Herceptin court victory for breast cancer patient
pharmafile | April 13, 2006 | News story | Sales and Marketing |
Ann Marie Rogers has won her legal battle to gain access to breast cancer drug Herceptin, with an appeal court ruling that denying her the treatment was "irrational and unlawful."
The High Court had previously upheld the decision by Swindon PCT not to provide Ms. Rogers with the drug, but the new ruling could have far-reaching implications for access to expensive medicines such as Herceptin.
The appeal judges said their ruling would not "open the floodgates" as only women who met the clinical criteria for Herceptin would qualify for the drug.
As many as 5,000 women could gain access to the drug thanks to the ruling, costing the NHS around 100m pounds a year.
Ms. Rogers said: "I did this for all women battling this dreadful disease. I believe everyone prescribed this treatment by their doctor should be given the same health care wherever they live. I can now look towards the future and have more confidence that I will win this battle against breast cancer."
She told the press: "I've got my life back."
While the ruling seems to send a clear message to PCTs that drugs cannot be denied to some patients and given to others, NHS managers say they are still considering the 'broader ramifications' of the case.
Dr. Gill Morgan, chief executive of the NHS Confederation which represents more than 90 per cent of NHS organisations, said: "Today's ruling will have significant implications for the prescription of all unlicensed drugs – not just Herceptin," but said the NHS would need to consider what its full impact will be.
"The decision to prescribe an unlicensed drug is not taken lightly by clinicians or managers. Until today, most funding organisations have made the decision based on individual exceptional circumstances. It will take time for organisations to work out the exact implications and the best way to respond.
"We are concerned that the complexity of the judgement and the uncertainty this will cause at a local level could affect the flexibility of local doctors and PCTs to make personalised judgements."
Herceptin is still not licensed for early stage breast cancer, and Morgan stressed that the licensing and regulatory processes had to be observed to ensure new drugs are both safe and effective.
"PCTs have a duty to spend taxpayers' money in the most effective way possible. Every pound spent on one expensive drug or treatment is potentially at the expense of other patients. These decisions are extremely difficult and best taken as close to the patient as possible.
"This case has shown the very difficult, and often heart-rending, decisions that doctors, nurses and managers in primary care trusts have to make every day."
Morgan concluded: "Our members have repeatedly warned that by-passing the licensing and regulatory processes for new drugs puts patient safety at risk and could also mean that less vocal patients and causes will lose out."
NICE is the clinical and cost effectiveness body that will ultimately decide how Herceptin will be prescribed in England and Wales. It has also underlined that it is not expected to make its recommendation until June 2006.
Andrew Dillon chief executive of NICE said: "Todays ruling is about how Swindon PCT made their decision. It doesn't reduce the importance of having a system for licensing drugs, to make sure we know they are safe to use, or the work that NICE does, in helping the NHS to use new drugs in the right way. Without these things, we risk exposing patients to risks and the health service to using its money unwisely.
"Herceptin still isn't licensed and it won't be until the summer. If and when it is, NICE stands ready to advise patients and those who care for them on the best way to use it. This will be advice for all the women who might potentially benefit from it and for all the primary care trusts who may need to make the funds available to enable its use."
He concluded: "It's only in this way that consistent decisions can be taken to bring an end to the uncertainty that faces both patients and the NHS."
