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NHS says no to new breast cancer drug Kadcyla | NHS says no to new breast cancer drug Kadcyla |
(35 minutes later) | |
A pioneering new breast cancer treatment will not be routinely available in England, the NHS drugs advisory body NICE is proposing. | A pioneering new breast cancer treatment will not be routinely available in England, the NHS drugs advisory body NICE is proposing. |
The drug - Kadcyla - adds six months of life on average to women dying with an aggressive form of breast cancer. | The drug - Kadcyla - adds six months of life on average to women dying with an aggressive form of breast cancer. |
NICE criticised makers Roche for not setting an affordable price, in its updated draft guidance. | NICE criticised makers Roche for not setting an affordable price, in its updated draft guidance. |
The drug costs £90,000 per patient but Roche said it had offered a lower - undisclosed - price in recent talks. | The drug costs £90,000 per patient but Roche said it had offered a lower - undisclosed - price in recent talks. |
The two organisations have been in negotiations since the first draft guidance from NICE (the National Institute for Health and Care Excellence), rejecting the drug, was published in April. | The two organisations have been in negotiations since the first draft guidance from NICE (the National Institute for Health and Care Excellence), rejecting the drug, was published in April. |
While this latest guidance is only the final draft version, there tends not to be any major changes when the official recommendations are published - normally a few months after this stage. | While this latest guidance is only the final draft version, there tends not to be any major changes when the official recommendations are published - normally a few months after this stage. |
The original cost of Kadcyla worked out at £90,000 per patient - that is based on the standard 14 months of treatment. | The original cost of Kadcyla worked out at £90,000 per patient - that is based on the standard 14 months of treatment. |
Roche said it had offered to lower the price "substantially", but NICE said the new price - which is not being disclosed - made little difference. | Roche said it had offered to lower the price "substantially", but NICE said the new price - which is not being disclosed - made little difference. |
Cancer drugs row: A sign of things to come? | |
There is a real sense of sadness - and anger for that matter - that the new breast cancer drug Kadcyla looks unlikely to be made routinely available on the NHS, something that is obvious from the bitter language being used by both sides. | |
The decision by England's official NHS advisory body, the National Institute for Health and Care Excellence (NICE), to reject Kadcyla prompted manufacturers Roche to claim the system was "broken". | |
NICE - not known for its strong use of language - responded by saying it was "really disappointed" in the approach taken by the drugs firm. | |
Read more analysis from Nick Triggle here | |
'Amazing' | 'Amazing' |
Kadcyla is used to treat people with HER2-positive breast cancer that has spread to other parts of the body and cannot be surgically removed. | Kadcyla is used to treat people with HER2-positive breast cancer that has spread to other parts of the body and cannot be surgically removed. |
About a fifth of breast cancer cases are HER2-positive, and it is thought this drug could benefit 1,500 women a year. | About a fifth of breast cancer cases are HER2-positive, and it is thought this drug could benefit 1,500 women a year. |
It works by seeking out and destroying cancerous cells, attacking them from within. | It works by seeking out and destroying cancerous cells, attacking them from within. |
Its novel action means it is unlikely to cause the side-effects, such as hair loss, seen with many other types of chemotherapy. | Its novel action means it is unlikely to cause the side-effects, such as hair loss, seen with many other types of chemotherapy. |
Kimberley Mawby, 44, who managed to get the drug through a trial at London's Royal Marsden Hospital, described it as "amazing". | Kimberley Mawby, 44, who managed to get the drug through a trial at London's Royal Marsden Hospital, described it as "amazing". |
She said: "I can have a great life. I don't feel ill, the side-effects are so minimal I lead a really normal life. | She said: "I can have a great life. I don't feel ill, the side-effects are so minimal I lead a really normal life. |
"And I know how much it costs but at the end of the day you can't put a price on your life and that's what [Roche] are asking people to do. | "And I know how much it costs but at the end of the day you can't put a price on your life and that's what [Roche] are asking people to do. |
"For all the people out there that need this drug, I really believe they should be able to get it" | "For all the people out there that need this drug, I really believe they should be able to get it" |
'Huge blow' | 'Huge blow' |
NICE chief executive Sir Andrew Dillon said: "We are really disappointed that Roche were not able to demonstrate more flexibility. | NICE chief executive Sir Andrew Dillon said: "We are really disappointed that Roche were not able to demonstrate more flexibility. |
"The company is well aware that we could not have recommended Kadcyla at the price it proposed." | "The company is well aware that we could not have recommended Kadcyla at the price it proposed." |
Jennifer Cozzone, head of health economics and pricing at Roche, said: "We're very disappointed with this decision and, frankly, not just for patients who would have had the opportunity to receive Kadcyla with a positive decision. | Jennifer Cozzone, head of health economics and pricing at Roche, said: "We're very disappointed with this decision and, frankly, not just for patients who would have had the opportunity to receive Kadcyla with a positive decision. |
"Considering Kadcyla is the eighth medicine in a row that NICE has declined to make available to women with advanced breast cancer in the UK, we don't believe this is a question of the price of Kadcyla. | "Considering Kadcyla is the eighth medicine in a row that NICE has declined to make available to women with advanced breast cancer in the UK, we don't believe this is a question of the price of Kadcyla. |
"We believe that this is an issue with how NICE considers medicines in advanced breast cancer." | "We believe that this is an issue with how NICE considers medicines in advanced breast cancer." |
Dr Jayson Dallas, of Roche, added: "NICE's rejection of Kadcyla demonstrates quite simply that their current system is broken, not fit for purpose and in need of a complete overhaul when it comes to advanced cancer." | Dr Jayson Dallas, of Roche, added: "NICE's rejection of Kadcyla demonstrates quite simply that their current system is broken, not fit for purpose and in need of a complete overhaul when it comes to advanced cancer." |
Mia Rosenblatt, head of policy and campaigns at Breast Cancer Campaign, said the news was a "huge blow". | Mia Rosenblatt, head of policy and campaigns at Breast Cancer Campaign, said the news was a "huge blow". |
"It is vital that this is not the end of the line for Kadcyla in respect of NICE approval, and we ask NICE and Roche to urgently revisit their negotiations to find a solution. | "It is vital that this is not the end of the line for Kadcyla in respect of NICE approval, and we ask NICE and Roche to urgently revisit their negotiations to find a solution. |
"It's not too late to review the cost of the drug," she added. | "It's not too late to review the cost of the drug," she added. |
It means the only way women will be able to get access to the treatment is through the Cancer Drugs Fund, for which their doctors would have to make special requests. | It means the only way women will be able to get access to the treatment is through the Cancer Drugs Fund, for which their doctors would have to make special requests. |
Since April more than 200 women have been given Kadcyla in this way, but the Cancer Drugs Fund is due to end in 2016. | Since April more than 200 women have been given Kadcyla in this way, but the Cancer Drugs Fund is due to end in 2016. |
While the guidance applies only to England, officials in Northern Ireland, Wales and Scotland do consider NICE recommendations. None of them currently fund the drug. | While the guidance applies only to England, officials in Northern Ireland, Wales and Scotland do consider NICE recommendations. None of them currently fund the drug. |