Neratinib

• Tablets 40mg

Notes

1. NICE TA612: Neratinib (Nerlynx) is recommended as an option for the extended adjuvant treatment of hormone receptor-positive, human epidermal growth factor receptor 2 (HER2)‑positive early stage breast cancer in adults (November 2019), only if:
   1. trastuzumab is the only HER2‑directed adjuvant treatment they have had, and
   2. if they had neoadjuvant chemotherapy-based regimens, they still had residual invasive disease in the breast or axilla following the neoadjuvant treatment, and
   3. the company provides neratinib according to the commercial arrangement.

Pertuzumab

• Solution for infusion vials 420mg/14ml

Notes

1. NICE TA424: Pertuzumab (Perjeta), in combination with trastuzumab and chemotherapy, is recommended, within its marketing authorisation, as an option for the neoadjuvant treatment of adults with human epidermal growth factor receptor 2 (HER2)-positive breast cancer; that is, in patients with HER2-positive, locally advanced, inflammatory or early-stage breast cancer at high risk of recurrence. It is recommended only if the company provides pertuzumab with the discount agreed in the patient access scheme (December 2016).
2. NICE TA509: Pertuzumab (Perjeta), in combination with trastuzumab and docetaxel, is recommended, within its marketing authorisation, for treating HER2-positive metastatic or locally recurrent unresectable breast cancer, in adults who have not had previous anti HER2 therapy or chemotherapy for their metastatic disease, only if the company provides pertuzumab within the agreed commercial access arrangement (March 2018).
3. NICE TA569: Pertuzumab (Perjeta), with intravenous trastuzumab and chemotherapy, is recommended for the adjuvant treatment of human epidermal growth factor receptor 2 (HER2)-positive early stage breast cancer in adults (March 2019), only if:
   1. they have lymph node-positive disease
   2. the company provides it according to the commercial arrangement.

Trastuzumab

• Solution for injection vials 600mg/5ml
• Powder for solution for infusion vials 150mg

Notes

1. Prescribe by brand. A biosimilar medicine is a biological medicine that is highly similar and clinically equivalent (in terms of quality, safety, and efficacy) to an existing biological medicine however they cannot be considered generic equivalents of the originator biological medicine. Because they are not identical, biological medicines must be prescribed by brand. The decision which brand to prescribe rests with the responsible clinician in consultation with the patient. Automatic substitution of brands at the point of dispensing is not appropriate for biological medicines.
2. The recommendations also apply to trastuzumab biosimilar products that have a marketing authorisation allowing the use of the biosimilar for the same indication.
3. NICE TA34: Guidance on the use of trastuzumab for the treatment of advanced breast cancer (March 2002):
   1. Trastuzumab in combination with paclitaxel is recommended as an option for people with tumours expressing human epidermal growth factor receptor 2 (HER2) scored at levels of 3+ who have not received chemotherapy for metastatic breast cancer and in whom anthracycline treatment is inappropriate.
   1. Trastuzumab monotherapy is recommended as an option for people with tumours expressing HER2 scored at levels of 3+ who have received at least two chemotherapy regimens for metastatic breast cancer. Prior chemotherapy must have included at least an anthracycline and a taxane where these treatments are appropriate. It should also have included hormonal therapy in suitable oestrogen receptor positive patients.
4. NICE TA257: Trastuzumab (Herceptin) in combination with an aromatase inhibitor is not recommended for first-line treatment in postmenopausal women with metastatic hormone-receptor-positive breast cancer that overexpresses HER2 (June 2012).
5. NICE TA509: Pertuzumab in combination with trastuzumab and docetaxel, is recommended, within its marketing authorisation, for treating HER2-positive metastatic or locally recurrent unresectable breast cancer, in adults who have not had previous anti HER2 therapy or chemotherapy for their metastatic disease, only if the company provides pertuzumab within the agreed commercial access arrangement (March 2018).
6. NICE TA208: Trastuzumab (Herceptin), in combination with cisplatin and capecitabine or 5-fluorouracil, is recommended as an option for the treatment of people with human epidermal growth factor receptor 2 (HER2)-positive metastatic adenocarcinoma of the stomach or gastro-oesophageal junction (November 2010) who:
   1. have not received prior treatment for their metastatic disease and
   1. have tumours expressing high levels of HER2 as defined by a positive immunohistochemistry score of 3 (IHC3 positive).

Trastuzumab deruxtecan

• Powder for solution for infusion vials 100mg

Notes

1. NICE TA704: Trastuzumab deruxtecan (Enhertu) is recommended for use within the Cancer Drugs Fund as an option for treating HER2‑positive unresectable or metastatic breast cancer in adults after 2 or more anti‑HER2 therapies, only if the conditions in the managed access agreement are followed (May 2021).
2. NICE TA862: Trastuzumab deruxtecan (Enhertu) is recommended with managed access as an option for treating HER2-positive unresectable or metastatic breast cancer after 1 or more anti-HER2 treatments in adults, only if the conditions in the managed access agreement are followed (February 2023).
3. NICE TA992: Trastuzumab deruxtecan (Enhertu) is not recommended, within its marketing authorisation, for treating HER2-low metastatic or unresectable breast cancer in adults after:
   1. chemotherapy in the metastatic setting or
   2. recurrence during adjuvant chemotherapy or within 6 months after finishing it (July 2024).

Trastuzumab emtansine

• Powder for solution for infusion vials 100mg, 160mg

Notes

1. NICE TA458: Trastuzumab emtansine (Kadcyla) is recommended, within its marketing authorisation, as an option for treating human epidermal growth factor receptor 2 (HER2)-positive, unresectable, locally advanced or metastatic breast cancer in adults who previously received trastuzumab and a taxane, separately or in combination (July 2017).
   1. Patients should have either received prior therapy for locally advanced or metastatic disease or developed disease recurrence during or within 6 months of completing adjuvant therapy.
   2. Trastuzumab emtansine is recommended only if the company provides it with the discount agreed in the patient access scheme.
2. NICE TA632: Trastuzumab emtansine (Kadcyla) is recommended, within its marketing authorisation, as an option for the adjuvant treatment of human epidermal growth factor receptor 2 (HER2)‑positive early breast cancer in adults who have residual invasive disease in the breast or lymph nodes after neoadjuvant taxane-based and HER2‑targeted therapy. It is recommended only if the company provides trastuzumab emtansine according to the commercial arrangement (June 2020).

Tucatinib

• Tablets 150mg

Notes

1. NICE TA786: Tucatinib (TUKYSA) with trastuzumab and capecitabine is recommended, within its marketing authorisation, as an option for treating HER2 positive locally advanced or metastatic breast cancer in adults after 2 or more anti HER2 treatment therapies, only if the company provides tucatinib according to the commercial arrangement (April 2022).

Lapatinib ditosylate monohydrate

• NICE TA257: Lapatinib (Tyverb) in combination with an aromatase inhibitor is not recommended for first-line treatment in postmenopausal women with metastatic hormone-receptor-positive breast cancer that overexpresses human epidermal growth factor receptor 2 (HER2) (June 2012).