By Counterforce Health Team in Strensiq (asfotase alfa) —

Myths vs. Facts: Getting Strensiq (asfotase alfa) Covered by Humana in New Jersey

Answer Box: Getting Strensiq Covered by Humana in New Jersey

Strensiq (asfotase alfa) requires prior authorization from Humana and is typically non-formulary, but coverage is possible for pediatric/juvenile-onset hypophosphatasia with proper documentation. Your prescriber must submit both a prior authorization AND formulary exception request with genetic testing results, low alkaline phosphatase levels, and clinical evidence of progressive bone disease. If denied, New Jersey's Independent Health Care Appeals Program (IHCAP) through Maximus Federal Services provides binding external review within 45 days. First step today: Contact your prescriber to gather ALPL mutation results and request they call Humana Clinical Pharmacy Review at 800-555-2546.

Table of Contents

Why Myths About Strensiq Coverage Persist

Strensiq (asfotase alfa) coverage generates confusion because it's the only FDA-approved treatment for hypophosphatasia (HPP), yet most insurance plans—including Humana—don't automatically cover it. The medication's seven-figure annual cost and complex diagnostic requirements create a perfect storm of misinformation.

Many families receive conflicting advice from well-meaning healthcare providers, online forums, and even insurance representatives who aren't familiar with rare disease protocols. The stakes are high: without coverage, annual costs can reach $4.9 million for pediatric patients requiring higher doses.

Counterforce Health helps patients navigate these complex approval processes by turning insurance denials into targeted, evidence-backed appeals. The platform identifies specific denial reasons and drafts point-by-point rebuttals aligned to each plan's own rules, making the appeals process more manageable for families facing rare disease coverage challenges.

Myth vs. Fact: Common Misconceptions

Myth 1: "If my doctor prescribes Strensiq, Humana has to cover it"

Fact: Humana requires both prior authorization AND a formulary exception for Strensiq, which is typically non-formulary. Your prescriber must prove medical necessity and explain why no formulary alternatives are appropriate. Source: Humana Coverage Determination Process

Myth 2: "Adult-onset HPP qualifies for Strensiq coverage"

Fact: Humana's 2024-2026 coverage criteria limit Strensiq to perinatal, infantile, and juvenile-onset HPP only. Adult-onset cases are excluded unless there's documented pediatric-onset disease progression. Source: Humana Prior Authorization Lists

Myth 3: "I need to try other medications first (step therapy)"

Fact: No step therapy applies to Strensiq because it's the only FDA-approved disease-modifying therapy for HPP. However, insurers may require documentation that supportive care alone was insufficient. Source: FDA Strensiq Label

Myth 4: "A simple blood test showing low alkaline phosphatase is enough"

Fact: Humana requires comprehensive documentation: ALPL genetic mutation confirmation, persistently low age-adjusted alkaline phosphatase levels, clinical symptoms, and imaging showing bone disease progression. Source: Humana Medical Policy

Myth 5: "If Humana denies coverage, there's nothing I can do"

Fact: New Jersey offers one of the nation's strongest external review processes through IHCAP. External decisions are legally binding on Humana, with about 50% of appeals favoring consumers nationwide. Source: NJ DOBI IHCAP Program

Myth 6: "Medicare patients can't get Strensiq covered"

Fact: Strensiq is covered under Medicare Part D, though prior authorization requirements apply. Humana Medicare Advantage plans follow the same coverage criteria but may have different formulary placement. Source: GoodRx Medicare Coverage Guide

Myth 7: "I have to pay full price while waiting for approval"

Fact: Humana may provide up to a 31-day transition supply for continuing therapy, and Alexion's Access Navigator program offers manufacturer support resources. Source: Humana Transition Policy

What Actually Influences Approval

Documentation Requirements

Successful Strensiq approvals hinge on comprehensive medical records demonstrating:

Requirement Specific Evidence Needed Where to Document
Genetic Confirmation ALPL pathogenic/likely pathogenic variants Genetic testing report
Biochemical Evidence Persistently low age-adjusted alkaline phosphatase Serial lab results
Clinical Symptoms Progressive bone disease, dental issues, growth delays Specialist notes, imaging
Onset Timing Pediatric/juvenile symptom onset (not adult-onset) Clinical history, growth charts
Treatment Response Objective improvement metrics planned Monitoring protocol

Medical Necessity Letter Components

Your prescriber's supporting statement must address:

  • Why Strensiq is necessary for your specific HPP phenotype
  • Documentation that supportive care alone is insufficient
  • Expected clinical benefits (bone mineralization, growth, function)
  • Monitoring plan for safety and efficacy

Formulary Exception Strategy

Since Strensiq is typically non-formulary, your prescriber must:

  1. Submit a formulary exception request simultaneously with prior authorization
  2. Explain why no formulary alternatives exist (Strensiq is the sole approved therapy)
  3. Use Humana's drug-specific Coverage Determination Form

Avoid These Critical Mistakes

1. Submitting Only Prior Authorization (Not Formulary Exception)

The Problem: Many providers submit standard prior authorization requests without realizing Strensiq requires a formulary exception for non-covered drugs. The Fix: Request both processes simultaneously by calling Humana Clinical Pharmacy Review at 800-555-2546.

