Centene Kadcyla Coverage Update & Prior Auth

Coverage and Medical Necessity Criteria

Initial Therapy — Breast Cancer

Covered when ALL of the following are met for breast cancer:

Breast Cancer Initial Therapy: 1. Diagnosis of HER2-positive breast cancer; 2. Prescribed by or in consultation with an oncologist; 3. Age >= 18 years; 4. Prescribed as a single agent; 5. One of the following: (a) documentation of prior use of trastuzumab-based therapy and a taxane; (b) Kadcyla prescribed as adjuvant treatment; 6. Request meets one of the following: (a) as adjuvant treatment: dose does not exceed 3.6 mg/kg every 21 days for a maximum of 14 doses; (b) for metastatic treatment: dose does not exceed 3.6 mg/kg every 21 days; (c) dose is supported by practice guidelines or peer-reviewed literature for the relevant off-label use (prescriber must submit supporting evidence).

Initial Therapy — NCCN Off-Label Uses

Covered when ALL of the following are met for NCCN-recommended off-label uses:

NCCN Off-Label Initial Therapy: 1. Diagnosis of one of the following: (a) recurrent, advanced, or metastatic non-small cell lung cancer (NSCLC); (b) recurrent salivary gland tumor; (c) brain metastases due to breast cancer; 2. Prescribed by or in consultation with an oncologist; 3. Age >= 18 years; 4. Disease is HER2-positive; 5. Prescribed as one of the following: (a) single agent; (b) in combination with neratinib for brain metastases; 6. For NSCLC, Kadcyla is prescribed as subsequent therapy; 7. Request meets one of the following: (a) dose does not exceed 3.6 mg/kg every 21 days; (b) dose is supported by practice guidelines or peer-reviewed literature for the relevant off-label use (prescriber must submit supporting evidence).

Continuation Therapy

Covered when ALL of the following are met for continuation:

Continuation Therapy: 1. Member is currently receiving Kadcyla via the Centene benefit, or documentation supports that the member has received Kadcyla for a covered indication for at least 30 days; 2. Member is responding positively to therapy; 3. If request is for a dose increase, request meets one of the following: (a) as adjuvant treatment for breast cancer: new dose does not exceed 3.6 mg/kg every 21 days for a maximum of 14 doses; (b) for all other indications: new dose does not exceed 3.6 mg/kg every 21 days; (c) new dose is supported by practice guidelines or peer-reviewed literature for the relevant off-label use (prescriber must submit supporting evidence).

Added indications / criteria updates

Policy changes and coverage additions per NCCN

new_indications: Includes brain metastases in HER2-positive breast cancer per NCCN; NSCLC added with criteria for use as subsequent therapy per NCCN.

Detailed patient eligibility and prior-treatment specifics are provided in the relevant initial therapy sections.

Initial approval duration

Approval duration for certain lines of business

approval_duration: Initial approval duration by line of business: Medicaid/HIM/ICHRA — 12 months; Commercial — 6 months or to the member's renewal date, whichever is longer.12 months

Extension to 12 months for Medicaid and HIM was a policy change per the update.

Non‑FDA approved indications that are not addressed in this policy are not authorized unless the provider submits sufficient documentation demonstrating efficacy and safety in accordance with the applicable off‑label use policies (see CP.CPA.09 for Commercial, HIM.PA.154 for HIM/ICHRA, and CP.PMN.53 for Medicaid) or the member's evidence of coverage documents.

When state Medicaid coverage provisions conflict with this clinical policy, the state Medicaid provisions take precedence; coverage decisions remain subject to state and federal requirements and the terms of the member's coverage documents.

Requests for uses that are non‑FDA approved and not specifically addressed in this policy require adequate supporting evidence per the applicable off‑label use policy; without such evidence these uses are considered not authorized.

This clinical policy is intended to guide medical necessity determinations. Final coverage and payment decisions are made in accordance with the member's contract, applicable law, and plan terms; this document does not guarantee coverage or payment.

