By Counterforce Health Team in Strensiq (asfotase alfa) —

Work With Your Doctor to Get Strensiq (asfotase alfa) Covered by Cigna in Washington: Forms, Appeals, and Success Strategies

Answer Box: To get Strensiq (asfotase alfa) covered by Cigna in Washington, you need confirmed pediatric-onset hypophosphatasia diagnosis with genetic testing, low alkaline phosphatase levels, and specialist prescription. Start by gathering your medical records, lab results, and genetic testing reports. Your doctor must submit a prior authorization with detailed clinical documentation. If denied, Washington law guarantees external review by an Independent Review Organization (IRO) within 180 days. First step today: Call your specialist's office to schedule a visit focused on Strensiq coverage documentation.

Table of Contents

  1. Set Your Goal: Understanding Cigna's Approval Requirements
  2. Visit Preparation: Building Your Clinical Case
  3. Evidence Kit: Documents That Win Coverage
  4. Letter of Medical Necessity Structure
  5. Peer-to-Peer Review Support
  6. After-Visit Follow-Up
  7. Respectful Persistence and Appeals
  8. Coverage Requirements at a Glance
  9. Common Denial Reasons and Solutions
  10. Washington State Appeals Process
  11. FAQ

Set Your Goal: Understanding Cigna's Approval Requirements

Getting Strensiq (asfotase alfa) covered by Cigna requires meeting strict clinical criteria for pediatric-onset hypophosphatasia. This isn't just about having low alkaline phosphatase levels—you need comprehensive documentation proving you have perinatal, infantile, or juvenile-onset HPP with specific clinical manifestations.

Your partnership with your provider is crucial because Cigna requires the prescription to come from or be coordinated with a geneticist, endocrinologist, metabolic disorder subspecialist, or physician experienced in HPP management. Your doctor becomes your advocate in this process, but you can help by being prepared and organized.

Strensiq is the only FDA-approved enzyme replacement therapy for pediatric-onset HPP, which strengthens your case. However, with annual costs potentially reaching hundreds of thousands of dollars, Cigna scrutinizes every request carefully.

Note: Counterforce Health specializes in turning insurance denials into targeted, evidence-backed appeals. Their platform helps patients and clinicians compile the exact documentation payers need, including Cigna's specific requirements for rare disease medications like Strensiq.

Visit Preparation: Building Your Clinical Case

Before your appointment, create a comprehensive symptom and treatment timeline. This preparation makes your visit more efficient and ensures nothing important gets overlooked.

Document your symptom timeline:

  • Early tooth loss (before age 4 with intact roots)
  • Fractures from minimal trauma
  • Growth delays or failure to thrive
  • Respiratory problems or recurrent pneumonia
  • Muscle weakness or delayed motor milestones
  • Bone pain or mobility issues
  • Any seizures (especially B6-responsive)

List all treatments tried and their outcomes:

  • Physical therapy results
  • Pain management approaches
  • Respiratory support needs
  • Nutritional interventions
  • Any medications that helped or caused side effects

Prepare functional impact notes:

  • How symptoms affect daily activities
  • School or work limitations
  • Impact on family life
  • Quality of life changes over time

Bring a written summary—your doctor can include these details in their clinical notes, which become part of your coverage request.

Evidence Kit: Documents That Win Coverage

Successful Strensiq coverage requests include specific laboratory, genetic, and imaging evidence. Work with your care team to gather these essential documents:

Required Laboratory Evidence:

  • Serial alkaline phosphatase (ALP) levels showing consistently low values for age and sex
  • Elevated pyridoxal 5'-phosphate (PLP/vitamin B6) levels
  • Phosphoethanolamine (PEA) measurements if available
  • Results should specify pediatric reference ranges and testing dates

Genetic Testing Results:

  • ALPL gene mutation analysis showing pathogenic or likely pathogenic variants
  • Genetic counselor interpretation if available
  • Family testing results if relevant

Imaging Studies:

  • X-rays showing rickets, osteomalacia, or fractures
  • Growth charts demonstrating delays
  • Any craniosynostosis imaging if applicable

Clinical Documentation:

  • Specialist consultation notes
  • Hospital records for any HPP-related admissions
  • Physical therapy evaluations
  • Developmental assessments

Your specialist's office can help coordinate these tests if any are missing. Some may need to be repeated to show current status.

Letter of Medical Necessity Structure

The letter of medical necessity (LMN) is your doctor's formal argument for why Strensiq is medically necessary for your specific case. A well-structured LMN addresses Cigna's criteria point by point.

Essential LMN Components:

  1. Patient demographics and diagnosis with ICD-10 codes
  2. Detailed clinical presentation showing HPP manifestations
  3. Laboratory confirmation of diagnosis with specific values
  4. Genetic testing results confirming ALPL mutations
  5. Treatment history and why alternatives aren't sufficient
  6. Proposed dosing based on FDA labeling (typically 6 mg/kg/week subcutaneously)
  7. Expected outcomes and monitoring plan
  8. Supporting literature from peer-reviewed sources

Your doctor should emphasize that Strensiq is the only FDA-approved disease-modifying therapy for pediatric-onset HPP and reference the FDA prescribing information directly.

Clinician Corner: Include specific citations to support medical necessity, such as the FDA approval letter, Clinical Practice Guidelines from the American College of Medical Genetics, and peer-reviewed efficacy studies. Attach relevant sections of Cigna's own coverage policy to show how the patient meets each criterion.

Peer-to-Peer Review Support

If Cigna requests a peer-to-peer review, your doctor will speak directly with a Cigna medical director. You can help by providing your doctor with a concise case summary and being available for scheduling.

