By Counterforce Health Team in Strensiq (asfotase alfa) —

Renewing Strensiq (Asfotase Alfa) Approval with Cigna in Michigan: Timeline, Documentation, and What to Prepare

Answer Box: Renewing Your Strensiq Coverage with Cigna

Cigna requires annual prior authorization renewal for Strensiq (asfotase alfa) with detailed documentation of continued medical necessity. Start the renewal process 6-8 weeks before your current PA expires to avoid treatment gaps. You'll need updated clinical notes, recent lab results (ALP levels within 6 months), genetic testing confirmation, and evidence of ongoing clinical benefit. Submit through your prescriber using Cigna's PA form or Express Scripts portal. Review takes 3-7 business days with complete documentation. If denied, you have 180 days for internal appeals and 127 days for Michigan DIFS external review.

First step today: Check your PA expiration date on your Cigna member portal or call member services at the number on your insurance card.

Table of Contents

When to Start Your Renewal

Begin your Strensiq renewal process 6-8 weeks before your current prior authorization expires. Cigna's PA approvals for Strensiq are typically valid for one year, and the clock starts ticking from your initial approval date—not when you first received the medication.

Key Renewal Triggers

  • 45-60 days before expiration: Schedule follow-up appointments with your prescribing specialist
  • 30-45 days before: Gather updated lab results and clinical documentation
  • 15-30 days before: Submit complete renewal packet
  • If no response within 7 days: Follow up with Cigna or Express Scripts
Tip: Set calendar reminders at 60, 45, and 30 days before your PA expires. Many patients don't realize their approval has lapsed until their pharmacy calls with a rejection.

Evidence Update Requirements

Your renewal must demonstrate continued medical necessity and ongoing clinical benefit from Strensiq therapy. This requires fresh evidence, not just copies of your original approval documents.

Clinical Response Documentation

Your prescriber must document:

  • Stabilization or improvement in skeletal symptoms
  • Reduced fracture frequency (if applicable)
  • Improved mobility or respiratory function
  • Growth improvements in pediatric patients
  • Quality of life measures using standardized tools

Laboratory Updates

Required within 6 months of renewal:

  • Serum alkaline phosphatase (ALP) levels with age/sex-appropriate reference ranges
  • Note: ALP may remain low on Strensiq therapy—this doesn't indicate treatment failure
Important: Don't use ALP levels to judge treatment response while on Strensiq. The medication affects measured ALP, making it unreliable for monitoring endogenous enzyme activity.

Safety and Adherence Review

Document any:

  • Adverse reactions or injection site issues
  • Missed doses or adherence challenges
  • Dose adjustments and clinical rationale
  • Monitoring for ectopic calcifications

Renewal Documentation Checklist

Document Type What's Required Where to Get It Timeline
Updated Clinical Notes Recent specialist visit (within 3 months) documenting current status Prescribing endocrinologist/geneticist Schedule 6-8 weeks before
Laboratory Results ALP levels within 6 months Lab or clinic Order 4-6 weeks before
Genetic Confirmation ALPL gene variant documentation (if not previously submitted) Genetic counselor/lab May use previous results
Dosing Justification Current weight-based dosing calculation Prescriber Include in clinical notes
Response Assessment Functional improvements or disease stabilization Prescriber Document in renewal letter

Medical Necessity Letter Update Structure

Your prescriber should include:

  1. Current diagnosis confirmation with ICD-10 codes
  2. Treatment history since last approval
  3. Clinical response with specific examples
  4. Ongoing medical necessity rationale
  5. Consequences of discontinuation

Submission Timeline and Process

Step-by-Step Renewal Process

1. Prescriber Submits PA Request (Days 1-3)

  • Use Cigna's PA form or Express Scripts portal
  • Include all supporting documentation
  • Request expedited review if medically urgent

2. Cigna Initial Review (Days 3-7)

  • Standard review timeline with complete documentation
  • May request additional information if incomplete

3. Decision Communication (Day 7-10)

  • Approval: New PA number and validity dates
  • Denial: Written explanation with appeal rights

4. If Additional Information Needed

  • Cigna may request peer-to-peer review
  • Provide requested documents within specified timeframe
Note: Incomplete submissions significantly delay approval. Double-check all required elements before submission.

