CurrentCignaPolicy N/A

Oncology - Xpovio Prior Authorization Policy

Defines Cigna's prior authorization requirements and medical necessity criteria for coverage of Xpovio (selinexor) for FDA‑approved indications and selected other B‑cell lymphoma uses; applies to Cigna-administered health benefit plans.

Policy Summary

PayerCigna

PolicyOncology - Xpovio Prior Authorization Policy

Policy CodePolicy N/A

Change TypeNo material change

Effective DateN/A

Next Review DateMar 19, 2025

Key ActionSubmit prior authorization documenting age, diagnosis, prior therapies/regimens, and planned concomitant therapy to meet criteria for FDA‑approved or supported B‑cell lymphoma uses.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

1 yeartypical approval duration

≥18minimum patient age

≥2 priorDLBCL threshold

combo w/ dexMM requirement

Coverage Criteria for Xpovio (selinexor)

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B‑Cell Lymphoma (Supportive evidence)

Approve for 1 year if ALL of the following are met:

Other B-cell lymphoma criteria: A) Patient is ≥ 18 years of age; AND B) Patient has one of: i) High‑grade B‑cell lymphoma; OR ii) HIV‑related B‑cell lymphoma; OR iii) Post‑transplant lymphoproliferative disorder; AND C) Patient has tried least two prior therapies.age >=18; prior therapies >=2

These uses are supported by evidence rather than FDA approval

Xpovio (selinexor) is considered experimental, investigational or unproven for any use(s) not specified in this policy. Requests for indications outside the FDA‑approved uses and the selected B‑cell lymphoma indications supported by evidence may be denied and will be reviewed as new published data become available.

Regimen	Coverage status
Xpovio (selinexor) + dexamethasone
Xpovio (selinexor) + bortezomib + dexamethasone
Xpovio (selinexor) + carfilzomib + dexamethasone
Xpovio (selinexor) + daratumumab + dexamethasone
Xpovio (selinexor) + pomalidomide + dexamethasone

Provider Requirements and Prior Authorization

Prior Authorization

Prior Authorization Required

Prior authorization is required for Xpovio. Approvals are provided for 1 year when patients meet the specified criteria.

Applies to Xpovio (selinexor tablets)
Approval duration: 1 year

Step Therapy

Prior Therapy Requirements

Coverage requires documentation of prior lines/regimens as specified for each indication. For diffuse large B‑cell lymphoma (including histologic transformation of indolent lymphomas) the patient must have tried at least two prior therapies. For multiple myeloma, the patient must meet one of the specified prior‑therapy paths: (i) at least four prior regimens; OR (ii) at least two prior regimens and planned combination with pomalidomide; OR (iii) at least one prior regimen and planned combination with bortezomib, daratumumab (IV or Darzalex Faspro SC), or carfilzomib.

DLBCL: ≥2 prior therapies
Multiple myeloma: one of the following — ≥4 prior regimens; OR ≥2 prior regimens + combination with pomalidomide; OR ≥1 prior regimen + combination with bortezomib, daratumumab (IV or Faspro), or carfilzomib

Documentation Required

Required Clinical Documentation

Prior authorization requests must document patient age (≥ 18 years), the qualifying diagnosis, the prior therapies or regimens tried (with examples or regimen names where relevant), and the planned concomitant therapy (e.g., dexamethasone, pomalidomide, bortezomib, daratumumab, or carfilzomib) when required by the indication.

Document patient age (≥18)
Document diagnosis and prior therapies/regimens tried (include regimen names or examples)
Document planned concomitant therapy when applicable (e.g., dexamethasone, pomalidomide, bortezomib, daratumumab, carfilzomib)

Denial Risk

Non‑Covered Indications

Requests for Xpovio for any use not listed as FDA‑approved indications or the specified B‑cell lymphoma uses with supporting evidence are not covered.

Non‑covered: any indication other than the FDA‑approved indications described (DLBCL and multiple myeloma) or other uses without supportive published evidence

Line of Therapy Requirements

third-line

third-line: Use in relapsed or refractory diffuse large B‑cell lymphoma after at least two lines of systemic therapy (third‑line or subsequent).>=2 prior lines

Approved under accelerated approval for DLBCL based on response rate; continued approval may be contingent on confirmatory trials

second-line_or_later

second-line_or_later: Multiple myeloma coverage depends on prior regimens: ≥4 prior regimens for selinexor + dexamethasone in refractory disease, OR fewer prior regimens when used in combination with other agents per policy (e.g., ≥2 prior regimens when combined with pomalidomide; ≥1 prior regimen when combined with bortezomib, daratumumab [IV or Faspro SC], or carfilzomib).varies (>=1, >=2, >=4)

See policy for examples of prior regimens and specific combination requirements

Definitions and Examples

Diffuse large B‑cell lymphoma (DLBCL) — definition

TermDiffuse large B‑cell lymphoma (DLBCL)

DefinitionDLBCL, not otherwise specified, including DLBCL arising from follicular lymphoma; relapsed or refractory disease in adults after at least two lines of systemic therapy.

Minimum age≥ 18 years (adult patients)

Line of therapy requirementUse in relapsed or refractory DLBCL after at least two prior systemic therapies (third‑line or subsequent).

Approval contextApproved under accelerated approval based on response rate; continued approval may be contingent on confirmatory trials.

Prior regimen examples (multiple myeloma)

ContextExamples describe prior therapies by drug class relevant to multiple myeloma prior‑regimen requirements.

Proteasome inhibitors (examples)Bortezomib; carfilzomib (Kyprolis).

Immunomodulatory agents (examples)Lenalidomide; pomalidomide (Pomalyst).

Anti‑CD38 monoclonal antibody (example)Daratumumab (Darzalex) — includes IV daratumumab and subcutaneous Faspro formulations.

Most actionable prior‑therapy ruleFor selinexor + dexamethasone in refractory multiple myeloma: patient must have received ≥4 prior therapies and disease refractory to ≥2 proteasome inhibitors, ≥2 immunomodulatory agents, and an anti‑CD38 monoclonal antibody.

Background

Xpovio (selinexor) is a nuclear export inhibitor with FDA‑approved indications and guideline‑supported uses in B‑cell malignancies. The medication is approved for relapsed/refractory diffuse large B‑cell lymphoma (DLBCL) in patients who have received at least two prior systemic therapies and is also approved for use in multiple myeloma in specific combination regimens and prior‑therapy settings. NCCN guidelines recommend selinexor for third‑line and subsequent therapy in DLBCL and list several selinexor‑containing combinations for multiple myeloma.

Per policy operational requirements, prior authorization is required for Xpovio and approvals are issued for 1 year when patients meet the applicable criteria. Prior authorization requests must document patient age (≥18), diagnosis, prior therapies or regimens tried, and the planned concomitant therapy (for example, dexamethasone or the specified agents in multiple myeloma combinations) to demonstrate that the use meets the policy criteria.