By Counterforce Health Team in Oxlumo (lumasiran) —

Humana's Coverage Criteria for Oxlumo (lumasiran) in California: What Counts as "Medically Necessary"?

Quick Answer: Humana requires prior authorization for Oxlumo (lumasiran) in California with documented PH1 diagnosis, elevated urinary oxalate levels, and nephrology specialist prescribing. Submit PA via Humana provider portal with genetic testing, baseline labs, and medical necessity letter. If denied, file internal appeal within 60 days, then California Independent Medical Review (IMR) through DMHC. Start by gathering PH1 confirmation and recent oxalate measurements today.

Table of Contents

Policy Overview

Humana Medicare Advantage and commercial plans in California require prior authorization for Oxlumo (lumasiran), a high-cost specialty medication for primary hyperoxaluria type 1 (PH1). The drug carries an annual list price of approximately $493,000, making it subject to stringent utilization management.

Plan Types and Coverage

  • Medicare Advantage: Prior authorization mandatory; follows CMS guidelines with plan-specific criteria
  • Commercial HMO/PPO: Prior authorization required; may include additional step therapy requirements
  • Medicaid (Medi-Cal): Coverage varies by managed care plan; often requires specialist consultation

All Humana plans in California classify Oxlumo as a specialty medication requiring prior authorization, regardless of plan type. You can verify current requirements using Humana's Prior Authorization Search Tool.

Indication Requirements

FDA-Approved Use

Oxlumo is FDA-approved for primary hyperoxaluria type 1 (PH1) to lower urinary oxalate in pediatric and adult patients. Humana requires strict adherence to this labeled indication.

Key Documentation Needed:

  • Confirmed PH1 diagnosis via genetic testing (AGXT gene mutations) or liver enzyme analysis
  • Age verification (approved for all ages, including infants as young as 4 months)
  • Treatment goal: documented need to reduce urinary oxalate levels

Off-Label Considerations

Humana does not typically cover off-label use of Oxlumo for other hyperoxaluria types. Any off-label request requires exceptional medical necessity documentation and specialist consultation.

Step Therapy & Exceptions

Required Prior Treatments

Unlike many specialty medications, Oxlumo generally does not require step therapy failure documentation for PH1 patients. However, Humana may request evidence of:

  • Conservative management attempts (dietary oxalate restriction, increased fluid intake)
  • Previous treatments for complications (kidney stones, chronic kidney disease)
  • Documentation of why alternative treatments are inadequate

Medical Exception Pathways

If step therapy applies to your specific plan, exceptions can be granted for:

  • Contraindications: Medical reasons why alternatives cannot be used
  • Prior failures: Previous unsuccessful trials with documented outcomes
  • Clinical urgency: Progressive kidney disease requiring immediate intervention

Required Diagnostics

Baseline Laboratory Values

Humana requires specific lab values to establish medical necessity:

Test Required Value Timing Documentation
24-hour urinary oxalate >0.514 mmol/24hr/1.73m² Within 90 days Lab report with BSA correction
eGFR ≥30 mL/min/1.73m² Within 30 days Current kidney function
Genetic testing AGXT mutations Any time Pathogenic variants confirmed
Spot urine oxalate:creatinine Elevated (pediatric <6 years) Within 90 days Alternative to 24-hour collection

Monitoring Requirements

For ongoing coverage, Humana expects:

  • Month 3: Urinary oxalate reduction documentation
  • Month 6: Target ≥65% reduction from baseline or normalization (≤0.514 mmol/24hr/1.73m²)
  • Annual renewals: Continued response and clinical benefit

Site of Care & Specialty Pharmacy

Administration Requirements

  • Healthcare provider administered: Oxlumo must be given by trained medical professionals
  • Subcutaneous injection: Monthly for 3 months, then quarterly maintenance
  • Weight-based dosing: Requires accurate weight documentation for proper vial calculation

Specialty Pharmacy Routing

Humana typically requires Oxlumo to be obtained through their specialty pharmacy network. Confirm routing requirements with Humana Pharmacy before prescribing.

