By Counterforce Health Team in Qalsody (tofersen) —

How to Get Qalsody (Tofersen) Covered by Blue Cross Blue Shield in Illinois: Complete Guide to Prior Authorization, Appeals, and Financial Assistance

Answer Box: Getting Qalsody Covered by Blue Cross Blue Shield in Illinois

Qalsody (tofersen) requires prior authorization from Blue Cross Blue Shield of Illinois and is limited to patients with confirmed SOD1 gene mutation causing ALS. The fastest path to approval: (1) Confirm SOD1 mutation with genetic testing results, (2) Have your neurologist submit prior authorization through BCBSIL's provider portal with complete clinical documentation, and (3) Apply for Biogen's copay assistance program simultaneously. If denied, Illinois law guarantees external review within 30 days of your final appeal denial. Start today by calling BCBSIL at the number on your insurance card to verify coverage and request prior authorization forms.

Table of Contents

  1. What Drives Qalsody Costs: Understanding Your Benefits
  2. Investigating Your BCBSIL Coverage
  3. Financial Assistance Options
  4. Prior Authorization: Step-by-Step Process
  5. Common Denial Reasons and How to Fix Them
  6. Appeals Process in Illinois
  7. Specialty Pharmacy Coordination
  8. Annual Renewal and Budget Planning
  9. Scripts for Key Conversations
  10. FAQ

What Drives Qalsody Costs: Understanding Your Benefits

Qalsody (tofersen) carries a list price of approximately $14,230-$14,754 per 100mg vial. With a typical first-year treatment schedule of 15 doses (3 loading doses plus 12 monthly maintenance), your annual drug cost could reach $200,000-$220,000 before insurance coverage and rebates.

Your out-of-pocket costs depend on several benefit design factors:

  • Formulary tier: Qalsody is not listed on BCBSIL's standard 2024 drug formulary, meaning it typically requires specialty or non-formulary review
  • Prior authorization requirements: All BCBSIL plans require PA for Qalsody
  • Specialty pharmacy networks: Must be filled through approved specialty pharmacies
  • Annual out-of-pocket maximums: Your plan's annual cap protects you from unlimited costs
  • Coinsurance vs. copays: Specialty drugs often have percentage-based coinsurance rather than flat copays
Note: Blue Cross Blue Shield of Illinois contracts with multiple specialty pharmacy networks, including Accredo Health Group, which commonly handles rare disease medications like Qalsody.

Investigating Your BCBSIL Coverage

Before starting the approval process, gather this essential information about your specific plan:

Call BCBSIL member services (number on your insurance card) and ask:

  1. Is Qalsody covered under my plan's pharmacy or medical benefit?
  2. What's my specialty drug coinsurance percentage?
  3. What's my annual out-of-pocket maximum?
  4. Which specialty pharmacies are in-network for my plan?
  5. Do I need a referral to see a neurologist?

Document everything: Write down the representative's name, date, time, and reference number for your call.

Coverage Requirements at a Glance

Requirement What It Means Where to Find It
Prior Authorization BCBSIL must approve before dispensing BCBSIL PA code list
SOD1 Mutation Confirmed genetic testing required Your genetic counselor or neurologist
Neurologist Prescriber Must be prescribed by ALS specialist BCBSIL provider directory
Specialty Pharmacy Cannot fill at retail pharmacy BCBSIL specialty pharmacy list

Financial Assistance Options

Biogen Copay Program

If you have commercial insurance (not Medicare, Medicaid, or other government coverage), Biogen's copay program can significantly reduce your out-of-pocket costs for both the medication and administration expenses.

Eligibility requirements:

  • Age 18 or older
  • Commercial or private insurance
  • Legal US resident
  • Insurance must be billed first
  • Not valid in Massachusetts, Minnesota, or Rhode Island for administration costs

How to apply: Your healthcare provider must complete and submit a Biogen Start Form by faxing to 888-538-9781 or emailing [email protected]. For questions, call Biogen Support Services at 877-725-7639.

