By Counterforce Health Team in Oxlumo (lumasiran) —

How to Get Oxlumo (Lumasiran) Covered by Aetna CVS Health in Virginia: Complete Prior Authorization Guide

Answer Box: Getting Oxlumo (Lumasiran) Approved by Aetna CVS Health in Virginia

Aetna CVS Health requires prior authorization for Oxlumo (lumasiran) in Virginia with genetic confirmation of PH1, baseline urinary oxalate levels, and specialist prescriber. Submit the Aetna Oxlumo Precertification Request Form with AGXT testing and labs. Standard approval takes 14-45 days; expedited reviews complete within 72 hours. If denied, appeal internally within 180 days, then pursue Virginia external review through the State Corporation Commission Bureau of Insurance within 120 days.

Table of Contents

Set Your Goal: Understanding Aetna's Requirements

Working with your doctor to get Oxlumo (lumasiran) approved by Aetna CVS Health requires meeting specific clinical criteria and following Virginia's insurance regulations. Your partnership with your healthcare provider is crucial—they'll handle the medical documentation while you ensure all administrative steps are completed properly.

Coverage Requirements at a Glance

Requirement What It Means Where to Find It Source
Prior Authorization Required for all plans Submit precert form before treatment Aetna Precert List
PH1 Diagnosis AGXT gene mutation or liver enzyme deficiency Genetic testing report or liver biopsy Aetna Policy
Specialist Prescriber Nephrologist, hepatologist, or geneticist Provider credentials verification Aetna Policy
Baseline Labs Urinary oxalate ≥0.5 mmol/24h/1.73m² Recent lab results Aetna Policy
Kidney Function eGFR ≥30 mL/min/1.73m² Creatinine and eGFR testing Aetna Policy

The annual cost of Oxlumo averages approximately $493,000, making thorough preparation essential for approval success.

Visit Preparation: Building Your Case

Before your appointment, gather comprehensive information about your primary hyperoxaluria type 1 (PH1) journey. This preparation helps your doctor craft a compelling medical necessity letter.

Symptom Timeline Documentation

Create a detailed timeline including:

  • First kidney stones (age, frequency, composition if known)
  • Nephrocalcinosis findings on imaging
  • Progression of kidney function decline
  • Emergency department visits or hospitalizations
  • Impact on daily activities and quality of life

Previous Treatment History

Document all therapies attempted:

  • Conservative management (high fluid intake, dietary oxalate restriction, calcium supplementation, pyridoxine if tried)
  • Outcomes and reasons for discontinuation
  • Side effects or intolerances experienced
  • Current supportive care measures
Tip: Aetna specifically looks for evidence that conservative measures are insufficient, so detailed documentation of failed or inadequate responses strengthens your case.

Evidence Kit: Essential Documentation

Your evidence kit should include all documents supporting your PH1 diagnosis and need for Oxlumo. Work with your healthcare team to ensure completeness.

Diagnostic Confirmation

Genetic Testing Results:

  • AGXT gene analysis showing biallelic pathogenic mutations
  • Lab report with specific variant details
  • Genetic counselor interpretation if available

Alternative Confirmation:

  • Liver biopsy results showing absent or reduced AGT enzyme activity
  • Specialist consultation notes confirming PH1 diagnosis

Laboratory Evidence

Required Baseline Studies:

  • 24-hour urine oxalate collection (target: ≥0.5 mmol/24h/1.73m²)
  • Plasma oxalate levels if urine collection unreliable
  • Serum creatinine and calculated eGFR
  • Urinalysis and microscopy

Supporting Labs:

  • Urine glycolate levels (often elevated in PH1)
  • Stone analysis showing calcium oxalate monohydrate composition
  • Imaging reports documenting nephrocalcinosis or stones

Clinical Guidelines and Literature

Include peer-reviewed evidence supporting Oxlumo use:

  • FDA prescribing information for primary hyperoxaluria type 1
  • Relevant nephrology or genetics society guidelines
  • Published studies on lumasiran efficacy in PH1

Counterforce Health specializes in turning insurance denials into targeted, evidence-backed appeals by identifying the specific denial basis and drafting point-by-point rebuttals aligned to each plan's own rules. Their platform helps patients and clinicians gather the right citations and clinical facts needed for successful appeals.

Medical Necessity Letter Structure

Your specialist should structure the medical necessity letter to directly address Aetna's coverage criteria. Here's the essential framework:

Letter Components Checklist

Patient Information Section:

  • Full name, date of birth, Aetna member ID
  • Prescribing physician NPI and specialty credentials
  • Diagnosis code: E72.53 (Other hyperoxaluria)

Clinical Justification:

  1. Diagnosis Confirmation: "Patient has confirmed primary hyperoxaluria type 1 based on [genetic testing/liver biopsy] showing [specific findings]."
  2. Disease Severity: Document baseline urinary oxalate levels, kidney function, stone burden, and functional impact.
  3. Treatment Rationale: "Oxlumo is indicated for PH1 to reduce urinary oxalate production independent of AGXT mutation status."
  4. Dosing Plan: Weight-based dosing with loading phase (monthly × 3) followed by quarterly maintenance.
  5. Monitoring Plan: Regular urinary oxalate monitoring, kidney function assessment, and clinical evaluation.

Supporting Evidence:

  • Attach genetic testing results
  • Include baseline laboratory values
  • Reference FDA approval and clinical trial data
  • Cite relevant treatment guidelines

Peer-to-Peer Review Support

If Aetna requests a peer-to-peer review, your doctor will discuss your case directly with an Aetna medical director. You can support this process by providing key talking points.

