CurrentCignaPolicy N/A

Drug Quantity Management Policy - Oral NK1 (Substance P) Receptor Antagonists — Per‑Rx quantity limits

Defines per‑prescription quantity limits and approval criteria for oral NK1 receptor antagonist antiemetics (Akynzeo, aprepitant formulations, Varubi) for Cigna-administered health plans.

Policy Summary

PayerCigna

PolicyDrug Quantity Management Policy - Oral NK1 (Substance P) Receptor Antagonists — Per‑Rx quantity limits

Policy CodePolicy N/A

Change TypeNo material changes

Effective DateN/A

Next Review DateSep 3, 2024

Key ActionApprove requested quantity when per‑Rx quantity limits are met; authorizations are provided for 1 year.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

1 yearapproval duration for authorizations

1Akynzeo retail max per Rx

3Akynzeo home delivery max

≤12Aprepitant 80 mg retail max

≤4Varubi retail max

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Coverage Criteria

Per‑Rx Quantity Limits (Covered when ALL conditions met)

Products are covered as medically necessary when the following per‑Rx quantity criteria are met for patients receiving these agents for prevention of chemotherapy-associated nausea and vomiting within 1 month:

Akynzeo per‑Rx limit: If the patient is receiving Akynzeo for the prevention of nausea and vomiting associated with multiple courses of cancer chemotherapy within 1 month, approve the requested quantity not to exceed 6 capsules per dispensing at retail and 18 capsules per dispensing at home delivery.Retail ≤6; Home ≤18

Approval duration 1 year

Aprepitant 40 mg: No overrides recommended.Retail/Home as listed in Drug Quantity Limits table

Policy states no overrides recommended for 40 mg capsules.

Aprepitant 80 mg per‑Rx limit: If the patient is receiving aprepitant for the prevention of nausea and vomiting associated with multiple courses or multiple days of cancer chemotherapy within 1 month, approve the requested quantity not to exceed 12 capsules per dispensing at retail and 36 capsules per dispensing at home delivery.Retail ≤12; Home ≤36

Aprepitant 125 mg per‑Rx limit: If the patient is receiving aprepitant for the prevention of nausea and vomiting associated with multiple courses or multiple days of cancer chemotherapy within 1 month, approve the requested quantity not to exceed 6 capsules per dispensing at retail and 18 capsules per dispensing at home delivery.Retail ≤6; Home ≤18

Aprepitant TriPack per‑Rx limit: If the patient is receiving aprepitant for the prevention of nausea and vomiting associated with multiple courses or multiple days of cancer chemotherapy within 1 month, approve the requested quantity not to exceed 18 capsules (6 TriPacks) per dispensing at retail and 54 capsules (18 TriPacks) per dispensing at home delivery.Retail ≤6 TriPacks; Home ≤18 TriPacks

Emend 125 mg powder for oral suspension per‑Rx limit: If the patient is receiving aprepitant for the prevention of nausea and vomiting associated with multiple courses or multiple days of cancer chemotherapy within 1 month, approve the requested quantity not to exceed 18 packets per dispensing at retail and 54 packets per dispensing at home delivery.Retail ≤18; Home ≤54

Varubi per‑Rx limit: If the patient is receiving Varubi for the prevention of nausea and vomiting associated with multiple courses of cancer chemotherapy within 1 month, approve the requested quantity not to exceed 4 tablets (2 wallets) per dispensing at retail and 12 tablets (6 wallets) per dispensing at home delivery.Retail ≤4; Home ≤12

Varubi dosing: 180 mg (two 90 mg tablets) per cycle and not more frequently than every 2 weeks.

Any exception to the specified quantity limits is considered not medically necessary.

Requests not meeting the listed Drug Quantity Limits criteria are considered not medically necessary.

Provider Actions and Authorization

Prior Authorization

Quantity management and authorization duration

If the Drug Quantity Management rule is not met for the requested medication at the point of service, coverage will be determined by the criteria in this policy. All prior authorizations (approvals) are provided for 1 year in duration unless otherwise noted.

Authorizations: 1 year duration (unless otherwise specified).
Operational note: If quantity-management rule is not met at point of sale, adjudication will follow the policy criteria and may result in denial.

Note

Guideline-based note

NCCN Antiemesis Guidelines (NCCN v1.2024 - December 13, 2023) inform recommended use of oral Substance P/NK1 receptor antagonists; dosing generally follows FDA labeling and accommodates multiple courses or days of chemotherapy. Note: Varubi has an extended half-life and should not be administered more frequently than every 2 weeks.

Reference: NCCN Antiemesis Guidelines v1.2024 (Dec 13, 2023).
Varubi dosing interval: do not administer more frequently than every 2 weeks.

