Health Net selpercatinib (Retevmo) Coverage

Coverage and Authorization Criteria

Initial Approval — NSCLC

Covered when ALL of the following are met:

NSCLC initial criteria: 1. Diagnosis of recurrent, advanced, or metastatic non-small cell lung cancer; 2. Prescribed by or in consultation with an oncologist; 3. Age ≥ 18 years; 4. Documentation of RET fusion-positive disease; 5. Retevmo is not prescribed concurrently with Gavreto; 6. Member has not received prior RET-targeted therapy; 7. Prescribed as a single agent; 8. For brand Retevmo requests, member must use generic selpercatinib, if available, unless contraindicated or clinically significant adverse effects are experienced; 9. Dosing does not exceed specified weight-based limits (weight < 50 kg: ≤240 mg/day; weight ≥ 50 kg: ≤320 mg/day) and follows the dosing regimen (weight < 50 kg: 120 mg PO BID; weight ≥ 50 kg: 160 mg PO BID); 10. Dose is supported by practice guidelines or peer-reviewed literature when used off-label; 11. Prescribed regimen must be FDA-approved or recommended by NCCN.

Initial Approval — Thyroid Cancer

Covered when ALL of the following are met:

Thyroid cancer initial criteria: 1. Diagnosis of medullary thyroid carcinoma (MTC), differentiated thyroid carcinoma (DTC; including oncocytic/ Hurthle cell, papillary, follicular), or anaplastic thyroid carcinoma (ATC); 2. Prescribed by or in consultation with an oncologist; 3. Age ≥ 2 years (for age 2 to <12 years, BSA ≥ 0.33 m2); 4. Disease is recurrent, advanced, or metastatic; 5. For MTC, documentation of RET mutation-positive disease; 6. For fusion-positive DTC/other thyroid cancer, documentation of RET fusion-positive disease; 7. If radioactive iodine is appropriate, member is radioactive iodine-refractory (where specified); 8. Retevmo is not prescribed concurrently with Gavreto; 9. Member has not received prior RET-targeted therapy; 10. Prescribed as a single agent; 11. For brand Retevmo requests, member must use generic selpercatinib, if available, unless contraindicated or clinically significant adverse effects are experienced; 12. Dosing follows weight- or BSA-based limits by age groups (examples: age ≥12 or adult: weight <50 kg: 120 mg PO BID; weight ≥50 kg: 160 mg PO BID; pediatric BSA bands for ages 2 to <12 years with specified mg/day and capsule/tablet limits); 13. Dose is supported by practice guidelines or peer-reviewed literature when used off-label; 14. Prescribed regimen must be FDA-approved or recommended by NCCN.

Initial Approval — RET Fusion-Positive Solid Tumors

Covered when ALL of the following are met:

RET fusion-positive solid tumors initial criteria: 1. Diagnosis of a locally advanced, recurrent, or metastatic solid tumor (see policy Appendix D for examples); 2. Prescribed by or in consultation with an oncologist; 3. Age criteria per indication (e.g., age ≥ 12 years for many solid tumors; pediatric use age ≥2 years for select tumor types with BSA dosing rules where specified); 4. Documentation of RET fusion-positive disease; 5. Disease has progressed on or following systemic treatment OR patient has no satisfactory alternative treatment options; 6. Retevmo is not prescribed concurrently with Gavreto; 7. Member has not received prior RET-targeted therapy; 8. Prescribed as a single agent; 9. For select tumor types (ampullary adenocarcinoma, biliary tract cancer, pancreatic adenocarcinoma, soft tissue sarcoma, uterine sarcoma) Retevmo may be used as first-line per NCCN; 10. For brand Retevmo requests, member must use generic selpercatinib, if available, unless contraindicated or clinically significant adverse effects are experienced; 11. Dosing follows weight- or BSA-based limits by age groups (examples: weight <50 kg: ≤240 mg/day; weight ≥50 kg: ≤320 mg/day; pediatric BSA dosing bands apply where indicated); 12. Dose is supported by practice guidelines or peer-reviewed literature when used off-label; 13. Prescribed regimen must be FDA-approved or recommended by NCCN.

