CurrentUnitedHealthcarePolicy 2025 P 1319-6

Qinlock (ripretinib) prior authorization

Prior authorization and coverage criteria for Qinlock (ripretinib) for treatment of advanced gastrointestinal stromal tumor (GIST) and cutaneous melanoma; affects prescribing providers and UnitedHealthcare members.

Policy Summary

PayerUnitedHealthcare

PolicyQinlock (ripretinib) prior authorization

Policy CodePolicy 2025 P 1319-6

Change TypeCriteria updatednew indication added

Effective Date10/01/2025

Next Review Date

Key ActionSubmit prior authorization; initial approvals issued for 12 months when coverage criteria for GIST or KIT‑mutant cutaneous melanoma are met.

SourceLink

POLICY UPDATE CHANGES

Updated clinical criteria for gastrointestinal stromal tumors section based on NCCN recommendations.

Added background and formal criteria for cutaneous melanoma indication with KIT activating mutations.

Reformatted sections for GIST and cutaneous melanoma and clarified disease type for GIST.

12 monthsauthorization duration

3+prior kinase inhibitors (GIST)

2 indicationsdisease areas

2025 P 1319-6program

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Coverage Criteria

Initial Therapy - GIST

Covered when ALL of the following are met

GIST initial authorization: Diagnosis of gastrointestinal stromal tumor (GIST)

Disease status for GIST: One of: gross residual disease (R2 resection); unresectable primary disease; tumor rupture; recurrent/metastatic disease

Prior treatment history for GIST: Either: history of progression on imatinib, sunitinib, and regorafenib; OR history of progression on imatinib plus history of intolerance to sunitinib

PDGFRA exon 18 variant pathway: Alternatively, all of: PDGFRA exon 18 mutations that are insensitive to imatinib (including PDGFRA D842V); history of progression on avapritinib (Ayvakit); history of progression on dasatinib

Alternate pathway for certain PDGFRA-mutant tumors

Reauthorization - GIST

Reauthorization

GIST reauthorization: Patient does not show evidence of progressive disease while on Qinlock therapy

Initial Therapy - Cutaneous Melanoma

Covered when ALL of the following are met

Cutaneous melanoma initial authorization: Diagnosis of cutaneous melanoma

Disease extent: Disease is unresectable or metastatic

Molecular requirement: Positive for activating mutations of KIT

Prior therapy or progression: Disease progression, intolerance, and/or projected risk of progression with BRAF-targeted therapy

Reauthorization - Cutaneous Melanoma

Reauthorization

Melanoma reauthorization: Patient does not show evidence of progressive disease while on Qinlock therapy

For members under 19 years of age, prescriptions for Qinlock will automatically process without a coverage review. For members age 19 and older, coverage is subject to the criteria specified elsewhere in this policy and requests that do not meet those criteria may be denied. Some states may have mandates that supersede the benefit language in this document for off‑label uses or require use of specific compendia; where applicable, those state mandates take precedence.

Provider Actions & Authorization

Prior Authorization

Prior Authorization Required

Prior authorization is required for Qinlock (ripretinib). Initial approvals are issued for up to 12 months; reauthorization requirements follow clinical criteria and may be subject to automated review. Supply limits may apply.

Prior authorization required
Initial approval duration: up to 12 months
Supply limits may be enforced

Step Therapy

Position in Treatment Sequence

Qinlock is positioned as later-line therapy for GIST per labeling and guideline recommendations. Coverage requires prior treatment with multiple kinase inhibitors (imatinib, sunitinib, regorafenib) unless member has specific PDGFRA exon 18 mutations with progression on avapritinib and dasatinib. For cutaneous melanoma, use is limited to unresectable/metastatic disease with activating KIT mutations after progression/intolerance to BRAF-targeted therapy when applicable.

