Panorama: Herceptin: Wanting the Wonder Drug

The latest episode of Panorama—one of the most respected investigative current affairs programmes on UK television—delved into the key issues surrounding the recent decision to make trastuzumab (Herceptin) available free on the NHS for selected women with early breast cancer. As it unravelled, the story was of policy making determined at a raw socio-political level rather than on the more traditional clinical grounds.

On one side of the debate were enthusiasts arguing that trastuzumab was a “wonder” drug, and a “must have” medicine for the early treatment of women with an aggressive form of breast cancer in which the malignant cells are HER2 (human epidermal growth factor receptor 2) positive. On the other were more wary prescribers who saw the drug as costly and of unproven value and one that still needed careful cost effectiveness and benefit/harm evaluations before the NHS could adopt it wholesale. The debate began to involve a vociferous patient group, the law courts, and the health secretary, and was played out in public through headlines in a hungry national media. The National Institute for Health and Clinical Excellence (NICE), remained some-what aloof throughout, and there was an eerie and uncharacteristic silence from the drug's manufacturer (Roche).

Panorama told the story primarily through the eyes of the seven women from North Staffordshire who lead the patient lobby. All seven had HER2 positive early breast cancer and all were demanding to have the drug from the NHS to save their lives—an emotive position. Lobbying on screen took them to money raising raffles, to their local primary care trust (PCT), out on to the streets singing and shouting at the head of processions, to the local newspaper, to television and radio studios, and, in their uniform pink T shirts inscribed with “Herceptin,” to Number 10 Downing Street. The group had decided that the way to get the drug was by campaigning together and making as loud a noise as possible (the decibel effect). This they did, and it worked—each of the seven women got her drug before the programme ended.

Patient power: lobbying for trastuzumab outside 10 Downing Street

Credit: BBC1

Somehow the conventional procedures used when considering a new drug were brushed aside. The drug is not licensed for early use in these particular circumstances, and the award of a licence seems months off as the manufacturer still has to apply to the authorities. However, this limitation has not proved a bar. NICE would normally have to approve any new drug of this sort before the NHS could supply it, but that process will not start for months—again, no impediment.

The local PCTs declined to approve the product for local use, arguing that they were not convinced of its cost effectiveness and because they were already in deficit. On the evidence available, it was suggested that around 18 women would need to receive the drug for a year for one to be free of recurrence at the end of this period, and on current prices that makes it £400 000 ($699 000; €584 000) per recurrence prevented. PCTs would have to withdraw money from other patients with conditions for which the evidence of likely benefit was stronger. Such a switch was seen as difficult to justify.

The initial decisions to decline the drug were reversed overnight, however, after at least one PCT apparently received call(s) from the office(s) of the prime minister or the health secretary—a position in keeping with public statements previously (and some would say inappropriately) made by the health secretary to the effect that that trastuzumab should be offered to all such patients and that cost alone should not rule out provision on the NHS.

In many ways the programme was a success as it set out the issues at least at a superficial level. It reminded us of the power and importance of the patient view, of how society at large is increasingly involved in health decisions, and how decisions by those in power are corruptible. What it did not do was to ask why there should have been such an unnecessary and unsightly public spat in which patients were set against doctors, and doctors against one another and against PCTs. Nor did it probe into the manufacturer's role in the whole sorry story, nor ask to what extent the health secretary's intervention had undermined the independence of NICE, her (and the NHS's) own advisory body. Finally, and most critically, it failed to expose the cost of the drug as a diversion of the government's making. Every year the health secretary negotiates with drug companies the amount the NHS will pay individual manufacturers for their drugs. The formula, set out in the Pharmaceutical Price Regulation Scheme (PPRS), requires that the price of each drug shall be “reasonable” for the NHS (that is, that it is affordable by the NHS). Moreover, if the returns from sales to the NHS exceed the predetermined level, agreements are in place for the drug company to refund the difference. So, if the sales of Herceptin were to mean that Roche's annual “allowance” were exceeded, the money would simply be returned to the NHS. At the moment it is difficult to know exactly what the government does with such returns. If they were directed back to the overdrawn PCTs (or hospitals), as they always should have been, the issue would be resolved at a stroke.

Panorama has now been going for 52 years. In many ways the Herceptin programme reflected the experience and skill of such longevity, but by its very omissions one has to ask whether Panorama's teeth have lost their cutting edge.