New pharmaceutical products in France must show a significant improvement in therapeutic value to achieve a premium price, and are compared to products in the same therapeutic class. Unique to the French market, regulators look beyond the drug’s clinical trial endpoints and consider whether a given drug represents an improvement in medical services or whether it is cheaper than similar existing drugs. Therapeutic effect (not just clinical value) expands the definition of “value” in France.
France’s Payer Stakeholders
Once a drug has is approved for marketing in France, the manufacturer can set its price. For the new drug to be reimbursed by the French Social Security system (multiple public national health insurance funds), the Transparency Commission, or Commission de Transperence, must determine the comparative evidence-based value that in turn influences its 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 if the new drug has better effect in a more restricted population.
- ASMR I to IV: possibility of higher price as compared to comparators.
- 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 takes into account 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)|
Once the ASMR and SMR ratings are determined, the manufacturer enters into 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 to establish the 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. While hospital drugs remain 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. Expensive hospital drugs are said to be on the T2A exclusion list and are completely reimbursed by the health insurance system.
Important Points to Keep in Mind
All drugs have to 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.
More than 90 percent of medical consultations in France result in a prescription, one of the highest rates in Europe. But the French market is moving to a more restrictive approach, assessing 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, Médiator. 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 new 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 reevaluation. It’s important to demonstrate improvements to justify higher price and reimbursement levels.
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