By Counterforce Health Team in Mavenclad (cladribine tablets) —

How to Get Mavenclad (Cladribine Tablets) Covered by Cigna in New York: A Complete Prior Authorization and Appeals Guide

Answer Box: Getting Mavenclad Covered by Cigna in New York

Cigna requires prior authorization for Mavenclad (cladribine tablets) with strict step therapy requirements. You must document failure/intolerance of two other MS therapies OR one high-efficacy agent (Ocrevus, Tysabri, Kesimpta, Lemtrada, or Briumvi). Your neurologist submits the PA through Cigna's provider portal or Express Scripts. If denied, you have 180 days to appeal internally, then can request New York's external review through DFS within 4 months. First step today: Gather documentation of all prior MS therapies and their outcomes—this is critical for meeting Cigna's step therapy criteria.

Table of Contents

  1. Coverage Requirements at a Glance
  2. Step-by-Step: Fastest Path to Approval
  3. Common Denial Reasons & How to Fix Them
  4. Appeals Playbook for Cigna in New York
  5. Medical Necessity Letter Essentials
  6. Costs & Patient Assistance Programs
  7. When to Escalate: New York External Review
  8. Frequently Asked Questions

Coverage Requirements at a Glance

Requirement What It Means Documentation Needed Source
Prior Authorization Required before dispensing PA form via provider portal Cigna PA Policy
Step Therapy Must fail 2 MS therapies OR 1 high-efficacy agent Chart notes showing inadequate response/intolerance Cigna Coverage Criteria
Specialist Requirement Neurologist or MS specialist Prescriber credentials verification Cigna PA Policy
Diagnosis Confirmation Relapsing MS (not CIS) ICD-10 codes, MRI reports, clinical notes FDA Prescribing Information
Safety Requirements Lymphocyte monitoring, contraception Lab results, pregnancy test, contraception plan FDA Prescribing Information

Step-by-Step: Fastest Path to Approval

1. Confirm Your Diagnosis Documentation

Who: Patient and neurologist
What: Ensure you have a confirmed diagnosis of relapsing MS (including active secondary progressive MS). Mavenclad is not approved for clinically isolated syndrome.
Timeline: Before PA submission
Source: FDA Prescribing Information

2. Document Prior Therapy Failures

Who: Neurologist's office
What: Gather records showing inadequate efficacy or significant intolerance to either:

  • Two other disease-modifying MS therapies, OR
  • One of these high-efficacy agents: Kesimpta (ofatumumab), Tysabri (natalizumab), Briumvi, Lemtrada, Ocrevus, or Ocrevus Zunovo
    Timeline: Can take 1-2 weeks to collect records
    Source: Cigna Step Therapy Requirements

3. Complete Safety Screening

Who: Patient with neurologist
What: Obtain baseline lymphocyte count, liver function tests, pregnancy test (if applicable), and contraception counseling
Timeline: 1-2 weeks before PA submission
Source: FDA Prescribing Information

4. Submit Prior Authorization

Who: Neurologist's office
What: Submit PA through Cigna provider portal or Express Scripts with all documentation
Timeline: Cigna has up to 15 business days to respond
Portal: Contact Cigna provider services for current portal access

5. Monitor for Decision

Who: Patient and neurologist's office
What: Check PA status; Cigna will notify of approval or denial
Timeline: Typically 5-15 business days
Next step: If denied, proceed to appeals process

Common Denial Reasons & How to Fix Them

Denial Reason Fix Strategy Required Documentation
Insufficient step therapy Document specific failures/intolerances Chart notes with dates, adverse events, MRI progression
Not prescribed by specialist Transfer prescription to neurologist Neurologist credentials, referral documentation
Inadequate MS subtype confirmation Clarify relapsing vs. progressive Updated neurologist assessment, MRI reports
Missing safety requirements Complete all monitoring Lab results, pregnancy test, contraception plan
"Not medically necessary" Strengthen clinical rationale Guidelines citations, peer-reviewed literature

Appeals Playbook for Cigna in New York

Internal Appeals (Required First Step)

Level 1 Appeal

  • Timeline: Must file within 180 days of denial
  • Process: Submit written appeal with additional clinical documentation
  • Decision time: 72 hours for standard, 24 hours for expedited
  • Contact: Use denial letter instructions or Cigna member services

Level 2 Appeal

  • Timeline: Within 60 days of Level 1 denial
  • Process: Request peer-to-peer review with Cigna medical director
  • Preparation: Have neurologist ready to discuss case directly

New York External Review (After Internal Appeals)

If Cigna denies your internal appeals, you have powerful rights under New York law:

  • Timeline: 4 months after final internal denial (expanded from 60 days in 2025)
  • Process: File with NY Department of Financial Services (DFS)
  • Cost: Maximum $25 (waived for Medicaid or financial hardship)
  • Decision: Binding on Cigna if overturned
  • Urgent cases: 72-hour decision for specialty drugs critical to care

How to file: Visit the DFS External Appeals Portal or call the Healthcare Appeals Ombudsman at 1-800-NYS-APPEAL.

