2024-11-05 11:30:00
When a medicine has a marketing authorization (AMM) in France, the pharmaceutical laboratory can request that it be reimbursed by Health Insurance. To do this, he submits a file to the transparency commission of the High Authority for Health (HAS) so that his medical benefit (SMR) – insufficient, low, moderate, significant or major – can be assessed. Once established, this SMR allows the National Union of Health Insurance Funds to set the reimbursement rate: 0% (non-reimbursed), 15% (low SMR), 30% (moderate SMR), 65% ( important or major SMR), or even 100% for irreplaceable and expensive medicines. The remainder, called the co-payment, can be reimbursed by mutual insurance companies or complementary organizations.
For many years, medications have been reimbursed by Health Insurance at 15% or 30%. For example, Tanganil (acetylleucine) for dizziness, Toplexil (oxomemazine) or Polery (codeine) syrups for coughs, or even Spasfon (phloroglucinol) for dysmenorrhea (painful periods). However, these drugs have not demonstrated their clinical effectiveness, according to modern research standards (randomized clinical trials). There are probably many others.
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Their AMM was issued based on old criteria, which are not those of today’s transparency commission. For most marketing authorizations for medicinal products intended for symptomatic purposes (pain, cough, etc.), it is necessary to demonstrate their clinical effectiveness, that is to say that their effectiveness perceived by patients is not simply linked to a spontaneous evolution of the symptom or the placebo effect.
Benefit-risk balance
The prescribing of drugs of unproven clinical effectiveness is problematic for several reasons. Ethics first. This prescription does not comply with the public health code (article R4127-32) having introduced this article into the code of medical ethics: “Once he has agreed to respond to a request, the doctor undertakes to personally provide the patient with conscientious, dedicated care based on data acquired from science. » Likewise, such a requirement does not respect the ethical principle of “non-maleficence”. In fact, it exposes the patient to an unacceptable risk, even if it is rare. Medications always have the potential to cause side effects that can be serious – allergic reactions, for example. In the absence of demonstrated clinical effectiveness, the benefit-risk balance of the drug is therefore unfavorable.
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**Interview: Understanding the Reimbursement of Medical Costs in France**
**Host:** Good morning, and welcome to our program! Today, we have Dr. Marie Lefèvre, a health policy expert, to discuss the intricacies of medical reimbursement in France, particularly in light of the recent updates to the pharmaceutical reimbursement system. Welcome, Dr. Lefèvre!
**Dr. Lefèvre:** Thank you for having me! It’s a pleasure to be here.
**Host:** To start, can you explain the process a pharmaceutical company must go through to have a medicine reimbursed in France?
**Dr. Lefèvre:** Absolutely. Once a medication receives marketing authorization, the pharmaceutical laboratory can request reimbursement from Health Insurance. They submit a comprehensive file to the transparency commission at the High Authority for Health (HAS). This file assesses the medical benefit, or SMR, which determines how the medicine will be classified and subsequently, what reimbursement rate it will receive.
**Host:** And what are the categories of SMR and corresponding reimbursement rates?
**Dr. Lefèvre:** The SMR can be classified as insufficient, low, moderate, significant, or major. Depending on this classification, the reimbursement rates can vary widely: from 0% for non-reimbursed medications to 100% for irreplaceable and particularly expensive treatments. For example, low SMR medicines might receive only 15% reimbursement, while significant SMR might get 65%.
**Host:** Interesting! Are there any specific medications that exemplify this system?
**Dr. Lefèvre:** Yes, there are several. Many medications, like Tanganil for dizziness or Toplexil for coughs, are reimbursed at 15% or 30%. Interestingly, despite being reimbursed, some of these medicines have not demonstrated clinical effectiveness according to modern standards, like randomized clinical trials. This raises concerns about the efficiency of our healthcare spending.
**Host:** That’s a critical point. What implications does this have for patients and healthcare costs?
**Dr. Lefèvre:** It highlights the importance of rigorous evaluation in our healthcare system. Patients might be paying significant co-payments for medications that may not be the most effective choice. This also affects the overall sustainability of the health system because it influences how funds are allocated.
**Host:** So, what can be done to improve this situation?
**Dr. Lefèvre:** One key step would be to increase transparency and ensure that funds are directed towards medications that have proven effectiveness. Additionally, we need to prioritize funding for research and development of treatments that truly benefit patients.
**Host:** Thank you, Dr. Lefèvre, for shedding light on this vital topic. It’s clear that understanding the reimbursement system is crucial for both healthcare providers and patients.
**Dr. Lefèvre:** Thank you! It’s been a pleasure discussing this with you.
**Host:** And to our listeners, I encourage you to stay informed about your health coverage and the medications you’re prescribed. Until next time!
