By Counterforce Health Team in Strensiq (asfotase alfa) —

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

Answer Box: Getting Strensiq Covered by Cigna in North Carolina

Strensiq (asfotase alfa) requires prior authorization from Cigna and is typically covered only for pediatric-onset hypophosphatasia with strict documentation requirements. Your fastest path to approval: (1) Work with an HPP specialist to gather genetic testing, low ALP levels, and clinical evidence of pediatric onset, (2) Submit comprehensive PA documentation through Cigna's provider portal, and (3) If denied, appeal internally within 60 days, then request external review through Smart NC within 120 days. North Carolina's external review system has a 40-50% overturn rate for specialty drug denials.

First step today: Contact your prescribing physician to ensure they have all required documentation and can submit through Cigna's specialty pharmacy channel (typically Accredo).

Table of Contents

  1. Coverage at a Glance
  2. Understanding Cigna's Plan Types and Implications
  3. Formulary Status and Tier Placement
  4. Prior Authorization and Utilization Controls
  5. Specialty Pharmacy Requirements
  6. Cost-Share Dynamics
  7. Step-by-Step: Fastest Path to Approval
  8. Common Denial Reasons and How to Fix Them
  9. Appeals Playbook for North Carolina
  10. When to Escalate to Smart NC
  11. Cost Assistance Programs
  12. Frequently Asked Questions

Coverage at a Glance

Requirement What It Means Where to Find It Official Source
Prior Authorization Required before coverage Cigna provider portal Cigna PA Requirements
Formulary Tier Specialty (Tier 4/5) Plan formulary document Cigna Formularies
Step Therapy May be required Coverage policy Cigna PA Criteria
Specialist Requirement Geneticist, endocrinologist, or metabolic specialist Medical policy Coverage Position
Age Restriction Pediatric-onset HPP only Clinical criteria PA Documentation
Appeals Deadline 60 days internal, 120 days external NC insurance law Smart NC Appeals

Understanding Cigna's Plan Types and Implications

HMO vs. PPO Considerations

If you have a Cigna HMO plan, you'll need a referral from your primary care physician to see the required HPP specialist. PPO and EPO plans typically allow direct specialist access, which can speed up the documentation process.

Network Requirements

Strensiq must be prescribed by an in-network specialist whenever possible. Out-of-network prescriptions face additional hurdles and higher cost-sharing. Use Cigna's provider directory to locate in-network geneticists or endocrinologists experienced with hypophosphatasia.

Medicaid Managed Care Plans

North Carolina expanded Medicaid in 2023, and Cigna operates Medicaid managed care plans in the state. These follow different appeal processes through the NC Medicaid program rather than Smart NC.

Formulary Status and Tier Placement

Specialty Tier Placement

Strensiq is placed in Cigna's highest formulary tier (Specialty, often Tier 4 or 5), meaning you'll pay coinsurance rather than a flat copay. Typical coinsurance ranges from 25-40% of the drug cost, though your specific plan may vary.

No Generic Alternatives

Unlike many specialty drugs, Strensiq has no approved biosimilar or generic alternatives. This is the only FDA-approved enzyme replacement therapy for hypophosphatasia, which can strengthen your medical necessity argument.

Step Therapy Considerations

While there are no direct alternatives to step through, Cigna may require documentation that supportive therapies (vitamin D, calcium supplements) were insufficient before approving Strensiq.

Prior Authorization and Utilization Controls

Core Documentation Requirements

Cigna's medical policy requires comprehensive evidence of pediatric-onset HPP:

  • Genetic confirmation: Pathogenic ALPL gene mutation identified through molecular testing
  • Biochemical evidence: Low serum alkaline phosphatase levels using age/sex-adjusted pediatric reference ranges
  • Clinical manifestations: Documentation of HPP symptoms before age 18 (skeletal abnormalities, premature tooth loss, muscle weakness, respiratory issues, or vitamin B6-dependent seizures)
  • Specialist involvement: Prescription by or consultation with a geneticist, endocrinologist, or metabolic disease subspecialist

Dosing Justification

The requested dose must align with FDA labeling (6 mg/kg/week subcutaneously, divided into multiple injections). If requesting higher doses up to 9 mg/kg/week for severe infantile cases, provide clinical rationale and current weight for calculation.

Tip: Gather all documentation before starting the PA process. Missing pieces often lead to automatic denials that could have been avoided.

Specialty Pharmacy Requirements

Accredo Partnership

Cigna typically requires Strensiq to be dispensed through Express Scripts Accredo, their preferred specialty pharmacy. Your prescription cannot be filled at regular retail pharmacies.

Setup Process

  1. Your doctor submits the prescription to Accredo along with PA documentation
  2. Accredo contacts you to set up delivery and injection training
  3. The medication is shipped in temperature-controlled packaging
  4. Follow-up calls ensure proper storage and administration

Patient Responsibilities

You'll need refrigerator storage, injection supplies, and a plan for proper disposal of used syringes. Accredo provides injection training and ongoing support.

Cost-Share Dynamics

Understanding Coinsurance

As a specialty tier medication, you'll pay a percentage of Strensiq's cost rather than a fixed copay. With annual costs potentially exceeding $500,000, even a 25% coinsurance could mean substantial out-of-pocket expenses.

Annual Out-of-Pocket Maximums

ACA-compliant plans have annual out-of-pocket maximums (around $9,450 for individuals in 2024). Once you reach this limit, Cigna covers 100% of covered services for the rest of the year.

Deductible Considerations

High-deductible health plans may require you to meet your full deductible before coinsurance kicks in. This could mean paying thousands upfront before Cigna's coverage begins.

