By Counterforce Health Team in Enbrel (etanercept) —

A Realistic Enbrel (etanercept) Approval Scenario with Blue Cross Blue Shield in Pennsylvania: From Request to Yes

Answer Box: Getting Enbrel Covered by Blue Cross Blue Shield in Pennsylvania

Fastest path to approval: Submit prior authorization through your BCBS provider portal with complete documentation (diagnosis, failed DMARDs/biosimilars, TB/hepatitis screening). If denied, use Pennsylvania's Independent External Review—50% overturn rate. Start today: Call BCBS member services (number on your card) to confirm PA requirements and request forms.

Table of Contents

  1. Patient Profile: Sarah's Journey
  2. Pre-Authorization Preparation
  3. Initial Submission Process
  4. The Verdict: Initial Denial
  5. Appeal Strategy and Execution
  6. Resolution: Getting to Yes
  7. What We'd Do Differently
  8. Templates and Checklists
  9. FAQ

Patient Profile: Sarah's Journey

Sarah, a 34-year-old teacher from Pittsburgh, was diagnosed with rheumatoid arthritis two years ago. Despite trying methotrexate and leflunomide, her joint pain and morning stiffness continued to interfere with her work. Her rheumatologist at UPMC recommended Enbrel (etanercept), but Sarah's Highmark Blue Shield plan required prior authorization.

Sarah's Medical History:

  • Moderate to severe RA (DAS28 score: 5.2)
  • Failed methotrexate (liver enzyme elevation)
  • Failed leflunomide (inadequate response after 4 months)
  • No history of tuberculosis or hepatitis B
  • Currently on prednisone 10mg daily for symptom control

Insurance Details:

  • Highmark Blue Shield Pennsylvania (employer-sponsored)
  • Enbrel listed as non-preferred, requiring PA and step therapy
  • Annual deductible: $2,000

Pre-Authorization Preparation

Sarah's rheumatologist, Dr. Martinez, knew that thorough preparation was key to BCBS approval. Based on Highmark's PA requirements, they needed to document:

Required Safety Screening

TB Screening (completed within 12 months):

  • QuantiFERON-TB Gold: Negative
  • Chest X-ray: Normal
  • TB risk assessment: Low risk

Hepatitis B Screening:

  • HBsAg: Negative
  • Anti-HBc: Negative
  • Anti-HBs: Positive (prior vaccination)

Baseline Labs:

  • CBC: Normal
  • Liver function tests: Mildly elevated ALT (reason for MTX discontinuation)

Step Therapy Documentation

Dr. Martinez compiled detailed records showing:

  1. Methotrexate trial: 15mg weekly for 16 weeks
    • Outcome: 40% increase in ALT, discontinued for hepatotoxicity
    • Documentation: Lab results, progress notes
  2. Leflunomide trial: 20mg daily for 18 weeks
    • Outcome: <20% improvement in joint count, inadequate response
    • Documentation: DAS28 scores, patient-reported outcomes

Medical Necessity Letter

The letter included:

  • ICD-10 diagnosis: M05.79 (Rheumatoid arthritis with rheumatoid factor, multiple sites)
  • Disease severity metrics (DAS28, HAQ-DI scores)
  • Failed conventional DMARDs with specific reasons
  • Clinical rationale for Enbrel over biosimilars
  • Treatment goals and monitoring plan
Tip: Counterforce Health helps clinicians create targeted, evidence-backed appeals by analyzing denial letters and plan policies to draft point-by-point rebuttals that align with each payer's specific requirements.

Initial Submission Process

Portal Submission

Dr. Martinez's office submitted the PA request through the Availity provider portal, as Highmark requires electronic submission for all pharmacy PAs.

Documents Included:

  • Prescription Drug Medication Request Form
  • Medical necessity letter (2 pages)
  • Lab results (TB screening, hepatitis B, CBC, LFTs)
  • Progress notes from last 3 visits
  • Prior therapy documentation with dates and outcomes

Submission Details:

  • Date submitted: March 15, 2024
  • Highmark case number: PA-2024-789456
  • Requested quantity: 50mg weekly injections
  • Days supply: 90 days

Timeline Expectations

According to Highmark's policies:

  • Standard review: 5-15 business days
  • Urgent review: 24-72 hours
  • Status tracking available through provider portal

The Verdict: Initial Denial

Denial Date: March 28, 2024 (13 days after submission)

Reason for Denial: "Prior authorization denied. Member must trial and fail preferred biosimilar etanercept (Erelzi) before Enbrel can be considered. Please resubmit with documentation of Erelzi failure or contraindication."

Understanding the Denial

The denial was based on Highmark's step therapy requirements, which prefer biosimilars over originator biologics. While Sarah had failed conventional DMARDs, she hadn't tried the preferred etanercept biosimilar.

Sarah's Options:

  1. Trial Erelzi (biosimilar) first
  2. Appeal with contraindication to biosimilar
  3. Pay out-of-pocket (~$5,000/month)

Appeal Strategy and Execution

Dr. Martinez decided to appeal based on a patient-specific contraindication to biosimilars. Sarah had a documented history of severe allergic reactions to inactive ingredients commonly found in biosimilar formulations.

