Relief for campaigners as NICE approves Herceptin
pharmafile | June 9, 2006 | News story | |Â Â Â
Breast cancer drug campaigners have breathed a sigh of relief after NICE said Herceptin should be used to treat women with early breast cancer on the NHS where appropriate.
The positive recommendation from the England and Wales clinical and cost effectiveness body is its fastest ever for any drug, and the decision has been mirrored by Scotland's equivalent authority, the SMC. In Northern Ireland, women have had access to the drug, where clinically appropriate, since November 2005.
The decision could bring to an end a row of unprecedented scale over access to new medicines in the UK. For around a year, primary care trusts have been at loggerheads with patients and Health Secretary Patricia Hewitt over access to the drug – even though the drug only gained its licence in May.
While campaigners are happy with the recommendation, the NHS Confederation, which represents 90% of NHS managers, has warned funding the drug will cause financial problems for the health service.
Campaigners say between 5,000 – 9,000 women with the HER2 positive form of early stage breast cancer could be eligible for Herceptin treatment, which could cost the NHS as much as 100 million a year.
Ann Marie Rogers, a breast cancer patient who won a High Court victory against her local PCT to gain access to Herceptin, welcomed the breakthrough for access to the drug
"I hope this means an end to the battle for others who are still fighting their PCTs for the drug," she told the BBC.
Around 20% of women with breast cancer have the aggressive HER2 positive type, but NICE has warned that women with certain heart problems should not be given the drug.
Clinical trials of Herceptin have shown it has some cardiotoxicity and could worsen a number of existing heart problems, such as congestive heart failure or poorly controlled hypertension.
NICE says doctors should test cardiac function when they first prescribe Herceptin and then make a further check every three months.
Joanne Rule, chief executive of Cancerbackup, one of several charities which had campaigned for access to the drug, also welcomed the news
"Women with early breast cancer who are HER2 positive will feel immense relief after today's decision to approve Herceptin," she said.
"We hope this means that no woman will be forced to fight for treatment to help save her life. We urge PCTs to implement this guidance today by funding the treatment to patients when clinicians recommend it."
How will PCTs pay for Herceptin?
Dr Gill Morgan, chief executive of the NHS Confederation has also welcomed the NICE ruling, indicating it provided clarity after the confusion generated by Health Secretary Patricia Hewitt's intervention in the access row, even before Herceptin received marketing approval.
"We have always said that the licensing and regulatory processes are there to ensure that new drugs are both safe and effective as well as to protect patients," she said.
"However, there is no doubt that this will present a significant financial challenge to some NHS organisations. Primary care trusts plan their expenditure some 18 months in advance and so, when a new and expensive drug is licensed and no new funding is provided, it inevitably causes difficulties.
"PCTs receive a fixed allocation of money to deliver all the services for their local community and have to take difficult decisions on competing priorities. For example, this year, many PCTs have been faced with decisions about spending money on expensive drugs, cutting waiting lists and investing in infertility treatment."
She concluded: "Every decision about spending taxpayers' money is a moral one because a pound spent on one drug means a pound less for another. There will always be a finite amount of money and difficult decisions will always need to be taken. We strongly believe that those decisions are best made by clinicians and trusts locally."
Cancerbackup says it remains concerned about how PCTs will find the money to fund Herceptin treatment, and wants the government to create a national pot of money to fund new and innovative treatments.
Joanna Rule said: "The Department of Health should help PCTs by announcing an innovations fund to assist local areas absorb the costs of new treatments."
The announcement is only NICE's preliminary decision, with its final guidance expected to be issued by the beginning of July. After this point, England's PCTs will have a further three months in which to organise funding for the treatment.
This is in contrast to Scotland, where health boards are expected to find money for the drug immediately in most cases. The SMC says additional service infrastructure such as cardiac monitoring will be required in some locations, and that this should take a few weeks to put in place.
