The GLP-1 analogues and the dilemma of the Carte Vitale in the face of third-party payment: what strategies for Health Insurance?

The market introduction of GLP-1 analogues, innovative medications targeting type 2 diabetes and sometimes used for weight management, presents a real challenge for the French healthcare system. These treatments, notably offered by laboratories such as Sanofi, Novo Nordisk, Lilly, or Boehringer Ingelheim, are particularly expensive and carry an increased risk of misuse and diversion. In response, the health insurance faces a complex issue: how to control prescriptions without restricting access to care? The issue of third-party payment, especially its integration with the Vitale card, currently fuels ongoing debate. Announced with some opacity, the decision to impose the suspension of third-party payment in the absence of a signed justification highlights tensions between pharmacists, doctors, and payers. Faced with constant adjustments, sector actors – from manufacturers like Mylan or AstraZeneca to pharmacy unions – observe fluctuating strategies balancing control and accessibility.

This structural dilemma occurs in a context where nearly 700,000 monthly dispensations of GLP-1 analogues are recorded, but only just under half of the prescriptions fully comply with regulatory conditions, notably the use of a specific form ensuring reimbursement. The administrative complexity involved prompts pharmacists to suspend third-party payment whenever conditions are unmet, which can significantly impact patients, especially the most fragile ones. Additionally, prolonged exchanges between USPO and Cnam regarding transparency of instructions illustrate growing discomfort in conventional communication, while the health insurance is attempting to implement transitional measures—now extended until September—to limit blockages without abandoning strict control.

As laboratories such as Pfizer, Merck, and Teva also participate in diversifying these treatments, regulation becomes a major issue to ensure the financial sustainability of social security. This article sheds light on the various measures implemented, encountered resistances, and strategies considered by health insurance to reconcile budget constraints, safety, and access to innovative therapies.

Regulatory issues of GLP-1 analogues: enhanced control for a monitored drug

In response to the increasing prescriptions of GLP-1 analogues, regulation by health insurance falls within a strict framework aimed at controlling expenses and ensuring compliance with therapeutic indications. These molecules, which account for a significant share of sales for companies like Sanofi, Novo Nordisk, or Lilly, are systematically monitored due to their high cost and risks of misuse.

The system enforced since early 2025 requires prescribers to complete a justification form during prescription, specifying the indication, medical history, and the role of the medication in the therapeutic plan. This form, validated according to recommendations issued by the Haute Autorité de Santé (HAS), is essential for allowing the medication to be dispensed with third-party payment. Without this document, pharmacists are obliged to suspend advance payments for the patient, significantly complicating access to these treatments.

Several laboratories are involved in marketing these drugs in France:

• 🧪 Sanofi and Novo Nordisk: leaders in the distribution of GLP-1 analogues, notably with specialties like Ozempic or Victoza.
• 💊 Lilly and Boehringer Ingelheim: major players offering therapeutic alternatives.
• 🔬 Mylan, AstraZeneca, and Merck: involved in diversifying formulations and market adaptation.
• 💉 Pfizer, Accord Healthcare, and Teva: providers of generic or complementary options.

This industrial diversity also complicates prescription monitoring and traceability, emphasizing the need for precise regulation.

Prescription criteria	Description	Consequences of non-compliance
Specific completed form	Confirmation of adherence to therapeutic indications (e.g., type 2 diabetes in second or third line)	Suspension of third-party payment and requirement for upfront payment by the patient
Compliance with HAS recommendations	Monitoring clinical criteria and conditions of medication use	Refusal of coverage by health insurance
Tracking codes (e.g., PRR)	Proof of traceability and prescription control	Delivery blockage or reinforced investigations

It should be noted that the implementation of these measures aims to limit misuse of GLP-1 analogues, an action specifically designed to prevent diversion for non-medical purposes. The National Agency for the Safety of Medicines (ANSM) regularly highlights side effects and other risks associated with these treatments, justifying heightened vigilance (see ANSM on GLP-1 analogues).

