France: Reimbursement rate of gliptins revised downwards

In line with legislation published in the Official Journal (Journal Officiel) on 1st February 2022, the reimbursement rate of gliptins has been revised downwards. Accordingly, as of 1st February 2022: 

• The reimbursement rate of sitagliptin (Januvia 50mg and 100mg, and Xelevia 50mg and 100mg), and sitagliptin in combination with metformin (Janumet 50mg/1000mg and Velmetia 50mg/1000mg) is set at 30% (down from 65%) 
• The reimbursement rate of vildagliptin (Galvus 50mg), and vildagliptin in combination with metformin (Eucreas 50mg/1000mg), as well as saxagliptin (Onglyza 5mg), and saxagliptin in combination with metformin (Komboglyze 2.5mg/1000mg) is set at 15% (also down from 65%).  

The changes follow a July 2021 review by the Transparency Commission (Commission de la Transparence, CT) of the drugs’ medical benefit (service médical rendu, SMR) and improvement in medical benefit (amélioration du service médical rendu, ASMR) ratings in response to the arrival of new therapeutic options to treat diabetes eg SGLT2 inhibitors.  

The CT also specified that gliptins should only be used in combination with other diabetes treatments either as bitherapy (with metformin or a sulfonylurea) or as tritherapy (with metformin and a sulfonylurea or with metformin and insulin). Only sitagliptin (25mg and 50mg doses) can be used as a monotherapy in type 2 diabetes patients with moderate, severe or terminal renal insufficiency.  

Sources:

1. www.legifrance.gouv.fr, “Avis relatif à la décision de l’Union nationale des caisses d’assurance maladie portant fixation du taux de participation de l’assuré applicable à des spécialités pharmaceutiques – texte no 110”, 1st February 2022 
2. www.legifrance.gouv.fr, “Avis relatif à la décision de l’Union nationale des caisses d’assurance maladie portant fixation du taux de participation de l’assuré applicable à des spécialités pharmaceutiques – texte no 109”, 1st February 2022 
3. www.vidal.fr, “Diabète de type 2: baisse du taux de remboursement des gliptines (sita-, vilda-, saxa-)”, 3rd February 2022 
4. www.has-sante.fr, “COMMISSION DE LA TRANSPARENCE AVIS 21 JUILLET 2021”, accessed 7th February 2022  
5. https://www.has-sante.fr/upload/docs/evamed/CT-19184_GLIPTINES_REEVAL_PIC_%20Avis%20def_CTEVAL520.pdf 
6. https://www.vidal.fr/actualites/28657-diabete-de-type-2-baisse-du-taux-de-remboursement-des-gliptines-sita-vilda-saxa.html