European price applies if:
- The drug is bring compared to a drug which has a had an ASMR I to III rating for at least five years
- It is found to be “dominant in cost-effectiveness terms” in a cost-effective evaluation
- If there are few comparators in the indication
- If it is an antibiotic with a new active ingredient
- If it is an orphan drug or a new combined drug used in combination therapy
If the conditions are not met, the drug’s price will be based on its patent-protected comparators and will be “lower than its lowest price in the reference European countries”.
To “ensure cost-effectiveness conditions” are met when a drug gets a European public price, first-time reimbursement discounts will also apply.
It stipulates that the prices for drugs with ASMR I to III ratings and valid cost-effectiveness evaluations will not change for five years, which drops to three years for other drugs. When this period finishes, a programme of annual price cuts will apply.
The price agreement can be revised after France’s economic and public health evaluation committee, CEESP, re-evaluates the drug using real-world data. If sales after a drug’s second year on the market are forecast to exceed €50 million, a budgetary impact analysis must be given to CEESP and CEPS.
This new price regulating agreement places a major shift in ex-factory and list pricing, affecting the competitiveness of indications in the French market as well as the overall EU price corridor. While France has historically been one of the lowest-priced markets across EU5; this new regulation will change this when coming into effect.
The regulation will also have IRP implications, owing to France being included as a reference market in many countries within their baskets. Furthermore, while public prices are referenced, the regulation will certainly increase prices in applicable markets.
The agreement highlights the importance of reliable regulatory tracking and legislative updates, impacting pricing and reimbursement. Regulatory and policy information forms part of GPI’s six core market access data segments: policy, regulatory, price, value and access, treatment costs and reimbursement.
GPI’s new and updated platform pulseTM 2.0 has a built-in journey tracker function, allowing users to track price changes that are aligned to major events, such as this new legislation. To understand more about this new legislation, or about how GPI can help you track important events, contact one of our experts.
If you would like to learn how GPI pulse can meet those needs and transform your value-based market access strategy in Europe and beyond then please book in some time with our experts below.