By Counterforce Health Team in Strensiq (asfotase alfa) —

Get Strensiq (Asfotase Alfa) Approved by Aetna CVS Health in Ohio: Complete Coverage Guide

Answer Box: Quick Start Guide

Yes, Aetna CVS Health covers Strensiq (asfotase alfa) for hypophosphatasia in Ohio with prior authorization. You need documented perinatal/infantile or juvenile-onset HPP with genetic confirmation (ALPL mutation) or biochemical proof (low alkaline phosphatase + elevated substrates + skeletal abnormalities). Your doctor submits the precertification request to Aetna at (866) 752-7021. If denied, Ohio law gives you two internal appeals plus external review within 180 days. Start today: Have your doctor gather your HPP diagnosis records, genetic test results, and complete Aetna's Strensiq precertification form.

Table of Contents

  1. Coverage Basics
  2. Prior Authorization Process
  3. Timeline and Urgency
  4. Medical Necessity Criteria
  5. Costs and Financial Assistance
  6. Denials and Appeals in Ohio
  7. Renewal Requirements
  8. Specialty Pharmacy Process
  9. Troubleshooting Common Issues
  10. Frequently Asked Questions

Coverage Basics

Is Strensiq Covered by Aetna CVS Health?

Strensiq (asfotase alfa) is covered by Aetna CVS Health plans in Ohio, but it requires prior authorization for all members. This ultra-rare disease medication—the only FDA-approved treatment for pediatric-onset hypophosphatasia—falls under specialty drug management due to its high cost (potentially $1-5 million annually) and specific indication requirements.

Coverage applies to:

  • Commercial Aetna plans (employer-sponsored and individual)
  • Aetna Better Health Medicaid plans in Ohio
  • Medicare Advantage plans with Part D coverage

Which Plans Require Prior Authorization?

All Aetna plans require precertification for Strensiq, regardless of formulary tier. This includes:

  • Standard and Advanced Control formularies
  • High-deductible health plans (HDHPs)
  • Medicaid managed care plans
  • Medicare Part D coverage

Prior Authorization Process

Step-by-Step: Fastest Path to Approval

  1. Doctor gathers documentation (1-2 days)
    • HPP diagnosis confirmation (genetic test or biochemical criteria)
    • Clinical signs/symptoms documentation
    • Prior treatment history
    • Current weight for dosing calculation
  2. Complete Aetna forms (same day)
  3. Submit to Aetna (same day)
    • Phone: (866) 752-7021
    • Fax: (888) 267-3277
    • Include all supporting clinical documentation
  4. Aetna reviews request (5-15 business days)
    • Standard review: up to 15 calendar days
    • Expedited review: 72 hours if urgent
  5. Receive determination (immediate notification)
    • Approval: specialty pharmacy contacts patient
    • Denial: appeal rights notice included
  6. If approved, specialty pharmacy coordination (2-5 days)
    • Benefit verification and copay assistance enrollment
    • Delivery scheduling and injection training

Who Submits the Request?

Your prescribing physician or their authorized staff must submit the prior authorization request. Patients cannot submit directly, but you can:

  • Ensure your doctor has all required documentation
  • Follow up on submission status
  • Request expedited review if medically urgent

Timeline and Urgency

Standard Processing Times

Aetna's review timelines in Ohio:

  • Standard prior authorization: 15 calendar days
  • Expedited/urgent requests: 72 hours
  • Internal appeal (first level): 30 calendar days
  • Internal appeal (second level): 30 calendar days
  • External review: 30 calendar days (72 hours if expedited)

When to Request Expedited Review

Request expedited processing if delay would:

  • Seriously jeopardize your health
  • Compromise your ability to regain maximum function
  • Cause severe pain or suffering
Note: For pediatric patients with severe HPP manifestations (respiratory compromise, failure to thrive, seizures), always request expedited review with detailed clinical justification.

