By Counterforce Health Team in Pomalyst (pomalidomide) —

How to Get Pomalyst (Pomalidomide) Covered by Aetna (CVS Health) in Texas: Complete Prior Authorization and Appeals Guide

Answer Box: Getting Pomalyst (Pomalidomide) Covered by Aetna (CVS Health) in Texas

Aetna (CVS Health) requires prior authorization for Pomalyst (pomalidomide) with documented failure of both lenalidomide and a proteasome inhibitor, plus mandatory PS-Pomalidomide REMS enrollment. To get approval in Texas: (1) Complete REMS certification through the BMS portal within 1-3 business days, (2) Submit prior authorization with treatment timeline showing lenalidomide + proteasome inhibitor failure, and (3) Include oncologist medical necessity letter with recent labs. If denied, you have 4 years to appeal in Texas with binding external review available.

Table of Contents

  1. Understanding Aetna's Pomalyst Coverage Requirements
  2. Step-by-Step: Fastest Path to Approval
  3. Common Denial Reasons & How to Fix Them
  4. Medical Necessity Letter Requirements
  5. Texas Appeals Process: Internal and External Review
  6. REMS Program Requirements for CVS Specialty Pharmacy
  7. Cost Savings and Patient Support Programs
  8. Frequently Asked Questions

Understanding Aetna's Pomalyst Coverage Requirements

Pomalyst (pomalidomide) is a specialty oral medication manufactured by Bristol Myers Squibb for treating relapsed/refractory multiple myeloma. With retail costs often reaching $23,400 for a 21-capsule pack, securing insurance coverage is critical for most patients.

Coverage at a Glance

Requirement What It Means Documentation Needed Source
Prior Authorization Required for all Aetna plans PA form with clinical documentation Aetna Provider Portal
Diagnosis Relapsed/refractory multiple myeloma ICD-10: C90.02, pathology reports FDA Label
Prior Therapies Failed lenalidomide AND proteasome inhibitor Timeline with dates, outcomes Aetna Coverage Criteria
Prescriber Oncologist or hematologist NPI verification REMS Requirements
REMS Enrollment Mandatory safety program Certification confirmation BMS REMS Portal
Formulary Status Specialty tier (non-formulary) May require exception Aetna Formulary

Step-by-Step: Fastest Path to Approval

1. Complete REMS Enrollment (1-3 business days)

Who: Prescriber and patient
What: Register with PS-Pomalidomide REMS program
How: Visit bmsremspatientsafety.com or call BMS support
Timeline: 1-3 business days for certification

2. Gather Required Documentation (Same day)

Who: Clinical team
What: Compile treatment history and recent labs
Required: SPEP, UPEP, CBC, CMP within 30 days; prior therapy timeline; pathology confirming multiple myeloma diagnosis

3. Submit Prior Authorization (24-48 hours after REMS)

Who: Prescriber's office
What: Complete PA request via Aetna provider portal
Include: REMS authorization number, medical necessity letter, treatment timeline
Timeline: 3-5 business days for standard review; 24 hours for expedited

4. Follow Up and Track Status

Who: Patient or clinical staff
What: Monitor PA status and respond to requests for additional information
Contact: Aetna provider services for status updates

Tip: Request expedited review if disease progression is rapid or patient's condition is deteriorating. Include physician statement of urgency.

Common Denial Reasons & How to Fix Them

Denial Reason How to Overturn Required Documentation
Missing prior therapy documentation Submit detailed timeline with specific dates Pharmacy records, infusion logs, physician notes showing lenalidomide + PI failure
REMS not completed Complete enrollment and resubmit REMS authorization number and certification proof
Non-specialist prescriber Transfer prescription to oncologist/hematologist New prescription from board-certified specialist
Insufficient disease progression evidence Provide recent labs showing progression SPEP/UPEP, bone marrow biopsy, imaging within 30 days
Non-formulary status Request formulary exception Medical necessity letter explaining why alternatives failed

Medical Necessity Letter Requirements

Your oncologist's medical necessity letter is crucial for approval. Here's what Aetna requires:

Essential Components

Patient Information:

  • Full name, DOB, Aetna member ID
  • Multiple myeloma diagnosis with ICD-10 code (C90.02)
  • Date of initial diagnosis and current disease status

Treatment History:

  • Specific prior therapies with dates, durations, and outcomes
  • Documentation of lenalidomide failure (progression or intolerance)
  • Documentation of proteasome inhibitor failure
  • Reasons for discontinuation of each therapy

Clinical Rationale:

  • FDA indication alignment (≥2 prior therapies including lenalidomide + PI)
  • NCCN guideline support (Category 1 recommendation)
  • Expected clinical benefit based on patient's specific situation
  • Contraindications to alternative therapies

Monitoring Plan:

  • Dosing schedule (typically 4mg days 1-21 of 28-day cycles)
  • Combination with dexamethasone if applicable
  • Laboratory monitoring schedule
  • REMS compliance confirmation
Clinician Corner: Include peer-reviewed evidence supporting pomalidomide use in your patient's specific situation. Reference the FDA prescribing information and current NCCN guidelines for multiple myeloma treatment.