Dosing, Codes, and Product Availability

Covered HCPCS CodesHCPCSCovered

J9354

Injection, ado-trastuzumab emtansine, 1 mg

Affected codesmixed

affected codes

Codes referenced for prior authorization/coverage (document does not list explicit CPT/HCPCS/NDC codes in this section)

Dosing

Recommended dose3.6 mg/kg every 21 days (IV)

Adjuvant maximumMaximum of 14 doses when used as adjuvant therapy

Metastatic dosing3.6 mg/kg every 21 days until disease progression or unacceptable toxicity

Initial approval duration (coding note)

Initial approval duration (Medicaid & HIM)12 months

Commercial approval durationCommercial: 6 months or to member's renewal date, whichever is longer (per document summary)

Prior Authorization, Documentation, and Step Therapy

Prior Authorization

Prior Authorization Required

Prior authorization required. Provider must submit documentation (such as office chart notes, lab results, or other clinical information) supporting that the member meets all approval criteria and demonstrates medical necessity consistent with this clinical policy.

Prior authorization with supporting documentation is required (diagnosis, prescriber specialty, age, prior therapies, current treatment status, response to therapy, dosing).
Requests for off‑label uses not addressed in this policy may be denied without sufficient supporting evidence per applicable off‑label use policies (CP.CPA.09, HIM.PA.154, CP.PMN.53).

Documentation Required

Documentation Required to Demonstrate Medical Necessity

Provider must submit clinical documentation demonstrating medical necessity at the time of request. Acceptable documentation includes office/clinic visit notes, pathology reports, imaging, prior treatment records (including dates and agents), and laboratory results. Documentation must show active clinical indication, prior response if applicable, and rationale for prescribed dose or off‑label use with supporting literature when required.

Initial Therapy Authorization Details

Initial Therapy — Initial approval criteria and durations

Initial approval criteria and durations

Initial therapy nodes: For covered indications, member must meet diagnosis, prescriber specialty, age >=18, single-agent use (or specified combination for brain metastases), prior trastuzumab and taxane requirement unless prescribed as adjuvant treatment, and dosing limits (<=3.6 mg/kg every 21 days; adjuvant max 14 doses). Off-label regimens must be supported by practice guidelines or peer-reviewed literature with prescriber-submitted evidence.

Initial therapy: approval duration

Initial therapy authorization detail for specific lines of business.

initial_approval_medicaid_him: Initial approval duration: Medicaid/HIM/ICHRA — 12 months; Commercial — 6 months or to the member's renewal date, whichever is longer.12 months

Continuation and Ongoing Therapy Requirements

Continuation Therapy

Continuation approval requirements and duration

Continuation Therapy: Member currently receiving Kadcyla via Centene benefit or has received at least 30 days; member responding positively to therapy; dose increases must meet specified dosing limits (adjuvant: <=3.6 mg/kg q21d for max 14 doses; other indications: <=3.6 mg/kg q21d) or be supported by practice guidelines/peer-reviewed literature with prescriber evidence.

Continuation therapy

Continuation/ongoing therapy considerations referenced via NCCN alignment and approval durations.

continuation_generic: Continuation criteria align with NCCN recommendations and are subject to prior authorization and coverage terms; approval durations follow line-of-business rules (e.g., Medicaid/HIM/ICHRA 12 months, Commercial 6 months or to renewal). Specific continuation rules are provided in the continuation therapy section of the policy.

