A coalition of cancer patients, doctors and campaigners have called for the Health Secretary Jeremy Hunt, to step in after the NHS decided a breast cancer treatment was too costly.
‘Kadcyla,’ also known simply as ‘T-DM1,’ will now no longer be available to new NHS patients with advanced breast cancer, although those already on the drug will still be able to receive it.
The National Institute for Health and Care Excellence (NICE) rejected the drug for NHS use on the grounds of cost. NHS England also dropped the drug from the government’s Cancer Drugs Fund list.
Kadcyla offers an additional six months of life to patients with HER2-positive (human epidermal growth factor receptor 2) tumours for whom the medicine, Herceptin no longer works. But according to NICE, the drug costs up to £90,000 a year - well above the cost threshold deemed acceptable by NICE even for end-of-life drugs.
The ‘Coalition for Affordable T-DM1’ has challenged the government to scrap the patent on Kadcyla and instead allow the import and manufacture of a cheaper generic copy.
Breast Cancer Now - the UK’s biggest breast cancer charity said the Cancer Drugs Fund’s decision to drop the drug has led to “distress and despair” from patients who may need Kadcyla in the future. It is believed that the drug, which is manufactured by Roche, could benefit up to 1,500 women a year.
Lady Morgan, Chief Executive of Breast Cancer Now, said, “Time is running out for patients living with incurable secondary breast cancer for whom Kadcyla would be their next treatment option.
“The situation is becoming increasingly desperate - it’s time for Roche to act, and make this one-of-a-kind treatment available at a price that the NHS can afford.
“We need a completely overhauled system of pricing and access, but until this is finally in place, Roche must do the right thing and take steps to keep this amazing drug available through the Cancer Drugs Fund.”
In a letter to Mr Hunt, the coalition also called for measures to allow cheaper access to other expensive drugs in the future, “We propose an approach that addresses the effects of a drug’s monopoly, when prices are unreasonable and/or unaffordable as a result, and which creates a more sustainable model for innovation and access going forward, as the population of the UK ages, and medical science provides new hope for treating disease.”
The letter argues for the government to use the Patents Act 1977 to disregard the patent on Kadcyla and allow the generic manufacture or import of the drug without the permission of Roche. Philippa Saunders of the Union for Affordable Cancer Treatment said, “The time has come to challenge pharmaceutical manufacturers charging ever higher prices for important medicines because they can.”
After Breast Cancer Now petitioned Roche to bring the cost of Kadcyla down, the firm said it was still negotiating with NHS England. Deborah Lancaster, the director of Roche Products, said, “Although we understand the financial pressures NHS England is under, patients in the UK should not be denied access to innovative and clinically effective medicines that are routinely available to patients in Europe. We need to work together to put in place a pragmatic, flexible and sustainable system - one that puts patients first and one that works for clinicians, government, the NHS, patient groups and companies.”
This story raises two difficult issues. The first is how to put a value on the benefits of a drug. Research suggests Kadcyla can offer some breast cancer victims an extra six months of life - so how much is it reasonable to pay for those six months? NICE’s conclusion is that a cost of £90,000 per year is too much. The second is how to draw the balance between the need for pharmaceutical companies to make a profit from developing and selling their drugs and the need to ensure drugs are affordable for those that need them.
Where should the balance lie between shareholders wanting their dividend and patients wanting treatment? This is a difficult and controversial area. Campaigners want to overrule the patent on Kadcyla so that other manufacturers can copy the drug and make it available more cheaply, but manufacturers will no doubt say that this threatens their ability to carry out research and develop such drugs.
Whatever the outcome, we know that success rates in the treatment of cancer are lower than we would like and many other countries do much better than the UK. Some of this may be due to patients consulting doctors too late, some is due to avoidable clinical negligence, and some is due to the fact that resources simply aren’t always available, whether through prohibitive costs or otherwise.
Paul Sankey is a Senior Medical Negligence Solicitor at Slater and Gordon in London.
The Slater and Gordon Clinical Negligence team are widely experienced in handling claims related to delayed diagnosis and misdiagnosed cancer errors which can cause particular harm when it comes to breast cancer cases.
For a free consultation call our Medical Negligence Solicitors on freephone 0808 175 8105 or start your claim online.