Medical Necessity Criteria

Aetna's Strensiq Coverage Requirements

Aetna's current policy requires all of the following:

Diagnosis Requirements:

  • Clinical signs and/or symptoms of hypophosphatasia
  • Perinatal/infantile-onset OR juvenile-onset HPP
  • For patients ≥18 years: documentation of onset before age 18

Confirmation of Diagnosis (either):

  • Pathogenic ALPL gene mutation confirmed by genetic testing, OR
  • All of the following:
    • Radiographic evidence of skeletal abnormalities
    • Serum alkaline phosphatase below age/gender-specific range
    • Elevated TNSALP substrate levels (serum PLP, urine PEA, or plasma PPi)

Dosing Limits:

  • Perinatal/infantile-onset: maximum 9 mg/kg/week
  • Juvenile-onset: maximum 6 mg/kg/week

Clinician Corner: Medical Necessity Letter Checklist

✅ Problem Statement:

  • Document specific HPP manifestations (bone pain, fractures, dental issues, growth failure)
  • Include onset timing and progression

✅ Prior Treatments:

  • List supportive therapies tried (vitamin D, calcium, phosphate)
  • Note limitations of conventional treatments for genetic HPP

✅ Clinical Rationale:

  • Reference FDA approval for pediatric-onset HPP
  • Cite lack of alternative disease-modifying therapies
  • Include expected treatment goals (bone mineralization, growth, function)

✅ Supporting Evidence:

  • Attach genetic test results or biochemical confirmation
  • Include recent imaging showing skeletal abnormalities
  • Provide growth charts for pediatric patients

Costs and Financial Assistance

Understanding Your Out-of-Pocket Costs

Strensiq costs vary significantly based on:

  • Your specific Aetna plan's specialty drug tier
  • Whether you've met your deductible
  • Copay vs. coinsurance structure

Typical cost-sharing:

  • Specialty tier copay: $100-500 per month
  • Coinsurance: 20-40% of allowed amount
  • Out-of-pocket maximum protections apply

Manufacturer Support Programs

Alexion OneSource™ Program:

  • Copay assistance for commercially insured patients
  • Prior authorization support
  • Appeals assistance
  • Patient education and injection training

Eligibility: Available for patients with commercial insurance. Government insurance (Medicare, Medicaid) patients may qualify for other assistance programs.

To enroll: Your specialty pharmacy will typically initiate enrollment, or contact Alexion directly through their access navigator.

Denials and Appeals in Ohio

Common Denial Reasons and Solutions

Denial Reason How to Overturn Required Documentation
Adult-onset HPP without pediatric documentation Provide childhood medical records showing early symptoms Growth charts, dental records, early X-rays
Insufficient genetic confirmation Submit ALPL gene testing or comprehensive biochemical workup Genetic test report or lab results showing low ALP + elevated substrates
Dosing above guidelines Justify escalation with clinical response data Treatment response metrics, specialist consultation
"Experimental/investigational" Emphasize FDA approval for pediatric-onset HPP FDA labeling, clinical guidelines

Ohio Appeals Process

Your Rights in Ohio:

  1. Two internal appeals with Aetna (30 days each level)
  2. External review through Ohio Department of Insurance
  3. 180-day deadline to request external review after final denial

Internal Appeals:

External Review in Ohio:

  • File request with Aetna (they forward to Ohio Department of Insurance)
  • Independent medical experts review your case
  • Decision is binding on Aetna
  • Contact Ohio Department of Insurance Consumer Hotline: 1-800-686-1526
From our advocates: "We've seen Strensiq appeals succeed when families provided comprehensive childhood documentation—even something as simple as early dental records showing premature tooth loss helped establish juvenile-onset HPP when genetic testing was inconclusive. The key is painting a complete clinical picture of early disease manifestations."

Renewal Requirements

Annual Reauthorization

Aetna typically requires annual renewal for Strensiq coverage. Your doctor must demonstrate:

Clinical Benefit Evidence:

  • Improvement in skeletal manifestations (radiographic changes)
  • Growth improvements in pediatric patients (height/weight z-scores)
  • Functional improvements (mobility, respiratory function)
  • Standardized assessment scores when available

Continued Medical Necessity:

  • Dosing remains within approved limits
  • No significant adverse events requiring discontinuation
  • Ongoing need for disease-modifying therapy

What Triggers Re-Review?

