New cancer medicines approved in Scotland, available via NHS
pharmafile | October 12, 2015 | News story | Sales and Marketing | Scottish Medicines Consortium, Zytiga, abiraterone acetate, prostate cancer
The Scottish Medicines Consortium (SMC) has today recommended Janssen’s Zytiga (abiraterone acetate) for use before chemotherapy in men with advanced prostate cancer who are no longer responding to conventional hormone therapy, while those in England and Wales await a decision from NICE.
Eligible men in Scotland can now routinely benefit from earlier treatment with a medicine that will allow them to delay or avoid chemotherapy and that can delay disease progression, prolong life and provide a better quality of life with less pain.
In England, abiraterone is currently only available before chemotherapy for the treatment of metastatic castration resistant prostate cancer, via applications to the Cancer Drugs Fund (CDF) and is the second most requested treatment on the list. However, the Fund is limited to patients in England and is due to end in March 2016.
A positive NICE recommendation will be the only route to ensure that men in England and Wales who could benefit from abiraterone before chemotherapy are able to get routine access to abiraterone, with a final decision expected later this year.
The SMC also approved Bayer’s Xofigo (radium-223 dichloride) for use within NHS Scotland for the treatment of adult patients with castration-resistant prostate cancer (CRPC), symptomatic bone metastases and no known visceral metastases.
While the National Institute for Health and Care Excellence (NICE) has published draft guidance recommending radium-223 dichloride in advanced prostate cancer, this does not cover all patients and may not be confirmed for a number of months and could change.
In Scotland, under SMC guidance, clinicians will have the choice to use Xofigo prior to chemotherapy or after.
Prostate cancer is the most common cancer affecting men in the UK. In 2011 there were approximately 41,700 men diagnosed with prostate cancer, which is more than 110 every day.
In Scotland, prostate cancer accounted for over one in five new cases of cancer in men in 2013 and between 2008 and 2012 there were 14,935 new cases in Scotland alone, with the number of cases projected to increase by a further 35% within the next 10 years.
A third cancer treatment okayed today by the Consortium was Roche’s Herceptin (trastuzumab), the approval of which gives Scottish patients access to a treatment for an advanced and incurable form of gastric cancer via the NHS (this time after its English and Welsh approval).
Herceptin has been recommended for use in combination with chemotherapy (capecitabine or 5-fluorouracil and cisplatin) for previously untreated patients with HER2-positive metastatic adenocarcinoma of the stomach or gastro-oesophageal junction. It was approved under the SMC’s new Patient and Clinician Engagement (PACE) process – with access now in line with England and Wales.
Data from the landmark study of the drug (ToGA) showed that the Herceptin combination prolongs the lives of certain patients by nearly half a year (5.6 months) in the pre-planned analysis – representing a 45.2% increase in median life-expectancy, compared with the current standard of care, chemotherapy alone (median overall survival: 18.0 months versus 12.4 months).
Less than half the patients of this cancer survive for a year following diagnosis, and therefore these results are considered a genuine breakthrough.
Herceptin is a humanised, targeted antibody, which targets the HER2 protein receptor found on the surface of cells, which turns cancerous when over-produced, and blocks the ‘survive and multiply’ signals it sends directly into the cell. The mode of action of Herceptin activates the body’s immune system and suppresses HER2 to target and destroy the tumour.
Joel Levy
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