By Counterforce Health Team in Strensiq (asfotase alfa) —

How to Get Strensiq (Asfotase Alfa) Covered by UnitedHealthcare in Michigan: Complete PA Guide, Appeals Timeline & Approval Scripts

Quick Answer: Getting Strensiq Covered by UnitedHealthcare in Michigan

UnitedHealthcare requires prior authorization for Strensiq (asfotase alfa) with strict clinical criteria: documented perinatal/infantile or juvenile-onset hypophosphatasia, low alkaline phosphatase levels, ALPL mutation or elevated TNSALP substrates, and prescribing by a specialist. Start by confirming your plan's formulary status, gathering genetic testing and lab results, then submit the PA through OptumRx with complete documentation. If denied, Michigan allows internal appeals (180 days) and external review through DIFS (127 days). Success rates improve significantly with comprehensive clinical evidence and specialist support letters.

Table of Contents

  1. UnitedHealthcare Plan Types in Michigan & Network Implications
  2. Strensiq Formulary Status & Tier Placement
  3. Prior Authorization Requirements & Clinical Criteria
  4. Specialty Pharmacy Network & Dispensing Rules
  5. Step-by-Step: Fastest Path to Approval
  6. Common Denial Reasons & How to Fix Them
  7. Michigan Appeals Process & Timelines
  8. Costs & Financial Assistance Options
  9. When to Escalate & Get Help

UnitedHealthcare Plan Types in Michigan & Network Implications

Michigan residents with UnitedHealthcare have three main plan types, each affecting how you access rare disease specialists:

HMO (Health Maintenance Organization)

  • Must use in-network providers only
  • Requires PCP referrals for specialists
  • Lowest premiums but limited flexibility
  • For HPP: Need PCP referral to endocrinologist/geneticist

PPO (Preferred Provider Organization)

  • Covers out-of-network care at higher cost
  • No referral requirements
  • Best for accessing specialized HPP centers outside Michigan
  • Higher premiums but maximum flexibility

EPO (Exclusive Provider Organization)

  • In-network only like HMO
  • No PCP or referral requirements
  • Mid-range premiums
  • Direct specialist access within network
Tip: If your HPP specialist is at University of Michigan or Detroit Medical Center, verify they're in your specific UnitedHealthcare network before selecting a plan.

Strensiq Formulary Status & Tier Placement

Strensiq is typically placed on Tier 3 or specialty tiers with high coinsurance (20-50%) rather than flat copays. According to OptumRx formularies, specialty medications require:

  • Prior authorization (PA) flag
  • Specialty pharmacy (SP) dispensing
  • Weight-based dosing limits

Coverage at a Glance

Requirement What It Means Where to Find It Source
PA Required Must get approval before filling Member portal drug lookup UHC PA Policy
Specialty Tier 20-50% coinsurance Plan's drug list/formulary Plan-specific PDL
Specialty Pharmacy Must use designated pharmacy OptumRx network Commercial PDL
Dose Limits ≤6-9 mg/kg/week depending on onset PA approval letter UHC Policy 2025 P 2136-10

Prior Authorization Requirements & Clinical Criteria

UnitedHealthcare's 2025 Strensiq policy requires all of the following for initial approval:

Essential Documentation Checklist

1. Diagnosis & Onset Confirmation

  • Medical records documenting perinatal/infantile or juvenile-onset HPP
  • Evidence that disease onset was before age 18 (even for adult patients)

2. Biochemical Evidence (Choose One Pathway)

Pathway A - Lab Confirmation:

  • Two or more serum alkaline phosphatase results below age/sex reference ranges
  • Elevated TNSALP substrates: plasma pyridoxal 5'-phosphate (PLP) and/or urinary phosphoethanolamine (PEA)
  • Radiographic/clinical skeletal manifestations (rickets-like changes, fractures, growth delays)

Pathway B - Genetic Confirmation:

  • Pathogenic or likely pathogenic ALPL mutation from CLIA-certified lab
  • Clinical/radiographic findings compatible with pediatric-onset HPP

3. Prescriber Requirements

  • Must be prescribed by endocrinologist or metabolic bone disease specialist
  • Board certification documentation may be required

4. Dosing Compliance

  • Request must not exceed policy limits (typically ≤6 mg/kg/week for juvenile-onset, ≤9 mg/kg/week for perinatal/infantile-onset)

Specialty Pharmacy Network & Dispensing Rules

Strensiq requires dispensing through UnitedHealthcare's designated specialty pharmacy network. The process typically involves:

Patient Enrollment Steps:

  1. PA approval received from UnitedHealthcare
  2. Prescription routed to Optum Specialty Pharmacy or approved network partner
  3. Specialty pharmacy contacts patient for enrollment
  4. Insurance verification and copay assistance coordination
  5. Delivery scheduling and injection training (if needed)
Note: "Buy and bill" through your clinic is typically not allowed. Claims will be denied if the medication isn't dispensed through an approved specialty pharmacy.

