ModifiedPeach State Health PlanPolicy CP.PMN.102

Rolapitant (Varubi) coverage

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Defines medical necessity, prior authorization, and coverage criteria for rolapitant (Varubi) for prevention of chemotherapy-induced nausea and vomiting for applicable Peach State Health Plan lines of business.

Policy Summary

PayerPeach State Health Plan

PolicyRolapitant (Varubi) coverage

Policy CodePolicy CP.PMN.102

Change TypeStep therapy bypass addedHCPCS code added

Effective DateFeb 1, 2017

Next Review DateN/A

Key ActionSubmit prior authorization with clinical documentation showing member meets criteria and evidence of aprepitant trial or applicable state exception.

SourceLink

POLICY UPDATE CHANGES

Added allowance for bypassing redirection if state regulations do not allow step therapy in Stage IV or metastatic cancer settings with additional details in Appendix E.

Added HCPCS code J2797 for rolapitant injection (0.5 mg).

180 mgmaximum single dose

2 tabletsmax tablets / interval

J8670, J2797HCPCS codes referenced

04.27.21

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ModifiedPeach State Health PlanPolicy CP.PMN.102

Rolapitant (Varubi) coverage

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Policy Summary

PayerPeach State Health Plan

PolicyRolapitant (Varubi) coverage

Policy CodePolicy CP.PMN.102

Change TypeStep therapy bypass addedHCPCS code added

Effective DateFeb 1, 2017

Next Review DateN/A

Key ActionSubmit prior authorization with clinical documentation showing member meets criteria and evidence of aprepitant trial or applicable state exception.

SourceLink

POLICY UPDATE CHANGES

Added allowance for bypassing redirection if state regulations do not allow step therapy in Stage IV or metastatic cancer settings with additional details in Appendix E.

Added HCPCS code J2797 for rolapitant injection (0.5 mg).

180 mgmaximum single dose

2 tabletsmax tablets / interval

J8670, J2797HCPCS codes referenced

04.27.21

chemo durationapproval duration

Coverage Criteria

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) Failure of aprepitant, unless contraindicated or clinically significant adverse effects are experienced; OR b) Request is for treatment associated with cancer for a State with regulations against step therapy in certain oncology settings (see Appendix E); 5) Prescribed in combination with a serotonin (5-HT3) receptor antagonist (ondansetron is preferred) and dexamethasone; 6) Dose does not exceed both of the following: a) 180 mg every 2 weeks; b) 2 tablets every 2 weeks.

Includes state-based exceptions to step therapy per Appendix E.

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 member has previously met initial approval criteria; OR b) Member is currently receiving medication and is enrolled in a state and 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 is 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.

Other Indications

Other uses (not initial indication) are handled as follows:

Other Indications: 1) If this drug has recently (within the last 6 months) undergone a label change that is not yet reflected in this policy, refer to: a) no coverage criteria policy for formulary/PDL drugs (HIM.PA.33 or CP.PMN.255) or b) non-formulary policy for non-formulary drugs (HIM.PA.103 or CP.PMN.16); 2) If the requested use is not listed under section III (Diagnoses/Indications for which coverage is NOT authorized) and criterion 1 does not apply, refer to the off-label use policy for the relevant line of business (HIM.PA.154 or CP.PMN.53).

Non-FDA approved indications that are not specifically addressed in this policy are not authorized unless the provider submits sufficient documentation demonstrating efficacy and safety in accordance with the applicable off‑label use policies (HIM.PA.154 for health insurance marketplace/ICHRA or CP.PMN.53 for Medicaid) or the member's evidence of coverage documents.

Coverage determinations under this clinical policy are intended to guide medical necessity decisions but do not guarantee payment. Coverage is subject to the terms, conditions, exclusions, and limitations of the member's benefit plan, and providers should consult the member's coverage documents for specific contract provisions.

For Medicaid members, when a state Medicaid coverage provision conflicts with this clinical policy, the state Medicaid provision takes precedence; consult the applicable state Medicaid manual for binding coverage rules.

Use of rolapitant for non‑FDA approved indications is not authorized unless adequate supporting clinical documentation is provided showing efficacy and safety consistent with the off‑label use policies referenced in this document or the member's coverage terms.

