mhn lapatinib prior auth & coverage update

Coverage Criteria

inv-01: Initial Therapy — Breast Cancer

Covered when ALL of the following are met:

Breast Cancer initial criteria: 1. Diagnosis of breast cancer; 2. Prescribed by or in consultation with an oncologist; 3. Age >= 18 years; 4. Member meets both: (a) disease is recurrent, advanced, or metastatic (stage IV) and (b) disease is HER2-positive; 5. Tykerb is prescribed in combination with one of the following: (a) capecitabine AND (i) member has received prior therapy OR (ii) member has brain metastases; OR (b) trastuzumab AND member has received at least 3 prior therapies; OR (c) both: (i) if HR-positive, an aromatase inhibitor (e.g., anastrozole, letrozole, exemestane) AND (ii) if male, an agent that suppresses testicular steroidogenesis (e.g., GnRH agonist); 6. If member is premenopausal or perimenopausal female, member has been treated with ovarian ablation or is receiving ovarian suppression; 7. For brand Tykerb requests, member must use generic lapatinib unless contraindicated or clinically significant adverse effects are experienced; 8. Request meets one of the following: (a) dose does not exceed 1,500 mg per day; OR (b) dose is supported by practice guidelines or peer-reviewed literature for the relevant off-label use (prescriber must submit supporting evidence).age >= 18; dose <= 1,500 mg/day unless supported

Prescribed regimen must be FDA-approved or recommended by NCCN

inv-02: Initial Therapy — Bone Cancer (off-label)

Must meet ALL of the following:

Bone Cancer (chordoma) initial criteria: 1. Diagnosis of recurrent conventional or chondroid chordoma; 2. Prescribed by or in consultation with an oncologist; 3. Age >= 18 years; 4. Disease is EGFR-positive; 5. Prescribed as a single agent; 6. For brand Tykerb requests, member must use generic lapatinib unless contraindicated or clinically significant adverse effects are experienced; 7. Dose is within the FDA maximum limit for any FDA-approved indication OR is supported by practice guidelines or peer-reviewed literature for the relevant off-label use (prescriber must submit supporting evidence).age >= 18

Prescribed regimen must be FDA-approved or recommended by NCCN

inv-03: Initial Therapy — Colorectal Cancer (off-label)

Must meet ALL of the following:

Colorectal Cancer initial criteria: 1. Diagnosis of unresectable, advanced, or metastatic colorectal cancer AND both: (a) disease is HER2-amplified; and (b) disease is RAS (KRAS and NRAS) and BRAF wild-type; 2. Prescribed by or in consultation with an oncologist; 3. Age >= 18 years; 4. Prescribed in combination with trastuzumab; 5. For brand Tykerb requests, member must use generic lapatinib unless contraindicated or clinically significant adverse effects are experienced; 6. Dose is within the FDA maximum limit for any FDA-approved indication OR is supported by practice guidelines or peer-reviewed literature for the relevant off-label use (prescriber must submit supporting evidence).age >= 18

Prior authorization may be required; prescribed regimen must be FDA-approved or recommended by NCCN

inv-04: Continuation Therapy — All Indications in Section I

Covered when ALL of the following are met:

Continuation criteria: 1. Currently receiving medication via Centene benefit OR documentation supports member has received Tykerb for at least 30 days; 2. Member is responding positively to therapy; 3. For brand Tykerb requests, member must use generic lapatinib unless contraindicated or clinically significant adverse effects are experienced; 4. If request is for a dose increase, meets one of the following: (a) new dose does not exceed 1,500 mg per day; OR (b) new dose is supported by practice guidelines or peer-reviewed literature for the relevant off-label use (prescriber must submit supporting evidence).>=30 days prior therapy

Prescribed regimen must be FDA-approved or recommended by NCCN

inv-05: Coverage criteria highlights

Highlights and recent material changes (high-level):

Breast cancer (capecitabine combination): Disease is recurrent, advanced, or metastatic (stage IV) and lapatinib is prescribed in combination with capecitabine; prior therapy is required per NCCN unless patient has brain metastases (bypass for capecitabine).