Texas Appeals Process: Internal and External Review

If your initial prior authorization is denied, Texas law provides strong appeal rights with extended timelines and binding external review.

Internal Appeal (First Level)

Filing Deadline: 4 years from denial notice (Texas law supersedes Aetna's standard 180-day limit)
Decision Timeline: 45 business days standard; 72 hours expedited
How to File: Aetna provider portal, mail, or fax with supporting documentation

Required for Appeal:

  • Copy of original denial letter
  • Updated medical necessity letter addressing specific denial reasons
  • Additional clinical documentation (recent labs, imaging, physician notes)
  • Peer-reviewed literature supporting pomalidomide use

External Review (Independent Review Organization)

When Available: After internal appeal denial or for urgent cases
Filing Deadline: 4 months from final internal denial
Decision Timeline: 20 days standard; 72 hours expedited
Cost: Up to $650 filing fee (waivable for financial hardship)
Authority: IRO decision is legally binding on Aetna for Texas-regulated plans

Contact for External Review:

Note: ERISA self-funded employer plans, Medicare, and Medicaid follow federal appeal rules rather than Texas state processes.

REMS Program Requirements for CVS Specialty Pharmacy

Pomalyst is only available through the PS-Pomalidomide REMS program due to serious embryo-fetal toxicity risks. CVS Caremark Specialty Pharmacy, as Aetna's preferred specialty provider, must be REMS-certified to dispense.

Key REMS Requirements

Prescriber Certification:

  • Complete mandatory training and confidential survey
  • Obtain authorization number for each prescription
  • Fax signed Patient-Physician Agreement Form to certified pharmacy

Patient Registration:

  • Sign Patient-Physician Agreement acknowledging risks
  • Comply with pregnancy testing (females of reproductive potential)
  • Use two forms of contraception as required
  • Complete brief survey (male patients)

Pharmacy Certification:

  • Verify prescriber certification and patient authorization
  • Document training and processes
  • Report deviations within 30 days

Timeline: REMS enrollment typically takes 1-3 business days. Contact BMS REMS support at 1-888-423-5436 for assistance.

Cost Savings and Patient Support Programs

Even with insurance coverage, Pomalyst can have significant out-of-pocket costs. Several programs can help reduce expenses:

BMS Access Support

  • Benefits investigation and prior authorization assistance
  • Copay assistance for eligible commercially insured patients
  • Free drug program for qualifying uninsured patients
  • Appeals support with template letters and clinical evidence

Foundation Support

Contact patient advocacy organizations for additional grant opportunities and financial assistance programs specific to multiple myeloma patients.

Formulary Exception Process

If Pomalyst is non-formulary on your Aetna plan, request a formulary exception by documenting that covered alternatives are less effective or cause adverse effects. Submit via Aetna's exception process with prescriber support.

Frequently Asked Questions

How long does Aetna prior authorization take in Texas?
Standard PA decisions take 3-5 business days. Expedited reviews for urgent cases are completed within 24 hours when medical urgency is documented.

What if Pomalyst is not on my Aetna formulary?
Request a formulary exception with documentation that covered alternatives have failed or are contraindicated. The drug will be covered at Tier 4 non-preferred cost-sharing if approved.

Can I request an expedited appeal?
Yes, if delay would jeopardize your health or significantly reduce your ability to regain function. Include a physician statement of urgency with your appeal.

Does step therapy apply if I failed prior treatments outside Texas?
Yes, documented failures from any location count toward step therapy requirements. Provide complete treatment records from all providers.

What happens if my appeal is denied?
You can request external review through Texas's Independent Review Organization within 4 months. The IRO decision is binding on Aetna for state-regulated plans.

How does the REMS program affect my prescription?
REMS enrollment is mandatory and typically adds 1-3 business days to the process. Your prescriber and pharmacy must both be certified, and you'll need to complete patient registration.

Are there alternatives if Pomalyst isn't approved?
Discuss other multiple myeloma treatments with your oncologist, including other immunomodulatory drugs, proteasome inhibitors, or anti-CD38 antibodies depending on your treatment history.

Can I appeal directly to external review?
For urgent cases, you may request expedited external review concurrently with an expedited internal appeal if delay would jeopardize your health.

About Counterforce Health

Counterforce Health helps patients, clinicians, and specialty pharmacies get prescription drugs approved by turning insurance denials into targeted, evidence-backed appeals. The platform analyzes denial letters and plan policies to create point-by-point rebuttals with the right clinical evidence and procedural requirements for each payer.

When navigating complex prior authorizations like those for Pomalyst, having the right documentation and understanding payer-specific requirements can make the difference between approval and denial. Counterforce Health's platform streamlines this process by identifying exactly what evidence each payer needs and creating compliant submissions that meet their specific criteria.

Sources & Further Reading

Disclaimer: This guide provides general information about insurance coverage and appeals processes. It is not medical advice and should not replace consultation with your healthcare provider or insurance plan. Always verify current policies and procedures with your specific plan and follow your healthcare team's recommendations. For personalized assistance with appeals, consult qualified healthcare advocates or legal professionals familiar with Texas insurance law.

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