Voranigo (vorasidenib) Glioma Access: Pricing, Biomarker Testing, and Payer PA

The FDA approval of Voranigo (vorasidenib, Servier) on August 6, 2024, marked a major therapeutic milestone in neuro-oncology. As the first targeted therapy specifically approved for patients with Grade 2 IDH1- or IDH2-mutant astrocytoma or oligodendroglioma, Voranigo represents a shift in the treatment paradigm for low-grade gliomas. Low-grade gliomas are slow-growing but progressive brain tumors that primarily affect young adults in their 30s and 40s. Historically, the management of low-grade glioma consisted of surgical resection followed by a high-risk period of "watchful waiting," as early treatment with chemotherapy and radiotherapy was delayed to avoid long-term neurocognitive toxicity.

While Voranigo offers an oral, highly effective option that significantly delays disease progression, its access landscape presents unique challenges for neuro-oncology clinical teams, specialty pharmacies, and payers. With a launch price of approximately $39,881 per month (~$478,572 per year), Voranigo ranks among the highest-priced oral small-molecule oncology launches in history. This access landscape maps Voranigo’s clinical evidence, analyzes the biomarker-testing requirements that gate utilization, summarizes NCCN compendia placement, synthesizes multi-payer prior-authorization (PA) policies (UnitedHealthcare, Cigna, Highmark, and Excellus), and outlines limited specialty distribution and patient-support workflows.

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Quick answer

What is the scenario question? A neuro-oncology clinic and its specialty pharmacy want to know how to get Voranigo (vorasidenib) to a Grade 2 IDH-mutant glioma patient post-surgery—what does the FDA label require (IDH test, surgery), what will it cost (~$40K/month), where does NCCN place it, and what do UHC/Cigna/Highmark demand for prior authorization?

Direct Answer: Voranigo (vorasidenib, Servier), the first targeted therapy for Grade 2 IDH1/2-mutant astrocytoma/oligodendroglioma (FDA-approved Aug 6, 2024 on the INDIGO trial: PFS 27.7 vs 11.1 months, HR 0.39), launched at $39,881/month ($478,572/yr)—among the highest annual oral-oncology prices—with IDH1/2 status confirmed by the FDA-approved Oncomine Dx Target Test, NCCN category 1 (KPS≥60) preferred placement in CNS v1.2025, and payer prior authorization (UHC/Cigna/Highmark/Excellus) universally requiring age ≥12, Grade 2 astrocytoma/oligodendroglioma, a susceptible IDH1/2 mutation by an FDA-approved test, and prior surgery (biopsy/sub-total/gross-total resection), dispensed through the Biologics by McKesson limited specialty-pharmacy network with ServierONE manufacturer support.

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Who this is for

• Oncology Pharmacists and Clinic Access Teams: Navigating prior-authorization workflows, verifying companion-diagnostic requirements, and coordinating limited distribution drug delivery.
• Payer Medical Directors and Formulary Managers: Structuring evidence-based utilization management criteria and medical benefit policies for high-cost oral orphan oncology agents.
• Neuro-Oncology Clinicians: Aligning treatment initiation with FDA labels, NCCN guidelines, and safety-monitoring requirements (e.g., LFT monitoring).
• Specialty Pharmacy Managers: Coordinating benefits verification, co-pay assistance, and manufacturer-support programs (ServierONE) for low-grade glioma patients.

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Methodology, in one paragraph

