By Counterforce Health Team in Strensiq (asfotase alfa) —

How to Get Strensiq (asfotase alfa) Covered by Aetna (CVS Health) in California: Prior Authorization, Appeals, and Coverage Strategies

Answer Box: Getting Strensiq (asfotase alfa) Covered by Aetna (CVS Health) in California

Fastest path to approval: Submit Aetna's 2025 Strensiq Precertification Form (fax 1-888-267-3277) with genetic testing confirming ALPL mutation, lab results showing persistently low alkaline phosphatase, radiographic evidence of bone disease, and medical records documenting pediatric-onset hypophosphatasia. Standard review takes 15 business days; expedited review 72 hours. If denied, California residents have strong appeal rights through the Department of Managed Health Care's Independent Medical Review (IMR) process.

First step today: Contact your prescriber to gather required documentation and submit the prior authorization request with comprehensive clinical evidence of pediatric-onset HPP.

Table of Contents

  1. Coverage Requirements at a Glance
  2. Step-by-Step: Fastest Path to Approval
  3. Common Denial Reasons & How to Fix Them
  4. Appeals Process for California Residents
  5. Clinician Corner: Medical Necessity Documentation
  6. Cost Assistance and Support Programs
  7. When to Escalate to State Regulators
  8. Frequently Asked Questions

Coverage Requirements at a Glance

Requirement What It Means Where to Find It Source
Prior Authorization Required Must get approval before dispensing Tier 5 specialty medication Aetna Formulary
Pediatric-Onset HPP Disease onset before age 18 Medical records, growth charts Aetna PA Criteria
Genetic/Biochemical Confirmation ALPL mutation OR low ALP + elevated substrates Lab reports, genetic testing Aetna PA Criteria
No Step Therapy No required prior treatments Only FDA-approved therapy for HPP FDA Label
Standard Review Time 15 business days PA submission to decision Aetna Policy
Expedited Review 72 hours for urgent cases Risk of bone/respiratory complications Aetna Policy

Step-by-Step: Fastest Path to Approval

1. Gather Required Documentation

Who: Your prescriber's office
Timeline: 1-2 weeks
Documents needed:

  • Genetic testing report confirming ALPL mutation (preferred)
  • Lab results showing persistently low alkaline phosphatase for age/sex
  • Evidence of elevated HPP substrates (PLP, PEA)
  • Radiographic imaging showing HPP-related bone disease
  • Medical records documenting pediatric onset (before age 18)

2. Complete Aetna's Precertification Form

Who: Prescriber
Form: 2025 Aetna Strensiq Precertification Form
Submit to: Fax 1-888-267-3277
Timeline: Submit within 24-48 hours of gathering documents

3. Include Medical Necessity Letter

Who: Prescriber
Content: Diagnosis, clinical severity, pediatric onset documentation, dosing rationale
Timeline: Same submission as PA form

4. Follow Up on Decision

Standard: 15 business days
Expedited: 72 hours (if marked urgent)
Contact: 1-855-582-2025 for status updates

5. If Approved: Coordinate Specialty Pharmacy

Who: Patient/caregiver
Pharmacy: CVS Specialty typically handles Strensiq
Timeline: 3-7 days for first shipment

6. If Denied: File Internal Appeal

Who: Patient or prescriber
Timeline: Within 180 days of denial
Method: Call 1-855-582-2025 or written appeal

7. Escalate to California IMR if Needed

Who: Patient
Timeline: After internal appeal completion
Contact: DMHC Help Center at 888-466-2219

Common Denial Reasons & How to Fix Them

Denial Reason How to Overturn Required Documentation
"Adult-onset HPP not covered" Provide pediatric onset evidence Medical records before age 18, growth charts, dental history
"Insufficient diagnostic confirmation" Submit comprehensive testing ALPL genetic testing, ALP labs with reference ranges, elevated PLP/PEA
"Not medically necessary" Document clinical severity and progression risk Functional assessments, fracture history, respiratory complications
"Experimental/investigational" Cite FDA approval and guidelines FDA label, published treatment guidelines
"Dosing above label" Provide clinical justification Response documentation, specialist recommendations for dose escalation
From Our Advocates: In our experience helping families navigate HPP coverage, the most successful appeals include both genetic confirmation and detailed documentation of pediatric onset. One family's initial denial was overturned after providing school records showing delayed motor milestones and dental records of early tooth loss with intact roots—both classic signs of childhood HPP that supported their case for disease-modifying therapy.

Appeals Process for California Residents

California offers exceptionally strong patient protections through a two-regulator system that provides multiple appeal pathways.

Internal Appeal with Aetna (CVS Health)

Timeline: 180 days from denial to file
Process: Call 1-855-582-2025 or submit written appeal
Decision time: 30 days standard, 72 hours expedited
Required: Original denial letter, member ID, updated medical necessity letter

California Independent Medical Review (IMR)

Most Aetna plans in California fall under the Department of Managed Health Care (DMHC) oversight, giving you access to California's powerful IMR process.

