CurrentColorado Rocky Mountain Health Plans | UnitedHealthcare Commercial PlansPolicy 2025 P 1112-13

Tykerb® (lapatinib) - Prior Authorization/Notification - UnitedHealthcare Commercial Plansopen_in_new

Defines prior authorization and reauthorization clinical criteria for lapatinib (Tykerb) across multiple indications (breast cancer, CNS cancers, chordoma, colon and rectal cancers) for UnitedHealthcare commercial plans; includes age exception for <19 years and NCCN recognition clause. Authorizations are generally for 12 months.

Policy Summary

PayerColorado Rocky Mountain Health Plans | UnitedHealthcare Commercial Plans

PolicyTykerb® (lapatinib) - Prior Authorization/Notification - UnitedHealthcare Commercial Plansopen_in_new

Policy CodePolicy 2025 P 1112-13

Change TypeAnnual review (criteria revised)

Effective DateJan 1, 2026

Next Review DateN/A

Key ActionMembers must meet the listed clinical criteria for initial authorization; for members under age 19 the prescription auto-processes without coverage review. Authorization length is 12 months.

SourceLink

POLICY UPDATE CHANGES

Annual review 10/2025 updated criteria for breast cancer, central nervous system cancer, colon cancer, and rectal cancer per NCCN recommendations.

10/2024 annual review updated coverage criteria for breast cancer, CNS cancers, chordoma, colon and rectal cancer per NCCN guidelines.

10/2022 annual review updated coverage criteria for colon cancer and added state mandate.

5Covered Indications (breast, CNS, chordoma, colon, rectal)

12 monthsAuthorization duration

NCCN 1/2A/2BNCCN recognized categories allowed

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Coverage Summary

Scope: Defines prior authorization and reauthorization clinical criteria for lapatinib (Tykerb) across multiple indications: breast cancer, central nervous system (CNS) cancers, chordoma, colon cancer, and rectal cancer. Age exception: prescriptions for members 19 years auto-process without coverage review.

Coverage stance: Covered with criteria — UnitedHealthcare will approve Tykerb when the specified clinical criteria are met (including diagnosis, biomarker status, prior therapies, and required combination agents).

Covered indications count: 5 (breast, CNS, chordoma, colon, rectal).

Authorization duration: 12 months for initial authorizations and reauthorizations (explicitly stated for pediatric auto-approvals and multiple indications).

NCCN acceptance: NCCN recognized regimens are permitted — the policy accepts NCCN Drugs & Biologics Compendium recommendations with Category of Evidence and Consensus of 1, 2A, or 2B and aligns criteria to NCCN guidance; state mandates may supersede policy language.

Key thresholds and quick facts

Authorization duration12 months

Tumor mutation burden (TMB) threshold> 50 mut/Mb

Covered indications (count)5 (breast, CNS, chordoma, colon, rectal)

NCCN recognition allowedCategory of Evidence and Consensus 1, 2A, or 2B

Auto-approval for age <19Prescription auto-processes without coverage review for members <19 years

Medical-Necessity Criteria

Patients less than 19 years of age

Tykerb will be approved based on the following criterion:

ALL of the following

Patient is less than 19 years of age
Authorization will be issued for 12 months.

Breast cancer - Initial Authorization (hormone receptor positive metastatic HER2+ with aromatase inhibitor)

Tykerb will be approved based on all of the following criteria:

ALL of the following

Diagnosis of breast cancer
Disease is recurrent unresectable (local or regional) or stage IV breast cancer

Coding

ICD-10 diagnoses referencedICD-10

No codes listed

Drug / medicationNDCCovered

lapatinib

Tykerb (lapatinib) medication referenced for prior authorization

Provider Actions

Prior Authorization

Prior authorization required

Prior authorization is required for Tykerb for covered indications. Members under age 19 auto-process without coverage review. Authorizations are issued for 12 months.

Members must meet listed clinical criteria for initial authorization.
Prescriptions for members <19 years auto-process (no coverage review).
Authorization length: 12 months.

Documentation Required

Clinical documentation required

Clinical documentation must be provided to support coverage decisions, including diagnosis, relevant biomarker status, prior therapies, and the combination agent to be used.

Required biomarkers as applicable: HER2, RAS, BRAF, EGFR, MMR/MSI, POLE/POLD1, and TMB (>50 mut/Mb when applicable).

Background and Evidence

Background: Tykerb (lapatinib) is a kinase inhibitor indicated in combination with letrozole (Femara) for postmenopausal women with hormone receptor–positive, HER2-overexpressing metastatic breast cancer when hormonal therapy is indicated, and in combination with capecitabine (Xeloda) for patients with advanced/metastatic HER2-overexpressing breast cancer who have received prior therapy (including an anthracycline, a taxane, and trastuzumab) with progression on trastuzumab prior to Tykerb plus capecitabine.

