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

The launch of GLP-1 analogues, innovative medications targeting type 2 diabetes and sometimes used for weight management, poses a significant challenge for the French healthcare system. These treatments, offered notably by laboratories such as Sanofi, Novo Nordisk, Lilly, or Boehringer Ingelheim, are particularly costly 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 question of third-party payment, especially its coordination with the Vitale card, is currently at the center of 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. Amid ongoing adjustments, sector stakeholders—including manufacturers like Mylan and AstraZeneca, as well as pharmaceutical unions—are observing fluctuating strategies that balance control and accessibility.

This structural dilemma occurs in a context where nearly 700,000 monthly prescriptions of GLP-1 analogues are recorded, yet only a little less than half of these prescriptions fully comply with regulatory conditions, notably the use of a specific form ensuring reimbursement. Administrative complexity prompts pharmacists to suspend third-party payment whenever conditions are not met, which can significantly impact patients, especially the most vulnerable. Additionally, prolonged exchanges between USPO and Cnam regarding transparency of instructions illustrate growing discomfort within conventional communication, while the health insurance is attempting to implement transitional measures—now extended until September—to limit blockages without abandoning rigorous control.

As laboratories like Pfizer, Merck, and Teva also participate in diversifying these treatments, regulation becomes a key issue to ensure the financial sustainability of social security. In this article, we shed 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 Medication

In light of increasing prescriptions of GLP-1 analogues, the regulation enforced by health insurance follows strict guidelines aimed at controlling expenses and ensuring appropriate therapeutic indications. These molecules, representing a significant share of sales for companies like Sanofi, Novo Nordisk, or Lilly, are systematically monitored due to their high cost and misuse risks.

The system introduced since early 2025 requires prescribers to complete a justification form during prescription, specifying the indication, medical history, and the medication’s role in the therapeutic plan. This form, validated according to recommendations from the Haute Autorité de Santé (HAS), is essential for the medication to benefit from third-party payment. Without this document, pharmacists must suspend the advance payment for the patient, greatly complicating access to these treatments.

Several laboratories are involved in marketing these medications in France:

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

This industrial diversity also complicates prescription tracking and traceability, reinforcing the need for precise regulation.

Prescription Criteria	Description	Consequences of Non-compliance
Specific form filled out	Certificate of compliance with therapeutic indications (e.g., type 2 diabetes as second- or third-line treatment)	Suspension of third-party payment and requirement for upfront payment by the patient
Adherence to HAS recommendations	Monitoring clinical criteria and conditions of medication use	Rejection of reimbursement by health insurance
Tracking codes (e.g., PRR)	Guarantee of traceability and prescription control	Blocking of dispensing or reinforced investigation

It should be noted that the implementation of these measures aims to limit misuse of GLP-1 analogues, a decisive action to prevent, among others, diversion for non-medical purposes. The National Agency for the Safety of Medicines (ANSM) regularly highlights side effects and other risks related to these treatments, which also justifies increased vigilance (see ANSM on GLP-1 analogues).

Impact on Healthcare Professionals and Patients

This new regulation increases physicians’ responsibilities. Drafting a compliant prescription from MG France helps to clarify requirements, emphasizing that prescriptions must be motivated by:

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

Controlling these elements requires well-informed prescribers and the availability of suitable documents. However, the limited dissemination of the form and the lack of clear communication, as pointed out by unions like USPO, weaken implementation.

For patients, the suspension of third-party payment presents a significant obstacle, especially for those in precarious situations. The need to pay upfront can hinder treatment continuity, highlighting a major public health issue.

The Third-party Payment and Vitale Card: A Tensioned System Serving Control

The third-party payment system, a flagship of the French social security system, allows beneficiaries to avoid paying upfront at the point of dispensing certain medications. Its implementation for GLP-1 analogues, however, raises several debates.

Faced with high misuse risks, 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 concerns professionals, as recently highlighted by the Union of Pharmacist Unions (USPO).

Key points of this policy are:

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

This situation creates notable tension between pharmacists, patients, and payers, directly impacting a “broken conventional dialogue.” The delayed and sometimes contradictory communication from Cnam worsens this discomfort, as pointed out by Pierre-Olivier Variot, president of USPO, who denounces a lack of prior consultation and information (more details can be found in Le Moniteur des Pharmacies).

Actor	Role	Consequences of the suspension of third-party payment
Pharmacists	Dispensing the medication, verifying documents	Must request upfront payment, creating tension with patients
Patients	Recipients of treatment based on medical prescription	Access to care impeded, risk of treatment discontinuation
Health Insurance (Cnam)	Control of reimbursement, healthcare budget oversight	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 imperatives. Director Thomas Fatome has already expressed a willingness to restore a constructive dialogue with unions, including USPO, suggesting potential adjustments.

Economic and Social Impacts

The risk of exceeding the budget allocated to GLP-1 analogues highlights the importance of regulation. Cnam must face:

• 📈 Exponential growth in prescriptions and monthly dispensations.
• 🔍 Increased investigations into potential diversions.
• ⚠️ The need to combine usage control with accessibility.
• 🤝 Maintaining trust among system stakeholders.

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

Conflicts and Negotiations Between Pharmaceutical Unions and Health Insurance

For several months, the relationship between Cnam and the Union of Pharmacist Unions (USPO) has gradually deteriorated, with increased tension around the communication of new rules concerning GLP-1 analogues.

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

Nonetheless, after an appeal from Cnam director Thomas Fatome, assurances have been given to establish a constructive contact again. Maintaining a partnership with unions remains a priority to continue adapting these systems. Philippe Besset, president of the Federation of Pharmaceutical Unions of France (FSPF), describes the situation as “a delay of a few days in information,” but affirms the necessity of improving consultative processes (FSPF explanations).

