August 8, 2008

Can It Ever Be Right for the NHS to Reject Drugs That Could Extend Life?


The big question

Why are we asking this now?

CANCER CHARITIES, kidney specialists and campaigners were outraged yesterday when the National Institute for Clinical Excellence (Nice), announced that it had rejected four new drugs for advanced kidney cancer as too expensive for the NHS. In draft guidance, the medicines watchdog said that the drugs can extend life by five to six months on average but they cost too much. The money would do more good if it were spent elsewhere in the NHS, it said.

Surely the NHS should provide these drugs?

Of course they should. There are 3,600 patients with advanced kidney cancer in the UK who might benefit from the drugs and who will now - if the draft guidance is confirmed - be left with only one option, interferon, to which many do not respond. Kidney specialists will be forced to turn away patients and families will be left without hope. Most people will instinctively feel it is inhumane to deny a clinically effective drug to terminally ill cancer patients which could give them even a few months extra of good quality life.

So why wouldn't Nice give the go-ahead?

Because, it said, the drugs were not "cost-effective". Nice does itself no favours by using the language of accountancy and business, which is likely to increase the public perception of it as an inhumane organisation. But it is difficult to see what other words it could have employed. The reality is that the cost of drugs - as of any treatment - cannot be ignored. If we did so, we would quickly find the country's entire Gross Domestic Product (GDP) spent on health. With a limited healthcare budget, the NHS, like public health systems around the world, has to decide what it can afford. A couple of decades ago it was called "rationing", but that was just as unpopular.

What do the drugs cost?

Between 20,000 and 35,000 per patient per year. But that is only half the story. We also need to know how much benefit they bring. Nice uses a complex formula to assess cost effectiveness based on the degree to which a drug extends life and improves its quality, known as a Quality Adjusted Life Year (Qualy). Broadly, it approves drugs with a cost per Qualy of less than 20,000 and rejects those above 30,000 (though there are exceptions). Between the two figures it accepts some and rejects others.

The cost per Qualy of the drugs for kidney cancer - Sutent (sunitinib), Avastin (bevacizumab), Nexavar (sorafenib) and Torisel (temsirolimus) - is a matter of dispute. According to the manufacturers it ranges from 28,500 to 90,600 but according to independent academics, who assessed the evidence for Nice, it is 71,500 to 171,300. That is a big gap and it is difficult to understand why it should be so large

Why are the drugs so expensive?

This is the question that dare not speak its name. It is incomprehensible that the manufacturers of the four drugs have so far escaped criticism. They are charging astronomical prices for drugs that offer little benefit - in effect, holding a gun to the heads of kidney cancer sufferers and saying to the NHS: "Give us the money or we shoot." Yet, not a single critic yesterday - from James Whale, the TV presenter who had kidney cancer and set up a charity for patients, to Cancer Research UK - had a word to say against the drug companies. Instead they turned their ire on Nice. Many charities are dependent on the drug companies for funding.

Are these sums too much to pay for an extra year of life?

Not if you have it to spare. But it is the ethical duty of any public health system to spend the available cash to get the best results for patients. Every pound spent on a patient for a less effective treatment is a pound denied to another patient for a more effective treatment. Drug spending has risen sharply and although many drugs save NHS money - by reducing the need for hospital treatment - others offer only marginal gains. Some experts believe this is the case with many of the new cancer drugs - whose costs are measured in the tens of thousands but which add only a few months to life.

Could the makers winNice approval?

Yes - by reducing their prices. They argue that they must recoup heavy research costs and that means high prices. But if the drugs are not approved they sell nothing (to the NHS). The real reason they are holding the NHS to ransom is because approval from Nice has a major influence in the global market. Nice has established an international reputation as an arbiter of cost effectiveness and health systems around the world, faced with similar cost pressures, are beating a path to its door.

Are these drugs available on the Continent?

Yes, and as a result Britain is frequently portrayed as the sick man of Europe. Cancer specialists complain that they are treated as the poor relations when they attend international conferences because they cannot prescribe the drugs. It is this that is fuelling criticism of Nice as a penny pinching bureaucracy. But other countries lack any means of systematically assessing drugs, and are feeling the cost pressures as a result. Increasingly they are moving to follow Nice's lead.

Aren't there treatments we should cut before cancer drugs?

Perhaps. Cosmetic surgery, varicose veins, fertility treatment are the usual examples trotted out in every debate about NHS rationing in the last 20 years. But the savings would be imperceptible - in the context of a 90bn NHS these represent the loose change. There is no avoiding tough decisions about what the NHS can and cannot afford - and the Nice approach is the least bad way of facing them.

Is there any hope on the horizon?

Yes. The drug industry is experimenting with the Department of Health on new ways of funding, which tie the prices charged for drugs to the results achieved. In addition, Sir Michael Rawlins, chairman of Nice, has suggested the existing Nice threshold of 20,000 to 30,000 per Qualy should be raised. Both moves could help patients get access to new drugs.

So did Nice do the wrong thing?


*Patients in need of these drugs have few other options available to them

*Expensive or not, other European countries find the funds to provide the drugs

*It is inhumane to deny anyone the chance of living longer, even if the drug is not a cure


*They are too expensive for the benefit they deliver, which is not ultimately life-saving

*This is a zero-sum game: a pound spent on one patient is a pound denied to another

* It is unrealistic to expect every drug to be approved: the NHS budget is not unlimited

Originally published by JEREMY LAURANCE HEALTH EDITOR.

(c) 2008 Independent, The; London (UK). Provided by ProQuest Information and Learning. All rights Reserved.