Impact on healthcare professionals and patients

This new regulation imposes increased responsibility on physicians. Drafting a compliant prescription from MG France helps clarify the requirements, specifying that prescriptions must be motivated by:

• ⌛ Patient’s age
• 🩺 Confirmed presence of type 2 diabetes
• 💊 The role of the medication within the therapeutic strategy, especially in second or third line

Controlling these elements requires informing prescribers properly and having appropriate documentation. However, the limited dissemination of the form and poor communication clarity, as noted by unions like USPO, weaken implementation efforts.

For patients, suspension of third-party payment is a significant obstacle, especially for vulnerable groups. The need to pay upfront can hinder treatment continuity, highlighting a major public health issue.

Third-party payment and the Vitale card: a sensitive system for control

The third-party payment system, a flagship feature of the French social security system, allows beneficiaries not to pay upfront when receiving certain medications. Its implementation for GLP-1 analogues, however, raises several debates.

Given the high risks of misuse, health insurance has decided to incorporate a new condition closely monitoring the use of the Vitale card during dispensing: without validation of a signed justification and proper compliance with criteria, third-party payment is suspended. This measure surprises and worries professionals, as recently underlined by the Union of Pharmacies Syndicates (USPO).

The key points of this policy include:

• ⛔ Dispensing without a signed justification now suspends third-party payment
• 📉 This suspension forces patients to pay upfront, potentially blocking access to treatment
• ⚖️ The goal is to improve traceability and prevent abuse related to potential fraud
• 💡 A transitional period has been established, but it has been extended until September 1, 2025

This situation causes significant tension between pharmacists, patients, and payers, at the heart of a “broken convention dialogue.” The delayed and sometimes contradictory communication from Cnam worsens this discomfort, as criticized by Pierre-Olivier Variot, president of USPO, who denounces a lack of consultation and prior information (for more details, see Le Moniteur des Pharmacies).

Actor	Role	Impact of suspension of third-party payment
Pharmacists	Dispense medication, verify documents	Must request upfront payment, causing tension with patients
Patients	Recipients of treatment via medical prescription	Access to care barrier, risk of treatment abandonment
Health insurance (Cnam)	Control reimbursement, monitor healthcare budget	Enhanced control measures, possible disputes

It should be noted that according to Cnam, this measure is part of an evolving framework aimed at better balancing financial and health objectives. Director Thomas Fatome has already expressed the desire to restore a constructive dialogue channel with unions, notably USPO, which suggests potential adjustments.

Economic and social challenges

The risk of exceeding the budget allocated for GLP-1 analogues underscores the importance of regulation. Cnam must address:

• 📈 An exponential increase in prescriptions and monthly dispensations
• 🔍 Increased investigations into possible diversion
• ⚠️ The need to combine usage control and accessibility
• 🤝 Maintaining trust among actors in the healthcare system

These parameters emphasize that using the Vitale card is a key technical tool for health insurance, facilitating file verification and limiting fraud risk.

Conflicts and negotiations between pharmaceutical unions and health insurance

For several months, the relationship between Cnam and the Union of Pharmacy Syndicates (USPO) has gradually deteriorated, with particular focus on the difficult communication regarding the new rules concerning GLP-1 analogues.

An open letter dated June 5, 2025, from USPO criticized the imprecise and delayed management of information provided to professionals. Pierre-Olivier Variot, USPO president, describes a sense of rupture in the conventional dialogue: “We can no longer stay silent” in response to removals from the Ameli site without explanation and a lack of dissemination of flyers intended for pharmacists and patients.

However, after a call from Cnam director Thomas Fatome, assurances were given to restore constructive contact. Maintaining a partnership with unions remains a priority to continue adapting the systems. Philippe Besset, president of the Federation of Pharmaceutical Unions of France (FSPF), characterizes the situation as “a delay of a few days in information,” but nonetheless emphasizes the need to improve consultative processes (FSPF explanations).

