By Counterforce Health Team in Strensiq (asfotase alfa) —

How to Get Strensiq (Asfotase Alfa) Covered by Cigna in California: Complete Coverage Guide & Appeal Process

Quick Answer: Cigna Strensiq Coverage in California

Strensiq (asfotase alfa) is covered by Cigna as a Tier 4 specialty drug with prior authorization required. You must have pediatric-onset hypophosphatasia (HPP) with genetic confirmation (ALPL mutations) or low alkaline phosphatase levels. The fastest path: gather genetic testing, ALP labs, and specialist notes, then submit through Accredo Specialty Pharmacy. If denied, California's Independent Medical Review (IMR) has high overturn rates for rare disease treatments. Start today by calling Accredo at 844-516-3319 to begin enrollment.

Table of Contents

  1. Plan Types & Coverage Implications
  2. Formulary Status & Tier Placement
  3. Prior Authorization Requirements
  4. Specialty Pharmacy Setup Process
  5. Cost-Share Dynamics
  6. Submission Mechanics
  7. Common Approval Patterns
  8. California Appeals Process
  9. FAQ
  10. Sources & Further Reading

Plan Types & Coverage Implications

Cigna offers three main plan types in California through Covered California and employer groups, each with different implications for Strensiq access:

HMO vs. PPO vs. EPO Differences

Feature HMO PPO EPO
Specialist Referrals Required from PCP Not required Not required
Out-of-Network Coverage Emergencies only Yes (higher cost) Emergencies only
Monthly Premiums Lowest Highest Moderate
Specialty Drug Access Through network only In/out network options In-network only

For Strensiq, all Cigna plan types require prior authorization and use the same specialty pharmacy network (Accredo). The main difference is referral requirements—HMO members need PCP referrals to see endocrinologists or geneticists, while PPO and EPO members can schedule directly.

California Tip: Cigna operates in California through two entities: Cigna HealthCare of California (HMO plans) and Cigna Health and Life Insurance Company (PPO plans). Both follow the same Strensiq coverage policies.

Formulary Status & Tier Placement

Strensiq is classified as Tier 4 (Brand-Name Specialty) on Cigna's formulary, placing it in the highest cost-sharing category. This tier typically requires:

  • Prior authorization for all requests
  • Specialty pharmacy dispensing only
  • Higher copays or coinsurance (often 20-50% after deductible)
  • Annual quantity limits based on FDA-approved dosing

Alternative Agents

There are no FDA-approved alternatives to Strensiq for hypophosphatasia. Supportive care options like vitamin B6, physical therapy, and orthopedic interventions don't require prior authorization but aren't disease-modifying treatments.

Prior Authorization Requirements

Cigna requires comprehensive documentation to approve Strensiq. Here's what you need:

Core Eligibility Criteria

All patients must meet these requirements:

  1. Confirmed HPP diagnosis through one of:
    • Pathogenic ALPL gene mutations (genetic testing)
    • Low serum alkaline phosphatase (ALP) below age/sex norms
    • Elevated substrates (pyridoxal 5'-phosphate, inorganic pyrophosphate, phosphoethanolamine)
  2. Pediatric-onset symptoms (before age 18)
  3. Clinical manifestations such as:
    • Skeletal abnormalities or fractures
    • Premature tooth loss
    • Muscle weakness or delayed walking
    • Respiratory problems
    • Vitamin B6-dependent seizures
    • Failure to thrive
  4. Specialist involvement (endocrinologist, geneticist, or metabolic specialist)

Required Documentation Checklist

Document Timeline Where to Obtain
ALPL genetic testing report 2-3 weeks Invitae, Labcorp, Prevention Genetics
Low ALP lab results Within 6 months Physician office labs
Elevated substrate levels Within 6 months Specialty labs
Medical records proving pediatric onset Historical Medical charts, growth records
Specialist consultation notes Recent Endocrinologist/geneticist

Specialty Pharmacy Setup Process

Cigna routes all Strensiq prescriptions through Accredo Specialty Pharmacy. Here's the enrollment process:

Step-by-Step Setup

  1. Call Accredo at 844-516-3319 to start new patient enrollment
  2. Provide required information:
    • Patient demographics and insurance details
    • Prescriber information and clinic affiliation
    • Clinical data (diagnosis, weight, allergies, concurrent medications)
    • Prescription details (strength, dosing, quantity)
  3. Submit enrollment form via:
    • Fax: 888-302-1028
    • Online: MyAccredoPatients.com
    • Phone enrollment during initial call
  4. Wait for prior authorization processing (3-7 business days for complete submissions)
  5. Arrange delivery once approved:
    • Cold-chain shipping coordination
    • Injection training and ongoing support
    • 24/7 clinical support access
Note: Track your prescription status through the myCigna app or website once Accredo processes your order.

Cost-Share Dynamics

As a Tier 4 specialty drug, Strensiq carries significant out-of-pocket costs. Understanding your specific plan's structure helps with financial planning:

Typical Cost-Sharing Patterns

  • HMO plans: Often copay-based ($50-200 per fill)
  • PPO/EPO plans: Usually coinsurance-based (20-50% after deductible)
  • Deductible impact: Most plans require meeting the deductible first
  • Out-of-pocket maximum: Annual caps apply (typically $8,000-15,000)

Financial Assistance Options

Several programs can help reduce costs:

  • Alexion OneSource: Patient support program with copay assistance
  • State pharmaceutical assistance programs
  • Foundation grants for rare disease treatments
  • Hospital charity care programs

Contact Alexion OneSource at 844-787-6747 to explore assistance options.