Initial Approval — Histiocytic Neoplasms (Off-label)

Covered when ALL of the following are met:

Histiocytic neoplasms initial criteria: 1. Diagnosis of a histiocytic neoplasm (Erdheim-Chester disease, Langerhans cell histiocytosis, Rosai-Dorfman disease); 2. Prescribed by or in consultation with an oncologist or hematologist; 3. Age > 18 years; 4. Documentation of RET fusion-positive disease; 5. Retevmo is not prescribed concurrently with Gavreto; 6. Member has not received prior RET-targeted therapy; 7. Prescribed as a single agent; 8. For brand Retevmo requests, member must use generic selpercatinib, if available, unless contraindicated or clinically significant adverse effects are experienced; 9. Dosing follows specified weight-based limits (weight <50 kg: ≤240 mg/day; weight ≥50 kg: ≤320 mg/day) and formulation-specific capsule/tablet limits; 10. Dose is supported by practice guidelines or peer-reviewed literature for the relevant off-label use (prescriber must submit supporting evidence); 11. Prescribed regimen must be FDA-approved or recommended by NCCN.

Continuation Therapy

Covered when ALL of the following are met:

Continued therapy criteria: 1. Member is currently receiving Retevmo via the Centene benefit with documentation that they have received it for at least 30 days; 2. Documentation supports that the member is responding positively to therapy; 3. Retevmo is not prescribed concurrently with Gavreto; 4. Member has not received prior RET-targeted therapy; 5. For brand Retevmo requests, member must use generic selpercatinib, if available, unless contraindicated or clinically significant adverse effects are experienced; 6. Dosing remains within specified weight- or BSA-based limits by age (examples: adults weight <50 kg: ≤240 mg/day; weight ≥50 kg: ≤320 mg/day; pediatric BSA bands per policy); 7. Dose is supported by practice guidelines or peer-reviewed literature for off-label uses as applicable.

Covered Indications — FDA‑approved or NCCN‑supported indications and applicable testing/age criteria

Covered when meeting FDA‑approved or NCCN‑supported indications and applicable testing/age criteria as stated in this policy and referenced guidance.

Indications: Includes FDA‑approved indications: RET-mutant medullary thyroid cancer (MTC), RET fusion‑positive non‑small cell lung cancer (NSCLC), RET fusion‑positive solid tumors (tumor-agnostic accelerated/full approvals as applicable), and thyroid cancers requiring systemic therapy per labeling; NCCN‑listed tumor types for RET fusion‑positive solid tumors include examples such as ampullary adenocarcinoma, biliary tract cancer, pancreatic adenocarcinoma, soft tissue sarcoma, uterine sarcoma (see Appendix D).

Dosing and Age Limits

Dosing and age criteria:

Adult and pediatric dosing: Adult dosing examples by weight: weight < 50 kg: 120 mg PO twice daily (maximum 240 mg/day); weight ≥ 50 kg: 160 mg PO twice daily (maximum 320 mg/day). Pediatric dosing: age ≥12 years generally follows adult weight-based dosing; for age 2 years to <12 years, dosing is based on BSA bands (BSA 0.33–0.65 m2: 40 mg PO TID [~120 mg/day]; BSA 0.66–1.08 m2: 80 mg PO BID [~160 mg/day]; BSA 1.09–1.52 m2: 120 mg PO BID [~240 mg/day]; BSA ≥1.53 m2: 160 mg PO BID [~320 mg/day]); dosing not recommended for BSA 0.33 m2. Maximum daily doses correspond to the capsule/tablet limits specified in the policy (capsule/tablet counts revised to reflect formulation availability). Refer to full prescribing information for complete dosing tables and formulation-specific capsule/tablet limits.

Non‑FDA approved indications that are not specifically addressed in this policy are not authorized unless the request includes sufficient documentation of efficacy and safety in accordance with the applicable off‑label use policies (see CP.CPA.09 for Commercial, HIM.PA.154 for Health Insurance Marketplace, and CP.PMN.53 for Medicaid).

Off‑label use of selpercatinib (Retevmo) may be considered only when the request is supported by adequate clinical documentation demonstrating efficacy and safety per the referenced off‑label policies (CP.CPA.09, HIM.PA.154, CP.PMN.53). Providers should submit objective clinical evidence (for example, peer‑reviewed literature, practice guidelines, or other documentation) showing that the specific off‑label indication meets those standards.