When to use: After internal appeal denial or if Aetna doesn't respond within 30 days
Timeline: 45 days for standard IMR decision, 7 days or less for expedited
Cost: Free to patients
Success rate: High for medically appropriate rare disease treatments

How to file IMR:

  1. Call DMHC Help Center: 888-466-2219
  2. Submit online at healthhelp.ca.gov
  3. Independent physician experts review your case
  4. Decision is binding on Aetna

External Review for CDI-Regulated Plans

If your Aetna plan is regulated by the California Department of Insurance (some PPO plans), contact CDI Consumer Hotline: 800-927-4357.

Clinician Corner: Medical Necessity Documentation

Medical Necessity Letter Checklist

Diagnosis & Onset:

  • Specific HPP type (perinatal/infantile/juvenile-onset)
  • Age at first symptoms with supporting documentation
  • ICD-10 codes: E83.30 (disorder of phosphorus metabolism)

Clinical Evidence:

  • Characteristic HPP features (rickets, respiratory issues, fractures, dental problems)
  • Functional limitations and quality of life impact
  • Risk of progression without treatment

Diagnostic Confirmation:

  • ALPL genetic testing results (preferred)
  • Persistently low alkaline phosphatase with age/sex reference ranges
  • Elevated HPP substrates (pyridoxal-5-phosphate, phosphoethanolamine)
  • Radiographic findings consistent with HPP

Treatment Rationale:

  • Strensiq as only FDA-approved disease-modifying therapy
  • Dosing plan (typically 2 mg/kg three times weekly)
  • Monitoring plan for efficacy and safety

Supporting Guidelines:

  • FDA-approved indication for perinatal/infantile and juvenile-onset HPP
  • Published treatment recommendations from bone specialists
  • Manufacturer clinical data supporting efficacy

Cost Assistance and Support Programs

Manufacturer Support

Alexion Access Navigator: Comprehensive support program including:

  • Prior authorization assistance
  • Appeals support
  • Financial assistance evaluation
  • Specialty pharmacy coordination

Contact: Visit alexionaccessnavigator.com or call patient support

Copay Assistance

For commercially insured patients, copay cards may be available to reduce out-of-pocket costs. Check eligibility restrictions and annual maximums.

Foundation Support

Several rare disease foundations provide grants for medication costs. Research foundations specific to metabolic bone diseases and hypophosphatasia.

When to Escalate to State Regulators

Contact DMHC Help Center If:

  • Aetna doesn't respond to appeals within required timeframes
  • You need help filing an IMR
  • The health plan isn't following California insurance laws
  • Phone: 888-466-2219
  • Website: healthhelp.ca.gov

File a Complaint If:

  • Unreasonable delays in prior authorization
  • Denial without proper medical review
  • Failure to provide required appeal information

What to include:

  • Member ID and policy information
  • Denial letters and correspondence
  • Medical records supporting medical necessity
  • Timeline of interactions with Aetna

Frequently Asked Questions

How long does Aetna (CVS Health) prior authorization take in California? Standard review takes 15 business days. Expedited review for urgent cases is completed within 72 hours. You can request expedited review if there's risk of bone disease progression or respiratory complications.

What if Strensiq (asfotase alfa) is non-formulary on my plan? Strensiq is typically covered as a Tier 5 specialty medication on Aetna formularies, but you can request a formulary exception by calling 1-855-582-2025 and providing medical necessity documentation.

Can I request an expedited appeal in California? Yes, if your condition is urgent or if delay could seriously jeopardize your health. Both Aetna internal appeals and California IMR offer expedited timelines for urgent cases.

Does step therapy apply if I haven't tried other treatments? No, step therapy typically doesn't apply to Strensiq because it's the only FDA-approved disease-modifying therapy for pediatric-onset hypophosphatasia. Vitamin D and phosphate are supportive measures, not required prior treatments.

What happens if my internal appeal is denied? California residents can file for Independent Medical Review (IMR) through the DMHC. This external review by independent physicians is binding on Aetna and has high success rates for medically appropriate treatments.

How much does Strensiq cost without insurance? Strensiq is extremely expensive, with annual costs potentially reaching several hundred thousand to over a million dollars depending on weight and dosing. This makes insurance coverage essential for most patients.

Can I switch from another specialty pharmacy to CVS Specialty? Yes, CVS Specialty typically handles Strensiq for Aetna members, but you may be able to use other specialty pharmacies in Aetna's network. Confirm coverage and copays before switching.

What if I move to California from another state while on Strensiq? Contact Aetna to ensure continuity of coverage and confirm your new plan's prior authorization requirements. California's consumer protections may provide additional appeal rights if coverage issues arise.

Counterforce Health helps patients, clinicians, and specialty pharmacies get prescription drugs approved by turning insurance denials into targeted, evidence-backed appeals. The platform ingests denial letters, plan policies, and clinical notes to draft point-by-point rebuttals aligned to each payer's specific rules, pulling the right citations and clinical evidence to support coverage requests for complex medications like Strensiq.

For additional support with Aetna coverage challenges, Counterforce Health's automated appeal system can help identify the specific denial basis and generate targeted responses that address Aetna's criteria while incorporating California's regulatory requirements and appeal processes.

Sources & Further Reading

Disclaimer: This information is for educational purposes only and does not constitute medical or legal advice. Insurance coverage decisions depend on individual circumstances, plan specifics, and clinical factors. Always consult with your healthcare provider and insurance plan directly for personalized guidance. Coverage policies and requirements may change.

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