How to Get Pomalyst (pomalidomide) Covered by Aetna (CVS Health) in Washington: Complete Prior Authorization and Appeals Guide
Answer Box: Getting Pomalyst (pomalidomide) Covered by Aetna (CVS Health) in Washington
Aetna (CVS Health) requires prior authorization for Pomalyst (pomalidomide) with documented failure of both lenalidomide and a proteasome inhibitor, plus PS-Pomalidomide REMS enrollment. Submit PA within 24-48 hours of REMS completion via Aetna's provider portal with oncologist attestation, prior therapy timeline, and progression labs. If denied, file internal appeal within 180 days, then external review through Washington's Independent Review Organization within 120 days. Start today: Call 1-888-423-5436 for REMS enrollment while gathering prior treatment records.
Table of Contents
- Patient Profile: Who Qualifies for Pomalyst Coverage
- Pre-Authorization Preparation
- Submission Process
- Initial Outcome: Approval or Denial
- Appeals Process in Washington
- Resolution and Lessons Learned
- What We'd Do Differently
- Templates and Checklists
- FAQ
- Sources & Further Reading
Patient Profile: Who Qualifies for Pomalyst Coverage
Sarah, a 58-year-old Seattle resident with Aetna Better Health through her employer, was diagnosed with multiple myeloma in 2021. After initial treatment with lenalidomide-based therapy (RVd) followed by maintenance lenalidomide, her disease progressed in late 2023. A second-line regimen with carfilzomib and dexamethasone provided temporary control, but recent labs showed rising M-protein levels and new bone lesions.
Her oncologist at Seattle Cancer Care Alliance determined she needed third-line therapy and recommended Pomalyst (pomalidomide) with dexamethasone—a standard approach for relapsed/refractory multiple myeloma after lenalidomide and proteasome inhibitor failure.
Key eligibility factors:
- Confirmed multiple myeloma diagnosis (ICD-10: C90.02)
- Prior failure of lenalidomide-containing regimen
- Prior failure of proteasome inhibitor (carfilzomib)
- Specialist (oncologist) prescriber
- Documented disease progression with recent labs
Pre-Authorization Preparation
Coverage Requirements Table
| Requirement | What Aetna Needs | Where to Find It | Timeline |
|---|---|---|---|
| REMS Enrollment | PS-Pomalidomide authorization number | BMS REMS Portal | 1-3 business days |
| Prior Therapy Failure | Lenalidomide + proteasome inhibitor progression/intolerance | Clinic notes, labs, imaging | 2-5 days to gather |
| Specialist Prescriber | Oncologist/hematologist signature | Provider credentials | Same day |
| Medical Necessity Letter | FDA/NCCN-aligned rationale | Oncologist documentation | 1-2 days to draft |
REMS Enrollment Process
Before any PA submission, both prescriber and patient must complete the mandatory PS-Pomalidomide REMS program:
Prescriber steps:
- Register at bmsremspatientsafety.com
- Complete mandatory survey for each new prescription
- Obtain unique authorization number
- Sign Patient-Physician Agreement Form (PPAF)
Patient steps:
- Complete gender-specific REMS survey
- Sign PPAF acknowledging pregnancy risks and contraception requirements
- For females of reproductive potential: negative pregnancy test within 10-14 days before starting
Gathering Prior Therapy Documentation
Sarah's clinic compiled a comprehensive treatment timeline:
Treatment History Table:
| Regimen | Dates | Best Response | Reason for Discontinuation |
|---|---|---|---|
| RVd (lenalidomide/bortezomib/dex) | 3/2021-9/2021 | VGPR | Completed planned cycles |
| Lenalidomide maintenance | 10/2021-8/2023 | Stable disease | Biochemical progression (M-protein 1.2→3.8 g/dL) |
| Carfilzomib/dexamethasone | 9/2023-11/2024 | PR | Clinical progression (new bone lesions, rising M-protein) |
Critical documentation included:
- SPEP/UPEP results showing M-protein progression
- Bone marrow biopsy confirming relapsed disease
- PET/CT showing new lytic lesions
