By Counterforce Health Team in Qinlock (ripretinib) —

Cigna's Coverage Criteria for Qinlock (Ripretinib) in New York: What Counts as "Medically Necessary"?

Quick Answer: Getting Qinlock (Ripretinib) Covered by Cigna in New York

Cigna requires prior authorization for Qinlock (ripretinib) and enforces strict step therapy: you must have tried and failed imatinib, sunitinib, and regorafenib first. Medical necessity requires documented GIST diagnosis, progression after these three therapies, and oncologist prescription. First step today: Have your oncologist gather treatment history and submit the PA request through Cigna's provider portal. If denied, New York offers strong external appeal rights through the Department of Financial Services within 4 months of Cigna's final denial.

Table of Contents

Policy Overview

Cigna manages Qinlock (ripretinib) coverage through their specialty pharmacy benefit, typically via Express Scripts/Accredo. The drug requires prior authorization across all Cigna plan types—commercial HMO, PPO, and Medicare Advantage plans in New York.

Plan Type Considerations:

  • Commercial plans: Standard PA requirements apply with 180-day internal appeal window
  • Medicare Advantage: May have additional CMS-mandated coverage determination timelines
  • Medicaid managed care: Subject to both Cigna and New York State Medicaid policies

Official Cigna coverage policies can be found in their Coverage Position Criteria documents, which are updated regularly and should be verified before submission.

Indication Requirements

Qinlock meets medical necessity criteria when prescribed for its FDA-approved indication: advanced gastrointestinal stromal tumor (GIST) in adults who have received prior treatment with three or more kinase inhibitors, including imatinib.

Key FDA/Clinical Requirements:

  • Age: 18 years or older
  • Diagnosis: Histologically confirmed GIST with immunohistochemistry markers (KIT/CD117, DOG1)
  • Disease status: Advanced, unresectable, or metastatic disease
  • Prior therapy: Documented treatment with at least three kinase inhibitors, including imatinib

The NCCN Guidelines (2024) designate Qinlock as the only Category 1 recommendation for fourth-line GIST treatment, strengthening medical necessity arguments.

Step Therapy & Exceptions

Cigna enforces a strict step therapy sequence that cannot be bypassed without documented medical exceptions:

Required Sequence:

  1. First-line: Imatinib (Gleevec) - must document adequate trial and failure/progression
  2. Second-line: Sunitinib (Sutent) - must document progression or intolerance
  3. Third-line: Regorafenib (Stivarga) - must document progression or intolerance
  4. Fourth-line: Qinlock (ripretinib) - eligible only after completing above sequence

Medical Exception Pathways:

  • Contraindications: Document specific medical reasons why a required therapy cannot be used
  • Prior intolerance: Provide detailed records of adverse events requiring discontinuation
  • Drug interactions: Show clinically significant interactions preventing safe use
Tip: Keep detailed records of dates, doses, duration, and specific reasons for discontinuation of each prior therapy. Vague documentation like "patient didn't tolerate" often results in denial.

Quantity and Frequency Limits

Cigna typically covers Qinlock based on FDA-approved dosing with specific quantity limits:

Standard Coverage:

  • Dose: 150 mg once daily (30 tablets per 30-day supply)
  • Quantity limit: 90 tablets per 90-day fill
  • Refill restrictions: Early refills generally not permitted without clinical justification

Dose Escalation Scenarios:

  • With CYP3A inducers: May approve 150 mg twice daily (60 tablets/30 days) with documentation
  • Progression on standard dose: NCCN guidelines support dose escalation, but requires prior authorization modification

Documentation for quantity limit exceptions should include the specific clinical rationale and reference to FDA prescribing information.

Required Diagnostics

Cigna requires current diagnostic evidence to support ongoing medical necessity:

Initial Authorization:

  • Pathology report: Confirming GIST diagnosis with appropriate markers
  • Imaging studies: CT or MRI showing measurable disease (within 3 months)
  • Performance status: ECOG 0-2 typically required
  • Baseline labs: CBC, comprehensive metabolic panel, liver function tests

Reauthorization Requirements:

  • Response assessment: Imaging every 2-3 months per NCCN recommendations
  • Toxicity monitoring: Documentation of tolerance and any dose modifications
  • Continued benefit: Evidence that treatment remains appropriate

Site of Care & Specialty Pharmacy

Qinlock must be dispensed through Cigna's designated specialty pharmacy network:

Cigna Specialty Pharmacy Requirements:

  • Primary: Express Scripts/Accredo specialty pharmacy
  • Alternative: Cigna-approved specialty pharmacies in network
  • Retail exclusion: Cannot be filled at standard retail pharmacies

Prior to First Fill:

  • Patient enrollment in specialty pharmacy required
  • Insurance verification and copay assistance coordination
  • Delivery logistics and refill scheduling setup

Contact Cigna Specialty Pharmacy to confirm current network and enrollment procedures.