Coding

HCPCS Codes referencedHCPCS

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

HCPCS CodesHCPCS

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

Dose limits — maximum single dose and tablets per dosing interval

Maximum single dose180 mg as a single dose (administered 2 hours prior to chemotherapy)

Maximum per dosing interval (mg)180 mg every 2 weeks

Maximum tablets per dosing interval2 tablets every 2 weeks

Provider Actions

Prior Authorization

Prior authorization required

Prior authorization is required for rolapitant; aprepitant is listed as a therapeutic alternative and may also require prior authorization.

Codes referenced for rolapitant: J8670 (oral) and J2797 (injection).
Providers must follow plan-level prior authorization procedures and ensure clinical documentation supports medical necessity.

Prior Authorization

PA & coding guidance for rolapitant products

Prior authorization and coding guidance apply to all rolapitant products (oral and injection); providers should reference the HCPCS codes J8670 and J2797 when requesting authorization and follow plan-level PA procedures.

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

Definitions

5-HT3 definition

Term5-HT3

Definitionserotonin 5-hydroxytryptamine, type 3 receptor

Context of useRequired co-prescription with rolapitant for prevention of chemotherapy-induced nausea/vomiting (ondansetron preferred)

NK1 definition

TermNK1

Definitionneurokinin 1 receptor

Drug classNeurokinin 1 (NK1) receptor antagonists — rolapitant is an NK1 antagonist used for prevention of delayed CINV

Background

Rolapitant (Varubi) is a neurokinin‑1 (NK1) receptor antagonist indicated in combination with other antiemetics for the prevention of delayed nausea and vomiting associated with initial and repeat courses of emetogenic chemotherapy. Clinical guidance (for example ASCO and NCCN) recommends NK1 antagonists for regimens with high emetic risk; rolapitant is dosed as a single 180 mg oral administration with specified dosing interval and combination with a 5‑HT3 receptor antagonist and dexamethasone per the coverage criteria.

Initial Therapy Criteria

Initial coverage for CINV

Initial coverage for CINV when all criteria met:

Initial therapy nodes: Prescribed for prevention of chemotherapy-induced nausea/vomiting; age >=18 years; scheduled to receive moderately to highly emetogenic chemotherapy (see Appendix D); meets step therapy requirement or state exception (see Appendix E); prescribed in combination with a 5-HT3 receptor antagonist (ondansetron preferred) and dexamethasone; dosing: 180 mg as a single dose approximately 2 hours prior to chemotherapy at no less than 2-week intervals, not exceeding 180 mg and 2 tablets every 2 weeks.

Continuation Criteria

Continued coverage criteria

Criteria for continued coverage

Continued therapy nodes: Member meets continuity criteria (currently receiving via Centene benefit or previously met initial approval criteria, or enrolled in a state/product with continuity of care regulations), is responding positively to therapy, continues to receive moderately to highly emetogenic chemotherapy (see Appendix D), is prescribed rolapitant in combination with a 5-HT3 receptor antagonist (ondansetron preferred) and dexamethasone, and any requested dose increase does not exceed 180 mg and 2 tablets every 2 weeks.

Step Therapy

Step	Requirement	Notes / Exceptions
1
Aprepitant trial is required prior to rolapitant unless contraindicated or clinically significant adverse effects are experienced.
State-specific exceptions apply: requests for treatment associated with cancer in states with regulations against step therapy in certain oncology settings may bypass the aprepitant requirement (see Appendix E for applicable states and details).

Bypass Scenario	Policy Language Added	Appendix / State Details
Stage IV / advanced or metastatic cancer (and similar oncology settings)
Policy updated to allow bypassing step therapy redirection for certain states/settings; language generalized to 'Request is for treatment associated with cancer for a State with regulations against step therapy in certain oncology settings.'
Appendix E lists states and notes (e.g., FL, GA, IA, IN, LA, MS, NV, OH, OK, PA, TN, TX) with specific exceptions and stage-related detail; Appendix E has been updated over time (see revision history).

