By Counterforce Health Team in Tremfya (guselkumab) —

UnitedHealthcare's Coverage Criteria for Tremfya in California: What Counts as "Medically Necessary"?

Answer Box: Getting Tremfya Covered by UnitedHealthcare in California

UnitedHealthcare requires prior authorization for Tremfya (guselkumab) with step therapy through TNF inhibitors first, documented disease severity (PASI ≥12 or BSA ≥10%), and negative TB screening within 12 months. If denied, California's Independent Medical Review (IMR) has a 73% success rate for specialty drug appeals. First step today: Contact your dermatologist to document PASI/BSA scores and gather records of failed TNF inhibitor trials. Submit PA via OptumRx provider portal with complete clinical documentation.

Table of Contents

  1. Policy Overview: How UHC Plans Handle Tremfya
  2. Medical Necessity Requirements
  3. Step Therapy & Exception Pathways
  4. Quantity Limits & Dosing Rules
  5. Required Diagnostics & Documentation
  6. Specialty Pharmacy Network Requirements
  7. Evidence to Support Medical Necessity
  8. Sample Medical Necessity Letter
  9. Appeals Process in California
  10. Common Denial Reasons & Solutions
  11. Cost Savings & Support Programs

Policy Overview: How UHC Plans Handle Tremfya

UnitedHealthcare covers Tremfya (guselkumab) across most plan types but with varying requirements based on your specific coverage:

Coverage by Plan Type

Plan Type Prior Authorization Step Therapy Formulary Tier
Commercial HMO/PPO Required TNF inhibitor failure Tier 6 (specialty)
Medicare Advantage Required TNF inhibitor failure Specialty tier
Medicaid Plans Required State-specific rules Covered with PA

All UnitedHealthcare plans route Tremfya through their OptumRx specialty pharmacy network, not retail pharmacies.

Note: Individual plan documents may have additional restrictions. Always verify your specific formulary through the UHC member portal or by calling member services.

Medical Necessity Requirements

UnitedHealthcare's medical necessity criteria for Tremfya vary by indication but share core requirements:

Plaque Psoriasis Criteria

Initial Authorization Requirements (both must be met):

  • Prescribed by or in consultation with a dermatologist
  • Disease Severity Documentation: One of the following:
    • PASI score ≥12
    • Body Surface Area (BSA) ≥10%
    • Involvement of palms, soles, face, or genitals
    • Severe scalp psoriasis affecting quality of life

Psoriatic Arthritis Criteria

All of the following must be documented:

  • Active psoriatic arthritis diagnosis confirmed by rheumatologist or dermatologist
  • Step therapy completion (see next section)
  • Contraindications to methotrexate OR 3+ months of maximum tolerated methotrexate dose
Clinician Corner: UnitedHealthcare may approve based on automated claims review if previous TNF inhibitor use is documented in their system. However, Janssen CarePath samples or free trial programs don't count toward step therapy requirements.

Step Therapy & Exception Pathways

UnitedHealthcare mandates step therapy for most Tremfya approvals, but exceptions exist for medical contraindications.

Required Prior Therapies

For Plaque Psoriasis:

  • Failure of ≥1 TNF inhibitor (adalimumab/Humira, etanercept/Enbrel, certolizumab/Cimzia, or golimumab/Simponi)
  • Document drug name, dosage, duration of trial, and reason for discontinuation

For Psoriatic Arthritis:

  • Either methotrexate at maximum tolerated dose for ≥3 months
  • OR failure of ≥1 TNF inhibitor with documented trial details

Medical Exception Pathways

Step therapy can be bypassed if you have:

  • Documented contraindications to required first-line agents
  • History of serious adverse events with TNF inhibitors
  • Drug interactions that prevent safe use of preferred agents

The prescriber must submit a medical exception request with supporting clinical documentation.

Quantity Limits & Dosing Rules

UnitedHealthcare applies specific quantity limits based on FDA-approved dosing:

Standard Dosing Allowances

Indication Initial Dose Maintenance Quantity Limit
Plaque Psoriasis 100mg at weeks 0, 4 100mg every 8 weeks 13 doses/year
Psoriatic Arthritis 100mg at weeks 0, 4 100mg every 8 weeks 13 doses/year
IBD (Crohn's/UC) IV induction + SC 100mg every 8 weeks Per protocol

Authorization Duration: 12 months for initial and reauthorization approvals across all indications.

Reauthorization Requirements

To maintain coverage beyond the initial 12-month period:

  • Document positive clinical response (e.g., PASI 75 improvement for psoriasis)
  • Confirm no concurrent biologic therapy
  • Submit updated clinical notes showing continued medical necessity

Required Diagnostics & Documentation

Tuberculosis Screening (Mandatory)

All patients must have current TB screening documented within 12 months:

Required Tests:

  • Interferon-Gamma Release Assay (IGRA) such as QuantiFERON-Gold OR tuberculin skin test (TST)
  • Chest X-ray (required if TST positive or clinical suspicion)
  • Results must be negative or show treated/inactive TB with specialist clearance

Disease Activity Documentation

For Psoriasis:

  • PASI score or BSA percentage
  • Dermatology Quality of Life Index (DLQI) scores
  • Clinical photographs (helpful but not required)

For Psoriatic Arthritis:

  • Joint count assessments
  • Functional status measures
  • Imaging results showing active inflammation

Specialty Pharmacy Network Requirements

UnitedHealthcare requires Tremfya to be dispensed through their contracted specialty pharmacy network.

