Retevmo

Selpercatinib

• Brand(s): Retevmo
• Dosage Form/Strength: 40 mg and 80 mg capsules
• Effective date: July 31, 2023

Initiation Criteria for non–small cell lung cancer (NSCLC)

For the treatment of metastatic rearranged during transfection (RET) fusion-positive non–small cell lung cancer (NSCLC) in adult patients meeting all the following criteria:

1. Patient is 18 years of age or older;
   AND
2. Has previously untreated NSCLC with documented RET-fusion positive NSCLC;
   OR
   Previously treated with one or more systemic therapies for NSCLC in a patient with documented RET-fusion positive NSCLC;
   AND
3. Has a good performance status;
   AND
4. Selpercatinib is administered as monotherapy;
   AND
5. Prescribed by a clinician with expertise in the management of lung cancer.

Exclusion Criteria:

• Selpercatinib will not be funded in combination therapy with another systemic cancer treatment for NSCLC.

Renewal Criteria:

Renewals will be considered until the patient is experiencing clinically meaningful disease progression or unacceptable toxicity.

Approval Durations:
- Initial: 6 months
- Renewals: 1 year

Initiation Criteria for differentiated thyroid cancer (DTC)

For the treatment of rearranged during transfection (RET) fusion-positive, advanced or metastatic, differentiated thyroid cancer (DTC) in patients meeting all the following criteria;

1. Patient is 18 years of age or older;
   AND
2. Has differentiated thyroid cancer that is advanced or metastatic (not amenable to surgery or radioactive iodine therapy);
   AND
3. Patient is using selpercatinib as third or subsequent line after experiencing failure or intolerance to radioactive iodine (Note 1), and lenvatinib or sorafenib for DTC;
   AND
4. Has a good performance status;
   AND
5. Selpercatinib is administered as monotherapy;
   AND
6. Prescribed by a clinician with expertise in the management of thyroid cancer.

Notes:

1. Patients with a contraindication to the use of radioactive iodine therapy are considered for funding on a case-by-case basis. Please provide details of the contraindication with your request.

Exclusion Criteria:

• Selpercatinib will not be funded in combination therapy with another systemic cancer treatment for DTC.

Renewal Criteria:

Renewals will be considered until the patient is experiencing clinically meaningful disease progression or unacceptable toxicity.

Recommended dose:
- Under 50 kg: 120 mg orally every 12 hours.
- 50 kg or greater: 160 mg orally every 12 hours.

Approval Durations:
- Initials: 6 months
- Renewals: 1 year

Initiation Criteria for medullary thyroid cancer (MTC)

For the treatment of rearranged during transfection (RET) - mutant unresectable advanced or metastatic medullary thyroid cancer (MTC) in patients meeting all the following criteria;

1. Patient is 12 years of age or older;
   AND
2. Has medullary thyroid cancer that is unresectable advanced or metastatic;
   AND
3. Patient is using selpercatinib as second line therapy after experiencing failure or intolerance to vandetanib for MTC;
   AND
4. Has a good performance status;
   AND
5. Selpercatinib is administered as monotherapy;
   AND
6. Prescribed by a clinician with expertise in the management of thyroid cancer.

Notes:

1. Patients with a contraindication to the use of vandetanib are considered for funding. Please provide details of the contraindication with your request.
2. Case-by-case consideration will be provided for those who have progressed on cabozantinib (not publicly funded).

Exclusion Criteria:

• Selpercatinib will not be funded in combination therapy with another systemic cancer treatment for MTC.

Renewal Criteria:

Renewals will be considered until the patient is experiencing clinically meaningful disease progression or unacceptable toxicity.

Recommended dose:
- Under 50 kg: 120 mg orally every 12 hours.
- 50 kg or greater: 160 mg orally every 12 hours.

Approval Durations:
- Initials: 6 months
- Renewals: 1 year

EAP Drug Request Form:

Standard Form for EAP Drug Requests