CurrentCignaPolicy N/A

Oncology - Qinlock Prior Authorization Policy

Cigna prior authorization policy governing coverage of Qinlock (ripretinib tablets) for FDA-approved indication (GIST) and an NCCN-supported use (cutaneous melanoma with KIT mutation), including medical necessity criteria, approval duration, and non-covered uses.

Policy Summary

PayerCigna

PolicyOncology - Qinlock Prior Authorization Policy

Policy CodePolicy N/A

Change TypeMaterial revisions to GIST prior therapy requirements; addition of cutaneous melanoma criteria

Effective Date

Next Review Date

Key ActionPrior Authorization is required; document prior therapies and KIT mutation status and approvals will be for 1 year when criteria are met.

POLICY UPDATE CHANGES

Gastrointestinal Stromal Tumor criteria changed to require patient has tried imatinib or Ayvakit and one of: sunitinib + regorafenib; or dasatinib; or is intolerant to sunitinib.

Melanoma, Cutaneous indication and criteria were added to Other Uses with Supportive Evidence based on NCCN guideline recommendations.

Annual revision history entries updated (2023-2025) including minor wording and example regimen modifications in melanoma note.

2Covered Indications

1 yearApproval Duration

≥18Minimum Age

Coverage Summary

Coverage stance: covered_with_criteria for the FDA-approved gastrointestinal stromal tumor (GIST) indication and an NCCN-supported cutaneous melanoma use. The policy approves Qinlock for 1 year when criteria are met and requires a minimum age of 18 years. The FDA-approved GIST indication is for advanced GIST after prior treatment with three or more kinase inhibitors including imatinib, and NCCN guidelines support use in select KIT‑mutant cutaneous melanoma settings as described in the policy.

FDA-Approved Indication — Gastrointestinal Stromal Tumor (GIST)

FDA-Approved Indication - Gastrointestinal Stromal Tumor

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

ALL of the following

A
- Patient is ≥ 18 years of age
B
- Patient has tried imatinib or Ayvakit (avapritinib tablets)
C
- i: Patient has tried sunitinib and Stivarga (regorafenib tablets)
- ii: Patient has tried dasatinib
- iii: Patient is intolerant of sunitinib

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Prior Authorization

Prior authorization required

Prior Authorization is required for prescription benefit coverage of Qinlock. When the policy criteria are met, approvals are provided for 1 year.

Documentation Required

Documentation of prior therapies and mutation status

Provider must document prior therapies and relevant mutation status. For Gastrointestinal Stromal Tumor (GIST) document: prior treatment with imatinib or avapritinib (Ayvakit) AND one of the following—sunitinib plus regorafenib (Stivarga), dasatinib, or intolerance to sunitinib.

Other Uses with Supportive Evidence — Cutaneous Melanoma

Other Uses with Supportive Evidence - Cutaneous Melanoma

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

ALL of the following

A: Patient is ≥ 18 years of age
B: Patient has metastatic or unresectable disease
C: Patient has an activating KIT mutation
D: Patient has tried at least ONE systemic regimen
Examples of systemic regimens provided in policy (e.g., Opdivo + Yervoy, Opdualag, Keytruda, BRAF/MEK combinations)

Documentation Required

Documentation of prior therapies and mutation status

Document that the patient has an activating KIT mutation and the prior systemic regimen used. For cutaneous melanoma the policy requires documentation of an activating KIT mutation and that the patient has tried at least one systemic regimen (examples of systemic regimens are provided in the policy note).

Definition — Systemic regimen: examples include immune checkpoint inhibitor combinations (e.g., nivolumab + ipilimumab, Opdualag, pembrolizumab) and targeted BRAF/MEK combinations (e.g., dabrafenib + trametinib, vemurafenib + cobimetinib, encorafenib + binimetinib) as listed in the policy note. See the melanoma criteria note for the full list of example regimens and related documentation requirements. The policy cites the FDA prescribing information and NCCN guideline recommendations as supportive evidence for these uses.

Conditions Not Covered / Unproven

Conditions Not Covered

Not covered when experimental, investigational or unproven

Qinlock (ripretinib tablets) is considered experimental, investigational or unproven for ANY other use(s) not listed above; criteria will be updated as new published data are available

Denial Risk

Not covered when experimental, investigational or unproven

Requests for uses not listed in the policy (any indication other than the FDA‑approved GIST criteria or the NCCN‑supported cutaneous melanoma setting with KIT mutation) are considered experimental, investigational or unproven and will be denied.

Provider Actions

Prior Authorization

Prior authorization required

Prior authorization is required for prescription benefit coverage of Qinlock; approvals are provided for 1 year when the policy criteria are met.

Documentation Required

Documentation of prior therapies and mutation status

Provider must document prior therapies and mutation status per indication:

GIST: prior treatment with imatinib or avapritinib (Ayvakit) AND one of the following: sunitinib plus regorafenib (Stivarga), dasatinib, or intolerance to sunitinib.
Cutaneous melanoma: presence of an activating KIT mutation AND documentation that the patient has tried at least one systemic regimen (policy provides examples such as checkpoint inhibitor combinations and BRAF/MEK regimens).

Clinical Evidence & References

Evidence: Qinlock tablets [prescribing information], Oct 2023 (FDA Prescribing Information).

Evidence: NCCN Gastrointestinal Stromal Tumor Clinical Practice Guidelines in Oncology (version 2.2024 - July 31, 2024) and NCCN Melanoma: Cutaneous Clinical Practice Guidelines in Oncology (version 2.2025 - January 28, 2025).

Background

Qinlock (ripretinib) is a kinase inhibitor indicated for treatment of advanced gastrointestinal stromal tumor in adults who have received prior treatment with three or more kinase inhibitors including imatinib; NCCN guidelines also include Qinlock for specified GIST settings and as a recommended option for KIT‑mutant metastatic or unresectable cutaneous melanoma in certain circumstances.

Revision History

2025-04-02revisedLatest

material: Gastrointestinal Stromal Tumor criteria changed — replaced prior wording that required imatinib AND one of sunitinib or dasatinib AND regorafenib (or alternative configuration) with criteria requiring the patient has tried imatinib or Ayvakit (avapritinib) AND ONE of: sunitinib + Stivarga (regorafenib); or dasatinib; or is intolerant to sunitinib. (See FDA-approved indication criteria.)

2025-04-02added

material: Melanoma, Cutaneous indication and criteria were added to Other Uses with Supportive Evidence — approve for 1 year if patient is ≥18, has metastatic or unresectable disease, has an activating KIT mutation, and has tried at least one systemic regimen (examples provided).

2023-04-19 to 2024-04-19revised

non-material: Annual revision history entries (2023–2024) updated including removal of the Sprycel brand name from dasatinib criterion and minor wording/example systemic regimen modifications in melanoma note.

Policy Summary

PayerCigna

PolicyOncology - Qinlock Prior Authorization Policy

Policy CodePolicy N/A

Change TypeMaterial revisions to GIST prior therapy requirements; addition of cutaneous melanoma criteria

Effective Date

Next Review Date

Key ActionPrior Authorization is required; document prior therapies and KIT mutation status and approvals will be for 1 year when criteria are met.

On This Page

OpenPayer

Oncology - Qinlock Prior Authorization Policy

Coverage Summary

FDA-Approved Indication — Gastrointestinal Stromal Tumor (GIST)

Other Uses with Supportive Evidence — Cutaneous Melanoma

Conditions Not Covered / Unproven

Applicable Codes

Provider Actions

Clinical Evidence & References

Background

Revision History