CurrentHealth NetPolicy CP PHAR.431

Selinexor (Xpovio) — Clinical Policy

Defines medical necessity criteria, dosing limits, and prior authorization requirements for selinexor (Xpovio) for multiple myeloma and B-cell lymphomas for Health Net lines of business including Commercial, HIM, and Medicaid.

Policy Summary

PayerHealth Net

PolicySelinexor (Xpovio) — Clinical Policy

Policy CodePolicy CP PHAR.431

Change TypeNo material change

Effective DateJul 16, 2019

Next Review Date

Key ActionObtain prior authorization and document oncologist/hematologist involvement plus clinical records showing the member meets the specified diagnostic and prior‑treatment criteria.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

2primary FDA indications listed (MM, DLBCL)

12 motypical approval duration (commercial)

6–12 moapproval duration varies by LOB

10–60 mgtablet strengths available

Coverage Criteria

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MM initial criteria: 1) Diagnosis of multiple myeloma; 2) Prescribed by or in consultation with an oncologist or hematologist; 3) Age >= 18 years; 4) Disease is relapsed, refractory, or progressive; 5) Prescribed in combination with bortezomib and dexamethasone OR in one of the specified combination regimens (daratumumab + dexamethasone; carfilzomib + dexamethasone; pomalidomide + dexamethasone with prior exposure requirements) as detailed in policy; 6) Prior therapy requirements per regimen: for some combinations member must have received >=2 prior therapies including an immunomodulatory agent and a proteasome inhibitor, or >=4 prior therapies including 2 immunomodulatory agents and 1 anti-CD38 antibody as applicable; 7) Dose does not exceed specified weekly limits (100 mg/week when combined with bortezomib and dexamethasone; all other combination regimens limited to tablet-equivalent weekly maxima as listed) unless supported by practice guidelines or peer-reviewed literature; 8) Prescribed regimen must be FDA-approved or recommended by NCCN.

Dose limits and regimen-specific prior therapy requirements are specified in policy.

Initial Therapy — B‑Cell Lymphoma

Initial approval — B‑cell lymphoma (DLBCL and select B‑cell lymphomas): Covered when ALL of the following are met

B-cell lymphoma initial criteria: 1) Diagnosis of DLBCL (including DLBCL arising from indolent lymphomas) or other listed B-cell lymphomas (high-grade B-cell lymphoma, HIV-related B-cell lymphoma, monomorphic post-transplant lymphoproliferative disorder B-cell type); 2) Prescribed by or in consultation with an oncologist or hematologist; 3) Age >= 18 years; 4) Disease is relapsed, refractory (no or partial response), or progressive; 5) Member has received >=2 prior therapies; 6) Dose does not exceed 120 mg weekly (6 tablets/week) unless supported by practice guidelines or peer-reviewed literature; 7) Prescribed regimen must be FDA-approved or recommended by NCCN.

DLBCL indication includes accelerated approval language in FDA section.

Continuation Therapy

Continued therapy — All indications: Covered when ALL of the following are met

Continued therapy criteria: 1) Member is currently receiving selinexor via Centene benefit or has documentation of receiving Xpovio for a covered indication for at least 30 days; 2) Member is responding positively to therapy; 3) For dose increases, new dose must not exceed regimen-specific weekly limits (same as initial dose limits) unless supported by practice guidelines or peer-reviewed literature; 4) For Xpovio requests, member must use selinexor formulation if available unless contraindicated or clinically significant adverse effects occur.

Approval durations differ by line of business.

Requests for indications that are not FDA‑approved and not specifically addressed in this policy are not authorized unless the provider supplies sufficient documentation of efficacy and safety in accordance with the applicable off‑label use policies (e.g., CP.CPA.09 for commercial, HIM.PA.154 for marketplace, CP PMN.53 for Medicaid) or as otherwise specified in the member’s evidence of coverage documents.

Provider Actions & Requirements

Prior Authorization

Prior Authorization Required

Prior authorization is required for selinexor (Xpovio) — provider must document that the request was prescribed by or in consultation with an oncologist or hematologist and that the member meets the diagnostic and clinical criteria for the requested indication (e.g., multiple myeloma or B‑cell lymphoma per policy).

Provider must indicate oncologist/hematologist involvement on the request
Request must demonstrate member meets all applicable diagnosis-specific criteria

Prior Authorization

Prior Authorization & Approval Duration

When prior authorization is granted, approval durations have varied historically by line of business. Current standard initial approval duration for Commercial is up to 12 months or the duration of the request, whichever is less; legacy WCG durations were consolidated into standard Medicaid durations per policy revisions. Refer to the plan-specific approval duration on the authorization for exact limits.

Commercial: approval duration revised to 12 months or duration of request, whichever is less
Medicaid: consolidated to standard Medicaid initial approval duration (per policy history)

Denial Risk

Non‑Covered Indications

Requests for indications not authorized by the FDA and not addressed in this policy are not covered unless sufficient documentation of efficacy and safety is provided in accordance with the Health Plan's off‑label use policies and applicable evidence of coverage documents.

Non‑FDA approved indications require supporting evidence per off‑label use policies (e.g., CP.CPA.09, HIM.PA.154, CP.PMN.53) or evidence of coverage
Absent adequate supporting documentation, requests for non‑covered/off‑label uses may be denied

Documentation Required

Required Documentation

Providers must submit supporting clinical documentation to demonstrate that the member meets all approval criteria. Acceptable documentation includes office chart notes, relevant laboratory results, prior therapy history, and any guideline or literature support for off‑label use when applicable.