The access landscape presented in this analysis is synthesized from primary regulatory, clinical, and payer sources. Regulatory facts are derived from the FDA drug approval package, the FDA-approved prescribing information (label) for Voranigo, and FDA companion-diagnostic approvals. Clinical efficacy and safety baselines are extracted from the published results of the Phase III INDIGO trial (NEJM, 2023) and extended follow-up data presented at the American Society of Clinical Oncology (ASCO) 2026 annual meeting. Compendia placement is verified against the National Comprehensive Cancer Network (NCCN) Clinical Practice Guidelines in Oncology for Central Nervous System Cancers (v1.2025, June 3, 2025). Payer prior-authorization criteria are extracted directly from active policy documents issued by UnitedHealthcare (Program 2024 P 1457-2, effective March 1, 2025), Cigna (Policy cnf_876), Highmark Blue Shield (Policy J-1401-002, effective July 18, 2025), and Excellus BlueCross BlueShield. Pricing and distribution details are sourced from Servier pharmaceuticals, specialty pharmacy network releases, and health technology assessment (HTA) reports. For broader context on companion diagnostic denials, see companion diagnostic denial in oncology prior authorization; for general specialty billing rules, see benefit verification medical versus pharmacy benefit specialty drugs; for electronic prior authorization standards, see electronic prior authorization readiness 2027; and for biomarker documentation guidelines, see [biomarker documentation mismatch in oncology prior authorization](/blog/biomarker-documentation-mismatch-oncology-prior-authorization].

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What is Voranigo approved for, and what did the INDIGO trial show?

Voranigo is an oral, small-molecule inhibitor of mutated isocitrate dehydrogenase 1 (IDH1) and isocitrate dehydrogenase 2 (IDH2) enzymes. The FDA approved Voranigo on August 6, 2024, for the treatment of adult and pediatric patients aged 12 years and older with Grade 2 astrocytoma or oligodendroglioma with a susceptible IDH1 or IDH2 mutation, following surgery (which includes biopsy, sub-total resection, or gross-total resection). The NDA submission was granted Fast Track, Breakthrough Therapy, Priority Review, and Orphan Drug designations.

The Clinical Baseline: The INDIGO Trial

The approval was based on the pivotal Phase III INDIGO trial (NCT04164901, published in the New England Journal of Medicine in 2023). INDIGO enrolled 331 patients aged 12 years and older with Grade 2 IDH-mutant glioma who had undergone prior surgery but had received no prior systemic therapy (chemotherapy or radiotherapy). Patients were randomized 1:1 to receive oral vorasidenib 40 mg once daily (n = 168) or placebo (n = 163).

Key efficacy findings from the trial showed a dramatic clinical benefit:

• Progression-Free Survival (PFS): The primary endpoint was significantly improved. The median PFS was 27.7 months for the vorasidenib arm compared to 11.1 months for the placebo arm, representing a 61% reduction in the risk of disease progression or death (Hazard Ratio [HR] = 0.39; 95% Confidence Interval [CI], 0.27 to 0.56; P < 0.001).
• Time to Next Intervention (TTNI): The key secondary endpoint measured the time until a patient required subsequent therapeutic intervention (such as radiotherapy or chemotherapy). Vorasidenib demonstrated an 74% reduction in the risk of needing a subsequent intervention (HR = 0.26; 95% CI, 0.15 to 0.43; P < 0.001).

Long-Term Efficacy: Extended ASCO 2026 Follow-Up

An extended analysis of INDIGO presented at the ASCO 2026 annual meeting (Servier, May 31, 2026; 21.3 months of additional unblinded follow-up, median follow-up 41.6 months) confirmed the durability of Voranigo's treatment effect, building on an earlier updated analysis published in The Lancet Oncology in which median PFS had not yet been reached:

• Median PFS Extension: With longer follow-up, the median PFS in the vorasidenib arm matured to 44.1 months — up from the 27.7-month median in the original 2023 NEJM report — while the original placebo-arm PFS remained 11.1 months.
• Durability of TTNI: The median Time to Next Intervention in the vorasidenib arm remained Not Estimable (only 23.8% of vorasidenib-treated patients had reached a next-intervention event by the January 2025 data cutoff), compared with 17.8 months in the original placebo arm.

This extended follow-up underscores Voranigo’s clinical value, demonstrating that early initiation of targeted therapy can delay the need for neurotoxic chemotherapy and cranial radiotherapy for several years. This clinical benefit forms the foundation for Voranigo’s rapid inclusion in guidelines and favorable payer coverage, despite its high cost.

