By Counterforce Health Team in Signifor / Signifor LAR (pasireotide) —

Getting Signifor LAR (Pasireotide) Approved by Aetna in Virginia: Prior Authorization Guide and Appeal Process

Answer Box: Fast Track to Approval

To get Signifor LAR (pasireotide) covered by Aetna in Virginia: Submit prior authorization with documented trial/failure of Somatuline Depot (lanreotide), elevated IGF-1 or cortisol labs, and surgical history via Aetna's precertification form. Appeals must be filed within 180 days, with Virginia external review available through the State Corporation Commission within 120 days of final denial. Start with your endocrinologist completing the PA paperwork today.

First step: Have your doctor gather your lab results (IGF-1 for acromegaly, UFC for Cushing's) and document your Somatuline failure before submitting the Aetna precertification form.

Table of Contents

Coverage Basics

Is Signifor LAR Covered by Aetna?

Yes, Aetna covers Signifor LAR (pasireotide pamoate) for FDA-approved indications, but prior authorization is required for all plans. The medication is covered for:

  • Acromegaly when surgery isn't an option or hasn't been curative
  • Cushing's disease when pituitary surgery isn't curative or the patient isn't a surgical candidate

Counterforce Health helps patients navigate these complex approval requirements by analyzing denial letters and crafting targeted appeals with the right clinical evidence and payer-specific documentation.

Which Aetna Plans Require PA?

Prior authorization is mandatory across:

  • Commercial Aetna plans
  • Aetna Medicare Part B
  • CVS Health plans
  • Aetna Better Health (Medicaid)

The medication is dispensed through specialty pharmacies only, typically including CVS Specialty for Aetna members.

Prior Authorization Process

Step-by-Step: Fastest Path to Approval

  1. Gather Required Labs (Your endocrinologist)
    • Acromegaly: Elevated IGF-1 levels above normal for age/gender
    • Cushing's: Elevated UFC, late-night salivary cortisol, or abnormal dexamethasone suppression test
    • Timeline: 1-2 weeks to obtain if not current
  2. Document Step Therapy (Your doctor)
    • Trial and documented failure of Somatuline Depot (lanreotide) within past 365 days
    • Include dosing, duration, and reason for discontinuation
    • Timeline: Immediate if already tried; 3-6 months if new trial needed
  3. Complete Aetna PA Form (Clinic staff)
  4. Submit Documentation (Clinic)
    • Fax or submit via Aetna provider portal (Availity)
    • Include surgical notes if applicable
    • Timeline: Same day submission
  5. Track Decision (You and clinic)
    • Standard decisions: 30-45 days
    • Expedited (urgent): 36-72 hours
    • Timeline: Monitor via provider portal

Required Documentation Checklist

For All Cases:

  • Completed Aetna precertification form
  • Current lab results (IGF-1 or cortisol studies)
  • Documentation of Somatuline Depot trial/failure
  • Primary and secondary ICD-10 diagnosis codes
  • Prescriber DEA and NPI numbers

For Acromegaly:

  • Pre-treatment IGF-1 levels above normal
  • Surgical history or contraindication to surgery
  • Evidence of inadequate response to first-line treatment

For Cushing's Disease:

  • Elevated cortisol studies (UFC, salivary, or DST)
  • Documentation that surgery was non-curative or not an option
  • Endocrinologist consultation notes

Common Denial Reasons & Solutions

Denial Reason How to Overturn Required Documentation
Lack of step therapy Document Somatuline failure Pharmacy records, clinical notes showing intolerance/inadequate response
Insufficient lab evidence Submit complete hormone studies Recent IGF-1 (acromegaly) or UFC/cortisol (Cushing's) within 90 days
Non-specialist prescriber Transfer to endocrinologist Referral and prescription from board-certified endocrinologist
Experimental/investigational Cite FDA approval FDA labeling for approved indications

Clinician Corner: Medical Necessity Letter

Your endocrinologist should include these elements in the letter of medical necessity:

Clinical Problem:

  • Specific diagnosis (acromegaly or Cushing's disease)
  • Symptom severity and impact on quality of life
  • Biochemical evidence (specific lab values and dates)

Prior Treatments:

  • Detailed history of Somatuline Depot trial
  • Dosing, duration, and specific reasons for failure
  • Any surgical interventions and outcomes

Clinical Rationale:

  • Why Signifor LAR is medically necessary
  • Expected benefits based on clinical studies
  • Risks of delaying treatment

Supporting Evidence:

  • Reference to FDA prescribing information
  • Cite relevant endocrine society guidelines
  • Include monitoring plan for glucose and gallbladder function

Appeals Process in Virginia

Internal Appeals with Aetna

If your initial PA is denied, you have 180 days to file an internal appeal:

Standard Appeal Process:

  1. Request peer-to-peer review immediately after denial
  2. File formal appeal via Aetna provider portal or mail
  3. Include additional documentation not in original submission
  4. Timeline: 45 business days for decision

Expedited Appeals:

  • Available for pre-service denials where delay jeopardizes health
  • Decision within 36-72 hours
  • Requires physician certification of urgency

When Internal Appeals Fail

After exhausting Aetna's internal process, Virginia residents can pursue external review through the State Corporation Commission.

