By Counterforce Health Team in Retevmo (selpercatinib) —

Blue Cross Blue Shield of Michigan's Coverage Criteria for Retevmo (Selpercatinib): Complete Prior Authorization and Appeal Guide

Answer Box: Getting Retevmo Covered by BCBSM

Fastest path to approval: Submit prior authorization with FDA-approved RET fusion test results, documented treatment history, baseline ECG showing QTc <500ms, and a detailed medical necessity letter citing FDA labeling. First step today: Contact BCBSM member services at the number on your ID card to confirm current PA requirements and preferred submission method. Michigan advantage: If denied, you have 127 days for external review through Michigan DIFS, with decisions typically within 56 days.

Table of Contents

  1. Policy Overview: How BCBSM Handles Specialty Oncology Drugs
  2. Indication Requirements: Proving Medical Necessity
  3. Step Therapy & Exception Pathways
  4. Required Diagnostics and Safety Documentation
  5. Site of Care and Specialty Pharmacy Requirements
  6. Evidence to Support Medical Necessity
  7. Common Denial Reasons & How to Fix Them
  8. Michigan Appeals Process: Internal to External Review
  9. Cost Support and Patient Assistance
  10. FAQ: Most Asked Questions

Coverage at a Glance

Requirement What It Means Where to Find It Source
Prior Authorization Required for all specialty oncology drugs BCBSM formulary documents BCBSM Drug Lists
RET Testing FDA-approved companion diagnostic required Pathology report with specific test name FDA Approvals
QT Monitoring Baseline ECG, QTc <500ms Cardiology or oncology records Retevmo Prescribing Info
Appeals Deadline 60 days internal, 127 days external Denial letter date Michigan DIFS

Policy Overview: How BCBSM Handles Specialty Oncology Drugs

Blue Cross Blue Shield of Michigan (BCBSM) covers approximately 67% of commercial plan members in the state and maintains strict prior authorization requirements for specialty oncology medications like Retevmo. The plan operates under Michigan's Patient's Right to Independent Review Act, providing members with robust appeal rights.

Plan Types and Coverage:

  • PPO Traditional: Most flexible, allows out-of-network providers with higher cost-sharing
  • HMO: Requires referrals, more restrictive formulary management
  • Medicare Advantage: Federal guidelines apply, but BCBSM-specific formulary rules still govern

All BCBSM plans require prior authorization for Retevmo, regardless of plan type. The drug typically falls under Tier 4 or 5 (specialty tier) coverage with significant cost-sharing requirements.

Tip: BCBSM has been working to reduce prior authorization requirements by approximately 20% through their "gold carding" program, but specialty oncology drugs remain subject to full PA review.

Indication Requirements: Proving Medical Necessity

Retevmo is FDA-approved for three specific indications, and BCBSM requires documentation matching these exact criteria:

FDA-Approved Indications

  1. RET fusion-positive non-small cell lung cancer (NSCLC) - metastatic disease
  2. RET-mutant medullary thyroid cancer - advanced or metastatic
  3. RET fusion-positive thyroid cancer - advanced or metastatic (adult and pediatric ≥12 years)

Required Documentation

  • Pathology report confirming cancer type and stage
  • Molecular testing results from an FDA-approved companion diagnostic:
    • Oncomine Dx Target Test (Thermo Fisher)
    • TruSight Oncology Comprehensive (Illumina)
    • FoundationOne CDx
  • ICD-10 diagnosis codes matching the specific indication
  • Treatment intent clearly stated (curative vs. palliative)
Note: BCBSM will not approve Retevmo based on laboratory-developed tests (LDTs) or non-FDA-approved testing platforms. The companion diagnostic requirement is strictly enforced.

Step Therapy & Exception Pathways

BCBSM typically does not require step therapy for RET-targeted therapies in first-line treatment of RET-altered cancers, as these represent precision medicine approaches. However, exceptions may apply:

When Step Therapy May Apply

  • Off-label use in cancer types not specifically FDA-approved
  • Combination therapy requests
  • Dose escalation beyond FDA labeling

Medical Exception Criteria

To bypass step therapy requirements, document:

  1. Contraindications to required first-line agents
  2. Previous treatment failures with specific adverse events
  3. Drug interactions that preclude standard therapy
  4. Comorbidities making alternatives inappropriate

Required Diagnostics and Safety Documentation

Retevmo carries specific safety monitoring requirements that BCBSM incorporates into their medical necessity criteria:

Baseline Requirements

  • ECG showing QTc interval <500ms
  • Complete metabolic panel with normal electrolytes (K+, Mg2+, Ca2+)
  • Liver function tests (baseline ALT, AST, bilirubin)
  • Blood pressure control documented
  • Thyroid function (TSH) if applicable

Ongoing Monitoring Plan

Your oncologist must submit a monitoring plan including:

  • ECG frequency (typically every 2-4 weeks initially)
  • Laboratory monitoring schedule
  • Drug interaction screening protocol
  • Dose modification criteria for toxicity
Clinician Corner: The medical necessity letter should specifically address QT prolongation risk management and include a statement like: "Patient has baseline QTc of [value] ms, normal electrolytes, and will undergo ECG monitoring every [frequency] per FDA labeling recommendations."

Site of Care and Specialty Pharmacy Requirements

BCBSM requires Retevmo to be dispensed through their contracted specialty pharmacy network. Using an out-of-network pharmacy will result in denial, as confirmed by recent Michigan DIFS cases.

