Viva Health isatuximab (Sarclisa) Coverage & Prior Auth

Coverage Criteria for Isatuximab (Sarclisa)

inv-01: Initial Approval — Multiple Myeloma

Covered when ALL of the following are met

Age and universal exclusions: Member is at least 18 years of age; AND therapy will not be used in combination with other anti-CD38 therapies.

Multiple myeloma indications (primary or previously treated): Either: used as primary therapy for symptomatic disease in specified combinations OR used for previously treated (relapsed, refractory, or progressive) disease in specified combinations.

Primary therapy combinations include: (1) isatuximab with bortezomib, lenalidomide, and dexamethasone; OR (2) isatuximab with lenalidomide and dexamethasone for non‑transplant candidates or if transplant is deferred; OR (3) isatuximab with carfilzomib, lenalidomide, and dexamethasone followed by maintenance with carfilzomib and lenalidomide (transplant candidates ONLY). Relapsed/refractory options include isatuximab with pomalidomide and dexamethasone after at least two prior therapies including lenalidomide and a proteasome inhibitor, OR isatuximab with carfilzomib and dexamethasone.

inv-02: Renewal Criteria — Authorization may be renewed when ALL of the following are met

Renewal criteria — Authorization may be renewed when ALL of the following are met

Continuation requirements: Member continues to meet the indication‑specific relevant criteria (including required concomitant therapy per Section III), duration of authorization has not been exceeded (refer to Section I), disease response defined as stabilization of disease or decrease in tumor burden, AND absence of unacceptable toxicity (e.g., severe infusion‑related reactions, severe infections, neutropenia, secondary primary malignancies).

Refer to Section I for specific duration limits; certain primary-therapy requests for transplant candidates (VRd) have a non‑renewable initial maximum as specified in Section I.

Use of isatuximab in combination with any other anti‑CD38 therapies (for example, daratumumab) is excluded. Requests must demonstrate the regimen does not include another anti‑CD38 monoclonal antibody to meet coverage criteria.

Medicare beneficiaries are subject to Medicare coverage rules; outpatient Part B drug coverage follows the Medicare Benefit Policy Manual (Pub. 100-02), Chapter 15 §50, and any applicable National Coverage Determinations (NCDs) or Local Coverage Determinations (LCDs). Where NCDs/LCDs or Local Coverage Articles (LCAs) apply, compliance with those policies is required and may affect coverage determinations in this policy. Non‑Medicare determinations in this document apply to non‑Medicare members and may differ from Medicare decisions.

When isatuximab is requested as part of primary therapy for newly diagnosed, transplant‑eligible multiple myeloma in combination with bortezomib, lenalidomide, and dexamethasone (VRd), prior authorization is required and initial authorization is limited. The policy provides an initial prior authorization validity of up to 18 weeks (11 doses) for this specific transplant‑candidate primary therapy regimen, and such requests are not eligible for renewal beyond that maximum.

Covered Regimens and Dosing

Regimen	Indication / setting	Dosing schedule (isatuximab 10 mg/kg)	Coverage status
Isatuximab 10 mg/kg IV in combination with carfilzomib, lenalidomide, dexamethasone (KRd) for induction and consolidation followed by maintenance with carfilzomib and lenalidomide
Newly diagnosed, transplant-eligible patients (transplant candidates only)
Induction: up to 8 cycles — Cycle 1: weekly (Days 1,8,15,22; 4 doses); Cycles 2–8: every 2 weeks (Days 1 & 15; 2 doses per cycle). Consolidation: Cycles 9–12 every 2 weeks (Days 1 & 15). Maintenance: every 2 weeks for 26 cycles (Days 1 & 15) until progression or unacceptable toxicity.
Covered with criteria

Regimen	Indication / setting	Dosing schedule (isatuximab 10 mg/kg)	Coverage status
Isatuximab 10 mg/kg IV in combination with lenalidomide and dexamethasone
Newly diagnosed, transplant-ineligible or transplant deferred (primary therapy)
Non-transplant candidates: Cycle 1 weekly (five doses; Days 1,8,15,22,29); Cycles 2–4 every 2 weeks (three doses per 42-day cycle; Days 1,15,29). Cycles 5–17 every 2 weeks (two doses per 28-day cycle; Days 1 & 15). Cycle 18+ every 4 weeks (one dose per 28-day cycle; Day 1). Treat until progression or unacceptable toxicity.
Covered with criteria

Regimen	Indication / setting	Dosing schedule (isatuximab 10 mg/kg)	Coverage status
Isatuximab 10 mg/kg IV in combination with pomalidomide and dexamethasone
Relapsed/Refractory multiple myeloma after ≥2 prior therapies including lenalidomide and a proteasome inhibitor
Cycle 1 weekly (four doses; Days 1,8,15,22); Cycle 2 and beyond every 2 weeks (two doses per 28-day cycle; Days 1 & 15). Continue until disease progression or unacceptable toxicity.
Covered with criteria

