Reason for request

Inclusion on list

Summary of opinion

Favourable opinion for reimbursement only:

  • as monotherapy, for the first-line treatment of adults with advanced RET fusion-positive non-small cell lung cancer (NSCLC), not previously treated with a RET inhibitor;
  • as monotherapy, for the second- and later-line treatment of adults with advanced RETfusion-positive non-small cell lung cancer (NSCLC), not previously treated with a RET inhibitor;
  • as monotherapy, for the first-line treatment of adults and adolescents 12 years and older with advanced RET-mutant medullary thyroid cancer (MTC);
  • as monotherapy, for the second and later-line treatment of adults and adolescents 12 years and older with advanced RET-mutant medullary thyroid cancer (MTC).

No clinical added value of the new film-coated tablet forms compared to the capsule forms already available.


Clinical Benefit

Substantial

The clinical benefit of RETSEVMO 40 mg and 80 mg (selpercatinib) film-coated tablets is substantial, as monotherapy, for the first-line treatment of adults with advanced RET fusion-positive non-small cell lung cancer (NSCLC), not previously treated with a RET inhibitor.

 

Low

The clinical benefit of RETSEVMO 40 mg and 80 mg (selpercatinib) film-coated tablets is low, as monotherapy, for the second and later-line treatment of adults and adolescents 12 years and older with advanced RET-mutant medullary thyroid cancer (MTC).


Clinical Added Value

no clinical added value

These new film-coated tablet forms of RETSEVMO 40 mg and 80 mg (selpercatinib) are range supplements that do not provide any clinical added value (CAV V) compared to the capsule forms already listed.


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