One of the world’s leading drug companies is threatening to withdraw some of its new cancer treatments from the process by which they are approved for use in the National Health Service.
Cancer patients in Britain will consequently be denied more effective drugs that are available to sufferers in other countries.
Roche, the Swiss pharmaceutical giant, has already refused to supply economic data on its drug Avastin for treatment of lung and breast cancer to the National Institute for Health and Clinical Excellence (Nice), the authority that evaluates the cost-effectiveness of medicines for the NHS. This means Avastin will not be available on the NHS for those diseases.
Avastin is said to double the time a breast cancer patient’s condition remains stable when compared with existing treatments. Studies have also shown improved survival rates for lung cancer victims.
Roche said last week it will consider withdrawing from other evaluations rather than submit products only for them to be rejected by Nice as too expensive.
The statement is the latest twist in the growing row over decisions by Nice. Earlier this month Nice caused an outcry in a preliminary decision when it rejected the use of Avastin (also known as bevacizumab), Sutent (sunitinib), Nexavar (sorafenib) and Torisel (temsirolimus) as too expensive to treat kidney cancer.
“The alternative to these drugs for many patients is death,” said Jonathan Waxman, professor of oncology at Imperial College, London. “Nice is making terrible mistakes.”
The survival rates for cancer in Britain are already among the lowest in Europe — on a par with Poland, Slovenia and the Czech Republic, according to data published last year.
However, cancer charities acknowledge there has been significant improvement in rates since the government made the issue a priority with its NHS Cancer Plan, first launched in 2000.
Some consultants argue, however, that Britain already spends less on cancer drugs than many other European countries and that it is “crazy” to reject drugs proven to prolong life.
Richard Barker, director- general of the Association of the British Pharmaceutical Industry, which represents the drug companies, said: “Nice does a tough and necessary job, but is making errors because of a very mechanistic approach.
It relies too much on arithmetic and not enough on clinical judgment.”
Nice was created in 1999 with the aim of ensuring that decisions on the best and most cost-effective drugs for the NHS were made at a national level, were transparent and could be challenged.
When the drug companies scrutinised the economic modelling used by Nice, they realised that the estimated costs of their drugs and effectiveness could vary widely.
Even more seriously, some of the calculations were wrong. There was an outcry in the medical community in February 2006 when Nice stated that Temodal (temozolomide) — declared as the biggest breakthrough in treating brain tumours for decades — did not offer value for money.
Temodal had won approval from the European regulator in 2004, but many British patients were denied treatment as Nice wrangled over costs.
Peter Davison, 48, a manager for Cambridge University Press, was among the few British patients who received the drug — because he was diagnosed with a brain tumour while working in Singapore.
“I was lucky to be abroad,” said Davison, who is now in remission. “Four months after I had the operation to remove the tumour, I was running and climbing mountains.”
When Schering-Plough — the pharmaceutical company which markets Temodal — prepared its appeal against the Nice decision, it identified an error in the modelling. Once corrected, the model showed the drug was cost-effective — and as a result it was ultimately approved for NHS use.
Not surprisingly, the drugs companies now want full access to the economic models, with the chance to check the accuracy of the calculations. In May, the High Court ruled that Pfizer and Esai, the companies which market the Alzheimer drug Aricept, should be given full access to these models.
“We believe this modelling might not be fit for purpose and we want to check it,” said a Pfizer spokesman last week. Nice said it was seeking leave to appeal to the House of Lords after the High Court decision.
Even where the models are correct, consultants and patients’ groups say Nice fails to give proper weight to the evidence from clinicians and patients’ groups.
The Sunday Times has highlighted the fact that NHS patients do not even have the option of paying for the drugs privately because of government ban on “co-payments”. The labour government has said it will review the issue.
Professor Sir Michael Rawlins, chairman of Nice, said the evaluation process was recognised internationally and Nice had been commended by the World Health Organisation for the quality of its work. He said: “We have a finite amount of money to spend on healthcare and we have to divide it up in as fair and as equitable a way as we can. We can’t say to yes to everything. It’s awkward, it’s difficult, it’s unpleasant.”