Virginia External Review

Virginia's external review process provides an independent assessment of medical necessity denials through the State Corporation Commission Bureau of Insurance.

Eligibility Requirements

You can request external review if:

  • You have a fully-insured Aetna plan (not self-funded ERISA)
  • The denial is based on medical necessity, experimental treatment, or similar clinical judgment
  • You've completed Aetna's internal appeals (or qualify for expedited review)

Filing Process

Required Forms:

Submission Methods:

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

Timelines

Review Type Filing Deadline Decision Timeline
Standard 120 days from final Aetna denial 45 days
Expedited 120 days from final denial 72 hours

Expedited Review Criteria: Your doctor must certify that waiting would "seriously jeopardize your life, health, ability to regain maximum function, or subject you to severe unmanaged pain."

What to Include

Submit these documents with your external review request:

  • All Aetna denial letters
  • Medical records supporting necessity
  • Provider letter explaining why Signifor LAR is essential
  • Clinical studies or guidelines supporting use
  • Documentation of failed alternatives
Note: The independent review organization's decision is binding on Aetna. If they overturn the denial, Aetna must provide coverage within 1-3 days.

Renewal Requirements

Signifor LAR authorizations are typically approved for 12 months initially, with annual renewals required.

Renewal Documentation

Indication Required Evidence Timeline
Acromegaly Decreased or normalized IGF-1 from baseline Submit 30-45 days before expiration
Cushing's Disease Reduced cortisol levels (UFC, salivary, or DST) Submit 30-45 days before expiration

Renewal Process:

  1. Schedule lab work 60 days before authorization expires
  2. Have endocrinologist document clinical response
  3. Submit renewal request with updated labs and clinical notes
  4. Counterforce Health can help ensure renewal submissions include all required evidence

Cost Assistance Options

Manufacturer Support Programs

Recordati Rare Diseases Patient Access Program:

  • Benefits verification and PA support
  • Copay assistance for commercially insured patients
  • Patient assistance program for uninsured/underinsured
  • Bridge therapy during coverage gaps

Eligibility:

  • Commercial insurance: Copay reduction programs available
  • Medicare/Medicaid: May qualify for charitable foundations
  • Uninsured: Income-based patient assistance program

Virginia-Specific Resources

  • Virginia Poverty Law Center: Health assistance for coverage appeals
  • SCC Consumer Services: Free guidance on external review process (1-877-310-6560)
  • Managed Care Ombudsman: Assistance with HMO/managed care issues

Frequently Asked Questions

How long does Aetna PA take in Virginia? Standard prior authorization decisions take 30-45 days. Expedited reviews for urgent cases are decided within 36-72 hours.

What if Signifor LAR is non-formulary on my plan? You can request a formulary exception with documentation of medical necessity and failure of preferred alternatives like Somatuline Depot.

Can I request an expedited appeal? Yes, if your doctor certifies that delay would seriously jeopardize your health. Expedited appeals are decided within 36-72 hours.

Does step therapy apply if I failed Somatuline outside Virginia? Yes, documented failure of Somatuline Depot from any state within the past 365 days typically satisfies step therapy requirements.

What happens if I miss my injection due to coverage delays? Contact the manufacturer's patient access program immediately for bridge therapy options. Also request expedited review citing health risks of treatment interruption.

Who can help with the appeals process? Your endocrinologist, the manufacturer's patient access team, Virginia's SCC Consumer Services (1-877-310-6560), and organizations like Counterforce Health that specialize in insurance appeals.

How much does Signifor LAR cost without insurance? List prices often exceed $20,000 per monthly dose. Patient assistance programs and charitable foundations may provide significant cost reduction for eligible patients.

Can my primary care doctor prescribe Signifor LAR? While technically possible, Aetna typically requires prescriptions from endocrinologists or specialists familiar with treating acromegaly and Cushing's disease.

Sources & Further Reading

Disclaimer: This guide provides general information about insurance coverage and should not be considered medical or legal advice. Coverage policies vary by plan and change over time. Always verify current requirements with your specific Aetna plan and consult with your healthcare provider about treatment decisions. For personalized assistance with appeals and prior authorizations, consider consulting with organizations that specialize in insurance advocacy.

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