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How much does Voranigo cost, and how does the ~$480K/yr launch price compare to other oral oncology launches?

Voranigo launched at a wholesale acquisition cost (WAC) of $39,881 per 30-day supply (which corresponds to the standard daily dose of 40 mg). This equates to an annual treatment cost of $478,572 per year, placing Voranigo among the most expensive oral oncology medications in the U.S. market.

Voranigo Pricing Benchmarks (2026):
- U.S. List Price (WAC): ~$39,881 per 30-day supply
- Annual U.S. Treatment Cost: ~$478,572
- Canadian Submitted Price: $798.33 per 40 mg tablet (~$22,353 per 28-day supply)
- ICER Health Technology Assessment: ~$571,629 per QALY (Quality-Adjusted Life Year)

In comparative assessments, Voranigo's pricing is significantly higher than other targeted oral oncology therapies launched in the early 2020s. For example:

• Welireg (belzutifan, Merck): Launched at approximately $26,400 per month.
• Krazati (adagrasib, BMS): Launched at approximately $19,778 per month.
• Sotyktu (deucravacitinib, BMS): Launched at approximately $6,164 per month (immunology pricing).

Voranigo’s high price is justified by the manufacturer based on its orphan drug status (it targets a specific sub-population of glioma patients), its first-in-class targeted mechanism, and the potential cost savings associated with delaying expensive hospital-based interventions (such as cranial radiotherapy, neurosurgery, and IV chemotherapy regimens).

In international pricing documents, Servier submitted a price of $798.33 per 40 mg tablet to the Canadian Agency for Drugs and Technologies in Health (CADTH), representing a 28-day supply cost of $22,353. The corresponding cost-effectiveness analysis by the Institute for Clinical and Economic Review (ICER) estimated that Voranigo carries an incremental cost-effectiveness ratio of approximately $571,629 per QALY in the U.S. context, indicating that while the clinical benefit is profound, the price sits well above traditional cost-effectiveness thresholds of $100,000 to $150,000 per QALY.

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What biomarker test is required, and how does the Oncomine Dx Target Test companion diagnostic gate access?

Because Voranigo targets mutated IDH1 and IDH2 enzymes, patient selection is strictly gated by biomarker testing. Approximately 80% of Grade 2 gliomas harbor an IDH mutation (with IDH1 R132H being the most common, accounting for ~90% of cases, followed by rarer IDH1 variants and IDH2 R172 mutations).

The FDA-Approved Companion Diagnostic

In tandem with the drug approval, the FDA approved the Ion Torrent Oncomine Dx Target Test (Thermo Fisher Scientific) as the companion diagnostic to select patients eligible for Voranigo. The Oncomine Dx Target Test is a next-generation sequencing (NGS) assay that detects multiple sequence variants, including IDH1 and IDH2 mutations, from formalin-fixed, paraffin-embedded (FFPE) tumor tissue.

For clinical access teams, this companion diagnostic requirement represents a critical prior-authorization gate. Payer policies universally require documentation confirming that the patient's tumor tissue harbors a susceptible IDH1 or IDH2 mutation using an FDA-approved companion diagnostic test or a highly validated laboratory-developed test (LDT) in a CLIA-certified laboratory.

Biomarker Access Workflow:
Neurosurgical Resection/Biopsy -> Tissue Pathology -> NGS Testing (Oncomine Dx Target Test) -> Mutation Confirmation (IDH1/2+) -> PA Submission with Lab Report -> Specialty Pharmacy Dispensing

Biomarker Prior-Authorization Friction Points

Clinics must avoid common documentation errors that lead to immediate PA denials:

• The "LDT" Mismatch: Many academic medical centers perform internal NGS panels (laboratory-developed tests) rather than sending tissue for the branded Oncomine Dx Target Test. While most payers accept CLIA-certified NGS reports, some strict commercial policies may initially deny coverage if the specific FDA-approved companion diagnostic brand is not listed on the lab report. Clinics must be prepared to submit validation data proving their internal NGS test is CLIA-certified and equivalent to the FDA-approved companion diagnostic, as detailed in our analysis of biomarker documentation mismatch in oncology prior authorization.
• Missing Pathology Reports: Simply typing "IDH mutant" in the physician's clinical notes is insufficient. Payer PA reviews require the submission of the actual signed pathology and molecular genetics laboratory report. The lab report must explicitly document the specific mutation (e.g., IDH1 R132H or IDH2 R172K).

