CurrentmhnPolicy CP.PHAR.502

Clinical Policy: Ripretinib (Qinlock)

Defines medical necessity criteria, prior authorization requirements, dosing limits, approval durations, and coverage exclusions for ripretinib (Qinlock) for Commercial, HIM, and Medicaid lines of business.

Policy Summary

Payermhn

PolicyClinical Policy: Ripretinib (Qinlock)

Policy CodePolicy CP.PHAR.502

Change TypeAnnual review (no significant changes in 2024 & 2025); substantive revisions in 2022–2023

Effective Date09.01.20

Next Review Date

Key ActionProvider must submit documentation supporting that the member meets all approval criteria; prior authorization is required.

POLICY UPDATE CHANGES

3Q 2025 annual review: no significant changes; references reviewed and updated.

3Q 2024 annual review: no significant changes; references reviewed and updated.

3Q 2023 annual review: added off-label criteria for cutaneous melanoma (category 2A); removed Sprycel as a prior option for fourth-line GIST; added pathway for second-line use following imatinib if sunitinib-intolerant; required single-agent use for GIST.

3Q 2022 annual review: added additional option for progressive GIST; clarified criteria to require either failure of 3 kinase inhibitors OR PDGFRA exon 18 mutation (not both); added dose escalation option to 300 mg/day for progression; added generic oral oncology redirection language.

Revised approval duration for Commercial line of business to 12 months or duration of request, whichever is less.

2Covered Indications (listed)

1Off-label indication allowed (NCCN 2A)

150 mg/dayStandard max daily dose

1Non-covered unspecified indications

Coverage Summary

coverage_stance: covered_with_criteria. Policy aligns use with FDA approval and NCCN recommendations and includes an NCCN-recognized off-label use for KIT-mutant cutaneous melanoma. (Policy number: CP.PHAR.502; Line of Business: Commercial, HIM, Medicaid.)

scope_summary: Defines medical necessity criteria, prior authorization requirements, dosing limits and escalation, approval durations, prescriber and documentation requirements, and coverage exclusions for ripretinib (Qinlock) across Commercial, HIM, and Medicaid lines of business.

FDA/NCCN evidence summary: FDA-approved for adult patients with advanced GIST after prior treatment with 3 or more kinase inhibitors including imatinib (Qinlock Prescribing Information, May 2025). NCCN GIST and Melanoma compendia (versions 2025) are referenced and support use; NCCN recognizes an off-label category 2A use for KIT‑mutant cutaneous melanoma.

Initial Therapy Criteria — Gastrointestinal Stromal Tumor (GIST)

I. Initial Approval Criteria - Gastrointestinal Stromal Tumor (GIST)

Must meet ALL of the following:

ALL of the following

Diagnosis of unresectable, locally advanced, recurrent, progressive, or metastatic GIST
Prescribed by or in consultation with an oncologist
Age ≥ 18 years
Request must meet ONE of the following (a, b, or c)
- a: Failure of all of the following, unless clinically significant adverse effects are experienced or all are contraindicated: imatinib, Sutent (sunitinib), and Stivarga (regorafenib)
  Prior authorization is required for imatinib, Sutent, and Stivarga per policy
- Option b: Both of the following: (i) Failure of imatinib, unless contraindicated or clinically significant adverse effects are experienced; and (ii) Member experienced clinically significant adverse effects to Sutent (sunitinib) used as second-line therapy
- Option c (PDGFRA exon 18 mutation): For members with PDGFRA exon 18 mutations that are insensitive to imatinib (including D842V): Failure of Ayvakit (avapritinib) and Sprycel (dasatinib), unless clinically significant adverse effects are experienced or both are contraindicated
Prescribed as a single agent
Member does not have active central nervous system metastases
For Qinlock requests, member must use ripretinib (generic) if available, unless contraindicated or clinically significant adverse effects are experienced
Dose requirement
- a: Dose does not exceed 150 mg (3 tablets) per day
- b: Dose is supported by practice guidelines or peer-reviewed literature for the relevant off-label use (prescriber must submit supporting evidence)
Prescribed regimen must be FDA-approved or recommended by NCCN
explicit policy requirement

