Outgoing chairman Prof. Michael Rawlins speaks about clinical guidance and preventing and treating disease.
By JUDY SIEGEL-ITZKOVICHmichael rawlins 311(photo credit: Judy Siegel-Itzkovich)
High-level medical services are such an expensive commodity that most Western societies struggle to supply at least basic healthcare for all their residents – well aware that the demand is unlimited and almost nobody will be completely satisfied. As people with higher incomes have easier access to care than the poor, governments intervene to ensure there is no discrimination in the provision of medications and outpatient/inpatient treatment.Despite its best efforts to supply health services equitably, the National Health Service (NHS) was criticized in the 1990s for the socalled “postcode lottery of healthcare” in England and Wales, where the level of care supposedly depended on which “primary care trust” (PCT, equivalent to Israeli health funds) one was a member of, according to area of residence. To counter this reputation, the NHS established in 1999 a unique organization with the acronym of NICE to see to it that wherever the British live, they will all be entitled to the same free services.THE FOUNDING chairman of this body was Prof. Michael Rawlins – a physician and clinical pharmacologist by training – who has headed NICE since 1999. Rawlins, who has been knighted by Queen Elizabeth II, is stepping down next April. He recently made his first visit to Israel, organized by the Jewish Medical Association of the United Kingdom with financial support from Hadassah UK and the British Friends of Hebrew University. During his short time in the country, he met Health Ministry director-general Dr. Ronni Gamzu and senior hospital and medical faculty administrators to learn about how health resources are allocated here; he also reciprocated with an explanation of how NICE does it.Sir Michael also gave an interview during his visit to The Jerusalem Post.An honorary professor at the London School of Hygiene and Tropical Medicine at the University of London, and emeritus professor at the University of Newcastle upon Tyne, he was professor of clinical pharmacology at the University of Newcastle upon Tyne from 1973 to 2006. At the same time, he was consultant physician and consultant clinical pharmacologist to the Newcastle Hospitals’ NHS Trust, vice-chairman and chairman of the Committee on Safety of Medicines, and chairman of the Advisory Council on the Misuse of Drugs.NICE has had two actual titles – the National Institute for Clinical Excellence and the National Institute for Health and Clinical Excellence in 2005 – and will expand in April 2012 to the National Institute for Health and Social Care. But it will retain its pleasant and easily remembered acronym, which is known by doctors and other relevant professionals around the world.SIR MICHAEL jokes that his being in the same job for so many years – longer than anyone else in the top level of the NHS – became “embarrassing,” although he has very much enjoyed it. Starting next spring, he will become president of the Royal Society of Medicine.That is an independent, apolitical organization, founded over 200 years ago that is one of the UK’s largest providers of continuing medical education for doctors, dentists, veterinary surgeons and other healthcare professionals.Although NICE was established to eliminate the “postcode lottery of healthcare,” it has gone far beyond that, gaining an international reputation as a role model for the development of clinical guidelines on preventing and treating disease.The Israeli system is much more circumscribed. The Health Ministry deals only with assessment of medications and other technologies proposed by Israeli manufacturers and importers for inclusion in the basket, to which all Israelis are entitled under the National Health Insurance System. This means that the four public health funds – Clalit Health Services, Maccabi Health Services, Kupat Holim Meuhedet and Kupat Holim Leumit – must pay for or partially subsidize technologies if a member has the medical condition that entitles him to it.