Preparation for Your Provider

Case Summary (one page):

  • Patient demographics and insurance information
  • PH1 diagnosis confirmation method
  • Current clinical status and disease progression
  • Specific Oxlumo dosing request
  • Expected outcomes based on clinical trials

Key Discussion Points:

  1. Disease Rarity: PH1 affects only 1-3 per million people, limiting treatment options
  2. Progressive Nature: Without treatment, continued oxalate production leads to kidney failure
  3. FDA Approval: Oxlumo is specifically approved for PH1 with demonstrated efficacy
  4. Alternative Limitations: Conservative management insufficient for this patient's disease severity

Availability Windows: Provide your doctor with times you're available for additional questions, as peer-to-peer reviews sometimes require patient input or clarification.

After-Visit Summary and Documentation

After your appointment, ensure all necessary documentation is properly submitted and tracked.

Immediate Follow-Up Actions

  • Confirm your doctor submitted the Aetna Oxlumo Precertification Request Form
  • Verify all required attachments were included
  • Obtain submission confirmation and reference number
  • Set calendar reminders for follow-up based on Aetna's timeline

Portal Communication

Use your patient portal to:

  • Request copies of all submitted documentation
  • Ask for updates on approval status
  • Communicate any new symptoms or clinical changes
  • Coordinate additional testing if requested by Aetna
Note: Aetna typically processes complete submissions within 14-45 days for standard reviews, with 95% of eligible specialty requests approved within 24 hours when documentation is complete.

Respectful Persistence and Escalation

Maintaining professional communication while advocating for timely approval requires strategic follow-up.

Follow-Up Schedule

  • Week 1: Confirm submission receipt
  • Week 2: Check processing status if no response
  • Week 3: Request expedited review if clinically appropriate
  • Week 4+: Initiate appeal process if denied or delayed

Professional Communication Scripts

For Status Updates: "I'm following up on the prior authorization request for Oxlumo submitted on [date] with reference number [number]. Could you please provide a status update and expected decision timeline?"

For Expedited Review: "Given the progressive nature of primary hyperoxaluria type 1 and risk of irreversible kidney damage, we request expedited review of this prior authorization. My physician can provide urgency documentation if needed."

Virginia-Specific Appeals Process

Virginia provides robust consumer protections for health insurance appeals through the State Corporation Commission Bureau of Insurance.

Internal Appeals with Aetna

Timeline: File within 180 days of initial denial Process: Submit written appeal with additional documentation Decision: 30-60 days for standard appeals, 72 hours for expedited

Virginia External Review Process

If Aetna upholds the denial, Virginia law provides independent external review:

Eligibility: Available after exhausting internal appeals for medical necessity denials Timeline: File Form 216-A within 120 days of final denial Decision: Independent Review Organization decides within 45 days (72 hours for expedited)

Required Documents:

  • Completed Form 216-A (External Review Request)
  • Copy of final denial letter from Aetna
  • Medical records release authorization
  • Copy of insurance card
  • Any new supporting evidence

Contact Information: Virginia State Corporation Commission Bureau of Insurance Consumer Services: 1-877-310-6560

The external review decision is binding on Aetna and provided at no cost to Virginia residents.

Common Denial Reasons and Solutions

Denial Reason How to Overturn Required Documentation
No PH1 confirmation Submit genetic testing AGXT gene analysis report
Non-specialist prescriber Obtain specialist consultation Nephrologist/hepatologist evaluation
Insufficient baseline oxalate Repeat 24-hour urine collection Lab results showing ≥0.5 mmol/24h/1.73m²
Experimental/investigational Cite FDA approval FDA prescribing information
Step therapy required Document conservative therapy failure Treatment history with outcomes

Appeal Strategy

When appealing, address each denial reason specifically with corresponding evidence. Counterforce Health can help identify the exact denial basis and draft targeted rebuttals using the plan's own criteria and supporting medical evidence.

Frequently Asked Questions

How long does Aetna CVS Health prior authorization take in Virginia? Standard processing takes 14-45 days for complete submissions. Expedited reviews for urgent cases are decided within 72 hours when proper urgency documentation is provided.

What if Oxlumo is not on Aetna's formulary? Request a formulary exception by demonstrating medical necessity and lack of appropriate alternatives. Include FDA approval documentation and specialist support.

Can I request expedited review in Virginia? Yes, if delay could seriously jeopardize your health. Your doctor must provide written certification of urgency for expedited processing.

Does step therapy apply if I've tried treatments outside Virginia? Previous treatment history from other states counts toward step therapy requirements. Provide complete documentation of all therapies attempted and outcomes.

What happens if Aetna denies my appeal? Virginia residents can pursue external review through the State Corporation Commission Bureau of Insurance within 120 days of the final denial.

Are there cost assistance programs for Oxlumo? Yes, Alnylam offers patient assistance through the Alnylam Assist program. Eligibility varies based on insurance status and income.

How do I track my prior authorization status? Use the Aetna member portal or call member services. Keep your reference number from the original submission for faster service.

What if I need Oxlumo while traveling outside Virginia? Contact Aetna in advance to arrange out-of-state administration. Some plans require pre-approval for out-of-network specialty infusions.

From Our Advocates: We've seen cases where patients initially denied for "insufficient documentation" were approved after submitting complete genetic testing results and specialist letters addressing each specific coverage criterion. The key is understanding exactly what Aetna requires and providing comprehensive evidence that directly addresses their medical policy requirements.

Sources & Further Reading

Disclaimer: This guide provides general information about insurance coverage and appeals processes. It is not medical advice. Always consult with your healthcare provider about your specific medical condition and treatment options. For personalized assistance with Virginia insurance regulations, contact the State Corporation Commission Bureau of Insurance at 1-877-310-6560.

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