UnitedHealthcare Tykerb Prior Auth Coverage Update

Coverage Criteria for Tykerb (lapatinib)

Pediatric

Tykerb will be approved if any of the following criteria are met (special rule for minors):

Pediatric automatic approval: Patient is less than 19 years of age

Authorization will be issued for 12 months

Initial — HR+/HER2+ breast cancer with aromatase inhibitor

Covered when ALL of the following are met:

Breast cancer with aromatase inhibitor: Diagnosis of recurrent unresectable (local or regional) or stage IV breast cancer AND disease is hormone receptor positive and human epidermal growth factor receptor 2-positive (HER2+) AND used in combination with an aromatase inhibitor (exemestane, letrozole, or anastrozole)

Initial — Later-line breast cancer

Covered when ALL of the following are met:

Fourth-line+ breast cancer: Diagnosis of recurrent unresectable or stage IV breast cancer (including disease unresponsive to preoperative systemic therapy) AND used as fourth-line therapy and beyond in combination with one of the following: trastuzumab (Herceptin) OR capecitabine (Xeloda)

Reauthorization — any approved indication

Reauthorization will be approved when the following is met:

No progression on therapy: Patient does not show evidence of progressive disease while on Tykerb therapy

Authorization will be issued for 12 months

Initial — CNS metastatic lesions

Covered when ALL of the following are met:

CNS metastases: Diagnosis of recurrent central nervous system (CNS) cancer with metastatic lesions AND disease is HER2+ AND Tykerb is used in combination with capecitabine (Xeloda) AND Tykerb is active against the primary (breast) tumor

Initial — Ependymoma

Or, covered when ALL of the following are met:

Recurrent/progressive intracranial or spinal ependymoma: Diagnosis of progressive or recurrent intracranial or spinal ependymoma (excluding subependymoma) AND patient has received previous radiation therapy AND one of the following: gross total or subtotal resection with negative cerebrospinal fluid (CSF) cytology, subtotal resection with evidence of metastasis, or unresectable disease AND used in combination with temozolomide (Temodar)

Initial — Chordoma

Covered when ALL of the following are met:

Chordoma: Diagnosis of recurrent conventional or chondroid chordoma AND disease is EGFR-positive

Initial — Colon cancer (HER2-amplified, molecularly selected)

Covered when ALL of the following are met:

Colorectal cancer with HER2 amplification: Diagnosis of colon cancer AND (either disease is pMMR/MSS OR disease is dMMR/MSI-H or POLE mutation) AND disease is HER2-amplified and RAS and BRAF wild-type AND patient is ineligible for or progressed on checkpoint inhibitor immunotherapy OR has a contraindication to checkpoint inhibitors AND used in combination with trastuzumab AND either used as initial therapy for unresectable metachronous metastases with prior FOLFOX or CapeOX within 12 months OR intensive chemotherapy options (oxaliplatin, irinotecan, capecitabine) are not recommended OR used as second-line and subsequent therapy for progression of advanced/metastatic disease AND patient has not previously been treated with a HER2 inhibitor

Initial Authorization — Rectal cancer (partial)

Tykerb will be approved when ALL of the following are met for rectal cancer (document provides partial criteria):

Rectal cancer initial authorization: Diagnosis of rectal cancer AND (disease is pMMR/MSS OR disease is dMMR/MSI-H or POLE mutation with additional conditions) AND disease is HER2-amplified and RAS and BRAF wild-type when applicable AND used in combination with trastuzumab for HER2-amplified disease AND patient has not previously been treated with a HER2 inhibitor AND certain branches require prior chemotherapy history (e.g., prior FOLFOX or CapeOX within 12 months) or ineligibility for intensive chemotherapy (oxaliplatin, irinotecan, capecitabine)

Some branches list use as initial therapy for unresectable metachronous metastases or as second-line/subsequent therapy for progression of advanced/metastatic disease

For members 19 years of age and older, requests for Tykerb (lapatinib) will be reviewed against the specific coverage criteria in this policy. Uses that do not meet the listed criteria are not approved, unless a state or federal mandate requires coverage for an off‑label indication.

Patients who have previously received a HER2‑targeted inhibitor (for example, trastuzumab, pertuzumab, neratinib) are excluded from certain Tykerb indications in this policy. Specifically, for the eligible colorectal and related HER2‑amplified indications Tykerb use requires that the patient has not previously been treated with a HER2 inhibitor.