Uses for indications not covered by this policy and lacking adequate off‑label justification will be considered not authorized (not medically necessary) and are subject to denial per the applicable off‑label and no‑coverage policies.

Requests for selpercatinib for non‑FDA approved indications must include sufficient documentation of efficacy and safety per the applicable off‑label use policies; absent such documentation, off‑label requests will be denied. Refer to CP.CPA.09 (Commercial), HIM.PA.154 (Health Insurance Marketplace), or CP.PMN.53 (Medicaid) for the evidentiary standards required.

Initial Authorization Requirements

Initial Therapy — diagnosis-specific criteria including documented RET alteration, oncologist involvement, age/BSA/weight dosing

Initial authorization requires meeting diagnosis-specific criteria including documented RET alteration, oncologist involvement, age/BSA/weight-specific dosing limits, absence of prior RET-targeted therapy, and single-agent use.

Diagnosis-specific requirements: 1. Documentation of the relevant RET alteration for the diagnosis: RET fusion for fusion-positive NSCLC, RET mutation for MTC, and RET fusion-positive disease for RET fusion-positive solid tumors and certain thyroid cancers; 2. Prescribed by or in consultation with an oncologist (or hematologist for histiocytic neoplasms as applicable); 3. Age and pediatric BSA requirements met per indication (e.g., NSCLC age ≥18 years; thyroid cancers and solid tumors pediatric expansions per policy).

Prior therapy and concurrent therapy exclusions: 1. Member has not received prior RET-targeted therapy; 2. Retevmo is not prescribed concurrently with Gavreto (pralsetinib).

Prescribing and formulation rules: 1. Prescribed as a single agent; 2. For brand Retevmo requests, member must use generic selpercatinib if available unless contraindicated or clinically significant adverse effects are experienced; 3. Dosing adheres to weight or BSA limits and formulation-specific capsule/tablet maximums.

Criteria for Continued Therapy

Continuation Therapy — criteria for continued therapy approvals

Criteria for continued therapy approvals

Continuation therapy general criteria: 1. Member has been receiving Retevmo via Centene benefit and has received the medication for at least 30 days; 2. Documentation demonstrates the member is responding positively to therapy (clinical benefit); 3. Retevmo is not prescribed concurrently with Gavreto; 4. Member has not received prior RET-targeted therapy; 5. For brand Retevmo requests, member must use generic selpercatinib if available unless contraindicated or clinically significant adverse effects are experienced; 6. Dosing remains within established weight- or BSA-based limits and is supported by guidelines or literature for any off-label uses.

Continuation Therapy — approval duration and continuation considerations

Approval duration and continuation considerations

Approval duration and reassessment: 1. Commercial approvals are standardized to up to 12 months or the duration of request, whichever is less; Medicaid/Health Insurance Marketplace typical review periods may be 6 months; 2. Continuation approvals require ongoing documentation of clinical benefit and adherence to dosing limits; 3. Any applicable policy or label changes should be followed and may require referral to line-of-business policies if the label changed within the last 6 months.

Prior Authorization, Documentation, and Routing

Prior Authorization

Prior Authorization Required

Prior authorization is required. Provider must submit a prior authorization request with documentation demonstrating the requested use meets the policy criteria, including diagnosis and RET alteration status. Requests must be prescribed by or in consultation with an oncologist when specified in the criteria. Brand requests must document justification if generic selpercatinib is available and not used (e.g., contraindication or clinically significant adverse effects). Concomitant use with other RET-targeted agents (e.g., Gavreto) is not allowed.

Include prescriber specialty (oncology) when required
Document prior targeted RET therapy history (has member received prior RET-targeted therapy?)
For brand Retevmo requests: confirm generic selpercatinib availability or provide contraindication/adverse event rationale

Note

Formulary Routing and Label Changes

Follow formulary and line-of-business routing rules. If the drug is on the formulary/PDL for the member's line of business, use the applicable formulary coverage/no-coverage policy. If not on the formulary/PDL, follow the non-formulary policy for the member's line of business. If there has been a label change within the last 6 months not reflected in this policy, refer to the specific line-of-business policy cited below.

