By Counterforce Health Team in Keytruda (pembrolizumab) —

UnitedHealthcare's Coverage Criteria for Keytruda in Washington: What Counts as "Medically Necessary"?

Answer Box: Getting Keytruda Covered by UnitedHealthcare in Washington

To get Keytruda (pembrolizumab) covered by UnitedHealthcare in Washington, you need prior authorization with specific biomarker testing results (PD-L1 CPS ≥1, MSI-H, or TMB-H ≥10 mutations/megabase for most indications). Submit through the UnitedHealthcare Provider Portal with complete pathology reports, clinical notes, and NCCN guideline alignment. If denied, Washington guarantees external independent review through the Office of the Insurance Commissioner at no cost to you.

First step today: Have your oncologist check your biomarker test results and initiate the prior authorization request online.

Table of Contents

  1. Policy Overview: How UnitedHealthcare Covers Keytruda
  2. Indication Requirements: FDA vs. Off-Label Use
  3. Step Therapy & Medical Exceptions
  4. Quantity and Frequency Limits
  5. Required Diagnostics and Biomarker Testing
  6. Site of Care and Specialty Pharmacy Rules
  7. Evidence to Support Medical Necessity
  8. Sample Medical Necessity Documentation
  9. Common Denial Reasons & Solutions
  10. Washington Appeals Process
  11. Costs and Patient Support Programs
  12. FAQ

Policy Overview: How UnitedHealthcare Covers Keytruda

UnitedHealthcare requires prior authorization for all Keytruda (pembrolizumab) infusions across commercial, Exchange, and Medicare Advantage plans. The drug is typically covered under medical benefits (not pharmacy) and administered in outpatient infusion centers or oncology clinics.

Plan Types and Coverage Differences

  • Commercial/Exchange Plans: Use OptumRx specialty pharmacy benefits with NCCN Compendium evidence categories 1, 2A, or 2B required
  • Medicare Advantage: Similar PA requirements but may have different quantity limits
  • Medicaid: Follows similar clinical criteria with state-specific variations
Note: Always verify current requirements through your specific plan documents, as policies update annually.

Indication Requirements: FDA vs. Off-Label Use

FDA-Approved Indications (Typically Covered)

Keytruda has FDA approval for multiple cancer types including:

  • Melanoma (adjuvant and metastatic)
  • Non-small cell lung cancer (NSCLC)
  • Head and neck squamous cell carcinoma
  • Urothelial carcinoma
  • MSI-H/dMMR solid tumors
  • Cervical cancer
  • Endometrial carcinoma

Off-Label Use Requirements

For off-label indications, UnitedHealthcare requires:

  • Evidence from recognized drug compendia (NCCN, AHFS-DI)
  • Published peer-reviewed literature supporting the use
  • Documentation that FDA-approved alternatives have failed or are contraindicated
  • Clear clinical rationale in medical necessity letter

Step Therapy & Medical Exceptions

When Step Therapy Applies

UnitedHealthcare rarely requires traditional step therapy for Keytruda when used for FDA-approved indications within NCCN guidelines. However, exceptions may apply for:

  • Off-label uses
  • First-line therapy when other treatments are typically preferred
  • Combination regimens not in standard guidelines

Medical Exception Criteria

To bypass step therapy requirements, document:

  1. Previous therapy failures: Specific drugs tried, duration, and clinical response
  2. Contraindications: Medical reasons why standard therapies can't be used
  3. Intolerance: Documented adverse reactions to preferred treatments
  4. Clinical urgency: Disease progression requiring immediate intervention
Tip: Include specific dates, drug names, and clinical outcomes for all prior therapies in your documentation.

Quantity and Frequency Limits

Standard Dosing Limits

UnitedHealthcare's Maximum Dosage Policy allows:

Patient Group Approved Dose Frequency Maximum Duration
Adults 200 mg Every 3 weeks 24 months (metastatic)
Adults 400 mg Every 6 weeks 24 months (metastatic)
Adjuvant therapy 200 mg or 400 mg Every 3 or 6 weeks 12 months
Pediatric 2 mg/kg (max 200 mg) Every 3 weeks Per indication

Renewal Requirements

For continued coverage beyond initial authorization:

  • Document ongoing clinical benefit
  • Confirm absence of disease progression
  • Show tolerable side effect profile
  • Maintain adherence to approved dosing schedule

Required Diagnostics and Biomarker Testing

Essential Biomarker Requirements

UnitedHealthcare requires specific biomarker testing based on tumor type:

PD-L1 Testing (CPS Score)

  • Required for cervical cancer, some NSCLC indications
  • Must show Combined Positive Score (CPS) ≥1
  • Use FDA-approved or validated assay from CLIA-certified lab

MSI-H/dMMR Testing

  • Required for pan-tumor solid tumor indication
  • Microsatellite instability-high OR mismatch repair deficient status
  • Can override PD-L1 requirements when positive

TMB-H Testing

  • Tumor mutational burden ≥10 mutations per megabase
  • Alternative pathway for solid tumors with low/absent PD-L1
  • Must use validated next-generation sequencing platform

Documentation Requirements

Include in your prior authorization:

  • Complete pathology report with biomarker results
  • Laboratory certification (CLIA number)
  • Test methodology and platform used
  • Date of tissue collection and testing

Site of Care and Specialty Pharmacy Rules

Approved Administration Sites

Keytruda must be administered at:

  • Hospital outpatient infusion centers
  • Oncology specialty clinics
  • Ambulatory surgery centers with oncology capabilities

