Selinexor (Sarclisa) — Coverage Criteria for Multiple Myeloma and Related Plasma Cell Disorders
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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.
No material clinical or coverage changes in this revision.
Coverage and Medical Necessity Criteria
COVERAGE CRITERIA
Covered when ALL of the following scenario-specific criteria are met:
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.
Continuation Therapy
Continuation of therapy
Indications for selinexor (Sarclisa) that are not listed among the FDA-approved uses or supported compendial indications are considered experimental/investigational and not medically necessary.
All uses of selinexor beyond the specified FDA-approved indications and the compendial uses listed in this policy are not medically necessary and will not be covered.
Covered Combination Regimens
| 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 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
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.
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)
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
Definitions and Compendial Uses
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.
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