How to Get Strensiq (Asfotase Alfa) Covered by Aetna in Michigan: Complete Guide to Prior Authorization, Appeals, and Cost Assistance
Answer Box: Getting Strensiq Covered by Aetna in Michigan
Fastest path to approval: Aetna requires prior authorization for Strensiq (asfotase alfa) with strict clinical criteria. You need documented perinatal/infantile or juvenile-onset hypophosphatasia, genetic testing or biochemical confirmation, and proof the condition started before age 18. First step today: Contact your prescribing physician to gather all diagnostic records, lab results showing low alkaline phosphatase, and genetic testing results. Submit the complete prior authorization package through CVS Specialty or your provider portal. If denied, Michigan law gives you 127 days to file an external review with the Department of Insurance and Financial Services.
Table of Contents
- Understanding Aetna's Coverage Requirements
- Step-by-Step: Fastest Path to Approval
- Common Denial Reasons & How to Fix Them
- Appeals Process in Michigan
- Cost and Financial Assistance Options
- Working with CVS Specialty Pharmacy
- Scripts for Key Conversations
- FAQ: Michigan-Specific Questions
Understanding Aetna's Coverage Requirements
Strensiq (asfotase alfa) is classified as a Tier 5 specialty medication under Aetna's formulary, requiring prior authorization and meeting strict medical necessity criteria. The drug treats hypophosphatasia (HPP), a rare genetic disorder affecting bone and tooth development.
Coverage at a Glance
Requirement | What It Means | Where to Find It | Source |
---|---|---|---|
Prior Authorization | Must be approved before dispensing | Aetna provider portal or CVS Specialty | Aetna PA List |
Formulary Tier | Tier 5 (specialty) with highest copay | Plan formulary document | Aetna Formulary |
Age Restriction | Disease onset before age 18 required | Medical records, diagnostic imaging | Aetna Policy |
Genetic Testing | ALPL mutation or biochemical markers | Lab results, genetic counselor report | Aetna Policy |
Dosing Limits | 6 mg/kg/week (juvenile), 9 mg/kg/week (infantile) | Prescription, medical records | FDA Label |
Aetna's specific criteria require ALL of the following:
- Clinical signs/symptoms of hypophosphatasia
- Disease onset in perinatal/infantile or juvenile period (before age 18)
- Genetic confirmation (ALPL mutation) OR biochemical/radiographic evidence
- Appropriate dosing within FDA-approved limits
Step-by-Step: Fastest Path to Approval
1. Gather Required Documentation (Patient/Family)
Timeline: 1-2 weeks
Who does it: Patient with physician support
Documents needed:
- Insurance card and member ID
- Complete medical history showing symptoms before age 18
- Previous treatment records and failures
- Family history of bone/dental problems
2. Obtain Diagnostic Confirmation (Physician)
Timeline: 2-4 weeks
Who does it: Prescribing physician (preferably metabolic specialist)
Required tests:
- Serum alkaline phosphatase (ALP) below age/gender norms
- ALPL genetic testing OR elevated TNSALP substrates
- Radiographic imaging showing skeletal abnormalities
- Clinical documentation of HPP symptoms
3. Submit Prior Authorization (Physician/CVS Specialty)
Timeline: Submit immediately after gathering docs
How to submit: CVS Specialty enrollment forms or Aetna provider portal
Expected response: 30-45 days for standard review, 72 hours for urgent
4. Follow Up and Track Status (Patient)
Timeline: Weekly check-ins
Contact: Aetna Member Services or CVS Specialty case manager
What to ask: Application status, missing documents, expected decision date
Clinician Corner: Medical Necessity Letter Checklist
Your letter should include:Problem statement: Confirmed HPP diagnosis with onset before age 18Prior treatments: Document any failed therapies or supportive careClinical rationale: Reference FDA labeling and HPP treatment guidelinesDosing justification: Weight-based calculation within approved limitsMonitoring plan: Laboratory and clinical follow-up schedule
Key citations: FDA Strensiq label, Aetna policy criteria
Common Denial Reasons & How to Fix Them
Denial Reason | How to Overturn | Required Documents |
---|---|---|
"Adult-onset HPP not covered" | Provide childhood records showing symptoms before age 18 | School records, dental records, growth charts, old X-rays |
"Insufficient genetic confirmation" | Submit ALPL testing or comprehensive biochemical panel | Genetic test results, elevated PLP/PEA levels, low ALP |
"Experimental/investigational" | Emphasize FDA approval for pediatric-onset HPP | FDA approval letter, prescriber attestation |
"Dosing exceeds guidelines" | Justify dose based on weight and severity | Weight documentation, clinical response data |
"Non-formulary drug" | Request formulary exception with no alternatives | Letter stating no therapeutic alternatives exist |
Most common successful appeal strategy: Comprehensive documentation showing clear pediatric-onset disease with genetic confirmation and failed conservative management.
Appeals Process in Michigan
If Aetna denies your Strensiq prior authorization, Michigan law provides robust appeal rights through the Department of Insurance and Financial Services (DIFS).
Internal Appeals with Aetna
Timeline: Must file within 180 days of denial
Process: Submit appeal letter with additional clinical documentation
Decision time: 30 days standard, 72 hours expedited
External Review through Michigan DIFS
Timeline: Must file within 127 days of final internal denial
How to file: Michigan DIFS External Review Request (verify current form link)
Decision time: 60 days standard, 72 hours expedited
Cost: Free to patients
Michigan's expedited external appeal is available when:
- Delay would seriously jeopardize patient health
- Denial involves urgently needed treatment
- Physician provides letter stating delay would cause harm
Note: Michigan's 127-day external review deadline is longer than the federal 120-day standard, giving patients extra time to gather documentation.
