By Counterforce Health Team in Opsumit (macitentan) —

How to Get Opsumit (Macitentan) Covered by Aetna CVS Health in Virginia: Complete Prior Authorization and Appeals Guide 2025

Answer Box: Getting Opsumit Covered in Virginia

Opsumit (macitentan) requires prior authorization from Aetna CVS Health for pulmonary arterial hypertension (PAH). Key steps: 1) Have your PAH specialist document WHO Group 1 PAH diagnosis with NYHA/WHO functional class, 2) Complete step therapy requirements (typically ambrisentan or bosentan trial), and 3) Submit PA via Availity portal or fax to 1-888-267-3277. Standard decisions take 30-45 days; expedited reviews available for urgent cases. If denied, Virginia offers external review through the State Corporation Commission within 120 days of final denial. Start with Aetna's PA form verification.

Table of Contents

Coverage Basics

Is Opsumit Covered by Aetna CVS Health?

Yes, Opsumit (macitentan) is covered by Aetna CVS Health plans, but it requires prior authorization and is typically placed on the specialty tier. The medication is approved for pulmonary arterial hypertension (PAH) to reduce the risk of disease progression and hospitalization.

Coverage at a Glance

Requirement Details Source
Prior Authorization Required for all Aetna plans Aetna Formulary
Formulary Tier Specialty (non-preferred) Aetna Drug Guides
Step Therapy Usually required (ambrisentan/bosentan first) Aetna PA Criteria
Quantity Limits 30 tablets per 30 days CVS Specialty Guidelines
Specialty Pharmacy CVS Specialty required after approval CVS Caremark
Appeals Deadline 180 days internal; 120 days external (Virginia) Virginia SCC

Which Aetna Plans Cover Opsumit?

Opsumit is covered across Aetna's commercial plans, including:

  • Aetna Standard Plans
  • Aetna Advanced Control Plans
  • Aetna Health Exchange Plans
  • Employer-sponsored group plans

Coverage may vary by specific plan design, but prior authorization requirements remain consistent across most Aetna products.

Prior Authorization Process

Step-by-Step: Fastest Path to Approval

1. Verify Coverage (Patient/Clinic)

  • Check member ID card for CVS Caremark pharmacy benefits
  • Confirm Opsumit is on formulary via Aetna member portal
  • Timeline: Same day

2. Gather Clinical Documentation (Prescriber)

  • PAH diagnosis with WHO Group 1 confirmation
  • Right heart catheterization results
  • NYHA/WHO functional class assessment
  • Prior therapy trials and outcomes
  • Timeline: 1-3 days

3. Complete Step Therapy Requirements (Prescriber)

  • Document trial and failure of preferred ERA (ambrisentan or bosentan)
  • Include contraindications if step therapy cannot be completed
  • Timeline: Ongoing clinical care

4. Submit Prior Authorization (Prescriber/Clinic)

  • Use Availity portal, CoverMyMeds, or fax to 1-888-267-3277
  • Include completed PA form and supporting documentation
  • Timeline: Same day submission

5. REMS Enrollment (Patient/Prescriber)

  • Complete pregnancy testing requirements for females of reproductive potential
  • Enroll in any remaining REMS requirements (program discontinued in 2024 but some legacy requirements may apply)
  • Timeline: 1-2 days

6. Await Decision (All parties)

  • Standard review: 30-45 days
  • Expedited review: 24-72 hours for urgent cases
  • Timeline: As specified above

7. Coordinate Specialty Pharmacy (Patient)

  • Contact CVS Specialty at 1-855-633-7673 once approved
  • Complete enrollment and shipping arrangements
  • Timeline: 2-3 days

Clinical Requirements & Documentation

Medical Necessity Criteria

For Opsumit approval, Aetna requires comprehensive documentation of:

Diagnosis Requirements:

  • Confirmed PAH (WHO Group 1) diagnosis
  • Right heart catheterization results supporting PAH
  • Exclusion of other causes of pulmonary hypertension

Functional Assessment:

  • Current NYHA/WHO functional class (typically Class II-IV)
  • Six-minute walk test results when available
  • Documentation of activity limitations and symptoms

Prior Therapy Documentation:

  • Trial of at least one preferred endothelin receptor antagonist (ERA)
  • Specific medications tried, doses, duration, and reasons for discontinuation
  • Contraindications to step therapy if applicable
Clinician Corner: Medical Necessity Letter Checklist

Your letter should include: 1) Clear PAH diagnosis with hemodynamic confirmation, 2) Current functional class with specific symptom documentation, 3) Complete prior therapy history with outcomes, 4) Clinical rationale for Opsumit based on FDA labeling and PAH guidelines, 5) Treatment goals and monitoring plan. Reference the 2019 CHEST PAH Guidelines and FDA prescribing information for evidence-based support.