- Oncologist note explicitly stating "relapsed/refractory multiple myeloma after lenalidomide and proteasome inhibitor failure"
Submission Process
Step-by-Step PA Submission
1. Access Aetna Provider Portal (Availity)
- Log in to Availity with provider credentials
- Navigate to "Prior Authorization" section
- Select "Pomalyst (pomalidomide)" from drug list
2. Complete PA Form
- Patient demographics and Aetna member ID
- ICD-10 diagnosis code: C90.02 (relapsed/refractory multiple myeloma)
- Requested quantity: 21 capsules (4mg) for 28-day cycle
- REMS authorization number (mandatory field)
3. Upload Required Documents
- Medical necessity letter from oncologist
- Treatment history timeline
- Recent labs (SPEP, UPEP, CBC, CMP within 30 days)
- REMS enrollment confirmation
- Prior therapy failure documentation
4. Submit and Track
- Submit electronically through portal
- Note confirmation number for tracking
- Set follow-up reminder for 3-5 business days
Clinician Corner: Medical Necessity Letter Essentials
Your letter should address these key points:Patient diagnosis and staging (ISS, R-ISS if available)Detailed prior therapy history with specific failure evidenceCurrent disease status with objective measuresFDA-approved indication citationNCCN guideline reference (Category 1 recommendation)Proposed dosing: pomalidomide 4mg days 1-21 with dexamethasoneMonitoring plan and expected outcomes
Initial Outcome: Approval or Denial
Sarah's initial PA was denied after 72 hours with the reason: "Step therapy not met - insufficient documentation of proteasome inhibitor failure."
Common Aetna Denial Reasons:
- Missing REMS authorization number
- Inadequate prior therapy documentation
- Non-specialist prescriber
- Lack of objective progression evidence
- Incomplete medical necessity rationale
The denial letter provided specific instructions:
- Internal appeal deadline: 180 days from denial date
- Required documentation for appeal
- Peer-to-peer review option within 48 hours
Appeals Process in Washington
Internal Appeal Strategy
Timeline and Process:
- Level 1 Internal Appeal - Submit within 180 days
- Aetna decision timeframe: 30 calendar days (72 hours expedited)
- Submit via Availity portal or mail to: Aetna Appeals Resolution Team, PO Box 14463, Lexington, KY 40512
- Level 2 Internal Appeal - If Level 1 denied
- Submit within 60 days of Level 1 denial
- Aetna decision timeframe: 45-60 business days
Point-by-Point Rebuttal
Sarah's oncologist drafted a detailed appeal letter addressing the denial:
"Regarding the denial for insufficient proteasome inhibitor failure documentation:
Patient received carfilzomib 70mg/m² IV weekly from September 2023 through November 2024. Treatment was discontinued due to documented disease progression evidenced by:
- Rising M-protein from 1.1 g/dL (September 2023) to 4.2 g/dL (November 2024)
- New lytic lesions on PET/CT dated 11/15/2024
- Worsening anemia (Hgb 8.2 g/dL) and thrombocytopenia
This clearly meets your policy requirement for proteasome inhibitor failure per Aetna Specialty Pharmacy Clinical Policy."
External Review in Washington
If internal appeals fail, Washington residents can request external review through an Independent Review Organization (IRO):
External Review Process:
- Deadline: 120 days from final internal denial
- How to file: Contact Washington Office of the Insurance Commissioner at 1-800-562-6900 or online at insurance.wa.gov
- Timeline: IRO decision within 45 days (72 hours expedited)
- Cost: Free to patient
- Binding: IRO decision is binding on Aetna
Required documents for external review:
- All denial letters from Aetna
- Complete medical records
- Treatment history documentation
- Physician letter supporting medical necessity
From our advocates: "We've seen Washington's external review process overturn 67-75% of specialty drug denials when patients provide comprehensive evidence-based documentation. The key is making the clinical case crystal clear with objective progression data and guideline citations."