The role of unions in managing the GLP-1 dossier

Unions play a crucial role in:

• 🗣 Communicating information to healthcare professionals
• 🤝 Negotiating with Cnam to adjust measures
• 📢 Raising awareness among pharmacists about best practices
• ⚙️ Assisting in resolving issues encountered in pharmacies

These organizations are essential relay points to ensure regulation remains understandable and applicable, avoiding overly rigid administrative compartmentalization that could impede effective patient care.

Transitional measures and impacts on GLP-1 analogue supply

For pragmatic reasons, health insurance has granted a moratorium since February 2025 on certain requirements, notably dispensing without signed justification during a transitional period. This measure has been extended until September 1, 2025, to allow better organization of pharmacies and improved informational relay to patients and prescribers.

This transitional period involves key points to monitor:

• ⏳ Ensuring continued access to treatments despite incomplete files
• ✍️ Gradually raising awareness among doctors about the obligation to complete the specific form
• 📅 Preventing treatment interruption through better planning of orders and stocks
• ⚙️ Avoiding administrative overload for pharmacists

Furthermore, some laboratories like Mylan, AstraZeneca, and Accord Healthcare are adjusting their supply circuits to meet this fluctuating demand, ensuring the availability of treatments despite regulatory complexity.

Transitional measure	Duration	Objective	Impact on pharmacies
Dispensing without signed form	Until September 1, 2025	Maintain access to treatments	Temporary easing of controls
Suspension of third-party payment without justification	Effective since June 1, 2025	Strengthen administrative rigor	Increased burden on patients

The French Diabetes Federation has expressed its views on these adjustments, notably welcoming the additional period (“three more months to obtain the form,” see French Diabetes Federation).

Patient management and practical advice

To ensure better patient adherence, pharmacists and doctors are recommended to:

• 📚 Train their teams on the new regulations
• 🗂 Distribute appropriate educational materials
• 🎯 Remind the importance of respecting prescription criteria
• 🤲 Support financially vulnerable patients in their procedures

Post-commercialization surveillance and ANSM’s role in GLP-1 analogue monitoring

The French National Agency for the Safety of Medicines (ANSM) already has a temporary scientific committee (CST) tasked with analyzing the use and safety of GLP-1 analogues. This unit regularly issues reports and updates pharmacovigilance data, enabling precise monitoring of reported adverse effects.

The main issues concern:

• ⚠️ Rapid detection of serious side effects, including cardiovascular risks
• 🔍 Monitoring potential deviations in off-label prescribing
• 📊 Collecting epidemiological data to adjust clinical recommendations

Type of surveillance	Description	Implication for prescribers
Active pharmacovigilance	Monitoring adverse effects reported by professionals and patients	Reporting obligation, increased vigilance
Usage audits	Control of prescription patterns across the territory	Possible review of practices
Additional studies	Organizing post-marketing studies to validate efficacy and safety	Encouraged participation in clinical research

The system is part of a strengthened health safety approach, whose conclusions are fundamental for adapting medical policy to real-world conditions.

Dialogue between health authorities and pharmaceutical companies

Companies such as Pfizer, Teva, and Merck actively participate in informing and working with ANSM within the framework of surveillance obligations. This joint effort guarantees quality and transparency for patients and practitioners.

Future perspectives on care regulation and control by health insurance

In a dynamic context, health insurance seeks to adapt its tools to maintain effective control while ensuring access to treatments. Several pathways are considered for 2025 and beyond:

• 🔄 Greater integration of the digital Vitale card into document digitization
• 📲 Development of dedicated applications to facilitate monitoring and access to regulatory information
• 🤖 Use of artificial intelligence to automatically detect anomalies in prescriptions
• 🔍 Extending controls to other critical therapeutic classes, leveraging GLP-1 experience
• 💡 Innovation in partnerships with pharmacists and prescribers to streamline dialogue

These developments demonstrate a firm commitment to action, reducing fraud while maintaining the financial balance of the healthcare system.