REMS and Safety Requirements

While the formal Opsumit REMS program was discontinued in 2024, pregnancy-related safety requirements remain:

  • Pregnancy Testing: Negative test before initiation for all females of reproductive potential
  • Monthly Testing: Continued monthly pregnancy tests during treatment
  • Contraception: Documentation of adequate contraceptive measures
  • Post-Treatment: Pregnancy testing one month after discontinuation

Timeline & Status Tracking

How Long Does Prior Authorization Take?

Standard Timeline:

  • Initial review: 30-45 days from complete submission
  • Additional information requests: 10-14 days for response
  • Final determination: Within 5 business days of receiving additional info

Expedited Timeline:

  • Urgent medical situations: 24-72 hours
  • Requires physician attestation of urgency
  • Available for life-threatening conditions or significant functional decline

Checking Your Status

For Patients:

  • Call Aetna Member Services (number on insurance card)
  • Log into Aetna member portal online
  • Ask for PA reference number and current status

For Providers:

  • Check Availity portal for real-time updates
  • Call Aetna Provider Services at 1-800-624-0756
  • Request peer-to-peer review if initial denial

Common Denial Reasons & Solutions

Denial Reason How to Overturn Required Documentation
Step therapy not met Provide trial/failure documentation Medication history, adverse effects, contraindications
Insufficient diagnosis Submit comprehensive PAH workup Right heart cath, echo, PFTs, specialist consultation
Missing functional class Update clinical notes Current NYHA/WHO class assessment with symptoms
REMS non-compliance Complete pregnancy testing Negative pregnancy test results, contraception plan
Non-formulary status Request formulary exception Medical necessity letter, prior auth supporting docs
Quantity limit exceeded Provide clinical justification Dosing rationale, specialist recommendation

Most Effective Appeal Strategies

Based on successful Virginia appeals, the most effective strategies include:

  1. Complete Clinical Picture: Provide comprehensive PAH documentation including hemodynamics
  2. Step Therapy Evidence: Clear documentation of prior therapy trials and specific reasons for failure
  3. Specialist Support: Letters from PAH specialists carry significant weight
  4. Guideline Citations: Reference current PAH treatment guidelines and FDA labeling
  5. Functional Impact: Document how denial affects patient's daily activities and prognosis

Appeals Process in Virginia

Internal Appeals with Aetna

Level 1 Internal Appeal:

  • Deadline: 180 days from denial notice
  • Timeline: 30 days for standard; 72 hours for expedited
  • Submit via: Aetna member portal, mail, or fax

Level 2 Internal Appeal:

  • Available if Level 1 is denied
  • Same timeline and submission methods
  • Often includes peer-to-peer review opportunity

Virginia External Review Process

If internal appeals are exhausted, Virginia offers external review through the State Corporation Commission (SCC) Bureau of Insurance.

Key Details:

  • Deadline: 120 days from final internal denial
  • Timeline: 45 days for standard review; 72 hours for expedited
  • Cost: Free to consumers
  • Forms Required: External Review Request Form 216-A

How to File:

  • Mail: SCC Bureau of Insurance, External Review, P.O. Box 1157, Richmond, VA 23218
  • Fax: (804) 371-9915
  • Email: [email protected]

What to Include:

  • Completed Form 216-A
  • Copy of final denial letter from Aetna
  • All supporting medical documentation
  • Written statement explaining why coverage should be granted
From Our Advocates

We've seen Virginia external reviews succeed when patients include a timeline of their PAH progression and how each prior therapy failed to control symptoms. One patient's appeal was approved after documenting that step therapy medications caused significant side effects that prevented adherence, making Opsumit medically necessary as a first-line option.

