The National Institute for Health and Care Excellence (NICE) has published draft guidance recommending trastuzumab deruxtecan for use in the Cancer Drugs Fund (CDF) as an option for treating HER2-positive unresectable or metastatic breast cancer in adults after two or more anti-HER2 therapies.
The decision means it will be the first time trastuzumab deruxtecan (Enhertu, Daiichi Sankyo), a HER2-directed antibody, has been commissioned for use in any European country.
Up to 400 people will have immediate access to the treatment while more data are collected showing how much longer people who are taking it live compared with people taking chemotherapy.
Current first-line treatment of HER2‑positive unresectable or metastatic breast cancer includes anti‑HER2 therapies pertuzumab with trastuzumab and docetaxel, or trastuzumab with paclitaxel. Standard care for people whose disease has progressed on or after two anti‑HER2 therapies is non-targeted chemotherapy, including capecitabine, vinorelbine or eribulin.
Trastuzumab deruxtecan can now be used after two or more anti‑HER2 therapies.
There is currently a lack of clinical trial data directly comparing trastuzumab deruxtecan with chemotherapy. However, the committee concluded that data from ongoing trials of trastuzumab deruxtecan and from NHS practice would help address the uncertainty about clinical effectiveness. Trastuzumab deruxtecan is therefore recommended for use in the CDF.
Meindert Boysen, Deputy Chief Executive and Director of the Centre for Health Technology Evaluation at NICE, said: “Trastuzumab deruxtecan is a promising new treatment that has the potential to increase the length of time before the disease gets worse and how long people live overall.”
Trastuzumab deruxtecan costs £1455 per vial and the average cost of a course of treatment at list price is £118,000. The company has a confidential commercial arrangement which makes trastuzumab deruxtecan available to the NHS with a discount.
NICE expects to publish final guidance on trastuzumab deruxtecan in May. In the meantime, interim funding for the drug will be available.
'Fantastic News'
Commenting, Baroness Delyth Morgan, chief executive of Breast Cancer Now, said the approval was "fantastic news for hundreds of patients with HER2 positive incurable secondary breast cancer who desperately need new effective targeted treatments which can delay the use of chemotherapy, its debilitating side effects and reduced quality of life.
"Crucially, this promising new targeted treatment may potentially offer patients more time before their disease progresses or may extend their lives, meaning more precious time with their loved ones, than chemotherapy brings. We look forward to further results to understand whether this new treatment could offer patients extra time to live.
“Women who’ve already had two or more targeted treatments and are fast running out of innovative options will be able to access Enhertu much sooner thanks to the Cancer Drugs Fund enabling promising treatments to reach patients on the NHS quickly while further data is collected. Upcoming proposals for the new Innovative Medicines Fund must ensure breast cancer patients continue to have quick access to potentially life-changing new drugs.
“Now, it is crucial Daiichi Sankyo and the Scottish Medicines Consortium work quickly to ensure that patients in Scotland also benefit from this exciting new drug."
This article was adapted from Univadis, part of the Medscape Professional Network.
