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Herceptin® (Trastuzumab) and Other HER2 Inhibitors, 5.01.514

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Herceptin® (Trastuzumab) and Other HER2 Inhibitors, 5.01.514 PHARMACY / MEDICAL POLICY – 5.01.514 Herceptin® (trastuzumab) and Other HER2 Inhibitors Effective Date: Mar. 1, 2021 RELATED MEDICAL POLICIES: Last Revised: June 10, 2021 None Replaces: 5.01.12 Select a hyperlink below to be directed to that section. POLICY CRITERIA | DOCUMENTATION REQUIREMENTS | CODING RELATED INFORMATION | EVIDENCE REVIEW | REFERENCES | HISTORY ∞ Clicking this icon returns you to the hyperlinks menu above. Introduction Genes contain instructions for how a cell makes proteins. Proteins drive the functions within a cell. HER2 (human epidermal growth factor receptor 2) is a gene that can affect the development of breast cancer. About one in four or five cases of breast cancer are caused by the HER2 gene making too many copies of itself. And because too many HER2 genes are being made, too much HER2 protein also is being made. HER2 inhibitors are drugs that block the function of the HER2 protein. They essentially cut off the growth signals to the cancerous cells. This policy discusses when HER2 inhibitors may be considered medically necessary. Note: The Introduction section is for your general knowledge and is not to be taken as policy coverage criteria. The rest of the policy uses specific words and concepts familiar to medical professionals. It is intended for providers. A provider can be a person, such as a doctor, nurse, psychologist, or dentist. A provider also can be a place where medical care is given, like a hospital, clinic, or lab. This policy informs them about when a service may be covered. Policy Coverage Criteria HER2-Positive Breast Cancer Drug Medical Necessity Oral Drugs Generic lapatinib Generic lapatinib may be considered medically necessary for the treatment of HER2-positive breast cancer: • In combination with capecitabine for patients with advanced or metastatic disease who received prior therapy including an anthracycline, a taxane, and trastuzumab and progressed on trastuzumab • In combination with letrozole for postmenopausal patients with hormone receptor-positive, metastatic disease that overexpresses the HER2 receptor for whom hormonal therapy is indicated AND • The dose prescribed is ≤ 1,500 mg per day Tykerb® (lapatinib) Tykerb® (lapatinib) may be considered medically necessary for the treatment of HER2-positive breast cancer: • In combination with capecitabine for patients with advanced or metastatic disease who received prior therapy including an anthracycline, a taxane, and trastuzumab and progressed on trastuzumab • In combination with letrozole for postmenopausal patients with hormone receptor-positive, metastatic disease that overexpresses the HER2 receptor for whom hormonal therapy is indicated AND • The patient has tried generic lapatinib first and had an inadequate response or intolerance to generic lapatinib AND • The dose prescribed is ≤ 1,500 mg per day Nerlynx ® (neratinib) Nerlynx® (neratinib) may be considered medically necessary for use as extended adjuvant treatment* in adult patients with breast cancer whose tumors overexpress or have amplified HER2 protein (HER2-positive breast cancer) when all of the following are true: • Neratinib is used as adjuvant therapy Page | 2 of 33 ∞ Drug Medical Necessity AND • Neratinib is used following adjuvant trastuzumab-based therapy AND • Patient has stage III or lower breast cancer AND • Patient has HER2-positive breast cancer AND • The dose is limited to 240 mg (six tablets) per day Nerlynx ® (neratinib) may be considered medically necessary for use in advanced or metastatic breast cancer in adult patients with breast cancer whose tumors overexpress or have amplified HER2 protein (HER2-positive breast cancer) when all of the following are true: • Neratinib is used in combination with capecitabine AND • Patient has stage III or IV breast cancer AND • Neratinib is used after patient received two or more prior anti- HER2 based regimens in the metastatic setting (stage IV) AND • Patient has HER2-positive breast cancer AND • The dose is limited to 240 mg (six tablets) per day Note: Total duration of neratinib therapy will be limited to maximum of 1 year when used for extended adjuvant treatment. Tukysa™ (tucatinib) Tukysa™ (tucatinib) may be considered medically necessary for the treatment of adult patients with advanced unresectable or metastatic HER2-positive breast cancer, including patients with brain metastases, when ALL the following are true: • Tukysa™ (tucatinib) is being used in combination with trastuzumab and capecitabine AND Page | 3 of 33 ∞ Drug Medical Necessity • Patient has received one or more prior anti-HER2-based regimens in the metastatic setting AND • The dose is limited to 600 mg per day (taken as 300 mg twice