Specialty Pharmacy Coordination

  • Drug procurement through UnitedHealthcare's preferred specialty pharmacy network
  • Prior authorization must be approved before drug ordering
  • Coordination between prescriber, infusion site, and specialty pharmacy required

Evidence to Support Medical Necessity

Clinical Documentation Checklist

Your medical necessity letter should include:

Patient-Specific Information

  • Complete diagnosis with ICD-10 codes
  • Cancer staging and pathology details
  • Performance status (ECOG or Karnofsky)
  • Relevant comorbidities

Treatment History

  • All prior cancer therapies with dates
  • Response to previous treatments
  • Reasons for treatment discontinuation
  • Documentation of treatment failures

Current Clinical Rationale

  • Why Keytruda is appropriate now
  • Expected clinical benefit
  • Treatment goals (curative vs. palliative)
  • Monitoring plan

Guideline References

Cite specific guidelines in your request:

  • NCCN Clinical Practice Guidelines for your cancer type
  • FDA prescribing information
  • Relevant medical society recommendations
  • Published clinical trial data when applicable

Sample Medical Necessity Documentation

Template Structure

"Patient [Name] has [specific diagnosis with stage] confirmed by [pathology details]. Biomarker testing shows [PD-L1 CPS/MSI-H/TMB-H results] performed at [CLIA-certified lab]. Previous treatments include [specific therapies with dates and outcomes]. Current NCCN guidelines support pembrolizumab as [line of therapy] for this indication. Expected clinical benefit includes [specific goals]. Patient will be monitored with [frequency and methods]."

Common Denial Reasons & Solutions

Denial Reason Solution Required Documentation
Missing biomarker testing Submit complete pathology report PD-L1, MSI-H, or TMB-H results from CLIA lab
Wrong line of therapy Provide treatment history Complete prior therapy documentation with outcomes
Off-label indication Submit literature support NCCN guidelines or peer-reviewed studies
Quantity limit exceeded Justify dosing Clinical rationale for specific dose/frequency
Missing prior authorization Resubmit with complete documentation All required clinical information

Washington Appeals Process

Internal Appeals with UnitedHealthcare

  1. File within 180 days of denial notice
  2. Submit through UnitedHealthcare member portal or by mail
  3. Include all supporting clinical documentation
  4. Request expedited review if clinically urgent (72-hour decision)

External Independent Review

Washington's Office of the Insurance Commissioner provides free external review:

Process Steps:

  1. Complete internal appeals first
  2. Request external review within 180 days of final internal denial
  3. Submit request through your health plan (triggers OIC assignment)
  4. Provide additional evidence within 5 business days to assigned IRO
  5. Receive binding decision within 30 days (72 hours if expedited)

Key Benefits:

  • No cost to patient
  • Independent medical experts review case
  • Decision is binding on UnitedHealthcare
  • Can override plan's medical necessity definitions
From our advocates: "We've seen Washington patients successfully overturn UnitedHealthcare denials for Keytruda by submitting comprehensive biomarker testing results and detailed treatment histories to the external review process. The key is providing complete documentation that clearly shows medical necessity according to established guidelines."

When to Contact Washington Insurance Commissioner

Call the Consumer Advocacy line at 1-800-562-6900 if:

  • UnitedHealthcare doesn't respond within required timeframes
  • You need help understanding the appeals process
  • You believe your case was mishandled

Costs and Patient Support Programs

Merck Patient Assistance

Keytruda Patient Support offers:

  • Co-pay assistance for eligible patients
  • Patient assistance program for uninsured/underinsured
  • Reimbursement support and prior authorization assistance

Washington State Resources

  • Washington Healthplanfinder: Premium tax credits and cost-sharing reductions
  • Apple Health (Medicaid): Coverage for eligible low-income patients
  • Prescription assistance programs: Through local health departments

Counterforce Health helps patients, clinicians, and specialty pharmacies turn insurance denials into targeted, evidence-backed appeals. The platform analyzes denial letters and plan policies to draft point-by-point rebuttals aligned with payer-specific requirements, pulling the right clinical evidence and regulatory citations to support Keytruda coverage requests.

FAQ

How long does UnitedHealthcare prior authorization take for Keytruda? Standard review takes 3-5 business days. Expedited review for urgent cases can be completed within 72 hours.

What if Keytruda isn't on my formulary? Keytruda is typically covered under medical benefits, not pharmacy formulary. If denied, request a formulary exception with clinical documentation.

Can I get expedited appeals in Washington? Yes, if delay could seriously jeopardize your health. Both UnitedHealthcare internal appeals and Washington external reviews offer expedited timelines.

Does step therapy apply if I've already failed treatments outside Washington? Previous treatment failures from any location count toward step therapy requirements. Provide complete documentation of all prior therapies.

What biomarker testing is required for my cancer type? Requirements vary by indication. Most solid tumors need PD-L1 CPS, MSI-H/dMMR, or TMB-H testing. Check with your oncologist about specific requirements.

How much does Keytruda cost without insurance? Approximately $23,591 per dose (every 6 weeks), with total treatment costs varying by duration and indication. Patient assistance programs may help reduce costs.

Sources & Further Reading

Disclaimer: This information is for educational purposes only and does not constitute medical or legal advice. Always consult with your healthcare provider and insurance plan for specific coverage decisions. Requirements may change; verify current policies with UnitedHealthcare and Washington state regulators. For personalized assistance with complex coverage challenges, Counterforce Health provides specialized support for turning denials into successful appeals with evidence-backed documentation.

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