Myths vs. Facts: Getting Strensiq (asfotase alfa) Covered by Blue Cross Blue Shield in Florida
Answer Box: Getting Strensiq Covered in Florida
Eligibility: Blue Cross Blue Shield Florida covers Strensiq for perinatal/infantile-onset or juvenile-onset hypophosphatasia with disease onset before age 12. Fastest path: Have your endocrinologist or bone specialist submit prior authorization with genetic testing, low ALP levels, radiographic evidence, and elevated PLP levels. First step today: Contact your prescriber to confirm they have all required documentation per Florida Blue's December 2024 policy. Appeals have 180 days from denial and external review is free through Florida's Department of Financial Services.
Table of Contents
- Why Myths About Strensiq Coverage Persist
- Myth vs. Fact: 10 Common Misconceptions
- What Actually Influences Approval
- Avoid These 5 Critical Mistakes
- Quick Action Plan: 3 Steps to Take Today
- Florida Appeals Process
- Resources and Support
Why Myths About Strensiq Coverage Persist
Strensiq (asfotase alfa) is one of the world's most expensive medications, with annual costs ranging from $890,000 to $4.9 million depending on patient weight and dosing requirements. When families hear these figures, it's natural to assume insurance won't cover it. However, this assumption has created persistent myths that prevent patients from accessing life-changing treatment.
The reality is that Blue Cross Blue Shield Florida has specific, well-defined coverage criteria for Strensiq. Understanding these requirements—rather than relying on outdated information or assumptions—is the key to successful approval.
Counterforce Health specializes in turning insurance denials into targeted, evidence-backed appeals for complex specialty medications like Strensiq. The platform helps patients, clinicians, and pharmacies navigate payer-specific requirements by analyzing denial letters, plan policies, and clinical documentation to create comprehensive appeals that address each insurer's unique criteria.
Myth vs. Fact: 10 Common Misconceptions
Myth 1: "Insurance never covers million-dollar medications"
Fact: Blue Cross Blue Shield Florida approved updated coverage guidelines for Strensiq on December 11, 2024, with clear criteria for both initiation and continuation of therapy.
Myth 2: "You need to try other treatments first"
Fact: Strensiq is the only FDA-approved disease-modifying therapy for pediatric-onset hypophosphatasia. There are no step therapy requirements because no alternative treatments exist for this indication.
Myth 3: "Adult patients can never get coverage"
Fact: While coverage is restricted to perinatal/infantile-onset or juvenile-onset HPP, adults can qualify if their disease onset occurred before age 12, as documented in medical records.
Myth 4: "Genetic testing isn't required if symptoms are obvious"
Fact: Florida Blue specifically requires ALPL genetic mutation confirmation through laboratory testing as part of their medical necessity criteria.
Myth 5: "Any doctor can prescribe Strensiq"
Fact: Coverage requires prescription by an endocrinologist or bone and mineral specialist, ensuring appropriate specialist oversight.
Myth 6: "Normal vitamin B6 levels mean you won't get approved"
Fact: While elevated PLP (vitamin B6) levels support diagnosis, successful appeals have addressed normal PLP levels by referencing peer-reviewed literature explaining why normal levels don't preclude HPP diagnosis.
Myth 7: "Denials are final"
Fact: Well-documented appeals show over 80% success rates when proper clinical evidence is presented. Florida offers both internal appeals and free external review.
Myth 8: "You can only get coverage at specialty infusion centers"
Fact: Florida Blue specifically states that administration in outpatient hospitals, ambulatory surgical suites, physician offices, or emergency facilities is not considered medically necessary, meaning home administration is preferred and covered.
Myth 9: "Prior authorization takes months"
Fact: Florida Blue processes standard requests within 72 hours and expedited requests within 24 hours when exigent circumstances exist.
Myth 10: "You need a lawyer to appeal denials"
Fact: Patients and providers can file appeals directly. Florida's external review process is free to consumers and handled by independent medical experts.
