CurrentCignaPolicy N/A

Lapatinib (Tykerb) — Drug Quantity Limits and Exceptions

Defines drug quantity limits and medical necessity exceptions for lapatinib (Tykerb, generic) tablets for Cigna-administered health benefit plans; affects providers and pharmacists requesting quantity limit overrides and prior authorizations.

Policy Summary

PayerCigna

PolicyLapatinib (Tykerb) — Drug Quantity Limits and Exceptions

Policy CodePolicy N/A

Change TypeRevised (approval duration)Clarified (home delivery limits)

Effective DateN/A

Next Review DateMay 24, 2023

Key ActionSubmit prior authorization requests per coverage criteria; approvals are issued for 1 year.

SourceLink

POLICY UPDATE CHANGES

Approval duration changed from 3 years to 1 year.

Policy updated to reflect the existing quantity limits when a product is obtained via home delivery.

180Retail max per Rx

540Home delivery max per Rx

660Retail exception (strong inducer)

1,980Home delivery exception (strong inducer)

1 yr

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Coverage Criteria

Drug Quantity Limits and Exceptions

Quantity limits apply; exceptions to these limits are covered as medically necessary only when the criteria below are met.

Default quantity limits: Tykerb (lapatinib) 250 mg tablets: retail maximum 180 tablets per Rx; home delivery maximum 540 tablets per Rx.Retail 180 tablets; Home delivery 540 tablets

All prescriptions are subject to these limits; if the Drug Quantity Management rule is not met at point of service, coverage will be determined by the criteria below. Approvals are provided for 1 year.

Exception for strong CYP3A4 inducer: If the patient is taking a strong cytochrome P450 (CYP)3A4 inducer, approve 660 tablets per dispensing at retail or 1,980 tablets per dispensing at home delivery.presence of a strong CYP3A4 inducer

Examples include dexamethasone, phenytoin, carbamazepine, rifampin, rifabutin, rifapentine, phenobarbital, St. John's wort; list is not all-inclusive.

Exceptions to the stated quantity limits for Tykerb (lapatinib 250 mg tablets) are covered as medically necessary only when the specific exception criteria in this policy are met. Any exception request that does not meet the listed criteria is considered not medically necessary.

Requests that exceed the specified maximum quantities for Tykerb (retail maximum 180 tablets per Rx; home delivery maximum 540 tablets per Rx) that do not meet the documented exception criteria are considered not medically necessary and will be denied.

Coding

Drug productNDC

Tykerb (lapatinib) 250 mg tablet

Strength and form specified for quantity limits

Maximum quantity per Rx — retail and home delivery limits and exception quantities

Retail maximum per prescription180 tablets per Rx

Home delivery maximum per prescription540 tablets per Rx

Exceptions covered as medically necessaryExceptions allowed only when documented criteria are met (see strong CYP3A4 inducer exception)

Provider Actions and Requirements

Prior Authorization

Quantity management and prior authorization

If a prescription exceeds the Drug Quantity Management limits at point of sale, providers must obtain prior authorization. Submit requests using the standard Cigna prior authorization process and include clinical rationale for quantities above the plan's retail and home-delivery limits.

Retail Maximum Quantity per Rx = 180 tablets (250 mg)
Home Delivery Maximum Quantity per Rx = 540 tablets (250 mg)

Documentation Required

Required documentation and approval duration

Providers must submit clinical documentation that supports the medical necessity of quantities above the published limits. Acceptable documentation includes diagnosis, treatment history, current dose and schedule, evidence of dose escalation or intolerance to alternative therapies, and any supporting lab or imaging results.

Include covered diagnosis and procedure codes as applicable

Background

Lapatinib is a small-molecule tyrosine kinase inhibitor used primarily for patients with HER2-overexpressing advanced or metastatic breast cancer. It is indicated in combination with capecitabine, or in certain postmenopausal women in combination with letrozole, per the prescribing information. Dose adjustments may be required when lapatinib is co-administered with CYP3A4 inducers or inhibitors and for specific toxicities.

Definitions

Examples of strong CYP3A4 inducers

Examples of strong CYP3A4 inducersDexamethasone; phenytoin; carbamazepine; rifampin; rifabutin; rifapentine; phenobarbital; St. John's wort

NoteList is illustrative, not all-inclusive as stated in policy

Quantity Limits

Tykerb (lapatinib) 250 mg tablets — Retail 180 tablets per Rx

Product and strengthTykerb (lapatinib) 250 mg tablets

Retail quantity limit180 tablets per Rx

Most actionableUse retail maximum of 180 tablets per prescription unless exception criteria are met

Tykerb (lapatinib) 250 mg tablets — Home delivery 540 tablets per Rx

Product and strengthTykerb (lapatinib) 250 mg tablets

Home delivery quantity limit540 tablets per Rx

Most actionable

Policy Summary

PayerCigna

PolicyLapatinib (Tykerb) — Drug Quantity Limits and Exceptions

Policy CodePolicy N/A

Change TypeRevised (approval duration)Clarified (home delivery limits)

Effective DateN/A

Next Review DateMay 24, 2023

Key ActionSubmit prior authorization requests per coverage criteria; approvals are issued for 1 year.

SourceLink

On This Page

All approvals are issued for 1 year in duration

Denial Risk

Denial triggers

Requests that do not meet the Drug Quantity Management rule or the exception criteria will be denied as not medically necessary. Claims submitted with non‑covered codes or without required documentation may be denied.

Exceptions to quantity limits are only covered when criteria are met
Claims billed for conditions or diagnoses not covered under the policy will be denied

Note

Provider responsibilities

Follow the instructions for use in the benefit plan and submit requests consistent with the member's applicable benefit document. When billing, use the most appropriate codes as of the date of submission.

Coverage determinations consider the applicable benefit plan, laws/regulations, collateral materials, and the specifics of the request

Use home delivery maximum of 540 tablets per prescription unless exception criteria are met

Tykerb (lapatinib) 250 mg tablets — Retail exception 660 tablets per dispensing when patient is taking a strong CYP3A4 inducer

Exception conditionPatient is taking a strong CYP3A4 inducer

Retail exception quantity660 tablets per dispensing

NoteException applies only when criteria are documented; other exceptions are not medically necessary

Tykerb (lapatinib) 250 mg tablets — Home delivery exception 1,980 tablets per dispensing when patient is taking a strong CYP3A4 inducer

Exception conditionPatient is taking a strong CYP3A4 inducer

Home delivery exception quantity1,980 tablets per dispensing

NoteException applies only when criteria are documented; other exceptions are not medically necessary