ModifiedCentenePolicy CP.PMN.102

Rolapitant (Varubi)

Defines medical necessity and prior authorization criteria for rolapitant (Varubi) for prevention of delayed chemotherapy-induced nausea and vomiting in adults and continuation criteria for members receiving moderately to highly emetogenic chemotherapy. Applies to Centene-affiliated health plans and affected provider requests.

Policy Summary

PayerCentene

PolicyRolapitant (Varubi) clinical coverage criteria

Policy CodePolicy CP.PMN.102

Change TypeMaterial updates to step therapy/Appendix Ecoding and formulation changes

Effective DateFeb 1, 2022

Next Review Date

Key ActionSubmit prior authorization requests with supporting documentation and cite HCPCS codes (J8670, J2797) demonstrating criteria for initial or continued therapy.

SourceLink

POLICY UPDATE CHANGES

Added step therapy bypass for Illinois HIM per IL HB 5395.

Updated Appendix E language and exceptions (including Tennessee) and expanded Appendix E to include additional states (Indiana, Mississippi, Oklahoma).

Added HCPCS code J2797 for rolapitant injection.

Added allowance for bypassing redirection if state regulations do not allow step therapy in certain oncology settings and expanded Appendix E with state listings.

Removed IV formulation as product is no longer on the market.

Added HCPCS code J2797.

Clarified quantity and dose limit as separate requirements.

≥18minimum age for coverage

180 mg

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Coverage Criteria

inv-01: Initial Therapy

Covered when ALL of the following are met:

Initial Approval - CINV: 1. Prescribed for the prevention of chemotherapy-induced nausea/vomiting; 2. Age ≥ 18 years; 3. Member is scheduled to receive moderately to highly emetogenic cancer chemotherapy (see Appendix D); 4. Member meets one of the following (a or b): (a) failure of aprepitant unless contraindicated or clinically significant adverse effects are experienced; (b) request is for treatment associated with cancer for a State with regulations against step therapy in certain oncology settings (see Appendix E). Note: For Illinois HIM requests, the step therapy requirements do not apply as of 1/1/2026 per IL HB 5395; 5. Prescribed in combination with a serotonin (5-HT3) receptor antagonist (ondansetron preferred) and dexamethasone; 6. Dose does not exceed both of the following: (a) 180 mg every 2 weeks; (b) 2 tablets every 2 weeks.

Approval duration: Projected duration of chemotherapy

inv-02: Continuation Therapy

Continued therapy covered when ALL of the following are met:

Continued Therapy - CINV: 1. Member meets one of the following: (a) currently receiving medication via Centene benefit or previously met initial approval criteria; or (b) member is currently receiving medication and is enrolled in a state/product with continuity of care regulations; 2. Member is responding positively to therapy; 3. Member continues to receive moderately to highly emetogenic cancer chemotherapy (see Appendix D); 4. Prescribed in combination with a 5-HT3 receptor antagonist (ondansetron preferred) and dexamethasone; 5. If request is for a dose increase, new dose does not exceed both: (a) 180 mg every 2 weeks; (b) 2 tablets every 2 weeks.

Approval duration: Projected duration of chemotherapy

inv-03: Other/Off-label

For other uses:

Other Indications: 1. If this drug has recently (within the last 6 months) undergone a label change (e.g., newly approved indication, age expansion, new dosing regimen) that is not yet reflected in this policy, follow the applicable formulary/no-coverage or non-formulary policies for the relevant line of business (HIM.PA.33 or HIM.PA.103 for health insurance marketplace; CP.PMN.255 or CP.PMN.16 for Medicaid).

Off-label / Not Listed Uses: 2. If the requested use (e.g., diagnosis, age, dosing regimen) is NOT specifically listed under section III (Diagnoses/Indications for which coverage is NOT authorized) AND criterion 1 above does not apply, refer to the off-label use policy for the relevant line of business (HIM.PA.154 for health insurance marketplace and CP.PMN.53 for Medicaid).

Non‑FDA approved indications that are not specifically addressed in this policy are excluded from coverage unless the provider submits sufficient documentation of efficacy and safety consistent with Centene off‑label use policies. See HIM.PA.154 for health insurance marketplace members and CP.PMN.53 for Medicaid members for the required evidentiary standard and documentation supporting off‑label requests.

When state Medicaid coverage provisions conflict with the coverage provisions of this clinical policy, the state Medicaid coverage provisions take precedence. Refer to the applicable state Medicaid manual for specific coverage requirements that apply to Medicaid members.

