By Counterforce Health Team in Strensiq (asfotase alfa) —

How to Get Strensiq (asfotase alfa) Covered by Humana in Washington: Prior Authorization Guide with Appeals Process

Answer Box: Getting Strensiq (asfotase alfa) Covered by Humana in Washington

Strensiq (asfotase alfa) requires prior authorization from Humana and is likely non-formulary for most Medicare Advantage plans in Washington. Your fastest path: (1) Have your prescriber submit a formulary exception request with medical necessity documentation to Humana Clinical Pharmacy Review at 800-555-2546, (2) Include genetic testing, low alkaline phosphatase levels, and proof of pediatric-onset hypophosphatasia, (3) If denied, file an internal appeal within 65 days, then request external review through Washington's Office of Insurance Commissioner within 180 days. Standard decisions come within 72 hours; expedited within 24 hours if health is at risk.

Table of Contents

When Formulary Alternatives Make Sense

For hypophosphatasia (HPP), the reality is straightforward: Strensiq (asfotase alfa) is the only FDA-approved disease-modifying therapy for perinatal, infantile, and juvenile-onset hypophosphatasia. Unlike other conditions where multiple treatment options exist, HPP patients face a unique situation where true therapeutic alternatives simply don't exist.

However, understanding the supportive care landscape can be important while navigating the approval process for Strensiq, especially if you're experiencing delays or denials.

Note: If your child has confirmed pediatric-onset HPP and Strensiq is medically necessary, pursuing formulary alternatives typically isn't appropriate. Focus your energy on the exception and appeals process instead.

Understanding Hypophosphatasia Treatment Options

Primary Treatment: Strensiq (asfotase alfa)

Strensiq is a recombinant enzyme replacement therapy that replaces the missing tissue-nonspecific alkaline phosphatase (TNSALP) enzyme. It's administered by subcutaneous injection, typically 2-6 mg/kg per week divided into multiple doses.

Key characteristics:

  • Only FDA-approved treatment for pediatric-onset HPP
  • Requires specialized monitoring for ectopic calcifications
  • Annual costs can range from $890,000 to $4.9 million depending on weight and dosing
  • Carries a boxed warning for anaphylaxis risk

Supportive Care Options

While not disease-modifying treatments, these approaches help manage HPP symptoms:

Pain and inflammation management:

  • NSAIDs (ibuprofen, acetaminophen) for bone pain
  • Physical therapy for mobility support
  • Orthopedic interventions for fractures

Nutritional and metabolic support:

  • Vitamin B6 for seizure control in severe cases
  • Calcium and phosphate monitoring
  • Dietary counseling for bone health

Dental care:

  • Specialized dental management for premature tooth loss
  • Orthodontic treatment
  • Dental implants when appropriate

Pros and Cons of Alternative Approaches

Treatment Approach Pros Cons Access Considerations
Strensiq (asfotase alfa) Only disease-modifying therapy; proven efficacy in trials Very high cost; frequent injections; monitoring requirements Requires PA; likely non-formulary; extensive documentation needed
Supportive care only Lower cost; readily available; addresses symptoms No disease modification; progressive bone disease continues Generally covered; minimal PA requirements
Clinical trial participation Access to experimental therapies; no cost Uncertain efficacy; strict eligibility; geographic limitations Limited availability; research centers only
Clinician Corner: When documenting medical necessity for Strensiq, emphasize that supportive care alone cannot address the underlying enzyme deficiency that drives HPP progression. Include specific clinical measures showing disease severity and functional impact.

Formulary Exception Strategy for Strensiq

Since Strensiq is likely non-formulary for most Humana plans in Washington, you'll need to request a formulary exception rather than a standard prior authorization.

When to Request an Exception

Immediate scenarios:

  • Confirmed perinatal, infantile, or juvenile-onset HPP diagnosis
  • Low alkaline phosphatase levels with clinical symptoms
  • Genetic testing showing ALPL mutations
  • Progressive bone disease despite supportive care

Evidence That Strengthens Your Case

Clinical documentation:

  • Genetic testing results confirming ALPL mutations
  • Serial alkaline phosphatase levels (typically <40 U/L)
  • Radiographic evidence of rickets, osteomalacia, or fractures
  • Growth charts showing failure to thrive
  • Pulmonary function tests if respiratory involvement

Specialist support:

  • Letters from pediatric endocrinologists or geneticists
  • Metabolic bone disease specialist consultation
  • Multidisciplinary team recommendations

Counterforce Health specializes in turning insurance denials into targeted, evidence-backed appeals by analyzing the denial basis and crafting point-by-point rebuttals aligned to each plan's specific policies and requirements.