Drug Formulations, Strengths, and Coding

Drug formulations/strengthsNDC

Capsules: 40 mg	Capsules: 40 mg
Capsules: 80 mg	Capsules: 80 mg
Tablets: 40 mg	Tablets: 40 mg
Tablets: 80 mg	Tablets: 80 mg
Tablets: 120 mg	Tablets: 120 mg
Tablets: 160 mg	Tablets: 160 mg
NDC not listed	No NDCs provided in this document portion.

Weight / BSA dosing thresholds

Adult weight threshold50 kg (used to distinguish ≤50 kg vs >50 kg dosing tiers)

Pediatric BSA bands0.33–0.65 m2; 0.66–1.08 m2; 1.09–1.52 m2; >1.53 m2 (used to determine per‑day mg and capsule/tablet counts)

BSA dosing restrictionDosing for pediatric patients with BSA 0.33 m2 is not recommended

Dosing Caps and Quantity Limits

Selpercatinib (Retevmo) dosing caps by weight/BSA and age

Adult example — ≤50 kgRecommended regimen: 120 mg PO twice daily (maximum 240 mg/day) — corresponds to 6 capsules/day or 2 tablets/day as specified

Adult example — >50 kgRecommended regimen: 160 mg PO twice daily (maximum 320 mg/day) — corresponds to 4 capsules/day or 2 tablets/day as specified

Pediatric example — age 2 to <12 (BSA 1.09–1.52 m2)Recommended regimen: 120 mg PO twice daily (240 mg/day) — corresponds to 6 capsules/day or 2 tablets/day

Most actionable capMaximum adult daily dosing caps: 240 mg/day for patients ≤50 kg and 320 mg/day for patients >50 kg

Capsule/tablet counts corresponding to maximum doses

6 capsules per dayCorresponds to maximum 240 mg per day when using 40 mg capsules (6 × 40 mg = 240 mg)

Step Therapy and Formulary Routing

Step	Requirement	Notes
1	For brand Retevmo requests, member must use generic selpercatinib if available	Generic substitution not required only if contraindicated or clinically significant adverse effects are experienced
Exception	Generic selpercatinib may be bypassed when there is a documented contraindication or clinically significant adverse effect to the generic formulation	Policy language applies across NSCLC, thyroid cancer, and RET fusion–positive solid tumor indications

Step	NCCN / Policy Addition	Details
1	NCCN additions permit use as single‑agent therapy	Policy notes NCCN-listed tumor types and allows single-agent use; specific step-sequencing requirements are not specified in the policy excerpt
Applicability	Applies to NSCLC and thyroid cancer indications	Policy references NCCN guidance for tumor types and dosing; consult full policy/NCCN for regimen specifics

Background and Clinical Context

Selpercatinib (Retevmo) is a selective RET kinase inhibitor indicated for treatment of tumors with RET alterations. This policy authorizes use for FDA‑labeled RET‑altered indications when coverage criteria are met and allows select off‑label uses only when supported by sufficient evidence per the referenced off‑label policies. Requests for non‑FDA indications not addressed in this policy will require documentation demonstrating efficacy and safety consistent with CP.CPA.09, HIM.PA.154, or CP.PMN.53 before coverage will be considered.

Definitions and Abbreviations

RET‑altered disease

DefinitionTumors harboring RET gene fusions or RET mutations as detected by an FDA‑approved test (e.g., RET fusion‑positive NSCLC, RET‑mutant MTC)

Testing requirementRET alterations must be detected by an FDA‑approved test per the FDA‑labeled indications

Applicable tumor typesIncludes RET fusion‑positive NSCLC, RET‑mutant or RET fusion‑positive thyroid cancers, and RET fusion‑positive solid tumors (tumor‑agnostic indication)

RET

RET acronymRET = rearranged during transfection (oncogenic driver alteration)

RoleDescribes the oncogenic driver (gene rearrangement/mutation) targeted by selpercatinib (Retevmo)

Site-of-Care Considerations

Note

No site‑of‑care restrictions specified

No site‑of‑care restrictions are specified in this excerpt of the policy.

OpenPayer

Selpercatinib (Retevmo) coverage

Coverage and Authorization Criteria

Initial Authorization Requirements

Criteria for Continued Therapy

Prior Authorization, Documentation, and Routing

Drug Formulations, Strengths, and Coding

Dosing Caps and Quantity Limits

Step Therapy and Formulary Routing

Background and Clinical Context

Definitions and Abbreviations

Site-of-Care Considerations