CurrentCignaPolicy N/A

Oncology - Lapatinib Drug Quantity Management Policy - Per Rx

Defines per‑prescription quantity limits and medically necessary exceptions for lapatinib (Tykerb) tablets for Cigna‑administered health benefit plans; applies to providers and pharmacy benefit adjudication.

Policy Summary

PayerCigna

PolicyOncology - Lapatinib Drug Quantity Management Policy - Per Rx

Policy CodePolicy N/A

Change TypeClarification and revision (quantity limits / approval duration)

Effective DateN/A

Next Review DateN/A

Key ActionApprove quantity exceptions for lapatinib for up to 1 year when the patient meets the listed criteria (e.g., taking a strong CYP3A4 inducer).

SourceLink

POLICY UPDATE CHANGES

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

Approval duration changed from 3 years to 1 year.

180Retail max per Rx

540Home delivery max per Rx

660Retail exception (strong CYP3A4 inducer)

1,980Home delivery exception (strong CYP3A4 inducer)

150

Bottle size available

Coverage Criteria

Drug quantity limits and exception

Standard quantity limits apply unless an exception is met; approvals are for 1 year.

Standard limits: For Tykerb (lapatinib) 250 mg tablets: Retail maximum quantity per prescription = 180 tablets; Home Delivery maximum quantity per prescription = 540 tablets.

These are the default per-dispensing limits.

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

Examples of strong CYP3A4 inducers include dexamethasone, phenytoin, carbamazepine, rifampin, rifabutin, rifapentine, phenobarbital, and St. John's wort (not all-inclusive).

EXCEPTIONS TO THE QUANTITY LIMITS LISTED ABOVE ARE COVERED AS MEDICALLY NECESSARY WHEN THE FOLLOWING CRITERIA ARE MET. ANY OTHER EXCEPTION IS CONSIDERED NOT MEDICALLY NECESSARY.

Exceptions to the stated quantity limits that do not meet the specified criteria are not eligible for coverage. In other words, if the exception request does not satisfy the listed criteria (for example, the patient is not taking a qualifying strong CYP3A4 inducer), the request will be considered not medically necessary.

Dosing and Coding Notes

HER2-Positive Metastatic Breast Cancer dosing pack

Pack size and cycle105 tablets per 21-day cycle (1,250 mg daily = 5 x 250 mg tablets daily)

Indication contextDose used for HER2‑positive metastatic breast cancer in combination with capecitabine as a 21‑day cycle

Dosing frequencyOrally once daily (QD) on Days 1–21 continuously

Hormone receptor‑positive, HER2‑positive dosing

Dose amount1,500 mg daily (6 x 250 mg tablets daily)

Indication contextUsed for hormone receptor‑positive, HER2‑positive metastatic breast cancer in combination with letrozole

Provider Actions and Billing

Prior Authorization

Quantity limits and approval duration

Approvals for lapatinib quantity exceptions are issued for a 1-year duration. Standard per-prescription quantity limits apply unless an exception criterion is met.

All approvals are provided for 1 year in duration.
Retail maximum quantity per Rx = 180 tablets; Home Delivery maximum quantity per Rx = 540 tablets.

Step Therapy

Step therapy not required

There are no step therapy requirements included in this Drug Quantity Management policy for lapatinib.

Background

Lapatinib (Tykerb) is an oral tyrosine kinase inhibitor used primarily in combination regimens for HER2-overexpressing advanced or metastatic breast cancer. Typical dosing varies by indication and combination therapy—for HER2-positive metastatic breast cancer the usual regimen is 1,250 mg daily (five 250 mg tablets daily), and dose adjustments (including escalation) may be required for interactions with strong CYP3A4 inducers or for toxicity. This policy governs per-prescription quantity limits for Tykerb 250 mg tablets and provides specific exceptions when dose escalation is clinically indicated.

Definitions

Lapatinib (Tykerb)

Drug classOral tyrosine kinase inhibitor

Brand and genericTykerb (lapatinib)

Typical useUsed in combination regimens for HER2‑overexpressing advanced or metastatic breast cancer

Strong CYP3A4 inducers

Examples of strong CYP3A4 inducersDexamethasone; Phenytoin; Carbamazepine; Rifampin; Rifabutin; Rifapentine; Phenobarbital; St. John's wort

Clinical impactMay necessitate lapatinib dose escalation due to increased metabolism

Dose titration guidance

Quantity Limits

Tykerb (lapatinib) 250 mg tablets — retail maximum

Retail maximum per prescription180 tablets per Rx

Strength and form250 mg tablets

Default policy statusStandard per‑dispensing limit unless an approved exception applies

Tykerb (lapatinib) 250 mg tablets — home delivery maximum

Home delivery maximum per prescription540 tablets per Rx

Strength and form250 mg tablets

Default policy status

Policy Summary

PayerCigna

PolicyOncology - Lapatinib Drug Quantity Management Policy - Per Rx

Policy CodePolicy N/A

Change TypeClarification and revision (quantity limits / approval duration)

Effective DateN/A

Next Review DateN/A

Key ActionApprove quantity exceptions for lapatinib for up to 1 year when the patient meets the listed criteria (e.g., taking a strong CYP3A4 inducer).

SourceLink

On This Page

Given orally once daily (QD) continuously

Billing Rule

Billing and documentation requirements

When submitting claims or coverage requests, providers must bill using the most appropriate codes as of the submission effective date; coverage requests are reviewed in the context of the applicable benefit plan terms, laws/regulations, collateral materials, and the specific facts of the case.

Use the most appropriate codes as of the effective date of the submission.
Coverage determinations consider the terms of the applicable benefit plan document, applicable laws/regulations, relevant collateral materials, and case facts.

Denial Risk

Denial triggers for uncovered codes or unmet quantity rules

Claims submitted for services that are not accompanied by covered code(s) under the applicable coverage policy will be denied as not covered; if the quantity management rule is not met at point of service, coverage will be determined by the policy criteria.

Claims lacking covered diagnosis or procedure codes under this policy will be denied as not covered.
Failure to meet the Drug Quantity Management rule at point of service prompts evaluation against the policy criteria and may result in denial.

Titrate lapatinib gradually from baseline to higher doses while on inducer; reduce if inducer discontinued

Standard per‑dispensing limit for home delivery unless an approved exception applies

Tykerb (lapatinib) 250 mg tablets — retail exception

Retail exception when on strong CYP3A4 inducer660 tablets per dispensing at retail

Basis for exceptionApproved when patient is taking a strong CYP3A4 inducer

Note on examplesExamples of inducers provided but list is not all‑inclusive

Tykerb (lapatinib) 250 mg tablets — home delivery exception

Home delivery exception when on strong CYP3A4 inducer1,980 tablets per dispensing at home delivery

Basis for exceptionApproved when patient is taking a strong CYP3A4 inducer

Note on examplesExamples of inducers provided but list is not all‑inclusive