#SFHS2607886ADecree of 27 March 2026 amending the list of pharmaceutical specialties approved for use by public authorities and various public services
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This French decree expands national health insurance reimbursement for the cancer immunotherapy drug Keytruda (pembrolizumab). It adds four new therapeutic indications effective 3 April 2026. The new covered uses are: (1) first-line treatment with enfortumab vedotin for adults with unresectable or metastatic urothelial carcinoma eligible for platinum chemotherapy; (2) combination with chemoradiotherapy (external radiotherapy followed by brachytherapy) for adult women with FIGO 2014 stage III locally advanced cervical cancer; (3) first-line treatment with trastuzumab and platinum/fluoropyrimidine chemotherapy for adults with HER2-positive, PD-L1 CPS ≥1 locally advanced unresectable or metastatic gastric or gastroesophageal junction adenocarcinoma; and (4) first-line combination with carboplatin and paclitaxel for adult women with newly diagnosed advanced or recurrent endometrial cancer eligible for systemic therapy. The two affected presentations are the 4 mL single-vial and 2-vial packs of 25 mg/mL pembrolizumab concentrate for solution for infusion marketed by MSD France.
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Key Changes
- Effective date: 3 April 2026
- Adds reimbursement for Keytruda + enfortumab vedotin as first-line therapy for unresectable/metastatic urothelial carcinoma eligible for platinum chemotherapy
- Adds reimbursement for Keytruda + chemoradiotherapy (external RT + brachytherapy) in FIGO 2014 stage III locally advanced cervical cancer without prior definitive treatment
+ 3 more changes with Pro
Obligations
What this law requires
Add four new therapeutic indications for Keytruda (pembrolizumab) to the national health insurance reimbursement list effective 3 April 2026
Limit Keytruda reimbursement for urothelial carcinoma to first-line treatment only when used in combination with enfortumab vedotin and patient is eligible for platinum-based chemotherapy
Limit Keytruda reimbursement for cervical cancer to combination use with chemoradiotherapy (external radiotherapy followed by brachytherapy) in adult women with FIGO 2014 stage III locally advanced cervical cancer who have not received prior definitive treatment
Limit Keytruda reimbursement for gastric cancer to first-line treatment only when used in combination with trastuzumab and platinum/fluoropyrimidine chemotherapy in HER2-positive patients with PD-L1 CPS ≥1
Limit Keytruda reimbursement for endometrial cancer to first-line treatment only when used in combination with carboplatin and paclitaxel in adult women with newly diagnosed advanced or recurrent endometrial cancer eligible for systemic therapy