CurrentClover HealthPolicy 4615-A

Herceptin Hylecta Coverage and Prior Authorization

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Medicare Part B coverage and authorization for Herceptin Hylecta in adults with HER2-positive breast cancer, including FDA-approved uses, specified compendial substitution for intravenous trastuzumab, and continuation when clinical benefit is demonstrated.

Policy Summary

PayerClover Health

PolicyHerceptin Hylecta Coverage and Prior Authorization

Policy CodePolicy 4615-A

Change TypeNo material change

Effective DateN/A

Next Review DateN/A

Key ActionEnsure HER2 status is available upon request for every submission.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

Up to 12 monthsAdjuvant or neoadjuvant authorization

12 monthsAdvanced or metastatic authorization

2 conditionsContinuation benefit requirements

HER2 requiredSubmission documentation

Coverage Criteria

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CurrentClover HealthPolicy 4615-A

Herceptin Hylecta Coverage and Prior Authorization

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Policy Summary

PayerClover Health

PolicyHerceptin Hylecta Coverage and Prior Authorization

Policy CodePolicy 4615-A

Change TypeNo material change

Effective DateN/A

Next Review DateN/A

Key ActionEnsure HER2 status is available upon request for every submission.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

Up to 12 monthsAdjuvant or neoadjuvant authorization

12 monthsAdvanced or metastatic authorization

2 conditionsContinuation benefit requirements

HER2 requiredSubmission documentation

Coverage Criteria

Adjuvant therapy

Authorization may be granted for up to 12 months.

Adjuvant treatment: The requested therapy is for adjuvant treatment of HER2-positive breast cancer.up to 12 months

Recurrent, advanced, or metastatic disease

Authorization may be granted for 12 months.

Advanced or metastatic disease: The member has HER2-positive breast cancer with no response to preoperative systemic therapy, or recurrent, unresectable, advanced, or metastatic disease, including brain metastases.12 months

Neoadjuvant therapy

Authorization may be granted for up to 12 months.

Neoadjuvant treatment: The requested therapy is for neoadjuvant treatment of HER2-positive breast cancer as part of a complete treatment regimen.up to 12 months

Adjuvant and neoadjuvant continuation

Authorization of 12 months, up to 12 months total, may be granted when all of the following criteria are met.

Adjuvant or neoadjuvant continuation

Benefit from therapy: There is no evidence of unacceptable toxicity while on the current regimen and no evidence of disease progression while on the current regimen.

Advanced or metastatic continuation

Authorization of 12 months may be granted when all of the following criteria are met.

Benefit from therapy: There is no evidence of unacceptable toxicity while on the current regimen and no evidence of disease progression while on the current regimen.

Do not substitute Herceptin Hylecta for or with ado-trastuzumab emtansine (Kadcyla) or fam-trastuzumab deruxtecan-nxki (Enhertu).

Continuation Criteria

Adjuvant and neoadjuvant continuation

For adjuvant or neoadjuvant breast cancer, authorization of 12 months, up to 12 months total, may be granted when all criteria are met.

Continuation requirements

Clinical benefit: There is no evidence of unacceptable toxicity and no evidence of disease progression while on the current regimen.

Advanced or metastatic continuation

For breast cancer with no response to preoperative therapy or in recurrent, unresectable, advanced, or metastatic disease, authorization of 12 months may be granted when all criteria are met.

Continuation requirements

Clinical benefit: There is no evidence of unacceptable toxicity and no evidence of disease progression while on the current regimen.

Provider Actions

Prior Authorization

Initial Breast Cancer Authorization

Submit an initial authorization request for Herceptin Hylecta for qualifying HER2-positive breast cancer indications. Authorization may be granted for up to 12 months, except that authorization for disease with no response to preoperative systemic therapy or recurrent, unresectable, advanced, or metastatic disease (including brain metastases) may be granted for 12 months.

Adjuvant treatment of HER2-positive breast cancer: authorization of up to 12 months.
Neoadjuvant treatment of HER2-positive breast cancer as part of a complete treatment regimen: authorization of up to 12 months.
HER2-positive breast cancer with no response to preoperative systemic therapy, or recurrent, unresectable, advanced, or metastatic disease (including brain metastases): authorization of 12 months.

Prior Authorization

Continuation Authorization

For continuation authorization, all members—including new members—must be currently receiving therapy with Herceptin Hylecta and must be receiving benefit from the current regimen. Benefit requires no unacceptable toxicity and no disease progression.

Adjuvant or neoadjuvant breast cancer: authorization of 12 months, up to 12 months total, when the member is currently receiving the requested medication and has benefit from therapy.
No response to preoperative therapy, or recurrent, unresectable, advanced, or metastatic breast cancer: authorization of 12 months when the member is currently receiving the requested medication and has benefit from therapy.
Document no evidence of unacceptable toxicity and no evidence of disease progression while on the current regimen.

Documentation Required

HER2 Status Documentation

Make Human epidermal growth factor receptor 2 (HER2) status available upon request for all Herceptin Hylecta submissions.

Documentation of HER2 status is required for all submissions upon request.

Documentation Required

Compendial Support for Other Indications

For indications other than those listed in the policy, submit supporting evidence from Medicare-approved compendia. Herceptin Hylecta may be substituted for intravenous trastuzumab for HER2-positive breast cancer as a single agent or in combination with other systemic therapies.

All other indications are assessed on an individual basis.
Include Medicare-approved compendia support with submissions for unlisted indications.
NCCN Drugs and Biologics Compendium support is identified for use as a substitute for intravenous trastuzumab in HER2-positive breast cancer.

Denial Risk

Failure to Meet Coverage Criteria

Coverage is denied when the requested use does not meet a covered indication or approval criteria, continuation therapy requirements are not satisfied, or required documentation is not available. The member must meet the applicable indication, currently be receiving the requested therapy for continuation, and demonstrate benefit without unacceptable toxicity or disease progression.

The requested indication is not covered or does not meet the applicable FDA-approved or compendial support requirements.
Initial authorization criteria are not met, including the qualifying HER2-positive breast cancer setting or applicable authorization duration.
For continuation requests, the member—including a new member—must be currently receiving Herceptin Hylecta and receiving benefit from therapy.
Benefit requires no evidence of unacceptable toxicity and no evidence of disease progression on the current regimen.
Required HER2 status documentation is unavailable upon request.

Denial Risk

Prohibited Drug Substitution

Do not substitute Herceptin Hylecta for or with ado-trastuzumab emtansine (Kadcyla) or fam-trastuzumab deruxtecan-nxki (Enhertu).

Herceptin Hylecta must not be substituted for or with Kadcyla.
Herceptin Hylecta must not be substituted for or with Enhertu.

Herceptin Hylecta Coverage and Prior Authorization

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Coverage Criteria

Herceptin Hylecta Coverage and Prior Authorization

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Coverage Criteria

Initial Therapy Criteria

Continuation Criteria

Provider Actions

Background

Definitions