Requests for use of rolapitant for non‑FDA approved indications that are not addressed in this policy are not authorized unless the provider documents sufficient evidence of efficacy and safety per the referenced off‑label use policies. Inadequate supporting documentation may result in denial as not medically necessary (NMN).

Coding

HCPCS Codes referencedHCPCS

J8670	Rolapitant, oral, 1 mg
J2797	Injection, Rolapitant, 0.5 mg

Covered HCPCS Codes (updates)HCPCSCovered

J2797

HCPCS code added (document notes addition)

Dose limit — Rolapitant (Varubi)

Maximum single dose180 mg every 2 weeks

Maximum tablets2 tablets every 2 weeks

Dosing timingSingle 180 mg dose given 2 hours prior to chemotherapy

Provider Actions & Requirements

Prior Authorization

Prior Authorization Required

Prior authorization is required for rolapitant (Varubi); requests must demonstrate that the member meets the clinical criteria and include applicable HCPCS codes where relevant.

Prior authorization required for rolapitant
Include applicable HCPCS codes (J8670 oral; J2797 injection) in submission if applicable

Documentation Required

Required Supporting Documentation

Providers must submit supporting clinical documentation with the prior authorization request. Acceptable documentation includes office chart notes, relevant laboratory results, medication history (including trials of aprepitant when applicable), and any other clinical information that demonstrates why the member meets the approval criteria.

Office chart notes
Relevant lab results

Background

Rolapitant (Varubi) is a substance P/neurokinin 1 (NK1) receptor antagonist indicated in combination with other antiemetics for prevention of delayed nausea and vomiting associated with initial and repeat courses of emetogenic cancer chemotherapy. NK1 receptor antagonists are used with a 5‑HT3 receptor antagonist and dexamethasone for prevention of chemotherapy‑induced nausea and vomiting and are recommended for highly emetogenic regimens; use with moderately emetogenic chemotherapy is determined per guideline and clinician judgment. Rolapitant is administered orally prior to chemotherapy and is intended to reduce delayed emesis when given as part of a multi‑agent antiemetic regimen.

Definitions

Definition — 5-HT3 receptor

Abbreviation5-HT3

Full nameserotonin 5-hydroxytryptamine, type 3 receptor

Role in regimenUsed in combination with rolapitant and dexamethasone for prevention of chemotherapy-induced nausea and vomiting (ondansetron preferred)

Definition — NK1 receptor antagonist

AbbreviationNK1

Full namesubstance P/neurokinin 1 receptor antagonist

Clinical role

Initial Therapy Criteria

inv-21: Initial Therapy

Initial therapy criteria:

Initial Therapy: Prescribed for prevention of chemotherapy-induced nausea/vomiting; age ≥18 years; scheduled to receive moderately to highly emetogenic chemotherapy; step therapy requirement met (failure of aprepitant) unless contraindicated or clinically significant adverse effects, or step therapy bypass applies per state regulations (see Appendix E) or Illinois HIM exception; prescribed in combination with a 5-HT3 receptor antagonist (ondansetron preferred) and dexamethasone; dose limits: does not exceed 180 mg every 2 weeks and does not exceed 2 tablets every 2 weeks.

Approval duration: Projected duration of chemotherapy

Continuation Criteria

inv-22: Continuation Therapy

Continued therapy criteria:

Continued Therapy: Member currently receiving medication via Centene benefit or previously met initial approval criteria or continuity of care applies; member is responding positively to therapy; continues to receive moderately to highly emetogenic chemotherapy; prescribed in combination with a 5-HT3 receptor antagonist (ondansetron preferred) and dexamethasone; if dose increase requested, new dose does not exceed 180 mg every 2 weeks and does not exceed 2 tablets every 2 weeks.

Approval duration: Projected duration of chemotherapy

Step Therapy

Step therapy requirement	Applicability / notes
Step therapy applies generally and requires prior failure of aprepitant unless contraindicated or clinically significant adverse effects are experienced.
May be bypassed per state-specific regulations listed in Appendix E; operational change: Illinois HIM requests are exempt from step therapy requirements as of 1/1/2026 per IL HB 5395 (policy update noted 3Q 2025).

