HAS - Avis économiques

ITOVEBI (inavolisib) - Breast cancer, at the locally advanced or metastatic stage

Wed, 21 Jan 2026 12:10:01 +0100

Inclusion on list

Favourable opinion for reimbursement in the indication: “ITOVEBI, in combination with palbociclib and fulvestrant, is indicated for the treatment of adult patients with PIK3CA-mutated, oestrogen receptor (ER)-positive, HER2-negative, locally advanced or metastatic breast cancer, following recurrence on or within 12 months of completing adjuvant endocrine treatment.

Patients previously treated with a CDK 4/6 inhibitor in the (neo)adjuvant setting should have had an interval of at least 12 months between termination of CDK 4/6 inhibitor treatment and the detection of recurrence.

In pre/perimenopausal women and in men, endocrine therapy should be combined with a luteinising hormone-releasing hormone (LHRH) agonist.”

IMFINZI (durvalumab) - Limited-stage small cell lung cancer (LS-SCLC)

Fri, 16 Jan 2026 12:10:00 +0100

Inclusion on list

Favourable opinion for reimbursement in the indication: “IMFINZI as monotherapy is indicated for the treatment of adults with lim ted-stage small cell lung cancer (LS-SCLC) whose disease has not progressed following platinum-based chemoradiation therapy”.

COMIRNATY (COVID-19 mRNA vaccine (nucleoside modified)) - SARS-CoV-2 in individuals 6 months of age and older

Thu, 15 Jan 2026 12:10:00 +0100

Inclusion on list

Favourable opinion for reimbursement for active immunisation to prevent COVID-19 caused by SARS-CoV-2 in individuals 6 months of age and older, in accordance with the current HAS recommendations.

EVOLUT PRO+

Tue, 6 Jan 2026 12:10:00 +0100

EVOLUT FX

Tue, 6 Jan 2026 12:10:00 +0100

VYJUVEK (beremagene geperpavec) - Dystrophic epidermolysis bullosa (DEB)

Tue, 4 Nov 2025 12:10:00 +0100

Inclusion on list

Favourable opinion for reimbursement in “the treatment of wounds in patients with dystrophic epidermolysis bullosa (DEB) with mutation(s) in the collagen type VII alpha 1 chain (COL7A1) gene, from birth”.

COLUMVI (glofitamab) - Diffuse large B-cell lymphoma not otherwise specified (DLBCL NOS)

Thu, 23 Oct 2025 12:10:00 +0200

Inclusion on list

Favourable opinion for reimbursement of COLUMVI in the indication: “COLUMVI in combination with gemcitabine and oxaliplatin is indicated for the treatment of adult patients with relapsed or refractory diffuse large B-cell lymphoma not otherwise specified (DLBCL NOS) who are ineligible for autologous stem cell transplant (ASCT)”.

OPDIVO/YERVOY (nivolumab/ipilimumab) - Colorectal cancer (CRC)

Tue, 14 Oct 2025 12:10:01 +0200

Indication extension

Favourable opinion for reimbursement only in the “first-line treatment of metastatic microsatellite instability-high (MSI-H) or mismatch repair deficient (dMMR) colorectal cancer (CRC) in adults unresectable from the outset”.

and

Unfavourable opinion for reimbursement in the other situations covered by the MA indication.

KAFTRIO (ivacaftor/tezacaftor/elexacaftor) / KALYDECO (ivacaftor) - Cystic fibrosis patients aged 2 years and older

Wed, 17 Sep 2025 12:10:00 +0200

Modification of the listing conditions

Favourable opinion for reimbursement of “KAFTRIO (ivacaftor/tezacaftor/elexacaftor) is indicated in combination with KALYDECO (ivacaftor) in the treatment of cystic fibrosis patients aged 2 years and older, who are carriers of at least one non-class I mutation of the CFTR (cystic fibrosis transmembrane conductance regulator) gene and who are not carriers of an F508del mutation of the CFTR gene”.

