By Counterforce Health Team in Qalsody (tofersen) —

How to Get Qalsody (Tofersen) Covered by Aetna CVS Health in Ohio: Forms, Appeals, and State Protections

Answer Box: Getting Qalsody (Tofersen) Covered by Aetna CVS Health in Ohio

Aetna CVS Health requires prior authorization for Qalsody (tofersen) in Ohio. The fastest path to approval: 1) Confirm SOD1 mutation with genetic testing, 2) Submit complete PA request via Availity portal or fax 1-855-734-9389 with clinical documentation, 3) Use Ohio's 72-hour step therapy override if needed. Appeals must be filed within 180 days, with external review through Ohio Department of Insurance available. Start with Aetna's precertification form.

Table of Contents

Why Ohio State Rules Matter

Ohio's insurance regulations work alongside Aetna CVS Health's policies to create specific protections for patients needing specialty medications like Qalsody (tofersen). Understanding these state-level protections can make the difference between approval and denial.

Key Ohio Advantages:

  • 72-hour step therapy override decisions (24 hours for urgent cases)
  • 180-day appeal window with binding external review
  • Continuity of care protections during plan transitions
  • State oversight through Ohio Department of Insurance

These protections apply to state-regulated plans but may not cover self-funded employer plans governed by federal ERISA law. However, many employers voluntarily adopt similar procedures.

Coverage Requirements at a Glance

Requirement What It Means Where to Find It Source
Prior Authorization Required before coverage Aetna precertification list Aetna PA Requirements
SOD1 Mutation Genetic confirmation needed Lab report/genetic testing FDA labeling requirement
Prescriber Type Often requires neurologist Medical records Plan-specific criteria
Baseline Documentation ALSFRS-R, NfL levels Clinical notes Specialty guidelines
Site of Care Intrathecal administration Facility certification Manufacturer requirements

Step-by-Step: Fastest Path to Approval

1. Confirm Genetic Testing (Patient/Clinic)

  • Document SOD1 mutation with genetic testing results
  • Ensure results are in medical record
  • Timeline: Immediate (if already done)
  • Source: FDA Qalsody labeling

2. Gather Clinical Documentation (Clinic)

  • ALSFRS-R scores and progression
  • Prior ALS treatments (riluzole, edaravone outcomes)
  • Baseline neurofilament light chain (NfL) if available
  • Timeline: 1-2 days
  • Submit via: Medical records compilation

3. Submit Prior Authorization (Prescriber)

  • Complete Aetna PA form
  • Submit via Availity portal or fax 1-855-734-9389
  • Timeline: Same day submission
  • Decision: 10 calendar days (48 hours if urgent)

4. Request Step Therapy Override if Needed (Prescriber)

  • If step therapy required, cite Ohio's 72-hour override law
  • Document medical necessity for immediate access
  • Timeline: 72 hours for decision (24 hours urgent)
  • Source: Ohio step therapy protections

5. Appeal if Denied (Patient/Prescriber)

  • File internal appeal within 180 days
  • Include additional clinical evidence
  • Timeline: 30 days for decision
  • Next step: External review if upheld

Ohio's Step Therapy Protections

Ohio law provides strong protections against inappropriate step therapy requirements for rare disease medications like Qalsody. Insurers must grant exemptions when:

  • The required drug is contraindicated or likely to cause harm
  • Patient has already tried and failed the required medication
  • Patient is stable on current medication
  • The medication is required per clinical practice guidelines for rare diseases

How to Request Override:

  1. Use Ohio-specific step therapy exception language
  2. Cite rare disease status (ALS with SOD1 mutation)
  3. Reference clinical guidelines supporting immediate access
  4. Submit with supporting clinical documentation

Timeline: Insurers must decide within 72 hours (24 hours for urgent cases). This is significantly faster than standard prior authorization timelines.

From Our Advocates: We've seen Ohio patients successfully obtain step therapy overrides for Qalsody by emphasizing the progressive nature of ALS and the narrow treatment window. The key is providing clear documentation that delay could worsen outcomes—Ohio's law specifically protects against this scenario.

Continuity of Care During Transitions

Ohio provides robust continuity protections when switching insurance plans, particularly important for patients already on Qalsody:

30-Day Protection Period:

  • New plans must honor existing prior authorizations for 30 days
  • Coverage continues while new medical necessity review occurs
  • Non-network providers can continue care via Single Case Agreement

Special Protections:

  • Terminal illness: Coverage continues through end-of-life care
  • Pregnancy: Coverage with original provider through postpartum
  • Life-threatening conditions: Coverage until stabilized

Action Steps During Transition:

  1. Notify new plan immediately about ongoing Qalsody treatment
  2. Provide existing authorization documentation
  3. Request continuity of care in writing
  4. Contact Ohio Department of Medicaid if issues arise

Appeals Process: Internal to External Review

Ohio's appeal structure provides multiple opportunities to overturn denials:

Internal Appeals (Aetna CVS Health)

  • First Level: 180 days to file, 30-day decision
  • Expedited: 72 hours for urgent cases
  • Required: Must exhaust before external review

External Review (Ohio Department of Insurance)

  • Timeline: 180 days from final internal denial to request
  • Decision: 30 days standard, 72 hours expedited
  • Binding: Decision is final and enforceable
  • Contact: Ohio Department of Insurance at 1-800-686-1526

Key Advantage: Ohio allows the Department of Insurance to independently determine external review eligibility, preventing insurers from wrongly blocking reviews.

