In the first article of our new 'Hot Topics' series, Dr Gerard Panting discusses how prescribing issues surrounding Herceptin may be seen with other drugs
Change has been one of the few constants for anyone associated with the NHS over the past few decades. Some of it – the merger of PCTs and Strategic Health Authorities – seems to take us back to where we were with Family Health Service Authorities and Regional Health Authorities; but when it comes to healthcare delivery, technological developments (such as drug advances) trigger questions of financial and human resourcing issues for all frontline clinical staff.
Healthcare has now become so complex that for GPs it is virtually impossible to have all the latest information at their fingertips; however, their patients are likely to have scoured the internet for information about their condition, the latest therapies and techniques available, and where to go to for whatever procedure might be necessary.
A patient with Crohn's disease is likely to know a great deal about the use of infliximab, and as monoclonal antibody therapies become available for more chronic conditions, the demands on those responsible for deciding whether or not patients fit the criteria for prescribing them will increase.
And here we run into the inevitable resourcing issue.These new therapies are expensive. Some might cost more than £1 million over a patient's lifetime, leading to debates on drug rationing. While media campaigns highlight evocative cases and politicians make promises, which they are unable to keep, it is the GPs who will be left to explain why the treatment is, unfortunately, unavailable.
Herceptin – a case in point
The Herceptin saga might well turn out to be a dress rehearsal for other expensive new therapies. Originally licensed for use in women with advanced breast cancer, Herceptin was shown in a New England Journal of Medicine paper to provide significant benefits to patients with early stage disease whose cancers are HER2 positive.1
Understandably, patients with early stage disease demanded access to the drug. In response, on 25 October 2005, the Secretary of State for Health, Patricia Hewitt, gave a speech at the Breakthrough Breast Cancer Fly-In in which she acknowledged that patients and their doctors would have seen the evidence presented in the New England Journal of Medicine.
She stated that, as with other unlicensed drugs: 'It is down to individual clinicians to decide whether or not to prescribe Herceptin for a woman who has tested positive for HER2.' She went on to say: 'I want to make it clear that PCTs should not refuse to fund Herceptin solely on the grounds of its cost. I know that some PCTs are already under financial pressure and may have to make difficult trade-offs in priorities to fund this new treatment for women who want it and whose clinicians want it for them. Although that will not be easy, I believe it is the right thing to do, particularly as they will be managing it over two financial years.
'And I have asked the National Institute for Health and Care Excellence to start on a fast track appraisal of the use of Herceptin in parallel with the licensing process so that they can issue their guidelines to the NHS on Herceptin within weeks of the licence being given.'2
In June 2006, NICE issued draft guidance on the use of Herceptin,3 which stated that the drug should be prescribed to women with early stage breast cancer who could benefit from it; the publication date of the final guidance has not been announced. The Scottish Medicines Consortium meanwhile issued its own final guidance, recommending that Herceptin should be available where breast cancer specialists recommend the drug to their patient.4
PCTs will have up to 3 months after NICE has issued its final guidance to set up appropriate funding arrangements for Herceptin.5
Public awareness over Herceptin has led to action in the courts; in April 2006, Ann Marie Rogers took Swindon PCT to the Court of Appeal over her right to receive Herceptin. Her doctor had prescribed the drug but the PCT had refused to fund it, so she had borrowed £5000 to pay for her treatment.6
Her application for Judicial Review was rejected with the judge finding that the PCT was within its rights to decide not to fund treatment unless the patient's case was 'exceptional'; however, in the Court of Appeal, the concept of exceptional circumstances was rejected as either the individual patient met the clinical criteria for the drug or he/she did not.7
Elsewhere, patients have resorted to direct action with the group 'Herceptin 4 Shropshire' staging a sit-in at Shropshire County PCT. The PCT did not fund Herceptin for breast cancer patients until the advanced stage was reached, and this sparked demonstrations when Sharon Moore, a 45-year-old with early stage disease, was refused treatment.6
Four days later, after a lengthy meeting, it was agreed that Mrs Moore would start treatment almost immediately, and the demonstration came to an end.6
It is estimated that each year, 5000 patients will benefit from Herceptin at a cost of £100 million to the NHS. Over the next few years many other costly therapies will be introduced, leaving PCTs and their GPs with the difficult and unenviable task of making 'difficult trade-offs in priorities', as Patricia Hewitt put it.2
Other financial constraints
But it is not just on expensive treatments that financial constraints are beginning to bite. On 24 June 2006, the Times reported 'Elite trainee GPs are left jobless by NHS funding cuts'.8 Having had its budget cut by the Department of Health, the London Deanery decided that training posts expected to start in August 2006 would have to be deferred until February 2007, leaving the doctors high and dry in the interim.
Rationing is inevitable – in the private sector as well as in the NHS. High expectations fuelled by media stories of medical and surgical breakthroughs, recommendations by guideline bodies, and the billions of pounds being poured into the NHS do not equate to withholding treatment, and if the Herceptin experience is anything to go by, patients won't be inclined to take no for an answer.
- Piccart-Gebhart M, Procter M, Leyland-Jones B et al. Trastuzumab after adjuvant chemotherapy in HER2-positive breast cancer. N Engl J Med 2005; 353 (16): 1659–1672.
- National Institute for Health and Care Excellence. Final Appraisal Determination: Trastuzumab for the adjuvant treatment of early-stage HER2-positive breast cancer. London: NICE, 2006.
- Department of Health. National Health Service Act 1977 Directions to Health Authorities, Primary Care Trusts and NHS Trusts in England 2001. London: DOH, 2001.