CurrentNeighborhood Health Plan of Rhode IslandPolicy N/A

Xpovio (selinexor) — Coverage Criteria

Defines accepted indications, coverage criteria, and authorization requirements for Xpovio (selinexor) for members; applies to providers submitting medication requests to Evolent on behalf of the payer's members.

Policy Summary

PayerNeighborhood Health Plan of Rhode Island

PolicyXpovio (selinexor) — Coverage Criteria

Policy CodePolicy N/A

Change TypeTemplate conversion and exclusion updates

Effective DateN/A

Next Review DateN/A

Key ActionSubmit selinexor medication requests to Evolent with supporting clinical documentation; continuation requests may be exempt if no disease progression and prior authorization conditions are met.

SourceLink

POLICY UPDATE CHANGES

Converted to new Evolent guideline template and updated exclusion criteria.

2+DLBCL prior lines required

>=4MM prior lines for selinexor + dex

1MM prior therapy for selinexor + bortezomib

J8999HCPCS code

noneContraindications listed

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Coverage Criteria and Medical Necessity

DLBCL (single-agent selinexor)

Covered when ALL of the following are met

DLBCL single-agent use: Selinexor as single agent for relapsed/refractory diffuse large B-cell lymphoma is covered when the member has documented disease progression on 2 or more lines of therapy AND has either failed autologous stem-cell transplant OR was not eligible/suitable for autologous stem-cell transplant based on clinical assessment2+ prior lines

Multiple Myeloma (selinexor combinations)

Covered when ALL of the following are met

MM covered regimens: Selinexor is covered for relapsed/refractory multiple myeloma in either: (1) in combination with dexamethasone for members with documented progression on at least 4 prior lines of therapy including two proteasome inhibitors and two immunomodulatory agents; OR (2) in combination with bortezomib +/- dexamethasone for members who have received one prior therapy>=4 prior lines for selinexor+dex; 1 prior therapy for selinexor+bortezomib

Specific combinations lacking Level 1 evidence (e.g., selinexor + daratumumab +/- dexamethasone) are not supported

Coverage excludes requests where there is disease progression while receiving selinexor (Xpovio). Requests will also be denied if dosing exceeds the stated single-dose limits of 60 mg for DLBCL or 100 mg for multiple myeloma, or if treatment would exceed the maximum monthly tablet limits of 32 (20 mg), 16 (40 mg), 8 (50 mg), or 4 (60 mg).

Selinexor prescribed for investigational use or off-label indications that lack sufficient supporting evidence as defined by CMS‑recognized compendia or acceptable peer‑reviewed literature is excluded. The policy uses the listed evidence standards to assess whether published data adequately represent the patient population, regimen, and clinically meaningful outcomes (e.g., ASCO criteria such as hazard ratio <0.80 or OS/PFS benefit ≥3 months).

Selinexor combined with daratumumab, with or without dexamethasone, for relapsed/refractory multiple myeloma is not supported by this policy due to the lack of Level 1 evidence (randomized trials or meta‑analyses) demonstrating superior outcomes compared with the policy’s recommended alternative regimens.

Regimens Supported by Policy

Regimen	Indication / Prior therapy requirement	Coverage status
Selinexor + dexamethasone
Relapsed/refractory multiple myeloma with documented progression on at least 4 prior lines of therapy, including two proteasome inhibitors and two immunomodulatory agents
Covered with criteria

Regimen	Indication / Prior therapy requirement	Coverage status
Selinexor + bortezomib +/- dexamethasone
Relapsed/refractory multiple myeloma in members who have received one prior therapy
Covered with criteria

Regimen	Indication / Prior therapy requirement	Coverage status
Selinexor (monotherapy)
Relapsed/refractory diffuse large B-cell lymphoma with documented progression on 2 or more lines of therapy AND failed autologous stem-cell transplant OR ineligible/suitable for autologous transplant based on clinical assessment
Covered with criteria

Regimen	Indication / Rationale	Coverage status
Selinexor + daratumumab +/- dexamethasone
Combination for relapsed/refractory multiple myeloma — not supported due to lack of Level 1 evidence demonstrating superior outcomes compared to recommended alternatives
Not covered

Billing and Coding

Drug HCPCS CodesHCPCSCovered

J8999

selinexor

inv-06: Maximum single dose — 60 mg (DLBCL); 100 mg (MM)

Maximum single dose (DLBCL)60 mg

Maximum single dose (Multiple Myeloma)100 mg

Source contextSingle-dose limits specified in exclusion criteria

inv-07: Maximum tablets per month — 32 (20 mg), 16 (40 mg), 8 (50 mg), 4 (60 mg)

Max tablets per month (20 mg)32 tablets

Max tablets per month (40 mg)16 tablets

Max tablets per month (50 mg)

Authorization, Documentation, and Denial Triggers

Prior Authorization

Prior Authorization Required

All medication requests for Xpovio (selinexor) must be processed by Evolent. Medications not authorized by Evolent may be deemed not approvable and not reimbursable. Continuation requests for a medication that would otherwise be not-approvable are exempt from this requirement if ALL of the following are met: the member has not experienced disease progression on the requested medication; the requested medication was used within the last year without a lapse of more than 30 days from an active authorization; and no additional medications are being added to the continuation request.

Evolent must process all medication requests from network ordering providers.
Continuation exemption applies when no disease progression, authorization lapse ≤30 days within last year, and no added medications.

Documentation Required

Documentation Requirements

Required supporting documentation must accompany requests and demonstrate that use of selinexor is supported by one of the following sources: FDA-approved product labeling; CMS-recognized compendia; National Comprehensive Cancer Network (NCCN) guidelines; American Society of Clinical Oncology (ASCO) clinical guidelines; or peer‑reviewed literature that meets CMS standards (see CMS Medicare Benefit Policy Manual Chapter 15). Documentation should include relevant clinical history, prior therapies and lines of therapy, evidence of response or progression, and regimen details (agents, doses, schedules).

Required Prior Therapies and Therapy Line Definitions

salvage

salvage: Documented disease progression on 2 or more lines of therapy; failed or ineligible for autologous stem-cell transplant

second-line

second-line: Either >=4 prior lines (for selinexor + dexamethasone) including two proteasome inhibitors and two immunomodulatory agents, OR 1 prior therapy (for selinexor + bortezomib +/- dexamethasone)

Evidence Standards and Outcome Definitions

inv-13: Accepted evidence — FDA labeling, CMS-approved compendia, NCCN/ASCO guidelines, or peer-reviewed literature meeting CMS standards

Accepted evidence (FDA labeling)FDA approved product labeling

Accepted evidence (Compendia)CMS-approved compendia

Accepted evidence (Guidelines)NCCN or ASCO clinical guidelines

Accepted evidence (Peer-reviewed literature)Peer-reviewed literature meeting CMS Medicare Benefit Policy Manual Chapter 15 standards

inv-14: Clinically meaningful outcomes — ASCO-recommended thresholds (e.g., HR <0.80; OS/PFS benefit >=3 months)

ASCO hazard ratio thresholdHazard Ratio < 0.80

Drug Background and Scope

Selinexor (Xpovio) is an oral selective inhibitor of nuclear export used in hematologic malignancies. In clinical practice this agent is applied in relapsed/refractory settings including diffuse large B‑cell lymphoma (DLBCL) as a single agent and in specified combinations for multiple myeloma (MM).

This policy references FDA labeling and accepted compendia/guidelines to define covered uses and specific limits. Key operational points for clinical review include the line‑of‑therapy requirements for covered regimens and the dosing limits noted in exclusions (single‑dose caps and maximum monthly tablet counts) that inform authorization decisions.