CurrentNeighborhood Health Plan of Rhode IslandPolicy N/A

Drug Policy: Sarclisa (isatuximab-irfc) — Coverage Criteria

Defines clinical coverage criteria, continuation, exclusions, and approval authority for use of Sarclisa (isatuximab-irfc) for multiple myeloma and related oncology indications for members whose medication requests are processed by the payer/UM vendor.

Policy Summary

PayerNeighborhood Health Plan of Rhode Island

PolicySarclisa (isatuximab-irfc) — Coverage Criteria

Policy CodePolicy N/A

Change TypeAdministrative review — no material coverage changes

Effective DateOct 25, 2024

Next Review DateOct 9, 2024

Key ActionSubmit prior authorization to Evolent/UM with documentation of required prior therapies and supporting evidence (FDA label, NCCN/ASCO/compendia) for approval.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

10 mg/kgsingle-dose maximum specified

ICARIA-MM, IKEMA, IMROZkey clinical trials referenced

FDA + NCCN/ASCO/Compendiaacceptable evidence sources

≤30 dayscontinuation lapse allowed

Coverage Criteria for Sarclisa (isatuximab-irfc)

Trek Health ingests and normalizes Transparency in Coverage data and payer policy updates to give provider organizations a clear view of how commercial reimbursement behaves across markets, payers, and services. Our platform transforms raw payer disclosures into structured intelligence that supports contract evaluation, payer negotiations, and service line strategy. By combining market benchmarks with ongoing policy visibility, Trek helps teams identify variability, risk, and opportunity in commercial reimbursement. The result is faster insight, stronger negotiating positions, and more informed financial decisions.

inv-01: Initial and line-specific coverage for Multiple Myeloma

Covered when criteria for specific multiple myeloma scenarios are met.

Operational note: Use is restricted to members who have not received daratumumab when applying the relapsed/refractory combination rules.

(chunk 4)

inv-02: Continuation Therapy

Continuation therapy conditions.

Continuation requests

No progression: The member has not experienced disease progression on the requested medication.
(chunk 3)
Recent use and lapse: The requested medication was used within the last year without a lapse of more than 30 days of having an active authorization.<=30 days lapse
(chunk 3)
No added medications: Additional medication(s) are not being added to the continuation request.
(chunk 3)

Operational note: Continuation requests meeting these criteria are exempt from full Evolent policy review per the policy rules.

(chunk 3)

This policy excludes use of Sarclisa (isatuximab-irfc) when the drug is being given on or after disease progression with the same regimen or after progression on a daratumumab-based regimen. Requests that exceed the documented single-dose maximum are also excluded — the policy specifies a single dose maximum of 10 mg/kg. Additionally, investigational or off-label uses that lack sufficient supporting evidence (for example, evidence not supported by CMS-recognized compendia, NCCN/ASCO guidance, or acceptable peer‑reviewed literature) are excluded; the policy details criteria for what constitutes adequate supportive evidence (trial representativeness, clinically meaningful outcomes, study design and size, and exclusion of anecdotal reports or unpublished abstracts).

Initial Therapy

inv-11: Initial Therapy — combination regimen and prior therapy history criteria (use branch logic)

Initial therapy — combination regimen and prior therapy history criteria (fulfill any single branch).

Documentation requirement: Prior therapy history must be documented to demonstrate failure of required prior agents per the selected combination pathway.

(chunk 4)

Continuation / Re-authorization Rules

inv-12: Continuation — continuity exceptions when specific criteria are met

Continuation — continuity exceptions when specific criteria are met.

Continuation exception conditions

No progression on therapy: The member has not experienced disease progression on the requested medication.
(chunk 3)
Active use within 1 year with short lapse: The medication was used within the last year and there has been no lapse of more than 30 days in active authorization.<=30 days lapse
(chunk 3)
No addition of new agents: No additional medication(s) are being added to the continuation request.
(chunk 3)

Operational note: If any of these conditions are not met (for example, progression, >30-day lapse, or adding agents), the request must follow full policy criteria and documentation requirements.

(chunk 3)

Provider Actions and Requirements

Prior Authorization

Prior Authorization Required

Prior authorization required. Evolent (Utilization Management) processes all medication requests from network ordering providers; final approval is by the Utilization Management Committee. Medications not authorized by Evolent may be deemed not approvable and not reimbursable.

All requests processed by Evolent/UM
Final approval by Utilization Management Committee
Medications not authorized by Evolent may be denied/not reimbursable

Documentation Required

Supportive Evidence Required

Documentation must include supportive evidence from one of the accepted sources: FDA-approved product labeling; CMS-recognized compendia; National Comprehensive Cancer Network (NCCN) or American Society of Clinical Oncology (ASCO) clinical guidelines; or peer‑reviewed literature that meets CMS standards. Evidence should demonstrate applicability to the patient’s clinical characteristics and the specific regimen being prescribed.