Evidence to Support Necessity

Clinical Guidelines and Citations

When preparing your medical necessity letter, reference these authoritative sources:

  • FDA Prescribing Information: Primary indication and dosing guidelines
  • ILLUMINATE-A and ILLUMINATE-B trials: Clinical efficacy data showing 65-72% oxalate reduction
  • Nephrology society guidelines: Expert consensus on PH1 management

Peer-Reviewed Evidence

Include references to published studies demonstrating:

  • Oxlumo's mechanism of action (siRNA targeting HAO1/glycolate oxidase)
  • Clinical trial outcomes in pediatric and adult populations
  • Long-term safety and efficacy data from open-label extensions

Sample Medical Necessity Letter

Template Structure

A successful medical necessity letter should address all Humana criteria:

Patient Information

  • Full name, date of birth, Humana member ID
  • Diagnosis: Primary hyperoxaluria type 1 (ICD-10: E74.8)

Prescriber Credentials

  • Board certification in nephrology, genetics, or related specialty
  • Clinical experience with PH1 management

Medical Necessity Statement "This [age]-year-old patient has confirmed primary hyperoxaluria type 1 with elevated baseline urinary oxalate of [value] mmol/24hr/1.73m² (normal ≤0.514). Genetic testing confirmed pathogenic AGXT mutations. Current eGFR is [value] mL/min/1.73m². Without treatment, this patient faces progressive kidney disease and potential end-stage renal disease. Oxlumo is the only FDA-approved therapy specifically targeting the underlying metabolic defect in PH1."

Clinical Rationale

  • Document PH1 complications (nephrolithiasis, nephrocalcinosis, CKD progression)
  • Explain why conservative measures are insufficient
  • Reference clinical trial data supporting efficacy expectations

Common Denial Reasons & Fixes

Denial Reason How to Overturn Required Documentation
"No PH1 confirmation" Submit genetic test results AGXT mutation report from certified lab
"Urinary oxalate not elevated" Provide corrected lab values 24-hour urine with BSA correction
"Non-specialist prescriber" Add nephrology consultation Consult note from PH1 expert
"Insufficient medical necessity" Strengthen clinical narrative Detailed letter with guidelines citations
"Missing baseline values" Submit recent lab work Labs within 90 days of request

Appeals Playbook for California

Internal Appeal Process

If Humana denies your initial prior authorization:

  1. File internal appeal within 60 days of denial notification
  2. Submit additional documentation addressing denial reasons
  3. Request peer-to-peer review with Humana medical director
  4. Timeline: Standard appeals decided within 30 days; expedited within 72 hours for urgent cases

California Independent Medical Review (IMR)

After exhausting internal appeals, California residents can request IMR through the Department of Managed Health Care (DMHC):

Process Steps:

  1. File IMR application via DMHC website or call 888-466-2219
  2. No cost to patient - DMHC covers review expenses
  3. Independent physician review by board-certified specialist
  4. Timeline: 45 days standard, 7 days expedited
  5. Binding decision - Humana must comply if overturned

Success Rates: California IMR has approximately 68% overturn rate for well-documented rare disease cases.

For complex prior authorization challenges, platforms like Counterforce Health help patients and clinicians turn insurance denials into targeted, evidence-backed appeals by analyzing denial letters, plan policies, and clinical notes to draft point-by-point rebuttals aligned with payer requirements.

FAQ

How long does Humana prior authorization take for Oxlumo in California? Standard decisions within 1-2 business days for electronic submissions; up to 14 days for paper submissions. Expedited reviews completed within 72 hours for urgent cases.

What if Oxlumo is non-formulary on my Humana plan? Request formulary exception with medical necessity documentation. Non-formulary medications can be covered when medically necessary and no formulary alternatives exist.

Can I request an expedited appeal in California? Yes, expedited appeals available for urgent medical situations. Contact Humana member services or file expedited IMR through DMHC for life-threatening conditions.

Does step therapy apply to Oxlumo for PH1? Generally no, due to lack of therapeutic alternatives for PH1. However, some plans may require documentation of conservative management attempts.

What happens if my child outgrows weight-based dosing? Submit updated weight and dosing calculations with renewal request. Humana will adjust authorization for appropriate vial quantities.

How do I find a PH1 specialist in California? Contact major academic medical centers with nephrology or genetics programs. The National Organization for Rare Disorders maintains specialist directories.

Sources & Further Reading

This information is for educational purposes only and does not constitute medical advice. Always consult with healthcare professionals and verify current insurance policies. For personalized assistance with prior authorizations and appeals, consider consulting with specialized advocacy services like Counterforce Health, which helps transform insurance denials into successful appeals through targeted, evidence-based strategies.

Disclaimer: Insurance policies and coverage criteria change frequently. Verify all information with current Humana policies and California regulatory requirements before making coverage decisions.

Powered by Counterforce Health—AI that turns drug denials into evidence-based appeals patients and clinicians can submit today.