CurrentNeighborhood Health Plan of Rhode IslandPolicy N/A

Kyprolis (carfilzomib) coverage for multiple myeloma

Defines accepted indications, continuation and exclusion criteria, and approval authority for Kyprolis (carfilzomib) use in cancer treatment, primarily multiple myeloma, including supported combinations, unsupported regimens for newly diagnosed disease, evidentiary requirements, and dosing limits.

Policy Summary

PayerNeighborhood Health Plan of Rhode Island

PolicyKyprolis (carfilzomib) coverage for multiple myeloma

Policy CodePolicy N/A

Change TypeNo material change

Effective DateNov 29, 2024

Next Review Date

Key ActionAll medication requests for Kyprolis must be processed by Evolent; medications not authorized by Evolent may be deemed not approvable and not reimbursable.

POLICY UPDATE CHANGES

No material clinical or coverage changes.

5Supported relapsed/refractory combos

Not supportedNewly diagnosed (transplant-ineligible)

Not supportedSpecific quadruplet (transplant-eligible)

56/70Dose exclusion thresholds

Coverage Summary

Coverage stance: Kyprolis (carfilzomib) is covered with clinical criteria per this policy. Scope: the policy defines accepted indications, continuation and exclusion criteria, approval authority, supported combinations, unsupported regimens for newly diagnosed disease, evidentiary requirements, and dosing limits for Kyprolis use in cancer treatment (primarily multiple myeloma). Effective date: November 29, 2024; Last review: November 13, 2024.

High-level summary: Kyprolis is covered when use is supported by FDA-approved labeling, CMS-recognized compendia, NCCN or ASCO clinical guidelines, or peer-reviewed literature meeting CMS Medicare Benefit Policy Manual Chapter 15 standards. Continuation request exemptions permit coverage for a not-approvable medication if the medication was used within the last year, the member has not experienced disease progression or intolerance, and no additional medications are being added to the continuation request.

Dose Threshold and Key Policy Stats

Single dose limit56 mg/m2 (twice weekly) or 70 mg/m2 (once weekly)

Supported relapsed/refractory combinationsAfter 1–3 prior therapies: may be used in any one of: with dexamethasone; with lenalidomide +/- steroid; with cyclophosphamide +/- steroid; with daratumumab +/- steroid; with pomalidomide +/- steroid.

Newly diagnosed — transplant-ineligibleKyprolis-based regimens (e.g., KRd) are not supported by policy for newly diagnosed, transplant-ineligible multiple myeloma (ENDURANCE trial: equivalent outcomes and increased cardiotoxicity vs bortezomib-based regimen).

Newly diagnosed — transplant-eligible specific quadrupletDaratumumab + Kyprolis + Lenalidomide + Dexamethasone is not supported for newly diagnosed, transplant-eligible multiple myeloma (lack of Level 1 evidence versus daratumumab + bortezomib + lenalidomide + dexamethasone).

Evidence & Acceptance Criteria

General Acceptance and Evidence Requirement

Use of Kyprolis must be supported by one of the following sources:

ANY of the following

FDA-approved product labeling
CMS-approved compendia
National Comprehensive Cancer Network (NCCN) clinical guidelines
American Society of Clinical Oncology (ASCO) clinical guidelines
Peer-reviewed literature that meets CMS Medicare Benefit Policy Manual Chapter 15 requirements

ENDURANCE trial: referenced for the policy position that Kyprolis-based regimens (e.g., KRd) are not supported for newly diagnosed, transplant-ineligible multiple myeloma because the trial showed equivalent outcomes and increased cardiotoxicity for carfilzomib + lenalidomide + dexamethasone versus bortezomib + lenalidomide + dexamethasone.

ENDEAVOR trial: cited as the randomized phase 3 comparison of carfilzomib + dexamethasone versus bortezomib + dexamethasone in relapsed/refractory multiple myeloma (reference).

CANDOR trial: cited as the randomized phase 3 study of carfilzomib + dexamethasone + daratumumab versus carfilzomib + dexamethasone in relapsed/refractory multiple myeloma (reference).

