New pharmaceutical products in France—including biologics, biosimilars and orphan drugs—must show a significant improvement in therapeutic value to achieve a premium price while being compared to products in the same therapeutic class. Unique to France’s market, regulators look beyond a drug’s clinical trial endpoints and consider if the drug represents an improvement in medical services and cost compared to existing drugs. Therapeutic effect (not just clinical value) expands the definition of “value” in France.
France’s Payer Stakeholders
For new drugs to receive reimbursement in France, a careful review of medical benefit, and medical innovation is conducted by the Transparency Commission, or Commission de la Transparence, which ultimately determines a drugs maximum price and reimbursement status.
The Transparency Commission considers the level of innovation the drug brings to the market, as well as how important it is to the health of French citizens. It determines the drug’s improvement of medical benefit or amelioration du service medical rendu (ASMR) compared to the current standard of care, and assigns a rating from 1 to 5:
- ASMR V: no improvement
- ASMR IV: minor improvement
- ASMR III: moderate improvement
- ASMR II: important improvement
- ASMR I: major improvement. This is reserved for an extremely few drugs that have demonstrated effect on mortality in a severe disease.
The ASMR answers the question: does the drug improve patients’ clinical situation as compared to existing therapies? Consequences of ASMR rating and level of price are as follows:
- ASMR V – the drug can be listed only if the costs are less than the comparators for cost savings to the French National Health Insurance (NHI). Discounted pricing for the new drug is typical.
- ASMR IV: the target population for the new drug is relevant. If the new drug targets the same population as the comparator drug, then a parity price is best possible outcome. Price can be higher than a comparator if the new drug has better effect in a more restricted population.
- ASMR I, II or III: Faster access (price notification instead of negotiation) and price consistency with rest of Europe. However, it is increasingly rare to secure ASMR I – III ratings.
The Transparency Commission also determines the product’s medical benefit or service medical rendu (SMR). The SMR answers the question: should the drug be reimbursed? Is the drug clinically differentiated (interesting)? The SMR considers five criteria:
- Severity of the disease to be treated and its impact on morbidity and mortality
- Clinical efficacy/effectiveness and safety of the medicine
- Aim of the drug: preventive, symptomatic or curative
- Therapeutic alternatives? Positioning in treatment strategy for the disease, indication or condition?
- Public health considerations – burden of disease, health impact at the community level, transposability of clinical trial results etc.
The SMR then determines the reimbursement level. The reimbursement rate is as follows:
Actual Benefit (Service Medical Rendu)
|Insufficient||Not included on the positive list (not reimbursed)|
The ASMR and SMR ratings described above, are determined concurrently. Once they are determined, the manufacturer enters negotiations with The Comité Economique des Produits de Santé (CEPS) to establish the reimbursement price and rate for innovative ambulatory (retail) drugs. The ASMR level determined by the TC and the expected annual sales volume are key considerations for the CEPS when establishing price. There is free (unregulated) pricing for drugs that are not covered by the French reimbursement system.
Hospital-only products, which are mostly reimbursed from the total health care budget allocated to the hospital, are not subject to assessment by CEPS. In France, manufacturers are free to set prices for most hospital drugs. However, hospitals purchase drugs from manufacturers through a competitive bid process which allows them to effectively negotiate these drug prices. While hospital drug pricing remains unregulated, an activity-based costing is implemented in the hospitals. Since 2004, payment for hospital acute care has operated on a type of Diagnosis Related Group (DRG) model. The Tarification à l’Activité (T2A) has strengthened the link between actual activity rates in hospitals and the payment they receive for this activity. For certain innovative and expensive products, there is an override mechanism, known as the “liste en sus” or extra list since 2004. However, a decree from 2016 restricted the conditions for inclusion on the “liste en sus” and introduced inequality in access to these drugs.
Important Points to Keep in Mind
All drugs must be assessed by HAS (Haute Autorité de Santé) – before inclusion on a positive list of reimbursed products:
- One list for access to hospital pharmacies
- One list for admission to community pharmacies
- Assessment is based on medical evidence.
Reimbursement and price are separately determined – CEPS and HAS are separate bodies.
The French market has a more restrictive approach when it comes to prescription drugs, as it assesses the benefits and risks of products throughout their lifecycle.
The French National Agency of Medicine and Health Products Safety replaced the French Agency for the Safety of Health Products (AFSSAPS) as the drug regulatory body in 2012 in the wake of a scandal involving the diabetes treatment, Mediator. The drug was widely prescribed off label as a weight loss aid. Growing evidence that it caused heart valve damage prompted the United States, Spain and Italy to ban the drug, but France took years longer to act to remove Mediator, manufactured by French company Servier.
In addition to conflict-of-interest and transparency rules brought on by the Mediator scandal, manufacturers in France may see previously approved drugs re-evaluated by the French regulatory agency to ensure they meet strict standards of improved medical benefit.
Implications for Industry
Market access in France will continue to require a value-based approach, beyond the measurement on clinical endpoints. Once a drug is priced and published in the Official Journal, it is valid for five years. At the end of this period, the Commission d’Evaluation des Médicaments reevaluates the SMR and ASMR level and the price can be reviewed accordingly. Health technology assessments (pre-launch) and observational studies (post-launch) influence French assessment of value, contribute to approved price and listing on reimbursed drug price list (“positive list” of reimbursed products).
Manufacturers must be able to show clinical and economic benefits of a product, and how each contributes to its value. This is true for new products as well as those undergoing reevaluations. It is important to demonstrate improvements to justify higher price and reimbursement levels.
This process must be reviewed in 2021 to not only be more adaptable to advanced therapy drugs (MTI): gene therapy, CAR-T cells, etc., but also to take into account production in France and in Europe to minimize drug shortages.
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