How to Get Strensiq (Asfotase Alfa) Covered by Cigna in Florida: Prior Authorization Guide and Appeals Strategy
Answer Box: Getting Strensiq Covered by Cigna in Florida
Strensiq (asfotase alfa) requires prior authorization from Cigna for hypophosphatasia (HPP) treatment. No step therapy is required since no alternatives exist. Key requirements: genetic testing showing ALPL mutation, low serum alkaline phosphatase, and pediatric-onset HPP documentation. First step: Have your specialist submit a comprehensive prior authorization through Cigna's provider portal with genetic, biochemical, and clinical evidence. If denied: Internal appeals must be filed within 180 days, followed by external review through Florida's Department of Financial Services within 4 months. Success rates are high with proper documentation.
Table of Contents
- Coverage Requirements at a Glance
- Step-by-Step: Fastest Path to Approval
- When Alternatives Make Sense
- Understanding Your Options
- Exception Strategy
- Common Denial Reasons & Solutions
- Appeals Playbook for Florida
- Costs & Patient Support
- FAQ
- Sources & Further Reading
Coverage Requirements at a Glance
| Requirement | What It Means | Where to Find It | Source |
|---|---|---|---|
| Prior Authorization | Required before coverage | Cigna provider portal | Cigna PA Policy |
| Formulary Tier | Specialty (Tier 4) | Cigna formulary documents | Cigna Formulary |
| Step Therapy | Not required | No alternatives exist | Coverage Policy |
| Genetic Testing | ALPL gene mutation | Lab reports within 6 months | Medical Necessity Criteria |
| Prescriber Requirements | HPP specialist required | Geneticist/endocrinologist | PA Requirements |
| Age Restrictions | Pediatric-onset HPP only | Clinical documentation | Coverage Criteria |
Step-by-Step: Fastest Path to Approval
- Confirm Diagnosis (Patient + Clinic)
- Obtain genetic testing showing ALPL gene mutation
- Document low serum alkaline phosphatase levels
- Timeline: 2-4 weeks for genetic results
- Source: Strensiq Diagnostic Resources
- Gather Clinical Evidence (Clinic)
- Compile records showing pediatric-onset HPP symptoms
- Document skeletal abnormalities, premature tooth loss, or respiratory issues
- Timeline: 1-2 weeks
- Source: FDA Prescribing Information
- Submit Prior Authorization (Prescriber)
- Complete PA request through Cigna provider portal
- Include all genetic, biochemical, and clinical documentation
- Timeline: 2-3 business days for review
- Source: Cigna PA Process
- Track Review Status (Patient + Clinic)
- Monitor PA status through provider portal
- Follow up if additional information is requested
- Timeline: Decision within 3-7 business days
- Source: Cigna Review Timelines
When Alternatives Make Sense
For Strensiq (asfotase alfa) in hypophosphatasia treatment, alternatives don't make clinical sense. Strensiq is the only FDA-approved disease-modifying therapy for pediatric-onset HPP. Unlike other conditions where multiple treatment options exist, HPP has no approved alternatives or biosimilars.
Important considerations:
- Supportive care (calcium, vitamin D, physical therapy) may be used alongside Strensiq but cannot replace it
- Bisphosphonates are contraindicated in HPP and may worsen bone mineralization
- Off-label treatments lack evidence and regulatory approval for HPP
Note: If your doctor suggests trying alternatives first, ensure they understand HPP's unique pathophysiology and the lack of approved alternatives.
Understanding Your Options
Since no therapeutic alternatives exist for HPP, your focus should be on optimizing your Strensiq approval strategy rather than considering substitutes.
Strensiq Coverage Pathway
- Indication: Only FDA-approved ERT for pediatric-onset HPP
- Mechanism: Replaces deficient alkaline phosphatase enzyme
- Administration: Subcutaneous injection 2-6 times weekly
- Monitoring: Regular assessment of bone mineralization and growth
Supportive Measures (Not Alternatives)
While not disease-modifying, these may be part of comprehensive care:
- Physical therapy for mobility and strength
- Orthopedic management for bone deformities
- Respiratory support if needed
- Pain management strategies
Counterforce Health helps patients navigate complex prior authorization requirements for specialty medications like Strensiq. Their platform analyzes denial letters and creates targeted, evidence-backed appeals that align with payer policies, significantly improving approval rates for rare disease treatments.
Exception Strategy
Since Strensiq has no alternatives, your exception strategy focuses on formulary exceptions if the drug is non-formulary or quantity limit overrides if dosing restrictions apply.
