By Counterforce Health Team in Enbrel (etanercept) —

If Enbrel Isn't Approved by Blue Cross Blue Shield in California: Formulary Alternatives & Exception Paths

Quick Answer: When Blue Cross Blue Shield Denies Enbrel in California

If Blue Cross Blue Shield California denies Enbrel (etanercept), you have formulary alternatives and exception pathways. Most denials stem from step therapy requirements favoring adalimumab biosimilars or other TNF inhibitors. Your fastest options: 1) Try a preferred alternative like Hadlima or adalimumab biosimilar, 2) Request a formulary exception with documented contraindications to preferred agents, or 3) Appeal through California's Independent Medical Review if medically necessary. Start by checking your plan's current specialty drug list and prior authorization policy.

Table of Contents

When Alternatives Make Sense

Blue Cross Blue Shield California typically denies Enbrel due to step therapy requirements that favor preferred TNF inhibitors or biosimilars. According to Blue Shield's 2024 specialty drug lists, adalimumab biosimilars and Hadlima are often grouped as preferred alternatives to Enbrel.

When to consider alternatives:

  • Your plan lists Enbrel as non-preferred or requires step therapy
  • You're starting TNF inhibitor therapy for the first time
  • Previous Enbrel appeals have been unsuccessful
  • You need coverage quickly and can't wait for exception processing

When alternatives may not be appropriate:

  • History of serious adverse reactions to adalimumab or other TNF inhibitors
  • Already stable and responding well to Enbrel
  • Specific contraindications to preferred agents (documented allergies, injection site reactions)
  • Rapid disease progression requiring immediate access to proven therapy
Note: California law provides step therapy override protections, especially when switching would be medically inappropriate or delay necessary care.

Typical Formulary Alternatives

Based on Blue Shield California's specialty formularies, here are common alternatives by therapeutic class:

TNF-α Inhibitors (Same Mechanism as Enbrel)

Adalimumab Products:

  • Adalimumab biosimilars (adalimumab-aacf, adalimumab-aaty, adalimumab-adaz)
  • Hadlima (adalimumab-bwwd)
  • Often preferred on formulary; subcutaneous injection every other week

Other TNF Inhibitors:

  • Infliximab products (IV infusion every 6-8 weeks)
  • Golimumab (Simponi) (monthly subcutaneous)
  • Certolizumab (Cimzia) (subcutaneous, pregnancy-compatible)

Non-TNF Biologics (Different Mechanisms)

IL-17 Inhibitors:

  • Cosentyx (secukinumab) - particularly effective for psoriatic arthritis and ankylosing spondylitis
  • Skyrizi (risankizumab) - IL-23 inhibitor for psoriasis and psoriatic arthritis

Other Mechanisms:

  • Stelara (ustekinumab) - IL-12/23 inhibitor
  • Rinvoq (upadacitinib) - JAK inhibitor
  • Xeljanz (tofacitinib) - JAK inhibitor

Pros and Cons Overview

Alternative Coverage Advantage Clinical Considerations Monitoring Requirements
Adalimumab biosimilars Often preferred; lower cost-sharing Therapeutically equivalent to reference adalimumab Same as Enbrel: TB/HBV screening, CBC monitoring
Hadlima Listed on Performance formulary FDA-approved adalimumab biosimilar Standard TNF inhibitor monitoring
Cosentyx Often preferred for PsA/AS Different mechanism; may work when TNF inhibitors fail Less infection risk vs TNF inhibitors
Rinvoq/Xeljanz Oral administration JAK inhibitor warnings (clotting, malignancy) Enhanced monitoring for cardiovascular events

Access Considerations

Testing Requirements:

  • All TNF inhibitors require tuberculosis screening (IGRA or TST plus chest X-ray)
  • Hepatitis B screening mandatory before starting any TNF inhibitor
  • JAK inhibitors need additional cardiovascular and malignancy risk assessment

Site of Care:

  • Most subcutaneous options (Enbrel alternatives) can be self-administered at home
  • Infliximab requires infusion center visits every 6-8 weeks
  • Oral JAK inhibitors offer convenience but require different monitoring

Exception Strategy

When formulary alternatives aren't medically appropriate, request a formulary exception using Blue Shield's process. Success depends on documenting why preferred alternatives won't work for your specific situation.

Required Documentation

According to Blue Shield's exception forms, you must provide:

  1. Complete diagnosis with ICD-10 codes
  2. Detailed drug history showing:
    • All preferred agents tried with dates and doses
    • Specific outcomes: therapeutic failure, intolerance, or contraindication
    • Duration of trials and maximum doses reached
  3. Medical necessity rationale explaining why Enbrel is uniquely appropriate

Strongest Exception Arguments

Prior Adverse Reactions:

  • Document specific allergic reactions or serious side effects to adalimumab
  • Include emergency department visits or hospitalizations related to preferred agents
  • Provide allergy testing results if available

Therapeutic Failure:

  • Show adequate trials of preferred TNF inhibitors (typically 3-6 months at therapeutic doses)
  • Document objective measures of disease activity during failed trials
  • Include specialist notes confirming lack of response

Contraindications:

  • Medical conditions making preferred agents unsafe
  • Drug interactions with current medications
  • Pregnancy considerations (some agents have different safety profiles)
Tip: Counterforce Health specializes in turning insurance denials into targeted appeals by analyzing your specific denial reasons and crafting evidence-backed rebuttals that align with your plan's own policies.

