By Counterforce Health Team in Qalsody (tofersen) —

How to Get Qalsody (Tofersen) Covered by Humana in New York: Appeals Guide with Forms and Timelines

Answer Box: Getting Qalsody Covered by Humana in New York

Qalsody (tofersen) requires prior authorization from Humana for SOD1-mutated ALS patients. If denied, you have 65 days to appeal internally, then 4 months for New York's external review. Key requirements: confirmed SOD1 mutation, neurologist prescription, baseline ALSFRS-R score, and medical necessity documentation. First step today: Call Humana at 1-866-315-7587 to request prior authorization forms or check your member portal for coverage determination requests.

Table of Contents

  1. Understanding Humana's Qalsody Coverage
  2. Reading Your Denial Letter
  3. Common Denial Reasons & How to Fix Them
  4. Step-by-Step: Fastest Path to Approval
  5. Medical Necessity Letter Checklist
  6. Humana Appeals Process in New York
  7. New York External Review Rights
  8. Cost Savings and Patient Support
  9. When to Escalate Your Case
  10. Frequently Asked Questions

Understanding Humana's Qalsody Coverage

Qalsody (tofersen) is an FDA-approved antisense oligonucleotide for adults with ALS caused by SOD1 mutations—affecting about 2% of ALS cases. At roughly $14,500 per monthly dose, this specialty drug typically requires prior authorization through Humana's pharmacy benefit.

Coverage Requirements at a Glance:

Requirement What It Means Where to Find It
SOD1 mutation confirmed Genetic test showing pathogenic SOD1 variant Lab report from CLIA-certified facility
Neurologist prescription ALS specialist or movement disorder physician Provider credentials verification
Baseline documentation ALSFRS-R score, NfL biomarker levels Clinical notes, lab results
Medical necessity Evidence standard therapies insufficient Prior therapy records, contraindications
Intrathecal administration Proper facility and monitoring capability Hospital/clinic certification
Important: Following CMS's December 2024 directive, Medicare Advantage plans (including Humana) must cover Qalsody for FDA-approved SOD1-ALS indications. This strengthens appeal arguments significantly.

Reading Your Denial Letter

Your Humana denial notice will include specific reason codes. Common denial categories include:

  • PA required but not submitted: Missing prior authorization paperwork
  • Non-formulary: Drug not on Humana's preferred list
  • Medical necessity not established: Insufficient clinical documentation
  • Step therapy: Must try preferred alternatives first
  • Quantity limits exceeded: Dosing frequency restrictions

Look for the appeal deadline (typically 65 days from the denial date) and note whether it's a pharmacy benefit (Part D) or medical benefit (Part C) denial, as timelines differ.

Common Denial Reasons & How to Fix Them

Denial Reason How to Overturn Required Documentation
No SOD1 mutation documented Submit genetic test results CLIA-certified lab report showing pathogenic SOD1 variant
Non-neurologist prescriber Transfer prescription or add consultation Neurologist evaluation, referral documentation
Missing baseline assessments Provide functional scores ALSFRS-R assessment, NfL biomarker levels
"Experimental" designation Cite FDA approval and CMS directive FDA label, CMS Medicare Advantage coverage mandate
Ventilator dependency Document respiratory function Pulmonary function tests, current respiratory status

Step-by-Step: Fastest Path to Approval

1. Confirm SOD1 Mutation Status (Patient/Clinic)

2. Gather Required Documentation (Clinic Staff)

  • ALS diagnosis with ICD-10 code (G12.21)
  • ALSFRS-R baseline score
  • Prior therapy trials (riluzole, edaravone) and outcomes
  • Timeline: 2-3 business days

3. Submit Prior Authorization (Prescriber)

  • Call Humana: 1-866-315-7587
  • Online: Humana provider portal
  • Include comprehensive supporting statement
  • Timeline: 30 days for standard decision

4. Request Expedited Review if Urgent (Prescriber)

  • Check expedited box on PA form
  • Provide clinical justification for 24-hour decision
  • Timeline: 24-72 hours

5. Monitor Decision (Patient)

6. File Appeal if Denied (Patient/Prescriber)

  • Submit within 65 days of denial notice
  • Include medical necessity letter and additional evidence

7. Pursue External Review (Patient)

  • Available after internal appeal exhaustion
  • New York DFS external review within 4 months

Medical Necessity Letter Checklist

Your neurologist's supporting statement should address these key elements:

Clinical Presentation:

  • Confirmed ALS diagnosis with upper and lower motor neuron signs
  • SOD1 mutation type and pathogenicity
  • Current functional status (ALSFRS-R score)
  • Disease progression rate

