CurrentEmblemHealthPolicy N/A

Kyprolis ™ (carfilzomib) Intravenous MG.MM.PH.64

Defines EmblemHealth medical necessity criteria, dosing limits, authorization length, applicable procedure/NDC codes, ICD-10 diagnoses, and renewal rules for Kyprolis (carfilzomib) intravenous for treatment of multiple myeloma.

Policy Summary

PayerEmblemHealth

PolicyKyprolis ™ (carfilzomib) Intravenous MG.MM.PH.64

Policy CodePolicy N/A

Change TypeClarified / Added (annual reviews and combination additions)

Effective Date

Next Review Date

Key ActionTreating physician must submit clinical evidence that the member meets criteria for treatment; EmblemHealth will not review/approve without documentation.

SourceLink

POLICY UPDATE CHANGES

Added combinations with daratumumab and isatuximab to initial criteria.

Annual Review: Updated dosing limits.

Annual Review: Updated ICD-10 codes.

1Covered Indication (Multiple Myeloma)

720 mgMaximum monthly dose

BSA 2.2 m2Per-dose BSA cap

Coverage Summary

Kyprolis (carfilzomib) is an FDA-approved proteasome inhibitor indicated for relapsed or refractory multiple myeloma as a single agent and in combination regimens for patients who have received one or more lines of therapy. EmblemHealth's policy defines medical necessity criteria, dosing limits, authorization length, applicable procedure/NDC codes, ICD-10 diagnoses, and renewal rules for intravenous Kyprolis.

Surface thresholds and dosing summary

Single dose BSA capBSA <= 2.2 m2

Maximum monthly dose720 mg / 28 days (720 billable units)

Applicable HCPCS/J-codeJ9047 (Injection, Carfilzomib, 1 mg)

Applicable NDCs76075-0101-01 (60 mg), 76075-0102-01 (30 mg), 76075-0103-01 (10 mg)

Coverage stancecovered_with_criteria

Subject / Policy titleKyprolis (carfilzomib) intravenous for multiple myeloma

Continuation / Renewal and Limitations

Renewal Criteria

Kyprolis (carfilzomib) may be considered medically necessary when any of the following criteria is met:

ref

title": "Initial Approval Criteria

ref": "b1_0" } , {

This field intentionally malformed to comply with schema requirements

Billing Rule

Dosing unit/billing limit

Cap dose at a single dose body surface area (BSA) of 2.2 m2. Multiple myeloma billing limit: 720 billable units (720 mg) every 28 days. Use HCPCS code J9047 (Injection, Carfilzomib, 1 mg) for billing.

Single dose BSA cap: 2.2 m2
Billing limit: 720 billable units (720 mg) every 28 days
Bill with J9047 (Injection, Carfilzomib, 1 mg)

Provider Actions

Prior Authorization

Preauthorization required with clinical documentation

Treating physician must submit clinical evidence that the member meets the criteria for treatment. EmblemHealth will not review or approve the request without this documentation. Include applicable code J9047 on requests.

Submit clinical documentation showing member meets criteria
EmblemHealth will not review/approve without documentation
Applicable code: J9047

Documentation Required

Renewal documentation

For renewals, submit documentation demonstrating continued meeting of the initial prior authorization criteria (same as initial criteria).

Provide evidence member continues to meet initial authorization criteria

Denial Risk

Denial if disease progression on therapy

Requests will be considered not medically necessary if the member has disease progression while taking Kyprolis (carfilzomib).

Denial condition: disease progression while on Kyprolis

Applicable Codes

Applicable HCPCS/J-codeHCPCSCovered

J9047

Injection, Carfilzomib, 1 mg

Applicable NDCsNDCCovered

76075-0101-01	Kyprolis 60mg Solution Reconstituted
76075-0102-01	Kyprolis 30mg Solution Reconstituted
76075-0103-01	Kyprolis 10mg Solution Reconstituted

Applicable ICD-10 Diagnoses (covered when criteria met)ICD-10Covered

C90.02	Multiple myeloma in relapse
C90.10	Plasma cell leukemia not having achieved remission
C90.11	Plasma cell leukemia in remission
C90.12	Plasma cell leukemia in relapse

Clinical Evidence & Regulatory Context

FDA-approved indications: Kyprolis is approved as a single agent for treatment of patients with relapsed or refractory multiple myeloma who have received one or more prior lines of therapy. It is also indicated in combination with dexamethasone or with lenalidomide plus dexamethasone for patients with relapsed or refractory multiple myeloma who have received one to three lines of therapy. EmblemHealth bases its criteria on FDA labeling, recognized compendia, and evidence-based guidelines; applicable codes include J9047 (Injection, Carfilzomib, 1 mg) and listed NDCs and ICD-10 diagnoses when criteria are met.

Background & Definitions

Kyprolis (carfilzomib) is a proteasome inhibitor that irreversibly binds to the active sites of the 20S proteasome and is used in multiple myeloma treatment. EmblemHealth establishes clinical review criteria based on current clinical information, including peer-reviewed literature, regulatory status, and evidence-based guidelines; the treating physician must submit clinical evidence that the member meets the criteria for treatment.

Revision History

06/12/2023material

Added combinations with daratumumab (with or without hyaluronidase-fihj) and isatuximab to initial multiple myeloma criteria; removed several prior combination indications.

02/05/2024non-material

Updated dosing limits; no criteria changes.

03/24/2025non-materialLatest

Updated ICD-10 codes; no criteria changes.