JEMPERLI (dostarlimab) - Endometrial cancer (EC)

Wed, 30 Jul 2025 12:10:00 +0200

Inclusion on list

Favourable opinion for reimbursement in the indication: “JEMPERLI is indicated in combi nation with carboplatin and paclitaxel for the first-line treatment of adult patients with pri mary advanced or recurrent endometrial cancer (EC) and who are candidates for systemic therapy.”

CARVYKTI (ciltacabtagene autoleucel) - Multiple myeloma

Mon, 4 Aug 2025 12:10:00 +0200

Inclusion on list

Favourable opinion for reimbursement in “the treatment of adult patients with relapsed and refractory multiple myeloma, who have received at least one prior therapy, including an immunomodulatory agent and a proteasome inhibitor, have demonstrated disease progression on the last therapy, and are refractory to lenalidomide”.

RYBREVANT / LAZCLUZE (amivantamab / lazertinib) - Non-small cell lung cancer (NSCLC)

Tue, 29 Jul 2025 12:10:00 +0200

Inclusion on list

Favourable opinion for reimbursement in the following indications:

RYBREVANT (amivantamab): “RYBREVANT, in combination with lazertinib for the first-line treatment of adult patients with advanced non-small cell lung cancer (NSCLC) with EGFR Exon 19 deletions or Exon 21 L858R substitution mutations.”
LAZCLUZE (lazertinib): “LAZCLUZE, in combination with amivantamab, for the first line treatment of adult patients with advanced non-small cell lung cancer (NSCLC) with EGFR Exon 19 deletions or Exon 21 L858R substitution mutations.”

BLINCYTO (blinatumomab) - Lymphoblastic leukaemia (ALL)

Fri, 11 Jul 2025 12:10:01 +0200

Indication extension

Favourable opinion for reimbursement “as monotherapy as part of consolidation therapy for the treatment of adult patients with Philadelphia chromosome negative CD19 positive B-cell precursor acute lymphoblastic leukaemia (ALL) in first complete remission with negative minimal residual disease (MRD).”

GARDASIL 9 (human papillomavirus 9-valent vaccine (recombinant, adsorbed)) - Vaccine against HPV

Thu, 3 Jul 2025 12:10:00 +0200

Modification of inclusion conditions following updating of the HAS recommendations in 2025

Favourable opinion for reimbursement in the MA indication in the prevention of infections and lesions due to certain oncogenic types of Human Papillomavirus (HPV), in girls and boys, in accordance with the conditions defined in the current vaccine schedule and the HAS vaccination recommendations of 30 April 2025.

TRICLIP G4

Thu, 26 Jun 2025 12:10:01 +0200

WINREVAIR (sotatercept) - Pulmonary arterial hypertension (PAH)

Mon, 19 May 2025 12:00:00 +0200

First listing.

Favourable opinion for reimbursement, in combination with other pulmonary arterial hypertension (PAH) therapies, for the treatment of PAH in adult patients with WHO Functional Class (FC) II to III, to improve exercise capacity.

EFLUELDA (trivalent influenza vaccine (split virion, inactivated) - Prevention of influenza

Tue, 20 May 2025 12:00:00 +0200

Inclusion on list

Favourable opinion for reimbursement in the prevention of influenza in adults 65 years of age and older in accordance with the current vaccination recommendations (HAS opinions of 6 February 2025 and 10 April 2025).

RYBREVANT (amivantamab) - cell lung cancer (NSCLC) - (Exon 19 deletions or Exon 21)

Wed, 7 May 2025 12:00:00 +0200

Indication extension

Favourable opinion for reimbursement in the indication: “In combination with carboplatin and pemetrexed for the treatment of adult patients with advanced non-small cell lung cancer (NSCLC) with epithelial growth factor receptor (EGFR) Exon 19 deletions or Exon 21 L858R substitution mutations after failure of prior therapy including an EGFR tyrosine kinase inhibitor (TKI).”

ELAHERE (mirvetuximab soravtansine) - Epithelial ovarian

Fri, 11 Apr 2025 12:00:00 +0200

Inclusion on list

Favourable opinion for reimbursement in the indication “ELAHERE as monotherapy is indicated for the treatment of adult patients with folate receptor-alpha (FRα) positive, platinum-resistant high grade serous epithelial ovarian, fallopian tube, or primary peritoneal cancer who have received one to three prior systemic treatment regimens”.