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Where does NCCN place Voranigo, and what does compendia category 1/2A mean for coverage?

Payer coverage for oncology therapies is heavily influenced by compendia listings, primarily the NCCN Clinical Practice Guidelines in Oncology. Under federal law (such as the Social Security Act for Medicare Part B/D and state insurance mandates for commercial plans), therapies listed with a Category 1 or 2A recommendation in NCCN must be covered by payers, as they are considered medically accepted standards of care.

NCCN Guidelines for Central Nervous System Cancers

The NCCN Guidelines for CNS Cancers (v1.2025, issued June 3, 2025) place Voranigo in a prominent clinical position:

• Adjuvant Therapy for Grade 2 Glioma: Voranigo is listed as a Category 1 preferred recommendation for the adjuvant treatment of patients with WHO Grade 2 IDH1- or IDH2-mutant astrocytoma or oligodendroglioma who have undergone surgery (biopsy or resection) and have a Karnofsky Performance Status (KPS) $\ge$ 60, and who do not require immediate radiotherapy or chemotherapy.
• Recurrent Disease: Voranigo carries a Category 2A recommendation as a therapeutic option for patients with recurrent or progressive low-grade glioma post-surgery, or for patients who have progressed following prior radiotherapy and chemotherapy.
• Off-Label Limitations (Grade 3/4 Gliomas): For WHO Grade 3 (high-grade) IDH-mutant gliomas, NCCN lists Voranigo with a Category 2B recommendation.

Compendia Implications for Payer Adjudication

The difference between Category 1/2A and Category 2B is critical for access. Because Voranigo carries a Category 1 preferred status for Grade 2 IDH-mutant glioma, payers cannot easily implement formulary exclusions or restrict access for this specific population. The Category 1 designation overrides standard cost-containment measures, ensuring that UHC, Cigna, and other commercial plans must cover the drug for its FDA-approved indication.

However, for patients with Grade 3 IDH-mutant glioma, the Category 2B designation means that payers are not mandated to cover the drug. Access teams seeking to obtain Voranigo for a Grade 3 patient will face severe prior-authorization friction and must submit extensive clinical literature, case notes, and compendia pages to support a medical necessity appeal, as discussed in compendia listing gaps in oncology access.

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What do UHC, Cigna, Highmark, and Excellus require for prior authorization?

Prior authorization is universally required for Voranigo across all commercial, Medicare Part D, and Medicaid plans. To guide clinical teams, we synthesize the criteria from four major payers:

1. UnitedHealthcare (Program 2024 P 1457-2, Effective March 1, 2025)

UnitedHealthcare covers Voranigo under the pharmacy or medical benefit. The policy implements a unique age-gated auto-approval rule:

• The Youth Auto-Approval: Under UHC commercial plans, if the patient is under the age of 19, the prior authorization is auto-approved without manual clinical review, provided the drug is prescribed by an oncologist.
• Adult Clinical Criteria (Age $\ge$ 19): For patients aged 19 and older, the PA requires:
  1. Patient is $\ge$ 12 years of age.
  2. Documented diagnosis of WHO Grade 2 astrocytoma or WHO Grade 2 oligodendroglioma.
  3. Susceptible IDH1 or IDH2 mutation confirmed by an FDA-approved companion diagnostic (or CLIA-certified NGS assay).
  4. Documentation of prior surgical resection (biopsy, sub-total, or gross-total).
  5. Prescribed by, or in consultation with, a neuro-oncologist, medical oncologist, or neurosurgeon.
• Initial Approval Duration: 12 months.
• Reauthorization: Requires documentation of clinical benefit (e.g., disease stabilization, lack of progression) and no objective radiographic disease progression on brain MRI.