  • Dose increases above standard limits
  • Change in prescribing physician
  • Plan changes or coverage transitions
  • Reported adverse events or hospitalizations

Specialty Pharmacy Process

Why Strensiq Goes Through Specialty Pharmacy

Strensiq requires specialty pharmacy dispensing due to:

  • Cold storage and shipping requirements
  • Patient injection training needs
  • Ongoing clinical monitoring
  • High-cost medication management
  • Copay assistance program coordination

What to Expect

After Approval:

  1. Pharmacy assignment (often CVS Specialty or contracted provider)
  2. Benefits investigation and copay assistance enrollment
  3. Delivery coordination with temperature monitoring
  4. Injection training via phone or video consultation
  5. Ongoing support for refills and clinical questions

Patient Responsibilities:

  • Maintain refrigerator storage (36-46°F)
  • Rotate injection sites to prevent lipodystrophy
  • Report any adverse reactions promptly
  • Schedule regular follow-up appointments

Troubleshooting Common Issues

Portal and Form Issues

Problem: Aetna provider portal down or forms not loading Solution: Use backup fax submission (888) 267-3277 or call precertification line (866) 752-7021

Problem: Missing required forms or outdated versions Solution: Download current forms from Aetna's provider resources

Documentation Delays

Problem: Genetic testing results pending Solution: Submit biochemical confirmation (low ALP + elevated substrates + imaging) with note that genetic results will follow

Problem: Prior medical records from childhood unavailable Solution: Provide detailed clinical history, current imaging, and specialist consultation confirming pediatric-onset pattern

Communication Breakdowns

Problem: No response from Aetna within stated timeframes Solution: Call member services, reference your prior authorization number, and escalate to supervisor if needed

Frequently Asked Questions

How long does Aetna prior authorization take for Strensiq in Ohio? Standard review takes up to 15 calendar days. Expedited review for urgent cases is completed within 72 hours. Submit requests via phone (866) 752-7021 or fax (888) 267-3277.

What if Strensiq is non-formulary on my plan? Even non-formulary medications can be covered through formulary exceptions when medically necessary. Your doctor submits the same prior authorization process with additional justification for why formulary alternatives aren't appropriate.

Can I request an expedited appeal in Ohio? Yes, if delay would seriously endanger your health. Both internal appeals and external review can be expedited, typically completed within 72 hours rather than 30 days.

Does step therapy apply if I've tried treatments outside Ohio? Yes, prior treatment history from any state counts toward step therapy requirements. Provide documentation of previous therapies tried and their outcomes.

What happens if I change doctors or insurance plans? New prior authorization is typically required. Your new doctor must submit fresh documentation, though previous approval history may support the request.

Can I appeal directly to the Ohio Insurance Commissioner? You must complete Aetna's internal appeals first, then request external review through the Ohio Department of Insurance. Direct regulatory complaints are for process violations, not medical necessity disputes.

How do I prove pediatric-onset HPP as an adult? Gather childhood medical records, dental records showing early tooth loss, growth charts, school health records, or family photos showing skeletal abnormalities. Genetic counseling may help interpret family history patterns.

What if my child needs higher than standard dosing? Aetna allows up to 9 mg/kg/week for infantile-onset HPP. Higher doses require detailed justification with clinical response data and specialist consultation.

About Counterforce Health: Counterforce Health helps patients, clinicians, and specialty pharmacies turn insurance denials into successful appeals by analyzing denial letters, identifying specific coverage criteria, and drafting evidence-backed rebuttals. Their platform streamlines the prior authorization process by matching clinical documentation to payer-specific requirements and tracking appeal deadlines.

Sources & Further Reading

Medical Disclaimer: This guide provides general information about insurance coverage and is not medical advice. Coverage decisions depend on your specific plan, clinical situation, and current policies. Always consult your healthcare provider for medical decisions and contact your insurance company for definitive coverage information. For assistance with Ohio insurance issues, contact the Ohio Department of Insurance Consumer Hotline at 1-800-686-1526.

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