Documentation Required

Required documentation context

Review the applicable member benefit plan, any relevant laws/regulations, and collateral source materials when evaluating coverage requests.

Coverage determinations must consider the member's specific benefit plan and applicable legal/regulatory requirements.
Clinical review should reference guideline sources and policy criteria as collateral materials.

Background

Oral NK1 receptor antagonists (netupitant/palonosetron, aprepitant formulations, rolapitant) are used in combination with other antiemetics for prevention of acute and delayed chemotherapy-associated nausea and vomiting, including HEC and MEC. Recommended dosing follows FDA labeling and NCCN antiemesis guidelines; some formulations have specific pediatric indications and age restrictions.

These agents are managed under a Drug Quantity Limits program that defines per‑prescription maximums when a patient is receiving medication for prevention of chemotherapy-associated nausea and vomiting within 1 month. Where applicable, the policy allows increased quantities per dispensing for multiple courses or multiple days of chemotherapy within a 1‑month period, provided the request meets the stated per‑Rx limits.

Providers should note guideline considerations from NCCN and product-specific dosing constraints (for example, rolapitant/Varubi dosing and frequency). Authorizations issued under this program are provided for 1 year, and if the quantity management rule is not met at point of service the request will be evaluated against the policy criteria.

Per‑Prescription Quantity Limits by Product

Akynzeo 300 mg/0.5 mg capsule — Quantity limits

Retail per‑Rx standard1 capsule per Rx (Retail maximum quantity per Rx = 1 capsule)

Home delivery per‑Rx standard3 capsules per Rx (Home Delivery maximum quantity per Rx = 3 capsules)

Multiple‑courses within 1 month allowanceWhen used for multiple chemotherapy courses within 1 month: Retail ≤6 capsules per dispensing; Home delivery ≤18 capsules per dispensing

Aprepitant 40 mg capsules (generic) — Limits

Standard limitNo overrides recommended; follow standard Drug Quantity Limits table

Retail per‑RxRetail maximum quantity per Rx = 1 capsule (see Drug Quantity Limits table)

Home delivery per‑RxHome Delivery maximum quantity per Rx = 3 capsules (see Drug Quantity Limits table)

Aprepitant 80 mg capsules (Emend, generic) — Limits

Retail per‑Rx when criteria metApprove up to 12 capsules per dispensing at retail when used for multiple courses or multiple days within 1 month

Home delivery per‑Rx when criteria metApprove up to 36 capsules per dispensing at home delivery when used for multiple courses or multiple days within 1 month

Standard per‑Rx maxima (single course)Refer to Drug Quantity Limits table for single‑course retail (2 capsules) and home delivery (6 capsules) maxima

Aprepitant 125 mg capsules (generic) — Limits

Retail per‑Rx when criteria metApprove up to 6 capsules per dispensing at retail when used for multiple courses or multiple days within 1 month

Home delivery per‑Rx when criteria metApprove up to 18 capsules per dispensing at home delivery when used for multiple courses or multiple days within 1 month

Standard per‑Rx maxima (single course)Refer to Drug Quantity Limits table for single‑course retail (1 capsule) and home delivery (3 capsules) maxima for some formulations

Aprepitant TriPack — Limits

Retail per‑Rx when criteria metApprove up to 18 capsules (6 TriPacks) per dispensing at retail when used for multiple courses or multiple days within 1 month

Home delivery per‑Rx when criteria metApprove up to 54 capsules (18 TriPacks) per dispensing at home delivery when used for multiple courses or multiple days within 1 month

TriPack compositionEach TriPack contains one 125 mg capsule and two 80 mg capsules

Emend 125 mg powder for oral suspension — Limits

Retail per‑Rx when criteria metApprove up to 18 packets per dispensing at retail when used for multiple courses or multiple days within 1 month

Home delivery per‑Rx when criteria metApprove up to 54 packets per dispensing at home delivery when used for multiple courses or multiple days within 1 month

Indication contextLimits apply when used for prevention of chemotherapy‑associated nausea and vomiting within 1 month

Varubi 90 mg tablets — Limits and dosing note

Retail per‑Rx when criteria metApprove up to 4 tablets (2 wallets) per dispensing at retail when used for multiple courses within 1 month

Home delivery per‑Rx when criteria metApprove up to 12 tablets (6 wallets) per dispensing at home delivery when used for multiple courses within 1 month

Dosing interval noteVarubi dosing: 180 mg (two 90 mg tablets) per cycle; administer prior to each chemotherapy cycle but at no less than 2‑week intervals

OpenPayer

Drug Quantity Management Policy - Oral NK1 (Substance P) Receptor Antagonists — Per‑Rx quantity limits

Coverage Criteria

Provider Actions and Authorization

Background

Definitions and Acronyms

Per‑Prescription Quantity Limits by Product