Acceptable sources: FDA labeling; CMS-approved compendia; NCCN; ASCO; peer-reviewed literature meeting CMS criteria
Peer-reviewed evidence must represent the patient population and regimen, and report clinically meaningful outcomes (ASCO recommendations — e.g., HR < 0.80 or ≥ 3 months benefit for OS/PFS where applicable)
Meeting abstracts without full peer‑reviewed publication are insufficient

Documentation Required

Prior Therapy Documentation

Prior therapy documentation is required for indication-specific combinations. For relapsed/refractory multiple myeloma, document prior lines of therapy, prior agents used (including proteasome inhibitors and immunomodulatory agents), and confirm absence of prior daratumumab therapy when relevant. Do not approve use on or after progression with the same regimen or after progression on a daratumumab-based regimen.

For Sarclisa + pomalidomide + steroid: documentation of failure of ≥2 prior therapies including a proteasome inhibitor and an immunomodulatory agent (other than pomalidomide)
For Sarclisa + carfilzomib + steroid: document 1 prior line of therapy (other than carfilzomib)
Confirm member has not received prior daratumumab therapy when the indication requires it
Do not approve when therapy is being used on/after disease progression with the same regimen or after progression on a daratumumab-based regimen

Denial Risk

Exclusion for Insufficient Evidence / Investigational Use

Investigational or off‑label use without sufficient supporting evidence is excluded. Ensure submitted evidence addresses study design quality and clinical relevance; single case reports or abstracts without full peer‑reviewed articles are generally inadequate.

Exclusion applies for investigational use lacking CMS compendia or acceptable peer‑reviewed literature
Case reports and meeting abstracts without full publications are insufficient
Review will consider whether published evidence adequately represents the patient population, regimen, and clinically meaningful outcomes

Coding and Dose Limits

inv-04: Single dose maximum — numeric limit for dosing

Single dose maximum10 mg/kg per single dose

Unit of measuremg per kg of body weight

ApplicationLimit applies to individual single doses of Sarclisa (isatuximab-irfc)

Exclusion consequenceDosing that exceeds this single-dose limit is listed as an exclusion criterion

Quantity Limits

inv-14: Sarclisa (isatuximab-irfc) — quantity / dosing limit (10 mg/kg)

Drug and strengthSarclisa (isatuximab-irfc) — 10 mg/kg single dose

Quantity/dosing limitMaximum single dose: 10 mg/kg

Context of useApplied for combination regimens in multiple myeloma per policy coverage criteria

Reference to exclusionDosing exceeding 10 mg/kg is an exclusion (denial risk)

Definitions

inv-10: Disease progression exclusion — definition noting exclusion when used on/after disease progression with the same regimen or after daratumumab progression

DefinitionUse of Sarclisa on or after disease progression with the same regimen is excluded

Related exclusionUse after disease progression on a daratumumab-based regimen is explicitly excluded

Coverage impactRequests meeting this progression definition are subject to denial per exclusion criteria

ScopeApplies regardless of combination regimen when progression occurred on the same regimen or on daratumumab-based therapy

Step Therapy / Prior Therapy Requirements

Combination regimen	Required prior therapies / step rule
Isatuximab + pomalidomide + steroid	Member has failed ≥2 prior therapies including a proteasome inhibitor (e.g., bortezomib, carfilzomib, ixazomib) and an immunomodulatory agent (e.g., lenalidomide, thalidomide) other than pomalidomide
Isatuximab + carfilzomib + steroid	Used following 1 prior line of therapy other than carfilzomib

Site of Care Considerations

Note

Site of care not specified — follow FDA label and UM processes

Policy does not specify an infusion site of care. Follow the FDA label and Evolent/UM processes when determining site (e.g., infusion center) and document site-of-care per UM request.

Refer to the FDA label for administration details.
Follow Evolent/UM site-of-care processes when scheduling and billing.

Background

Sarclisa (isatuximab-irfc) is an anti-CD38 monoclonal antibody used in combination regimens for multiple myeloma. The policy describes covered uses including combination therapy for newly diagnosed, transplant‑ineligible patients (isatuximab with bortezomib + lenalidomide + steroid) and specific relapsed/refractory settings when prior‑therapy requirements are met. The policy references the need for supportive clinical evidence and explicitly lists exclusions such as use after progression on the same regimen or after progression on a daratumumab-based regimen and dosing above the 10 mg/kg single-dose limit.