Redirection bypass condition	Appendix E / state exceptions
Step therapy redirection may be bypassed when state regulations prohibit step therapy in certain oncology settings (i.e., the request is for treatment associated with cancer for a State with regulations against step therapy in certain oncology settings).
See Appendix E for state-specific applicability and exceptions (Appendix E lists states including FL, GA, IA, IN, LA, MS, NV, OH, OK, PA, TN, TX; policy updates have added Nevada, Oklahoma, Mississippi, Indiana, and include a Tennessee exception; Appendix E referenced in multiple policy updates).

Quantity & Dose Limits

Rolapitant (Varubi) — Maximum single dose

ProductRolapitant (Varubi)

Maximum single dose180 mg (single dose)

Administration timingGiven 2 hours prior to initiation of each chemotherapy; at no less than 2 week intervals

Rolapitant (Varubi) — Quantity and dose limits

ClarificationQuantity and dose limits are specified as separate requirements in the policy

Policy noteDose and quantity limits clarified during 3Q 2023 review

Operational impact

Site of Care / Administration

Note

Administer orally 2 hours prior to chemotherapy (with dexamethasone and 5-HT3)

Administer rolapitant orally as a single 180 mg dose approximately 2 hours prior to the initiation of chemotherapy; it is used in combination with dexamethasone and a 5-HT3 receptor antagonist and may be given in office, infusion center, or hospital outpatient settings.

Dosing: 180 mg as a single dose 2 hours before chemotherapy, at intervals of no less than 2 weeks.
Use concurrently with a 5-HT3 antagonist (ondansetron preferred) and dexamethasone.

Revision History

2026-03-26Appendix E update

Updated Appendix E to include Indiana (state listings and exceptions for step therapy/redirection).

2025-04-18Policy change - step therapy bypass

Added step therapy bypass for Illinois HIM per IL HB 5395 and updated Appendix E language including a Tennessee exception for oncology redirection rules.

2024-06-05Appendix E update

Updated Appendix E to include Mississippi in the list of states with regulations against redirections in certain cancer settings.

Policy Summary

PayerCentene

PolicyRolapitant (Varubi) clinical coverage criteria

Policy CodePolicy CP.PMN.102

Change TypeMaterial updates to step therapy/Appendix Ecoding and formulation changes

Effective DateFeb 1, 2022

Next Review Date

Key ActionSubmit prior authorization requests with supporting documentation and cite HCPCS codes (J8670, J2797) demonstrating criteria for initial or continued therapy.

SourceLink

On This Page

Denial Risk

Non‑Covered Indications Risk

Requests for indications that are not FDA‑approved and not addressed in this policy may be denied unless sufficient off‑label evidence of efficacy and safety is provided per the plan's off‑label use policies.

Non‑FDA approved indications risk denial without sufficient off‑label documentation
Follow HIM.PA.154 (Marketplace) or CP.PMN.53 (Medicaid) for off‑label coverage requirements

Step Therapy

Step Therapy and Redirection

Step therapy applies: requests must document failure of aprepitant (unless contraindicated or the member experienced clinically significant adverse effects) prior to approval of rolapitant. For Illinois HIM requests, step therapy requirements do not apply as of 1/1/2026 per IL HB 5395. Prior authorization for aprepitant may be required.

Step therapy requires trial and failure of aprepitant unless contraindicated
IL HIM: step therapy requirements do not apply for specified requests effective 1/1/2026
Note: prior authorization may be required for aprepitant

Step Therapy

State‑Level Step Therapy Bypass

When a State has regulations that prohibit step therapy or redirection in certain oncology settings, providers may bypass the step therapy requirement. See Appendix E for the list of states and the specific scope of each state’s prohibition (examples include FL, GA, IA, IN, LA, MS, NV, OH, OK, PA, TN, TX, and updated inclusions).

State-level bypass allowed when state regulations prohibit step therapy in specified oncology settings
See Appendix E for state-specific scope and any exceptions (e.g., Tennessee exceptions for AB-rated generics/biosimilars)
IL HIM bypass per IL HB 5395 effective 1/1/2026

Note

Policy and Regulatory Adherence

Coverage decisions and administration of benefits are subject to the terms, conditions, exclusions, and limitations of the member’s coverage documents and to applicable state and federal requirements. The effective date of posting may differ from the Health Plan’s effective date; where a conflict exists, legal and regulatory requirements govern. The Health Plan may change, amend, or withdraw this policy at any time.

Decisions subject to evidence of coverage, certificate, policy, contract, and applicable regulations
Effective date posted may not equal Health Plan effective date — legal/regulatory requirements govern in case of discrepancy
Health Plan may change or withdraw this policy at any time