The new drugs – what all patients should know
Reproduced from Issue 107 of Arthritis Today
The arrival of the new COX-2 drugs and the expected appearance of the new anti-TNF therapies in the UK by next spring have led to increased patient expectation. But will rationing on grounds of cost prevent most arthritis patients from getting hold of these drugs on the NHS?
IT seems the same rules apply to arthritis drugs as they do to buses – you wait ages for one and then three come all at once. In the case of drugs to combat osteoarthritis, last year saw the launch in the UK of a new anti-inflammatory called Vioxx, with a similar drug, Celebrex, expected to follow shortly. And in rheumatoid arthritis, two of the new so-called "biologics" or anti-TNF therapies, Remicade and Enbrel, are lined up to gain UK licences by early spring.
Patients, whose pain and inflammation cannot be controlled by existing drug therapies, or who have suffered serious stomach problems caused by anti-inflammatories, are desperate to try anything new that might work.
The drug companies are more than happy to build up expectations about their product, and the media, always keen to report on the latest "breakthrough", also plays its part too in stoking up interest. arc too, which funded early pioneering research into the anti-TNF therapies, has been eagerly fuelling interest in the drugs, and giving out regular bulletins on their likely arrival date in the UK.
However, while Vioxx has been available on prescription in the UK since July 1999, there is precious little evidence that it is being widely prescribed by GPs as an alternative to existing NSAIDS such as Voltarol and Brufen. Indeed, a number of health authorities, hospitals trusts and primary care groups have recommended that doctors don't prescribe the drug at all until more is known about it, including any possible side effects. The National Prescribing Centre's guidelines make it quite clear: "Long term efficacy and safety needs to be established, and the paucity of data makes it difficult to assess its role within the health service for the foreseeable future."
But there is another reason why doctors aren't falling over themselves to prescribe Vioxx to patients who suffer serious adverse reactions to the older NSAIDS – cost. Although it's still relatively cheap, the price of a 28-day supply for Vioxx is £21.58 compared to just £3 for Ibuprofen.
"Vioxx would have to be very good indeed for us to start prescribing it, because of the cost," said Peter Glennon, a GP in Stoke, whose practice is part of a primary care group treating around 100,000 patients in the East Midlands. "The drugs companies have given a lot of publicity to the COX-2 inhibitors, but in the current situation it's exceedingly difficult to justify prescribing them. GPs are very sceptical about the new NSAIDs, but we're under a huge amount of pressure because new drugs are coming out all the time and patients are demanding them."
The Vioxx situation reveals that rationing is alive and well in the NHS, although most medics prefer the vaguer term "prioritising". But here is a real danger that people's access to the new treatments will be determined more by where they happen to live than by their clinical needs; that is, postcode prescribing.
The problem may be even more acute when the long awaited anti-TNF therapies Remicade and Enbrel are approved in the UK by the European Medicines Control Agency, probably in the early spring. (Both are now available in the US.)
After so much advance hyping of these new treatments as a major breakthrough in the treatment of rheumatoid arthritis, the reality may be that only a very small number of patients may actually be prescribed them. Wyeth Laboratories, which will be marketing the drug in the UK, now says that only about 3,000 RA patients with advanced disease, who have not responded to disease-modifying drugs, will be suitable.
At around £7,000 a year per patient, compared to just a few hundred pounds for existing DMARDs, again cost is likely to be a major stumbling block to rheumatologists who will want to prescribe Enbrel for good clinical reasons.
"The trusts may tell us that we can prescribe the new drug, but only if it comes out of existing resources," says Dr David Doyle, consultant rheumatologist at Whipps Cross Hospital.
The National Institute for Clinical Excellence was set up by the Government last year to produce national guidelines on which new drugs should be prescribed on the NHS. It showed its teeth immediately by banning the anti-flu drug Relenza on the grounds that there was insufficient evidence that it worked in the elderly. Sceptics believe Remicade and Enbrel may suffer a similar fate.
NICE is expected to begin deliberating on the COX-2s in April. Remicade and Enbrel are not yet on its list of drugs to be considered for the coming year, although they may be slotted in if there is sufficient public interest. In the meantime, it will be down to individual prescribing committees in each health authority, trusts and primary care groups to make their own judgement.
"Even if NICE guidelines say doctors can prescribe the new drugs, and health authorities and trusts have to go along with it, budgets will not match the cost of the number of patients we might want to treat; hence it will be a lottery," says David Doyle, a member of the British Society of Rheumatologist's working party, set up to look at the impact of the new treatments.
The BSR, together with Arthritis Care, is currently drawing up guidelines for rheumatologists to help them make clinical judgements about Remicade and Enbrel based on the evidence available.
"It's a real dilemma," adds Dr Doyle. "Do you say there should be no rationing, and that drugs should be given on grounds of clinical need? Or do you take the view that because it's a terribly expensive drug and we want a relatively even distribution, that we will produce strict guidelines limiting its use for people with the most severe problems."
Latest data from the Remicade trials has shown that used in combination with methotrexate it slows down the disease progression in RA, as well as helping to alleviate symptoms. This fact will no doubt be seized upon by those trying to justify making the anti-TNF therapies available on the NHS. Ultimately, the new drugs could improve their patients' prognosis – and in the long term save money because more people may be able to remain healthier and in work, less reliant on social services and the NHS.
Those awaiting the new drugs will have to hope that those making the decisions bear all that in mind. Their future quality of life could depend on it.