PADCEV (enfortumab vedotin) - Urothelial carcinoma

Tue, 11 Feb 2025 12:00:00 +0100

Inclusion on list.

Favourable opinion for reimbursement “in combination with pembrolizumab, in the first-line treatment of adult patients with unresectable or metastatic urothelial carcinoma who are eligible for platinum-based chemotherapy”.

JEMPERLI (dostarlimab) - Endometrial cancer

Fri, 17 Jan 2025 12:00:01 +0100

First listing.

Favourable opinion for reimbursement in the following indication: “in combination with carboplatin and paclitaxel for the treatment of adult patients with mismatch repair deficient (dMMR)/microsatellite instability-high (MSI-H) primary advanced or recurrent endometrial cancer (EC) and who are candidates for systemic therapy.

BRIUMVI (ublituximab) - Multiple sclerosis (MS)

Mon, 20 Jan 2025 12:00:00 +0100

First listing.

Favourable opinion for reimbursement in the treatment of adult patients with relapsing forms of multiple sclerosis (RMS) with active disease defined by clinical or imaging features.

WEGOVY (semaglutide) - Obesity

Fri, 29 Nov 2024 12:00:02 +0100

Second assessment of an unlisted medicinal product.

Favourable opinion for reimbursement only “as an adjunct to a reduced-calorie diet and increased physical activity for weight management, including weight loss and weight maintenance, in adults with an initial body mass index (BMI) ≥ 35 kg/m² in the event of failure of well-conducted nutritional management (< 5% weight loss after six months)”.

FABHALTA (iptacopan) - Paroxysmal nocturnal haemoglobinuria (PNH)

Fri, 22 Nov 2024 12:00:00 +0100

First listing.

Favourable opinion for reimbursement only in “the treatment of adult patients with paroxysmal nocturnal haemoglobinuria (PNH) who have symptomatic haemolytic anaemia after treatment with a C5 inhibitor for at least 6 months”.

Unfavourable opinion for reimbursement in the other situations covered by the MA indication.

LIBMELDY (atidarsagene autotemcel) - Metachromatic leukodystrophy (MLD)

Mon, 11 Nov 2024 12:00:00 +0100

First listing.

Favourable opinion for maintenance of reimbursement in the treatment of metachromatic leukodystrophy (MLD) characterised by biallelic mutations in the arylsulfatase A (ARSA) gene leading to a reduction of the ARSA enzymatic activity:

in asymptomatic children, without clinical manifestations of the disease in terms of motor, cognitive and/or behavioural functional impairment, with late infantile (onset before 30 months of age) or early juvenile (onset from 30 months to 6 years of age inclusive) forms,

In symptomatic children with early clinical manifestations of the disease, who still have the ability to walk independently and before the onset of cognitive decline, with the early juvenile form (onset from 30 months to 6 years of age inclusive).

DUPIXENT (dupilumab) - Chronic obstructive pulmonary disease (COPD)

Wed, 13 Nov 2024 12:00:00 +0100

Indication extension.

Favourable opinion for reimbursement “in adults as add-on maintenance treatment for uncontrolled chronic obstructive pulmonary disease (COPD) characterised by raised blood eosinophils on a combination of an inhaled corticosteroid (ICS), a long-acting beta2-agonist (LABA), and a long-acting muscarinic antagonist (LAMA), or on a combination of a LABA and a LAMA if ICS is not appropriate”.

CASGEVY (exagamglogEne autotemcel) - Transfusion-dependent β-thalassaemia (TDT)

Mon, 30 Sep 2024 12:00:00 +0200

First listing.

Favourable opinion for reimbursement only in patients 12 to 35 years of age in the indiction “treatment of transfusion-dependent β-thalassaemia (TDT) in patients for whom haematopoietic stem cell (HSC) transplantation is appropriate and a human leukocyteantigen (HLA)-matched related HSC donor is not available”.