GIST: intended for patients who have received ≥3 prior kinase inhibitors including imatinib

Initial Authorization Criteria

Initial authorization

Initial authorization criteria per indication

GIST - see detailed nodes: Diagnosis of gastrointestinal stromal tumor (GIST) AND disease status as gross residual disease (R2 resection), unresectable primary disease, tumor rupture, or recurrent/metastatic disease AND prior progression on imatinib, sunitinib, and regorafenib (or progression on imatinib plus intolerance to sunitinib); alternatively, PDGFRA exon 18 mutations insensitive to imatinib (including D842V) with progression on avapritinib and dasatinib

Refer to GIST initial authorization criteria for element-level details

Cutaneous melanoma - see detailed nodes: Diagnosis of cutaneous melanoma that is unresectable or metastatic AND positive for activating KIT mutations AND disease progression, intolerance, or projected risk of progression with BRAF-targeted therapy

Refer to cutaneous melanoma initial authorization criteria for element-level details

Continuation / Reauthorization Criteria

Reauthorization

Reauthorization requirement

Continuation/Reauthorization: Patient must not show evidence of progressive disease while on Qinlock therapy for reauthorization

Authorization issued for 12 months

Coding & Prior Therapies

No explicit billing or diagnosis codes listedmixed

No codes listed

Prior kinase inhibitors (GIST)

Required prior kinase inhibitorsMember must have received treatment with >= 3 prior kinase inhibitors (including imatinib)

ContextRequirement aligns with Qinlock indication for adults with advanced GIST

NCCN positioningPreferred fourth-line therapy after progression on imatinib, sunitinib, and regorafenib

Step Therapy / Sequencing

Step	Requirement	Details
4	Prior progression or intolerance per GIST criteria	Must have documented disease progression on imatinib, sunitinib, and regorafenib; OR progression on imatinib plus intolerance to sunitinib, consistent with NCCN-recommended fourth‑line use for GIST

Quantity Limits

Qinlock (ripretinib) — supply/quantity limits

Quantity limit noteSupply limits may be in place for Qinlock (ripretinib)

Automated approval impactUnitedHealthcare may use claim/medication history and claim logic that could include supply-limit enforcement

Program variabilityUse of automated approval and re-approval processes and supply-limit application varies by program and therapeutic class

Site of Care

Note

No explicit site‑of‑care restrictions specified

The policy does not specify site‑of‑care restrictions; no explicit infusion center or other site restrictions are listed in this document.

Definitions

GIST — definition used in criteria

DefinitionGIST (gastrointestinal stromal tumor): advanced disease including gross residual disease (R2 resection), unresectable primary disease, tumor rupture, or recurrent/metastatic disease

Treatment contextIndication considered after progression on prior kinase inhibitors per specified prior-treatment criteria

NCCN recommendationQinlock is recommended as preferred fourth-line therapy for certain GIST disease states

Cutaneous melanoma (KIT‑mutant) — definition used in criteria

DefinitionCutaneous melanoma (KIT‑mutant): cutaneous melanoma that is unresectable or metastatic and positive for activating KIT mutations

Therapy contextIndication considered for disease progression, intolerance, or projected risk of progression with BRAF‑targeted therapy

Background

Qinlock (ripretinib) is a kinase inhibitor indicated for adults with advanced gastrointestinal stromal tumor (GIST) after prior treatment with multiple kinase inhibitors, and is supported by the NCCN as a preferred fourth‑line therapy for certain GIST disease states. The agent is also supported for use in cutaneous melanoma with activating KIT mutations as second‑line or subsequent therapy.

UnitedHealthcare may, when permitted by internal claim logic and documentation, approve initial or reauthorization requests based solely on previous claim or medication history, diagnosis codes, and/or claim logic; supply limits or other utilization management rules may apply.

Revision History

2025-07annual review - clinical criteria updateLatest

Annual review updated clinical criteria for gastrointestinal stromal tumors (GIST) based on NCCN recommendations.

2024-07annual review - added indication

Annual review added background and formal criteria for cutaneous melanoma with KIT-activating mutations and updated GIST background and criteria per NCCN guidelines.

2023-07annual review - formatting and disease clarification