AIDS TREATMENT UPDATE, Issue 37, January 1996
Keith Alcorn
In the weeks after the results of Delta were released, it was widely assumed that it would be only a matter of time before the Department of Health made extra money available to meet increased drug costs. "We felt that the extent of the benefit shown by Delta compelled us to get the information out as quickly as possible" said one researcher at the time.
Three months later there has been no indication that the Department of Health will provide the money to meet an estimated increase of £15 million in drug costs this year. In fact, the AIDS treatment and care budget has been cut by nearly 8% nationally, leading to a shortfall of nearly £25 million next year.
FINDING THE MONEY
The Department of Health has justified its budget cut by arguing that the number of diagnosed AIDS cases is lower than the level projected back in 1993, so that money should be transferred to other areas of health spending. However, whilst the number of new AIDS cases fell last year, the group of people who are being encouraged to start treatment on the basis of current knowledge includes growing numbers who have low CD4 counts but have not developed an AIDS-defining illness, perhaps due to the success of prophylaxis and anti-viral treatment. This means that the total number of people in need of treatment is projected to remain stable for the rest of the decade at around 8000 during any given year, rather than fall.
Some doctors believe that the Department of Health is unlikely to increase the budget for HIV treatments until after the Licensing Authority, advised by the Medicines Control Agency, has formally approved the use of ddI or ddC in combination with AZT as first-line therapy. At present AZT is the only drug licensed for first line therapy, and ddI and ddC are licensed only for people who are failing to do well on AZT. New licences for these drugs are not likely to be granted in the UK until the results of the Delta trial are published in full later this year; licensing may then take four to six months longer. This means that even if the Department of Health eventually makes more money available, during 1996 clinics will have to pay for combination therapy from existing budgets, and cannot expect to be reimbursed later. However, other doctors point out that this approach wouldn't be consistent with other situations. For example, the Department of Health has funded the cost of beta interferon treatment for multiple sclerosis even though the drug is very expensive, unlicensed and of debatable effectiveness.
SURVEY RESULTS
AIDS Treatment Update questioned doctors and funders around the country to find out how the budget cut will affect the standard of care for people with HIV. We spoke to doctors at hospitals in Brighton, Glasgow, Manchester, Oxford, Leeds, Canterbury, Newcastle and seven major treatment centres in London, altogether covering well over two-thirds of people with HIV in the UK.
* Is combination therapy now routinely offered?
Yes, all clinics said that combination therapy was now offered to all patients as the first line of treatment, although some clinics said that they had only begun to offer combination treatment very recently. There appears to be a slight preference for AZT and ddI. Doctors have made this decision in the light of Delta and ACTG 175, even though ddI and ddC are not yet licensed for use as first line therapy in combination with AZT.
* How much will combination therapy cost?
All centres estimated that the cost of HIV drug treatment would double, and some believed the cost would treble because more people with HIV may decide to start taking anti-HIV drugs as a result of the favourable results of Delta and ACTG 175.
* Will everyone who wants combination therapy be able to get it?
A number of doctors told us that they already saw evidence of patients voting with their feet, and going to centres where they could get drugs prescribed more easily. But prescribing policies that differ from centre to centre seem to be influenced more by the medical views of the doctors in charge, rather than by cost. If clinics are not currently offering combination therapy to some patients, this is likely to be because doctors do not believe those patients will derive a clear-cut benefit from treatment.
* Will major treatment centres face problems in paying for treatment?
Clinics will not refuse to prescribe combination therapy for reasons of cost. However, if they try to meet increased drug costs within their existing AIDS budgets, other AIDS services will be affected. It is more likely that services such as complementary therapies, respite care and home care will be reduced first. It is also likely that once the AIDS budget is spent, some AIDS-related costs such as hospital admissions will have to be met from other budgets, placing a greater burden on the NHS as a whole.
* What happens in future if the costs increase further, for instance, if larger combinations are used earlier in the course of disease?
We don't know. Government spokesmen have been asked this question in Parliament and at private meetings on several occasions and have refused to give a commitment to funding the costs of combination therapy, or by implication, any future improvements in treatment. The most optimistic scenario is that the Department of Health will always wait for the licensing of new treatments before it adjusts its budget allocations, which means that there will always be a considerable time lag between improvements in treatment and the allocation of funding to pay for them. A more pessimistic scenario is that the Department of Health will insist that savings must be made in other areas of AIDS treatment and care if any increased drug costs are to be borne by the NHS, leading to cuts in both treatment and care and in prevention funding.
* Isn't it cost-effective to fund combination therapy if it keeps people alive and well?
Even if a drug treatment extends life, this doesn't guarantee that it works out cheaper in the long run. The drug treatment regime required to keep someone alive for an extra five or ten years may be so expensive that, in blunt financial terms, it would have been cheaper if they had died after a year of intermittent hospital treatment (which comprises the vast majority of the cost of treating people with AIDS). This is especially true if treated people are not working during the period of life 'bought' by drug therapy, and are thus not contributing to the Exchequer, although in practice combination treatment may allow many people to remain in work for longer. Remember too that treatment requires expensive monitoring for side-effects and resistance.
Researchers are planning studies to assess whether drug treatment works out cheaper than no drug treatment, because such data will be essential in winning the argument that combination therapy should be fully funded.
* Is combination therapy the only drug cost which is a worry?
No. One doctor told AIDS Treatment Update that even if it was proven that oral ganciclovir is highly effective as prophylaxis against CMV in people with low CD4 counts, his clinic simply couldn't afford to prescribe it at its current high price. The potential costs of prophylaxis against CMV and MAI are very high, and whilst drug treatment may keep increasing numbers of people alive with very low CD4 counts, it will also lead to larger prophylactic drug costs. However, this may be money well spent: it has been shown that MAI prophylaxis with rifabutin is cost-effective because the money spent on preventing MAI is roughly equal to the money saved by the reduced costs of diagnosing and treating MAI cases that would otherwise have occurred.
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