By Counterforce Health Team in Revlimid (lenalidomide) —

Aetna (CVS Health)'s Coverage Criteria for Revlimid (Lenalidomide) in Virginia: What Counts as "Medically Necessary"?

Answer Box: Getting Revlimid (Lenalidomide) Covered by Aetna (CVS Health) in Virginia

Aetna (CVS Health) covers Revlimid (lenalidomide) with prior authorization when medically necessary for FDA-approved indications like multiple myeloma and certain lymphomas. To qualify: (1) Submit PA with diagnosis confirmation, prior therapy history, and REMS enrollment proof; (2) Include medical necessity letter citing NCCN guidelines; (3) If denied, file internal appeal within 180 days, then Virginia external review within 120 days through the State Corporation Commission. Start today: Have your oncologist complete Aetna's lenalidomide PA form via Availity portal or call 1-866-814-5506 for specialty precertification.

Table of Contents

Policy Overview

Aetna (CVS Health) maintains diagnosis-specific prior authorization criteria for lenalidomide/Revlimid (policy ID 2232-A) that apply across most commercial plans, with some variations for Medicare and Medicaid products. The insurer generally requires documentation that use aligns with FDA-approved indications or evidence-based off-label use, with mandatory REMS program compliance.

Plan Types and Policy Application

Plan Type Coverage Rules Key Differences
Commercial/Exchange Standard PA criteria apply 12-month authorization periods
Medicare Advantage CMS guidelines + Aetna criteria May have formulary exceptions process
Aetna Better Health (Medicaid) State-specific formulary Quantity limits may vary

Indication Requirements

Aetna's lenalidomide policy covers FDA-approved indications and select evidence-based off-label uses. According to the current clinical criteria, covered indications include:

FDA-Approved Uses (Covered with PA)

  • Multiple myeloma (with dexamethasone; maintenance post-ASCT)
  • Myelodysplastic syndromes with deletion 5q
  • Relapsed/refractory mantle cell lymphoma
  • Follicular lymphoma and marginal zone lymphoma (with rituximab)

Documentation Requirements

Your oncologist must provide:

  • Confirmed diagnosis with pathology/cytogenetics and ICD-10 code
  • Disease stage and risk features as appropriate
  • Rationale referencing NCCN, ASCO, or FDA labeling
Tip: For multiple myeloma, include cytogenetics results and ISS staging. For lymphomas, provide WHO classification and Ann Arbor staging.

Step Therapy & Exceptions

While Aetna's policy doesn't mandate universal step therapy for lenalidomide, plan-level step therapy requirements may apply depending on your specific employer or exchange plan. Common scenarios include:

When Step Therapy May Apply

  • Multiple myeloma: Some plans require proteasome inhibitor-based therapy before lenalidomide combinations
  • Lymphomas: Documentation of appropriate line of therapy per NCCN guidelines

Medical Exception Pathways

To bypass step therapy requirements:

  1. Document treatment failures with start/stop dates and reasons for discontinuation
  2. Show intolerance or contraindications to required step drugs
  3. Request step-therapy exception via Aetna's precertification process

Submit exceptions via:

  • Online: Availity provider portal
  • Phone: 1-855-582-2025 (commercial) or 1-866-814-5506 (specialty)
  • Fax: 1-855-330-1716

Quantity & Frequency Limits

Due to REMS requirements, Aetna enforces strict quantity limits aligned with FDA safety protocols:

Dosing Schedule Maximum Supply Refill Rules
Daily dosing 28 capsules per 28 days No automatic refills
21/28 cycle 21 capsules per 28 days REMS verification required
Dose modifications Adjusted per renal function Requires PA update

Renewal Thresholds

  • Initial authorization: Up to 12 months
  • Continuation: Requires documentation of response/tolerance
  • Dose escalation: New PA required for increases above approved dose

Required Diagnostics

Aetna expects current lab values and imaging to support medical necessity:

Essential Lab Work (within 30 days)

  • Complete blood count with differential
  • Comprehensive metabolic panel including creatinine for dose adjustment
  • Pregnancy test for women of childbearing potential (required by REMS)

Disease-Specific Testing

  • Multiple myeloma: Serum/urine protein electrophoresis, free light chains, bone marrow biopsy
  • Lymphomas: Flow cytometry, imaging studies (CT/PET)
Note: Include lab reference ranges and flag abnormal values that support treatment need.

Site of Care Requirements

Most Aetna plans require lenalidomide to be dispensed through CVS Specialty or another contracted specialty pharmacy due to REMS requirements.

Specialty Pharmacy Routing

  • CVS Specialty: Primary for most plans
  • REMS-certified pharmacies: Alternative options must be pre-approved
  • Retail pharmacies: Generally not permitted for lenalidomide

Prior Authorization Integration

Your PA approval must specify the dispensing pharmacy to avoid delays. Coordinate with CVS Specialty at 1-800-237-2767 once PA is approved.

