Currentblue cross blue shield - tennesseePolicy ID_CHS_2025

Selinexor (Sarclisa) — Coverage Criteria for Multiple Myeloma and Related Plasma Cell Disorders

This policy governs coverage and authorization criteria for selinexor (Sarclisa) for FDA-approved and compendial indications in members of BlueCross BlueShield of Tennessee, including multiple myeloma and certain plasma cell disorders.

Policy Summary

Payerblue cross blue shield - tennessee

PolicySelinexor (Sarclisa) — Coverage Criteria for Multiple Myeloma and Related Plasma Cell Disorders

Policy CodePolicy ID_CHS_2025

Change TypeRoutine review — no material changes

Effective DateJul 31, 202650d

Next Review Date

Key ActionObtain prior authorization for selinexor with documentation of required prior therapies and supporting compendia references to receive a 12-month authorization when criteria are met.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

12 monthstypical authorization period

FDA+compendialcoverage approach

Tennesseestate

Coverage and Medical Necessity Criteria

COVERAGE CRITERIA

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Covered Indications (any of the following)

Relapsed/Refractory multiple myeloma with pomalidomide+dexamethasone: Selinexor in combination with pomalidomide and dexamethasone for adult patients who have received at least two prior therapies including lenalidomide and a proteasome inhibitor.
Newly diagnosed multiple myeloma in transplant-ineligible: Selinexor in combination with bortezomib, lenalidomide and dexamethasone as primary therapy for adult patients who are not eligible for autologous stem cell transplant (ASCT).
Relapsed or refractory multiple myeloma with carfilzomib+dexamethasone: Selinexor in combination with carfilzomib and dexamethasone for adult patients who have received one to three prior lines of therapy.
POEMS, MIDD, MGRS: Selinexor may be authorized for 12 months for treatment of POEMS, plasma cell–related MIDD, or plasma cell–related MGRS.

Regimen	Coverage status
Selinexor + pomalidomide + dexamethasone
Selinexor + bortezomib + lenalidomide + dexamethasone
Selinexor + carfilzomib + dexamethasone
Selinexor + carfilzomib + lenalidomide + dexamethasone
Selinexor + lenalidomide + dexamethasone

Prior Authorization, Documentation, and Provider Requirements

Prior Authorization

Prior Authorization Required

Prior authorization is required for the uses described below. Authorization may be granted for up to 12 months when approval criteria are met. Providers must document prior lines of therapy and reference standard compendia when submitting requests.

Authorization period: up to 12 months for initial approval or reauthorization when criteria met
Reauthorization: granted when there is no evidence of unacceptable toxicity or disease progression on current regimen

Denial Risk

Experimental / Investigational — Not Covered

All other indications not listed in the FDA-approved indications or accepted compendial uses are considered experimental/investigational and are not medically necessary. Requests for indications outside these uses should be denied.

Documentation Required

Supporting References Required

Providers must include supporting references from standard compendia for regimen, dosing, and evidence (examples: NCCN Drugs & Biologics, NCCN Guidelines®, Drugdex, AHFS). Consult these resources for appropriate chemotherapy regimens, dosage, contraindications, precautions, warnings, and monitoring information.

Acceptable references: NCCN Drugs & Biologics; NCCN Guidelines®; Drugdex (Micromedex); American Hospital Formulary Service (AHFS)

Step Therapy

Required Prior Therapies

Required prior therapies must be documented for the following indications: - For treatment in combination with pomalidomide and dexamethasone: member has received at least two prior therapies for multiple myeloma, including lenalidomide and a proteasome inhibitor (or if lenalidomide- or bortezomib-refractory, documentation that those agents were used). - For treatment in combination with carfilzomib and dexamethasone (relapsed/refractory setting): member has received one to three prior lines of therapy; document prior therapies and refractoriness where applicable.

Line-of-Therapy Requirements

second-line | third-line

Prior therapy requirements for specific combinations: For selinexor with pomalidomide/dexamethasone: member must have received at least two prior therapies including lenalidomide and a proteasome inhibitor. For selinexor with carfilzomib/dexamethasone: applicable for adult patients who have received one to three prior lines of therapy.

Definitions and Compendial Uses

Compendial uses

Multiple MyelomaListed as a compendial use and considered covered when approval criteria are met.

Plasma cell–related monoclonal immunoglobulin deposition disease (MIDD)Included among compendial indications eligible for coverage when criteria are satisfied.

POEMS syndrome(Polyneuropathy, organomegaly, endocrinopathy, monoclonal protein, skin changes) — listed as a compendial use eligible for coverage.

Monoclonal gammopathy of renal significance (MGRS)Included as a compendial indication that may be authorized when approval criteria are met.

Coverage scope for compendial usesIndications supported by recognized drug compendia (the items above) are considered covered when the policy’s approval criteria are met; all other indications are considered experimental/investigational and not medically necessary.

Background

Selinexor (Sarclisa) is addressed in this policy for treatment of plasma cell disorders, including multiple myeloma and recognized compendial indications such as MIDD, POEMS, and MGRS. Coverage aligns with FDA-approved indications and these compendial uses; indications outside of these are considered experimental/investigational and not covered.