Costs & Financial Assistance

Understanding Your Costs

Typical Cost Structure:

  • Specialty Tier: 20-35% coinsurance after deductible
  • Annual Cost: Often exceeds $100,000 without assistance
  • Copay Assistance: Available through manufacturer programs

Financial Assistance Programs

J&J withMe Opsumit Savings Program:

  • Eligible Patients: Commercial insurance (not Medicare/Medicaid)
  • Benefit: $5 copay per prescription, up to $20,000 annually
  • How to Apply: Through prescriber or manufacturer website

Foundation Support:

  • Patient Access Network Foundation
  • HealthWell Foundation
  • Pulmonary Hypertension Association assistance programs

CVS Specialty Support:

  • CareTeam assistance with financial programs
  • Insurance coordination and copay optimization
  • Patient assistance program navigation

CVS Specialty Pharmacy Requirements

Why CVS Specialty?

Once approved, Opsumit must be dispensed through CVS Specialty Pharmacy due to:

  • Specialty medication handling requirements
  • REMS compliance monitoring
  • Insurance coordination for high-cost therapies

Getting Started with CVS Specialty

Contact Information:

  • Phone: 1-855-633-7673
  • Hours: Monday-Friday 8 AM - 11 PM ET; Saturday 9 AM - 6 PM ET
  • Website: CVSSpecialty.com

What to Expect:

  1. Initial enrollment call to verify insurance and shipping preferences
  2. Coordination with prescriber for any missing documentation
  3. First shipment typically within 2-3 business days of approval
  4. Ongoing refill coordination and clinical support

For patients seeking comprehensive support with insurance approvals and appeals, Counterforce Health specializes in turning insurance denials into targeted, evidence-backed appeals. Their platform helps patients, clinicians, and specialty pharmacies navigate complex prior authorization requirements by analyzing denial letters, plan policies, and clinical notes to create point-by-point rebuttals aligned with each payer's specific criteria.

When to Escalate

Virginia State Resources

If you encounter issues with Aetna's appeal process, Virginia provides additional consumer protections:

Virginia State Corporation Commission Bureau of Insurance:

  • Consumer Services: 1-877-310-6560
  • Website: scc.virginia.gov
  • Services: External review, consumer complaints, insurance guidance

Virginia Managed Care Ombudsman:

  • Purpose: Assists with HMO and managed care plan issues
  • Contact: Through SCC Consumer Services
  • Services: Informal dispute resolution, appeal guidance

When to Contact State Regulators

Consider escalating to Virginia regulators if:

  • Aetna fails to meet appeal deadlines
  • Requests for expedited review are inappropriately denied
  • You suspect violations of Virginia insurance law
  • Internal appeal process appears compromised

Frequently Asked Questions

How long does Aetna CVS Health prior authorization take for Opsumit in Virginia? Standard prior authorization takes 30-45 days. Expedited reviews for urgent medical situations are completed within 24-72 hours when physician urgency is documented.

What if Opsumit is not on Aetna's formulary? Request a formulary exception by providing medical necessity documentation. Include specialist letters explaining why covered alternatives are inappropriate or have failed.

Can I request an expedited appeal in Virginia? Yes, expedited appeals are available for urgent medical situations. Your physician must document that waiting for standard review could jeopardize your health or ability to regain function.

Does step therapy apply if I tried medications outside Virginia? Yes, step therapy documentation from any state is typically accepted. Provide complete medication history with specific drugs, doses, durations, and outcomes.

What happens if CVS Specialty can't fill my prescription? Contact CVS Specialty immediately at 1-855-633-7673. They can coordinate with Aetna to resolve coverage issues or help locate alternative specialty pharmacies if needed.

How do I know if my external review was successful in Virginia? The Independent Review Organization will notify you in writing of their decision. If approved, Aetna must provide coverage within 1-3 days (24 hours for expedited reviews).

Can I get help with the appeals process? Yes, Virginia offers free assistance through the SCC Consumer Services. Counterforce Health also provides specialized support for complex medication appeals, helping patients and providers create evidence-backed appeals tailored to specific payer requirements.

What if I have Medicare or Medicaid coverage through Aetna? Different rules may apply for government programs. Contact Aetna directly for program-specific prior authorization requirements and appeal processes.

Sources & Further Reading

Disclaimer: This information is for educational purposes only and does not constitute medical or legal advice. Always consult with your healthcare provider and insurance plan for the most current coverage requirements and appeal procedures. Medication coverage and prior authorization criteria may change. For personalized assistance with complex appeals, consider consulting with healthcare coverage specialists or legal professionals familiar with Virginia insurance law.

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