Foundation Grants and Patient Assistance

HealthWell Foundation ALS Fund provides copayment assistance for Medicare patients. The HealthWell Foundation specifically supports ALS patients with medication costs.

ALS Foundation Support:

Medicare Advantage Note: Following widespread denials, CMS directed Medicare Advantage plans on December 12, 2024, to cover Qalsody for FDA-approved SOD1-ALS indications—a crucial point for appeals.

Prior Authorization: Step-by-Step Process

Step 1: Confirm SOD1 Mutation (Patient/Family)

Obtain certified genetic testing results showing SOD1 gene mutation. If you haven't been tested, ask your neurologist for a referral to a genetic counselor.

Step 2: Gather Clinical Documentation (Neurologist)

Your neurologist needs to compile:

  • Definitive ALS diagnosis with ICD-10 codes
  • ALSFRS-R baseline scores
  • Documentation of disease progression
  • Previous treatment history (riluzole, edaravone if tried)
  • Contraindications to standard therapies (if applicable)

Step 3: Submit Prior Authorization (Neurologist's Office)

The prescriber submits through BCBSIL's provider portal or by fax. Required elements include:

  • Completed prior authorization form
  • Letter of medical necessity
  • Genetic testing results
  • Recent clinic notes
  • Lab results if requested

Step 4: Track Your Request (Patient)

BCBSIL typically responds within 15 business days for standard requests, 24 hours for expedited reviews. Call member services with your PA reference number for status updates.

Tip: Ask your neurologist's office to request expedited review if you need treatment urgently. Include clinical justification for why delays would harm your health.

Common Denial Reasons and How to Fix Them

Denial Reason How to Overturn Required Documentation
No SOD1 mutation documented Submit certified genetic test results Laboratory report with SOD1 variant details
Non-neurologist prescriber Transfer prescription to ALS specialist Referral and prescription from board-certified neurologist
Lack of baseline assessments Provide ALSFRS-R and NfL documentation Recent clinic visit notes with functional assessments
"Experimental" determination Cite FDA approval and CMS guidance FDA approval letter, CMS December 2024 directive
Ventilator dependency Document ventilation status per policy Pulmonary function tests, ventilator records

Clinician Corner: Medical Necessity Letter Checklist

When writing the letter of medical necessity, neurologists should include:

  • Problem: Patient's specific ALS presentation and SOD1 mutation details
  • Prior treatments: History with riluzole, edaravone, or other therapies
  • Clinical rationale: Why Qalsody is medically necessary for this patient
  • Guideline citations: Reference FDA approval and ALS care guidelines
  • Dosing plan: Intrathecal 100mg every 28 days after loading doses
  • Monitoring plan: Regular ALSFRS-R assessments and safety monitoring

Appeals Process in Illinois

If BCBSIL denies your prior authorization, Illinois law provides a structured appeals process with strict timelines.

Internal Appeal (First Level)

Timeline: Must file within 60 days of denial Decision deadline: 15 business days for standard, 24 hours for expedited How to file: Use BCBSIL's member portal or mail/fax appeal forms

External Review (Independent Review)

If your internal appeal is denied, you can request external review through the Illinois Department of Insurance.

Key deadlines:

  • File within 30 days of final internal denial (shorter than most states)
  • IRO decision within 5 business days of receiving records
  • Total process typically completed within 45 days

No cost to you: Illinois insurers pay for external reviews

Contact for help:

  • Illinois Department of Insurance: 877-527-9431
  • Illinois Attorney General Health Care Helpline: 877-305-5145
Important: Illinois' 30-day external review deadline is shorter than the typical 4-month window in other states. Don't delay if your internal appeal is denied.

Specialty Pharmacy Coordination

Qalsody must be dispensed through BCBSIL's contracted specialty pharmacies. Accredo Health Group is the primary specialty pharmacy for many BCBSIL plans and commonly handles rare disease medications.