Timing and Submission

Standard Review: Blue Shield must respond within 72 hours for formulary exceptions Expedited Review: 24 hours if delay would jeopardize health (check expedited box on form)

Submit via:

  • Blue Shield provider portal (verify current link)
  • Fax to number listed on current exception form
  • Include all supporting documentation with initial submission

Switching Logistics

Coordination with Your Provider

Before Starting Alternative:

  1. Review contraindications specific to the new agent
  2. Confirm dosing schedule and administration method
  3. Plan monitoring - some alternatives require different lab schedules
  4. Discuss expectations - onset of action may differ from Enbrel

Switching Timeline:

  • From Enbrel to adalimumab: Start adalimumab at next scheduled Enbrel dose (weekly interval)
  • From Enbrel to infliximab: Coordinate infusion scheduling; may need bridging therapy
  • To different mechanism (IL-17, JAK): May allow immediate start or require brief washout

Pharmacy Coordination

Specialty Pharmacy Requirements:

Financial Assistance:

  • Manufacturer copay programs often available for commercial insurance
  • Foundation grants for Medicare patients or those with high deductibles
  • Verify eligibility before starting new therapy

Re-trying for Enbrel Later

What to Document During Alternative Therapy

If you plan to request Enbrel again after trying alternatives, document:

Treatment Response:

  • Objective disease measures at baseline and regular intervals
  • Functional assessments and quality of life scores
  • Adverse events or tolerability issues with alternative therapy

Reasons for Inadequate Response:

  • Specific symptoms or disease activity that remains uncontrolled
  • Comparison to previous Enbrel response if you were stable before
  • Impact on work, daily activities, or overall health

Building a Stronger Case

Timeline Documentation:

  • Keep detailed records of alternative therapy duration and outcomes
  • Document adequate trial periods (typically 3-6 months for biologics)
  • Note any dose escalations or combination therapies attempted

Specialist Support:

  • Regular rheumatology, dermatology, or gastroenterology follow-up
  • Specialist documentation of treatment failure with preferred agents
  • Guideline-based rationale for returning to Enbrel

Appeals Playbook for California

Internal Appeal Process

Level 1: Plan Grievance

  • Deadline: 60 days from denial
  • Decision time: 30 days (expedited: 72 hours for urgent cases)
  • Submit to: Blue Shield member services (address on denial letter)
  • Required: Copy of denial, medical records, prescriber letter

Level 2: Plan Redetermination (if applicable)

  • Some plans offer second internal level
  • Similar timeline and documentation requirements

External Review: California IMR

After internal appeals, California residents can request Independent Medical Review (IMR) through the Department of Managed Health Care.

Eligibility:

  • Plan upheld denial after internal appeal
  • Denial based on "medical necessity" or experimental/investigational status
  • Must request within 6 months of final plan denial

Process:

  • No cost to member
  • 45 days for standard review, 7 days for urgent cases
  • Independent physician specialists review case
  • Decision is binding on the health plan

Success Rates: California IMR has approximately 10-13% overturn rate overall, with pharmaceutical denials typically having lower overturn rates.

Contact Information:

Common Denial Reasons & Fixes

Denial Reason How to Overturn Required Documentation
Step therapy not met Show failure/contraindication to preferred agents Drug trial history with dates, doses, outcomes
Not medically necessary Provide guideline-based rationale Specialist letter citing ACR/EULAR/AAD guidelines
Experimental/investigational Reference FDA approval and standard of care FDA labeling, peer-reviewed studies, society guidelines
Quantity/dose exceeds limits Justify higher dose based on clinical factors Body weight, disease severity, pharmacokinetic factors
Site of care restriction Show medical necessity for requested setting Contraindications to alternatives, access barriers

Strengthening Your Appeal

Medical Necessity Letter Checklist:

  • Specific diagnosis with severity measures
  • Complete prior therapy history with outcomes
  • Contraindications to formulary alternatives
  • Clinical rationale citing current guidelines
  • Expected outcomes and monitoring plan

Supporting Evidence:

  • Recent lab results and imaging
  • Hospital/ED records related to disease activity
  • Functional assessment scores
  • Quality of life measures

FAQ

Q: How long does Blue Cross Blue Shield prior authorization take in California? A: Standard PA decisions are required within 72 hours. Expedited reviews for urgent cases must be completed within 24 hours. If the plan misses these deadlines, it may trigger automatic approval.

Q: What if Enbrel is completely non-formulary on my plan? A: You can request a formulary exception using Blue Shield's Non-Formulary Exception form. You'll need strong medical necessity documentation showing why all formulary alternatives are inappropriate.

Q: Can I request expedited appeal if I'm already stable on Enbrel? A: Yes, if switching to an alternative would pose serious risk to health or ability to regain maximum function. Document previous disease flares when off Enbrel and specialist recommendation against switching.

Q: Does step therapy apply if I failed TNF inhibitors outside California? A: Previous therapy failures should count regardless of where they occurred. Provide complete medical records documenting the failed trials, including dates, doses, and outcomes.

Q: What's the difference between formulary exception and tier exception? A: Formulary exception requests coverage for a non-covered drug. Tier exception requests lower cost-sharing for a covered drug that's on a high-cost tier. Use the appropriate Blue Shield form for tier exceptions.

Q: Can I appeal to the state if Blue Shield denies my IMR? A: IMR decisions are generally final and binding. Courts have very limited grounds to overturn IMR decisions, typically only for procedural errors or fraud.

Counterforce Health helps patients and clinicians navigate complex insurance denials by analyzing your specific case and crafting targeted appeals that address your plan's exact criteria. Their platform identifies the denial basis and creates point-by-point rebuttals using the right clinical evidence and regulatory requirements for your situation.

Sources & Further Reading

Disclaimer: This information is for educational purposes only and is not medical or legal advice. Insurance policies and coverage requirements change frequently. Always verify current requirements with your specific Blue Cross Blue Shield plan and consult your healthcare provider for medical decisions. For assistance with appeals or coverage disputes, contact the California Department of Managed Health Care at 888-466-2219.

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