Initial & Continuation Therapy Criteria

Multiple Myeloma - Relapsed or Refractory Disease (after 1-3 prior therapies)

ONE of

In combination with dexamethasone
In combination with lenalidomide +/- steroid
In combination with cyclophosphamide +/- steroid
In combination with daratumumab +/- steroid
In combination with pomalidomide +/- steroid

Continuation Requests Exemption

Continuation requests for a not-approvable medication are exempt if ALL of the following are met:

ALL of the following

The requested medication was used within the last year
The member has not experienced disease progression and/or no intolerance to the requested medication
Additional medication(s) are not being added to the continuation request

Exclusions and Not Medically Necessary Uses

Exclusion Criteria

Kyprolis is excluded when ANY of the following apply:

ANY of the following

Member has disease progression while taking Kyprolis (carfilzomib)
Dosing exceeds single dose limit of Kyprolis (carfilzomib) 56 mg/m2 twice weekly or 70 mg/m2 once weekly56 mg/m2 twice weekly or 70 mg/m2 once weekly
ALL of the following
- Sufficient evidence is defined by:
  - Whether the clinical characteristics of the patient and the cancer are adequately represented in the published evidence
  - Whether the administered regimen is adequately represented in the published evidence
  - Whether reported study outcomes represent clinically meaningful outcomes (ASCO definitions: HR < 0.80; OS/PFS benefit >= 3 months)
  - Whether experimental design is appropriate to address the investigative question (randomization, blinding, etc., when feasible)
  - Non-randomized trials with a significant number of subjects may be supportive evidence
  - Case reports are generally considered inadequate supportive evidence
  - Abstracts without full articles from approved peer-reviewed journals lack adequate supporting evidence

Multiple Myeloma - Newly Diagnosed (Transplant Ineligible)

Kyprolis-based regimens for newly diagnosed, transplant-ineligible multiple myeloma:

ALL of the following

Kyprolis (carfilzomib)-based regimens (e.g., KRd) are not supported by Evolent Policy for newly diagnosed, transplant ineligible multiple myeloma
Policy position based on ENDURANCE trial showing equivalent outcomes and increased cardiotoxicity for Kyprolis+lenalidomide+dexamethasone vs bortezomib+lenalidomide+dexamethasone
Refer to Evolent recommended alternative regimens (e.g., pathways.newcenturyhealth.com)

Multiple Myeloma - Newly Diagnosed (Transplant Eligible)

Specific quadruplet regimen not supported for newly diagnosed, transplant-eligible patients:

ALL of the following

Daratumumab + Kyprolis (carfilzomib) + Lenalidomide + Dexamethasone is not supported by Evolent Policy for newly diagnosed, transplant eligible multiple myeloma
Policy position based on lack of Level 1 evidence showing superiority or lower toxicity compared to Daratumumab + Bortezomib + Lenalidomide + Dexamethasone
Refer to Evolent recommended alternative regimens (e.g., pathways.newcenturyhealth.com)

Provider Actions & Prior Authorization

Prior Authorization

Medication requests processed by Evolent

All medication requests for Kyprolis must be processed by Evolent; medications not authorized by Evolent may be deemed not approvable and not reimbursable.

Documentation Required

Evidence requirement

Requests for Kyprolis must be supported by FDA-approved product labeling, CMS-recognized compendia, NCCN or ASCO clinical guidelines, or peer-reviewed literature that meets the requirements of the CMS Medicare Benefit Policy Manual Chapter 15; documentation must demonstrate these sources when requesting coverage.

Denial Risk

Exclusion for progression or excessive dosing

Requests will be denied if the member has disease progression while taking Kyprolis or if the proposed dosing exceeds policy limits.

56 mg/m2 twice weekly
70 mg/m2 once weekly

Background

Background: This policy defines the accepted indications for Kyprolis (carfilzomib), including FDA-approved indications and off-label uses supported by recognized compendia or guidelines. Evolent's Utilization Management function is responsible for processing all medication requests; medications not authorized by Evolent may be deemed not approvable and not reimbursable.

Accepted evidence: Use must be supported by FDA product labeling, CMS-approved compendia, NCCN or ASCO clinical guidelines, or peer-reviewed literature that meets CMS Medicare Benefit Policy Manual Chapter 15 requirements.

Continuation exemptions: Continuation requests for a not-approvable medication are exempt if ALL of the following are met: the requested medication was used within the last year; the member has not experienced disease progression and/or no intolerance to the requested medication; and additional medication(s) are not being added to the continuation request.

Definition (Continuation request exemption): A continuation request for a not-approvable medication is exempt if used within last year, no progression/intolerance, and no additional meds added.

Policy Summary

PayerNeighborhood Health Plan of Rhode Island

PolicyKyprolis (carfilzomib) coverage for multiple myeloma

Policy CodePolicy N/A

Change TypeNo material change

Effective DateNov 29, 2024

Next Review Date

Key ActionAll medication requests for Kyprolis must be processed by Evolent; medications not authorized by Evolent may be deemed not approvable and not reimbursable.

On This Page

OpenPayer

Kyprolis (carfilzomib) coverage for multiple myeloma

Coverage Summary

Evidence & Acceptance Criteria

Initial & Continuation Therapy Criteria

Exclusions and Not Medically Necessary Uses

Applicable Codes

Provider Actions & Prior Authorization

Background

Revision History