2. Cigna (Policy cnf_876)

Cigna’s National Formulary policy for Voranigo requires:

1. Documented diagnosis of WHO Grade 2 astrocytoma or oligodendroglioma.
2. Susceptible IDH1 or IDH2 mutation confirmed by molecular testing.
3. Patient has undergone prior surgery (biopsy, sub-total, or gross-total resection) for the tumor.
4. Prescribed by an oncologist or neurosurgeon.

• Initial Approval Duration: 1 year.
• Reauthorization: Requires documentation of clinical benefit and no objective disease progression.

3. Highmark Blue Shield (Policy J-1401-002, Effective July 18, 2025)

Highmark covers Voranigo under its commercial specialty pharmacy benefit. The criteria require:

1. Patient is $\ge$ 12 years of age.
2. Documented diagnosis of Grade 2 oligodendroglioma or astrocytoma.
3. Documentation of a susceptible IDH1 or IDH2 mutation.
4. Patient has undergone prior surgery (biopsy, sub-total, or gross-total resection).
5. Prescribed by or in consultation with an oncologist, neuro-oncologist, or neurosurgeon.
6. Baseline liver function tests (LFTs) have been performed, and the prescriber agrees to monitor LFTs throughout therapy (due to hepatotoxicity warning).

• Initial Approval Duration: 12 months.
• Reauthorization: Requires documentation of therapeutic response and absence of clinical or radiographic disease progression.

4. Excellus BlueCross BlueShield (CRPA Rx)

Excellus implements standard criteria matching the FDA label:

1. Patient is $\ge$ 12 years of age.
2. Documented diagnosis of WHO Grade 2 glioma (astrocytoma or oligodendroglioma).
3. Confirmed IDH1 or IDH2 mutation.
4. Prior surgical intervention has been performed.
5. Prescribed by an oncologist.

• Initial Approval Duration: 1 year.
• Reauthorization: Requires confirmation of clinical benefit and no objective disease progression.

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How is Voranigo distributed, what manufacturer support exists, and what monitoring is required?

Given its high cost and specialized patient population, Voranigo is not available at standard retail pharmacies. It is distributed through a limited distribution network.

1. Limited Specialty-Pharmacy Distribution

Servier selected Biologics by McKesson as the primary specialty pharmacy to distribute Voranigo in the U.S., effective September 25, 2024. Biologics by McKesson acts as the hub, coordinating benefits verification, clinical counseling, and drug delivery.

Specialty Pharmacy Workflow:
Prescription Intake -> Benefit Verification (Medical vs Pharmacy) -> PA Support -> Copay/PAP Integration -> Clinical Counseling -> Delivery Coordination -> LFT Monitoring Follow-up

For neuro-oncology clinics, this limited distribution means that prescriptions must be routed directly to the Biologics by McKesson hub (Fax: 800-823-4506; Phone: 800-850-4306) rather than the clinic's preferred health-system specialty pharmacy, unless the health-system pharmacy has secured specific access to the Voranigo limited network.

2. Manufacturer Patient Support: ServierONE

To mitigate high patient out-of-pocket costs, Servier maintains the ServierONE patient support program (Phone: 800-813-5905). ServierONE provides:

• Copay Assistance: For commercially insured patients, the copay card can reduce patient out-of-pocket costs to $0 per month, subject to an annual maximum cap.
• Quick Start Program (Free Trial): If a commercial insurer delays the prior-authorization decision by more than 5 business days, ServierONE can provide a free 30-day supply of Voranigo to prevent treatment delay.
• Patient Assistance Program (PAP): For uninsured or underinsured patients (who meet specific income guidelines), ServierONE provides free drug. Importantly, because Medicare Part D patients cannot use commercial copay cards due to federal Anti-Kickback laws, qualifying Medicare patients with high out-of-pocket costs are routed to independent charitable foundations for copay support or evaluated for PAP.