Primary Network Pharmacies

OptumRx Preferred Specialty Pharmacies:

  • Optum Specialty Pharmacy: 1-855-427-4682
  • CVS Specialty Pharmacy
  • Walgreens Specialty Pharmacy

View complete specialty pharmacy network

Site of Care Considerations

  • Self-injection (subcutaneous): Home administration covered through specialty pharmacy
  • IV infusion: Must use UHC-contracted infusion providers for medical benefit coverage
Important: Using out-of-network specialty pharmacies may result in higher costs or complete denial of coverage.

Evidence to Support Medical Necessity

Clinical Guidelines to Reference

When supporting your Tremfya request, cite these authoritative sources:

Primary Guidelines:

Supporting Evidence:

  • Peer-reviewed studies demonstrating efficacy in your specific clinical scenario
  • Documented failures of preferred agents with objective measures
  • Quality of life impact assessments

Documentation Best Practices

For Prescribers:

  • Include specific PASI/BSA scores with dates
  • Document exact prior therapies: drug names, doses, duration, discontinuation reasons
  • Reference current clinical guidelines supporting Tremfya use
  • Attach recent TB screening results with interpretation

Sample Medical Necessity Letter

Template for Prescribers

"This 45-year-old patient with moderate-to-severe plaque psoriasis (PASI score 18, BSA 25%) requires Tremfya (guselkumab) after documented failure of adalimumab (discontinued after 6 months due to inadequate response - PASI improved only to 14) and etanercept (discontinued after 4 months due to injection site reactions requiring emergency care). Current TB screening negative (QuantiFERON-Gold negative 10/2024, chest X-ray normal). The patient meets UnitedHealthcare's step therapy requirements per your policy [reference specific policy number] and FDA labeling supports use in this clinical scenario. Request 100mg subcutaneous every 8 weeks after standard induction dosing."

Appeals Process in California

California provides robust appeal rights through the Department of Managed Health Care (DMHC) for most UnitedHealthcare plans.

Step-by-Step Appeals Timeline

Step Timeline Action Required Success Rate
1. Internal Appeal File within 60-180 days of denial Submit via UHC portal with clinical documentation ~30-40%
2. Independent Medical Review (IMR) File within 180 days of final internal denial Apply via healthhelp.ca.gov or call 888-466-2219 73% success rate
3. Expedited Review Available for urgent cases Same process, decided within 72 hours Similar success rates

Required Documentation for Appeals

Clinical Evidence Package:

  • Complete medical records showing diagnosis and severity
  • Documentation of all prior therapies attempted
  • Current TB screening results
  • Specialist letter of medical necessity
  • Any relevant imaging or laboratory results

Administrative Documents:

  • Original denial letter
  • Insurance card and member ID
  • Prescriber NPI and contact information

Counterforce Health specializes in preparing evidence-backed appeals that address UnitedHealthcare's specific denial reasons and policy requirements, helping patients turn denials into approvals with targeted clinical documentation.

Common Denial Reasons & Solutions

Denial Reason Required Fix Documents to Include
Insufficient disease severity Document PASI ≥12 or BSA ≥10% Dermatologist assessment with objective scores
Step therapy not met Prove TNF inhibitor failure Pharmacy records, clinical notes with dates/outcomes
Missing TB screening Submit current negative results IGRA/TST results <12 months old, chest X-ray if indicated
Not prescribed by specialist Get dermatologist consultation Referral documentation, specialist assessment
Concurrent biologic use Confirm no overlapping therapy Current medication list, pharmacy claims review

Peer-to-Peer Review Strategy

If initially denied, request a peer-to-peer review with UnitedHealthcare's medical director:

  • Call 877-842-3210 for provider services
  • Prepare 5-10 minute clinical summary
  • Emphasize failed prior therapies and current disease impact
  • Reference specific UHC policy criteria being met

Cost Savings & Support Programs

Manufacturer Support

Janssen CarePath Program:

  • Copay assistance up to $20,000/year for eligible patients
  • PA support and denial management services
  • Enrollment: janssencarepath.com

California-Specific Resources

State Programs:

  • Medi-Cal coverage for eligible low-income patients
  • Covered California plans with specialty drug coverage
  • California Prescription Drug Discount Program

Patient Assistance:

  • Johnson & Johnson Patient Assistance Foundation for uninsured patients
  • Chronic Disease Fund specialty drug assistance
  • HealthWell Foundation psoriasis grants (when available)

From Our Advocates

We've seen numerous California patients successfully obtain Tremfya coverage after initial UnitedHealthcare denials. The key is thorough documentation of step therapy attempts and objective disease severity measures. One patient's appeal succeeded when we included detailed pharmacy records showing a 6-month adalimumab trial with documented PASI scores before and after treatment, clearly demonstrating inadequate response. The IMR reviewer specifically noted the objective evidence in their approval decision.

Disclaimer: This guide provides general information about insurance coverage and is not medical advice. Coverage decisions depend on your specific plan, medical history, and clinical circumstances. Always consult with your healthcare provider and insurance company for personalized guidance. For assistance with appeals or questions about your coverage, contact the California Department of Managed Health Care at 888-466-2219.

Sources & Further Reading

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