Step-by-Step: Fastest Path to Approval

1. Verify Coverage (Patient + Clinic)

Who: Patient calls member services Timeline: Same day Action: Call number on UnitedHealthcare ID card and ask:

  • "Is Strensiq on my formulary and what tier?"
  • "Which specialty pharmacy must I use?"
  • "What's my coinsurance for specialty tier medications?"

2. Gather Required Documentation (Clinic)

Who: Medical team Timeline: 1-2 weeks Documents needed:

  • Genetic testing report showing ALPL mutation
  • Two low alkaline phosphatase lab results with reference ranges
  • PLP and/or urinary PEA levels (if available)
  • Imaging reports showing skeletal abnormalities
  • Growth charts and functional assessments
  • Evidence of pediatric onset (childhood medical records)

3. Submit Prior Authorization (Prescriber)

Who: Specialist or clinic staff Timeline: Submit within 3-5 business days of gathering docs Method: UHC Provider Portal or OptumRx portal Form: Current Strensiq PA/Medical Necessity form (Program 2025 P 2136-10)

4. Follow Up on Decision (Clinic + Patient)

Timeline: 15-30 days for standard review Action: Track via provider portal; request expedited review if clinically urgent

5. Specialty Pharmacy Enrollment (Patient)

Timeline: 1-2 weeks after approval Action: Respond promptly to specialty pharmacy outreach for enrollment

Common Denial Reasons & How to Fix Them

Denial Reason How to Fix Required Documentation
"Adult-onset HPP" Provide childhood evidence Early medical records, family history, school health records showing symptoms before age 18
"Insufficient genetic confirmation" Submit complete genetic report CLIA-certified lab report with pathogenic ALPL variants clearly identified
"Missing biochemical evidence" Obtain additional labs Two separate low ALP results with age-adjusted reference ranges; PLP or PEA levels
"Not prescribed by specialist" Transfer care or get consultation Letter from board-certified endocrinologist or metabolic bone specialist
"Exceeds dosing limits" Provide clinical justification Literature supporting higher dosing for severe cases; document response to standard dosing

Michigan Appeals Process & Timelines

Michigan provides robust appeal rights under the Patient's Right to Independent Review Act. Here's your pathway:

Internal Appeals (UnitedHealthcare)

  • Timeline: 180 days from denial date
  • Process: Submit through member portal or mail/fax per denial letter
  • Documentation: Address each denial reason specifically with additional clinical evidence

External Review (Michigan DIFS)

Expedited Appeals

  • When: Doctor certifies delay would seriously jeopardize health
  • Timeline: 72 hours for decision
  • Required: Physician letter stating medical urgency
From our advocates: We've seen Michigan external reviews succeed when families include comprehensive genetic testing, detailed growth charts showing failure to thrive, and specialist letters clearly linking symptoms to pediatric-onset HPP. The key is demonstrating that Strensiq is the only FDA-approved disease-modifying therapy for this condition.

Costs & Financial Assistance Options

Strensiq's annual cost can exceed $500,000, making financial assistance crucial:

Manufacturer Support:

  • Alexion Access Navigator provides copay assistance and case management
  • Income-based patient assistance programs for uninsured/underinsured

Foundation Grants:

  • National Organization for Rare Disorders (NORD) Patient Assistance Programs
  • HealthWell Foundation rare disease grants
  • Patient Advocate Foundation copay relief programs

UnitedHealthcare Programs:

  • Case management for high-cost medications
  • Specialty pharmacy counseling on cost-sharing options

When to Escalate & Get Help

Contact Michigan DIFS if:

  • UnitedHealthcare doesn't respond to appeals within required timeframes
  • You believe the denial violates Michigan insurance law
  • You need help understanding your appeal rights

Michigan Department of Insurance and Financial Services

Additional Resources:

  • Counterforce Health specializes in turning insurance denials into successful appeals for complex medications like Strensiq, using evidence-based strategies tailored to each payer's specific requirements.

FAQ

How long does UnitedHealthcare PA take in Michigan? Standard review takes 15-30 days. Expedited review (with physician urgency letter) can be completed in 72 hours.

What if Strensiq isn't on my formulary? Request a formulary exception with clinical documentation showing medical necessity and lack of therapeutic alternatives.

Can I appeal if I'm denied for adult-onset HPP? Yes, if you can provide evidence that symptoms began before age 18, even if diagnosis was delayed until adulthood.

Does step therapy apply to Strensiq? No standard step therapy exists since Strensiq is the only FDA-approved enzyme replacement therapy for HPP. However, plans may require documentation of supportive care attempts.

What's the success rate for appeals in Michigan? Michigan external reviews have high success rates (often 80%+) when comprehensive clinical documentation is provided, especially for rare diseases with limited treatment options.

Medical Disclaimer: This information is for educational purposes only and does not constitute medical advice. Always consult with your healthcare provider and insurance plan for personalized guidance. Coverage policies can change, so verify current requirements with UnitedHealthcare and review your specific plan documents.

Sources & Further Reading:

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