If Your Coverage Lapses

There are no FDA-approved "bridge" therapies that can substitute for Strensiq during coverage gaps. If your PA expires before renewal approval:

Immediate Steps

  1. Contact your specialty pharmacy to request emergency supply (typically 7-14 days)
  2. Call Cigna member services to request expedited review
  3. Ask your prescriber to call for peer-to-peer review
  4. Document the gap for potential appeal

Supportive Care During Gaps

While waiting for coverage restoration:

  • Continue physical therapy and mobility exercises
  • Manage pain with NSAIDs as recommended by your provider
  • Monitor for any symptom changes
  • Maintain regular follow-up appointments

Patient Assistance Options

  • Manufacturer support: Alexion Access Navigator may provide temporary coverage
  • Foundation grants: Limited rare disease assistance programs
  • Hospital charity care: For emergency situations

Annual Plan Changes to Monitor

Cigna makes formulary changes annually that can affect Strensiq coverage. Key changes to watch for:

Formulary Updates (Effective January 1st)

  • Tier placement changes: Higher copays or coinsurance
  • New restrictions: Step therapy or quantity limits
  • Coverage criteria updates: Modified PA requirements

Mid-Year Changes

Cigna can make formulary changes mid-year with 60 days' notice for:

  • Generic or biosimilar substitutions
  • Safety-related removals
  • New FDA approvals affecting coverage

What to Review Annually

  • Your plan's drug formulary for Strensiq tier status
  • PA requirements and clinical criteria
  • Network specialty pharmacies
  • Appeals procedures and timelines
Action Item: During open enrollment (October 15-December 7), compare your current Cigna plan with alternatives if you rely on Strensiq.

Appeals Process in Michigan

If Cigna denies your Strensiq renewal, Michigan provides robust appeal protections through multiple levels of review.

Internal Appeals with Cigna

  • First-level appeal: 180 days from denial date
  • Second-level appeal: Available if first appeal denied
  • Expedited appeals: 72 hours for urgent medical situations

Michigan External Review

After exhausting Cigna's internal appeals:

  • File with Michigan DIFS: Within 127 days of final internal denial
  • Standard review: Decision within 60 days
  • Expedited review: 72 hours with physician letter stating urgency
  • Contact: Call DIFS at 877-999-6442 or file online at michigan.gov/difs

Required Appeal Documentation

  • Cigna's final denial letter
  • Medical records supporting necessity
  • Physician letter explaining urgency (for expedited appeals)
  • Any additional evidence not previously submitted

Personal Renewal Tracker

Use this template to stay organized:

Current PA Information:

  • PA Number: _______________
  • Approval Date: _______________
  • Expiration Date: _______________
  • Current Dose: _______________

Renewal Timeline:

  • 60 days before: Schedule specialist appointment
  • 45 days before: Order lab work
  • 30 days before: Collect all documentation
  • 15 days before: Submit renewal packet
  • 7 days after submission: Follow up if no response

Key Contacts:

  • Prescribing specialist: _______________
  • Specialty pharmacy: _______________
  • Cigna member services: _______________
  • Michigan DIFS: 877-999-6442

FAQ

How long does Cigna take to review Strensiq renewals? Standard review is 3-7 business days with complete documentation. Incomplete submissions can take 2-3 weeks as Cigna requests additional information.

What if my doctor is new and doesn't have my complete history? Request medical records from your previous provider and ensure genetic testing results are included. The new prescriber can reference previous documentation while providing current clinical assessment.

Can I request expedited renewal review? Yes, if delaying treatment would seriously jeopardize your health. Your physician must provide a letter supporting the urgent medical need.

What happens if Cigna changes Strensiq's formulary status? You can request a formulary exception to maintain current coverage terms. File the request before your current PA expires to avoid gaps.

Does step therapy apply to Strensiq renewals? Generally no, since Strensiq is the only FDA-approved treatment for pediatric-onset HPP. However, verify your specific plan's requirements.

How do I know if my renewal was approved? Check your Cigna member portal, call member services, or contact your specialty pharmacy. Approval letters include new PA numbers and validity dates.

Sources & Further Reading

Counterforce Health helps patients and clinicians navigate complex prior authorization and appeal processes for specialty medications like Strensiq. Our platform analyzes denial letters, identifies specific coverage criteria, and generates evidence-based appeals tailored to each payer's requirements. By streamlining the documentation process and providing payer-specific guidance, we help reduce approval delays and treatment interruptions for patients with rare diseases. Visit www.counterforcehealth.org to learn more about our coverage advocacy services.

This guide provides educational information about insurance processes and is not medical advice. Always consult your healthcare provider about treatment decisions. For official appeals procedures, contact Cigna member services or Michigan DIFS directly.

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