Coordination tips:

  1. Confirm network status: Verify your chosen specialty pharmacy is in-network before prescription submission
  2. Provide complete information: Share your prior authorization approval number with the pharmacy
  3. Plan for delivery: Qalsody requires special handling and cold storage
  4. Schedule administration: Coordinate with your infusion center for intrathecal administration

In-network specialty pharmacies for BCBSIL include:

  • Accredo Health Group
  • Amber Specialty Pharmacy
  • Advanced Pharmacy Solutions
  • Senderra RX Pharmacy
  • Rush Specialty Drug Solutions

Contact BCBSIL specialty pharmacy services for current network information.

Annual Renewal and Budget Planning

What can change annually:

  • Formulary tier placement
  • Prior authorization requirements
  • Specialty pharmacy networks
  • Out-of-pocket maximums
  • Coinsurance percentages

Budget planning reminders:

  • Review your plan's Summary of Benefits and Coverage during open enrollment
  • Confirm Qalsody remains covered under your renewed plan
  • Reapply for manufacturer copay assistance programs annually
  • Update any changes in income for foundation grant programs

Scripts for Key Conversations

Calling BCBSIL Member Services

"Hi, I'm calling to verify coverage for Qalsody, spelled Q-A-L-S-O-D-Y, for my ALS treatment. My member ID is [number]. I need to know: Is this covered under pharmacy or medical benefits? What's my coinsurance for specialty drugs? Which specialty pharmacies are in-network? Do I need prior authorization?"

Requesting Expedited Review

"My neurologist is requesting expedited prior authorization for Qalsody because delaying treatment could worsen my ALS progression. The medication targets my specific SOD1 mutation, and earlier treatment may slow disease advancement. Please process this as urgent."

Following Up on Denials

"I'm calling about my denied prior authorization for Qalsody, reference number [X]. I have confirmed SOD1 mutation ALS and my neurologist provided all required documentation. Can you tell me the specific reason for denial and what additional information you need?"

Counterforce Health specializes in turning insurance denials into successful appeals by analyzing denial letters, plan policies, and clinical notes to create targeted, evidence-backed rebuttals. Their platform identifies the specific denial basis and drafts point-by-point responses aligned with each plan's own rules, helping patients, clinicians, and specialty pharmacies navigate complex prior authorization requirements more effectively. Learn more at www.counterforcehealth.org.

FAQ

How long does BCBSIL prior authorization take for Qalsody? Standard prior authorization decisions are made within 15 business days. Expedited requests receive decisions within 24 hours if clinical urgency is documented.

What if Qalsody is non-formulary on my plan? Non-formulary drugs can still be covered through prior authorization and formulary exceptions. Your neurologist must demonstrate medical necessity and provide clinical justification.

Can I request an expedited appeal if I'm denied? Yes, if delaying treatment would seriously jeopardize your health. Document the urgency in your appeal and request expedited processing.

Does step therapy apply if I've tried other ALS drugs outside Illinois? Treatment history from other states should count toward step therapy requirements. Provide documentation of previous therapies tried and their outcomes.

What happens if I move to a different Blue Cross plan? Coverage may vary between different Blue Cross organizations. Verify Qalsody coverage and prior authorization requirements with your new plan immediately.

How do I find an ALS specialist in BCBSIL's network? Use BCBSIL's provider directory online or call member services to find neurologists who specialize in ALS and accept your specific plan.

Can I appeal to Illinois if I have an employer self-funded plan? Self-funded ERISA plans may not be subject to state external review laws. Check with your HR department about your plan's appeal rights and procedures.

What if my income is too high for patient assistance programs? Even with higher income, specialty drug costs can qualify as financial hardship. Some programs consider medication costs as a percentage of income rather than absolute income levels.

Sources & Further Reading

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 company for personalized guidance. For assistance with insurance appeals and prior authorization challenges, consider consulting with specialists like those at Counterforce Health who focus on overturning insurance denials through evidence-based advocacy.

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