Article L. 111-11 of the French Social Security Code stipulates that each year, before June 15, the National Union of Health Insurance Funds (UNCAM) must submit proposals to the Minister and to Parliament on trends in costs and incomes (the “Costs and Incomes” report) for the following year, and on the measures needed to achieve the balance provided for in the multi-year financial framework for health insurance expenditure.

On the basis of these provisions, the French Health Insurance system published yesterday its proposals for 2024, with a view to improving the quality of the healthcare system and controlling expenditure.

There are 30 proposals. Below is a summary of the main provisions concerning healthcare products, which could be included in the Social Security Finance Bill for 2024.

Ensuring rapid, uninterrupted access to medicines in France (proposal no. 17)

For medicines with therapeutic benefits

It is proposed to continue monitoring time-to-market at European level, in order to “stabilize France’s excellence in terms of early access to innovative medicines, thanks to the derogations introduced in recent years”.

For mature medicines

The French Health Insurance proposes to strengthen the fight against shortages through two measures: 

  • encourage companies to continue producing mature medicines:
    • a commitment by pharmaceutical companies to maintain a mature product on the market in the event of the reimbursement of an innovative medicine
    • price controls on import of mature medicines
  • clarify the rules governing the reimbursement of medicines to compensate for shortages:
    • exceptional reimbursement of magistral preparations delivered by pharmacies
    • temporary reimbursement of medicines likely to alleviate the shortage (without the manufacturer having requested it!). In this case, the price would be the same as that of the registered medicines (in a shortage situation)

For medicines with added medical benefit IV or V ( “ASMR” IV or V)

Several proposals have been put forward to strengthen the framework-agreement (Accord-Cadre) between the French Economic Committee for Health Products (CEPS) and the French National Union of the Pharmaceutical Companies (LEEM). 

  • for added medical benefit V (ASMR V): introduce a minimum discount of 20% compared with the cheapest comparator. It is specified that this discount may be higher depending on the number of products already on the market in the indication concerned
  • for added medical benefit IV (ASMR IV):  apply a net discount compared with the least expensive clinically relevant comparator if several products are already present in the same indication

Increase savings on generics and biosimilars (proposals no. 18 and 24)

For generics and biosimilars

It is proposed to specify in the framework agreement (“Accord-Cadre”) that discounts are calculated on net medicines prices and not on the facial price.

For biosimilars

The French health insurance recommends:

  • raise the discount rate for biosimilars in the framework agreement to the same level as for generics, i.e., an initial discount rate of 40% for the reference biologic medicine and the biosimilar in hospitals, and 20% and 60% respectively for these products in town
  • create a third-party payment system for biosimilars, when the pharmacist offers to substitute a reference biologic medicine with a biosimilar that he is authorized to substitute
  • expand the number of substitutable molecules

Reducing the environmental impact of healthcare products (proposal no. 18)

Healthcare products are responsible for half of our healthcare system’s greenhouse gas emissions.

To reduce their environmental impact, the French health insurance proposes:

  • to include environmental issues in the pricing of healthcare products in the next framework agreement. The value of manufacturers’ commitments in this field could take the form of rebate credits made available to them, along the lines of the strategic committee for healthcare industries (CSIS) credits
  • enable and encourage the reuse of unused products
  • encourage the reuse of reconditioned medical devices. Wheelchairs are particularly targeted (although splints and crutches are also mentioned)

Supporting the emergence of digital innovations (proposal no. 21)

For digital therapies in mental health

The French Health Insurance proposes to pilot a digital therapy for the treatment of depression in primary care. It is specified that digital therapy must be a medical innovation that implies a new way of treating patients, based on complementarity between digital therapies and conventional medical care.

For AI-assisted diagnostic innovations

In order to reimburse digital medical devices or diagnostic assistance algorithms, the French Health Insurance proposes changes to:

  • either the nomenclature
  • or the reimbursement of equipment

However, it recognizes that the French National Authority for Health (HAS) will not be able to evaluate all existing diagnostic aids. It is therefore recommended that they be categorized according to public health priorities.

Stabilize the regulatory framework for teleconsultation (proposal no. 20)

The French Health Insurance proposes that the practice of teleconsultation be further regulated by:

  • prohibiting the installation of a telecabin in a commercial premises that is not also the place of practice of a healthcare professional
  • prohibiting teleconsultation platforms from charging for ancillary costs “unrelated to care” (putting the user in touch with a healthcare professional, access to the teleconsultation tool)
  • banning incentives for healthcare professionals (Christmas bonuses, sponsorships) and regulating advertising
  • tequiring teleconsultation platforms to equip themselves with a SESAM-Vitale billing solution, and salaried doctors to identify themselves via their healthcare professional card (CPS)

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