The Committee makes maintenance of the substantial clinical benefit conditional on reevaluation of the medicinal product within a maximum period of 3 years, based on the additional results requested.

Unfavourable opinion for reimbursement in the other situations covered by the MA indication (patients over 35 years of age).

SKYCLARYS (omaveloxolone) - Friedreich’s ataxia

Fri, 20 Sep 2024 12:00:00 +0200

First listing.

Favourable opinion for reimbursement in “the treatment of Friedreich’s ataxia in adults and adolescents aged 16 years and older”.

LONSURF (trifluridine/tipiracil) - Colorectal cancer

Thu, 12 Sep 2024 12:00:00 +0200

Indication extension.

Favourable opinion for reimbursement within a restricted scope: patients with metastatic colorectal cancer (ECOG score 0-1) who have been previously treated with fluoropyrimidine-, oxaliplatin- and irinotecan-based chemotherapies, an anti-VEGF biologic therapy, and, in the event of a RAS wild type gene, an anti-EGFR agent.

ABRYSVO (respiratory syncytial virus vaccine (bivalent, recombinant)) - Respiratory syncytial virus (RSV)

Mon, 29 Jul 2024 14:00:00 +0200

First listing.

Favourable opinion for reimbursement in the passive protection against lower respiratory tract disease caused by respiratory syncytial virus (RSV) in infants from birth through 6 months of age following maternal immunisation during pregnancy in accordance with the current HAS vaccine recommendations of 6 June 2024.

LIFEVEST 4000

Fri, 14 Jun 2024 12:00:00 +0200

SHINGRIX (adjuvanted recombinant herpes zoster vaccine) - Zoster vaccine)

Tue, 23 Apr 2024 12:00:01 +0200

Initial inclusion.

Approval of reimbursement for prevention of herpes zoster and post-herpetic neuralgia in adults 65 years of age and older, and adults 18 years of age and older at increased risk of herpes zoster, according to the HAS guidelines in force dated 29 February 2024.

NUVAXOVID (SARS-CoV-2 Spike protein adjuvanted with Matrix-M) - COVID-19

Tue, 19 Mar 2024 12:00:00 +0100

Summary of opinion.

Favourable opinion for reimbursement for active immunisation to prevent COVID-19 caused by SARS-CoV-2 in individuals 12 years of age and older, in accordance with the current HAS recommendations.

OMNIPOD 5 (pompe à insuline et contrôleur OMNIPOD 5 + système de mesure du glucose interstitiel DEXCOM G6)

Fri, 16 Feb 2024 12:00:00 +0100

TRODELVY (sacituzumab govitecan) - Cancer du sein

Wed, 24 Jan 2024 12:00:02 +0100

Extension d'indication.

Avis favorable au remboursement en monothérapie pour les adultes atteints de cancer du sein avec récepteurs hormonaux positifs (RH+) et HER2-négatif non résécable ou métastatique ayant déjà reçu une hormonothérapie, et au moins deux traitements systémiques additionnels au stade avancé de la maladie.

Un progrès thérapeutique dans la prise en charge.

NUBEQA (darolutamide) - Metastatic hormone-sensitive prostate cancer

Fri, 1 Dec 2023 12:00:00 +0100

First assessment.

OPDIVO (nivolumab) - CBNPC (cancer bronchique non à petites cellules)

Tue, 7 Nov 2023 12:00:01 +0100

Extension d'indication.

Avis favorable au remboursement uniquement « en association à une chimiothérapie à base de sels de platine, dans le traitement néoadjuvant des patients adultes, atteints d'un cancer bronchique non à petites cellules résécable à haut risque de récidive, dont les tumeurs expriment PD-L1 au seuil ≥ 1 % et dont les tumeurs ne présentent pas de mutation sensibilisante de l’EGFR connue, ni de translocation ALK connue ».

Un progrès thérapeutique par rapport aux chimiothérapies à base de sels de platine.

VAXNEUVANCE (pneumococcal polysaccharide conjugate vaccine (15-valent, adsorbed)) - Streptococcus pneumoniae from 6 weeks to less than 18 years of age

Wed, 18 Oct 2023 12:00:00 +0200

First assessment.

