By Counterforce Health Team in Strensiq (asfotase alfa) —

How to Get Strensiq (Asfotase Alfa) Covered by Aetna CVS Health in Florida: Prior Authorization, Appeals, and Cost Assistance Guide

Answer Box: Getting Strensiq Covered by Aetna CVS Health in Florida

Fastest path to approval: Submit Aetna's Strensiq Precertification Form with genetic testing confirming ALPL mutation OR biochemical evidence (low alkaline phosphatase + elevated substrates + radiographic findings) plus proof of pediatric-onset HPP. Fax to 1-888-267-3277. Standard review takes 15 business days; expedited review (mark urgent if bone/respiratory decline risk) takes 72 hours. If denied, you have 180 days to appeal internally, then 120 days for Florida external review.

First step today: Contact your specialist to order ALPL genetic testing if not done, and request they complete the precertification form with all required HPP documentation.

Table of Contents

  1. Plan Types & Coverage Implications
  2. Formulary Status & Tier Placement
  3. Prior Authorization Requirements
  4. Specialty Pharmacy Network
  5. Cost-Share Dynamics
  6. Submission Process & Forms
  7. Common Approval Patterns
  8. Appeals Playbook for Florida
  9. Cost Assistance Programs
  10. FAQ

Plan Types & Coverage Implications

Aetna CVS Health offers different plan structures in Florida, each with distinct requirements for specialty drug coverage:

Plan Type Network Rules Referral Requirements Specialty Drug Impact
HMO In-network only PCP referral required Must see endocrinologist/metabolic specialist through PCP first
EPO In-network only Varies by plan Direct specialist access may be allowed
PPO In/out-of-network No referrals needed Can see any network specialist directly
Note: All plan types require prior authorization for Strensiq regardless of referral rules. The key difference is how you access the prescribing specialist.

For Florida state employees with Aetna HMO plans, you'll need your PCP to refer you to a metabolic bone disease specialist or endocrinologist who can diagnose HPP and prescribe Strensiq. PPO members can schedule directly with specialists.

Formulary Status & Tier Placement

Strensiq is classified as a Tier 5 specialty medication on Aetna's formulary, requiring:

  • Mandatory prior authorization for all plan types
  • CVS Specialty Pharmacy dispensing only
  • No step therapy requirements (Strensiq is the only FDA-approved disease-modifying therapy for pediatric-onset HPP)
  • Quantity limits based on weight-based dosing (6 mg/kg/week, escalating to 9 mg/kg/week if needed)

The medication is covered for perinatal/infantile-onset and juvenile-onset hypophosphatasia but not for adult-onset HPP without documented pediatric symptoms.

Prior Authorization Requirements

Coverage at a Glance

Requirement What It Means Where to Find It Source
Genetic confirmation ALPL gene mutation OR biochemical criteria Genetic testing lab report Aetna Policy
Pediatric onset Symptoms began before age 18 Medical history documentation Precert Form
Clinical presentation Active HPP signs/symptoms Physical exam, imaging, dental records Aetna Policy
Appropriate dosing 6-9 mg/kg/week based on severity Prescriber's dosing rationale FDA Label

Required Documentation Checklist

Genetic Evidence (one of the following):

  • Confirmed pathogenic ALPL gene mutation report
  • OR biochemical confirmation with ALL three:
    • Serum alkaline phosphatase below age/gender reference range
    • Elevated TNSALP substrate (serum PLP, urine PEA, or plasma PPi)
    • Radiographic skeletal abnormalities consistent with HPP

Clinical Documentation:

  • Medical records showing symptom onset during perinatal, infantile, or juvenile period
  • Current clinical presentation (bone pain, fractures, dental issues, growth delays)
  • Imaging studies (X-rays showing osteomalacia, fractures, or delayed healing)
  • Laboratory results (alkaline phosphatase levels, substrate measurements)

Specialty Pharmacy Network

Strensiq must be dispensed through CVS Specialty Pharmacy as part of Aetna's specialty network:

Contact Information:

  • Phone: 1-800-237-2767 (TTY: 711)
  • Hours: Monday-Friday, 7:30 AM to 9:00 PM

Setup Process:

  1. Once PA is approved, CVS Specialty will contact you to coordinate delivery
  2. Home delivery is standard (requires refrigerated shipping)
  3. Clinical support team will provide injection training and monitoring
  4. Refills are coordinated automatically based on your dosing schedule
Important: CVS Specialty handles limited distribution drugs like Strensiq through Coram CVS Specialty Infusion Services for complex injectable medications requiring special handling.

Cost-Share Dynamics

As a Tier 5 specialty medication, Strensiq typically requires:

Commercial Plans:

  • 20-50% coinsurance after deductible
  • Potential out-of-pocket costs of $1,000+ per fill before reaching annual maximum
  • Annual out-of-pocket maximums vary by plan (verify with member services)

Cost varies by:

  • Your specific plan's specialty tier structure
  • Whether you've met your annual deductible
  • Your plan's out-of-pocket maximum
Note: This is educational information only. Contact Aetna member services at the number on your insurance card for your specific cost-sharing details.