Approved Dispensing Locations

  • BCBSM contracted specialty pharmacies (verify current list with member services)
  • Health system specialty pharmacies with BCBSM contracts
  • Physician office dispensing (limited circumstances, requires separate authorization)
Important: A 2024 Michigan DIFS case upheld BCBSM's denial when a member used an out-of-network specialty pharmacy, emphasizing the importance of network compliance.

Evidence to Support Medical Necessity

Strengthen your prior authorization with evidence-based citations:

Primary Sources to Reference

  1. FDA Prescribing Information - Retevmo (selpercatinib) label
  2. NCCN Guidelines - Thyroid carcinoma and NSCLC panels (subscription required for full access)
  3. Clinical trial data - LIBRETTO-001 and LIBRETTO-531 studies
  4. Manufacturer resources - Retevmo HCP website

Sample Medical Necessity Statement

"Patient has metastatic NSCLC with RET fusion confirmed by FoundationOne CDx testing (FDA-approved companion diagnostic). Standard platinum-based chemotherapy is not optimal for RET fusion-positive disease per NCCN Guidelines v.2024. Retevmo is FDA-approved for this specific indication with demonstrated superior efficacy in the LIBRETTO-001 trial. Patient has baseline QTc of 420ms, normal electrolytes, and appropriate cardiac monitoring will be implemented per prescribing information."

Common Denial Reasons & How to Fix Them

Denial Reason Solution Required Documentation
"RET status not confirmed" Submit FDA-approved test results Pathology report with specific assay name
"Not medically necessary" Provide guideline citations NCCN, FDA label excerpts
"QT risk not addressed" Submit cardiac clearance ECG, electrolytes, monitoring plan
"Out-of-network pharmacy" Switch to contracted provider New prescription to approved pharmacy
"Insufficient prior therapy" Document treatment history Previous regimen details, response, toxicity

Michigan Appeals Process: Internal to External Review

Step 1: Internal Appeal (Required First Step)

  • Timeline: File within 60 days of denial
  • BCBSM response time: 30 days for preservice appeals
  • Submit to: BCBSM member services or provider portal
  • Required documents: Denial letter, medical records, prescriber letter

Step 2: External Review (Michigan DIFS)

  • Timeline: 127 days after final internal denial
  • Decision timeframe: 56 days (standard), 72 hours (expedited)
  • File online: DIFS External Review Portal
  • Phone: 877-999-6442
  • Binding decision: BCBSM must comply with IRO ruling
From our advocates: "We've seen Michigan external reviews succeed when the clinical documentation clearly links the FDA-approved indication to the patient's specific diagnosis and includes proper safety monitoring plans. The key is showing the insurer's criteria were actually met, not arguing they're wrong."

Expedited Review Criteria:

  • Serious jeopardy to health from delay
  • Physician letter stating urgency required
  • Impending treatment needs

Cost Support and Patient Assistance

With cash prices ranging $23,000-$26,000 monthly, financial assistance is crucial:

Manufacturer Support

  • Lilly Cares Foundation - Income-based free drug program
  • Retevmo Savings Program - Copay assistance for commercially insured patients
  • Contact: Visit manufacturer website for current eligibility

Other Resources

  • Patient Advocate Foundation - Copay relief programs
  • CancerCare - Financial assistance and counseling
  • State pharmaceutical assistance - Michigan has limited programs for specific populations

FAQ: Most Asked Questions

How long does BCBSM prior authorization take for Retevmo? Standard PA decisions are made within 30 days for preservice requests. Expedited reviews (when medically urgent) are completed within 72 hours.

What if Retevmo isn't on my BCBSM formulary? You can request a formulary exception with medical necessity documentation. The appeals process applies to formulary exceptions as well.

Can I get an expedited appeal in Michigan? Yes, if your physician provides a letter stating that delay would seriously jeopardize your health. DIFS expedited reviews are decided within 72 hours.

Does step therapy apply if I've tried treatments in another state? Yes, BCBSM will accept documented treatment history from other states if properly documented in medical records.

What happens if my specialty pharmacy is out-of-network? BCBSM will deny coverage. You must switch to a contracted specialty pharmacy - verify network status before filling.

How do I prove RET testing was done correctly? Submit the complete pathology report showing the specific FDA-approved test used (Oncomine Dx Target Test, TruSight Oncology, or FoundationOne CDx).

About Counterforce Health: Counterforce Health specializes in turning insurance denials into successful appeals for patients needing specialty medications like Retevmo. Our platform analyzes denial letters and plan policies to create targeted, evidence-backed appeals that address each payer's specific requirements. By combining clinical expertise with payer intelligence, we help patients navigate complex prior authorization processes and access life-saving treatments. Learn more at www.counterforcehealth.org.

When facing a Retevmo denial from BCBSM, remember that Michigan's robust external review process provides a meaningful path to coverage. The key is thorough documentation, adherence to network requirements, and persistent advocacy. Counterforce Health can help streamline this process by identifying the specific criteria your case must meet and crafting appeals that speak directly to BCBSM's requirements.

Sources & Further Reading

Disclaimer: This information is for educational purposes only and does not constitute medical or legal advice. Insurance coverage decisions depend on individual plan terms and clinical circumstances. Always consult with your healthcare provider and insurance company for guidance specific to your situation. For assistance with insurance appeals or questions about coverage, contact Michigan DIFS at 877-999-6442.

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