In this edition of Panorama (first broadcast in the UK on BBC1 at 20.30 on the August 18th 2008), reporter Shelly Jofre investigates the “postcode lottery”, an expression that has come into usage to describe differences in the availability of medicines and other treatments dependent upon where you live, and hence under the authority of which Primary Care Trust (PCT) your provision falls. This thirty minute episode focussed on discrepancies in the guidelines for prescribing three medications: Avastin, Lucentis and Aricept, which are used in the treatment of bowel cancer, wet age-related macular degeneration (wet AMD) and Alzheimer’s Disease, respectively. What all three drugs have in common is that they are licensed as safe and effective for use in the UK, but have not been approved for unrestricted provision on the NHS by the National Institute of Clinical Excellence (NICE).
Using the stories of patients – including the author Terry Pratchett – and their doctors, The NHS Postcode Lottery explores the various agencies who have a role in deciding whether or not these drugs could or should be provided at the point of NHS care, and to whom they should go.
This is an engaging, if a little sensational, introduction to some of the ethical issues raised by current resource allocation practices within the UK healthcare system, and – insofar as it is organised around three ‘case studies’ of approximately ten minutes in length – it could form the basis for discussion of resource allocation within a GCSE science or biology lesson (see the BioethicsBytes “Bioethics in the UK Curriculum” website for details of curricula requirements in this area). This post highlights the framework into which these cases fit and, based on the information presented in this episode of Panorama, it addresses two questions: How does the ‘postcode lottery’ arise? and What are the consequences of it? It also provides a rough guide to how the programme might be used in teaching.
How does the “postcode lottery” arise?
In the case of the three drugs examined in The NHS Postcode Lottery, all have been licensed for use in the UK by the European Medicines Agency (EMEA), however subsequent NICE guidance has either not approved the drug for NHS prescription, or restricted provision to a sub-set of suitable patients.
Avastin (Bevacizumab) was designated safe and effective in the treatment of metastatic colorectal cancer in 2005. The following year, however, NICE decided not to approve it for prescription on the NHS (see NICE Guidance dated January 2007). Lucentis (Ranibizumab) got its license in 2007, however, in that same year NICE issued preliminary guidance recommending Lucentis for wet AMD only when the patient had already lost sight in one eye (see RNIB Press Release, dated June 14 2007). Finally, Aricept (Donepezil), which was licensed in 2000, but was only approved for use in patients once their Alzheimer’s Disease had progressed to a clinically ‘moderate’ level (see NICE Press Release, issued on January 19 2001). This situation in summarised in Table 1.
In all the cases highlighted in this programme, doctors in England, Wales and Northern Ireland (who are bound by NICE guidelines) were left in the curious position of being able to legally prescribe these drugs, but with no automatic provision of funding for the treatment by the NHS; it is this that creates the basis for the ‘postcode lottery’ (the situation in Scotland is slightly different as NHS drug provision is overseen by the Scottish Medicines Consortium (SMC), though this episode of Panorama suggests it is currently attempting to bring prescribing practice in Scotland in to line with NICE recommendations for the rest of the UK – see 00:24:03 to 00:24:45).
What are the consequences of the ‘postcode lottery’?
In this situation, a GP or consultant wishing to prescribe one of these drugs to a patient on the NHS must apply for permission from the PCT within which the patient lives. These applications are made on the grounds of ‘exceptional circumstances’, however, since there is no UK wide framework for judging such applications (though NICE chief executive suggests there should be – see 00:08:42), decisions are currently made ‘locally’, and each PCT decides independently whether or not to provide treatment on the NHS. In doing this the PCT applies its own criteria, and – as The NHS Postcode Lottery suggests – weighs the needs of individuals against the needs of all patients within the trust’s boundaries, as represented by their obligations to manage their – tax-payer provided – financial resources effectively (see 00:07:18 to 00:08:11 for the position of the PCTs).
This means that ostensibly similar cases may receive different outcomes depending on which PCT the patient lives in. Two patients may have the same condition, may even be under the care of the same doctor and attending the same hospital, but receive different decisions on their ‘exceptional circumstances’ application, and consequently receive different treatment, if they live under the jurisdiction of different PCTs.
The NHS Postcode Lottery illustrates this graphically, and a particularly effective example is highlighted here (these graphics appear in the programme between 00:20:09 and 00:20:36).
A rough guide to The NHS Postcode Lottery
The two best-developed cases presented in the programme are the drugs Avastin and Lucentis for bowel cancer and wet AMD. However, as Panorama reveals, Avastin can also be used as an alternative to Lucentis in the treatment of wet AMD, this disease presents a more complex case. Thus, for teaching purposes, the different cases could be used to present healthcare resource allocation issues at different levels of complexity:
The treatment of bowel cancer (00:02:08 to 00:11:55) This is the simpler of the two cases. The programme features one patient and her doctor who are trying to gain access to Avastin to treat her recurrent bowel cancer from a PCT in Manchester. It focusses largely on the perspectives or the doctor and the patient, including their perceptions of the way decisions regarding drugs like Avastin are made. It also highlights the way differential decisions on applications for ‘exceptional circumstances’ are made by different PCTs (see below).
