By Counterforce Health Team in Strensiq (asfotase alfa) —

How to Get Strensiq (Asfotase Alfa) Covered by Cigna in New York: Complete PA Guide and Appeals Strategy

Answer Box: Getting Strensiq Covered by Cigna in New York

Eligibility: Cigna covers Strensiq (asfotase alfa) for pediatric-onset hypophosphatasia (HPP) only—perinatal, infantile, or juvenile onset before age 18. Required documentation: ALPL gene mutation, low alkaline phosphatase levels, and specialist prescription. First step: Contact your pediatric endocrinologist or geneticist to initiate prior authorization through Cigna's provider portal or Accredo specialty pharmacy. Timeline: 3-7 business days for complete submissions. If denied, New York residents have strong appeal rights through the state's external review program with 30-50% overturn rates for rare disease drugs.

Table of Contents

Plan Types and Network Requirements

Your Cigna plan type determines whether you need referrals and affects your out-of-pocket costs for Strensiq treatment:

Plan Type Referral Required? Specialist Access Out-of-Network Coverage
HMO Yes (from PCP) Must get referral first Emergency only
PPO No Direct access Yes, higher costs
EPO No Direct access Emergency only

For rare disease specialists: If you have an HMO and no in-network pediatric endocrinologist or geneticist is available, Cigna must facilitate access to an out-of-network provider at in-network rates.

Formulary Status and Tier Placement

Strensiq is classified as a Tier 3 (Non-Preferred Brand) or Tier 4 (Specialty) medication on most Cigna formularies, meaning it carries the highest copay or coinsurance rates. The drug requires dispensing through Accredo specialty pharmacy—retail pharmacies cannot fill Strensiq prescriptions.

No alternatives: Strensiq is the only FDA-approved disease-modifying therapy for pediatric-onset HPP. Step therapy typically doesn't apply since no comparable alternatives exist.

Prior Authorization Requirements

Cigna requires comprehensive documentation to approve Strensiq for pediatric HPP. All criteria must be met:

Medical Necessity Criteria

Confirmed Pediatric-Onset HPP:

  • Perinatal, infantile, or juvenile onset (symptoms before age 18)
  • Clinical manifestations: skeletal abnormalities, fractures, muscle weakness, respiratory issues, or premature tooth loss

Genetic Evidence:

  • Pathogenic ALPL gene mutation confirmed by genetic testing
  • Submit complete genetic testing report

Biochemical Profile:

  • Persistently low serum alkaline phosphatase (ALP) levels
  • Results must use age- and sex-appropriate reference ranges

Specialist Involvement:

  • Prescription from pediatric endocrinologist, geneticist, or metabolic disease specialist
  • General practitioners alone are insufficient for approval

Required Documentation Checklist

  • Patient demographics and Cigna member ID
  • ICD-10 diagnosis codes (E83.311, E83.312 for HPP)
  • Prescriber credentials and specialty certification
  • Clinical notes detailing symptom onset and disease progression
  • Laboratory results showing low ALP with reference values
  • Genetic testing report confirming ALPL mutation
  • Radiographic evidence of bone abnormalities (if available)
  • Dosing plan and medical justification

Step-by-Step Approval Process

1. Gather Documentation (Patient + Clinic)

Timeline: 1-2 weeks
Collect all required lab results, genetic testing, and clinical records. Ensure your specialist has complete medical history.

2. Submit Prior Authorization (Clinic)

Timeline: Same day
Methods:

  • Cigna Provider Portal (preferred)
  • Accredo PA tools: CoverMyMeds or fax to 1-855-476-4158
  • Paper forms available from Cigna or Accredo

3. Review Process (Cigna)

Timeline: 3-7 business days
Cigna reviews medical necessity against their coverage policy. Complete submissions process faster than incomplete ones.

4. Approval and Setup (Accredo)

Timeline: 2-3 days
Once approved, Accredo contacts patient to arrange delivery and injection training. Strensiq requires subcutaneous injection 2-6 times weekly.

Tip: Start the PA process 2-3 weeks before you need the medication to account for potential delays or appeals.

