By Counterforce Health Team in Strensiq (asfotase alfa) —

How to Get Strensiq (Asfotase Alfa) Covered by UnitedHealthcare in New York: 2025 Renewal Timeline and Appeal Guide

Quick Answer: Getting Strensiq Covered by UnitedHealthcare in New York

Strensiq requires prior authorization from UnitedHealthcare through OptumRx. Start renewal 30-60 days before expiration to avoid gaps. Submit complete documentation including genetic confirmation, treatment response data, and specialist attestation. If denied, file internal appeal within 180 days, then external review through New York Department of Financial Services within 4 months. First step today: Contact your specialist to begin gathering renewal documentation and verify your current authorization expiration date.

Table of Contents

  1. Renewal Triggers: When to Start Planning
  2. Evidence Update Requirements
  3. Complete Renewal Packet Checklist
  4. Timeline and Submission Process
  5. What to Do if Coverage Lapses
  6. Annual Changes to Monitor
  7. Appeals Process for New York
  8. Patient Assistance and Cost Support
  9. Frequently Asked Questions

Renewal Triggers: When to Start Planning

Standard Authorization Periods: UnitedHealthcare typically approves Strensiq for 6-month initial periods, followed by 12-month renewals. However, some plans may require more frequent reviews given the medication's high cost (potentially $890,000-$4.9 million annually).

Start Early Warning Signs:

  • Authorization expires within 60 days
  • Recent formulary changes from UnitedHealthcare
  • Plan year transitions (January 1st)
  • Changes in clinical status or dosing requirements
Tip: Set calendar reminders 90 days before expiration. OptumRx standard renewals take approximately 15 business days, and you'll want buffer time for any missing documentation.

Evidence Update Requirements

Treatment Response Documentation

Objective Clinical Measures (required for renewal):

  • Radiographic Global Impression of Change (RGI-C) scores
  • Growth velocity and height/weight Z-scores (pediatric patients)
  • Respiratory function assessments
  • Mobility improvements (6-minute walk test when appropriate)
  • Fracture frequency reduction

Important Monitoring Note: Serum alkaline phosphatase levels become unreliable during Strensiq treatment due to the drug's enzyme replacement mechanism. Labs should be informed the patient receives Strensiq, and alternative assays may be needed.

Safety Monitoring Updates

  • Injection site reaction documentation
  • Ophthalmology exams (monitoring for ectopic calcifications)
  • Renal ultrasounds
  • Serum PTH and calcium levels

Complete Renewal Packet Checklist

Required Clinical Documentation

Specialist Attestation Letter must include:

  • Board certification in endocrinology, genetics, or metabolic medicine
  • Confirmation of perinatal/infantile or juvenile-onset HPP diagnosis
  • ALPL gene mutation documentation
  • Objective evidence of continued clinical benefit
  • Dosing rationale (standard 6 mg/kg/week or escalated to 9 mg/kg/week)

Genetic and Diagnostic Confirmation:

  • ALPL gene sequencing results
  • Original very low serum alkaline phosphatase levels (pre-treatment)
  • Baseline radiographic findings
  • ICD-10 diagnosis codes for hypophosphatasia

Response Documentation:

  • Comparative imaging studies
  • Growth charts (pediatric patients)
  • Functional assessments
  • Adverse event reporting

Administrative Requirements

  • Current UnitedHealthcare member ID
  • Prescriber NPI and contact information
  • NDC/J-code information for billing
  • Site of care documentation (home vs. clinic administration)

Timeline and Submission Process

Optimal Submission Schedule

Timeline Action Responsible Party
60 days before expiration Schedule specialist appointment Patient/caregiver
45 days before Gather updated labs and imaging Clinic
30 days before Submit complete renewal packet Prescriber
15 days before Follow up on pending status Patient/clinic
7 days before Request emergency supply if needed Patient

Submission Methods

  • UnitedHealthcare Provider Portal: Electronic submission (preferred)
  • OptumRx Phone: 1-800-711-4555
  • Fax: Verify current fax number through provider portal
Note: OptumRx eliminated reauthorization requirements for 140+ chronic condition medications in July 2025, with additional changes planned for January 2026. Verify Strensiq's current status.

What to Do if Coverage Lapses

Immediate Response Steps

No FDA-approved bridge therapies exist for hypophosphatasia. If coverage lapses:

  1. Request Emergency Supply: Contact specialty pharmacy for 7-14 day emergency supply
  2. Expedited Review: Ask prescriber to request peer-to-peer review with UnitedHealthcare medical director
  3. Member Services: Call UnitedHealthcare at member services number on insurance card

Symptom Management During Gaps

  • Continue physical therapy and mobility exercises
  • Manage pain with NSAIDs as recommended
  • Monitor for symptom changes with regular follow-ups
  • Important: These are supportive measures only and do not replace disease-modifying therapy

Manufacturer Support

Alexion Access Navigator may provide temporary coverage assistance during gaps. Contact them immediately if coverage is interrupted.