Hundreds of new technologies that would cost billions of shekels if all were added to the basket are studied by the ministry’s Health Technology Assessment Unit headed by Dr. Osnat Luxenburg. Usually in the autumn, a public committee nominated by the health minister and approved by the government, including the finance minister, sits to sift through the applications and decide which technologies – usually between NIS 100 million and NIS 400 million – are recommended to the cabinet for inclusion.Senior Health Ministry officials are forced over weeks and months to go, hat in hand, to budget officials in the Treasury to persuade them to expand the basket. The tough bargaining, often in exchange for demands for higher efficiency, finally ends with the news that it will grow by a few hundred million shekels. Despite efforts by MKs and others to win an automatic updating system of some 2% of the basket of health services, the Treasury has always refused.The Health Technology Assessment Unit prepares its background material for the public committee on how many residents are estimated to need the new technology, and how much it would cost.The committee is comprised of representatives of the two ministries, the four health funds, medical ethicists, doctors, nurses, voluntary organizations and public representatives including ethicists, sitting until the hundreds of proposed additions are pared down to a few dozens new technologies (or new indications for an existing drug) to fit the budgetary limit set by the Treasury. The committee’s list of recommendations is then sent to be rubber-stamped by the National Health Council and the cabinet.BUT NICE works differently. Sir Michael notes that his organization publishes guidelines for the NHS, not only for the use of new and existing medicines, treatments and procedures, but also for clinical practice (guidance on the appropriate treatment and care of people with specific diseases and conditions), for public-sector workers on health promotion and disease prevention. These appraisals are based primarily on evaluations of efficacy and cost-effectiveness in various circumstances.“We don’t have a basket of new drugs. We look at their cost effectiveness to see if it offers value for the money. We say yes about 90% of the time. But we may say yes or no if it extends life only a few months and is very, very expensive. The money has to come from somewhere.”The quality-adjusted life year (QALY) is the basis for NICE assessments to measure the health benefits offered by each treatment.By comparing the value of expected QALYs with and without treatment, or compared to another treatment for the same condition, its panels calculate the health benefit derived from such a treatment.When combined with the relative cost of treatment, this information can be utilized to figure the Incremental Cost-Effectiveness Ratio (ICER) that compares suggested expenditure to what is currently allocated.Sir Michael explains that when judging proposed technologies, NICE accepts as cost effective those interventions with an incremental cost-effectiveness ratio of less than £20,000 per QALY; there should be stronger reasons for accepting as cost-effective interventions those with an incremental cost-effectiveness ratio of over £30,000 per QALY. A person’s primary care trust can decide to pay for costs that do not meet these criteria, as they are recommendations for PCTs and not mandatory. If the PCT decides that it can’t afford it, the patient could accept the standard NHS care for his condition or pay privately to purchase the expensive one. Only a small minority of Britons have private health insurance, and private hospitals are few and far between.NICE did not approve for treating breast and colon cancer the Genentech/Roche monoclonal-antibody drug bevacizumab (commercially known as Avastin), which blocks angiogenesis (the growth of new blood vessels), as its cost-effectiveness has not been proven for these conditions. However, they are approved for certain other conditions. “There is a copayment for outpatients of £7.50 per drug, but the elderly and the poor get it free. There are all kinds of exemptions.” This is similar to Israel. But Britons enjoy free psychiatric, dental and geriatric care, which Israelis cannot boast.“There are lobbying efforts by stakeholders, pharmaceutical companies, professional and patients’s groups and other interests. We let all voice their opinions. Then members of a professional committee – about 25 on each – make up their mind. They work mostly in the health system, and we make sure that they have no vested or financial interests or even a reputation of having some relevant interest. They have to have a clean slate. A draft is prepared, followed by a final one. There is an appeal process.”Sir Michael recalls that over the years, only about three times out of 800 has NICE been taken to court because the applicants were unsatisfied and angry. “The judicial process is bloody expensive. We prefer it doesn’t happen, but when we were re-examined and it all ended, we were not proven to be wrong.”WHILE ISRAEL spends some 8.2% of its Gross Domestic Product on healthcare, the British allocate more – 9.1%, less than Switzerland but significantly under the US, which spends a huge 16% on healthcare.“What we spend is as much as we can afford on medications and other medical technologies. Ironically, the British public is satisfied, and satisfaction levels are the highest ever. But the government is worried about expenditures due to the aging of the population and increased demand for healthcare,” says the NICE chairman. “We won’t get much additional money, so over the next five years we will probably have to save £20 billion.“The British government wants to eliminate PCTs and instead use public officials who would commission care from local hospitals. It argues that it would save the bureaucracy money.”Israeli medical administrators and physicians follow what NICE does, and some are jealous – although Sir Michael says he doesn’t presume to declare it better than the much-more-streamlined and limited system of medical technology assessment here known popularly as “the expansion of the basket” of medical technologies.Prof. Yehoshua Shemer, who in the mid-Nineties created the “basket committee” mechanism for updating Israel’s medical technologies, says “NICE is a role model, and what it does is blessed activity.” Shemer – former chief medical officer of the Israel Defense Forces, director-general of the Health Ministry and directorgeneral of Maccabi Health Services and a leading expert in healthcare assessment, which he teaches at Tel Aviv University’s Sackler Faculty of Medicine, heads TAU’s School of Public Health as well as chairing the private chain of Assuta Medical Centers – did not have the opportunity to meet Sir Michael. But he notes that Israel can learn from NICE.“It has the great advantage of doing assessments all year round, and does not have to conduct annual negotiations with the Treasury over how much money it will get. They work using QALYs, cost and quality. Our system is not ongoing like at NICE.”But Shemer said Israel’s assessment system has advantages too. “We have much less bureaucracy. It can take NICE a year or two to add things to the basket, while our system is usually quicker. But a drug rejected in our system one year because only NIS 100 million was given by the Treasury could have been approved for patients another year, when twice or three times as much was approved. And its activity on medical practice guidelines and health promotion would be wonderful to have; we must do much more in this field.”Sir Michael concludes: “I won’t say which one is a better system. I want to know how you do things here. You Israelis are very capable people.”