CurrentNeighborhood Health Plan of Rhode IslandPolicy N/A

Qinlock (ripretinib) — Coverage Criteria

Defines accepted indications, continuation and exclusion criteria, and utilization management processes for Qinlock (ripretinib) for members of Neighborhood Health Plan of Rhode Island processed by Evolent's UM department.

Policy Summary

PayerNeighborhood Health Plan of Rhode Island

PolicyQinlock (ripretinib) — Coverage Criteria

Policy CodePolicy N/A

Change TypeNo material changes

Effective DateMay 31, 2024

Next Review DateN/A

Key ActionObtain prior authorization documenting failure, intolerance, or contraindication to imatinib, sunitinib, and regorafenib for GIST patients.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

150 mgsingle dose maximum for Qinlock

90maximum monthly quantity limit

3required prior therapies failed

05/08/24committee approval date

Coverage Criteria for Qinlock (ripretinib)

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Continuation therapy

Continuation therapy — Covered when ALL of the following are met

Recent use: Requested medication was used within the last year

No progression/intolerance: Member has not experienced disease progression and/or no intolerance to the requested medication

No additional meds: No additional medication(s) are being added to the continuation request

Supporting evidence: Use is supported by FDA labeling, CMS-recognized compendia, NCCN or ASCO guidelines, or acceptable peer-reviewed literature meeting CMS evidence standards

Refer to CMS Medicare Benefit Policy Manual Chapter 15

The policy identifies specific exclusion and dosing restrictions for Qinlock (ripretinib). Requests will be denied if there is disease progression while receiving ripretinib or if the medication is being used concurrently with other anti-cancer therapy. Dosing must not exceed a single dose of 150 mg, nor may treatment exceed the program limit of 90 (50 mg) tablets per month. Additionally, the policy excludes requests for investigational or off-label indications when the evidence is insufficient or not generally accepted by the medical community as defined by the policy (see investigational evidence criteria).

Off-label or investigational use of ripretinib (Qinlock) is considered not approvable unless supported by adequate evidence from CMS-recognized compendia or acceptable peer-reviewed literature. The policy specifies criteria to assess sufficiency of evidence including whether the patient and disease characteristics are represented in the published evidence; whether the therapy regimen studied reflects the requested regimen; whether study outcomes are clinically meaningful (for example, ASCO-recommended thresholds such as hazard ratio < 0.80 or survival benefits of at least 3 months); the appropriateness of study design; and the strength of the evidence (randomized trials preferred, larger non-randomized trials may be supportive, while case reports and meeting abstracts without full publication are generally inadequate).

Provider Requirements and Authorization Rules

Prior Authorization

Prior Authorization Required

Prior authorization is required for use of Qinlock (ripretinib) for gastrointestinal stromal tumor (GIST). Requests must document that the member has advanced, metastatic, or inoperable GIST and has experienced disease progression on, or is intolerant to, three prior lines of therapy: imatinib (Gleevec), sunitinib (Sutent), and regorafenib (Stivarga).

Affected indication: Advanced/metastatic/inoperable GIST
Required prior therapies: imatinib, sunitinib, regorafenib

Step Therapy

Step Therapy Requirement

Step therapy is required: Qinlock is intended only for patients who have progressed on or are intolerant to three prior approved GIST therapies (imatinib, sunitinib, regorafenib). Authorization should not be granted if the member has not tried and failed or was intolerant to these agents.

Step requirement: progression or intolerance to 3 prior GIST therapies

Documentation Required

Supporting Documentation Required

Supporting documentation must be submitted with the authorization request. Acceptable evidence includes FDA labeling, CMS-recognized compendia, NCCN or ASCO guidelines, or peer‑reviewed literature that adequately represents the patient and regimen and demonstrates clinically meaningful benefit.

Acceptable sources: FDA labeling, CMS compendia, NCCN, ASCO, peer‑reviewed literature
Documentation should show prior therapies tried, reasons for intolerance/contraindication, and clinical rationale

Denial Risk

Exclusion Criteria / Denial Risk

Requests may be denied if exclusion criteria are met. Examples triggering denial include disease progression while receiving ripretinib, concurrent anti‑cancer therapy, dosing above the single‑dose limit (150 mg), monthly dispensing exceeding 90 tablets (50 mg), or investigational/off‑label uses lacking adequate supporting evidence.

Denial triggers: progression on ripretinib; concurrent anti‑cancer therapy; dose >150 mg single dose; >90 (50 mg) tablets/month; insufficient evidence for off‑label use

Background on Qinlock (ripretinib)

Ripretinib (Qinlock) is indicated for treatment of advanced, metastatic, or inoperable gastrointestinal stromal tumor (GIST) for members who have experienced disease progression on, or have contraindications/intolerance to, prior therapy. Authorization is reserved for patients who have failed or cannot tolerate the three specified prior agents (imatinib, sunitinib, and regorafenib) as part of the step-therapy requirement.

Continuation Criteria and Exemptions

Continuation exemption

Continuation requests for not-approvable medication may be exempt if all conditions met

Continuation exemption: Requested medication was used within the last year; member has not experienced disease progression or intolerance; no additional medications added

Applies to continuation requests as stated

Step Therapy Requirements and Prior Trials

Agent	Required prior trial documented
{"text":"Imatinib (Gleevec)","status":""}\|{"text":"Covered - document disease progression and/or contraindication or intolerance to imatinib as one of three prior GIST therapies","status":"covered"}
{"text":"Sunitinib (Sutent)","status":""}\|{"text":"Covered - document disease progression and/or contraindication or intolerance to sunitinib as one of three prior GIST therapies","status":"covered"}
{"text":"Regorafenib (Stivarga)","status":""}\|{"text":"Covered - document disease progression and/or contraindication or intolerance to regorafenib as one of three prior GIST therapies","status":"covered"}