CurrentCentenePolicy CP PHAR.482

Isatuximab-irfc (Sarclisa) coverage criteria for multiple myeloma

Defines Centene clinical coverage and authorization criteria for isatuximab-irfc (Sarclisa) for multiple myeloma across commercial, HIM, and Medicaid lines of business.

Policy Summary

PayerCentene

PolicyIsatuximab-irfc (Sarclisa) coverage criteria for multiple myeloma

Policy CodePolicy CP PHAR.482

Change TypeMultiple amendments (FDA additions, coding update)

Effective Date06.01.20

Next Review Date

Key ActionPrior authorization required; submit diagnosis, provider specialty, prior therapies, and supporting clinical documentation.

SourceLink

POLICY UPDATE CHANGES

Added FDA-approved indication for combination use with carfilzomib and dexamethasone for relapsed/refractory MM after 1 to 3 prior lines of therapy and updated dosing frequency to every 2 weeks after first cycle.

Added FDA indication for primary therapy in combination with bortezomib, lenalidomide, and dexamethasone for newly diagnosed MM not eligible for ASCT (per 2Q 2024 review).

Added HCPCS code(s) to coding section during 2Q 2021 annual review.

Added off-label (NCCN Compendium) primary therapy combination with carfilzomib, lenalidomide, and dexamethasone (2Q 2025).

10 mg/kgmaximum/standard dose per schedule

6 monthsinitial approval duration

12 monthscontinued therapy approval duration

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Coverage & Medical Necessity Criteria

Initial Therapy — Covered when ALL of the following are met (Initial Approval)

Covered when ALL of the following are met (Initial Approval)

Initial Approval Criteria: 1. Diagnosis of multiple myeloma (MM).; 2. Prescribed by or in consultation with an oncologist or hematologist.; 3. Age > 18 years.; 4. Therapy is one of the following regimens: a) Isatuximab in combination with pomalidomide and dexamethasone after ≥2 prior therapies including lenalidomide and a proteasome inhibitor (e.g., bortezomib); b) Isatuximab in combination with carfilzomib and dexamethasone for relapsed or refractory disease after 1–3 prior lines of therapy; c) Isatuximab in combination with bortezomib, lenalidomide, and dexamethasone for newly diagnosed MM in patients not eligible for autologous stem cell transplant (FDA-approved).; 5. Prescribed regimen is FDA‑approved or, for off‑label regimens, the prescriber has submitted supporting evidence showing the dose is supported by practice guidelines or peer‑reviewed literature.

Dose must not exceed 10 mg/kg per week for the first 4 weeks, then 10 mg/kg every 2 weeks thereafter. Approval duration: 6 months.

Continuation — Covered when ALL of the following are met (Continued Therapy)

Covered when ALL of the following are met (Continued Therapy)

Continued Therapy Criteria: 1. Member is currently receiving isatuximab via the Centene benefit or documentation shows the member has received isatuximab for at least 30 days.; 2. Diagnosis of multiple myeloma and member is responding positively to therapy.; 3. Dosing is within specified limits for the indicated combination: e.g., 10 mg/kg every 2 weeks for combinations with pomalidomide + dexamethasone or carfilzomib + dexamethasone; for the bortezomib + lenalidomide + dexamethasone (VRd) combination, dosing is 10 mg/kg every 2 weeks and may change to every 4 weeks starting Cycle 18 and beyond as specified.; 4. If a dose increase is requested, the new dose must be supported by practice guidelines or peer‑reviewed literature for the relevant off‑label use (prescriber must submit supporting evidence).

Approval duration: 12 months.

Non-FDA approved indications that are not specifically addressed in this policy are not authorized for coverage unless the provider submits sufficient documentation of efficacy and safety consistent with the applicable off‑label use policies (see CP.CPA.09 for commercial, HIM.PA.154 for marketplace, and CP PMN.53 for Medicaid).

Use of isatuximab-irfc (Sarclisa) for indications that are not FDA‑approved and are not otherwise addressed in this policy requires supporting evidence per the off‑label use policies; without such evidence the request will be handled as an off‑label use and may be denied.