Annual Changes to Monitor

2025 UnitedHealthcare Updates

  • Tier 4 Supply Limits: Part D prescriptions limited to 30-day supply (previously 90-day)
  • GLP-1 Requirements: Enhanced documentation requirements for diabetes medications
  • Formulary Modifications: Regular updates to covered drug lists

Plan Design Verification

Check annually:

  • Formulary tier placement
  • Prior authorization requirements
  • Quantity limits
  • Site of care restrictions
  • Copay/coinsurance amounts

Appeals Process for New York

Internal Appeals with UnitedHealthcare

Standard Timeline: 180 days from denial to file internal appeal Expedited Review: 72 hours for urgent cases Required Documents:

  • Original denial letter
  • Updated medical necessity documentation
  • Peer-reviewed literature supporting treatment

External Review Through New York DFS

New York offers robust external appeal rights through the Department of Financial Services:

Timeline: 4 months after final internal denial Cost: Maximum $25 (waived for Medicaid or financial hardship) Decision Timeline:

  • Standard: 60 days
  • Expedited: 72 hours (24 hours for urgent drug denials)

Success Rates: New York's external appeal system has a 46% combined overturn rate, and decisions are binding on the insurer.

Getting Help with Appeals

  • Community Health Advocates: Free counseling at 888-614-5400
  • Healthcare Appeals Ombudsman: 1-800-NYS-APPEAL
  • Online Portal: Submit appeals through DFS website

Counterforce Health specializes in turning insurance denials into targeted, evidence-backed appeals. Their platform analyzes denial letters and plan policies to draft point-by-point rebuttals aligned with payer requirements, incorporating the right clinical evidence and procedural documentation to maximize approval chances. Learn more about their appeal services.

Patient Assistance and Cost Support

Manufacturer Programs

  • Alexion Access Navigator: Coverage support and patient assistance
  • Prior Authorization Support: Dedicated team to help with approvals
  • Patient Services: Educational resources and injection training

Foundation Grants

Limited rare disease assistance programs exist, though funding is restricted given Strensiq's high cost. Contact:

  • National Organization for Rare Disorders (NORD)
  • Patient Advocate Foundation
  • HealthWell Foundation

State-Specific Resources

New York Medicaid covers Strensiq for eligible patients. The state's Essential Plan provides coverage for residents with income up to 200% of federal poverty level.

Frequently Asked Questions

How long does UnitedHealthcare prior authorization take for Strensiq? Standard reviews take 15 business days, with expedited reviews available within 72 hours for urgent cases.

What if Strensiq is non-formulary on my plan? Request a formulary exception with medical necessity documentation. If denied, appeal through internal process then external review via New York DFS.

Can I get expedited appeals in New York? Yes, New York allows expedited external appeals with 72-hour decisions (24 hours for urgent drug denials) when health is at serious risk.

Do I need to restart step therapy if I move to New York? Generally no, if you have documented treatment history. Provide records of prior therapy trials and failures/contraindications.

What specialists can prescribe Strensiq? Board-certified endocrinologists, geneticists, metabolic specialists, or other appropriate specialists as determined by UnitedHealthcare policy.

How often do I need reauthorization? Typically every 6-12 months, though this may vary by plan. Monitor your authorization expiration date closely.

What happens if my doctor retires or I change providers? New prescriber must submit fresh prior authorization with complete medical history and documentation of ongoing medical necessity.

Can I appeal if my pharmacy can't get the medication? Yes, if it's a coverage issue. If it's a supply chain problem, contact Alexion Access Navigator for alternative dispensing options.

Personal Progress Tracker

Authorization Details:

  • Current approval period: ___________
  • Expiration date: ___________
  • Prescribing specialist: ___________
  • Specialty pharmacy: ___________

Key Dates to Remember:

  • Start renewal process: ___________
  • Submit documentation: ___________
  • Follow-up call: ___________
  • Emergency supply request (if needed): ___________

Documentation Checklist:

  • Updated specialist letter
  • Recent imaging/growth data
  • Safety monitoring results
  • Insurance card copy
  • Prior authorization form

This guide provides educational information and is not medical advice. Coverage decisions depend on individual circumstances and plan details. For personalized assistance with complex appeals, consider consulting with Counterforce Health, which specializes in evidence-based insurance appeal strategies.

Need immediate help? Contact Community Health Advocates at 888-614-5400 for free insurance counseling, or visit the New York Department of Financial Services for external appeal information.

Sources & Further Reading

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