PCT fights Herceptin approval
pharmafile | July 12, 2006 | News story | |Â Â Â
A primary care trust has appealed against the NICE recommendation of Herceptin, apparently challenging how many women should receive the drug, and for how long.
The last 12 months have seen breast cancer drug Herceptin at the centre of unrelenting controversy in the UK, with a number of PCTs battling against concerted campaigns by patients for access to treatment.
By early June, the drug was licensed and had gained NICE's approval, with many stakeholders assuming the final barrier to access had been cleared.
But an appeal by Newbury and Community PCT will add further delay and confusion about which women can receive the drug.
Charity CancerBackup has condemned the move, and says it believes the PCT is using the appeal as a tactic to delay having to finance wider use of the costly drug.
Newbury and Community PCT was selected at random as a stakeholder organisation which could appeal against NICE's decision, and its objections will now be heard at a public hearing on 26 July.
NICE had initially refused to disclose which organisation was behind the appeal, but Newbury PCT identified itself a few days later and issued a press statement.
Bruce Laurie, chairman of Newbury & Community PCT stated that its appeal was "designed to clarify the practical implementation of the ruling for the benefit of patients and the population we serve."
Appeals against NICE decisions can be made on one of three grounds, and Newbury has used the "perverse in the light of the evidence" appeal route to challenge the approval.
This suggests the PCT believes the available evidence is not sufficient to justify NICE's recommendation, and it looks set to demand that fewer women be considered eligible for Herceptin and that treatment duration be shortened.
Richard Mills, interim service improvements director at the PCT told Pharmafocus: "We want to clarify the types of patients who will benefit from the drug. And the [length of] time these women will receive the drug."
NICE has recommended Herceptin be given at three-weekly intervals for one year or until disease recurrence (whichever is the shortest period) in women with early stage HER2 positive breast cancer.
Women with any one of a number of heart conditions, such as heart failure or arrhythmias are excluded because of the drug's known cardiotoxicity, and doctors are obliged to monitor patients with no existing heart condition as a precaution.
NICE estimates that treating a patient for one week will cost up to 25,000 pounds but representatives from Newbury PCT look set to challenge the evidence base for this decision.
"We are prepared to have a robust meeting with NICE at the appeal – we are not seeking to undermine the draft guidelines," said Richard Mills.
Joanna Rule, chief executive of cancer charity CancerBackup says the appeal is clearly intended to delay the time when PCTs must fund the drug's use.
Between 5,000 – 9,000 women with the HER2 positive form of early-stage breast cancer could be eligible for Herceptin, which could cost the NHS as much as 100 million pounds a year in total.
"NICE has approved Herceptin, showing that it is safe and effective for women with early stage HER2 positive breast cancer," said Joanne Rule.
"Any delay in this treatment becoming widely available on the NHS is completely unacceptable."
She concluded:" This postcode lottery must stop now. An appeal against NICE's decision looks like a last-ditch attempt to delay the funding of Herceptin."
Bruce Laurie, chairman of Newbury & Community PCT said patients in the Berkshire West area who had previously applied for NHS funding and who met the NICE criteria would receive treatment as soon as possible.
The PCT has indicated it is prepared for the appeal to fail, and would be ready to implement the NICE guidance by the original deadline of 1 October 2006.
In the meantime, the PCT says patients will be considered on an individual basis if their consultant considered there was an urgent need for treatment, and that patients currently receiving the treatment will continue to do so.
The appeal reflects widespread concern in the health service about the cost of funding expensive new drugs. At the time of NICE's approval of Herceptin in June, Dr Gill Morgan, chief executive of the NHS Confederation warned that the drug could force PCTs to make cuts to other services.
CancerBackup has called for a national NHS fund for new and expensive treatments, but the government looks unlikely to take up this suggestion, demanding that local NHS organisations follow clinical guidelines and manage their own finances.