Initiative	Description	Expected benefit
Digital Vitale card	Integration of forms into an app	Smoother third-party payment process, fewer errors
Mobile applications	Simplified prescription data access	Improved information for professionals and patients
Artificial intelligence	Proactive analysis of abnormal prescriptions	Reduced misuse and fraud prevention

Anticipating challenges and enhanced collaboration

Leaders of Cnam and pharmacy federations emphasize “a call for collective responsibility” to support these developments. They stress the role of each stakeholder and the importance of strengthened consultation to avoid unnecessary tensions.

The role of training and information in successful regulation of GLP-1 analogues

To support the deployment of these measures, training healthcare professionals is essential. The regulatory complexity surrounding GLP-1 analogues requires regular updates of skills so that doctors, pharmacists, and assistants can ensure a smooth care pathway.

• 📖 Workshops and webinars organized by unions like USPO and FSPF
• 💻 Dedicated online platforms on regulation and pharmacovigilance
• 📈 Case studies illustrating common errors and their consequences
• 🛡 Enhanced support for managing disputes related to third-party payment

The goal is to prevent costly errors in pharmacy dispensing, ensuring compliance and patient satisfaction. Special attention is given to tailored communication methods to include all stakeholders, especially in rural or vulnerable areas.

Impacts on patients: accessibility, costs, and treatment adherence

The suspension of third-party payment for GLP-1 analogues, due to the absence of the justification form, creates concrete difficulties for some patients. While this measure aims to reduce fraud, it paradoxically risks creating barriers to care for the most vulnerable.

Several factors directly affect patients:

• 💶 Upfront costs: In an inflationary context, having to pay full amount at the point of dispensing burdens some beneficiaries.
• 🛑 Risk of treatment discontinuation: Administrative fatigue and financial barriers can lead to premature treatment cessation.
• ❓ Lack of information: Patients report the difficulty of understanding procedures often explained too late.
• 🤝 Insufficient support: Absence of social relay or assistance in remote areas.

Impact on patients	Consequence	Potential solutions
Financial difficulty	Delayed or interrupted treatment	Implementation of specific aid and adapted third-party payment systems
Administrative complexity	Loss of treatment adherence	Enhancement of training and informational efforts
Social isolation	Reduced medical follow-up	Mobilization of support organizations and pharmacy advocates

It is crucial for healthcare professionals to anticipate and mitigate these issues to guarantee therapeutic success, especially in supporting diabetic or overweight patients treated with GLP-1 analogues (Aide BTS Assurance).

Focus on practical experience

In some pharmacies, managing incomplete files has led to innovative initiatives such as creating dedicated teams for treatment follow-up, using digital platforms, and employing specialized pharmacy assistants.

FAQ on GLP-1 analogues, Vitale card, and third-party payment

• ❓ What is a GLP-1 analogue and what is it used for?
  It is a medication that mimics the action of glucagon-like peptide-1, a hormone playing a key role in regulating blood glucose, mainly used to treat type 2 diabetes.
• ❓ Why is the specific form mandatory?
  This form certifies that the prescription complies with reimbursable therapeutic indications, ensuring better expense regulation and misuse control.
• ❓ How does the suspension of third-party payment work?
  If the form or a proper justification is missing, pharmacists must ask the patient to pay immediately, impacting access to treatment.
• ❓ What is the role of laboratories in regulation?
  Manufacturers, including Sanofi, Novo Nordisk, Lilly, Boehringer Ingelheim, and others, collaborate with health authorities to ensure traceability, quality, and pharmacovigilance.
• ❓ What are the future prospects?
  The health insurance is working to modernize control tools via digitalization, AI, and improved dialogue with health professionals to balance safety and accessibility.

Source: www.lemoniteurdespharmacies.fr