By Counterforce Health Team in Elelyso (taliglucerase alfa) —

How to Get Elelyso (Taliglucerase Alfa) Covered by Cigna in Pennsylvania: Appeals, Timelines & Step Therapy Override

Quick Answer: Getting Elelyso Covered by Cigna in Pennsylvania

Elelyso (taliglucerase alfa) requires prior authorization from Cigna before coverage. In Pennsylvania, you have strong appeal rights if denied, including step therapy override protections and a new state external review program with 50% overturn rates. First step today: Have your doctor submit a PA request through Accredo's provider portal or CoverMyMeds, including Gaucher disease diagnosis, prior therapy failures, and medical necessity documentation. If denied, you can appeal internally (60 days) then externally through Pennsylvania's Independent Review Program within 4 months.

Table of Contents

Why Pennsylvania State Rules Matter

Pennsylvania enacted significant healthcare coverage reforms in 2022 that directly impact how Cigna must handle specialty drug denials like Elelyso. Unlike many states that defer to federal standards, Pennsylvania now operates its own external review program with stricter timelines and higher overturn rates than the federal process.

Here's what this means for your Elelyso coverage:

  • Step therapy override protections: Pennsylvania law requires Cigna to grant exceptions when you've failed required drugs, have contraindications, or are stable on current therapy
  • Expedited appeals: 24-hour decisions for urgent cases, 72 hours for prescription drugs
  • Independent external review: 50% of denials overturned in the program's first year, with decisions binding on insurers

These state protections apply to most Cigna plans sold in Pennsylvania, including marketplace and employer-sponsored coverage (though self-funded employer plans may be exempt under federal ERISA rules).

Cigna's Prior Authorization Requirements

Elelyso requires mandatory prior authorization through Cigna's specialty pharmacy partner, Accredo. The PA process typically includes step therapy requirements, meaning you may need to try preferred alternatives first.

Coverage Requirements Table

Requirement What It Means Documentation Needed Source
PA Required Must get approval before dispensing Doctor submits PA request Cigna PA Requirements
Gaucher Disease Diagnosis Confirmed Type 1 Gaucher disease Enzyme test results, genetic testing, or clinical diagnosis FDA Label Requirements
Age Restriction Patients 4 years and older Birth date verification FDA Access Data
Step Therapy May require trying Cerezyme or VPRIV first Prior therapy records, failure/intolerance documentation Express Scripts PA FAQ
Specialist Prescriber Often requires specialist (hematologist, geneticist) Prescriber credentials verification Cigna Policy Guidelines

Submitting Your PA Request

Fastest path: Use electronic submission through:

Alternative methods:

  • Phone: 1-800-882-4462
  • Fax: Download forms from Cigna's provider portal (verify current number)

Timeline: Non-urgent requests decided within 72 hours; urgent cases within 24 hours.

Step Therapy Protections in Pennsylvania

Pennsylvania's 2022 healthcare reforms established clear criteria for step therapy override exceptions. If Cigna requires you to try Cerezyme or VPRIV before approving Elelyso, you can request an override if:

Override Criteria

  • Contraindication: The required drug would cause adverse reactions
  • Unlikely benefit: You're unlikely to achieve clinical benefit from the step drug
  • Previous failure: You've tried and failed the required drug under any insurance plan
  • Stability: You're currently stable on Elelyso and switching isn't clinically appropriate

Documentation Requirements

Your doctor must provide:

  • Clinical rationale for why step therapy isn't appropriate
  • Records of previous therapy attempts and outcomes
  • Any contraindications or risk factors
  • Evidence of current treatment stability (if applicable)

Timeline: Urgent override requests must be decided within 24 hours; non-urgent prescription requests within 72 hours.

From our advocates: We've seen patients successfully override step therapy by having their specialist clearly document why enzyme replacement therapies aren't interchangeable—each has different manufacturing processes and potential immunogenicity profiles. A detailed letter explaining why switching from a stable therapy could risk treatment interruption often strengthens the case.

Internal Appeals Process & Timelines

If Cigna denies your Elelyso PA request, Pennsylvania law gives you specific appeal rights with strict insurer deadlines.

Step-by-Step Internal Appeal Process

  1. File within 180 days of the denial notice
  2. Submit written appeal using Cigna's appeal form
  3. Include supporting documentation:
    • Original denial letter/EOB
    • Medical necessity letter from prescriber
    • Clinical notes and lab results
    • Prior therapy documentation
  4. Cigna reviews within 60 days (expedited: 24 hours if urgent)
  5. Independent reviewer (someone not involved in original denial)
  6. Medical necessity denials reviewed by clinical staff who can reverse but not uphold denials

When to Request Expedited Review

Your physician can request expedited review when:

  • Your health condition could seriously jeopardize your life or health
  • You could lose ability to regain maximum function
  • You're currently undergoing treatment with Elelyso

Contact for appeals: Use Cigna's member portal or call the number on your insurance card.

Pennsylvania's External Review Program

If Cigna upholds the denial after internal appeal, Pennsylvania's Independent External Review Program provides a powerful second chance. Launched in 2024, this state-run program has overturned approximately 50% of appealed denials in its first year.