Common Denial Reasons and Solutions

Denial Reason Solution Required Documentation
Adult-onset HPP claimed Provide pediatric onset evidence Medical records showing symptoms before age 18
Insufficient genetic confirmation Submit complete genetic testing ALPL mutation report from certified lab
Missing specialist involvement Get prescription from qualified specialist Credentials from pediatric endocrinologist/geneticist
Incomplete biochemical evidence Provide age-appropriate ALP results Lab reports with pediatric reference ranges
Dosing above FDA label Justify higher dosing medically Clinical notes explaining dose escalation need

Appeals Process in New York

New York has consumer-friendly appeal rights with binding external review through the Department of Financial Services (DFS).

Internal Appeals (Cigna)

  • Deadline: 180 days from denial date
  • Timeline: 30-60 days for standard appeals, 72 hours for expedited
  • Submit via: Cigna member portal or mail to appeals address on denial letter

External Review (NY DFS)

  • Eligibility: After Cigna upholds denial on internal appeal
  • Deadline: 4 months from final Cigna denial
  • Timeline: 30 days standard, 72 hours expedited
  • Fee: $25 (waived for financial hardship)
  • Success rate: 30-50% overturn rate for rare disease drugs

File external appeal: NY DFS Portal or call the Consumer Hotline at 1-800-342-3736.

Note: DFS decisions are binding on Cigna. If overturned, Cigna must cover treatment and refund the appeal fee.

Free Help Available

Community Health Advocates provides free assistance with insurance appeals at 888-614-5400.

Cost-Share and Financial Assistance

Typical costs: As a specialty tier medication, expect 20-40% coinsurance after deductible, potentially $1,000-$5,000+ monthly out-of-pocket.

Financial assistance options:

  • Alexion Access Navigator: Manufacturer copay assistance and patient support
  • State pharmaceutical assistance programs for qualifying New York residents
  • Private foundations offering rare disease grants

For Medicaid: New York Medicaid typically covers Strensiq with minimal patient cost-sharing when medically necessary.

When navigating complex insurance approvals for rare disease treatments like Strensiq, having expert support can make the difference between approval and denial. Counterforce Health helps patients, clinicians, and specialty pharmacies turn insurance denials into successful appeals by analyzing denial letters, plan policies, and clinical notes to create targeted, evidence-backed rebuttals aligned with each insurer's specific requirements.

Frequently Asked Questions

How long does Cigna prior authorization take for Strensiq in New York?
3-7 business days for complete submissions. Incomplete documentation can extend review to 2-3 weeks.

What if Strensiq is non-formulary on my Cigna plan?
Submit a formulary exception request with medical necessity documentation. Most Cigna plans include Strensiq as a covered specialty drug.

Can I request an expedited appeal if my child needs Strensiq urgently?
Yes. Both Cigna internal appeals and NY DFS external reviews offer 72-hour expedited decisions with physician attestation of urgency.

Does step therapy apply to Strensiq coverage?
Rarely, since no comparable alternatives exist for pediatric HPP. If required, your specialist can request a step therapy exception.

What happens if I move from another state to New York?
Your prior approval may need renewal under New York Cigna policies. Contact Cigna member services to confirm coverage continuity.

How often do I need to renew Strensiq approval?
Annually. Start renewal 6-8 weeks before expiration to avoid treatment gaps.

Can adults get Strensiq covered by Cigna?
Coverage is limited to pediatric-onset HPP. Adults with childhood-onset disease who continue treatment may qualify, but new adult diagnoses typically aren't covered.

The appeals process can feel overwhelming, but Counterforce Health's platform streamlines the entire workflow—from ingesting denial letters to drafting point-by-point rebuttals that include the right medical citations and clinical facts payers expect to see. Their system tracks deadlines and procedural requirements specific to each payer, helping ensure no critical steps are missed in the appeals process.

Sources & Further Reading

Disclaimer: This information is for educational purposes only and does not constitute medical advice. Treatment decisions should be made in consultation with qualified healthcare providers. Insurance coverage varies by plan and individual circumstances. For personalized assistance with your specific situation, contact your healthcare provider or insurance company directly.

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