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| NHS ruling on pioneering breast cancer drug Kadcyla | NHS ruling on pioneering breast cancer drug Kadcyla |
| (about 9 hours later) | |
| Women in Scotland with a particular type of terminal breast cancer are to find out whether they will get a pioneering treatment through the NHS. | |
| Kadcyla has been described as the "best drug in a generation" for women with HER-2 positive breast cancer. | Kadcyla has been described as the "best drug in a generation" for women with HER-2 positive breast cancer. |
| Women in England, Wales and Ireland have already been refused access to the drug on cost grounds. | Women in England, Wales and Ireland have already been refused access to the drug on cost grounds. |
| About 170 women in Scotland could benefit from the drug, which costs £90,000 for the 14-month course. | About 170 women in Scotland could benefit from the drug, which costs £90,000 for the 14-month course. |
| Kadcyla adds an average of six months to the lives of women whose breast cancer has become inoperable. | Kadcyla adds an average of six months to the lives of women whose breast cancer has become inoperable. |
| The drug is the first big test of changes to the Scottish Medicines Consortium (SMC), which decides what medicines should be routinely available on the NHS. | The drug is the first big test of changes to the Scottish Medicines Consortium (SMC), which decides what medicines should be routinely available on the NHS. |
| 'Huge effect' | 'Huge effect' |
| Earlier this year the SMC was reformed to give patients and clinicians a greater say on which new medicines are approved. | Earlier this year the SMC was reformed to give patients and clinicians a greater say on which new medicines are approved. |
| Breast Cancer Care supporter Kelly Doynanc, 35, from West Lothian, took part in a trial of Kadcyla after being diagnosed with secondary breast cancer in February. | Breast Cancer Care supporter Kelly Doynanc, 35, from West Lothian, took part in a trial of Kadcyla after being diagnosed with secondary breast cancer in February. |
| She said: "Kadcyla is having a huge effect on my life. I am so happy with the results so far. | She said: "Kadcyla is having a huge effect on my life. I am so happy with the results so far. |
| "The tumour in my neck has virtually disappeared and the marks on my lung have also shrunk. | "The tumour in my neck has virtually disappeared and the marks on my lung have also shrunk. |
| "It has made me feel so much better, particularly psychologically as knowing the drug is working so well has given me some real peace of mind." | "It has made me feel so much better, particularly psychologically as knowing the drug is working so well has given me some real peace of mind." |
| The drug approval body for England and Wales, NICE, ruled in August that Kadcyla was still too expensive to be approved for routine NHS use. | The drug approval body for England and Wales, NICE, ruled in August that Kadcyla was still too expensive to be approved for routine NHS use. |
| It led to claims by the manufacturer Roche that the system was "broken". | It led to claims by the manufacturer Roche that the system was "broken". |
| NICE generally approves treatments which cost no more than £30,000 per year of better-quality life. | NICE generally approves treatments which cost no more than £30,000 per year of better-quality life. |
| In the case of Kadcyla, NICE said the quality-to-cost ratio had been calculated at £166,000. | In the case of Kadcyla, NICE said the quality-to-cost ratio had been calculated at £166,000. |
| The Irish equivalent of NICE and the SMC, the National Centre for Pharmacoeconomics, has also ruled that Kadcyla is not cost-effective. | The Irish equivalent of NICE and the SMC, the National Centre for Pharmacoeconomics, has also ruled that Kadcyla is not cost-effective. |
| James Jopling, Breakthrough Breast Cancer's Director for Scotland, said. "We are very much hoping Kadycla is approved today so that women with incurable breast cancer can be given more precious time with the people they love. | James Jopling, Breakthrough Breast Cancer's Director for Scotland, said. "We are very much hoping Kadycla is approved today so that women with incurable breast cancer can be given more precious time with the people they love. |
| Support of patients | Support of patients |
| "Support for this drug has united the entire breast cancer community. | "Support for this drug has united the entire breast cancer community. |
| "It has the support of patients and oncologists, families and carers, along with the backing of all four breast cancer charities in Scotland. | "It has the support of patients and oncologists, families and carers, along with the backing of all four breast cancer charities in Scotland. |
| "In addition, an incredible 1,800 members of the public have signed our petition calling for more medicines like Kadcyla to be made available in Scotland." | "In addition, an incredible 1,800 members of the public have signed our petition calling for more medicines like Kadcyla to be made available in Scotland." |
| The SMC's decision is expected to be announced at 14:00 on Monday. | |
| If it does not approve the drug, the only way women will be able to access it will be through a new Peer Approved Clinical System (PACS). | |
| They will need the support of their consultant to argue that the drug offers them particular benefit over and above what has already been considered by the SMC. | They will need the support of their consultant to argue that the drug offers them particular benefit over and above what has already been considered by the SMC. |