Submission Process & Forms

Step-by-Step: Fastest Path to Approval

  1. Gather Documentation (Patient/Family)
    • Insurance card and policy information
    • Previous genetic testing results if available
    • Medical records showing pediatric-onset symptoms
  2. Complete Genetic Testing (Prescriber)
    • Order ALPL gene sequencing if not previously done
    • Document biochemical criteria if genetic testing unavailable
    • Timeline: 2-4 weeks for results
  3. Submit Precertification (Prescriber/Staff)
  4. Track Submission (Patient/Prescriber)
    • Call 1-866-752-7021 for status updates
    • Standard review: 15 business days
    • Expedited review: 72 hours (if urgent)
  5. Coordinate Specialty Pharmacy (Upon Approval)
    • CVS Specialty will contact patient directly
    • Set up delivery and injection training
    • Begin treatment coordination

Clinician Corner: Medical Necessity Letter

Your prescriber's letter should include:

Problem Statement: "Patient has confirmed hypophosphatasia with [genetic/biochemical] evidence and documented pediatric onset at age [X]."

Prior Treatments: Document supportive care measures tried (physical therapy, fracture management, dental interventions).

Clinical Rationale: Reference FDA labeling for perinatal/infantile and juvenile-onset HPP as the only approved disease-modifying therapy.

Dosing Justification: Weight-based calculation (6 mg/kg/week initially, with escalation rationale if higher doses needed).

Monitoring Plan: Laboratory follow-up schedule, imaging assessments, clinical response metrics.

Common Approval Patterns

Strong submissions typically include:

Definitive Diagnosis:

  • Clear genetic confirmation with pathogenic ALPL variant
  • Comprehensive biochemical workup if genetic testing inconclusive
  • Radiographic evidence of HPP-related bone disease

Pediatric Onset Documentation:

  • Medical records from childhood showing early symptoms
  • Growth charts, dental records, or fracture history
  • Family history if relevant (inheritance patterns)

Current Medical Necessity:

  • Active symptoms requiring disease-modifying therapy
  • Functional limitations or quality of life impacts
  • Risk of progression without treatment

Appeals Playbook for Florida

If your initial request is denied, Florida provides robust appeal rights:

Internal Appeals

  • Deadline: 180 days from denial notice
  • Timeline: 30 days for standard review, 72 hours for expedited
  • How to File: Use Aetna member portal or call customer service
  • Required: Include additional medical evidence, prescriber support

External Review (Independent Review Organization)

  • Deadline: 120 days after final internal denial
  • Timeline: 30 days for standard, 72 hours for expedited
  • Cost: No charge to member
  • Process: Florida contracts with independent medical experts
  • Decision: Binding on Aetna if overturned
Florida Consumer Assistance: Contact Florida Division of Consumer Services at 1-877-MY-FL-CFO (1-877-693-5236) for help navigating appeals.

Common Denial Reasons & Fixes

Denial Reason How to Overturn
"Adult-onset HPP not covered" Provide pediatric medical records showing early symptom onset
"Insufficient genetic evidence" Submit comprehensive ALPL sequencing or complete biochemical workup
"Experimental/investigational" Reference FDA approval and clinical guidelines for pediatric-onset HPP
"Step therapy required" Document that no alternative disease-modifying therapies exist

Cost Assistance Programs

Manufacturer Support:

  • Alexion Access Navigator provides coverage support and patient assistance
  • Copay assistance may be available for eligible commercial patients
  • Case management services for complex coverage situations

Foundation Grants:

  • National Organization for Rare Disorders (NORD) Patient Assistance Programs
  • HealthWell Foundation (verify current HPP coverage)
  • Patient Advocate Foundation Copay Relief Program

State Programs:

  • Florida Medicaid may cover Strensiq for eligible patients
  • Florida Department of Health rare disease resources

When to Escalate

Contact Florida regulators if:

  • Aetna fails to respond within required timelines
  • Appeals process is not followed properly
  • You need assistance understanding your rights

Florida Department of Financial Services:

FAQ

How long does Aetna prior authorization take in Florida? Standard review is 15 business days; expedited review is 72 hours if marked urgent due to risk of bone disease progression or respiratory complications.

What if Strensiq is denied as "not medically necessary"? Request internal appeal with additional clinical documentation emphasizing pediatric onset, genetic confirmation, and lack of alternative disease-modifying therapies. Consider peer-to-peer review.

Can I get expedited approval? Yes, if treatment delay could worsen bone disease, respiratory function, or quality of life. Your prescriber must document medical urgency on the PA request.

Does step therapy apply to Strensiq? No. Strensiq is the only FDA-approved disease-modifying therapy for pediatric-onset HPP, so no step therapy requirements apply.

What if I have adult-onset symptoms but no pediatric documentation? Aetna typically requires documented pediatric onset. Gather any available childhood medical records, dental records, or family history that might support early symptom onset.

How much will Strensiq cost with Aetna coverage? Costs vary by plan but typically involve 20-50% coinsurance as a Tier 5 specialty drug. Contact member services for your specific cost-sharing details and explore manufacturer assistance programs.

About Counterforce Health

Counterforce Health helps patients, clinicians, and specialty pharmacies turn insurance denials into successful appeals for prescription drugs. The platform analyzes denial letters and plan policies to create targeted, evidence-backed appeals that align with each payer's specific requirements, dramatically improving approval rates for complex specialty medications like Strensiq.

Sources & Further Reading

Disclaimer: This information is for educational purposes only and does not constitute medical advice. Always consult with your healthcare provider about your specific medical condition and treatment options. Insurance coverage details may vary by individual plan. Verify current requirements with Aetna member services and your healthcare provider.

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