How External Review Works

  1. Eligibility: Must complete Cigna's internal appeal first and receive "Final Adverse Benefit Determination"
  2. Deadline: Submit external review request within 4 months of final denial
  3. Submit request: Online at pa.gov or by mail/fax
  4. Review assignment: Independent Review Organization (IRO) assigned within 1 business day
  5. Additional evidence: You have 15 days to submit extra supporting information
  6. Decision timeline: 45 days for standard review, 72 hours for expedited
  7. Binding decision: If IRO overturns denial, Cigna must provide coverage immediately

Required Documentation

  • Final denial letter from Cigna
  • All medical records and clinical notes
  • Prescriber's medical necessity letter
  • Any relevant clinical studies or guidelines
  • Patient impact statement (optional but helpful)

Contact for help: Pennsylvania Insurance Department Consumer Services at 1-877-881-6388 or [email protected].

Practical Scripts & Documentation

Patient Phone Script for Cigna

"Hi, I'm calling about a prior authorization denial for Elelyso, reference number [X]. My doctor says this is medically necessary for my Gaucher disease, and I'd like to understand the specific denial reason and how to appeal. Can you walk me through the appeal process and send me the required forms?"

Medical Necessity Letter Checklist

Your prescriber should include:

  • ✓ Confirmed Gaucher disease Type 1 diagnosis (enzyme levels, genetics)
  • ✓ Clinical symptoms and disease progression
  • ✓ Previous treatments tried and outcomes (include dates, doses, reasons for discontinuation)
  • ✓ Why Elelyso is specifically needed vs. alternatives
  • ✓ Dosing rationale (60 U/kg every 2 weeks is standard)
  • ✓ References to FDA labeling and clinical guidelines
  • ✓ Patient's current clinical status and treatment goals

Key Clinical Evidence to Reference

  • FDA-approved labeling for Elelyso
  • American College of Medical Genetics practice guidelines for Gaucher disease
  • International Collaborative Gaucher Group recommendations
  • Peer-reviewed studies on enzyme replacement therapy effectiveness

Cost Savings & Patient Support

While pursuing coverage approval, explore these cost assistance options:

Manufacturer Support:

  • Pfizer Patient Assistance Program (verify current programs at pfizer.com)
  • Copay assistance for eligible commercially insured patients

Foundation Support:

  • National Gaucher Foundation: 1-800-504-3189
  • Patient Advocate Foundation: co-pay relief programs
  • HealthWell Foundation: rare disease assistance

State Resources:

  • Pennsylvania CHIP and Medicaid programs
  • Pharmaceutical Assistance Contract for the Elderly (PACE)

When to Contact State Regulators

Contact the Pennsylvania Insurance Department if:

  • Cigna fails to meet required timelines (72 hours for PA decisions, 60 days for appeals)
  • You're denied an expedited review despite meeting urgent criteria
  • Cigna doesn't provide clear denial reasons or appeal instructions
  • You need help navigating the external review process

Pennsylvania Insurance Department Consumer Services:

For complex cases, consider contacting patient advocacy organizations like the National Gaucher Foundation (1-800-504-3189) or the Pennsylvania Health Law Project for free legal assistance.

FAQ

How long does Cigna prior authorization take for Elelyso in Pennsylvania? Standard PA requests: up to 72 hours. Expedited requests (when health is at risk): 24 hours. Electronic submissions through CoverMyMeds or Accredo's portal are typically fastest.

What if Elelyso isn't on Cigna's formulary? You can request a formulary exception by having your doctor submit clinical documentation showing medical necessity. Pennsylvania's step therapy override protections apply if Cigna requires trying preferred alternatives first.

Can I get an expedited appeal if I'm already on Elelyso? Yes, if switching or discontinuing treatment would jeopardize your health. Your doctor must document the urgency and risk of treatment interruption.

Does step therapy apply if I failed other ERTs outside Pennsylvania? Yes, Pennsylvania law recognizes prior therapy failures under any insurance plan. Your doctor should document previous treatments and outcomes regardless of where they occurred.

How much does Elelyso cost without insurance? Wholesale acquisition cost is approximately $839-$899 per 200-unit vial (prices vary). Most patients require multiple vials per infusion based on weight and dosing (60 U/kg every 2 weeks).

What happens if Pennsylvania's external review overturns Cigna's denial? Cigna must immediately provide coverage for Elelyso, including retroactive coverage if you paid out-of-pocket during the appeal process. The decision is binding on the insurer.

About Counterforce Health: Counterforce Health specializes in turning insurance denials into successful appeals by analyzing denial letters, plan policies, and clinical evidence to create targeted, evidence-backed rebuttals. The platform helps patients, clinicians, and specialty pharmacies navigate complex prior authorization requirements and appeals processes for medications like Elelyso, ensuring proper documentation and procedural compliance to maximize approval chances.

Sources & Further Reading

Disclaimer: This information is for educational purposes only and does not constitute medical or legal advice. Always consult with your healthcare provider and insurance plan for specific coverage decisions. Insurance policies and state regulations may change; verify current requirements with official sources.

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