CurrentCignaPolicy N/A

Oncology - Venclexta Drug Quantity Management Policy - Per Rx

Defines per-prescription quantity limits and approval criteria for Venclexta (venetoclax tablets) across package sizes/strengths for Cigna-administered health benefit plans, including retail and home delivery maximums and specific override conditions for certain diagnoses.

Policy Summary

PayerCigna

PolicyOncology - Venclexta Drug Quantity Management Policy - Per Rx

Policy CodePolicy N/A

Change TypeRevised (quantity limits & override criteria)

Effective Date

Next Review Date

Key ActionIf the Drug Quantity Management rule is not met at point of service, determine coverage by the criteria; approvals when granted are provided for 1 year.

POLICY UPDATE CHANGES

Home delivery quantity limit for the CLL/SLL Starting Pack was changed from 126 tablets (3 packs) to 42 tablets (1 pack) per dispensing.

Venclexta 100 mg tablets override criteria updated to approve requested quantity up to 240 tablets retail or 720 tablets home delivery for certain diagnoses.

Annual revision noted 'No criteria changes' for 04/19/2024 review.

42CLL/SLL Starting Pack retail tablets per dispensing

240Max 100 mg retail tablets per dispensing (override)

720Max 100 mg home delivery tablets per dispensing (override)

Coverage Summary & Scope

This policy governs per-prescription quantity limits and approval criteria for Venclexta (venetoclax tablets) across available package sizes and strengths for Cigna-administered health benefit plans, including specified retail and home delivery maximums for each package/strength.

All approvals under this Drug Quantity Management program are provided for 1 year in duration.

Venclexta dosing frequently includes ramp-up schedules and multiple commercial package sizes/strengths (including a CLL/SLL Starting Pack and wallets/blisters/bottles of 10 mg, 50 mg, and 100 mg tablets) which are reflected in the package-specific quantity limits.

Drug Quantity Limits - General

Venclexta product(s) is(are) covered as medically necessary when the Drug Quantity Management rule is met. All approvals are provided for 1 year in duration. Any other exception is considered not medically necessary.

Drug Quantity Management rule: Requested quantity for the specific Venclexta package size/strength does not exceed the Retail or Home Delivery Maximum Quantity per Rx specified for that packageSee package-specific retail and home delivery maximums

All approvals are provided for 1 year in duration.

Override Criteria & Package-specific Rules

Override Criteria - Venclexta 100 mg tablets

Approve the requested quantity when ALL of the following are met:

Override for 100 mg tablets: Patient has one of the following diagnoses: multiple myeloma, systemic light chain amyloidosis, or Waldenström macroglobulinemia/lymphoplasmacytic lymphomaDiagnosis documented

For approved diagnoses, requested quantity may be up to 240 tablets per dispensing at retail or 720 tablets per dispensing at home delivery.

100 mg retail limit for approved diagnoses: Requested quantity does not exceed 240 tablets per dispensing at retail<= 240 tablets per dispensing

Applies only when qualifying diagnosis is documented.

100 mg home delivery limit for approved diagnoses:

Provider Actions & Billing Rules

Prior Authorization

Quantity Management rule enforcement

If the Drug Quantity Management rule is not met at point of service, coverage will be determined by the criteria. Approvals granted under this policy are provided for 1 year in duration.

Documentation Required

Diagnosis documentation for 100 mg override

For Venclexta 100 mg tablet quantity overrides, providers must document that the patient has one of the specified diagnoses to approve quantities above the standard package limits.

Multiple myeloma
Systemic light chain amyloidosis
Waldenström macroglobulinemia/lymphoplasmacytic lymphoma

Applicable Codes

N/A (no procedure/drug billing codes listed)mixed

No codes listed

Definitions & Clinical Evidence

The CLL/SLL Starting Pack contains four weekly wallet blister packs used for the 5‑week ramp-up dosing: Week 1: 14 x 10 mg tablets; Week 2: 7 x 50 mg tablets; Week 3: 7 x 100 mg tablets; Week 4: 14 x 100 mg tablets, and is supplied as one pack per dispensing under the policy limits.

Evidence and prescribing guidance are drawn from the Venclexta tablets prescribing information (AbbVie and Genentech; June 2022), as cited in the policy references.

Revision History

03/22/2023revised

Home delivery quantity limit for the CLL/SLL Starting Pack was changed from 126 tablets (3 packs) to 42 tablets (1 pack) per dispensing.

04/19/2024revised

Venclexta 100 mg tablets override criteria updated to approve requested quantity up to 240 tablets per dispensing at retail or 720 tablets per dispensing at home delivery for patients with systemic light chain amyloidosis or Waldenström macroglobulinemia/lymphoplasmacytic lymphoma (and multiple myeloma noted in criteria context).

2025-04-03clarifiedLatest

Per-dispensing quantity thresholds

100 mg tablets — retail (blisters & bottles)180 tablets per dispensing (standard); override up to 240 tablets for specified diagnoses

100 mg tablets — home delivery (blisters & bottles)540 tablets per dispensing (standard); override up to 720 tablets for specified diagnoses

CLL/SLL Starting Pack — retail42 tablets (1 pack) per dispensing

CLL/SLL Starting Pack — home delivery42 tablets (1 pack) per dispensing (home delivery limit revised from 126 to 42)

Wallet of 10 mg tablets — retail56 tablets (4 wallets) per dispensing

Wallet of 10 mg tablets — home delivery168 tablets (12 wallets) per dispensing

Wallet of 50 mg tablets — retail28 tablets (4 wallets) per dispensing

Wallet of 50 mg tablets — home delivery84 tablets (12 wallets) per dispensing

Blister of 10 mg tablets — retail56 tablets (28 blisters) per dispensing

Blister of 10 mg tablets — home delivery168 tablets (84 blisters) per dispensing

Blister of 50 mg tablets — retail28 tablets (28 blisters) per dispensing

Blister of 50 mg tablets — home delivery84 tablets (84 blisters) per dispensing