Approval of reimbursement for “monotherapy for the first-line treatment of adult and adolescent patients 12 years and older with advanced RET-mutant medullary thyroid cancer (MTC)”.
Clinical Benefit
Substantial
The Committee deems that the clinical benefit of RETSEVMO (selpercatinib) 40 mg and 80 mg, hard capsules, is substantial for the indication “as monotherapy for the first-line treatment of adult and adolescent patients 12 years and older with advanced RET-mutant medullary thyroid cancer (MTC)”.
Clinical Added Value
minor
As first-line treatment, in view of:
evidence of superiority of RETSEVMO (selpercatinib) in relation to cabozantinib or vandetanib in terms of progression-free survival assessed by an independent review committee (HR = 0.280; 95% CI [0.165; 0.475], p<0.0001), in a randomised, open-label phase III study (LIBRETTO-531);
safety deemed to be favourable;
treatment considered to be similar for both adults and adolescents. As the studies (LIBRETTO and LIBRETTO-531) only included 3 adolescents, the efficacy data for adults have been accepted as suitable for extrapolation to adolescents 12 years and older,
and despite:
the lack of evidence of an improvement in overall survival (non-ranked secondary outcome measure) during the interim analysis, in a context of advanced-stage disease with an unfavourable prognosis;
the lack of formal conclusions that can be drawn from the exploratory quality-of-life findings;
the findings available with a short follow-up period (median follow-up of 1 year at the interim analysis that has become the primary analysis);
the Committee deems that RETSEVMO (selpercatinib) 40 mg and 80 mg, hard capsules, provides minor clinical added value (CAV IV) in relation to vandetanib or cabozantinib, for the first-line treatment of adult and adolescent patients 12 years and older with advanced RET-mutant medullary thyroid cancer (MTC).
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