Step and Sequence Requirements

Step	Requirement	Notes
1	Prior use of trastuzumab-based therapy and a taxane is required for metastatic HER2‑positive breast cancer	Per initial approval criteria: documentation of prior trastuzumab-based therapy and a taxane (see criteria A.5.a); adjuvant setting may bypass prior-use requirement per NCCN updates
1	Bypass allowed if prescribed as adjuvant treatment	Criteria A.5.b allows Kadcyla prescribed as adjuvant treatment to meet requirement without prior trastuzumab/taxane; 2Q2025 update added this NCCN‑aligned bypass

Step	Requirement	Notes
1	Therapy to be prescribed as subsequent (later‑line) treatment for recurrent/advanced/metastatic NSCLC	Off‑label NCCN‑recommended use: NSCLC must be recurrent, advanced, or metastatic and Kadcyla is used as subsequent therapy per 2Q2023/2Q2026 clarifications
1	Prescribed by or in consultation with an oncologist and disease must be HER2‑positive	Initial approval criteria for NCCN off‑label uses require oncologist involvement and HER2 positivity; single‑agent use required per 2Q2022 update

Dosing Limits and Product Information

Ado-trastuzumab emtansine (Kadcyla) dosing

Drug and doseAdo-trastuzumab emtansine (Kadcyla) — 3.6 mg/kg per dose (IV)

Adjuvant maximumAdjuvant therapy: maximum of 14 doses (3.6 mg/kg Q3WK up to 14 cycles)

Metastatic useFor metastatic breast cancer: 3.6 mg/kg IV every 21 days until progression or unacceptable toxicity

Note

Infuse IV Q3WK in appropriate medical setting until completion or progression

Administer ado‑trastuzumab emtansine via IV infusion in an appropriate medical setting on a 21‑day cycle (Q3WK) per dosing guidance until completion, disease progression, or unacceptable toxicity.

Adjuvant breast cancer dosing: 3.6 mg/kg IV every 21 days for up to 14 cycles; metastatic dosing: 3.6 mg/kg IV every 21 days until progression or unacceptable toxicity.

Administration Setting

Note

No explicit site‑of‑care restrictions in policy excerpt; provider responsible for appropriate setting

No specific site‑of‑care restrictions are provided in this excerpt; providers are responsible for administering the infusion in an appropriate setting consistent with the member's coverage documents and applicable policies.

Confirm any plan- or state-specific site‑of‑care requirements prior to scheduling infusion services.

Key Terms and Abbreviations

HER2 / Kadcyla

HER2 definitionHER2 = human epidermal growth factor receptor 2 protein

Kadcyla mechanismAdo-trastuzumab emtansine (Kadcyla) is a HER2-targeted antibody and microtubule inhibitor conjugate

Clinical contextUsed for HER2-positive breast cancer as adjuvant therapy for residual disease after neoadjuvant taxane and trastuzumab, and for metastatic disease after prior trastuzumab and a taxane; NCCN also recommends select off-label uses

Individual Coverage Health Reimbursement Arrangement (ICHRA)

DefinitionIndividual Coverage Health Reimbursement Arrangement (ICHRA): a line of business referenced in the policy as an applicable coverage grouping (ICHRA added to lines of business)

Policy noteICHRA was added as a covered line of business in the policy update (applies with Medicaid, HIM, Commercial considerations)

Clinical Background

Ado‑trastuzumab emtansine (Kadcyla) is a HER2‑targeted antibody‑drug conjugate (trastuzumab linked to a microtubule inhibitor) used to treat HER2‑positive breast cancer. It is indicated for adjuvant therapy in patients with residual invasive disease following neoadjuvant taxane and trastuzumab‑based treatment and for certain metastatic HER2‑positive breast cancers after prior trastuzumab and a taxane. The product is administered by intravenous infusion at a standard dose of 3.6 mg/kg every 21 days (with an adjuvant maximum of 14 doses), and carries boxed warnings for hepatotoxicity, cardiac toxicity, and embryo‑fetal toxicity. NCCN also recommends select off‑label uses (for example, certain NSCLC, salivary gland tumors, and brain metastases from HER2‑positive breast cancer), which are reflected in this policy where specified.

Policy Updates and Material Changes

2022-05-26material_changeLatest

Added NCCN‑recommended indication for brain metastases in HER2‑positive breast cancer; added NSCLC criteria for use as subsequent therapy; extended initial approval duration for Medicaid and HIM from 6 to 12 months; added ICHRA line of business and updated references.

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Ado-Trastuzumab Emtansine (Kadcyla) Coverage