2. Inadequate Genetic Testing Documentation

The Problem: Submitting genetic results without clear pathogenic variant identification or using outdated variant classifications. The Fix: Ensure genetic reports explicitly state "pathogenic" or "likely pathogenic" ALPL variants and include updated ACMG classifications.

3. Missing Onset Documentation

The Problem: Failing to clearly establish pediatric/juvenile onset versus adult-onset symptoms. The Fix: Include growth charts, early developmental assessments, or childhood medical records showing symptom progression.

4. Incomplete Appeals Submissions

The Problem: Filing appeals without new supporting evidence or addressing specific denial reasons. The Fix: Obtain the detailed denial letter, identify each denial criterion, and provide point-by-point responses with additional evidence.

5. Missing New Jersey External Review Deadlines

The Problem: Not knowing about New Jersey's IHCAP process or missing the 4-month (180-day) external review deadline. The Fix: Mark your calendar for 180 days from final internal denial and submit through njihcap.maximus.com immediately after internal appeals are exhausted.

Your 3-Step Action Plan

Step 1: Gather Essential Documentation (Do Today)

  • Contact your prescriber to collect:
    • ALPL genetic testing results with pathogenic variant identification
    • Serial alkaline phosphatase lab results showing persistently low levels
    • Clinical notes documenting HPP symptoms and pediatric/juvenile onset
    • Imaging reports showing bone disease progression

Step 2: Coordinate Dual Submission (This Week)

  • Have your prescriber call Humana Clinical Pharmacy Review at 800-555-2546
  • Request both prior authorization AND formulary exception forms
  • Submit comprehensive medical necessity letter addressing all coverage criteria
  • Request expedited review (24 hours) if clinically urgent

Step 3: Prepare for Potential Appeals (Ongoing)

  • Save all denial letters and correspondence
  • Research New Jersey's IHCAP process at njihcap.maximus.com
  • Consider connecting with Counterforce Health for appeals assistance
  • Mark calendar deadlines: 65 days for internal appeals, 180 days for external review

New Jersey Appeals Process

Internal Appeals with Humana

  • Timeline: File within 65 days of denial
  • Decision: 7 days standard, 72 hours expedited
  • Submission: Online through member portal or fax to appeals department
  • Required: Denial letter, new medical evidence, prescriber support

External Review Through IHCAP

New Jersey's Independent Health Care Appeals Program provides binding external review administered by Maximus Federal Services.

Process Stage Timeline Action Required
File Appeal Within 180 days of final internal denial Submit at njihcap.maximus.com
Preliminary Review 5 business days Maximus confirms eligibility
Full Review 45 days standard, 48 hours expedited Independent physician panel review
Implementation 10 business days Humana must comply if approved

Key Advantage: External decisions are legally binding on Humana. If IHCAP approves coverage, Humana must provide the medication.

Contact for Questions: NJ DOBI Consumer Hotline at 1-800-446-7467 or IHCAP-specific line at 1-888-393-1062.

From our advocates: We've seen families successfully overturn Strensiq denials by focusing their external review submissions on peer-reviewed evidence of medical necessity rather than just restating the original request. Include recent HPP clinical studies and FDA approval data to strengthen your case—the independent physician reviewers appreciate seeing current medical literature that supports the treatment decision.

Resources and Next Steps

Official Resources

Patient Advocacy

  • Counterforce Health: Specializes in turning insurance denials into targeted appeals for rare disease medications
  • National Organization for Rare Disorders (NORD): General rare disease advocacy and resources
  • Soft Bones Foundation: HPP-specific patient support and educational materials

Emergency Assistance

If you're currently taking Strensiq and facing coverage interruption:

  1. Request expedited review (24-hour decision)
  2. Ask about transition supplies or emergency fills
  3. Contact Alexion's patient support at 1-888-765-4747
  4. Consider temporary manufacturer assistance programs

Disclaimer: This information is for educational purposes only and does not constitute medical or legal advice. Insurance coverage decisions depend on individual circumstances and plan specifics. Always consult with your healthcare provider and insurance plan directly for personalized guidance.

For additional consumer assistance in New Jersey, contact the Department of Banking and Insurance Consumer Hotline at 1-800-446-7467 or visit nj.gov/dobi for official resources and complaint procedures.

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