Patient power is a favorite 21st-century cliché, but it became an embarrassment to the U.K. government when a breast cancer patient went to court to get treatment. At issue was Herceptin
(trastuzumab) --- the breakthrough monoclonal antibody developed by Genentech and Roche to treat HER-2-positive breast cancer, which is a particularly aggressive form of the
disease.
British women with late-stage, HER-2-positive breast cancer can obtain Herceptin therapy free of charge under the country's publicly funded National Health Service (NHS). However, women with early-stage breast cancer are not entitled to receive it, unless they get special permission from their local NHS
body.
A few primary care trusts (PCTs) will fund Herceptin therapy, but most won't because of the high price. A course of the drug costs more than the equivalent of US$35,000. (Herceptin sales topped 2 billion Swiss francs or US$1.6 billion in 2005, nearly 50 percent up on the previous year). So the treatment is available in some places but not others
--- a policy that the British media scathingly calls
"postcode prescribing," with postcodes being synonymous with U.S. zip
codes.
This situation is anathema to backers of Britain's NHS system of socialized medicine. Founded just after World War II when food, gasoline, and nylon stockings were still rationed in the United Kingdom, the NHS is based on the principle that everyone should have access to the same standard of medical
care.
Pink ribbon groups such as the
"Need Herceptin Straightaway Campaign" have long been campaigning for free trastuzumab. Then in December 2005, early-stage tumor patient Ann Marie Rogers of Swindon got international attention when she sued her local PCT because it refused to fund the drug for her. The PCT insists its refusal was not made on economic grounds; in fact, private health insurers in the United Kingdom do not provide blanket funding for Herceptin,
either.
The High Court decided on February 15 in favor of Swindon PCT, but Rogers appealed the decision as
"arbitrary" and in breach of her human rights. In mid-April, Rogers prevailed, when the Court of Appeal ruled she should get the drug. Her reaction:
"I've got my life back," according to the BBC.
Have a NICE
Day
But how did this policy arise in the first place? Since 1999, Britain has insisted that every newly licensed drug must be evaluated by a government body called NICE (National Institute for Clinical Excellence). NICE convenes a panel of clinical and economic experts to decide whether a new therapy for a certain indication drug is good value for money. This is over and above the normal licensing process that decides whether a drug is safe and effective. In the United Kingdom, this is done by the Medicines and Healthcare Products Regulatory Authority, the equivalent of the
FDA.
If NICE says yes, then PCTs are duty bound to fund the use of that drug for that indication. If it says no, they don't have to fund it
--- and given the other calls on their money, they probably won't. Essentially, it is a rationing mechanism, according to Steve Webb, health spokesman for the opposition Liberal Democrat Party:
"It is no good pretending it is not about cost," he told Parliament after the Rogers
hearing.
NICE hasn't taken a view yet on whether to approve Herceptin for early-stage HER-2 tumors, although it approved it four years ago for late-stage cancer. Promising results in early-stage cancer have been widely publicized for some time now. In March, specialists at the fifth European Breast Cancer Conference noted that four large clinical trials of adjuvant Herceptin showed a remarkable (50 percent) reduction in recurrence for women with the
condition.
With characteristic sloth, NICE is not due to decide on Herceptin's efficacy until July at the earliest. Yet the cautious position taken by both NICE and Swindon PCT is not unreasonable. According to Joe Collier, a medicines policy expert and professor at St. George's Hospital Medical School in London, 18 women would need to receive the drug for a year for just one of them to avoid a tumor recurrence at the end of the year. This comes to about $70,000 for each recurrence prevented: Collier points out that, to achieve this, PCTs would have to withdraw funding from other therapies with much stronger evidence of
benefit. The situation is complicated by the fact that Herceptin is not yet licensed for early-stage cancer, in the United Kingdom, Europe, or the United States. Moreover, when the Swindon controversy broke out, Roche had not yet applied to market the drug for early-stage breast cancer. The drug giant has since asked for a license extension, and it will take a brave government to refuse: Media in the United Kingdom regularly refer to Herceptin as a
"wonder drug."
Health minister Patricia Hewitt has already buckled, publicly advising PCTs not to rule out Herceptin on cost grounds alone but to look at individual cases. Health economics expert Iain Chalmers of the Cochrane Library recently said Hewitt had undermined NICE's role
"on the basis of no very good evidence at all." In fact, NICE has been in a difficult position from the word go. The pharmaceutical industry has long been campaigning for the agency's abolition, demanding faster prescribing of expensive new drugs. Some of what industry wants has emerged from the Herceptin incident: The U.K. government now intends to introduce a new fast-track
"single technology appraisal" process, under which NICE can start evaluating a drug as soon as a marketing license is applied for, rather than waiting until it is granted. Inevitably, Herceptin will be one of the first beneficiaries: Secretary of State Hewitt said she expected Herceptin's evaluation to be completed within
"a few weeks" of the granting of the license.
The judgment forces all PCTs to reconsider their policies on Herceptin to make sure they are
"rational." They will have to choose whether to fund Herceptin for all clinically eligible patients, or for none.
"The real issue is whether patient lobbying can tip the balance on approvals here, just as it did in the U.S.," said a U.K. industry insider who prefers not to be quoted publicly on the matter. Many expect a replay of these same arguments at the end of 2006, when NICE is due to publish an appraisal of Roche's Avastin (bevacizumab) and Merck KGaA's Erbitux (cetuximab) for advanced colorectal cancer. "Avastin will be the next cancer
"wonder drug' and it will make Herceptin look cheap," noted Liberal Democrat Webb.
"Our answer to the question of access must work every time, for each expensive new treatment that comes along." It looks like a never-ending saga and presents a huge challenge to those who point to the U.K. health system as a model for U.S. policy makers. It also raises an important issue for oncology companies, many of which have long expected very high prices in return for even small benefits. Rationing is a problem that all countries are increasingly facing, whatever healthcare model they have adopted. Soon patients needing expensive therapies could be pitted against each other, as healthcare costs keep soaring overall.
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