CurrentBlue Cross Blue Shield - IowaPolicy 05.05.86

Romvimza (vimseltinib) — Coverage and Authorization Criteria for Tenosynovial Giant Cell Tumor (TGCT)

Defines coverage and authorization criteria for Romvimza (vimseltinib) for treatment of adult patients with symptomatic tenosynovial giant cell tumor (TGCT) when surgery would likely worsen function or cause severe morbidity; applies to members whose benefits include this therapy.

Policy Summary

PayerBlue Cross Blue Shield - Iowa

PolicyRomvimza (vimseltinib) — Coverage and Authorization Criteria for TGCT

Policy CodePolicy 05.05.86

Change TypeNo material changes

Effective DateJul 24, 2025

Next Review Date

Key ActionObtain prior authorization demonstrating measurable disease (lesion ≥2 cm) and that surgery would likely worsen function or cause severe morbidity.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

12 monthsinitial authorization

12 monthscontinuation authorization

30 mg twice weeklyFDA dosing

>= 2 cmlesion size required

carton (8)dispensing limit

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Coverage Criteria for Romvimza (vimseltinib)

inv-01: Initial Therapy

Covered when ALL of the following are met:

Initial Approval for TGCT: 1) Patient is an adult with symptomatic tenosynovial giant cell tumor (TGCT). 2) Surgical resection is expected to potentially cause worsening functional limitation or severe morbidity. 3) There is measurable disease (a lesion of at least 2 centimeters). 4) Prescribed dosing is consistent with FDA labeling and any applicable dosing limits.

Authorization of 12 months may be granted.

inv-02: Continuation Therapy

Covered for continuation when ALL of the following are met:

Continuation of Therapy: 1) Member was previously authorized for an FDA- or compendia-listed indication listed in the Initial Approval criteria. 2) There is documented clinical benefit (e.g., decreased tumor volume score, improved range of motion of the affected joint, or improvement in pain scores). 3) No evidence of unacceptable toxicity while on the current regimen.

Authorization of 12 months may be granted for continued treatment.

inv-03: Not Medically Necessary

Not Medically Necessary: Therapy is not medically necessary for members who do not meet the specified criteria for coverage (initial or continuation).

This policy applies only when the member's benefits include coverage for the requested drug and indication. Exclusions, limitations, or exceptions in the member's benefit contract may apply and must be verified prior to authorization. Wellmark (Blue Cross Blue Shield - Iowa) determines medical necessity only if coverage exists and no applicable contract exclusions are present; this policy may not apply to Federal Employee Program (FEP) members.

Romvimza (vimseltinib) is not medically necessary for members who do not meet the specific coverage criteria outlined in this policy (initial or continuation criteria). Requests that fail to satisfy the stated requirements should be denied as not medically necessary.

Initial Authorization Criteria

inv-15: Initial Therapy

Initial authorization of 12 months may be granted when criteria are met

Initial Therapy for TGCT: Adult patient with symptomatic TGCT; surgical resection would likely worsen function or cause severe morbidity; measurable lesion >= 2 cm; dosing aligned with FDA labeling and subject to standard dosing limits (e.g., carton of 8 capsules per 28 days).>= 2 centimeters

Authorization of 12 months may be granted.

Continuation Authorization Criteria

inv-16: Continuation Therapy

Continuation authorization may be granted for 12 months when criteria met

Continuation: Documented clinical benefit (e.g., decreased tumor volume score, improved range of motion, or reduction in pain) and absence of unacceptable toxicity; member previously authorized for an indicated use.

Authorization of 12 months may be granted.

Coding and Measurable Disease

Procedures and billing codesmixed

No codes listed

Measurable lesion size — required threshold

Required lesion sizeMeasurable lesion of at least 2 centimeters (>= 2 cm)

ContextApplies to members with TGCT who are not candidates for surgical resection

Authorization durationInitial authorization may be granted for 12 months when criteria are met

Provider Requirements and Authorization Actions

Prior Authorization

Prior Authorization Required

Prior authorization is required for Romvimza (vimseltinib) for the treatment of symptomatic tenosynovial giant cell tumor (TGCT). Approval may be granted for up to 12 months for members with measurable disease (lesion ≥ 2 cm) who are not candidates for surgical resection or when surgical resection would likely worsen function or cause severe morbidity. Approvals may be limited to dosing in accordance with FDA labeling and evidence-based guidelines.

Affected drug: Romvimza (vimseltinib)
Authorization duration: up to 12 months
Measurable disease defined as lesion ≥ 2 centimeters

Step Therapy

No step therapy (fail-first) requirements are specified for Romvimza; members do not need to trial an alternative systemic therapy prior to authorization when they meet the clinical criteria.

Background

Tenosynovial giant cell tumor (TGCT) is a neoplasm arising from the synovium that can produce pain, reduced range of motion, and functional impairment. Romvimza (vimseltinib) is an FDA‑approved tyrosine kinase inhibitor for symptomatic adult TGCT when surgical resection is expected to worsen function or cause severe morbidity. Treatment goals include reduction in tumor volume and improvement in symptoms and function; dosing and administration should follow FDA labeling and may be subject to standard dispensing limits.

Key Definitions

Measurable disease definition — lesion size

DefinitionMeasurable disease: a lesion of at least 2 centimeters (>= 2 cm)

Use in criteriaRequired for initial authorization of Romvimza for TGCT when surgery is not a candidate

DocumentationClinical records should demonstrate lesion measurement >= 2 cm (e.g., imaging reports)

Romvimza (vimseltinib) — drug indication definition

IndicationTreatment of adult patients with symptomatic tenosynovial giant cell tumor (TGCT) for which surgical resection would potentially cause worsening functional limitation or severe morbidity

DrugRomvimza (vimseltinib)

Dispensing and Quantity Limits

Romvimza 14 mg capsule — dispensing limit

Standard dispensing limitCarton (8 capsules) per 28 days

Strength14 mg capsule

FDA recommended dosing noteFDA recommended dosing: 30 mg orally twice weekly; dose reductions to 20 mg twice weekly and 14 mg twice weekly for adverse reactions/hepatotoxicity

Romvimza 20 mg capsule — dispensing limit

Standard dispensing limitCarton (8 capsules) per 28 days

Strength20 mg capsule

FDA recommended dosing note

Site of Care and Administration

Note

Home/outpatient administration and dosing adjustments

Romvimza is an oral medication administered in the outpatient/home setting as prescribed; dosing and dose reductions must follow FDA labeling, including reductions for adverse reactions or hepatotoxicity.

FDA recommended dosing: 30 mg orally twice weekly.
Dose reduction sequence for adverse reactions/hepatotoxicity: reduce to 20 mg twice weekly, then 14 mg twice weekly if further reduction needed.
Standard dispensing limit: carton (8 capsules) per 28 days per strength.