By Counterforce Health Team in Strensiq (asfotase alfa) —

How to Get Strensiq (Asfotase Alfa) Covered by Blue Cross Blue Shield North Carolina: Complete Forms, Appeals, and State Resources Guide

Answer Box: Getting Strensiq Covered in North Carolina

Blue Cross Blue Shield North Carolina requires prior authorization for Strensiq (asfotase alfa) through their MHK Provider Portal via Blue e. Submit clinical documentation confirming pediatric-onset hypophosphatasia with genetic/biochemical evidence. If denied, file internal appeals within 180 days, then request Smart NC external review within 120 days. Urgent cases receive decisions within 24 hours. First step: Verify your specific Blue Cross NC plan type and access the correct PA form through the Blue Cross NC Prior Authorization page.

Table of Contents

  1. Verify Your Plan & Find the Right Forms
  2. Prior Authorization Forms & Requirements
  3. Submission Portals & Electronic Filing
  4. Fax & Mail Submission Options
  5. Specialty Pharmacy Network Requirements
  6. Support Lines & Contact Information
  7. Smart NC External Review Process
  8. Appeals Playbook for Blue Cross NC
  9. Medical Necessity Documentation
  10. Common Denial Reasons & Solutions
  11. Costs & Patient Assistance Programs
  12. FAQ

Verify Your Plan & Find the Right Forms

Blue Cross Blue Shield of North Carolina operates multiple plan types with different prior authorization processes. Your first step is identifying which specific product you have:

Plan Types & Their PA Processes:

  • Individual/Small Group QHP (Marketplace): Uses Prime Therapeutics formulary and PA system
  • North Carolina State Health Plan: Managed through CVS Caremark with separate PA requirements
  • Commercial/Employer Plans: Standard Blue Cross NC PA process via MHK Portal
  • Medicare Advantage: Separate Medicare PA requirements and forms

Check your insurance card for plan details, then visit the Blue Cross NC Prior Authorization page to confirm whether Strensiq requires PA under your specific benefit structure.

Note: Strensiq may be covered under the medical benefit (buy-and-bill) or pharmacy benefit (specialty pharmacy) depending on your plan. This affects which forms and submission processes apply.

Prior Authorization Forms & Requirements

Core Documentation Needed

Clinical Requirements for Strensiq PA:

  • Confirmed diagnosis of perinatal, infantile, or juvenile-onset hypophosphatasia
  • Age at disease onset documentation
  • Serum alkaline phosphatase levels below age-adjusted normal range
  • Clinical manifestations (growth failure, fractures, respiratory compromise)
  • Genetic testing results (ALPL mutations) when available
  • Weight-based dosing plan (6 mg/kg/week standard, up to 9 mg/kg/week for infantile HPP)

Required Forms by Plan Type:

Submission Portals & Electronic Filing

Primary Electronic Submission: Blue e Portal

For Commercial and Most Blue Cross NC Plans:

  1. Log into Blue e (Blue Cross NC's provider portal)
  2. Access the MHK Provider Portal for utilization management
  3. Select "New Prior Authorization Request"
  4. Search for "Strensiq" or "asfotase alfa"
  5. Complete drug-specific clinical questions
  6. Upload supporting documentation
  7. Select standard (72 hours) or urgent (24 hours) review

Portal Access: Available through Blue Cross NC provider login

Alternative Electronic Options

  • CoverMyMeds: Accepted for most Blue Cross NC PA requests
  • SureScripts: Electronic PA submission for participating providers
  • Availity: Check eligibility and submit certain PA types
Tip: Electronic submissions typically process faster than fax/mail and provide real-time status updates.

Fax & Mail Submission Options

When Electronic Submission Isn't Available:

Fax Numbers by Plan Type:

  • Commercial Plans: Contact provider services for current fax (verify with source linked below)
  • State Health Plan: Submit via CVS Caremark fax system
  • Medicare Plans: Use Medicare-specific PA fax numbers

Mailing Address: Blue Cross and Blue Shield of North Carolina Utilization Management Department (Confirm current address via provider services at 800-672-7897)

Cover Sheet Requirements:

  • Member name and ID number
  • Provider name and NPI
  • Drug name (Strensiq/asfotase alfa)
  • Urgency level (standard or expedited)
  • Complete page count

Specialty Pharmacy Network Requirements

Strensiq requires dispensing through Blue Cross NC's approved specialty pharmacy network. After PA approval:

Network Pharmacy Options

Enrollment Process

  1. PA approval notification triggers pharmacy assignment
  2. Assigned specialty pharmacy contacts prescriber for prescription
  3. Pharmacy coordinates with patient for delivery and injection training
  4. Initial doses may require supervised administration due to anaphylaxis risk

Support Lines & Contact Information

Provider Support:

  • Utilization Management: 800-672-7897 (Monday-Friday, 8 AM-5 PM ET)
  • Pharmacy Services: Number on provider ID card
  • Electronic Services Help: Blue e portal support line

Member Support:

  • Customer Service: Number on member ID card
  • PA Status Inquiries: Available through member portal or phone
  • Urgent Issues: Request expedited review through any contact method

What to Ask When Calling:

  • Confirm PA requirement for your specific plan
  • Request current PA form or electronic submission instructions
  • Verify specialty pharmacy network requirements
  • Check status of pending PA requests

Smart NC External Review Process

North Carolina offers robust external review rights through Smart NC, administered by the NC Department of Insurance.