The Role of Unions in Managing GLP-1

Unions play a crucial role in:

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

These organizations serve as an essential relay to ensure regulation remains understandable and applicable, avoiding overly rigid administrative divisions that could hinder effective patient care.

Transitional Measures and Impact on GLP-1 Analogue Supply

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

This transitional period is accompanied by key points to observe:

• ⏳ Ensuring continued access to treatments despite incomplete files.
• ✍️ Gradually raising awareness among doctors about the obligation to complete the specific form.
• 📅 Preventing dispensing disruptions through better planning of orders and stock management.
• ⚙️ Reducing administrative overload for pharmacists.

Additionally, laboratories such as Mylan, AstraZeneca, and Accord Healthcare are adapting their supply chains 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 from June 1, 2025	Strengthen administrative rigor	Increased burden on patients

The Federation of Diabetics has expressed views on these adjustments, notably welcoming the extension of a further period (“three additional months to obtain the form,” see Federation of Diabetics).

Patient Management and Practical Advice

To improve patient adherence, pharmacists and doctors are recommended to:

• 📚 Provide training on the new rules for healthcare teams.
• 🗂 Distribute appropriate educational materials.
• 🎯 Remind the importance of respecting prescription criteria.
• 🤲 Support financially vulnerable patients in their procedures.

Post-marketing Surveillance and ANSM’s Role in Monitoring GLP-1 Analogues

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

Major issues concern:

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

Type of Monitoring	Description	Implication for Prescribers
Active Pharmacovigilance	Monitoring adverse effects reported by professionals and patients	Mandatory reporting, increased vigilance
Usage Audit	Control of prescription patterns across the territory	Potential review of practices
Additional Studies	Post-marketing studies to validate efficacy and safety	Encouraging participation in clinical research

This system is part of a strengthened public health safety approach, with conclusions that are essential for adapting medical policies to real-world conditions.

Dialogue Between Health Authorities and Pharmaceutical Companies

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

Future Perspectives for Health Insurance’s Support and Control Systems

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

• 🔄 Greater integration of digital Vitale cards in the digitization of justification procedures.
• 📲 Development of dedicated apps to facilitate monitoring and regulatory information access.
• 🤖 Use of artificial intelligence to automatically detect anomalies in prescriptions.
• 🔍 Extending controls to other critical therapeutic classes, based on GLP-1 experience.
• 💡 Enhancing partnerships with pharmacists and prescribers to streamline dialogue.

These developments embody a committed effort to limit fraud while maintaining the financial balance of the healthcare system.

Initiative	Description	Expected Benefit
Digital Vitale Card	Integration of the form into the application	Streamlined third-party payment, fewer errors
Mobile Applications	Simplified prescription data access	Better information for professionals and patients
Artificial Intelligence	Proactive analysis of abnormal prescriptions	Reduced misuse and fraud prevention

Anticipating Challenges and Strengthening Collaboration

Cnam leaders and pharmaceutical federations emphasize “a call for collective responsibility” to support these changes. They stress the importance of each actor’s role and of enhanced consultation to avoid unnecessary tensions.

The Role of Training and Information in the Successful Regulation of GLP-1 Analogues

To support the implementation of the system, training healthcare professionals is an essential lever. The regulatory complexity of GLP-1 analogues requires regular skill updates to ensure doctors, pharmacists, and assistants can provide seamless care pathways.

• 📖 Workshops and webinars offered by unions such as USPO and FSPF
• 💻 Online platforms dedicated to regulation and pharmacovigilance
• 📈 Case studies illustrating common errors and their consequences
• 🛡 Enhanced support for managing third-party payment disputes

The goal is to prevent costly errors during dispensing in pharmacies while ensuring compliance and patient satisfaction. Special attention is given to adapted communication methods that include all stakeholders, especially in rural or fragile areas.

Impacts on Patients: Accessibility, Costs, and Treatment Adherence

The suspension of third-party payment for GLP-1 analogues, linked to the absence of the justification form, presents practical difficulties for some patients. While aimed at reducing fraud, this measure paradoxically raises barriers to care for the most vulnerable.

Several factors directly affect patients:

• 💶 Upfront Costs: In an inflationary context, having to pay full amount at dispensing complicates access for some beneficiaries.
• 🛑 Risk of Discontinuation: Administrative fatigue and financial barriers can lead to premature treatment stopping.
• ❓ Lack of Information: Patients report the complexity of procedures, sometimes explained too late.
• 🤝 Insufficient Support: Absence of social relay or assistance in remote areas.

Impact on Patients	Consequence	Proposed Solutions
Financial Difficulty	Delayed or interrupted treatment	Implementation of specific aids and adapted third-party payment systems
Administrative Complexity	Decreased medication adherence	Enhanced training and information efforts
Social Isolation	Reduced medical follow-up	Mobilization of associative support and pharmacy relay services

It is essential for healthcare professionals to anticipate and mitigate these difficulties to ensure therapeutic success, especially for diabetic or overweight patients treated with GLP-1 analogues (aide bts assurance).

Focus on Field Experience

In some pharmacies, managing incomplete files has led to innovative initiatives such as creating specialized teams for treatment monitoring, 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 in treating type 2 diabetes.
• ❓ Why is the specific form mandatory?
  This form verifies that the prescription complies with reimbursable therapeutic indications, ensuring better expense control and misuse prevention.
• ❓ How does third-party payment suspension work?
  When the form or necessary justification is missing, pharmacists must ask the patient to pay immediately, impacting treatment access.
• ❓ 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, medication quality, and pharmacovigilance.
• ❓ What are future prospects?
  Health insurance is working on modernizing control tools through digitization, artificial intelligence, and improving dialogue with healthcare professionals to balance safety and accessibility.

Source: www.lemoniteurdespharmacies.fr