Include office notes and pertinent labs
Document prior therapies (number and agents) and responses
For off‑label requests, include peer‑reviewed literature or guideline support

Denial Risk

Coverage Governance & Payment Caveat

Coverage decisions and payment are subject to the member's evidence of coverage, certificate of coverage, contract terms, exclusions, limitations, and applicable state and federal requirements. The Health Plan may request additional documentation and retains discretion to deny or modify coverage in accordance with these terms.

Coverage and payment are governed by the member's plan documents and applicable law
Plan may require additional documentation and may deny payment if contractual criteria are not met

Step Therapy

Therapeutic Alternatives / Potential Step Therapy

Therapeutic alternatives and potential step therapy are described in Appendix B. For multiple myeloma and B‑cell lymphoma, alternatives include regimens containing proteasome inhibitors, immunomodulatory agents, and/or anti‑CD38 monoclonal antibodies per NCCN examples; clinicians should consider these alternatives prior to selinexor when clinically appropriate.

See Appendix B for example regimens (e.g., bortezomib, lenalidomide, pomalidomide, daratumumab, carfilzomib, ixazomib)
Step therapy may be applied where plan policies or Appendix B indicate safer/effective alternatives should be used first

Note

Oral Oncology Management

Oral oncology management and redirection policies apply. Selinexor is an oral oncology agent and may be subject to oral oncology routing, generic redirection, or specialty pharmacy requirements per plan policy. Confirm applicable oral oncology templates and routing rules when submitting authorization requests.

Oral oncology generic redirection language has been added to the policy
Follow plan-specific oral oncology templates and specialty pharmacy routing requirements

Initial Therapy Criteria

Initial therapy — top-level initial authorization nodes

Initial therapy — Covered when the applicable indication-specific initial criteria are met

Initial therapy overview: Initial approval requires: diagnosis of the covered hematologic malignancy (MM or listed B-cell lymphomas), prescriber is an oncologist or hematologist (or consulted), age >=18 years, disease is relapsed/refractory/progressive, adherence to regimen-specific prior therapy and combination requirements, and compliance with regimen-specific weekly dose limits unless dose is supported by practice guidelines or peer-reviewed literature. Prior authorization may be required and prescribed regimens must be FDA-approved or recommended by NCCN.

Continuation Therapy Criteria

Continuation — continued therapy requirements

Continuation — Continued therapy is authorized when ALL of the following are met

Continued therapy: 1) Member is currently receiving selinexor for a covered indication via the plan benefit or has documentation of receiving Xpovio for at least 30 days; 2) Member is demonstrating a positive clinical response to therapy; 3) Any requested dose increase does not exceed regimen-specific weekly limits (MM: 100 mg/week with bortezomib+dexamethasone or tablet-equivalent limits for other regimens; B-cell lymphoma: 120 mg/week or 6 tablets/week) unless the increase is supported by practice guidelines or peer-reviewed literature; 4) Member uses selinexor formulation if available unless contraindicated or clinically significant adverse effects occur.

Approval durations differ by line of business (Medicaid/HIM vs Commercial).

Quantity Limits and Dosing

Selinexor (Xpovio) — Dose limits by regimen

MM — bortezomib + dexamethasoneMaximum 100 mg per week when selinexor is prescribed in combination with bortezomib and dexamethasone.

MM — other specified combination regimensAll other combination regimens limited to a tablet-equivalent maximum (policy notes examples of 5 tablets per week or up to 160 mg/week); prescriber must supply supporting evidence for doses above regimen limits.

MM — per dosage appendixDocumented maximum dose for MM: 160 mg/week (maximum dose noted in dosing table).

DLBCL — weekly capMaximum 120 mg per week (equivalent to 6 tablets per week) for treatment of DLBCL and other listed B-cell lymphomas unless supported by guidelines or literature.

DLBCL — daily maximum notedDosing appendix notes a DLBCL maximum of 60 mg/day in dosage table.

Definitions

Definition — diffuse large B-cell lymphoma (DLBCL)

TermDiffuse large B-cell lymphoma (DLBCL): defined in policy appendix as 'diffuse large B-cell lymphoma' and included in the list of covered B-cell lymphomas (DLBCL, including DLBCL arising from indolent lymphomas).

Included subtypesPolicy explicitly lists DLBCL arising from indolent lymphomas; high-grade B-cell lymphoma; HIV-related B-cell lymphomas; and monomorphic post-transplant lymphoproliferative disorder (B-cell type) as related B-cell lymphoma diagnoses.

Age/PrescriberCoverage criteria require diagnosis in adults (age ≥18 years) and that therapy is prescribed by or in consultation with an oncologist or hematologist.

Definition — multiple myeloma (MM)

TermMultiple myeloma (MM): abbreviated as 'MM' in the policy appendix and referenced throughout the coverage and dosing criteria for selinexor use in combination regimens.

Treatment contextPolicy covers MM when relapsed, refractory, or progressive and when selinexor is prescribed in specified combination regimens (examples include combinations with bortezomib + dexamethasone, daratumumab + dexamethasone, carfilzomib + dexamethasone, pomalidomide + dexamethasone) with regimen-specific prior therapy requirements.

Dose notesDosing guidance for MM appears in the dosage table: regimens include 80 mg on specified weekly days in combination with dexamethasone and a maximum MM dose listed as 160 mg/week.

Background

Selinexor (Xpovio) is an oral selective inhibitor of nuclear export (XPO1) used in oncology for FDA‑approved indications and select NCCN‑recommended regimens. This policy defines coverage criteria, dosing limits, and prior authorization requirements for selinexor; non‑FDA uses require documentation per off‑label policies, and Medicaid members remain subject to state Medicaid coverage provisions where those provisions differ from this policy.