NCCN recommendations: The NCCN also recommends Tykerb for select metastatic CNS lesions from breast primary (used with capecitabine), intracranial and spinal ependymomas (used with temozolomide under specified surgical/radiation conditions), EGFR-positive chordoma, and certain colon and rectal cancers not previously treated with HER2 inhibitors; the policy states criteria were updated to align with NCCN guidance in multiple annual reviews.

State mandate note: Some states mandate coverage for off-label uses or require other compendia; where such state mandates apply, they supersede the benefit document or the notification criteria.

Evidence / Package References

Definitions

Revision History

10/2025revisedLatest

Annual review 10/2025 updated criteria for breast cancer, central nervous system cancer, colon cancer, and rectal cancer per NCCN recommendations.

10/2024revised

10/2024 annual review updated coverage criteria for breast cancer, CNS cancers, chordoma, colon and rectal cancer per NCCN guidelines.

10/2022revised

Policy Summary

PayerColorado Rocky Mountain Health Plans | UnitedHealthcare Commercial Plans

PolicyTykerb® (lapatinib) - Prior Authorization/Notification - UnitedHealthcare Commercial Plansopen_in_new

Policy CodePolicy 2025 P 1112-13

Change TypeAnnual review (criteria revised)

Effective DateJan 1, 2026

Next Review DateN/A

SourceLink

On This Page

Disease is hormone receptor positive

Used in combination with an aromatase inhibitor (e.g., exemestane, letrozole, anastrozole)

Breast cancer - Initial Authorization (fourth-line+ trastuzumab or capecitabine combinations)

Tykerb will be approved when BOTH of the following are met:

ALL of the following

One of the following
- Disease is recurrent unresectable (local or regional) or stage IV breast cancer
- Breast cancer is unresponsive to preoperative systemic therapy
Used as fourth line therapy and beyond in combination with one of the following: trastuzumab (Herceptin) or capecitabine (Xeloda)

Breast cancer - Reauthorization

Tykerb will be approved for reauthorization based on the following criterion:

ALL of the following

Patient does not show evidence of progressive disease while on Tykerb therapy

Central Nervous System (CNS) cancers - Initial Authorization

Tykerb will be approved based on one of the following criteria:

ANY of the following

ALL of the following
- Diagnosis of brain metastases in HER2-positive breast cancer
- Used in combination with capecitabine (Xeloda)
ALL of the following
- Diagnosis of progressive or recurrent intracranial or spinal ependymoma (excluding subependymoma)
- Patient has received previous radiation therapy
- One of the following
  - Patient has received gross total or subtotal resection with negative cerebrospinal fluid (CSF) cytology
  - Patient has received subtotal resection and evidence of metastasis (brain, spine, or CSF)
  - Patient has unresectable disease
- Used in combination with temozolomide (Temodar)

Central Nervous System (CNS) cancers - Reauthorization

Tykerb will be approved for reauthorization based on the following criterion:

ALL of the following

Patient does not show evidence of progressive disease while on Tykerb therapy

Chordoma - Initial Authorization

Tykerb will be approved based on both of the following criteria:

ALL of the following

Diagnosis of recurrent conventional or chondroid chordoma
Disease is EGFR-positive

Chordoma - Reauthorization

Tykerb will be approved for reauthorization based on the following criterion:

ALL of the following

Patient does not show evidence of progressive disease while on Tykerb therapy

Colon cancer - Reauthorization

Tykerb will be approved for reauthorization based on the following criterion:

ALL of the following

Patient does not show evidence of progressive disease while on Tykerb therapy

Rectal cancer - Reauthorization

Tykerb will be approved for reauthorization based on the following criterion:

ALL of the following

Patient does not show evidence of progressive disease while on Tykerb therapy

NCCN Recommended Regimens recognition clause

Recognition clause

The drug has been recognized for treatment of the cancer indication by The National Comprehensive Cancer Network (NCCN) Drugs and Biologics Compendium with a Category of Evidence and Consensus of 1, 2A, or 2B

Document prior therapies, including prior HER2 inhibitors and chemotherapy regimens (e.g., trastuzumab, FOLFOX, CapeOX).

Document the combination agent planned (e.g., letrozole, capecitabine, trastuzumab, temozolomide).

Denial Risk

Denial for disease progression

Reauthorization requires absence of documented disease progression while on Tykerb; claims may be denied if progressive disease is documented.

Reauthorization criterion: no evidence of progressive disease during Tykerb therapy.
Claims/reauthorization may be denied when progression is documented.

Billing Rule

Automated approvals permitted

UnitedHealthcare may use automated processes to approve initial authorizations and reauthorizations based on claims, medication history, diagnosis codes, and claim logic without additional documentation.

Approvals can be based solely on previous claim/medication history and ICD-10 diagnosis codes.
Use of automated approval/re-approval processes varies by program or therapeutic class.

10/2022 annual review updated coverage criteria for colon cancer and added state mandate.