Prior Treatments:

  • Riluzole trial: dose, duration, response, tolerability
  • Edaravone experience: effectiveness, adverse events
  • Other interventions attempted

Medical Necessity Arguments:

  • SOD1-ALS rapid progression without targeted therapy
  • Qalsody's unique mechanism: antisense oligonucleotide reducing toxic SOD1 protein
  • Clinical trial evidence: 25% stabilization/improvement in early treatment
  • No alternative SOD1-targeted therapies available

Monitoring Plan:

  • Intrathecal administration schedule (monthly)
  • Safety monitoring protocols
  • Functional assessment tracking

Humana Appeals Process in New York

Internal Appeal (First Level):

  • Deadline: 65 days from denial notice
  • Timeline: 30 days for Part C, 7 days for Part D
  • How to file: Call 1-866-315-7587 or submit written request
  • Required: Medical necessity letter from prescriber

Expedited Internal Appeal:

  • Timeline: 72 hours (24 hours for non-formulary drugs)
  • Criteria: Delay would seriously jeopardize health
  • Documentation: Physician attestation of urgency
Tip: For Qalsody appeals, emphasize the rapid progression of SOD1-ALS and the time-sensitive nature of neuroprotective intervention.

New York External Review Rights

If Humana upholds the denial after internal appeal, New York residents have robust external review rights through the Department of Financial Services.

Key Benefits:

  • Independent medical review by certified experts
  • Binding decision on the insurer
  • Timeline: 30 days standard, 72 hours expedited
  • Cost: $25 maximum (waived for financial hardship)

Eligibility for Qalsody:

  • Final adverse determination from Humana
  • Denial based on medical necessity or experimental designation
  • Specialty drug appeals specifically covered

Required Forms:

Submission Deadline: 4 months from final internal denial

Note: New York's external appeal program has successfully overturned many specialty drug denials, particularly when supported by peer-reviewed evidence and FDA approval.

Cost Savings and Patient Support

While pursuing coverage, explore these financial assistance options:

Manufacturer Support:

Foundation Grants:

  • ALS Association financial assistance
  • Patient advocacy foundation grants
  • State pharmaceutical assistance programs

Additional Resources:

Counterforce Health specializes in turning insurance denials into targeted, evidence-backed appeals for specialty medications like Qalsody. Their platform analyzes denial letters and plan policies to draft point-by-point rebuttals aligned with payer requirements, potentially saving months in the appeals process.

When to Escalate Your Case

Contact New York regulators if you experience:

  • Delayed decisions beyond stated timelines
  • Repeated denials without substantive review
  • Procedural violations in the appeals process

New York Department of Financial Services:

For Medicare Advantage issues, also contact:

  • Medicare: 1-800-MEDICARE (1-800-633-4227)
  • State Health Insurance Assistance Program: 1-800-701-0501

Frequently Asked Questions

How long does Humana prior authorization take for Qalsody? Standard decisions take up to 30 days for Medicare Part C, 7 days for Part D. Expedited reviews are completed within 24-72 hours with proper clinical justification.

What if Qalsody isn't on Humana's formulary? Request a formulary exception with prescriber support showing medical necessity and lack of covered alternatives.

Can I get expedited review for ALS progression? Yes, if your neurologist attests that delay would seriously jeopardize your health or functional status. SOD1-ALS's rapid progression often qualifies.

Does step therapy apply to Qalsody? Some plans require trials of riluzole or edaravone first. Document prior use, inadequate response, or contraindications to these standard therapies.

What happens if my appeal is denied? You can pursue New York's external review through DFS within 4 months. The independent medical reviewer's decision is binding on Humana.

How much does Qalsody cost without insurance? Approximately $14,500 per monthly dose, with first-year costs around $200,000-220,000 including loading doses.

Do I need a specialist to prescribe Qalsody? Most insurers prefer neurologist prescriptions, particularly ALS specialists familiar with SOD1-mutated disease management.

Can I appeal if I live in New York but have coverage from another state? New York's external review rights apply to residents regardless of where their insurer is based, providing additional protection for specialty drug appeals.

This information is for educational purposes and does not constitute medical or legal advice. Coverage decisions vary by individual circumstances and plan specifics. For personalized guidance, consult with your healthcare provider and insurance representative.

Need help with your Qalsody appeal? Counterforce Health provides specialized support for complex medication appeals, helping patients and providers navigate payer-specific requirements and build compelling cases for coverage.

Sources & Further Reading

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