By Counterforce Health Team in Qalsody (tofersen) —

How to Get Qalsody (tofersen) Covered by Aetna (CVS Health) in California: Complete Prior Authorization and Appeals Guide

Answer Box: Getting Qalsody (tofersen) Approved by Aetna (CVS Health) in California

Aetna (CVS Health) requires prior authorization for Qalsody (tofersen) with documented SOD1 mutation, neurologist prescription, and baseline assessments. First step: Submit Aetna's Qalsody precertification form with genetic test results, ALSFRS-R scores, and clinical notes. Standard approval takes 10 days; urgent cases 48-72 hours. If denied, California's Independent Medical Review (IMR) overturns 55-73% of specialty drug denials. Contact DMHC Help Center (888-466-2219) for appeal assistance.

Table of Contents

Coverage Requirements at a Glance

Requirement What It Means Where to Find It Source
Prior Authorization Required for all Qalsody requests Aetna precertification form Aetna Policy
SOD1 Mutation Documented genetic test showing pathogenic variant CLIA-certified lab report Aetna Clinical Policy
Age Requirement 18 years or older Medical records FDA Label
Prescriber Board-certified neurologist preferred Provider credentials Aetna Policy Bulletin
Pulmonary Function FVC or SVC ≥ 45% predicted Recent pulmonary function test Clinical Criteria
No Tracheostomy Patient must not have tracheostomy Clinical documentation Aetna Requirements
Appeals Deadline 180 days from denial Denial letter California Insurance Code

Step-by-Step: Fastest Path to Approval

1. Confirm SOD1 Mutation Status

Who: Neurologist orders genetic testing
Document: CLIA-certified lab report showing pathogenic SOD1 variant
Timeline: 2-4 weeks for results
Source: ALS Association genetic testing guide

2. Gather Required Clinical Documentation

Who: Medical team compiles records
Documents:

  • ALSFRS-R baseline and recent scores
  • Neurofilament light chain levels (if available)
  • Pulmonary function tests
  • Prior ALS treatment history (riluzole, edaravone) Timeline: 1-2 days

3. Complete Aetna Precertification Form

Who: Provider or clinic staff
Form: Qalsody precertification request
Submit: Availity portal or fax as specified on form
Timeline: Same day submission

4. Submit Complete Package

Who: Provider office
Include: PA form + genetic test + clinical notes + ALSFRS-R + prior therapies
Method: Electronic via Availity portal
Timeline: Submit within 24-48 hours of completion

5. Track Decision Timeline

Standard: 10 calendar days
Expedited: 48-72 hours (if medically urgent)
Follow-up: Call Aetna provider services if no response
Source: Aetna PA timelines

Common Denial Reasons & How to Fix Them

Denial Reason Fix Strategy Required Documents
No SOD1 mutation documented Submit CLIA-certified genetic test report Lab report with pathogenic variant
Prescriber not neurologist Have neurologist co-sign or transfer care Board certification documentation
Missing baseline assessments Provide ALSFRS-R and NfL data Recent clinical assessments
"Experimental/investigational" Cite CMS December 2024 guidance CMS memo requiring MA coverage
Step therapy not completed Document riluzole/edaravone trials or contraindications Treatment history with outcomes
Pulmonary function insufficient Verify FVC/SVC ≥ 45% or request exception Updated PFTs with rationale
From Our Advocates: We've seen denials overturned when providers submitted a comprehensive "disease progression timeline" showing ALSFRS-R decline over 3-6 months, emphasizing the urgency of SOD1-targeted therapy. This visual documentation often resonates with medical reviewers who may not specialize in ALS.

Appeals Playbook for California

Internal Appeal (First Level)

  • Deadline: 180 days from denial
  • Timeline: 30 days for standard; 72 hours for expedited
  • Submit: Written appeal with supporting documentation
  • Include: Medical necessity letter, updated clinical data, peer-reviewed studies
  • Contact: Aetna member services number on denial letter

Independent Medical Review (IMR) - California's External Review

  • When: After internal appeal denial or 30 days without response
  • Cost: Free to patient
  • Timeline: 45 days standard; 7 days expedited
  • Success Rate: 55-73% overturn rate for specialty drugs
  • Apply: DMHC online portal or call 888-466-2219

Key California Protections

  • Binding decisions: If IMR approves, Aetna must authorize within 5 business days
  • No patient cost: California covers all IMR fees
  • Multiple languages: IMR applications available in Spanish, Chinese, others
  • Help available: DMHC Help Center provides free assistance

Costs & Patient Assistance Options

Qalsody Pricing

  • List price: ~$14,230-$14,754 per vial
  • Annual cost: $200,000-$220,000 first year; $170,000-$180,000 thereafter
  • Source: Industry pricing reports

Financial Assistance

  • Biogen Support: Contact via Qalsody Start Form
  • Frontier Therapies: Limited distribution pharmacy with patient assistance programs
  • Copay Support: Available for commercially insured patients
  • Free Drug Programs: For uninsured/underinsured patients meeting criteria

California-Specific Resources

  • Medi-Cal: Expanded Medicaid coverage for qualifying patients
  • Covered California: State exchange plans with essential health benefits
  • Health Consumer Alliance: Nonprofit providing free insurance navigation

When to Escalate to State Regulators

File a DMHC Complaint If:

  • Aetna delays beyond required timelines
  • Repeated denials despite meeting criteria
  • Failure to respond to IMR decision
  • Contact: DMHC Help Center at 888-466-2219

California Department of Insurance (CDI)

  • For non-HMO plans regulated by CDI
  • Hotline: 800-927-4357
  • Online: File complaints at insurance.ca.gov

FAQ: Aetna (CVS Health) Qalsody Coverage

Q: How long does Aetna prior authorization take in California?
A: Standard decisions within 10 days; expedited (urgent) within 48-72 hours. Source: Aetna PA guidelines

Q: What if Qalsody is non-formulary on my plan?
A: Request formulary exception with medical necessity documentation. California law supports step-therapy overrides when medically appropriate.

Q: Can I request an expedited appeal?
A: Yes, if delay could seriously endanger health. ALS progression qualifies for expedited review in most cases.

Q: Does step therapy apply if I've failed other ALS treatments?
A: Document prior riluzole/edaravone trials and outcomes. Contraindications or failures may waive step therapy requirements.

Q: What's the success rate for Qalsody appeals in California?
A: California's IMR overturns 55-73% of specialty drug denials. Source: DMHC data analysis

Q: Who can prescribe Qalsody for Aetna coverage?
A: Board-certified neurologist preferred. Some approvals possible with ALS specialist involvement.

Q: Is genetic counseling required before SOD1 testing?
A: Recommended but not always required for coverage. Check with your provider about counseling options.

Q: How do I get help with the appeals process?
A: Contact DMHC Help Center at 888-466-2219 for free assistance with appeals and IMR applications.

About Counterforce Health: Counterforce Health specializes in turning insurance denials into successful appeals for specialty medications like Qalsody. Our platform analyzes denial letters, identifies specific coverage criteria, and generates evidence-based appeals that address each payer's requirements. For complex cases involving rare disease therapies, we help patients and providers navigate the documentation requirements and appeal processes that lead to coverage approval.

For patients facing Qalsody denials, Counterforce Health can help draft targeted appeals that reference California's specific protections and Aetna's clinical criteria, improving the chances of approval through both internal appeals and IMR processes.

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 details, and clinical factors. Always consult with your healthcare provider and insurance company for specific coverage determinations. For assistance with appeals, contact the California DMHC Help Center or consider consulting with a healthcare advocate.

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