Prepare a one-page case summary including:

  • Age at symptom onset (emphasizing pediatric onset)
  • Key diagnostic findings (low ALP, genetic results)
  • Clinical manifestations affecting quality of life
  • Previous treatments and their limitations
  • Why delay in treatment poses risks

Offer scheduling flexibility by giving your doctor several time windows when you're available for questions. Peer-to-peer calls often happen within 24-48 hours of request.

Key talking points for your doctor:

  • FDA approval specifically for pediatric-onset HPP
  • No alternative disease-modifying therapies available
  • Progressive nature of untreated HPP
  • Patient meets all Cigna coverage criteria
  • Standard dosing per FDA labeling

After-Visit Follow-Up

After your appointment, maintain organized records and clear communication with your care team.

Save everything:

  • Copies of all forms submitted
  • Confirmation numbers from prior authorization submissions
  • Communication logs with Cigna
  • Any additional documentation requests

Use patient portal messaging to:

  • Ask about prior authorization status
  • Request copies of submitted documents
  • Clarify next steps if additional information is needed

Track important dates:

  • Prior authorization submission date
  • Expected decision timeline (typically 15 business days)
  • Appeal deadlines if denied (180 days in Washington)

Set calendar reminders to follow up if you haven't heard back within the expected timeframe.

Respectful Persistence and Appeals

If your initial request is denied, don't give up. Appeals have high success rates when properly documented, especially for FDA-approved treatments like Strensiq.

Maintain professional communication:

  • Call your doctor's office weekly for updates
  • Ask specific questions about next steps
  • Offer to help gather additional documentation

When to escalate politely:

  • If prior authorization is pending beyond normal timeframes
  • If Cigna requests information you've already provided
  • If you receive conflicting information from different representatives

Remember that your care team wants you to get coverage too. They're navigating the same complex system and appreciate patients who are organized and helpful rather than demanding.

Coverage Requirements at a Glance

Requirement What It Means Where to Find It Source
Prior Authorization Required for all Strensiq prescriptions Cigna provider portal or call Cigna PA Policy
Specialist Prescription Must be prescribed by geneticist, endocrinologist, or HPP specialist Provider credentials verification Cigna PA Policy
Pediatric-Onset HPP Limited to perinatal/infantile/juvenile-onset cases Medical records showing early symptoms Cigna PA Policy
Low ALP Levels Below age/sex-adjusted normal range Lab reports with pediatric reference ranges Cigna PA Policy
Genetic Testing ALPL mutation confirmation Genetic testing report Cigna PA Policy
Clinical Manifestations HPP symptoms documented Physician notes, imaging studies Cigna PA Policy

Common Denial Reasons and Solutions

Denial Reason How to Overturn
"Adult-onset HPP not covered" Provide documentation of pediatric symptom onset, early medical records
"Insufficient genetic confirmation" Submit complete ALPL mutation analysis with pathogenicity interpretation
"Dosing above FDA labeling" Justify dose based on weight, provide prescribing information reference
"Not medically necessary" Submit comprehensive LMN with clinical guidelines, peer-reviewed literature
"Alternative treatments available" Document that no other FDA-approved HPP therapies exist

Washington State Appeals Process

Washington offers strong consumer protections for insurance denials, including guaranteed external review rights.

Internal Appeals with Cigna:

  • File within 180 calendar days of denial
  • Submit completed Cigna appeal form
  • Include original denial letter and supporting medical records
  • Decision within 30 days for medical necessity appeals

External Review (IRO):

  • Available after internal appeals are exhausted
  • File through Washington Office of Insurance Commissioner
  • Independent medical experts review your case
  • Decision is binding on Cigna
  • No cost to you

Contact Washington OIC for help:

From our advocates: We've seen Washington patients successfully overturn Cigna denials for rare disease medications by providing comprehensive clinical documentation to the IRO. The key is including peer-reviewed literature showing the medication is standard of care, along with detailed records proving the patient meets diagnostic criteria. External reviews often favor patients when the evidence clearly supports medical necessity.

Companies like Counterforce Health can help compile the specific evidence needed for successful appeals, turning denial letters into targeted rebuttals that address each of Cigna's stated reasons for denial.

FAQ

How long does Cigna prior authorization take in Washington? Typically 15 business days for standard reviews, 72 hours for urgent requests. Washington law doesn't change Cigna's internal processing times.

What if Strensiq is non-formulary on my Cigna plan? You can request a formulary exception through the prior authorization process. Your doctor must demonstrate medical necessity and that formulary alternatives aren't appropriate.

Can I request an expedited appeal if denied? Yes, if delay could seriously jeopardize your health. Mark "urgent" on appeal forms and provide supporting documentation from your doctor.

Does step therapy apply to Strensiq? Typically no, since there are no alternative FDA-approved HPP treatments. However, Cigna may require documentation that supportive care measures were insufficient.

What's the success rate for overturning Cigna denials in Washington? Nationally, about 41% of health plan denials are overturned during the appeals process. Success rates are higher for rare disease medications with strong clinical evidence.

How much does Strensiq cost without insurance? Approximately $10,000 per vial, with annual costs potentially reaching several hundred thousand dollars depending on weight-based dosing.

Are there patient assistance programs available? Yes, Alexion offers support through their Access Navigator program. Income-based assistance may be available.

What if my employer plan is self-funded? Self-funded ERISA plans may not be subject to Washington state appeal rights. Contact the U.S. Department of Labor for ERISA plan appeals guidance.

Sources & Further Reading

Disclaimer: This information is for educational purposes only and does not constitute medical or legal advice. Insurance coverage decisions depend on individual circumstances and plan details. Always consult with your healthcare provider and insurance company for guidance specific to your situation. For additional help with insurance appeals in Washington, contact the Office of the Insurance Commissioner at 1-800-562-6900.

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