Retevmo - NC Standard
Restricted Product(s)
- Retevmo® (selpercatinib)
FDA Approved Use
- For the treatment of adult patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) with a rearranged during transfection (RET) gene fusion, as detected by an FDA-approved test
- For the treatment of adult and pediatric patients 2 years of age and older with advanced or metastatic medullary thyroid cancer (MTC) with a RET mutation, as detected by an FDA-approved test, who require systemic therapy.
- For the treatment of adult and pediatric patients 2 years of age and older with advanced or metastatic thyroid cancer with a RET gene fusion, as detected by an FDA-approved test, who require systemic therapy and who are radioactive iodine-refractory (if radioactive iodine is appropriate).
- For the treatment of adult and pediatric patients 2 years of age and older with locally advanced or metastatic solid tumors with a RET gene fusion, as detected by an FDA-approved test, that have progressed on or following prior systemic treatment or who have no satisfactory alternative treatment options.
Criteria for Approval of Restricted Product(s)
- The patient is currently taking the requested medication for a cancer diagnosis; AND
- The patient will utilize the generic formulation of this product (if available); OR
- The patient is being managed by or in consultation with an oncologist; AND
- The patient has a confirmed diagnosis of metastatic non-small cell lung cancer (NSCLC); AND
- The patient is 18 years of age and older; AND b. The tumor has been identified as RET fusion-positive by an FDA-approved test (medical record documentation required); OR
- The patient has a confirmed diagnosis of advanced or metastatic medullary thyroid cancer (MTC); AND
- The patient is 2 years of age and older; AND
- The tumor has been identified as RET-mutant by an FDA-approved test (medical record documentation required); AND
- The patient requires systemic therapy to stop or delay disease progression; OR
- The patient has a confirmed diagnosis of advanced or metastatic thyroid cancer; AND
- The patient is 2 years of age and older; AND
- The tumor has been identified as RET fusion-positive by an FDA-approved test (medical record documentation required); AND
- The patient requires systemic therapy to stop or delay disease progression; AND
- The patient’s disease is radioactive iodine-refractory or radioactive iodine is inappropriate; OR
- The patient has a confirmed diagnosis of locally advanced or metastatic solid tumors; AND
- The patient is 2 years of age and older; AND
- The tumor has been identified as RET fusion-positive by an FDA-approved test (medical record documentation required); AND
- The patient has progressed on prior systemic therapy or has no satisfactory alternative treatment option; AND
- Indications outside of FDA labeling will be subject to medical necessity review in accordance with specific strong endorsement or support by nationally recognized compendia, when such recommendation is based on strong/high levels of evidence, and/or uniform consensus of clinical appropriateness has been reached. Medical records and references / evidence must be provided; AND
- For formularies that exclude (non-formulary) the requested medication, Non-formulary Exception Criteria applies.
Duration of Approval: 365 days (1 year)
Quantity Limitations
Quantity limitations apply to brand and associated generic products.
Medication | Quantity per Day (unless specified) |
---|---|
Retevmo (selpercatinib) 40 mg capsule | 6 capsules |
Retevmo (selpercatinib) 80 mg capsule | 4 capsules |
Retevmo (selpercatinib) 40 mg tablet | 3 tablets |
Retevmo (selpercatinib) 80 mg tablet | 2 tablets |
Retevmo (selpercatinib) 120 mg tablet | 2 tablets |
Retevmo (selpercatinib) 160 mg tablet | 2 tablets |
Quantity Limit Exception Criteria
- The quantity (dose) requested is for documented titration purposes at the initiation of therapy (authorization for a 90 day titration period); AND
- The prescribed dose cannot be achieved using a lesser quantity of a higher strength; AND
- The quantity (dose) requested does not exceed the maximum FDA labeled dose, when specified, or to the safest studied dose per the manufacturer’s product insert; OR
- If the quantity (dose) requested exceeds the maximum FDA labeled dose, when specified, or to the safest studied dose per the manufacturer’s product insert, then the prescriber must submit documentation in support of therapy with a higher dose for the intended diagnosis (submitted documentation may include medical records OR fax form which reflects medical record documentation that shows the length of time the requested dose has been used, and what other medications and doses have been tried and failed).
Duration of Approval: 365 days (1 year)
References
All information referenced is from FDA package insert unless otherwise noted below.
Policy Implementation/Update Information
August 2024: Criteria Change: Added expanded indication for adult patients with locally advanced or metastatic non-small cell lung cancer with a RET gene fusion, as detected by an FDA-approved test; patients 2 years and older with advanced or metastatic medullary thyroid cancer with a RET mutation, as detected by an FDA-approved test, who require systemic therapy; patients 2 years and older with advanced or metastatic thyroid cancer with a RET gene fusion, as detected by an FDA-approved test, who require systemic therapy and who are refractory to radioactive iodine (if radioactive iodine is appropriate); and patients 2 years and older with locally advanced or metastatic solid tumors with a RET gene fusion, as detected by an FDA-approved test, that have progressed on or following prior systemic treatment or who have no satisfactory alternative treatment options. Added new to market 40 mg, 80 mg, 120 mg, 160 mg tablets to quantity limit chart.
September 2022: Criteria change: Added new indication for the treatment of adults with locally advanced or metastatic solid tumors with a RET gene fusion that have progressed on or following prior systemic treatment or who have no satisfactory alternative treatment options.
May 2020: Original utilization management criteria issued.
Disclosures:
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