Evidence to Support Necessity

Strong medical necessity letters should reference specific clinical evidence:

Primary Sources to Cite:

  • FDA approval: FDA approval announcement for fourth-line GIST
  • NCCN Guidelines: Category 1 recommendation for fourth-line treatment
  • INVICTUS trial: Pivotal trial data showing efficacy after multiple prior therapies
  • Prescribing information: Official dosing and monitoring recommendations

Clinical Evidence Framework:

  1. Problem statement: Patient's current disease status and prior treatment failures
  2. Treatment rationale: Why Qinlock is appropriate for this specific patient
  3. Guidelines support: Reference to NCCN Category 1 recommendation
  4. Alternative analysis: Why other options are not suitable
  5. Monitoring plan: How treatment response and toxicity will be assessed

Sample "Meets Criteria" Narrative

Here's a template paragraph structure for medical necessity letters:

"[Patient name] is an [age]-year-old adult with histologically confirmed advanced GIST who meets criteria for Qinlock (ripretinib) coverage. The patient has completed the required step therapy sequence with documented progression on imatinib ([dates, dose, duration]), sunitinib ([dates, dose, duration]), and regorafenib ([dates, dose, duration]). Recent imaging on [date] demonstrates progressive disease with [specific findings]. Per NCCN Guidelines v.2024, ripretinib is the Category 1 recommended fourth-line therapy for advanced GIST after failure of these three prior kinase inhibitors. The patient has adequate performance status (ECOG [0-2]) and no contraindications to ripretinib therapy. Treatment will be monitored per standard protocols with imaging every 8-12 weeks and toxicity assessments."

Edge Cases

Pediatric Considerations:

  • Qinlock is not FDA-approved for patients under 18
  • Compassionate use requests require extensive documentation and often face denial

Pregnancy and Reproductive Health:

  • Contraindicated in pregnancy (Category D)
  • Requires pregnancy testing and contraception counseling documentation

Comorbidities Requiring Special Attention:

  • Cardiac conditions: QT prolongation monitoring required
  • Hypertension: Blood pressure management plan needed
  • Hepatic impairment: May require dose modifications

Escalation Paths:

  • Peer-to-peer review with Cigna medical director
  • Formulary exception request if non-formulary
  • Clinical trial enrollment consideration if all options exhausted

Coverage at a Glance

Requirement What It Means Documentation Needed Source
Prior Authorization Required before first fill PA form via provider portal Cigna PA Policy
Step Therapy Must try 3 prior TKIs first Treatment records for imatinib, sunitinib, regorafenib Same
Diagnosis Advanced GIST confirmed Pathology report with IHC markers Same
Prescriber Oncologist required DEA and specialty credentials Same
Age Limit 18+ years Date of birth verification FDA Label
Quantity Limit 30 tablets/30 days Standard dosing justification Cigna Formulary
Specialty Pharmacy Express Scripts/Accredo only Enrollment in SP network Same
Appeals Deadline 180 days (internal) Denial letter and medical records Cigna Appeals

Common Denial Reasons & Fixes

Denial Reason How to Overturn Required Documentation
Step therapy not met Submit complete prior therapy records Detailed treatment timeline with dates, doses, outcomes
Insufficient progression evidence Provide recent imaging CT or MRI within 3 months showing disease progression
Not medically necessary Request peer-to-peer review NCCN guidelines, FDA approval documentation
Missing diagnosis confirmation Submit pathology report IHC staining for KIT/CD117, DOG1 markers
Prescriber not qualified Verify oncologist credentials Board certification, DEA registration
Quantity limit exceeded Justify dose escalation Clinical rationale per FDA label

Appeals Playbook for New York

New York residents have particularly strong appeal rights when Cigna denies coverage:

Internal Appeals (First Step):

  • Timeline: Must file within 180 days of denial
  • Process: Submit via Cigna appeals portal or mail
  • Documentation: Include denial letter, medical records, prescriber letter
  • Decision: Cigna has 30 days for standard appeals, 72 hours for expedited

External Appeals (New York Specific):

  • Timeline: Must file within 4 months of Cigna's final denial
  • Authority: New York Department of Financial Services (DFS)
  • Process: Submit DFS external appeal form online, mail, or fax
  • Fee: Maximum $25 (waived for Medicaid or financial hardship)
  • Decision: Binding on Cigna if overturned

Expedited Appeals:

  • When available: If delay would seriously jeopardize health
  • Timeline: 72 hours for internal, 72 hours for external
  • Requirements: Physician attestation of urgency
Note: Community Health Advocates offers free assistance at 888-614-5400 for New Yorkers navigating insurance appeals.

FAQ

How long does Cigna prior authorization take for Qinlock in New York? Standard PA decisions are issued within 72 hours of complete submission. Expedited requests (for urgent cases) are decided within 24 hours.

What if Qinlock is non-formulary on my Cigna plan? You can request a formulary exception with clinical justification. If denied, the same appeal rights apply.

Can I get an expedited appeal if my GIST is progressing rapidly? Yes, if your oncologist certifies that delay would seriously jeopardize your health, both Cigna and New York DFS offer expedited review timelines.

Does step therapy apply if I tried these drugs in another state? Yes, prior therapy records from any location count toward step therapy requirements, as long as they're properly documented.

What's the success rate for external appeals in New York? New York doesn't publish specific success rates, but external appeals have binding authority and independent medical review, making them particularly valuable for rare disease cases with strong clinical support.

How much does Qinlock cost without insurance coverage? Cash prices typically range from $43,000-$48,000 per month. Deciphera's patient assistance program may help eligible patients.

About Counterforce Health

Counterforce Health specializes in turning insurance denials into successful appeals for complex medications like Qinlock. Our platform analyzes denial letters, identifies the specific coverage gaps, and generates evidence-backed appeals that address each payer's unique requirements. For patients facing Cigna denials in New York, we help navigate both internal appeals and the state's external review process to maximize approval chances.

Disclaimer: This information is for educational purposes only and does not constitute medical or legal advice. Always consult with your healthcare provider about treatment decisions and contact qualified legal counsel for specific appeals guidance.

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