Medical Policy

Effective Date:05/01/2020 Title:Enhertu
Revision Date:01/01/2023 Document:BI644:00
CPT Code(s):J9358
Public Statement

Effective Date:

a)    This policy will apply to all services performed on or after the above revision date which will become the new effective date.

b)    For all services referred to in this policy that were performed before the revision date, contact customer service for the rules that would apply.

1)    Enhertu requires prior authorization.

2)    Enhertu is used to treat advanced or unresectable breast cancer and gastric and esophagogastric junction cancer.

3)    Enhertu is considered a specialty medication.

Medical Statement

Enhertu (fam-trastuzumab deruxtecan-nxki) is considered medically necessary for members meeting the following criteria:

 

A. Breast Cancer (must meet all):

1)    Diagnosis of unresectable or metastatic HER2-positive or HER2-low (IHC1+ or IHC2+/ISH-)breast cancer;

2)    Prescribed by or in consultation with an oncologist;

3)    Age > 18 years;

4)    For HER2-positive breast cancer, member meets one of the following (a or b):

a.    Failure of one anti-HER2-based regimen;*

b.    Rapid disease progression within 6 months of neoadjuvant or adjuvant therapy (12 months for pertuzumab-containing regimens);

5)    For HER2-low(IHC1+ or IHC2+/ISH-) breast cancer, members meets one of the following:

a.    Failure of at least one prior line of chemotherapy (if hormone-receptor [HR]-positive, previouis therapy should include an endocrine therapy, unless ineligible);

b.    DIsease recurrence during or within 6 months of completing adjuvant cheomotherapy;

6)    Dose does not exceed 5.4mg/kg every 3 weeks or off-label dose is recommended by NCCN

 

B. Gastric and Esophagogastric Junction Cancer (must meet all):

1)    Diagnosis of HER2-positive gastric or EGJ adenocarcinoma;

2)    Prescribed by or in consultation with an oncologist;

3)    Age ≥ 18 years;

4)    Disease is locally advanced or metastatic;

5)    Failure of trastuzumab-based regimen (see Appendix B);

6)    Dose does not exceed 6.4 mg/kg every 3 weeks or off-label dose is recommended by NCCN

 

C. Non-Small Cell Lung Cancer (must meet all):

            1) Diagnosis of unresectable or metastatic NSCLC;

2) Disease has activating HER2 (ERBB2) mutations;

3) Prescribed by or in consultation with an oncologist;

4) Age > 18 years;

5) Failure of one prior line of chemotherapy (if know EGFR mutation, BRAF mutation, ALK fusion, or ROS1 fusion, previous systemic therapy should include at least one targeted therapy corresponding to the driver mutation or rearrangement) (see Appendix B for examples);

6) Requests meets one of the following (a or b):*

            a) Dose does not exceed 5.4mg/kg every 3 weeks;

            b) Dose is supported by practice guidelines or peer-reviewed literature for the relevant off-label use (prescriber must submit supporting evidence).

 

Initial Approval Duration: 6 months

 

*Anti-HER2-based regimens

Trastuzumab + any of the following:

·         Aromatase inhibitor + Tykerb

·         fulvestrant

Aromatase inhibitor + Tykerb

Perjeta + trastuzumab +either of following:

·         docetaxel

·         paclitaxel

Kadcyla

Trastuzumab + any of following:

·         paclitaxel + carboplatin

·         docetaxel

·         vinorelbine

·         capecitabine

·         Tykerb

Tykerb + capecitabine

 

 

Appendix B: Therapeutic Alternatives

 

This table provides a listing of preferred alternative therapy recommended in the approval criteria. The drugs listed here may not be a formulary agent for all relevant lines of business and may require prior authorization. 

Drug Name        

Dosing Regimen

Dose Limit/
Maximum Dose

HER2+ Breast Cancer

NCCN examples of systemic therapies for recurrent or metastatic disease:

·         Aromatase inhibitor ± trastuzumab

·         Aromatase inhibitor ± lapatinib

·         Pertuzumab + trastuzumab + docetaxel

Varies

Varies

Breast Cancer

·         Examples of systemic therapies include but are not limited to: eribulin, capecitabine, gemcitabine, nab-paclitaxel, paclitaxel

·         Examples of endocrine therapies for HR+ disease include but are not limited to: sacituzumab, palbocicib, ribociclib, abemacicilib, tamoxifen, letrozole, anastrozole, exemestane

Varies

Varies

Gastric and Esophagogastric Junction Cancer

trastuzumab-based regimen

8 mg/kg IV q 3 weeks

8 mg/kg

NSCLC

Examples of systemic therapies include but are not limited to:

·         Carboplatin or cisplatin + pemetrexed + pembrolizumab

·         Carboplatin + paclitaxel + bevacizumab + atezolizumab

·         Carboplatin + albumin-bound paclitaxel + atezolizumab

·         Carboplatin + paclitaxel or albumin-bound paclitaxel + pembrolizumab

·         Nivolumab + ipilimumab + paclitaxel + carboplatin or cisplatin

 

Examples of targeted therapies include but are not limited to:

·         EGFR mutation positive: afatinib, erlotinib, dacomitinib, gefitinib, osimertinib, erlotinib + ramucirumab, erlotinib + bevacizumab (non-squamous)

·         BRAF: dabrafenib/trametinib, dabrafenib, vemurafenib

·         ALK: alectinib, brigatinib, ceritinib, crizotinib, lorlatinib

·         ROS1: ceritinib, crizotinib, entrectinib

Varies

Varies

Therapeutic alternatives are listed as Brand name® (generic) when the drug is available by brand name only and generic (Brand name®) when the drug is available by both brand and generic.

 

 

Codes Used In This BI:

 

1)    J9358       Injection, fam-trastuzumab deruxtecan-nxki, 1mg

Limits
Intentially left empty
Reference

1)    Enhertu Prescribing Information. Basking Ridge, NJ: Daiichi Sankyo, Inc.; January 2021.

2)    NCCN Drugs & Biologics Compendium. Accessed online 11-04-2022.

3)    Modi S, Saura C, Yamashita T, et al. Trastuzumab deruxtecan in previously treated HER2-positive breast cancer. N Engl J Med. 2019 Dec 11: doi: 10.1056/NEJMoa1914510.

Addendum:

1)    Effective 07-01-2020: Updated Enhertu code (J9358).

2)    Effective 06-01-2021: Added Gastric and Esophagogastric Junction Cancer.

3)    Effective 09-01-2022: Updated coverage criteria for breast cancer.

4)    Effective 01/01/2023: Updated breast cancer coverage criteria to include HER2-low indication. Added criteria for NSCLC.

Application to Products
This policy applies to all health plans administered by QualChoice, both those insured by QualChoice and those that are self-funded by the sponsoring employer, unless there is indication in this policy otherwise or a stated exclusion in your medical plan booklet. Consult the individual plan sponsor Summary Plan Description (SPD) for self-insured plans or the specific Evidence of Coverage (EOC) for those plans insured by QualChoice. In the event of a discrepancy between this policy and a self-insured customer’s SPD or the specific QualChoice EOC, the SPD or EOC, as applicable, will prevail. State and federal mandates will be followed as they apply.

Changes: QualChoice reserves the right to alter, amend, change or supplement benefit interpretations as needed.