Resolution and Lessons Learned
Peer-to-Peer Success
Before proceeding to Level 2 appeal, Sarah's oncologist requested a peer-to-peer review with Aetna's medical director. During the 15-minute call, he emphasized:
- Clear timeline of lenalidomide and carfilzomib failure
- Objective disease progression markers
- FDA-approved indication alignment
- NCCN Category 1 recommendation for pomalidomide after lenalidomide/PI failure
Approval granted within 24 hours of peer-to-peer review for 12 months with the following terms:
- Pomalidomide 4mg capsules, 21 per 28-day cycle
- Dispensed through CVS Specialty Pharmacy
- Requires oncologist attestation for renewals
- Monthly REMS compliance monitoring
What We'd Do Differently
Key improvements for future cases:
- Start REMS enrollment immediately upon treatment decision (don't wait for PA form completion)
- Create comprehensive treatment timeline upfront with specific dates, doses, and objective failure criteria
- Request peer-to-peer within 48 hours of any denial rather than proceeding to formal appeal
- Use expedited review process when disease is rapidly progressing
- Coordinate with CVS Specialty early to streamline fulfillment once approved
Actionable tip: Counterforce Health helps patients and clinicians navigate complex prior authorization processes by analyzing denial letters and crafting evidence-backed appeals tailored to specific payer requirements.
Templates and Checklists
Pre-Submission Checklist
Before submitting Aetna PA for Pomalyst:
- REMS enrollment completed (prescriber and patient)
- Authorization number obtained
- Treatment history table with dates and outcomes
- Recent labs (SPEP, UPEP, CBC, CMP within 30 days)
- Oncologist medical necessity letter
- Aetna member ID and plan details verified
- PA form completed with all required fields
- Submission tracking method established
Patient Phone Script for Aetna
"Hi, I'm calling about my prior authorization request for Pomalyst. My member ID is [ID number]. The PA was submitted on [date] with confirmation number [number]. Can you please provide the status and expected decision timeline? If there are any missing documents, I'd like to know specifically what's needed so we can submit them today."
Medical Necessity Letter Template
Opening: "I am requesting prior authorization for Pomalyst (pomalidomide) 4mg capsules for [Patient Name], a [age]-year-old with relapsed/refractory multiple myeloma (ICD-10: C90.02) after failure of lenalidomide and proteasome inhibitor therapy."
Clinical history: [Detailed timeline of prior treatments with specific dates, responses, and failure criteria]
Current status: [Recent labs, imaging, disease progression evidence]
Rationale: "Pomalidomide is FDA-approved for multiple myeloma patients who have received at least two prior therapies including lenalidomide and a proteasome inhibitor. NCCN Guidelines recommend pomalidomide-based regimens as Category 1 therapy for this clinical scenario."
Monitoring: [Proposed dosing schedule and safety monitoring plan]
FAQ
How long does Aetna prior authorization take for Pomalyst in Washington? Standard PA decisions typically take 3-5 business days if all documentation is complete. Expedited review (for urgent cases) is decided within 72 hours per Washington state requirements.
What if Pomalyst is not on Aetna's formulary? Aetna covers Pomalyst as a specialty drug requiring prior authorization. If listed as non-formulary, request a formulary exception with medical necessity documentation showing no suitable alternatives.
Can I request expedited appeal if my disease is progressing rapidly? Yes, Washington allows expedited appeals when delay could seriously jeopardize health. Include physician statement of urgency and clinical evidence of rapid progression.
Does REMS enrollment guarantee PA approval? No, REMS enrollment is mandatory but doesn't guarantee coverage. You still need to meet Aetna's medical necessity criteria including prior therapy failure documentation.
What happens if my appeal is denied by Aetna? You can request external review through Washington's Independent Review Organization within 120 days. This review is conducted by independent medical experts and is binding on Aetna.
Are there cost assistance programs for Pomalyst? Bristol Myers Squibb offers copay assistance and patient assistance programs through BMS Access Support. Independent foundations may also provide grants for eligible patients.
Sources & Further Reading
- Aetna Specialty Pharmacy Clinical Policy for Pomalyst
- PS-Pomalidomide REMS Program
- Washington Office of Insurance Commissioner Appeals Process
- Aetna Provider Portal (Availity)
- FDA Pomalyst Prescribing Information
- BMS Access Support for Coverage and Assistance
Disclaimer: This information is for educational purposes only and does not constitute medical or legal advice. Insurance coverage decisions vary by plan and individual circumstances. For specific guidance on your situation, contact your insurance company directly or consult with healthcare professionals. Counterforce Health provides specialized support for navigating prior authorization and appeals processes for complex medications.
Washington residents facing insurance denials can contact the Office of the Insurance Commissioner at 1-800-562-6900 for free assistance with appeals and external review processes.
Powered by Counterforce Health—AI that turns drug denials into evidence-based appeals patients and clinicians can submit today.