TECENTRIQ (atezolizumab) - Carcinome hepatocellulaire (CHC)

Key points

Favourable opinion for reimbursement in combination with bevacizumab for the treatment of adult patients with advanced or unresectable hepatocellular carcinoma (HCC), who have not received prior systemic therapy only in patients with preserved hepatic function (Child-Pugh A), an ECOG score of 0 or 1, andnot eligible for locoregional therapies or in the event of failure of one of these therapies.

Unfavourable opinion for reimbursement in other situations.

What therapeutic improvement?

Therapeutic improvement compared to sorafenib.

Role in the care pathway?

The treatment of hepatocellular carcinoma (HCC) depends on the disease stage and general health status of patients.

Patients in whom HCC was diagnosed at an early stage (BCLC stage A) are generally eligible for curative treatment via surgery, transplantation or radiofrequency ablation. In the event of non-eligibility, treatment by transcatheter arterial chemoembolisation (TACE) may be proposed.

In patients in whom the disease has progressed, or who are diagnosed at the multinodular stage (BCLB stage B) with an ECOG score of 0 and preserved hepatic function (Child-Pugh A), TACE is recommended. In the event of a contraindication to TACE, or following the failure of TACE, a systemic treatment is recommended. Selective internal radiation therapy may be considered, but only concerns certain patients selected following a specific opinion reached at a multidisciplinary team meeting.

In patients in whom the disease has progressed, or who are diagnosed at the portal invasion and/or extrahepatic extension stage (BCLC C), with an ECOG score of between 0 and 2 and preserved hepatic function (Child-Pugh A), systemic treatment is recommended as first-line therapy (sorafenib). It should be noted that the adverse effects frequently associated with sorafenib are hand-foot syndrome, diarrhoea, alopecia, decreased appetite, fever and rash.

In patients in whom the disease has progressed, or who are diagnosed at a very advanced staged with impaired hepatic function and an ECOG stage of 3 or 4, only supportive care or inclusion in a clinical trial are recommended.

Role of the medicinal product in the care pathway

Considering demonstration of a clinically relevant benefit compared to sorafenib in terms of overall survival in a highly selective patient population (Child-Pugh A, ECOG 0 or 1), the Transparency Committee deems that TECENTRIQ (atezolizumab), in combination with bevacizumab, is a first-line treatment in patients with advanced or unresectable hepatocellular carcinoma, who have not received prior systemic therapy, with preserved hepatic function (Child-Pugh A), an ECOG score of 0 or 1, and not eligible for locoregional therapies or in the event of failure of one of these therapies. Outside these situations, this combination has no role in the absence of clinical data.

The safety profile of atezolizumab is marked by a lower incidence of hand-foot syndrome, diarrhoea, alopecia, decreased appetite, fever and rash (known to be associated with sorafenib), and by a more frequent occurrence of infusion reactions and immunological hypo and hyperthyroidism.

Uncertainties with respect to the level of efficacy depending on the various aetiologies persist, particularly in the event of non-viral aetiology, encouraging the implementation of follow-up of patients treated with TECENTRIQ (atezolizumab).

The Committee wishes to draw the attention of prescribers to the need for specific vigilance with respect to the risk of GI bleeding (cirrhotic patients and combination with an anti-angiogenic: bevacizumab).

It also wishes to remind prescribers that all patients with active hepatitis B (HVB) must be given concomitant anti-HVB therapy throughout the duration of treatment.

Avis économique

Ce produit a fait l'objet d'un avis économique rendu par la Commission d'évaluation économique et de santé publique le 13 avril 2021.

L’avis économique porte sur l’indication demandée au remboursement, à savoir l’atezolitumab en association au bevacizumab, dans le traitement des patients adultes atteints d'un carcinome hépatocellulaire (CHC) avancé ou non résécable, n’ayant pas reçu de traitement systémique antérieur, avec une fonction hépatique préservée (stade Child-Pugh A) et non éligibles aux traitements locorégionaux ou en échec à l’un de ces traitements. Cette indication est plus restreinte que celle décrite par l’AMM, et concerne moins de 40% de la population couverte par l’AMM.

La CEESP a été en mesure de conclure sur le niveau d’efficience du produit, avec un ratio différentiel coût-résultat (RDCR) de 144 156 €/QALY gagné versus le sorafenib sur un horizon temporel de 15 ans. L’impact budgétaire de l’arrivée de l’atezolizumab dans cette indication génère une hausse d’environ 163% des dépenses de l’Assurance maladie par rapport à la prise en charge actuelle de ces patients.

> TECENTRIQ - Avis économique (pdf)