By Counterforce Health Team in Enbrel (etanercept) —

Humana's Coverage Criteria for Enbrel (etanercept) in Ohio: What Counts as "Medically Necessary"?

Answer Box: Getting Enbrel Covered by Humana in Ohio

Humana requires prior authorization for Enbrel (etanercept) with step therapy requirements favoring biosimilars first. Medical necessity requires: specialist prescriber (rheumatologist/dermatologist), documented failure of conventional DMARDs for 3+ months, negative TB/hepatitis B screening within 12 months, and clear diagnosis with ICD-10 codes. First step: Have your specialist submit a comprehensive prior authorization through Humana's provider portal with all required documentation. If denied, you have 65 days to file an internal appeal, then 180 days for external review through the Ohio Department of Insurance.

Table of Contents

Policy Overview: How Humana Covers Enbrel

Humana covers Enbrel (etanercept) across its Medicare Advantage, commercial, and Ohio Medicaid plans, but with strict utilization management requirements. The medication typically appears on the specialty tier (Tier 5) with prior authorization requirements and quantity limits.

Plan Types and Coverage:

  • Medicare Advantage: Specialty tier placement with 30-day quantity limits and Limited Access (LA) designation requiring specialty pharmacy dispensing
  • Commercial plans: Similar PA requirements with step therapy protocols
  • Ohio Medicaid (Humana): Must use network pharmacies per Ohio Department of Medicaid guidelines

Enbrel's annual cost exceeds $100,000 before rebates, making it subject to Humana's most stringent coverage criteria. The formulary placement includes the "DL" (Dispensing Limit) indicator, restricting fills to 30-day supplies.

Indication Requirements: FDA-Approved Uses

Humana covers Enbrel for FDA-approved indications with appropriate ICD-10 coding:

Covered Conditions:

  • Rheumatoid arthritis (moderate to severe)
  • Psoriatic arthritis
  • Ankylosing spondylitis
  • Plaque psoriasis (moderate to severe)
  • Polyarticular juvenile idiopathic arthritis

Off-label uses require additional justification with peer-reviewed literature and recognized drug compendia support. The prescriber must document why FDA-approved alternatives are inappropriate for the specific clinical scenario.

Step Therapy & Biosimilar Requirements

Humana implements step therapy protocols requiring trial of preferred alternatives before approving Enbrel. This reflects the preference for biosimilars when clinically appropriate.

Required First-Line Therapies:

  1. Conventional DMARDs: Methotrexate, sulfasalazine, or hydroxychloroquine for minimum 3 months
  2. Preferred biosimilars: Erelzi (etanercept-szzs) or Eticovo (etanercept-ykro) if available on formulary
  3. Alternative TNF inhibitors: Humira biosimilars may be preferred in some cases

Medical Exceptions to Step Therapy:

  • Documented contraindication to preferred agents
  • Previous intolerance with specific adverse events
  • Drug-drug interactions precluding use
  • Clinical urgency requiring immediate biologic therapy
Clinician Corner: Medical Necessity Letter Essentials

Your prior authorization should include: (1) Specific diagnosis with ICD-10 code, (2) Documentation of 3+ months conventional DMARD trial with outcomes, (3) Clinical rationale for Enbrel over biosimilars, (4) Current disease activity measures (joint counts, lab values), (5) TB and hepatitis B screening results, (6) Treatment goals and monitoring plan. Reference FDA labeling and specialty society guidelines where applicable.

Required Diagnostics & Screening

Due to Enbrel's immunosuppressive effects, Humana requires comprehensive screening before approval:

Mandatory Screening Tests:

  • Tuberculosis screening: PPD, QuantiFERON, or T-SPOT.TB within 12 months
  • Hepatitis B panel: Surface antigen and core antibody testing
  • Complete blood count: Baseline values for monitoring
  • Liver function tests: AST/ALT within normal limits

Clinical Documentation Requirements:

  • Current disease activity assessment
  • Swollen/tender joint counts (for arthritis indications)
  • Inflammatory markers (ESR, CRP)
  • Functional assessment scores when applicable
  • Imaging studies supporting diagnosis

The screening must be current—typically within 6-12 months of the PA request. Positive TB or hepatitis B results require specialist clearance and appropriate treatment before Enbrel approval.

Specialty Pharmacy Requirements

Humana designates Enbrel as Limited Access (LA), requiring dispensing through CenterWell Specialty Pharmacy or other approved specialty pharmacies in Ohio.

