theWhen a drug has a marketing authorization (AMM) in France, the pharmaceutical laboratory can request reimbursement from the health insurance company. To this end, he submits a dossier to the transparency commission of the High Authority of Health (HAS) so that his medical performance (SMR) can be assessed: insufficient, low, moderate, significant or greater. Once established, this SMR allows the National Union of Health Insurance Funds to set the reimbursement rate: 0% (not reimbursed), 15% (low SMR), 30% (moderate SMR), 65% (major or higher), or even 100% for irreplaceable and expensive medicines. The remaining part, called ticket, can be reimbursed by mutual societies or complementary organisations.
For many years, drugs 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 (phhloroglucinol) for dysmenorrhea (painful menstruation). However, these drugs have not proven their clinical effectiveness, according to modern research standards (randomized clinical trials). There are probably many more.
Their AMM was issued based on old criteria, which are not those of today’s transparency commission. For the majority of marketing authorizations for medicinal products intended for symptomatic purposes (pain, cough, etc.), it is necessary to demonstrate their clinical efficacy, i.e. that their efficacy perceived by patients is not simply linked to a spontaneous evolution of the symptom or the placebo effect.
Risk-benefit balance
Interview Between Time.news Editor and Health Policy Expert
Time.news Editor (TNE): Welcome to Time.news, where we delve into the most pressing issues of our time. Today, we have Dr. Claire Martin, a health policy expert, to discuss the intricacies of drug reimbursement processes in France. Thank you for joining us, Dr. Martin!
Dr. Claire Martin (CM): Thank you for having me! I’m excited to discuss this important topic.
TNE: Let’s start with the basics. Once a drug receives marketing authorization in France, what’s the next step for pharmaceutical companies when it comes to reimbursement?
CM: That’s a great question! After obtaining marketing authorization, pharmaceutical companies can request reimbursement from the national health insurance system. To do this, they must submit a dossier to the transparency commission at the High Authority of Health, known as HAS.
TNE: And what does this dossier contain, specifically?
CM: The dossier contains comprehensive data that allows the HAS to evaluate the medical performance of the drug, known as the “Service Médical Rendu” or SMR. This assessment categorizes the drug’s performance as insufficient, low, moderate, significant, or greater.
TNE: Those categories seem quite varied. How does this categorization affect reimbursement rates?
CM: Exactly! The classification into these categories is crucial because it dictates the reimbursement rate set by the National Union of Health Insurance Funds. For instance, a drug with a low SMR might receive only 15% reimbursement, while one deemed significant could be reimbursed at 65% or even 100% for essential medications.
TNE: So, for patients, this directly impacts the out-of-pocket expenses they might face?
CM: Absolutely! The part that is not covered by health insurance is referred to as the “ticket” and can sometimes be reimbursed by mutual insurance or complementary organizations. Understanding this system is vital for patients when considering their treatment options.
TNE: There’s a lot of intricacy in this system. What do you think are the biggest challenges that arise during this reimbursement process?
CM: One major challenge is the transparency of the criteria used for evaluating SMR. Sometimes, the rationale behind the assessments can be unclear, leading to confusion among patients and healthcare providers. Additionally, the delays in the reimbursement process can impact patient access to necessary medications.
TNE: Is there a push for reform in this area?
CM: Yes, indeed! Many stakeholders, including patient advocacy groups, are calling for clearer guidelines and faster decision-making processes. The aim is to ensure that patients have timely access to medications while also balancing the need for rigorous assessment.
TNE: Fantastic insights, Dr. Martin. Before we wrap up, what would you advise patients to do if they’re navigating this reimbursement process?
CM: I would encourage patients to stay informed. They should consult with their healthcare providers about their medication options and reach out to their insurance representatives to understand their coverage. It’s also beneficial for patients to advocate for themselves and engage with patient support groups.
TNE: Thank you so much for sharing your expertise with us today, Dr. Martin. Your insights into the French drug reimbursement system are incredibly valuable.
CM: Thank you for having me! It’s been a pleasure discussing a topic that affects so many lives.
TNE: And thank you to our audience for tuning in! We hope this conversation has shed light on the complexities of drug reimbursement in France. Stay informed and engaged with us for more discussions on crucial health policies.