CAMZYOS (mavacamten) - Obstructive hypertrophic cardiomyopathy

Wed, 25 Oct 2023 12:00:01 +0200

Initial inclusion.

TIBSOVO (ivosidenib) - Acute myeloid leukaemia (AML)

Wed, 11 Oct 2023 12:00:01 +0200

SPIKEVAX (elasomeran / davesomeran / andusomeran) - COVID-19

Thu, 5 Oct 2023 12:00:00 +0200

Initial inclusion.

BREYANZI (lisocabtagene maraleucel) 1.1-70x10^6 cells/mL/1.1-70x10^6 cells/mL dispersion for infusion

Tue, 3 Oct 2023 12:00:00 +0200

ROCTAVIAN (valoctocogène roxaparvovec) - Hémophilie A

Fri, 15 Sep 2023 12:00:00 +0200

Première évaluation.

Avis favorable au remboursement dans l’indication de l’AMM.

Pas de progrès dans la prise en charge.

HEMGENIX (etranacogene dezaparvovec) - Hémophilie B

Thu, 7 Sep 2023 12:00:00 +0200

Primo-inscription.

Avis favorable au remboursement dans l’indication de l’AMM.

Un progrès dans la stratégie de prise en charge.

EBVALLO (tabelecleucel) - Malignant hematopathy

Tue, 4 Jul 2023 12:00:00 +0200

Primo-inscription.

Avis favorable au remboursement en monothérapie dans le traitement des patients adultes et pédiatriques âgés de 2 ans et plus atteints d’une maladie lymphoproliférative post-transplantation et positive au virus d’Epstein-Barr récidivante ou réfractaire (LPT EBV+) qui ont reçu au moins un traitement antérieur. Pour les patients ayant reçu une transplantation d’organe solide, le traitement antérieur comprend la chimiothérapie, sauf si celle-ci est inappropriée.

Un progrès dans la stratégie de prise en charge.

ENHERTU (trastuzumab deruxtecan) - HER2-low breast cancer

Tue, 6 Jun 2023 12:01:19 +0200

New indication.

ZOLGENSMA (onasemnogene abeparvovec) - Spinal muscular atrophy (SMA)

Tue, 23 May 2023 12:00:00 +0200

Reassessment.

Favourable opinion for reimbursement only in “the treatment of patients with 5q spinal muscular atrophy (SMA) (biallelic mutation in the SMN1 gene):

in pre-symptomatic patients with up to 3 copies of the SMN2 gene
with a clinical diagnosis of SMA type 1, 2 or 3”.

Therapeutic improvement only in pre-symptomatic patients with 3 copies of the SMN2 gene.

PLUVICTO (lutetium (177Lu) vipivotide tetraxetan) - Prostate cancer

Wed, 24 May 2023 12:00:01 +0200

First assessment.

Favourable opinion for reimbursement “in combination with androgen deprivation therapy (ADT) with or without androgen receptor (AR) pathway inhibition for the treatment of adult patients with progressive prostate-specific membrane antigen (PSMA)-positive metastatic castration-resistant prostate cancer (mCRPC) who have been treated with AR pathway inhibition and taxane-based chemo-therapy”.

DUPIXENT (dupilumab) - Prurigo nodularis (PN)

Fri, 14 Apr 2023 12:00:00 +0200

New indication.

Favourable opinion on reimbursement in "the treatment of adults with moderate-to-severe prurigo nodularis (PN) who are candidates for systemic therapy".

Therapeutic improvement in the management strategy.

ENHERTU (trastuzumab déruxtécan) - Cancer du sein HER2

Wed, 29 Mar 2023 12:00:00 +0200

Nouvelle indication.

Avis favorable au remboursement dans « en monothérapie est indiqué dans le traitement des patients adultes présentant un cancer du sein HER2 positif non résécable ou métastatique ayant reçu préalablement au moins une ligne de traitement anti-HER2 ».

Un progrès thérapeutique dans la stratégie de prise en charge.