Internal Appeal (Level 1)

Appeal Submitted: April 5, 2024 Method: Highmark provider portal + fax backup

New Evidence Presented:

  • Allergy testing results showing sensitivity to polysorbate 80 (present in Erelzi)
  • Immunologist consultation note recommending originator biologic
  • Updated medical necessity letter emphasizing safety concerns
  • Patient impact statement describing functional limitations

Peer-to-Peer Review

Scheduled: April 12, 2024 Duration: 15 minutes Participants: Dr. Martinez and Highmark medical director

Key Talking Points:

  • "Patient has documented Type I hypersensitivity to polysorbate 80, which is present in Erelzi but not in Enbrel"
  • "Forcing biosimilar trial could result in serious allergic reaction and treatment delay"
  • "ACR guidelines support individualized biologic selection based on patient factors"
  • "Enbrel has established safety profile for this patient population"

Level 1 Appeal Result

Decision Date: April 18, 2024 Outcome: Partial approval for 90-day trial with requirement for efficacy documentation

Resolution: Getting to Yes

Final Approval Terms

Coverage Approved:

  • Enbrel 50mg weekly injections
  • Initial approval: 6 months
  • Copay: $75/month (with manufacturer copay card)
  • Specialty pharmacy delivery required

Monitoring Requirements:

  • Labs every 3 months (CBC, LFTs)
  • Rheumatology follow-up every 3 months
  • Documentation of clinical response for renewal PA

Patient Outcome

3-Month Follow-up:

  • DAS28 improved from 5.2 to 2.8
  • Morning stiffness reduced from 2 hours to 30 minutes
  • Able to return to full teaching duties
  • No adverse effects reported

6-Month Renewal:

  • Submitted with response documentation
  • Approved for 12-month continuation
  • No additional requirements

What We'd Do Differently

Earlier Preparation

  • Order safety screening labs 2-3 weeks before appointment
  • Document all prior therapies with specific dates and outcomes
  • Consider allergy testing if patient has reaction history

Stronger Initial Submission

  • Include patient impact statement in original PA
  • Attach relevant guidelines supporting first-line biologic use
  • Submit via portal AND fax for backup documentation

Proactive Communication

  • Call BCBS PA department to confirm complete submission
  • Request expedited review if patient experiencing flare
  • Engage Counterforce Health early for complex cases
From our advocates: We've found that BCBS denials often stem from incomplete safety screening documentation. One composite case involved a patient whose initial PA was denied for "missing TB screening," even though results were submitted. The issue was that the test date was 13 months old—just outside the 12-month window. Reordering current labs and resubmitting led to quick approval.

Templates and Checklists

Pre-PA Checklist

Patient Information:

  • Insurance card copy
  • Policy/group number
  • Prior authorization history

Clinical Documentation:

  • Current diagnosis with ICD-10 code
  • Disease severity assessment (DAS28, HAQ-DI)
  • Prior therapy table with dates, doses, outcomes
  • Contraindications to preferred agents

Safety Screening (within 12 months):

  • TB screening (IGRA or PPD + chest X-ray)
  • Hepatitis B panel (HBsAg, anti-HBc, anti-HBs)
  • Baseline CBC and liver function tests
  • Infection risk assessment

Medical Necessity Letter Template

Re: Prior Authorization Request for Enbrel (etanercept)
Patient: [Name], DOB: [Date], ID: [Member ID]

DIAGNOSIS: [ICD-10 code and description]

CLINICAL PRESENTATION:
- Disease duration and severity
- Current symptoms and functional impact
- Objective measures (joint counts, lab values)

PRIOR TREATMENTS:
1. [Drug name]: [dose], [duration], [outcome/reason for discontinuation]
2. [Drug name]: [dose], [duration], [outcome/reason for discontinuation]

RATIONALE FOR ENBREL:
- FDA-approved indication
- Contraindications to preferred agents
- Patient-specific factors favoring this choice

SAFETY SCREENING:
- TB screening: [test type], [date], [result]
- Hepatitis B: [tests], [date], [results]
- Baseline labs: [date], [relevant values]

TREATMENT PLAN:
- Dosing schedule
- Monitoring plan
- Expected outcomes

[Prescriber signature and credentials]

Appeal Script for Patients

"Hello, I'm calling about a prior authorization denial for Enbrel. My member ID is [number]. The denial letter dated [date] states [reason]. My doctor has additional medical information showing why I need this specific medication. Can you please tell me how to submit an appeal and what forms I need?"

FAQ

How long does BCBS PA take in Pennsylvania? Standard reviews take 5-15 business days. Urgent reviews are completed in 24-72 hours if medical urgency is documented.

What if Enbrel is non-formulary on my plan? You can request a formulary exception with medical necessity documentation. If denied, Pennsylvania's Independent External Review has overturned about 50% of denials.

Can I request an expedited appeal? Yes, if delay would seriously jeopardize your health. Your doctor must complete a Physician Certification Form documenting the urgency.

Does step therapy apply if I failed similar drugs outside Pennsylvania? Yes, but you must provide documentation from your previous providers showing specific drugs tried, doses, durations, and reasons for discontinuation.

What's Pennsylvania's external review success rate? About 50% of health insurance denials are overturned through Pennsylvania's Independent External Review process.

How much does Enbrel cost with BCBS coverage? Costs vary by plan. With prior authorization approval, typical copays range from $50-200/month. Manufacturer copay cards can reduce this to $5-25/month for eligible patients.

Can I use Enbrel copay cards with BCBS? Most commercial BCBS plans allow manufacturer copay assistance. Check with your plan and the Enbrel support program for eligibility.

What happens if my appeal is denied? You can file an Independent External Review with Pennsylvania's Insurance Department within 4 months of your final denial letter. This is a free, state-supervised process with independent medical reviewers.

Sources & Further Reading

Disclaimer: This information is for educational purposes only and does not constitute medical or legal advice. Insurance coverage policies vary by plan and change frequently. Always consult with your healthcare provider and insurance company for the most current requirements and procedures. For personalized assistance with complex appeals, consider consulting with healthcare coverage advocates or legal professionals specializing in insurance matters.

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