Initial Therapy (Drug-specific)

Initial therapy coverage nodes

Initial drug-specific criteria: 1. Diagnosis of multiple myeloma.; 2. Prescribed by or in consultation with an oncologist or hematologist.; 3. Age > 18 years.; 4. Regimen is one of the FDA‑approved combinations: isatuximab + pomalidomide + dexamethasone (after ≥2 prior therapies including lenalidomide and a PI), isatuximab + carfilzomib + dexamethasone (for relapsed/refractory disease after 1–3 prior lines), or isatuximab + bortezomib + lenalidomide + dexamethasone for newly diagnosed MM not eligible for ASCT. Off‑label regimens may be considered only with supporting evidence from practice guidelines or peer‑reviewed literature.; 5. Dose does not exceed 10 mg/kg IV weekly for the first 4 weeks (Cycle 1: Days 1, 8, 15, 22), then 10 mg/kg IV every 2 weeks thereafter (Cycle 2 and beyond: Days 1, 15), except where the bortezomib/lenalidomide/dexamethasone schedule modifies spacing in later cycles as specified in dosing guidance.; 6. Prescribed regimen must be FDA‑approved or recommended by NCCN when used off‑label.

Approval duration: 6 months; treatment is repeated until disease progression or unacceptable toxicity.

Criteria for Continued Therapy

Continuation Therapy

Criteria for continued therapy

Continued therapy nodes: 1. Member has been receiving isatuximab via the Centene benefit or has documentation of at least 30 days of therapy.; 2. Member is responding positively to therapy (clinical benefit).; 3. Ongoing dosing remains within specified limits: standard maintenance dosing 10 mg/kg IV every 2 weeks for listed combinations; for the bortezomib + lenalidomide + dexamethasone combination, dosing is 10 mg/kg every 2 weeks with extension to every 4 weeks starting Cycle 18 and beyond per the dosing schedule.; 4. Any requested dose increase must be supported by practice guidelines or peer‑reviewed literature for the relevant off‑label indication (prescriber must submit supporting evidence).

Approval duration: 12 months; continue until disease progression or unacceptable toxicity.

Provider Requirements & Authorization

Prior Authorization

Prior Authorization Required

Prior authorization is required for Sarclisa (isatuximab). Requests must document the diagnosis, provider specialty, patient age, prior therapies, and the requested regimen. Authorization may be required for prior therapies (e.g., lenalidomide, bortezomib, carfilzomib/Kyprolis, ixazomib/Ninlaro) when those agents are referenced as prior lines of therapy.

Affected drugs: lenalidomide, bortezomib, carfilzomib (Kyprolis), ixazomib (Ninlaro), pomalidomide
Approval duration: 6 months

Step Therapy

Prior Therapy Context

Requests must describe prior therapy context — indicate number and identity of prior lines (for example: prior exposure to lenalidomide and a proteasome inhibitor such as bortezomib; regimens including carfilzomib for 1–3 prior lines when seeking isatuximab + carfilzomib + dexamethasone). Specify whether use is for relapsed/refractory disease or primary therapy and include prior response/intolerance when relevant.

Examples of prior therapies: lenalidomide, bortezomib, carfilzomib, ixazomib

Billing Codes & Dosing Information

HCPCS codes referencedHCPCS

J9227

Maximum dosing frequency/amount

Maximum dosing frequency/amount10 mg/kg per week for the first 4 weeks, then every 2 weeks thereafter

Administration Setting

Note

Infusion center — IV administration in appropriate oncology infusion setting

Isatuximab must be administered intravenously in an appropriate infusion setting consistent with standard oncology practice (infusion center).

Verify administration will occur in an infusion center or equivalent oncology infusion setting per dosing and monitoring needs.

Prior Treatments / Step Therapy Context

Prior therapy examples referenced
bortezomib
lenalidomide
carfilzomib
daratumumab
ixazomib
melphalan

Definitions & Abbreviations

Definition / Abbreviation

TermMultiple myeloma (MM)

Definition / Abbreviation

TermProteasome inhibitor (PI)

Quantity Limits & Packaging

Isatuximab‑irfc (Sarclisa) — quantity limit / drug-specific

DrugIsatuximab‑irfc (Sarclisa)

Vial strengths available100 mg and 500 mg single‑dose vials (20 mg/mL)

Quantity limit (per policy)No specific per‑course numeric limit listed in policy; dosing per regimen and maximum dose limits apply

AdministrationIntravenous infusion per dosing schedule; repeated until disease progression or unacceptable toxicity

Background & Indication Summary

Isatuximab‑irfc (Sarclisa) is a CD38‑directed cytolytic monoclonal antibody used in combination regimens for adults with multiple myeloma in specified settings. Indications covered by this policy include FDA‑approved combinations for relapsed/refractory disease and newly diagnosed disease in patients not eligible for autologous stem cell transplantation; dosing is given per the regimen‑specific schedule and therapy is continued until disease progression or unacceptable toxicity. For any non‑FDA indications, documentation of safety and efficacy per off‑label policies is required.