Submission Mechanics

Successful prior authorization requires attention to submission details:

Key Forms and Portals

  • Primary submission: Cigna provider portal or Express Scripts
  • Supporting documents: Fax to prior authorization department
  • Patient enrollment: Through Accredo (as detailed above)
  • Appeals: Cigna National Appeals Unit (if needed)

Critical Fields for Approval

When your provider submits the PA request, ensure these elements are complete:

  • ICD-10 codes: E83.30 (disorder of phosphorus metabolism)
  • Diagnosis details: Specific HPP subtype and onset timing
  • Clinical justification: Symptom severity and functional impact
  • Laboratory values: Actual ALP levels with reference ranges
  • Genetic results: Specific ALPL mutations identified
  • Dosing rationale: Weight-based calculation (6-9 mg/kg/week)

Common Approval Patterns

Based on successful submissions, strong applications typically include:

Elements of Winning Submissions

  1. Clear diagnostic narrative connecting genetic/biochemical findings to clinical symptoms
  2. Pediatric onset documentation with specific age at first symptoms
  3. Specialist endorsement from recognized HPP expert or major medical center
  4. Objective measures like growth charts, bone density, or pulmonary function
  5. Treatment goals with measurable outcomes (ALP normalization, symptom improvement)

Red Flags That Trigger Denials

  • Adult-onset HPP without pediatric history
  • Missing genetic confirmation
  • Incomplete laboratory workup
  • Dosing requests above FDA label without justification
  • Lack of specialist involvement

California Appeals Process

California offers robust appeal rights through two regulatory agencies:

Internal Appeals with Cigna

Timeline: 180 days from denial notice to file Level 1 appeal

Process:

  1. Submit written appeal to Cigna National Appeals Unit
  2. Include all supporting documentation
  3. Request expedited review if medically urgent (72-hour decision)
  4. Await decision (30 days standard, 60 days post-service)

Level 2: Available within 60 days of Level 1 denial

California Independent Medical Review (IMR)

If Cigna upholds the denial, California's IMR process offers strong patient protections:

Eligibility: Available after internal appeal completion for medical necessity denials

Process:

  • HMO plans: File with Department of Managed Health Care (DMHC)
  • PPO plans: File with California Department of Insurance (CDI)
  • Timeline: 45 days for standard review, 7 days for expedited
  • Cost: Free to patients
  • Decision: Binding on insurance company

Success rates: California IMRs have favorable overturn rates for rare disease treatments, particularly when supported by specialist documentation and published guidelines.

Getting Help

  • DMHC Help Center: 888-466-2219
  • CDI Consumer Hotline: 800-927-4357
  • Health Consumer Alliance: Free assistance with complex appeals
  • Online IMR application: healthhelp.ca.gov
From our advocates: "We've seen California IMRs consistently favor patients with rare diseases when the clinical evidence is clear. One case involved a pediatric HPP patient where Cigna initially denied Strensiq despite genetic confirmation. The IMR reviewer, a pediatric endocrinologist, overturned the denial within 30 days, citing the FDA approval and lack of alternatives. The key was submitting the complete genetic report and growth charts showing failure to thrive."

Counterforce Health specializes in turning insurance denials into successful appeals by creating evidence-backed, policy-aligned rebuttals. The platform analyzes denial letters, identifies specific coverage criteria, and drafts targeted appeals with the right clinical evidence and procedural requirements. For complex cases like Strensiq denials, having expert support can significantly improve approval odds and reduce the time to access life-changing treatments.

FAQ

Q: How long does Cigna prior authorization take for Strensiq in California? A: Standard processing takes 3-7 business days for complete submissions. Expedited review (for urgent cases) requires a decision within 72 hours.

Q: What if Strensiq is non-formulary on my specific Cigna plan? A: Request a formulary exception emphasizing medical necessity and the absence of therapeutic alternatives. Include FDA approval documentation and specialist support.

Q: Can I request an expedited appeal if Cigna denies coverage? A: Yes, if the delay could jeopardize your health. California requires expedited appeals to be decided within 72 hours for urgent situations.

Q: Does step therapy apply to Strensiq? A: Typically no, since Strensiq is the only FDA-approved disease-modifying therapy for HPP. However, document any prior supportive treatments attempted.

Q: What genetic testing labs does Cigna accept for ALPL mutations? A: Major labs like Invitae, Labcorp, and Prevention Genetics are generally accepted. Ensure the report specifically identifies pathogenic ALPL variants.

Q: How much will Strensiq cost with Cigna coverage in California? A: As a Tier 4 specialty drug, expect significant cost-sharing. Exact amounts depend on your specific plan's copay or coinsurance structure and whether you've met your deductible.

Q: Can I use a local pharmacy instead of Accredo? A: No, Cigna requires specialty drugs like Strensiq to be dispensed through their designated specialty pharmacy network, primarily Accredo.

Q: What happens if I miss the 180-day appeal deadline? A: You may lose the right to internal appeal, but could potentially file a new prior authorization request with additional documentation or seek assistance from California consumer advocacy groups.

Sources & Further Reading

Disclaimer: This information is for educational purposes only and does not constitute medical or legal advice. Coverage policies and appeal processes may vary by specific plan and can change over time. Always consult your insurance documents, healthcare providers, and the official sources linked above for the most current information. For personalized assistance with complex coverage issues, consider consulting with Counterforce Health or other qualified healthcare advocacy services.

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