Contact Michigan DIFS: 877-999-6442 for questions about the external review process.
Cost and Financial Assistance Options
Strensiq's annual cost can exceed $500,000, making financial assistance crucial for most families.
Manufacturer Support: Alexion OneSource
Eligibility: Commercially insured patients (not Medicare/Medicaid)
Benefits: Copay assistance, case management, insurance navigation
How to apply: Alexion OneSource website or call during enrollment
Patient Assistance Foundations
PAN Foundation
- Copay assistance: Up to $14,700 annually for Strensiq
- Premium assistance: Up to $4,800 annually for insurance premiums
- Eligibility: Income ≤400% federal poverty level, U.S. resident
- Apply: PAN Foundation HPP fund
NORD (National Organization for Rare Disorders)
- Coverage: Premiums, copays, deductibles, travel expenses
- Eligibility: U.S. citizen/resident, HPP diagnosis, financial need
- Contact: [email protected] or 800-828-8902
The Assistance Fund
- Support: Various health-related costs and copays
- Application: Direct through their website
Michigan-Specific Resources
While no Michigan-specific HPP grants exist, residents can access all national programs. Michigan's expanded Medicaid program ("Healthy Michigan") may provide coverage for eligible low-income residents.
Working with CVS Specialty Pharmacy
As Aetna's preferred specialty pharmacy, CVS Specialty handles most Strensiq dispensing and can streamline the prior authorization process.
Services CVS Specialty provides:
- Prior authorization submission on physician's behalf
- Insurance benefit verification
- Patient education and injection training
- Coordination with Alexion OneSource
- Home delivery and cold-chain management
Key contact information:
- CVS Specialty enrollment: Use specialty enrollment forms
- Patient support: Available through CVS Specialty patient portal
Tip: CVS Specialty case managers can often identify coverage issues early and work with your physician to address them before formal denial.
Scripts for Key Conversations
Calling Aetna Member Services
"Hi, I'm calling to check the status of a prior authorization for Strensiq, generic name asfotase alfa. My member ID is [ID number]. Can you tell me if the request has been received and what the current status is? If there are any missing documents, I'd like to know exactly what's needed and the best way to submit them."
Physician Office: Requesting Peer-to-Peer Review
"We'd like to request a peer-to-peer review for our Strensiq prior authorization. The patient has confirmed pediatric-onset hypophosphatasia with genetic testing. Can you schedule a call between Dr. [Name] and Aetna's medical director to discuss the clinical rationale?"
CVS Specialty Enrollment
"We're enrolling a patient for Strensiq therapy. They have Aetna coverage and we'll need help with prior authorization. Can you assign a case manager and walk us through the enrollment process? We have all the diagnostic documentation ready."
FAQ: Michigan-Specific Questions
Q: How long does Aetna prior authorization take in Michigan?
A: Standard reviews take 30-45 days. Expedited reviews (for urgent cases) are completed within 72 hours. Michigan law doesn't change these federal timelines.
Q: What if Strensiq is non-formulary on my Aetna plan?
A: Request a formulary exception by documenting medical necessity and lack of therapeutic alternatives. Aetna must review exception requests even for non-formulary drugs.
Q: Can I get an expedited appeal in Michigan?
A: Yes, both Aetna internal appeals and Michigan DIFS external reviews offer expedited options (72 hours) when delay would jeopardize patient health.
Q: Does step therapy apply if I've tried treatments outside Michigan?
A: Yes, Aetna will consider prior treatment failures regardless of where they occurred. Provide complete documentation from all previous providers.
Q: What's the difference between Aetna's internal appeal and Michigan's external review?
A: Internal appeals are reviewed by Aetna staff. External reviews through Michigan DIFS use independent medical experts and are binding on Aetna.
Q: Can my doctor file appeals for me?
A: Yes, Michigan law allows physicians to file appeals on patients' behalf with written consent. This is often faster than patient-initiated appeals.
When to Contact Michigan Regulators
Contact Michigan DIFS if you experience:
- Delays beyond stated timelines
- Requests for inappropriate documentation
- Denial of expedited review for urgent cases
- Failure to provide written denial reasons
Michigan DIFS Consumer Services: 877-999-6442
Getting Strensiq covered by Aetna requires persistence and comprehensive documentation, but Michigan's strong consumer protections and multiple financial assistance programs provide significant support for families navigating this process. Counterforce Health specializes in turning insurance denials into targeted, evidence-backed appeals by analyzing denial letters, plan policies, and clinical notes to create point-by-point rebuttals aligned with each payer's specific requirements.
From our advocates: "One family's initial Aetna denial cited 'insufficient genetic confirmation' despite having ALPL testing results. We helped them resubmit with a detailed genetic counselor interpretation and biochemical correlation, leading to approval within two weeks. The key was presenting the genetic data in the exact format Aetna's medical reviewers expected to see."
Sources & Further Reading
- Aetna Strensiq Prior Authorization Policy
- FDA Strensiq Prescribing Information
- Michigan DIFS External Review Process
- CVS Specialty Enrollment Forms
- Alexion OneSource Patient Support
- PAN Foundation Hypophosphatasia Fund
- NORD HPP Patient Assistance
Disclaimer: This information is for educational purposes only and does not constitute medical or legal advice. Insurance coverage decisions depend on individual plan terms and clinical circumstances. Always consult with your healthcare provider and insurance company for guidance specific to your situation. For additional support with insurance appeals and prior authorization, consider consulting with Counterforce Health, which helps patients and clinicians navigate complex coverage challenges for specialty medications.
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