Initial Therapy Criteria and Examples

inv-25: Initial therapy examples

Initial authorization criteria vary by indication; examples include:

Breast cancer options: Either HR+/HER2+ recurrent/unresectable/stage IV breast cancer used with an aromatase inhibitor OR recurrent/unresectable/stage IV breast cancer as fourth-line+ therapy in combination with trastuzumab or capecitabine

inv-26: Initial therapy (partial)

Initial therapy rules (partial criteria shown in this excerpt)

Molecular criteria branch: Either disease is pMMR/MSS OR disease is dMMR/MSI-H or POLE mutation with additional conditions related to immunotherapy ineligibility or progression; for HER2-amplified colorectal disease, RAS/BRAF wild-type required and use is in combination with trastuzumab.

Continuation / Reauthorization Criteria

inv-27: Continuation therapy

Reauthorization requirement:

Continuation: Patient must not show evidence of progressive disease while on Tykerb therapy

Authorization will be issued for 12 months

inv-28: Continuation therapy / Reauthorization

Continuation / reauthorization rules

Continuation: Approval renewed for 12 months if no evidence of progressive disease while on Tykerb therapy.

inv-10: Reauthorization — Reauthorization for Tykerb

Reauthorization for Tykerb:

Provider Actions, Prior Authorization, and Documentation Requirements

Prior Authorization

Prior Authorization Required

Prior authorization is required for Tykerb for members age 19 and older. When clinical criteria for the requested indication are met, approvals are issued for a 12-month authorization period. State mandates, federal regulatory requirements, and member-specific benefit plan coverage may alter coverage decisions.

Prior authorization required for members 19 and older
Authorization period: 12 months when criteria met
State mandates and member-specific coverage may supersede

Documentation Required

Documentation must include the diagnosis (recurrent unresectable or stage IV breast cancer, or other approved indication such as rectal cancer), hormone receptor and HER2 status when applicable, and the planned combination therapy. Include relevant ICD-10 diagnosis codes and prior treatment history in the request.

Step Therapy and Sequencing Considerations

Scenario	Step therapy requirement
Breast cancer — later-line (recurrent unresectable or stage IV) used in combination with trastuzumab or capecitabine
Step: fourth-line therapy and beyond (used as fourth-line+ in combination with trastuzumab or capecitabine)

Indication	Prior therapy / sequencing requirement
HER2-amplified colorectal (including colon and rectal branches) used in combination with trastuzumab
Must be used in combination with trastuzumab; patient must be RAS/BRAF wild-type and, for certain molecular branches (dMMR/MSI-H or POLE), ineligible for or progressed on checkpoint inhibitor immunotherapy (or have a contraindication).
General prior HER2 inhibitor restriction
Patient has not previously been treated with a HER2 inhibitor (e.g., trastuzumab, pertuzumab, neratinib)

Coding Considerations and Quantity Limits

Tykerb (lapatinib) — Quantity limits

Quantity limit statusSupply limit may be in place for Tykerb (lapatinib)

Unitper month (supply limit may be applied)

RationaleUtilization management may include supply limits as an additional control alongside prior authorization

Definitions and Biomarker Terms

Definition — HER2+

Termhuman epidermal growth factor receptor 2-positive (HER2+)

MeaningTumors that overexpress the HER2 receptor protein

RelevanceRequired biomarker for multiple covered indications of Tykerb, including HER2-overexpressing breast cancer and HER2-amplified colorectal/rectal cancers

Definition — dMMR/MSI-H

TermdMMR/MSI-H (deficient mismatch repair / microsatellite instability-high)

MeaningTumor testing result indicating deficient DNA mismatch repair or high microsatellite instability

Clinical role

Background

Lapatinib (Tykerb) is a small‑molecule tyrosine kinase inhibitor that targets HER2 and is used in combination regimens for HER2‑overexpressing metastatic breast cancer. The agent is referenced in guideline sources (NCCN) for selected uses including combination therapy with capecitabine for central nervous system metastases and with aromatase inhibitors for hormone receptor–positive, HER2‑positive disease.

Revision History

2025-01-01policy_effective_dateLatest

Policy effective date updated to 2025-01-01 with standard 12-month authorization period and note that state mandates and member benefit plan coverage may impact criteria.

process_update

Clarified that UnitedHealthcare may approve initial and reauthorization based on prior claim/medication history, diagnosis codes (ICD-10), and/or claim logic; automated approval processes vary by program and supply limits may be applied.

OpenPayer

Tykerb (lapatinib) prior authorization and coverage criteria

Coverage Criteria for Tykerb (lapatinib)

Initial Therapy Criteria and Examples

Continuation / Reauthorization Criteria

Provider Actions, Prior Authorization, and Documentation Requirements

Step Therapy and Sequencing Considerations

Coding Considerations and Quantity Limits

Definitions and Biomarker Terms

Background

Revision History