Step-by-Step: Fastest Path to Approval

Step 1: Specialist Consultation (Patient/Family) Schedule with an in-network geneticist, endocrinologist, or metabolic specialist experienced with HPP. Bring all prior medical records, genetic testing, and lab results. Timeline: 2-4 weeks for appointment

Step 2: Gather Documentation (Clinic Staff) Collect ALPL genetic testing, age-adjusted ALP levels, clinical notes documenting pediatric onset, imaging studies, and treatment history. Timeline: 1-2 weeks

Step 3: Submit PA Request (Prescriber) Submit through Cigna's provider portal with comprehensive clinical documentation and letter of medical necessity. Expected response: 72 hours (standard) or 24 hours (urgent)

Step 4: Accredo Setup (If Approved) Accredo contacts patient for delivery setup, insurance verification, and injection training. Timeline: 3-5 business days

Step 5: Appeal if Denied (Patient/Prescriber) Submit Level 1 internal appeal within 60 days with additional documentation addressing denial reasons. Response time: 30 days (standard) or 72 hours (expedited)

Step 6: External Review (If Needed) Request Smart NC external review within 120 days of final internal denial. Decision time: 45 days (standard) or 4 business days (expedited)

Common Denial Reasons and How to Fix Them

Denial Reason How to Overturn Required Documentation
"Adult-onset HPP not covered" Provide pediatric medical records showing symptom onset before age 18 Childhood growth charts, dental records, early X-rays
"Insufficient genetic evidence" Submit complete ALPL mutation analysis with pathogenicity interpretation Molecular genetic testing report with variant classification
"Lab values not age-adjusted" Resubmit with pediatric reference ranges clearly marked Age/sex-specific ALP reference ranges with patient values
"Lack of specialist involvement" Ensure prescription is from required subspecialist Referral letter or co-signature from geneticist/endocrinologist
"Dosing exceeds label" Provide clinical justification for higher doses in severe cases Growth data, respiratory function, bone density improvements

Appeals Playbook for North Carolina

Level 1 Internal Appeal

  • Deadline: 60 days from denial notice
  • How to file: Cigna member portal or written request
  • Response time: 30 days (standard), 72 hours (expedited)
  • What to include: Denial letter, additional medical records, prescriber's clinical justification

Level 2 Internal Appeal

  • Deadline: 60 days from Level 1 denial
  • Process: Same as Level 1 with any new evidence
  • Response time: 30 days (standard), 72 hours (expedited)

Peer-to-Peer Review Request a clinical discussion between your prescriber and Cigna's medical director. This informal step often resolves denials without formal appeals.

Note: Keep detailed records of all communications, including reference numbers and representative names.

When to Escalate to Smart NC

External Review Eligibility

You can request external review through Smart NC if:

  • You've completed both internal appeal levels
  • Your plan is state-regulated (not self-funded employer plan)
  • The denial involves medical necessity or experimental treatment determination
  • You file within 120 days of Cigna's final denial

Smart NC Process

  1. Submit request: Use the official external review form on the NC DOI website
  2. Free advocacy: Call Smart NC at 1-855-408-1212 for assistance
  3. Independent review: An outside medical expert reviews your case
  4. Binding decision: If overturned, Cigna must cover within 3 business days

Success Rates

Smart NC overturns 40-50% of insurance denials statewide, with higher success rates for well-documented rare disease cases.

For patients and clinicians navigating complex insurance denials like these, Counterforce Health helps turn denials into targeted, evidence-backed appeals. The platform analyzes denial letters and payer policies to draft point-by-point rebuttals with the right clinical documentation and medical literature citations, significantly improving approval rates for specialty medications like Strensiq.

Cost Assistance Programs

Manufacturer Support

Alexion provides patient assistance through their Access Navigator program, including:

  • Insurance verification and PA support
  • Copay assistance for eligible patients
  • Free drug program for uninsured patients meeting income criteria

Foundation Grants

Organizations like the National Organization for Rare Disorders (NORD) and HealthWell Foundation offer grants for rare disease medications. Applications typically require financial documentation and physician attestation.

State Programs

North Carolina's expanded Medicaid may cover Strensiq for eligible low-income patients. Contact your local Department of Social Services for application assistance.

Frequently Asked Questions

How long does Cigna prior authorization take in North Carolina? Standard PA decisions come within 72 hours of complete submission. Urgent requests receive decisions within 24 hours. Incomplete submissions reset the clock.

What if Strensiq is non-formulary on my plan? You can request a formulary exception through Cigna's exception process. This requires demonstrating medical necessity and lack of suitable formulary alternatives.

Can I request an expedited appeal? Yes, if delay would seriously jeopardize your health. Both internal appeals and Smart NC external review offer expedited pathways with faster decision timelines.

Does step therapy apply if I tried alternatives outside North Carolina? Medical records from other states count toward step therapy requirements. Ensure your new NC provider has complete documentation of prior treatments.

What happens if Smart NC overturns my denial? Cigna must provide coverage within 3 business days of an external review decision in your favor. The decision is binding and cannot be appealed by the insurer.

How much will Strensiq cost with Cigna coverage? Your cost depends on your plan's specialty tier coinsurance (typically 25-40%) and whether you've met your annual deductible and out-of-pocket maximum.

Sources & Further Reading

Disclaimer: This information is for educational purposes only and does not constitute medical or legal advice. Insurance coverage varies by plan and individual circumstances. Always consult with your healthcare provider and insurance company for decisions about your specific situation. For personalized assistance with insurance appeals and prior authorizations, consider working with advocacy services like Counterforce Health that specialize in overturning insurance denials for specialty medications.

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