下载澳门新葡亰官网app_诚信官网-welcome

86-571-56050590

Technology appraisal guidance for T-DM1 by NICE of UK

From:DAC Biotech  Time:2017-07-20 09:20:53

Description of the technology

    Trastuzumab emtansine (Kadcyla; Roche) is an antibody?drug conjugate consisting of trastuzumab linked to maytansine, which is a cytotoxic agent. Because the antibody targets human epidermal growth factor receptor 2 (HER2), and HER2 is overexpressed in breast cancer cells, the conjugate delivers the toxin directly to the cancer cells.

Marketing authorisation

    Trastuzumab emtansine, as a single agent, has a UK marketing authorisation 'for the treatment of adult patients with HER2?positive, unresectable locally advanced or metastatic breast cancer who previously received trastuzumab and a taxane, separately or in combination. 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'.

Adverse reactions

    The summary of product characteristics includes the following adverse reactions for trastuzumab emtansine: increase in serum transaminases, left ventricular dysfunction, infusion-related reactions, hypersensitivity reactions, decreased platelet counts, an immune response to trastuzumab emtansine, and reactions secondary to the accidental administration of trastuzumab emtansine around infusion sites. For full details of adverse reactions and contraindications, see the summary of product characteristics.

Recommended dose and schedule

    Trastuzumab emtansine is administered as an intravenous infusion. The recommended dose is 3.6 mg/kg bodyweight every 3 weeks (21?day cycle). Patients should have treatment until the disease progresses or unacceptable toxicity occurs.

Price

    The list price for trastuzumab emtansine is £1,641.01 for a 100mg vial and £2,625.62 for a 160mg vial (excluding VAT, British national formulary online, accessed February 2017). The company estimates that the average cost of a course of treatment is £91,614, using the list price, and based on a 3 weekly dose of 3.6 mg/kg, a patient weight of 70.1 kg and an average length of treatment of 14.5 months.

    The pricing arrangement considered during guidance development was one in which the company (Roche) had agreed a complex patient access scheme with the Department of Health. At the end of the appraisal process, the patient access scheme was replaced with a commercial access agreement between Roche and NHS England. The commercial access agreement provides similar reductions in the total costs of treatment to the latest patient access scheme offer, and a simpler operational approach. The details of the agreement are commercial in confidence.