Updated to include 'advanced' in staging and brain metastases bypass; approval duration updated in reviews.

Breast cancer (trastuzumab combination): Lapatinib prescribed in combination with trastuzumab requires documented prior therapies; combination is considered fourth-line (member has received at least 3 prior therapies) per NCCN compendium updates.

Updated in 4Q2023 to require >=3 prior therapies.

Breast cancer (letrozole combination): For HER2-positive (HER2-amplified) disease, lapatinib may be used in combination with letrozole at 1,500 mg PO QD continuously; applicable dosing adjustments apply.

Dosing detail from Dosage and Administration.

Requests for uses that are not FDA‑approved and that are not specifically addressed in this policy will not be authorized unless the provider submits sufficient documentation of efficacy and safety consistent with the applicable off‑label use policies: CP.CPA.09 (Commercial), HIM.PA.154 (Health Insurance Marketplace), or CP.PMN.53 (Medicaid), or unless the use is covered by an applicable evidence of coverage document.

Coverage determinations follow updates from the NCCN compendium and periodic policy review. Recent revisions clarified disease staging language for breast cancer (added advanced), aligned colorectal terminology to HER2‑amplified, and updated chordoma qualifiers to conventional or chondroid; providers should cite guideline or peer‑reviewed support when deviating from FDA‑labeled regimens.

Off‑label requests are considered only when they meet the policy's off‑label criteria and are supported by guideline‑level or peer‑reviewed evidence. Absent such support, non‑FDA indications described by the provider will be denied. When an off‑label indication is addressed by this policy (for example, chordoma or HER2‑amplified colorectal cancer), approval is conditioned on the specific clinical requirements listed in the Initial Therapy sections and any documentation requested per prior authorization procedures.

For indications added or clarified in recent reviews (for example, chordoma), the policy specifies qualifying disease subtypes—see the chordoma criterion requiring recurrent conventional or chondroid disease. As with other non‑FDA uses, NMN determinations apply when an off‑label indication is not addressed in this policy or lacks sufficient supporting evidence; providers should submit clinical documentation to demonstrate that the request meets the policy or applicable off‑label standards.

Initial Therapy Criteria and Dosing

inv-25: Initial Therapy — Breast Cancer Dosing

Breast cancer initial approval requires specified dosing and prescriber conditions:

Breast Cancer dosing and prescriber requirements: 1. Prescribed by or in consultation with an oncologist; 2. Age >= 18 years; 3. Dosing: See indication-specific regimens (e.g., 1,250 mg PO QD continuously with capecitabine for advanced/metastatic disease; 1,500 mg PO QD continuously with letrozole for HER2-positive HR+ disease); 4. Dose must not exceed 1,500 mg/day unless supported by practice guidelines or peer-reviewed literature (prescriber must submit supporting evidence); 5. For brand Tykerb requests, member must use generic lapatinib unless contraindicated or clinically significant adverse effects are experienced.age >= 18; dose <= 1,500 mg/day unless supported

Dose modifications apply for strong CYP3A4 inhibitors or inducers; prescribed regimen must be FDA-approved or recommended by NCCN

inv-26: Initial dosing regimens

Initial dosing regimens by indication (alternative regimens and maximums):

Continuation and Renewal Criteria

inv-27: Continuation Therapy — requirements for patients already on therapy (renewal checklist)

Renewal/continuation requires evidence of benefit and adherence to dosing/generic requirements:

Continuation checklist: 1. Member currently receiving Tykerb via Centene benefit OR documentation supports at least 30 days of therapy; 2. Documented positive response to therapy; 3. For brand Tykerb requests, member must use generic lapatinib unless contraindicated or clinically significant adverse effects are experienced; 4. If requesting a dose increase, new dose does not exceed 1,500 mg/day OR is supported by practice guidelines or peer-reviewed literature (prescriber must submit supporting evidence).>=30 days prior therapy

Prescribed regimen must be FDA-approved or recommended by NCCN; providers should submit supporting clinical documentation (office notes, labs, prior therapies, disease stage, menopausal status where applicable).

inv-28: Continuation and approval duration

Approval duration and continuation policies:

Approval duration:

Provider Actions and Requirements

Prior Authorization

Prior Authorization Required

Prior Authorization Required: Prior authorization is required for lapatinib (Tykerb) and may be required when used in combination regimens (for example, with capecitabine or trastuzumab). Requests lacking an approved prior authorization will be denied.