From our advocates: We've seen Cigna specialty drug denials overturned in New York external review when patients provided strong medical literature and documented progression on prior therapies. The key is thorough documentation and citing published MS treatment guidelines. Success rates approach 57% statewide for complex drug appeals, but individual outcomes vary.

Medical Necessity Letter Essentials

Your neurologist's medical necessity letter should include:

Clinical History Section

  • Confirmed relapsing MS diagnosis with ICD-10 code
  • Disease duration and progression pattern
  • Current EDSS score and functional status
  • Recent MRI findings showing activity

Prior Therapy Documentation

  • For each failed therapy: Drug name, duration, reason for discontinuation
  • Specific outcomes: Breakthrough relapses, MRI progression, adverse events
  • Contraindications: Why alternatives aren't suitable

Mavenclad Rationale

  • Why Mavenclad is appropriate for this patient's MS subtype
  • Expected benefits based on clinical trials
  • Monitoring plan for lymphocytes and safety parameters

Supporting Evidence

Costs & Patient Assistance Programs

Mavenclad's 2-year treatment course typically costs over $100,000 before insurance. Financial assistance options include:

  • Merck Patient Assistance Program: Income-based free drug program
  • Mavenclad Copay Program: Reduces out-of-pocket costs for commercially insured patients
  • State pharmaceutical assistance: New York's Elderly Pharmaceutical Insurance Coverage (EPIC) program
  • Foundation grants: National MS Society, Patient Access Network Foundation

Contact the manufacturer at Mavenclad.com for current program details.

When to Escalate: New York External Review

Consider New York's external review if:

  • Cigna denies both internal appeal levels
  • You have strong medical evidence supporting Mavenclad
  • Delay in treatment could worsen your MS progression

Counterforce Health helps patients navigate complex insurance denials by analyzing denial letters, identifying specific policy gaps, and drafting evidence-backed appeals tailored to each insurer's requirements. Our platform automates much of the appeals process, pulling relevant medical literature and ensuring all procedural requirements are met for New York external reviews.

The DFS External Appeals Database shows precedent cases you can reference. Search for MS drugs and Cigna to see successful appeal strategies.

Frequently Asked Questions

How long does Cigna prior authorization take for Mavenclad in New York?
Standard PA decisions take up to 15 business days. Expedited reviews (for urgent medical needs) are processed within 24-72 hours.

What if Mavenclad is non-formulary on my Cigna plan?
You can request a formulary exception by demonstrating medical necessity and showing that formulary alternatives are inappropriate or have failed.

Can I request an expedited appeal if my MS is worsening?
Yes. If delay could seriously jeopardize your health, your neurologist can request expedited review with 24-hour decision timelines.

Does Cigna's step therapy apply if I failed therapies while living outside New York?
Yes. Prior therapy failures from any state count toward step therapy requirements, as long as they're properly documented.

What happens if I'm approved for only part of the Mavenclad treatment course?
Partial approvals sometimes occur. Your neurologist can appeal for the complete 2-year course using clinical evidence about the drug's intended dosing schedule.

Who can help me file an external appeal in New York?
Community Health Advocates offers free assistance at 888-614-5400. The DFS Healthcare Appeals Ombudsman (1-800-NYS-APPEAL) also provides guidance.

Checklist: What to Gather Before You Start

Before beginning the PA process, collect:

  • Insurance card and policy details
  • Complete medical records from neurologist
  • MRI reports showing MS lesions and activity
  • Documentation of all prior MS therapies tried
  • Reasons each prior therapy failed or caused intolerance
  • Current lab results (lymphocyte count, liver function)
  • Pregnancy test results (if applicable)
  • Contact information for neurologist's office
  • Any previous denial letters from Cigna

Getting Mavenclad covered by Cigna in New York requires careful preparation, but the state's strong appeal rights give you multiple pathways to success. Focus on thorough documentation of prior therapy failures and work closely with your neurologist to build a compelling medical necessity case. Counterforce Health can help streamline this process by identifying the specific evidence Cigna requires and crafting appeals that address their policy criteria directly.

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 and policy terms. Always consult with your healthcare provider and insurance company for guidance specific to your situation. For additional help with insurance appeals in New York, contact Community Health Advocates at 888-614-5400 or the NY Department of Financial Services.

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