3. Boxed Warnings and Clinical Monitoring: Hepatotoxicity

Voranigo carries a significant risk of hepatotoxicity (liver injury). In the pivotal INDIGO trial:

• ALT/AST Elevations: Grade $\ge$ 3 alanine aminotransferase (ALT) or aspartate aminotransferase (AST) elevations occurred in 9.6% of patients treated with vorasidenib, compared to 0% in the placebo group.
• Half-life: The elimination half-life of vorasidenib is long, approximately 10 days, meaning liver enzyme elevations can persist for weeks after drug discontinuation.
• Brain Tumor Penetration: The drug's brain tumor-to-plasma ratio is 1.69, demonstrating high blood-brain barrier penetration, which accounts for its central efficacy but also requires systemic exposure that drives hepatic metabolism.

Monitoring Protocol: The FDA label requires liver function tests (ALT, AST, and bilirubin) to be performed:

• Baseline: Prior to starting therapy.
• Initial Phase: Every 2 weeks for the first 2 months of therapy.
• Maintenance Phase: Monthly for the first year of therapy.
• Long-term: Every 3 months thereafter, or as clinically indicated.

Specialty pharmacists must verify that the patient has scheduled or completed their LFTs before releasing subsequent refills. If a patient’s ALT or AST exceeds 5 times the upper limit of normal (ULN), Voranigo must be held until enzymes recover to $\le$ 1.5 times ULN, and restarted at a reduced dose (from 40 mg to 20 mg), or permanently discontinued if elevations recur or are accompanied by bilirubin elevations.

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What this means for specialty pharmacy, neuro-oncology, and access teams

• Establish a Pre-Surgery Pathology Protocol: Neuro-oncology access teams must coordinate with pathology departments to ensure that all Grade 2 glioma tissue samples are automatically routed for IDH1/2 mutation testing using CLIA-certified NGS panels. Delaying biomarker testing until after surgery delays Voranigo initiation.
• Prepare the Prior-Authorization Evidence Packet: To prevent immediate PA denials, access teams must submit the signed neurosurgery report (documenting the surgical resection/biopsy), the molecular genetics laboratory report (documenting the IDH1/2 mutation), and the clinical notes detailing the patient's Karnofsky Performance Status (KPS $\ge$ 60).
• Integrate LFT Scheduling into Specialty Dispensing: Specialty pharmacies (Biologics by McKesson) must synchronize their clinical follow-up calls with the patient's bi-weekly (months 1-2) and monthly (months 3-12) liver function test schedules. Refills should not be shipped without confirming that LFTs have been monitored and remain within safe parameters.
• Leverage ServierONE Support Programs: Clinic financial navigators should immediately enroll all newly prescribed patients in the ServierONE hub. For commercially insured patients, the copay card must be applied, and if the prior authorization is delayed, the Quick Start free-trial program should be triggered to avoid treatment delay.

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FAQs

Is Voranigo covered by Medicare and commercial insurance, and what is the prior-authorization criterion?

Yes. Voranigo is covered by most commercial and Medicare Part D plans, but it requires prior authorization. The PA criteria universally require a documented diagnosis of WHO Grade 2 astrocytoma or oligodendroglioma, a confirmed IDH1 or IDH2 mutation, and documentation of a prior surgical intervention (biopsy or resection).

How much does Voranigo cost per month and per year, and is there a copay or assistance program?

Voranigo’s wholesale list price (WAC) is approximately $39,881 per month, which equates to an annual treatment cost of $478,572. Servier offers the ServierONE support program, which provides a copay card for commercially insured patients (lowering out-of-pocket costs to $0) and a patient assistance program for uninsured or underinsured patients who meet income criteria.

What IDH biomarker test is required before starting Voranigo, and is it FDA-approved?

The FDA approved the Ion Torrent Oncomine Dx Target Test (Thermo Fisher Scientific) as the official companion diagnostic for Voranigo to detect IDH1 and IDH2 mutations. While most payers accept other CLIA-certified next-generation sequencing (NGS) panels, the actual lab report documenting the mutation must be submitted with the prior-authorization request.