The treatment of wet AMD (00:11:57 to 00:20:51) This is the more complex of the two cases (although it does include a direct comparison between two patients living 13 miles apart with the same condition and the same consultant, one of whose treatment with Lucentis was approved by their PCT, whereas the other’s PCT did not – see 00:14:46 to 00:16:18). Initially the focus of this section is on the use of Lucentis in the treatment of wet AMD, and the cost-benefit calculations involved in NICE’s preliminary guidelines, however, as the programme continues, the use of Avastin – the drug explored above in context of cancer treatment – is also discussed.
As noted above, Lucentis, at £1,000 per dose (00:17:34), was initially judged by NICE to be too expensive to provide on the NHS to patients who had not already lost their sight in one eye. This was unacceptable to both doctors and patients, who wished to treat wet AMD before it had progressed to this stage, and, since this was only NICE’s preliminary guidance, Lucentis was referred back to NICE for further consideration. This, however, lengthened the decision making process, and for more than two years there were no firm guidelines for the provision of Lucentis on the NHS in England. In seeking interim treatments doctors turned to Avastin, which is in use internationally for the treatment of wet AMD (see 00:17:46). In the context of wet AMD, treatment with Avastin costs far less than the thousands of pounds required to fund it for bowel cancer. As The NHS Postcode Lottery reports it “only costs £25 a dose” (00:17:41), and appears to be just as effective as Lucentis at, both, slowing the progression of wet AMD, and, improving a patient’s condition.
On the basis of this cost-benefit calculation, it would seem that Avastin would be an ideal candidate for NICE approval for the treatment of wet AMD. However, Avastin is not licensed for use in the treatment of wet AMD; the European Medicines Agency (EMEA) had only licensed it for use in colorectal cancer. Thus, while it may have been found to be an effective treatment for wet AMD, it could not even be considered by NICE for this use as it was outside the terms of its licence. In this case, the programme suggests, “NICE’s hands are tied even though Avastin could save the health service a fortune” (00:18:14). Panorama puts forward the view that this is results from a conflict of interest: both Lucentis and Avastin are produced by the same company, Genentech.
EMEA licenses are granted (or refused) on the basis of applications received from pharmaceutical companies, such as Genentech. These applications must be supported by evidence of the drug’s safety and efficacy, as demonstrated by rigourous clinical trials in the relevant patient population (for further details of the clinical trials process see this BioethicsBytes post, Her-2: The Making of Herceptin). In the case of Avastin, Genentech had only conducted trials in the treatment of metastatic colorectal cancer, and hence had only applied for a license for this use. Thus, in order to obtain the license that would allow NICE to even consider recommending Avastin as an NHS treatment for wet AMD, Genentech would have to conduct further trials and submit an application to amend their EMEA license. This would be a costly process for the company, and one that Panorama suggests they would be reluctant to enter into, particularly since it would put Avastin and Lucentis – their existing licensed, and more expensive, wet AMD treatment – in direct competition. As Jofre notes (with tongue in cheek), from Genentech’s point of view this may not be “the best use of its resources” (00:19:06).
While NICE eventually issued guidance recommending NHS provision of Lucentis for all wet AMD patients (see NICE Guidance, dated August 2008), this is still an interesting and complex case which, for the purposes of teaching, highlights the intersection between patient, clinician, pharmaceutical company, NICE and PCT interests in healthcare resource allocation (the recent programme broadcast on BBC Radio 4: “How nice is NICE?”, provides an excellent overview of the role of NICE in resource allocation which includes consideration of the competing pressures upon it).
- How NICE decides upon which drugs to recommend for NHS prescription: Includes an explanation of how Quality Adjusted Life Years (QALYs) are calculated and the £30,000 per QALY ‘value for money’ threshold (00:03:56 to 00:04:32), though also the perception by clinicians that these calculations do not reflect the way drugs like Avastin, Lucentis and Aricept would be used by clinicians (00:05:10 to 00:05:40). Further, the way that patient numbers (i.e. demand), and evidence on specific effectiveness impact upon NICE’s decision making (00:21:25 to 00:21:39, and 00:22:36 to 00:23:12, respectively)
- The evidence that different decisions are made on similar ‘exceptional circumstances’ applications by different PCTs: Primarily based on an interview with a doctor who systematically compared rates of approval for ‘exceptional circumstances’ applications in his local PCTs (00:06:03 to 00:06:53).
- Private funding of particular drug treatments: Includes an illustration of how, on the one hand, the real costs of integrating a medication obtained privately into treatment involving other NHS services seems unfair (00:10:25 to 00:11:24), though on the other, how allowing for ‘cold payments’ could create a systematic inequality which is much more serious than the current ‘postcode lottery’ (00:11:25 to 00:11:55). Also featured are the emotions experienced by author Terry Pratchett, who is able to fund his own treatment with Aricept, as he reflects on the situation faced by those who cannot (00:21:40 to 00:22:05).