By Counterforce Health Team in Gilenya (fingolimod) —

How to Get Gilenya (Fingolimod) Covered by Blue Cross Blue Shield in Washington: Prior Authorization Guide and Appeals Process

Answer Box: Getting Gilenya Covered in Washington

Gilenya (fingolimod) requires prior authorization from Blue Cross Blue Shield plans in Washington. To get approved, you'll need baseline testing (EKG, eye exam, labs), documentation of MS diagnosis, and often proof that you've tried other therapies first. If denied, you have 365 days to appeal internally, then 4 months for external review through Washington's Independent Review Organization (IRO). Start today: Contact your neurologist to gather required monitoring documentation and submit the PA request through your plan's provider portal.

Table of Contents

Coverage Requirements at a Glance

Requirement What It Means Where to Find It
Prior Authorization Required before coverage Premera PA drug list
Formulary Status Tier 3-4 specialty drug Your plan's formulary document
Step Therapy May need to try other MS drugs first Plan's step therapy guidelines
Specialty Pharmacy Must use designated network pharmacy Member portal or customer service
First-Dose Monitoring 6-hour EKG monitoring required FDA safety requirements
Baseline Testing Eye exam, labs, vaccinations Provider PA form requirements

Step-by-Step: Fastest Path to Approval

  1. Schedule baseline testing (Patient + Clinic): Get EKG, complete eye exam, CBC, liver function tests, and VZV immunity check. Timeline: 1-2 weeks.
  2. Gather prior therapy records (Clinic): Document previous MS treatments, dates, outcomes, and reasons for discontinuation. Timeline: 3-5 days.
  3. Submit PA request (Clinic): Complete insurer's PA form and submit through provider portal with all supporting documents. Timeline: Same day.
  4. Await decision (Insurer): Standard review takes up to 72 hours for Premera plans. Expedited available if medically urgent.
  5. If approved: Coordinate with specialty pharmacy for delivery and first-dose monitoring appointment. Timeline: 3-7 days.
  6. If denied: Request peer-to-peer review immediately, then file internal appeal within 365 days if needed.

Prior Authorization Requirements

All Blue Cross Blue Shield plans in Washington require prior authorization for Gilenya before coverage begins. The process typically involves:

Required Documentation:

  • Confirmed diagnosis of relapsing multiple sclerosis with ICD-10 code
  • Clinical notes documenting disease activity or progression
  • Baseline laboratory results and monitoring plan
  • Prior therapy history and outcomes

Decision Timeline:

  • Standard PA decisions: Within 72 hours for Premera plans
  • Expedited reviews: 24 hours when urgent medical need is documented
  • Coverage during transition: Some plans provide 90-day temporary coverage while PA is processed
Tip: Submit PA requests early in the week to avoid weekend delays, and include all required documents in the initial submission to prevent back-and-forth requests.

Step Therapy and Medical Exceptions

Many Blue Cross Blue Shield plans require step therapy, meaning you must try preferred alternatives before Gilenya is covered. Common first-line therapies include:

  • Injectable interferons (Avonex, Betaseron, Copaxone)
  • Oral alternatives (Aubagio, Tecfidera)
  • Infusion therapies (Ocrevus, Tysabri)

Medical Exception Criteria:

  • Contraindications to preferred agents (documented allergies, cardiac issues)
  • Previous treatment failures with specific dates and discontinuation reasons
  • Documented intolerance with detailed adverse events
  • Rapidly progressing disease requiring immediate intervention

Required Baseline Testing

Before Gilenya approval, insurers require comprehensive baseline testing to ensure safe initiation:

Cardiac Monitoring:

  • Baseline EKG to check for conduction abnormalities
  • 6-hour first-dose monitoring with hourly pulse and blood pressure checks
  • Post-dose EKG at 6 hours
  • Extended monitoring if heart rate drops below 45 bpm

Laboratory Tests:

  • Complete blood count (CBC) to check for lymphopenia
  • Liver function tests (ALT, AST, bilirubin)
  • Varicella zoster virus (VZV) antibody testing

Ophthalmologic Evaluation:

  • Complete eye exam including macular assessment
  • Follow-up exam recommended 3-4 months after starting therapy

Vaccination Status:

  • VZV vaccination if not immune
  • Live vaccines must be completed at least 1 month before starting Gilenya
Note: Incomplete baseline testing is one of the most common reasons for PA denials. Ensure all required tests are current (typically within 30-90 days) before submission.

