CurrentCignaPolicy N/A

Oncology (Oral) - Qinlock Prior Authorization Policy

Defines prior authorization requirements and medical necessity criteria for coverage of Qinlock (ripretinib tablets) for Cigna-administered health benefit plans, including FDA-approved and select guideline-supported uses.

Policy Summary

PayerCigna

PolicyOncology (Oral) - Qinlock Prior Authorization Policy

Policy CodePolicy N/A

Change TypeNo material change

Effective DateN/A

Next Review DateApr 8, 2026

Key ActionObtain prior authorization and submit documentation of diagnosis, prior therapies (including imatinib and other specified agents or intolerance), age, and mutation status as applicable.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

1 yearApproval duration for covered indications

Adults ≥18Age requirement for approvals

GIST; MelanomaIndications addressed

Other usesExclusions

Coverage Criteria for Qinlock (ripretinib)

FDA-Approved Indication — Gastrointestinal Stromal Tumor

Policy Summary

PayerCigna

PolicyOncology (Oral) - Qinlock Prior Authorization Policy

Policy CodePolicy N/A

Change TypeNo material change

Effective DateN/A

Next Review DateApr 8, 2026

Key ActionObtain prior authorization and submit documentation of diagnosis, prior therapies (including imatinib and other specified agents or intolerance), age, and mutation status as applicable.

SourceLink

On This Page

Trek Health ingests and normalizes Transparency in Coverage data and payer policy updates to give provider organizations a clear view of how commercial reimbursement behaves across markets, payers, and services. Our platform transforms raw payer disclosures into structured intelligence that supports contract evaluation, payer negotiations, and service line strategy. By combining market benchmarks with ongoing policy visibility, Trek helps teams identify variability, risk, and opportunity in commercial reimbursement. The result is faster insight, stronger negotiating positions, and more informed financial decisions.

Other Uses with Supportive Evidence — Cutaneous Melanoma

Approve for 1 year if the patient meets ALL of the following (A, B, C, and D):

Cutaneous melanoma approval criteria

Age: Patient is ≥ 18 years of age
Disease extent: Metastatic or unresectable disease
Genomic requirement: Activating KIT mutation present
Prior systemic therapy: Patient has tried at least one systemic regimen (examples include PD-1/CTLA-4 combinations, PD-1 monotherapy, or BRAF/MEK combinations)
Examples: nivolumab + ipilimumab; nivolumab/relatlimab; pembrolizumab; dabrafenib + trametinib; vemurafenib + cobimetinib; encorafenib + binimetinib.

Operational note: Approval duration: 1 year when criteria are met.

Initial Therapy Criteria

Initial therapy criteria

Initial authorization criteria

GIST initial: See FDA-Approved Indication — Gastrointestinal Stromal Tumor criteria: age ≥ 18 years, prior imatinib, and prior sunitinib + Stivarga (regorafenib) or intolerance of sunitinib.

Melanoma initial: See Other Uses with Supportive Evidence — Cutaneous Melanoma criteria: age ≥ 18 years, metastatic or unresectable disease, activating KIT mutation, and at least one prior systemic regimen.

Step Therapy Requirements

Indication	Required prior therapy / step	Notes
Gastrointestinal stromal tumor (GIST)	Patient must have tried imatinib; AND patient must have tried sunitinib and regorafenib (Stivarga) OR be intolerant to sunitinib.	Approve for 1 year when all criteria met; patient must be ≥ 18 years of age.
Cutaneous melanoma (metastatic or unresectable) with activating KIT mutation	Patient must have tried at least one systemic regimen (examples: PD‑1/CTLA‑4 combos, PD‑1 monotherapy, or BRAF/MEK targeted combinations).	Approve for 1 year when all criteria met; patient must be ≥ 18 years of age and have an activating KIT mutation.

Provider Actions and Authorization Requirements

Prior Authorization

Prior Authorization Required

Prior authorization is required for Qinlock (ripretinib) for both FDA‑approved and supportive‑evidence indications. Approvals are issued for the duration noted in the policy (typically 1 year for approved indications).

Prior authorization required for Qinlock (ripretinib).
Approvals issued for the duration specified in the policy (e.g., 1 year).

Documentation Required

Required Clinical Documentation

Provider must submit documentation supporting the diagnosis and that required prior therapies have been tried or are contraindicated/intolerant. For GIST, documentation must show prior treatment with imatinib, and either trials of sunitinib and regorafenib or documented intolerance to sunitinib. For cutaneous melanoma with activating KIT mutation, documentation must show metastatic or unresectable disease, activating KIT mutation, and trial of at least one systemic regimen.

For GIST: prior imatinib required; plus sunitinib and regorafenib tried OR documented intolerance to sunitinib.
For cutaneous melanoma with KIT mutation: metastatic/unresectable disease, activating KIT mutation, and ≥1 prior systemic regimen tried (examples of systemic regimens listed in policy).

Denial Risk

Noncompliant Requests / Denial Risk

Requests that do not meet the documented coverage criteria or are for uses described as not medically necessary will be denied. Providers should ensure all required supporting records (diagnosis, mutation testing, prior therapies or reasons for intolerance/contraindication) are included with the authorization request to avoid denial.

Noncompliant requests (missing required documentation or for indications outside criteria) will be denied as not medically necessary.
Include diagnostic confirmation, mutation test results where applicable, and records of prior systemic therapies or documented intolerances/contraindications.

Definitions and Key Terms

Gastrointestinal stromal tumor (GIST) — definition and relation to FDA indication

DefinitionGastrointestinal stromal tumor (GIST): a type of tumor for which Qinlock (ripretinib) is indicated in adults who have received prior treatment with three or more kinase inhibitors, including imatinib.

FDA-approved indication (relation to Qinlock)Qinlock is indicated for treatment of advanced GIST in adults previously treated with three or more kinase inhibitors (including imatinib); approvals are provided per policy for 1 year when criteria are met.

NCCN guidanceNCCN GIST guidelines (v1.2026) discuss Qinlock as a recommended option for unresectable, progressive, or metastatic disease: as a preferred second-line option for patients intolerant of sunitinib and as a fourth-line option after imatinib, sunitinib, and regorafenib; dose escalation to 150 mg twice daily is noted in specific scenarios.

Age scopePolicy applies to adults (≥18 years) per approval criteria.

Activating KIT mutation — definition and use context

DefinitionActivating KIT mutation: a genomic alteration in cutaneous melanoma that, when present, supports use of Qinlock per NCCN guidance for metastatic or unresectable disease.

Use context per NCCNNCCN (Cutaneous Melanoma v1.2026) lists Qinlock as 'Useful in Certain Circumstances' (category 2A) for metastatic or unresectable cutaneous melanoma with an activating KIT mutation as second-line or subsequent therapy for progression, intolerance, or projected risk with BRAF-targeted therapy.

Policy coverage conditionPolicy authorizes Qinlock for cutaneous melanoma when the patient is ≥18 years, has metastatic or unresectable disease, has an activating KIT mutation, and has tried at least one systemic regimen; approvals are for 1 year when criteria are met.

Background

Qinlock (ripretinib) is a kinase inhibitor with an FDA indication for treatment of advanced gastrointestinal stromal tumor (GIST) in adults who have received prior treatment with multiple kinase inhibitors. NCCN guidelines also reference Qinlock for select GIST settings and as an option for cutaneous melanoma with activating KIT mutations. This policy defines the specific medical necessity criteria and prior authorization requirements for those covered indications; uses outside those specified indications are addressed under the policy’s "conditions not covered" language.

OpenPayer