Common Denial Reasons & How to Fix Them

Denial Reason How to Overturn Required Documentation
"No SOD1 mutation documented" Submit genetic testing results Lab report with SOD1 variant
"Experimental/investigational" Cite FDA approval and CMS coverage directive CMS Dec 12, 2024 directive
"Non-neurologist prescriber" Obtain neurologist consultation or referral Specialist evaluation
"Step therapy not completed" Request Ohio step therapy override Medical necessity letter
"Not medically necessary" Provide comprehensive clinical documentation ALSFRS-R scores, progression data

Recent Development: CMS directed Medicare Advantage plans to cover Qalsody for on-label SOD1-ALS use, providing strong appeal ammunition for denials claiming "experimental" status.

Practical Scripts for Calls and Appeals

Patient Phone Script for Aetna CVS Health

"I'm calling about prior authorization for Qalsody for ALS with SOD1 mutation. My doctor submitted the request on [date]. Under Ohio law, step therapy overrides must be decided within 72 hours for rare diseases. Can you confirm the status and timeline?"

Appeal Letter Key Paragraph

"This denial violates Ohio's step therapy protection law (ORC 3901.83) which requires exemptions for rare disease medications when clinical guidelines support immediate access. The FDA has approved Qalsody specifically for SOD1-ALS, and CMS has directed Medicare Advantage plans to provide coverage. Delaying treatment for this progressive neurological condition contradicts both federal guidance and Ohio consumer protections."

Peer-to-Peer Request Script (for Clinicians)

"I'm requesting a peer-to-peer review for Qalsody prior authorization. The patient has confirmed SOD1 mutation with [specific variant], documented ALS progression, and meets FDA labeling criteria. Under Ohio law, we're also requesting step therapy override given the rare disease status and narrow treatment window."

Understanding ERISA Plan Limits

Important Limitation: Self-funded employer plans are governed by federal ERISA law, not Ohio state insurance regulations. This affects approximately 60% of employer-sponsored coverage.

What This Means:

  • Ohio's 72-hour step therapy override may not apply
  • External review process may be different (often through federal contractors)
  • Appeal timelines may follow federal rather than state requirements

How to Check: Ask HR if your plan is "self-funded" or "fully insured." Self-funded plans often have similar procedures but aren't legally required to follow Ohio timelines.

ERISA Appeal Rights: Even self-funded plans must provide appeal processes, typically with 180-day filing deadlines and external review options.

Quick Reference: Ohio Resources

Ohio Department of Insurance

Aetna CVS Health Contacts

Additional Support

  • UHCAN Ohio (Consumer advocacy): Provides assistance with appeals
  • Ohio Senior Health Insurance Information Program (OSHIIP): Medicare-related issues
  • Counterforce Health: Helps turn insurance denials into targeted, evidence-backed appeals

FAQ

How long does Aetna CVS Health prior authorization take in Ohio? Standard requests: 10 calendar days. Urgent requests: 48 hours. Ohio's step therapy override decisions must come within 72 hours (24 hours urgent).

What if Qalsody is non-formulary on my Aetna plan? Request a formulary exception with documentation that covered alternatives are ineffective or cause adverse effects. Include genetic testing confirming SOD1 mutation and clinical necessity.

Can I request expedited appeal if my condition is worsening? Yes. If delays would seriously jeopardize your health, request expedited review. Decisions come within 72 hours for internal appeals, same for external review.

Does step therapy apply if I failed treatments in another state? Yes, prior treatment failures from other states count toward step therapy requirements. Provide documentation of previous trials and outcomes.

What happens if Aetna denies my external review request? In Ohio, the Department of Insurance can independently determine external review eligibility. Contact ODI at 1-800-686-1526 if Aetna claims you're not eligible.

How much does Qalsody cost without insurance? List price is approximately $14,230-$14,754 per vial. First-year costs can reach $200,000-$220,000. Biogen offers patient support programs that may help with costs.

Navigating insurance approval for Qalsody requires understanding both Aetna CVS Health's specific requirements and Ohio's consumer protections. The combination of federal FDA approval, recent CMS guidance, and Ohio's step therapy override protections creates multiple pathways to coverage for eligible patients.

Counterforce Health specializes in turning insurance denials into targeted, evidence-backed appeals by analyzing denial letters, plan policies, and clinical notes to draft point-by-point rebuttals aligned with each plan's specific rules. Their platform helps patients, clinicians, and specialty pharmacies navigate complex prior authorization requirements and appeal processes.

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

Sources & Further Reading

Powered by Counterforce Health—AI that turns drug denials into evidence-based appeals patients and clinicians can submit today.