Quantity Limits

rolapitant (Varubi) — 180 mg quantity limit

Drugrolapitant (Varubi)

Quantity limit180 mg per dose; maximum 2 tablets every 2 weeks

Dosing intervalSingle 180 mg dose given 2 hours prior to chemotherapy, at no less than 2-week intervals

Rolapitant — quantity and dose limit clarified as separate requirements

ClarificationQuantity limit and dose limit are separate requirements — dose limit: 180 mg per dose; quantity limit: maximum 2 tablets every 2 weeks

ImplicationRequests exceeding either the single-dose limit or the maximum tablets per interval do not meet dosing requirements

Reviews, Revisions, and Approvals

04.27.21material_change

Policy language updated to add an allowance to bypass step therapy redirection when state regulations prohibit step therapy in Stage IV or metastatic cancer settings (details referenced in Appendix E).

2017-02-01effective_date

Policy effective date established as 2017-02-01.

hcpcs_addedLatest

Policy Summary

PayerPeach State Health Plan

PolicyRolapitant (Varubi) coverage

Policy CodePolicy CP.PMN.102

Change TypeStep therapy bypass addedHCPCS code added

Effective DateFeb 1, 2017

Next Review DateN/A

Key ActionSubmit prior authorization with clinical documentation showing member meets criteria and evidence of aprepitant trial or applicable state exception.

SourceLink

On This Page

Step Therapy

Aprepitant trial required before rolapitant

Step therapy requires a trial and failure of aprepitant prior to approval of rolapitant unless aprepitant is contraindicated or causes clinically significant adverse effects.

Appendix B lists aprepitant (Emend) as a therapeutic alternative (125 mg day 1; 80 mg days 2–3).
State-specific exceptions to step therapy are described in Appendix E.

Step Therapy

Step therapy bypass allowed in certain states/settings

Step therapy may be bypassed when state regulations prohibit redirection/step therapy in specified oncology settings (e.g., Stage IV or metastatic cancer); Appendix E lists applicable states and notes.

Operational change added 04.27.21 allowing bypass where state regulations do not permit step therapy in Stage IV/metastatic cancer.
Appendix E identifies states and the scope of prohibitions (for example FL, GA, TX, PA, TN, etc.).

Documentation Required

Submit supporting clinical documentation

Providers must submit supporting clinical documentation (such as office chart notes, laboratory results, or other clinical information) demonstrating the member meets all approval criteria when requesting prior authorization.

Documentation should show indication (prevention of chemotherapy-induced nausea/vomiting), age, chemotherapy emetogenicity, concomitant antiemetics, and prior trial/failure of aprepitant when applicable.
Failure to include required documentation may delay or prevent authorization.

Billing Rule

Reference current coding guidance and document medical necessity

Providers should reference the most up-to-date professional coding guidance prior to claim submission and ensure documentation supports medical necessity consistent with coverage documents and state/federal requirements.

Inclusion or exclusion of any HCPCS codes in the policy does not guarantee coverage; confirm current coding guidance before billing.
Ensure clinical records justify the site-of-care, dose, and combination therapy requirements in the policy.

Denial Risk

Denial risk if documentation not provided

Failure to submit documentation (office notes, lab results, or other clinical information) demonstrating that the member meets approval criteria may result in denial of the request.

Documentation must substantiate indication, prior therapy (aprepitant) or applicable state exception, combination with 5-HT3 RA and dexamethasone, and dosing limits (≤180 mg and ≤2 tablets every 2 weeks).

Denial Risk

Coverage and coding omission may affect claims

Coverage decisions are subject to the terms, conditions, exclusions, and limitations of the member's coverage documents; omission of relevant codes or documentation does not guarantee coverage and may affect claims.

Codes referenced are for informational purposes only; inclusion/exclusion of codes does not ensure payment.
State Medicaid provisions and plan benefit terms take precedence for Medicaid members.

'Health Plan' definition

TermHealth Plan

DefinitionA health plan that has adopted this clinical policy and that is operated or administered, in whole or in part, by Centene Management Company, LLC, or any of such health plan's affiliates

NotePolicy guidance is advisory and does not constitute a contract or guarantee of payment

Prescriptions should specify dose and dosing interval to demonstrate compliance with both limits

HCPCS code J2797 (Injection, Rolapitant, 0.5 mg) was added to the coding table.