Initial Therapy Criteria — Cutaneous Melanoma (off‑label)

I. Initial Approval Criteria - Cutaneous Melanoma (off-label)

Must meet ALL of the following:

ALL of the following

Diagnosis of metastatic or unresectable cutaneous melanoma
Prescribed by or in consultation with an oncologist
Presence of KIT activating mutations
Member has experienced disease progression, intolerance, and/or has projected risk of progression with BRAF-targeted therapy
See Appendix B for examples

Continuation Therapy Criteria

II. Continued Therapy (All Indications in Section I)

Must meet ALL of the following:

ALL of the following

Currently receiving medication via Centene benefit, or documentation supports that member is currently receiving Qinlock for a covered indication and has received this medication for at least 30 days
Member is responding positively to therapy
For Qinlock requests, member must use ripretinib (generic) if available, unless contraindicated or clinically significant adverse effects are experienced
If request is for a dose increase, must meet ONE of the following

Unapproved Uses / Coverage Exclusions

III. Other diagnoses/indications and III. Diagnoses/Indications for which coverage is NOT authorized

Must meet one of the following:

ANY of the following

If this drug has recently (within the last 6 months) undergone a label change that is not yet reflected in this policy, follow the specified formulary/no-coverage or non-formulary policies (CP.CPA.190, HIM.PA.33, CP.PMN.255 or CP.CPA.190, HIM.PA.103, CP.PMN.16 as applicable)
If the requested use is NOT listed under section III (Diagnoses/Indications for which coverage is NOT authorized) AND criterion 1 above does not apply, refer to the off-label use policy for the relevant line of business (CP.CPA.09, HIM.PA.154, CP.PMN.53)

ALL of the following

Non-FDA approved indications not addressed in this policy are not authorized unless there is sufficient documentation of efficacy and safety according to the off-label use policies (CP.CPA.09, HIM.PA.154, CP.PMN.53) or evidence of coverage documents

Applicable Codes

HCPCS / J‑codes / NDCmixed

No codes listed

Provider Actions & Requirements

Prior Authorization

Prior Authorization Required

Prior authorization is required. Submit a prior authorization request and include supporting documentation (office chart notes, lab results, imaging, and other relevant clinical information) demonstrating the member meets the clinical criteria.

Prior authorization may be required for prior therapies: imatinib, sunitinib (Sutent), regorafenib (Stivarga), avapritinib (Ayvakit), dasatinib (Sprycel)

Documentation Required

Prescriber specialty & documentation

Prescriptions must be written by or in consultation with an oncologist. Documentation submitted with the request must include the member's diagnosis, relevant mutation status (e.g., PDGFRA exon 18 including D842V when applicable), prior therapy history including failures or intolerances to prior kinase inhibitors, and clinical response for continuation requests.

Clinical Evidence

FDA approval: Qinlock is indicated for the treatment of adult patients with advanced gastrointestinal stromal tumor (GIST) who have received prior treatment with 3 or more kinase inhibitors, including imatinib (Qinlock Prescribing Information, May 2025).

NCCN guidance: NCCN GIST and Melanoma compendia (versions 2025) are referenced for recommended regimens and off-label uses; the policy cites NCCN GIST (Version 1.2025) and Melanoma; Cutaneous (Version 2.2025).

The policy notes that dose escalation to 300 mg/day for GIST with progression on 150 mg/day is off-label per NCCN and that dosing for GIST is 150 mg/day standard (tablet 50 mg).

Background

Ripretinib (Qinlock) is a kinase inhibitor indicated for adult patients with advanced gastrointestinal stromal tumor (GIST) after prior treatment with three or more kinase inhibitors including imatinib.

The policy aligns use with FDA approval and NCCN recommendations (NCCN GIST and Melanoma compendia, 2025) and includes a NCCN-recognized off-label indication for KIT-activating mutant cutaneous melanoma (policy provides specific initial and continued therapy criteria for this off-label use).