Can Voranigo be used for Grade 3 or 4 IDH-mutant glioma, or after radiation/chemotherapy?

Voranigo is FDA-approved only for Grade 2 IDH-mutant gliomas. While the NCCN guidelines list Voranigo with a Category 2A recommendation for recurrent low-grade gliomas post-radiotherapy/chemotherapy, it carries a Category 2B recommendation for Grade 3 gliomas. Off-label use for Grade 3/4 gliomas faces severe prior-authorization friction, and payers are not mandated to cover it.

What is the hepatotoxicity risk, and how are liver function tests monitored?

Grade $\ge$ 3 liver enzyme (ALT/AST) elevations occurred in 9.6% of patients treated with Voranigo in the INDIGO trial. The FDA label requires liver function tests (LFTs) to be monitored at baseline, every 2 weeks for the first 2 months, monthly for the first year, and every 3 months thereafter. Dose interruptions or reductions are required if LFTs exceed 5 times the upper limit of normal.

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Sources

1. U.S. Food and Drug Administration (FDA). FDA approves vorasidenib for Grade 2 astrocytoma or oligodendroglioma with a susceptible IDH1 or IDH2 mutation. FDA Drug Approval Announcements. https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-vorasidenib-grade-2-astrocytoma-or-oligodendroglioma-susceptible-idh1-or-idh2-mutation
2. Mellinghoff IK, van den Bent MJ, Blumenthal DT, et al. "Vorasidenib in IDH1- or IDH2-Mutant Low-Grade Glioma (INDIGO trial)." New England Journal of Medicine. 2023;389(7):589-601. PubMed
3. National Comprehensive Cancer Network (NCCN). NCCN Clinical Practice Guidelines in Oncology: Central Nervous System Cancers (Version 1.2025). https://www.nccn.org/guidelines/category_1
4. UnitedHealthcare. (2025). Pharmacy Prior Authorization Notification Program: Voranigo (Program 2024 P 1457-2, Effective March 1, 2025). https://www.uhcprovider.com/content/dam/provider/docs/public/prior-auth/drugs-pharmacy/commercial/r-z/PA-Notification-Voranigo.pdf
5. Cigna. (2025). National Formulary Coverage Policy: Oncology Voranigo Prior Authorization Criteria (cnf_876). https://static.cigna.com/assets/chcp/pdf/coveragePolicies/cnf/cnf_876_coveragepositioncriteria_oncology_voranigo_pa.pdf
6. Highmark Blue Shield. (2025). Pharmacy Policy Bulletin J-1401: Voranigo (vorasidenib) Prior Authorization Criteria. https://securecms.highmark.com/content/dam/pharmacypolicy/en/highmark/all/policy/J-1401-1500/1401/J-1401-002.pdf
7. McKesson Corporation. (2024). Biologics by McKesson Selected by Servier as Limited Distribution Partner for VORANIGO. Press Release. https://www.mckesson.com/About-McKesson/Newsroom/Press-Releases/2024/Biologics-by-McKesson-Selected-by-Servier/
8. U.S. Food and Drug Administration (FDA). FDA Approves Companion Diagnostic for Vorasidenib (Ion Torrent Oncomine Dx Target Test). FDA Diagnostics Announcements. https://www.fda.gov/medical-devices/in-vitro-diagnostics/nucleic-acid-based-tests
9. Institute for Clinical and Economic Review (ICER). Vorasidenib for the Treatment of IDH-Mutant Low-Grade Glioma: Effectiveness and Value. Launch Price and Access Report. https://icer.org/assessment/vorasidenib-2024/
10. Servier. (2026, May 31). Servier to Present Extended Follow-Up Results from the Phase 3 INDIGO Trial Showing Durable and Sustained Treatment Benefits of VORANIGO (vorasidenib) at ASCO 2026. Extended analysis (median follow-up 41.6 months; median PFS 44.1 months). Servier Media Room