When to Request Exceptions
- Non-formulary status: If Strensiq isn't on your specific Cigna formulary
- Quantity limits: If prescribed dose exceeds standard limits
- Site of care restrictions: If home administration is preferred over clinic
Evidence That Helps
- FDA labeling supporting your specific indication and dosing
- Clinical guidelines from genetics or endocrine societies
- Peer-reviewed studies demonstrating efficacy in your HPP type
- Specialist attestation regarding medical necessity
Clinician Corner: Medical necessity letters should reference the 2015 FDA approval, cite the lack of alternatives, and include specific patient factors (genotype, phenotype severity, prior supportive care outcomes).
Common Denial Reasons & Solutions
| Denial Reason | How to Overturn | Required Documents |
|---|---|---|
| "Adult-onset HPP not covered" | Prove pediatric onset with childhood records | School health records, dental history, growth charts |
| "Insufficient genetic confirmation" | Submit comprehensive genetic testing | ALPL mutation analysis, family history |
| "Experimental/investigational" | Cite FDA approval and clinical evidence | FDA approval letter, published studies |
| "Dosing above label" | Provide clinical justification | Specialist notes, treatment response data |
| "Missing specialist evaluation" | Ensure HPP expert involvement | Genetics/endocrinology consultation |
Appeals Playbook for Florida
Internal Appeal Process
Timeline: File within 180 days of denial notice Method: Submit through Cigna provider portal or mail Review time: 30 days for standard, 72 hours for expedited Required: Denial letter, additional clinical evidence, physician letter
External Review Process
When: After unsuccessful internal appeal Timeline: Request within 4 months of final internal denial Authority: Florida Department of Financial Services Contact: Florida Insurance Consumer Helpline (1-877-693-5236) Cost: Free to consumer
Expedited Review
Available when delay could seriously jeopardize health. Can request expedited internal and external review simultaneously for urgent cases.
From our advocates: We've seen HPP cases succeed on appeal when families provided comprehensive childhood medical records showing early symptoms that were initially misdiagnosed as rickets or growth delays. This historical documentation often clinches the "pediatric-onset" requirement.
Costs & Patient Support
Manufacturer Support
- Alexion Access Navigator: Patient assistance programs
- Copay support: May reduce out-of-pocket costs
- Prior authorization assistance: Help with PA submissions
- Contact: Alexion Access Navigator
Foundation Support
- National Organization for Rare Disorders (NORD): Financial assistance programs
- HealthWell Foundation: Copay assistance for eligible patients
- Patient Advocate Foundation: Insurance appeal support
FAQ
How long does Cigna prior authorization take in Florida? Standard PA reviews take 2-3 business days once all documentation is submitted. Expedited reviews are completed within 24 hours for urgent cases.
What if Strensiq is non-formulary on my plan? Request a formulary exception with clinical justification. Since no alternatives exist, exceptions are often approved with proper documentation.
Can I request an expedited appeal? Yes, if delay in treatment could seriously jeopardize your health. Both internal and external expedited reviews are available in Florida.
Does step therapy apply to Strensiq? No, Cigna does not require step therapy for Strensiq because there are no approved therapeutic alternatives for HPP.
What counts as pediatric-onset HPP? Symptoms must have begun before age 18, including perinatal, infantile, or juvenile-onset forms. Adult-onset HPP is typically not covered.
How do I file a complaint with Florida regulators? Contact the Florida Department of Financial Services Insurance Consumer Helpline at 1-877-693-5236 or submit online through their consumer portal.
What if my doctor isn't an HPP specialist? Cigna requires prescriptions from or consultation with genetics, endocrinology, or other specialists with HPP expertise. Your primary doctor can refer you.
Can I appeal if I live in Florida but have coverage from another state? Appeal rights depend on where your insurance plan is regulated, not your residence. Check your plan documents for specific appeal procedures.
For complex cases involving multiple denials or appeals, Counterforce Health specializes in turning insurance denials into successful appeals by creating evidence-backed rebuttals aligned with payer policies.
Sources & Further Reading
- Cigna Strensiq Coverage Policy
- FDA Strensiq Prescribing Information
- Florida Insurance Consumer Rights
- Cigna Prior Authorization Process
- Alexion Access Navigator
- Strensiq Healthcare Provider Resources
Disclaimer: This information is for educational purposes only and does not constitute medical or legal advice. Insurance coverage varies by plan, and policies change frequently. Always consult your healthcare provider and insurance plan documents for the most current requirements. For assistance with insurance appeals in Florida, contact the Department of Financial Services Insurance Consumer Helpline at 1-877-693-5236.
Powered by Counterforce Health—AI that turns drug denials into evidence-based appeals patients and clinicians can submit today.