Dispensing Process:

  1. Prescriber submits prescription electronically to CenterWell
  2. Pharmacy verifies insurance coverage and PA status
  3. Patient receives delivery coordination call (often from unknown number)
  4. Medication ships with cold storage requirements
  5. Patient must be available for immediate refrigeration

Ohio Network Requirements: For Ohio Medicaid Humana members, specialty pharmacy services must be through network providers as designated by Gainwell, the state's Pharmacy Benefit Manager.

Medical Necessity Documentation

Counterforce Health helps patients and clinicians navigate complex prior authorization requirements by analyzing denial patterns and crafting evidence-based appeals. Their platform identifies specific coverage criteria and matches clinical documentation to payer requirements, streamlining the approval process for specialty medications like Enbrel.

Core Medical Necessity Elements:

  • Specialist prescriber: Rheumatologist, dermatologist, or other appropriate specialist
  • Adequate trial duration: Minimum 3 months conventional therapy unless contraindicated
  • Objective disease measures: Laboratory values, imaging, validated assessment tools
  • Treatment goals: Specific, measurable outcomes expected
  • Safety monitoring plan: Regular follow-up schedule and parameters

Evidence Hierarchy:

  1. FDA prescribing information
  2. Peer-reviewed clinical studies
  3. Professional society guidelines (ACR, AAD)
  4. Recognized drug compendia for off-label uses

The medical necessity letter should directly address Humana's specific criteria and explain why preferred alternatives are inappropriate for the individual patient.

Appeals Process in Ohio

When Humana denies Enbrel coverage, Ohio residents have multiple appeal levels with specific timelines:

Internal Appeals (First Level):

  • Timeline: 65 days from denial notice
  • Process: Submit through Humana provider portal or by mail
  • Decision timeframe: 30 days standard, 72 hours expedited
  • Required documents: Complete medical records, specialist letter, screening results

External Review (Final Level):

  • Timeline: 180 days from final internal denial
  • Process: File with Ohio Department of Insurance
  • Contact: ODI Consumer Services at 1-800-686-1526
  • Decision: Binding on insurer if overturned
From Our Advocates

We've seen successful Enbrel appeals when specialists provide detailed documentation of biosimilar trials and outcomes. One effective approach involved submitting pharmacy records showing specific adverse events with preferred alternatives, along with clinical notes demonstrating improved disease control with Enbrel. Clear documentation of medical necessity—not just preference—makes the difference in appeal outcomes.

Expedited Appeals: Available when delays could seriously jeopardize health. Requires physician certification of urgency and typically decides within 72 hours.

Common Denial Reasons & Solutions

Denial Reason Solution Strategy Required Documentation
Step therapy not completed Document DMARD trial duration and outcomes Pharmacy records, clinical notes showing 3+ months therapy
Missing TB screening Submit current screening results PPD, QuantiFERON, or T-SPOT results within 12 months
Non-specialist prescriber Transfer care or obtain specialist consultation Referral to rheumatologist or dermatologist
Biosimilar not tried Document contraindication or previous failure Specific adverse events, drug interaction documentation
Insufficient disease activity Provide objective measures Joint counts, lab values, validated assessment scores

Costs & Patient Assistance

Manufacturer Support:

  • Enbrel SupportPlus copay assistance
  • Maximum savings vary by insurance type
  • Income restrictions may apply

Foundation Assistance:

  • Patient Access Network Foundation
  • HealthWell Foundation
  • State pharmaceutical assistance programs

Ohio-Specific Resources:

  • Ohio Department of Aging prescription assistance
  • Community health center sliding fee programs

Quick Reference Checklist

Before Starting PA Process:

  • Specialist prescriber identified
  • TB screening completed (within 12 months)
  • Hepatitis B panel results available
  • DMARD trial documented (3+ months)
  • Current disease activity assessment
  • Insurance coverage verified

PA Submission Requirements:

  • Complete medical history
  • Specialist consultation notes
  • Laboratory results and imaging
  • Prior therapy documentation
  • Treatment goals and monitoring plan
  • Screening test results

If Denied:

  • Review denial letter for specific reasons
  • Gather additional documentation
  • Submit internal appeal within 65 days
  • Consider expedited review if urgent
  • Prepare for external review if needed

When navigating complex coverage requirements, Counterforce Health provides specialized support for turning insurance denials into successful appeals through targeted, evidence-based documentation.

Disclaimer: This information is for educational purposes only and does not constitute medical or legal advice. Coverage policies change frequently—always verify current requirements with Humana directly and consult healthcare providers for medical decisions.

Sources & Further Reading:

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