What Actually Influences Approval
Required Documentation Checklist
Florida Blue's approval criteria are specific and non-negotiable. Your submission must include:
Diagnosis Confirmation:
- Radiographic evidence of skeletal abnormalities (chest wall deformities, hypomineralized skeleton, rickets, or nonhealing fractures)
- Alkaline phosphatase (ALP) level below age-adjusted lower limit of normal
- Pyridoxal-5'-phosphate (PLP) level greater than two times the laboratory's upper limit of normal
- ALPL genetic mutation confirmed through laboratory testing
Clinical Requirements:
- Onset of clinical signs and symptoms prior to 12 years of age
- Prescription from an endocrinologist or bone and mineral specialist
- Initial dosing not exceeding 6 mg/kg/week
Continuation Criteria
For ongoing coverage, you'll need:
- Documentation of clinical response to treatment
- Continued specialist oversight
- Dosing within approved limits (9 mg/kg/week for perinatal/infantile-onset, 6 mg/kg/week for juvenile-onset)
Avoid These 5 Critical Mistakes
1. Incomplete Initial Submission
The most common error is submitting incomplete documentation. Include all lab results, imaging studies, genetic testing, and specialist consultation notes with your initial request.
2. Wrong Prescriber Type
Coverage requires prescription by an endocrinologist or bone and mineral specialist. Requests from other providers may be automatically denied.
3. Inadequate Age Documentation
For patients over 18, you must provide clear documentation that HPP symptoms began before age 12. Gather early medical records, growth charts, and pediatric consultation notes.
4. Dosing Above Guidelines
Initial requests exceeding 6 mg/kg/week require additional justification. Ensure your prescriber documents why standard dosing is insufficient.
5. Missing Genetic Confirmation
Even with clear clinical symptoms, genetic testing confirmation is required. Don't assume clinical presentation alone will suffice.
From our advocates: We've seen families wait months for genetic testing results, delaying their prior authorization submission. One effective strategy is to submit the PA request with a note that genetic testing is pending, then provide results as soon as available. This gets the review process started while ensuring all requirements are eventually met.
Quick Action Plan: 3 Steps to Take Today
Step 1: Verify Your Specialist
Confirm your prescriber is an endocrinologist or bone and mineral specialist. If not, request a referral immediately. This specialist will need to submit your prior authorization.
Step 2: Gather Required Documentation
Contact your medical team to compile:
- Recent ALP and PLP lab results
- Radiographic studies showing skeletal abnormalities
- Genetic testing results (ALPL mutation)
- Documentation of symptom onset before age 12
Step 3: Submit Complete Prior Authorization
Have your specialist submit the complete prior authorization package to Florida Blue. Use their member portal or provider forms (verify current submission method).
Florida Appeals Process
Internal Appeal (Level 1)
- Timeline: 180 days from denial notice
- Review period: 72 hours for urgent, 15 calendar days for non-urgent
- Submit to: Florida Blue member services or provider portal
External Review (Level 2)
- Timeline: 4 months after final internal denial
- Cost: Free to consumers
- Authority: Florida Department of Financial Services
- Decision: Binding on insurer
Expedited Reviews
For urgent medical situations, request expedited review when:
- Your condition may seriously jeopardize life, health, or ability to regain maximum function
- You're currently on Strensiq and facing treatment interruption
Contact Counterforce Health for assistance with complex appeals that require detailed clinical documentation and payer-specific strategies.
Resources and Support
Official Forms and Policies
- Florida Blue Strensiq Coverage Policy (December 2024)
- Florida Blue Protocol Exemption Forms
- Florida Department of Financial Services Insurance Appeals
Manufacturer Support
- Alexion Access Navigator - Prior authorization assistance
- Strensiq Patient Support - Treatment information and resources
Patient Advocacy
- The Assistance Fund for Hypophosphatasia - Financial assistance for eligible patients
- Florida Insurance Consumer Helpline: 1-877-MY-FL-CFO (1-877-693-5236)
Disclaimer: This information is for educational purposes only and does not constitute medical or legal advice. Coverage policies may change, and individual circumstances vary. Always consult with your healthcare provider and insurance company for the most current information regarding your specific situation. For assistance with insurance appeals and prior authorization, contact Counterforce Health or your state's insurance department.
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