Eligibility Requirements

  • State-regulated plan (not self-funded ERISA plans)
  • Completed all internal appeals with Blue Cross NC
  • Denial based on medical necessity or experimental treatment determination
  • Request filed within 120 days of final internal denial

Filing Process

  1. Gather Documents: Final denial letters, medical records, prescriber letters
  2. Complete Form: Smart NC Request for Assistance
  3. Submit: Online portal, mail, or fax to NC Department of Insurance
  4. Timeline: 45 days for standard review, 72 hours for expedited

Smart NC Contact:

  • Phone: 855-408-1212
  • Website: NC Department of Insurance external review page
  • Services: Free advocacy and assistance with appeal preparation
Key Advantage: Smart NC's external review decisions are binding on Blue Cross NC. If approved, coverage must be provided within 3 business days.

Appeals Playbook for Blue Cross NC

Internal Appeals Process

Level 1 Appeal:

  • Deadline: 180 days from denial date
  • Timeline: 30 days for standard, 72 hours for expedited
  • Submission: Same portals as original PA, plus appeal-specific forms

Level 2 Appeal (if applicable):

  • Deadline: 60 days from Level 1 denial
  • Timeline: 30 days for standard, 72 hours for expedited
  • Requirements: New clinical evidence or peer-to-peer review

External Review (Smart NC)

Standard External Review:

  • Deadline: 120 days after final internal denial
  • Timeline: 45 days for IRO decision
  • Cost: Free to members

Expedited External Review:

  • Criteria: Delay would seriously jeopardize health or function
  • Timeline: 72 hours for decision
  • Special: Can bypass incomplete internal appeals for urgent cases

Medical Necessity Documentation

Clinician Corner: Medical Necessity Letter Checklist

Essential Elements for Strensiq Approval:

✓ Diagnosis Confirmation

  • Clinical presentation consistent with HPP
  • Age at disease onset (perinatal/infantile/juvenile)
  • Radiographic findings (rickets-like changes, fractures)

✓ Laboratory Evidence

  • Serum alkaline phosphatase below normal for age/sex
  • Elevated substrates (PLP, phosphoethanolamine) if available
  • Genetic testing results (ALPL mutations)

✓ Clinical Severity

  • Growth parameters and percentiles
  • Respiratory status and support requirements
  • Functional limitations and quality of life impact

✓ Treatment Rationale

  • FDA labeling alignment for pediatric-onset HPP
  • No equivalent disease-modifying alternatives available
  • Weight-based dosing plan and monitoring strategy

✓ Supporting Guidelines

  • Reference FDA-approved indication
  • Cite relevant medical literature when appropriate
  • Include specialist consultation notes

Common Denial Reasons & Solutions

Denial Reason Documentation to Provide How to Address
"Not medically necessary" Detailed clinical presentation, growth charts, functional assessments Emphasize FDA labeling and lack of alternatives
"Experimental/investigational" FDA approval documentation, clinical guidelines Submit FDA label and approval letter
"Insufficient documentation" Complete medical records, lab results, genetic testing Provide comprehensive clinical summary
"Age criteria not met" Documentation of pediatric-onset disease Clarify onset timing vs. current age
"Dosing exceeds guidelines" Clinical justification for higher doses Reference FDA labeling for infantile HPP escalation

Costs & Patient Assistance Programs

Manufacturer Support:

  • Alexion Access Navigator: Comprehensive support program
  • Copay Assistance: Available for eligible commercial plans
  • Patient Services: 855-756-8657

Foundation Resources:

  • National Organization for Rare Disorders (NORD): Medication assistance programs
  • HealthWell Foundation: Copay assistance for rare diseases
  • Patient Access Network Foundation: Specialty drug support

State Programs:

  • North Carolina Medicaid expansion (effective 2024) may provide additional coverage options
  • State pharmaceutical assistance programs for eligible residents

FAQ

How long does Blue Cross NC prior authorization take? Standard PA decisions are made within 72 hours once all required information is received. Urgent requests are processed within 24 hours.

What if Strensiq is non-formulary on my plan? Use the non-formulary exception process to request coverage. Document that no formulary alternatives provide disease-modifying therapy for HPP.

Can I request an expedited appeal if my child needs Strensiq urgently? Yes, if delay would seriously jeopardize health or function. Provide physician attestation of urgency with your appeal submission.

Does step therapy apply to Strensiq? Step therapy requirements vary by plan, but Strensiq is the only FDA-approved disease-modifying therapy for HPP, which strengthens arguments against step therapy requirements.

What happens if Smart NC external review approves my appeal? Blue Cross NC must provide coverage within 3 business days of the external review decision. The IRO decision is binding on the insurer.

Can I use an out-of-state specialist's documentation? Yes, clinical documentation from qualified specialists in any state is generally acceptable, provided it meets Blue Cross NC's medical necessity criteria.

About Counterforce Health

Counterforce Health helps patients, clinicians, and specialty pharmacies navigate insurance denials for prescription drugs like Strensiq. Our platform analyzes denial letters and plan policies to create targeted, evidence-backed appeals that align with each payer's specific requirements. For complex cases involving rare disease medications, having expert support can significantly improve approval outcomes and reduce the administrative burden on healthcare providers.

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 plan benefits and medical circumstances. Always consult with your healthcare provider and insurance plan for specific coverage determinations. For additional assistance with insurance appeals in North Carolina, contact Smart NC at 855-408-1212.

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