Prior authorization may be required for combinations such as capecitabine + lapatinib and trastuzumab + lapatinib.
Prior authorization requirement aligns with NCCN-based criteria and program-specific PA workflows.

Step Therapy

Step / Sequence Therapy Requirements

Step/Sequence and Prior Therapy Requirements: Certain breast cancer combination regimens require documented prior therapies before approval. Specifically, when lapatinib is prescribed in combination with capecitabine or trastuzumab, the member must have received prior therapy per NCCN-based sequencing requirements (capecitabine combination may be bypassed if the member has brain metastases). Failure to document prior therapies may result in denial unless a bypass condition applies.

Coding and Dosage Limits

No explicit billing codes listedmixed

No codes listed

Maximum dose thresholds

Standard maximum daily dose1,500 mg/day

If taking a strong CYP3A4 inhibitorReduce maximum to 500 mg/day

If taking a strong CYP3A4 inducerIncrease maximum to 5,500 mg/day

Step Therapy and Substitution Rules

Requirement	Policy
Brand substitution requirement
For brand Tykerb requests, member must use generic lapatinib unless contraindicated or clinically significant adverse effects are experienced.

Scenario	Step/Sequence requirement
Lapatinib prescribed in combination with capecitabine
Prior therapy is required per NCCN; bypass allowed if member has brain metastases (capecitabine). Prior authorization may be required.
Lapatinib prescribed in combination with trastuzumab
Prior therapy is required per NCCN; combination considered fourth-line — member must have received at least 3 prior therapies. Prior authorization may be required.

Quantity Limits and Packaging

Lapatinib (Tykerb) — tablets per day

Example tablet calculation1,250 mg daily = five 250 mg tablets per day

Standard advanced/metastatic dosingLapatinib 1,250 mg PO QD (with capecitabine) — tablets as above

HER2-positive with letrozole dosingLapatinib 1,500 mg PO QD (with letrozole) — requires six 250 mg tablets

CYP3A4 interaction effect on maximumsMaximum tablets/day adjusted per inhibitor/inducer (see dose thresholds)

Site of Care

Note

Oral administration appropriate for home/outpatient

Lapatinib is administered orally and is appropriate for home or outpatient settings; ensure prescribing and dispensing reflect oral home/outpatient administration.

Background

Lapatinib (Tykerb) is an oral small‑molecule tyrosine kinase inhibitor that targets HER2 (and EGFR) and is used primarily for HER2‑overexpressing/ HER2‑amplified advanced or metastatic breast cancer, typically in combination regimens (for example, with capecitabine or letrozole). Tablet strength is available as 250 mg, and dosing regimens and maximum daily doses are specified in the Dosage and Administration section and aligned with guideline recommendations.

Definitions

HER2 definition

TermHER2

Definitionhuman epidermal growth factor receptor 2

ContextRelevance: HER2 overexpression/amplification guides use of lapatinib in breast and colorectal cancer per policy

EGFR definition

TermEGFR

Definitionepidermal growth factor receptor

ContextRelevance: EGFR positivity is required for chordoma (bone cancer) off-label use per policy

OpenPayer

Lapatinib (Tykerb) coverage and authorization

Coverage Criteria

Initial Therapy Criteria and Dosing

Continuation and Renewal Criteria

Provider Actions and Requirements

Coding and Dosage Limits

Step Therapy and Substitution Rules

Quantity Limits and Packaging

Site of Care

Background

Definitions