CurrentNeighborhood Health Plan of Rhode IslandPolicy N/A

Zydelig 1706 A Sgm P2022

Defines coverage criteria for idelalisib (Zydelig) for FDA-approved and compendial indications (relapsed CLL in combination with rituximab and relapsed/refractory CLL/SLL), authorization duration, continuation criteria, and exclusions (other indications considered experimental).

Policy Summary

PayerNeighborhood Health Plan of Rhode Island

PolicyZydelig 1706 A Sgm P2022

Policy CodePolicy N/A

Change TypeClarified

Effective Date

Next Review Date

Key ActionPrior authorization is required; document indication, prior therapies/comorbidities, absence of exclusions, and provide evidence of response/no progression for reauthorization (initial and reauthorization may be granted for 12 months when criteria are met).

SourceLink

POLICY UPDATE CHANGES

Policy cites FDA-approved relapsed CLL indication in combination with rituximab and compendial use for relapsed/refractory CLL/SLL with 12-month authorizations.

2Covered Indications

12Authorization Duration (months)

2Referenced Sources

Coverage Summary & Indications

Scope: This policy defines coverage criteria for idelalisib (Zydelig) and states that Zydelig is covered with criteria for the FDA-approved indication of relapsed chronic lymphocytic leukemia (CLL) when used in combination with rituximab, as well as for compendial uses for relapsed or refractory CLL/SLL. The policy restricts use to non-first-line settings and excludes use in certain combinations and other indolent lymphoma indications. Effective/last review date: 2022-06-02.

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Provider Actions & Documentation Requirements

Prior Authorization

Authorization required

Prior authorization is required for idelalisib (Zydelig). When criteria are met, initial authorization may be granted for 12 months. Reauthorization may also be granted for 12 months when continuation criteria are satisfied (no unacceptable toxicity or disease progression).

Documentation Required

Clinical documentation required

Provider must document the indication (relapsed CLL in combination with rituximab or relapsed/refractory CLL/SLL), prior therapies and comorbidities supporting that rituximab is appropriate, absence of any exclusions to therapy, and, for reauthorization, evidence of response or no disease progression and no unacceptable toxicity on the current regimen.

Clinical Evidence & References

Evidence and background: Key references cited by the policy include the Zydelig (idelalisib) package insert, February 2022 and the NCCN Drugs & Biologics Compendium (accessed June 2, 2022). The FDA approval covers relapsed CLL in combination with rituximab in patients for whom rituximab alone would be appropriate, and compendial sources support use in relapsed or refractory CLL/SLL. The policy applies 12-month authorizations when compendial criteria are met and allows 12-month reauthorizations when there is no unacceptable toxicity or disease progression.

Policy Summary

PayerNeighborhood Health Plan of Rhode Island

PolicyZydelig 1706 A Sgm P2022

Policy CodePolicy N/A

Change TypeClarified

Effective Date

Next Review Date

SourceLink

On This Page

OpenPayer

Zydelig 1706 A Sgm P2022

Coverage Summary & Indications

Authorization & Continuation Criteria

Not Covered / Limitations of Use

Provider Actions & Documentation Requirements

Applicable Codes

Clinical Evidence & References

Definitions

Policy Revision History