CurrentNeighborhood Health Plan of Rhode IslandPolicy N/A

Zydelig (idelalisib) drug coverage and utilization policy

Defines accepted indications, continuation and exclusion criteria, and utilization management authority for Zydelig (idelalisib) for members whose medication requests are processed by Evolent on behalf of Neighborhood Health Plan of Rhode Island.

Policy Summary

PayerNeighborhood Health Plan of Rhode Island

PolicyZydelig (idelalisib) drug coverage and utilization policy

Policy CodePolicy N/A

Change TypeNo material changes

Effective DateMay 31, 2024

Next Review DateN/A

Key ActionProviders must support Zydelig use with FDA labeling, CMS‑approved compendia, NCCN or ASCO guidelines, or acceptable peer‑reviewed literature meeting CMS Chapter 15 criteria.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

May 31, 2024Effective date

15+Committee review dates recorded

CLL excludedChronic Lymphocytic Leukemia coverage stance

Coverage and Exclusion Rules for Zydelig (idelalisib)

General coverage prerequisites

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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 the requirements of the CMS Medicare Benefit Policy Manual Chapter 15

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 the requirements of the CMS Medicare Benefit Policy Manual Chapter 15

Continuation requests exemption

Continuation requests for a not-approvable medication are exempt from this policy 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
No additional medication(s) are being added to the continuation request

Chronic Lymphocytic Leukemia (CLL)

Coverage position for CLL:

ALL of the following

Zydelig (idelalisib) is not supported by Evolent Policy for the treatment of CLL
Position is based on risk of severe toxicities outweighing benefits and increased mortality; FDA withdrew Zydelig indications for Follicular Lymphoma and Small Lymphocytic Leukemia on January 19, 2022
Providers should refer to Evolent recommended alternative agents/regimens (e.g., pathways.newcenturyhealth.com)

Exclusion (Investigational/Not Accepted Off‑Label Use)

Zydelig is excluded for investigational use or off‑label indications lacking sufficient evidence as defined by any of the following insufficient evidence criteria:

ANY of the following

Clinical characteristics of the patient and the cancer are not adequately represented in the published evidence
The administered regimen is not adequately represented in the published evidence
Reported study outcomes do not represent clinically meaningful outcomes (ASCO definitions: Hazard Ratio < 0.80 or OS/PFS benefit >= ~3 months expected)
Experimental design is inappropriate to address the investigative question
Non‑randomized trials without sufficient subjects are inadequate as sole supportive evidence
Case reports are considered anecdotal and inadequate supportive evidence
Abstracts without full peer‑reviewed articles lack adequate supporting evidence

What Providers Must Do

Documentation Required

Support use with recognized evidence source

Providers must support requests for Zydelig (idelalisib) with one of the recognized sources: FDA approved product labeling, CMS‑approved compendia, NCCN or ASCO clinical guidelines, or peer‑reviewed literature that meets the CMS Medicare Benefit Policy Manual Chapter 15 requirements.

Prior Authorization

Prior authorization processing

Evolent, on behalf of the plan, is responsible for processing all medication requests; medications not authorized by Evolent may be deemed not approvable and therefore not reimbursable.

Denial Risk

Risk of denial for investigational/off‑label use

Requests for investigational or off‑label uses of Zydelig that lack sufficient evidence as defined by the policy’s exclusion criteria (e.g., inadequate representativeness of patients/regimens, non‑clinically meaningful outcomes, weak study design, reliance on case reports or abstracts) are subject to denial and non‑reimbursement.

Clinical and Administrative Background

This policy defines the accepted indications and utilization requirements for Zydelig (idelalisib). Use must be supported by one of the following: FDA-approved product labeling, CMS‑recognized compendia, NCCN or ASCO clinical guidelines, or peer‑reviewed literature that meets the criteria in the CMS Medicare Benefit Policy Manual Chapter 15.

Continuation requests for prior use of idelalisib are exempt from denial when all of the following are met: 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.

The policy documents significant safety concerns and regulatory actions. Specifically, Evolent does not support the use of Zydelig for chronic lymphocytic leukemia (CLL) because the risk of severe toxicities outweighs the benefits; additionally, the FDA withdrew Zydelig indications for follicular lymphoma and small lymphocytic leukemia on January 19, 2022.

Off‑label or investigational uses that lack sufficient supporting evidence are excluded. Evidence is considered insufficient when the patient or regimen is not represented in published studies, reported outcomes are not clinically meaningful by ASCO benchmarks, study design is inappropriate, nonrandomized or anecdotal reports are the sole support, or only abstracts without full peer‑reviewed publications are available.

Defined Terms

Definitions - Sufficient evidence

TermSufficient evidence

DefinitionEvidence supported by CMS-recognized compendia or acceptable peer-reviewed literature; assessed by: representativeness of the patient population and cancer characteristics in published evidence; whether the administered regimen is adequately represented; whether reported outcomes are clinically meaningful (ASCO definitions: e.g., HR < 0.80 or OS/PFS benefit ≥ ~3 months); appropriateness of experimental design; recognition that non-randomized trials with sufficient subjects may be supportive, while case reports and meeting abstracts without full peer-reviewed articles are inadequate.

Evidence sourcesCMS-recognized compendia or acceptable peer-reviewed literature meeting CMS Medicare Benefit Policy Manual Chapter 15 criteria.

Examples of inadequate evidenceCase reports considered anecdotal; abstracts without full peer-reviewed articles lack adequate support.

Policy Summary

PayerNeighborhood Health Plan of Rhode Island

PolicyZydelig (idelalisib) drug coverage and utilization policy

Policy CodePolicy N/A

Change TypeNo material changes

Effective DateMay 31, 2024

Next Review DateN/A

Key ActionProviders must support Zydelig use with FDA labeling, CMS‑approved compendia, NCCN or ASCO guidelines, or acceptable peer‑reviewed literature meeting CMS Chapter 15 criteria.

SourceLink

On This Page

OpenPayer

Zydelig (idelalisib) drug coverage and utilization policy

Coverage and Exclusion Rules for Zydelig (idelalisib)

What Providers Must Do

Drug Identifier / Codes

Clinical and Administrative Background

Defined Terms

Policy Dates & Review History