daily) Injectable Drugs First-line: Herceptin® (trastuzumab) OR Trazimera™ (trastuzumab-qyyp) Herceptin® (trastuzumab), may be considered medically necessary for the treatment of Trazimera™ (trastuzumab- patients with HER2-positive breast cancer. This includes use as qyyp) adjuvant therapy, neoadjuvant therapy, and treatment of metastatic disease: • For adjuvant treatment of HER2-positive breast cancer (node positive or negative) as part of several different combination therapy regimens or as a single agent following prior chemotherapy • For treatment of HER2-positive metastatic breast cancer in combination therapy or as a single agent Note: Herceptin® (trastuzumab) and Trazimera™ (trastuzumab-qyyp) are administered as an IV infusion. Herceptin Hylecta™ Herceptin Hylecta™ (trastuzumab and hyaluronidase-oysk) (trastuzumab and may be considered medically necessary for the treatment of hyaluronidase-oysk) patients with HER2-positive breast cancer. This includes use as adjuvant therapy, neoadjuvant therapy, and treatment of metastatic disease: • For adjuvant treatment of HER2-positive breast cancer (node positive or negative) as part of several different combination therapy regimens or as a single agent following prior chemotherapy • For treatment of HER2-positive metastatic breast cancer in combination therapy or as a single agent Note: Herceptin Hylecta™ (trastuzumab and hyaluronidase-oysk) is administered subcutaneously and should be administered by a healthcare professional. Page | 4 of 33 ∞ Drug Medical Necessity Second-line: Herzuma® (trastuzumab-pkrb), Kanjinti™ (trastuzumab-anns), Herzuma® (trastuzumab- Ogivri™ (trastuzumab-dkst) and Ontruzant® (trastuzumab- pkrb), dttb) may be considered medically necessary for the treatment Kanjinti™ (trastuzumab- of patients with HER2-positive breast cancer after adequate anns), trial and failure of Herceptin® OR Trazimera™. This includes Ogivri™ (trastuzumab- use as adjuvant therapy, neoadjuvant therapy, OR treatment of dkst), metastatic disease. Ontruzant® (trastuzumab- • For adjuvant treatment of HER2-positive breast cancer (node dttb) positive or negative) as part of several different combination therapy regimens or as a single agent following prior chemotherapy • For treatment of HER2-positive metastatic breast cancer in combination therapy or as a single agent Note: Herzuma® (trastuzumab-pkrb), Kanjinti™ (trastuzumab-anns), Ogivri™ (trastuzumab-dkst) and Ontruzant® (trastuzumab-dttb) are biosimilars to Herceptin® (trastuzumab) and are administered as an IV infusion. Perjeta® (pertuzumab) Perjeta® (pertuzumab) may be considered medically necessary for the treatment of previously untreated HER2-positive breast cancer or recurrent breast cancer after adjuvant therapy, when used in combination with trastuzumab and docetaxel or paclitaxel. This includes use as adjuvant therapy, neoadjuvant therapy, and treatment of metastatic disease. Perjeta® (pertuzumab) may be considered medically necessary when used in combination with trastuzumab and chemotherapy as: • Neoadjuvant treatment of patients with HER2-positive, locally advanced, inflammatory, or early-stage breast cancer as part of a complete treatment regimen for early breast cancer. • Adjuvant treatment of patients with HER2-positive early breast cancer. Note: Perjeta® (pertuzumab) can be used in combination with Herceptin® (trastuzumab) or Herceptin Hylecta™ (trastuzumab and hyaluronidase- oysk). Perjeta® (pertuzumab) can also be used in combination with the biosimilars Herzuma® (trastuzumab-pkrb), Kanjinti™ (trastuzumab-anns), Page | 5 of 33 ∞ Drug Medical Necessity Ogivri™ (trastuzumab-dkst), Ontruzant® (trastuzumab-dttb) and Trazimera™ (trastuzumab-qyyp). Phesgo™ (pertuzumab, Phesgo™ (pertuzumab, trastuzumab, and hyaluronidase-zzxf) trastuzumab, and may be considered medically necessary for the treatment of hyaluronidase-zzxf) SC previously untreated HER2-positive breast cancer or recurrent breast cancer after adjuvant therapy, when used in combination with docetaxel or paclitaxel. This includes use as adjuvant therapy, neoadjuvant therapy, and treatment of metastatic disease. Phesgo™ (pertuzumab, trastuzumab, and hyaluronidase-zzxf) may be considered medically necessary when used in combination with chemotherapy as: • Neoadjuvant treatment of patients with HER2-positive, locally advanced, inflammatory, or early-stage breast cancer as part of a complete treatment regimen for early breast cancer. • Adjuvant treatment of patients with HER2-positive early breast cancer. Kadcyla™ (ado- Kadcyla™ (ado-trastuzumab emtansine) may be considered trastuzumab emtansine) medically necessary as a single agent when used for: • The treatment of patients with HER2-positive, metastatic breast cancer who previously received trastuzumab and a taxane separately or in combination AND o Patient has received prior treatment
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