Dosing guidance in the policy: standard GIST dosing is 150 mg PO once daily with a dose escalation option to 300 mg/day for progression on 150 mg/day per NCCN (noted as off-label per NCCN); tablet strength is 50 mg.

Revision History

2020-01-20material

Revised Commercial approval duration to 12 months or duration of request, whichever is less (Effective Date noted 01.20.22 in revision history and P&T Approval recorded 05.22).

2022-08-22material

3Q 2022 annual review: added additional option for progressive GIST; clarified criteria to require either failure of 3 kinase inhibitors OR presence of PDGFRA exon 18 mutation (not both); added dose escalation option to 300 mg/day for progression on 150 mg/day; added generic oral oncology redirection language.

2023-08-23material

3Q 2023 annual review: added off-label criteria for cutaneous melanoma (NCCN category 2A); removed Sprycel as a prior option for fourth-line GIST; added pathway for second-line use following imatinib if sunitinib-intolerant; removed distinct handling of non-D842V PDGFRA exon 18 mutations and required single-agent use for GIST.

Policy Summary

Payermhn

PolicyClinical Policy: Ripretinib (Qinlock)

Policy CodePolicy CP.PHAR.502

Change TypeAnnual review (no significant changes in 2024 & 2025); substantive revisions in 2022–2023

Effective Date09.01.20

Next Review Date

Key ActionProvider must submit documentation supporting that the member meets all approval criteria; prior authorization is required.

On This Page

Prescribed as a single agent

For Qinlock requests, member must use ripretinib (generic) if available, unless contraindicated or clinically significant adverse effects are experienced

Dose is within FDA maximum limit for any FDA-approved indication or is supported by practice guidelines or peer-reviewed literature for the relevant off-label use (prescriber must submit supporting evidence)

Prescribed regimen must be FDA-approved or recommended by NCCN

explicit policy requirement

This off-label use for cutaneous melanoma is recognized by NCCN as category 2A (policy added off-label criteria for cutaneous melanoma category 2A per NCCN).

The policy includes specific initial and continued therapy criteria for metastatic or unresectable cutaneous melanoma with KIT activating mutations and requires the regimen to be FDA-approved or recommended by NCCN for coverage.

New dose does not exceed 150 mg (3 tablets) per day

b: For GIST only: New dose does not exceed 300 mg (6 tablets) per day, and member experienced disease progression with 150 mg per day dosing

c: New dose is supported by practice guidelines or peer-reviewed literature for the relevant off-label use (prescriber must submit supporting evidence)

Prescribed regimen must be FDA-approved or recommended by NCCN

explicit policy requirement

Include mutation testing results (e.g., PDGFRA, KIT) when pertinent to the indication

Detail prior therapies tried, reasons for discontinuation (progression, intolerance, contraindication), and dates/duration of therapy

For continuation/renewal requests, provide objective evidence of clinical benefit or tumor response

Billing Rule

Use generic ripretinib when available

Use generic ripretinib when available. Ripretinib (generic) should be used unless contraindicated or the prescriber documents a clinically significant adverse effect to the generic product.

If brand Qinlock is requested for a non-formulary/off-label dose or formulation, prescriber must submit supporting evidence documenting medical necessity for the brand or off-label dosing

Step Therapy

Step therapy / prior-agent requirements for GIST

Step therapy/prior-agent requirements for GIST: initial approval requires either failure of the specified prior kinase inhibitors or a PDGFRA exon 18 mutation insensitive to imatinib (see criteria). The agents listed below are referenced in the coverage criteria and may require prior authorization.

Initial GIST approval options include failure of imatinib, sunitinib (Sutent), and regorafenib (Stivarga) or alternative specified pathways for PDGFRA exon 18 mutations
These prior agents and their requirement status are detailed in the policy criteria and may require submission of prior authorization documentation

2024-08-24non-material

3Q 2024 annual review: no significant changes; references reviewed and updated.

2025-08-25non-materialLatest

3Q 2025 annual review: no significant changes; references reviewed and updated.

2020-09-01baseline

Policy effective date established (Effective Date = 09.01.20).