The French Higher Authority on Healthcare's Transparency Commission has assessed the clinical value and therapeutic advantage of Roche (Switzerland)'s Gazyvaro (obinutuzumab) and Takeda (Japan)'s Entyvio (vedolizumab) against their comparators.
IHS Life Sciences perspective | |
Significance | France's Transparency Commission has issued recommendations for the inclusion of two treatments to the national reimbursement list. |
Implications | Roche (Switzerland)'s Gazyvaro and Takeda (Japan)'s Entyvio will be included on the reimbursement list. |
Outlook | The reimbursement opinion provided by the commission will inform negotiations between the companies and the French pricing committee, with the decision to be taken by the National Union of Health Insurance Funds on the level of reimbursement granted to the treatments. |
Gazyvaro brings moderate improvement in actual benefit for CLL
France's Transparency Commission (TC) has issued a positive opinion for reimbursement for Roche (Switzerland)'s Gazyvaro (obinutuzumab) granting an "important" clinical value rating (SMR) for its use in combination with chlorambucil for the treatment of adult patients with previously untreated chronic lymphocytic leukaemia (CLL) and with co-morbidities making them unsuitable for full-dose fludarabine-based therapy.
Furthermore, the Commission concluded that Gazyvaro provides a moderate improvement in terms of therapeutic advantage (ASMR III). In particular, the TC assigned an ASMR III taking into account the efficacy improvement brought by the combination Gazyvaro + chlorambucil compared to MabThera (rituximab; Roche, Switzerland) + chlorambucil, mainly in terms of reduction of residual disease rates. However, a higher toxicity was observed for the combination Gazyvaro + chlorambucil versus MabThera + chlorambucil. The full decision is available, in French, here.
Entyvio receives mixed opinion for reimbursement
The TC also assigned Takeda (Japan)'s Entyvio (vedolizumab) an "important" clinical value rating (SMR) for its use in the treatment of moderate-to-severe active ulcerative colitis (UC) in patients with an inadequate or lost response to, or were intolerant of corticosteroids, immunosuppressants, or tumour necrosis factor-alpha (TNFa). Entyvio also received a "moderate" SMR rating for its use in the treatment of adult patients with moderately to severely active Crohn's disease who have had an inadequate or lost response to, or were intolerant of corticosteroids or a tumour necrosis factor-alpha (TNFa) antagonist. Finally, the TC assigned an "insufficient" rating for use of Entyvio in the treatment of moderate-to-severe active UC in anti-TNF-naïve patients in the absence of a comparative study with Entyvio versus anti-TNF treatments.
In terms of therapeutic advantage, Entyvio provides a minor improvement (ASMR IV) in patients with a moderate to severe active ulcerative colitis with an inadequate response with, lost response to, or were intolerant to corticosteroids, immunosuppressants or tumour necrosis factor-alpha (TNFa). In the patient population with moderately to severely active Crohn's disease who has had an inadequate response with, lost response to, or was intolerant to corticosteroids, or a tumour necrosis factor-alpha (TNFa) antagonist, Entyvio does not provide any improvement in therapeutic advantage (ASMR V). The ASMR rating for anti-TNF-naïve UC patients means the medicine is not reimbursed for this patient population. The full decision is available, in French, here.
Outlook and implications
The TC decisions will constitute the basis for final decisions from the French pricing committee, the CEPS, and the National Union of Health Insurance Funds (UNCAM) on the price of the drug and the level of reimbursement, respectively. Furthermore, as the two drugs are expected to generate sales of more than EUR20 million (USD21.5 million) in the second year of commercialisation, they have been subject to a pharmaco-economic analysis conducted by the Commission for Economic Evaluation and Public Health (CEESP), which also plays a role in the negotiation between the manufacturer and the CEPS for setting the price of the therapies.
The decision published for Gazyvaro is likely to be favourable for Roche as the medicine is expected to receive full reimbursement through the French healthcare system due to the severity of the disease and the SMR rating. Furthermore, in terms of pricing, the ASMR III may enable Gazyvaro to obtain the European-level price guarantee, whereby the price will not be lower than the lowest price in the four countries that France uses as references, namely the United Kingdom, Germany, Italy, and Spain, for a period of five years starting from inclusion in the reimbursement list. Gazyvaro was approved for commercialisation in Europe in July 2014 (see Europe: 29 July 2014: Roche's CLL treatment Gazyvaro approved by European Commission).
Meanwhile, the mixed decisions published for Entyvio may weaken Takeda's position at the negotiation table with the CEPS. In particular, the ASMR V granted to the drug for its use in Crohn's disease patients may counterbalance the ASMR IV assigned due to the minor improvement found for its use in UC patients.