How much will Herceptin really cost?

The Herceptin debate

Herceptin is a monoclonal antibody against the HER2 protein that is overexpressed in 20-25% of patients with breast cancer. For palliation and in certain other clinical circumstances, NICE recommended its use in women whose tumours have high (3+) expression of the HER2 receptor.4 The NICE appraisal of Herceptin as adjuvant treatment has just been released, and the National Cancer Research Institute has also issued clinical guidelines.3 5

Readers will be aware of the heated debate surrounding this treatment.6 7 The media have made little mention of the restricted categories of patients for whom Herceptin may be appropriate, or of the lack of long term toxicity data, especially concerning effects on the heart. Although the three published trials showed a statistically significant improvement in rates of recurrence, as yet, only one has shown a benefit in survival (4.8% at four years).8 9 10 Despite the lack of NICE approval at the time, several patients obtained Herceptin through their local NHS by appealing to the courts.11 NICE promised to “fast track” Herceptin, and it is no surprise that the resulting guidance is positive.12

This means that our trust (Norfolk and Norwich University Hospital) will have to find £1.9m (€2.9m; $3.6m) each year in drug costs alone to make Herceptin available to the 75 patients who may be eligible. This becomes £2.3m if the costs of pathology testing, cardiac monitoring, pharmacy preparation, and drug administration are added. On the face of it, the answer to our question is simple—Herceptin will cost our trust £2.3m—but the real cost lies in the services that will be cut to provide this money. This is an important element currently missing from the debate.

Cost effectiveness comparison

To illustrate this, we audited drug costs in the oncology centre of our hospital. We then hypothesised how we could save £1.9m by cutting curative and palliative chemotherapy treatments (tables 11 and 2⇓).

The sum of £1.9m would enable us to treat 75 patients with Herceptin, but at four times the cost of the adjuvant treatments shown in table 1⇑. These treatments have been proved to be clinically effective and their estimated cost effectiveness is far greater than that currently expected for Herceptin. The cost of giving adjuvant Herceptin is double that of all the palliative treatments shown in table 2⇑.

So we could fund Herceptin if we did not treat 355 patients receiving adjuvant treatment (16 of whom would be cured) or 208 patients receiving palliative chemotherapy, and if we found £0.5m from another source. These untreated patients will be people we know. We will be the ones to tell them they are not getting a treatment that has been proved to be effective, which costs relatively little, because it is not the “treatment of the moment.”

These results are obviously not definitive, but illustrate the fundamental challenge facing the NHS—the tension between national priority setting and local implementation.13 Currently central government allocates the overall NHS budget to primary care trusts and other substructures. Local bodies, such as primary care trusts, then divide these funds between primary and secondary care, treatment, and prevention, etc.14 The situation is more complex for long term treatments (such as Herceptin), which—under practice based commissioning—fall on primary care budgets rather than hospitals. Although in practice this means that Herceptin may eventually be vying with other clinical areas, such as paediatrics or orthopaedic surgery, it does not affect the central message of our example here—that the real cost of Herceptin is in the other patients not treated, whether they are patients with cancer or those with other conditions. NICE gives no guidance on this issue. The current situation with Herceptin highlights our central argument—that as NICE guidance provides no extra funding or suggestions of which services to cut, medical professionals ultimately have to make these difficult decisions.

A further complicating factor, well illustrated by Herceptin but seen in many other cases, is the susceptibility of these decisions to external pressures.15 16 The relative media and public appeal of “sexy” versus “Cinderella” services and the power of different clinical specialties have always exerted external pressure on allocation of resources in the NHS (and other healthcare systems).17 In the case of Herceptin, high profile patients, media bias, industry support, and political gaming put considerable pressure on the NHS to offer this drug in early stage breast cancer. NICE's decision highlights the “rubber stamping” role that this government appointed body seems to have adopted, and that in priority setting NICE's bark is much worse than its bite.18

Their decision is understandable as an appeal to the emotional principle of “rule of rescue” (the imperative people feel to rescue identified individuals facing avoidable death).19 When new technologies (such as Herceptin) arise, it is relatively easy to pit the known patient in need against either the system in general or a set of “anonymous” patients elsewhere. Priority setting tends to be focused at this “anonymous” level.20 But no patient is anonymous, especially not to the attending doctor who also has the ultimate rationing responsibility in the current system. We have deliberately not discussed priority setting between Herceptin and, for example, neonatal intensive care or hip replacements. We think that it is important to focus, for a change, on the “clinical coal face” as this is the ultimate reality. We, not NICE, have to choose which other treatments will not be provided and which of our patients will not be treated.

Nobody has suggested what treatments we cut in favour of Herceptin—not the media, medical advocates of the drug, the courts who upheld patient appeals, or NICE. It would be especially interesting to know what the secretary of state for health would like us to cut.

Political pressure, patient advocacy, and media hyperbole should not determine who is treated and what they are treated with. NICE is an established system, but it currently creates more problems than solutions. This organisation must be given responsibility to decide what should be cut to fund newly recommended technologies or the ability to allocate extra funds for implementation (or both). Without these changes Herceptin will not be the last controversial case of “rationing by media.”