Common Denial Reasons & Solutions

Denial Reason Solution
Missing baseline EKG Submit recent EKG results and first-dose monitoring plan
Incomplete eye exam Provide comprehensive ophthalmology report with macular assessment
Step therapy not completed Document medical contraindications or previous failures with dates
Insufficient diagnosis documentation Include MRI reports, clinical notes confirming relapsing MS
Missing vaccination records Submit VZV immunity testing or vaccination documentation
Quantity limit exceeded Request exception with clinical justification for dosing frequency

Appeals Process for Washington

If your Gilenya PA is denied, Washington provides a robust appeals process:

Internal Appeals (Required First):

First-Level Appeal:

  • File within 365 days of denial
  • Submit to: Premera Blue Cross, ATTN: Member Appeals, PO Box 91102, Seattle, WA 98111-9202
  • Fax: 425-918-5592
  • Decision timeline: 30 calendar days

Second-Level Appeal:

  • File within 30 days of first-level denial
  • Same submission process
  • Decision timeline: 30 calendar days

External Review (Independent):

  • File within 4 months of final internal denial
  • Handled by Independent Review Organization (IRO)
  • Free process paid by insurer
  • Decision timeline: 30 days (72 hours if expedited)
  • IRO decisions are binding on the insurer

Washington State Support:

  • Office of the Insurance Commissioner: 1-800-562-6900
  • File complaints online
  • External review requests can be submitted through the OIC
Important: Use certified mail for all appeal submissions to prove timely filing. Late appeals are automatically rejected.

Clinician Corner: Medical Necessity Documentation

When preparing medical necessity letters for Gilenya, include these key elements:

Clinical Rationale Checklist:

  • Specific MS subtype (relapsing-remitting, secondary progressive with relapses)
  • Recent disease activity (relapses, MRI progression, disability worsening)
  • Previous DMT trials with specific names, durations, and outcomes
  • Contraindications to preferred formulary alternatives
  • Patient-specific factors (age, comorbidities, lifestyle considerations)

Supporting Evidence:

  • FDA prescribing information for approved indications
  • Recent MRI reports showing new or enhancing lesions
  • EDSS scores or other disability measures
  • Laboratory monitoring plan and baseline results

Template Language: "Patient has relapsing multiple sclerosis with documented disease activity despite treatment with [specific prior therapies]. Gilenya is medically necessary as [patient-specific rationale]. Baseline monitoring has been completed per FDA requirements, and ongoing surveillance plan is established."

Cost Support Options

Manufacturer Support:

  • Novartis Gilenya co-pay program: May reduce out-of-pocket costs to $10/month for eligible patients
  • Patient assistance programs for uninsured or underinsured patients
  • Contact: 1-800-GILENYA (1-800-445-3692)

Foundation Support:

  • National Multiple Sclerosis Society: Financial assistance programs
  • Patient Advocate Foundation: Copay relief programs
  • Healthwell Foundation: Disease-specific grants

Generic Options:

  • Multiple fingolimod generics now available at significantly lower costs
  • May have different PA requirements than brand Gilenya

FAQ

How long does Blue Cross Blue Shield PA take in Washington? Standard PA decisions are typically made within 72 hours for Premera plans. Expedited reviews for urgent medical situations are decided within 24 hours.

What if Gilenya is not on my formulary? You can request a formulary exception by documenting medical necessity and why preferred alternatives are inappropriate. This requires clinical documentation from your neurologist.

Can I get expedited appeals in Washington? Yes, if your health could be seriously harmed by waiting for a standard appeal timeline. Expedited external reviews are decided within 72 hours.

Do I need specialty pharmacy for Gilenya? Yes, Gilenya must be dispensed through designated specialty pharmacies, not retail pharmacies. Your plan will provide a list of approved network specialty pharmacies.

What if I've already failed step therapy in another state? Prior therapy failures should transfer between states. Provide documentation of previous treatments, dates, and outcomes to support your PA request.

How much does Gilenya cost without insurance? Brand Gilenya can cost over $10,000 per month without coverage. Generic fingolimod options are significantly less expensive and may be more easily approved.

From our advocates: We've seen many Washington patients successfully overturn initial Gilenya denials by working closely with their neurologists to document previous treatment failures and ensure all baseline testing is complete before resubmission. The key is thorough preparation and understanding your plan's specific requirements.

Counterforce Health specializes in turning insurance denials into targeted, evidence-backed appeals. The platform helps patients, clinicians, and specialty pharmacies get prescription drugs approved by analyzing denial letters, plan policies, and clinical notes to draft point-by-point rebuttals aligned with each plan's specific requirements.

For complex cases involving multiple denials or unclear coverage criteria, platforms like Counterforce Health can help identify the specific denial basis and develop targeted appeal strategies using payer-specific workflows and evidence requirements.

Sources & Further Reading

Disclaimer: This information is for educational purposes only and is not medical advice. Coverage policies vary by specific plan and are subject to change. Always consult with your healthcare provider and insurance plan directly for the most current requirements and procedures. For additional help with insurance appeals in Washington, contact the Office of the Insurance Commissioner at 1-800-562-6900.

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