Step-by-Step: Fastest Path to Approval

1. Verify Coverage and Requirements

Who does it: Patient or caregiver
Action: Log into MyHumana portal or call member services
Timeline: Same day
Document needed: Member ID card

2. Gather Clinical Documentation

Who does it: Healthcare team
Action: Compile genetic testing, ALP levels, imaging, clinical notes
Timeline: 1-2 weeks
Documents needed: Lab results, radiology reports, specialist letters

3. Submit Formulary Exception Request

Who does it: Prescriber
Action: Contact Humana Clinical Pharmacy Review at 800-555-2546
Timeline: Must include prescriber supporting statement
Forms: Use Humana's Request for Medicare Prescription Drug Coverage Determination

4. Follow Up on Decision

Who does it: Patient or caregiver
Action: Check MyHumana portal or call member services
Timeline: 72 hours for standard; 24 hours for expedited
Next step: If denied, proceed to appeals process

5. File Internal Appeal if Denied

Who does it: Patient, representative, or prescriber
Action: Submit redetermination request within 65 days
Timeline: 7 days for standard Part D appeals
Required: Copy of denial letter, additional medical evidence

6. Request External Review (if needed)

Who does it: Patient or representative
Action: Contact Washington Office of Insurance Commissioner at 1-800-562-6900
Timeline: Within 180 days of final internal denial
Decision timeframe: 30 days standard; 72 hours expedited

Appeals Playbook for Humana in Washington

Internal Appeals Process

Level 1: Redetermination

  • Deadline: 65 days from denial notice
  • Decision timeline: 7 days (standard), 72 hours (expedited)
  • How to file: Online via MyHumana, phone, fax, or mail
  • Required documents: Original denial letter, new medical evidence

Expedited appeals criteria:

  • Delay could seriously jeopardize health
  • Prescriber confirms urgency in writing
  • Decision within 24-72 hours

External Review (Washington State)

Washington provides robust external review rights through certified Independent Review Organizations (IROs).

Key advantages:

  • Decision is binding on Humana if approved
  • Independent medical specialists review the case
  • No cost to the patient
  • Strong track record for rare disease approvals

Timeline:

  • Filing deadline: 180 days from final internal denial
  • Standard review: 30 days
  • Expedited review: 72 hours for urgent cases

How to file: Contact the Washington Office of Insurance Commissioner at 1-800-562-6900 or submit a request through their online portal.

Common Denial Reasons & How to Fix Them

Denial Reason How to Overturn Required Documentation
"Not medically necessary" Provide genetic testing and specialist letters ALPL mutation results, endocrinologist letter
"Experimental/investigational" Cite FDA approval and clinical guidelines FDA label, treatment guidelines
"Insufficient documentation" Submit comprehensive clinical records Complete medical history, imaging, lab results
"Alternative treatments available" Demonstrate that supportive care is inadequate Documentation of disease progression despite current care
"Age restrictions" Confirm pediatric-onset diagnosis Early childhood medical records, growth charts
Tip: When appealing, address each specific denial reason point-by-point. Generic appeals are less effective than targeted responses to the plan's stated concerns.

Costs & Patient Support Programs

Manufacturer Support

Alexion Access Navigator: Provides case management, insurance support, and financial assistance for eligible patients. Contact through the Strensiq website or 1-888-765-4747.

Foundation Assistance

  • National Organization for Rare Disorders (NORD): Rare Disease Financial Assistance Programs
  • HealthWell Foundation: May provide copay assistance for eligible patients
  • Patient Access Network Foundation: Covers specific rare disease medications

State Resources

Washington Apple Health (Medicaid): May provide coverage for eligible low-income patients. Contact Washington Healthplanfinder at 1-855-923-4633.

When to Escalate

If you've exhausted internal appeals and external review without success, consider these additional steps:

State regulator complaint: File a complaint with the Washington Office of Insurance Commissioner if you believe Humana violated state insurance laws or regulations.

Legal consultation: For complex cases involving significant medical necessity disputes, consider consulting with a healthcare attorney experienced in insurance law.

Congressional assistance: Contact your Washington state representatives' offices, which often have staff dedicated to helping constituents navigate federal program issues like Medicare.

Frequently Asked Questions

How long does Humana prior authorization take in Washington? Standard formulary exception decisions take 72 hours once Humana receives the prescriber's supporting statement. Expedited requests are decided within 24 hours if health risks justify urgency.

What if Strensiq is non-formulary on my Humana plan? Request a formulary exception rather than standard prior authorization. Your prescriber must demonstrate that Strensiq is medically necessary and that formulary alternatives are ineffective or inappropriate.

Can I request an expedited appeal in Washington? Yes, if your prescriber confirms that delays could seriously jeopardize your health. Expedited appeals receive decisions within 24-72 hours depending on the appeal level.

Does step therapy apply to Strensiq? Step therapy typically doesn't apply since there are no therapeutic alternatives to Strensiq for HPP. However, plans may require documentation that supportive care alone is insufficient.

What happens if Washington external review approves coverage? The decision is legally binding on Humana. They must provide coverage and cannot appeal the external reviewer's decision.

How much does Strensiq cost without insurance? Cash prices can exceed $10,000 per vial, with annual costs potentially reaching $4.9 million for pediatric patients requiring higher doses. This makes insurance coverage essential.

Can I switch Humana plans to get better Strensiq coverage? During Medicare open enrollment (October 15 - December 7), you can switch to plans with more favorable formularies. However, all Medicare plans can require prior authorization for high-cost specialty drugs.

What documentation should I keep during the appeals process? Maintain copies of all denial letters, appeal submissions, medical records, and correspondence. Counterforce Health can help organize and strengthen your documentation strategy to improve appeal success rates.

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 circumstances, plan specifics, and medical necessity determinations. Always consult with your healthcare provider and insurance plan directly for personalized guidance. For assistance with insurance appeals and coverage issues in Washington, contact the Office of the Insurance Commissioner at 1-800-562-6900.

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