Billing Codes and Diagnosis Codes

Covered HCPCS CodesHCPCSCovered

J9227

Injection, isatuximab-irfc, 10 mg

NDCsNDC

00024-0654-xx	Sarclisa 100 mg/5 mL single-dose vial
00024-0656-xx	Sarclisa 500 mg/25 mL single-dose vial

Covered ICD-10 Diagnosis CodesICD-10Covered

C90.00	Multiple myeloma not having achieved remission
C90.02	Multiple myeloma, in relapse
C90.10	Plasma cell leukemia not having achieved remission
C90.12	Plasma cell leukemia in relapse
C90.20	Extramedullary plasmacytoma not having achieved remission
C90.22	Extramedullary plasmacytoma in relapse
C90.30	Solitary plasmacytoma not having achieved remission
C90.32	Solitary plasmacytoma in relapse
Z85.79	Personal history of other malignant neoplasms of lymphoid, hematopoietic and related tissues

Covered ICD-10 Diagnosis CodesICD-10Covered

C90.00	Multiple myeloma not having achieved remission
C90.02	Multiple myeloma, in relapse
C90.10	Plasma cell leukemia not having achieved remission
C90.12	Plasma cell leukemia in relapse
C90.20	Extramedullary plasmacytoma not having achieved remission
C90.22	Extramedullary plasmacytoma in relapse
C90.30	Solitary plasmacytoma not having achieved remission
C90.32	Solitary plasmacytoma in relapse
Z85.79	Personal history of other malignant neoplasms of lymphoid, hematopoietic and related tissues

Medicare Part B Covered Diagnosis Codes (applicable to NCD/LCD/LCA)ICD-10

No codes listed

Max units per dose

Max units per dose (short-term)120 billable units weekly x 5 doses

Max units per dose (maintenance interval)720 billable units every 84 days

HCPCS unit definition1 billable unit = 10 mg (see HCPCS J9227)

Medicare Part B Covered Diagnosis Codes

Medicare Part B covered diagnosis codesN/A

Notes on MAC jurisdictionsApplicable Medicare Part B Administrative Contractor (MAC) jurisdictions listed in Appendix (see document for regional contractor assignments)

Provider Requirements, Documentation, and Billing Notes

Prior Authorization

Prior Authorization Required

Prior Authorization Required: Prior authorization is required for initial and renewal therapy. Initial authorization is typically provided for 6 months (180 days) unless otherwise specified. Specific regimens may have different initial or renewal validity (for example, certain primary therapy regimens have shorter or non-renewable authorizations).

Initial authorization: 6 months (180 days) unless otherwise specified.
Some regimens (e.g., primary therapy in transplant candidates with bortezomib/lenalidomide/dexamethasone) have regimen-specific validity periods and renewal rules.

Documentation Required

Required Documentation

Documentation must show the member meets age and diagnosis requirements and that the requested use meets the coverage criteria.

Member is ≥18 years of age.
Documentation of an applicable covered diagnosis using one of the Appendix 1 ICD-10 codes (see list).

Line of Therapy Specifications

inv-32: first-line | second-line — 1 top-level node

Line of therapy: Used as primary (frontline) therapy in newly diagnosed symptomatic disease (transplant‑eligible or transplant‑ineligible/deferred) OR used for relapsed/refractory disease per regimen specifications.

For transplant‑eligible primary therapy the policy distinguishes regimens (e.g., KRd induction/consolidation followed by KR+lenalidomide maintenance available only for transplant candidates). Standard administered dose across listed combinations is 10 mg/kg IV as described in dosing guidance.

Definitions and ICD-10 Terms

Anti-CD38 therapies (e.g., daratumumab, isatuximab)

DefinitionAnti-CD38 therapies are monoclonal antibodies targeting the CD38 antigen expressed on plasma cells (examples include daratumumab and isatuximab)

Common agentsDaratumumab, isatuximab

Coverage interactionTherapy will not be used in combination with other anti-CD38 therapies (combination use is excluded)

C90.00

CodeC90.00

DescriptionMultiple myeloma not having achieved remission

Use

Background

Isatuximab is an anti‑CD38 monoclonal antibody used intravenously in combination regimens for treatment of multiple myeloma. The policy covers use in both newly diagnosed (transplant‑eligible and ‑ineligible) and relapsed/refractory settings when given in authorized combination regimens and meeting age and documentation requirements. Note that therapy must not be combined with other anti‑CD38 agents, and Medicare beneficiaries remain subject to applicable Medicare manuals and NCD/LCD requirements which may modify coverage.

OpenPayer

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