Evidence to Support Medical Necessity

Strong medical necessity letters reference current treatment guidelines and peer-reviewed evidence:

Guideline Citations to Include

  • NCCN Guidelines for specific indication
  • FDA labeling for dosing and safety
  • ASH/ASCO recommendations for combination regimens

Key Clinical Data Points

  • Prior therapy response with objective measures (M-protein reduction, imaging response)
  • Treatment intolerance with specific adverse events documented
  • Contraindications to alternative therapies
Clinician Corner: A compelling medical necessity letter should follow this structure: (1) Clinical scenario and diagnosis, (2) Prior treatments tried and outcomes, (3) Rationale for lenalidomide citing guidelines, (4) Expected monitoring plan.

Sample Medical Necessity Narrative

"Mr. [Patient] is a 67-year-old male with newly diagnosed multiple myeloma (IgG kappa, ISS Stage II) who is transplant-ineligible due to age and comorbidities. Per NCCN Guidelines Version 1.2025, lenalidomide + dexamethasone represents a category 1 preferred regimen for this population. He has adequate renal function (creatinine 1.2 mg/dL) and no contraindications to immunomodulatory therapy. The patient is enrolled in the Revlimid REMS program with documented counseling on embryo-fetal risks. Treatment will be monitored with monthly CBC and chemistry panels as outlined in FDA labeling."

Edge Cases

Special Populations

  • Renal impairment: Dose adjustments required per FDA labeling; include creatinine clearance calculation
  • Pregnancy: Contraindicated; must document negative pregnancy test and contraception plan
  • Pediatric use: Off-label; requires additional justification with pediatric oncology literature

Escalation Paths

If standard PA is denied for edge cases:

  1. Request peer-to-peer review with Aetna medical director
  2. Submit additional literature supporting off-label use
  3. Consider compassionate use programs through Bristol Myers Squibb

Quick Reference Table

Requirement What to Include Common Errors Source
Diagnosis ICD-10 code, pathology report Missing cytogenetics Aetna PA policy
Prior therapy Start/stop dates, response Vague "failed" without details Clinical documentation
REMS enrollment Patient/prescriber/pharmacy certification Missing enrollment numbers BMS REMS portal
Labs CBC, CMP within 30 days Outdated values Lab reports
Guidelines NCCN category/page reference Generic "standard of care" NCCN.org

Appeals Playbook for Virginia

If your Revlimid PA is denied, Virginia law provides robust appeal rights through the State Corporation Commission:

Internal Appeals (First Step)

  • Deadline: 180 days from denial for commercial plans
  • Timeline: 30 days for standard review, 72 hours for urgent
  • How to file: Call Aetna member services or submit written appeal

Virginia External Review

After exhausting internal appeals, you can request external review through the Virginia State Corporation Commission Bureau of Insurance:

Review Type Timeline When Available
Standard 45 days Medical necessity denials
Expedited 72 hours Cancer treatment, life-threatening conditions

To file external review:

  1. Complete Virginia Form 216-A within 120 days of final denial
  2. Include all denial letters and medical records
  3. For expedited review, have physician complete Form 216-C certifying urgency

Cancer-Specific Provisions

Virginia law allows simultaneous expedited internal and external review for cancer treatment denials, recognizing that delays can jeopardize outcomes.

FAQ

How long does Aetna (CVS Health) PA take in Virginia? Standard PA decisions typically take 15 calendar days for commercial plans, with expedited review available within 72 hours for urgent medical situations.

What if Revlimid (lenalidomide) is non-formulary on my plan? You can request a formulary exception by demonstrating that formulary alternatives are not clinically appropriate.

Can I request an expedited appeal for cancer treatment? Yes, Virginia law specifically allows expedited external review for cancer treatment denials, with decisions required within 72 hours.

Does step therapy apply if I've failed therapies outside Virginia? Treatment history from other states is generally accepted if properly documented with medical records showing dates, doses, and reasons for discontinuation.

What if my prescriber isn't REMS-certified? Lenalidomide can only be prescribed by REMS-certified providers. Your prescriber must enroll at bmsremspatientsafety.com before submitting any PA.

About Counterforce Health: When insurance denials threaten your access to critical cancer treatments like Revlimid, Counterforce Health helps turn those denials into successful appeals. Our platform analyzes denial letters and creates evidence-backed appeals that speak directly to your insurer's own criteria, dramatically improving approval rates for patients and their care teams.

If you're facing a complex Revlimid denial or need help navigating Aetna's requirements, Counterforce Health can provide the specialized support you need to get your treatment approved.

This guide is for informational purposes only and does not constitute medical or legal advice. Always consult with your healthcare provider and insurance plan for the most current requirements. For assistance with insurance appeals in Virginia, contact the State Corporation Commission Bureau of Insurance at 1-877-310-6560.

Sources & Further Reading

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