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Rapid Responses: Rapid Responses published:
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Watchdog set to reject four drugs for kidney cancer on the NHS
- DR MATTHEW THALANANY (14 August 2008)
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Re: Watchdog set to reject four drugs for kidney cancer on the NHS
- Gustav Ando (15 August 2008)
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Will my question remain without response?
- Andrea Messori (17 August 2008)
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Vested Interest
- Umesh Prabhu (18 August 2008)
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Re: Vested Interest
- Jay Ilangaratne (19 August 2008)
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The UK postcode lottery and survival of patients with metastatic renal cancer
- Nicholas D James, Jennifer Pascoe, Abel Zachariah, Daniel Ray, Alice Oldroyd, Helen Parry, Helen Benghiat, Maria Karina, Stuart Collins, Emilio Porfiri (21 August 2008)
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DR MATTHEW THALANANY, ----- COLCHESTER, ESSEX, UK
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It is good to see at last that the overblown hype around the value of cancer chemotherapy is beginning to get exposed by NICE. No doubt it will infuriate several different groups with vested interests, but it is time that patients, their families, and some politicians, were given the honest truth that many of these so called wonder drugs are not curative, are toxic, with nasty side effects, and divert funds away from much needed palliative and terminal care. Women's groups in New Zealand have now backed PHARMAC (a body similar to NICE) to forego the unnecessary expense of 12 months treatment with Herceptin for breast cancer - they've shown that clinically it's no better than the 9 week course. Let cancer chemotherapy research focus on finding genuine cures. NICE WORK NICE Competing interests: None declared |
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Gustav Ando, Manager EC1M 3NN
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Dr. Matthew Thalanany's celebration of NICE's verdict to reject 4 key new drugs to treat renal cell carcinoma raises some disturbing questions. He refers to "groups with vested interests" as if organisations such as PHARMAC and NICE do not have precisely the same vested interests in terms of the remit they are given and the role that they serve - as organisations that work not for public health, but rather for "health- economic health". NICE itself admits that these drugs offer significant clinical benefit. No one has ever claimed - except perhaps tabloid reporting - that the extraordinary developments that we have seen in diseases such as renal cell carcinoma, GIST, non-Hodgkin's lymphoma and elsewhere are "curative" and without "nastive side-effects". However, these drugs do undoubtedly offer highly significant improvements over existing therapies, although I suppose the opinions of those that Dr. Thalanany consider to have "vested interests" (eg. patients who are dying from this disease) are of little value. He mentions a poorly designed and small study from Finland to support PHARMAC's dubious adherence to a 9 -week course of Herceptin. Competing interests: I work for Global Insight, which provides healthcare and pharma services for numerous healthcare organisations, including pharmaceutical companies, regulatory bodies and universities. |
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Andrea Messori, Coordinator Lab. of Pharmacoeconomics, Careggi Hospital, Firenze, Italy
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I would ask Dr. Ando to consider the following question. Sunitinib (which “undoubtedly offers highly significant improvements over existing therapies”) is sold at the price of about 150 EUR per day. According to Dr.Ando, what is the upper price limit over which reimbursing this drug would be wrong or inappropriate or unacceptable or unethical? 150,000 EUR per day or 15,000 EUR per day or 1,500 EUR per day or 150 EUR or 15 EUR per day? Competing interests: None declared |
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Umesh Prabhu, Consultant Paediatrician The Pennine Acute Hospitals NHS Trust, OLO11 5RF
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'Vested interest' group is an interesting concept. Our interests depend on 'what is in it for me'. It is just a human nature. If I am a patient suffering with the disease or if one my friends or relatives is suffering with the illness then I would like everything to be done to help me or my friends and relatives. Even if it costs £10,000 a day and gives me another 3 months to live, I would consider it is worth spending that money. But the question is whose money are we spending? If it is the public money then public must have a say in which that money is spent. NHS is publicly funded and it is wrong for patients or their relatives to say how the money should be spent. They would be biased. It is equally wrong for managers and clinicians to give that freedom that too when drugs are very costly. Drugs may be clinically effective but when one spends public money then drug should be cost effective. Unfortunately in most cases these concepts are relative and not absolute. If, I am spending my own money then I should have the right to do so for anything I please. Only solution is for patients to have a right to pay 'top up' fees. Of course if one can't afford it then it is not fair. But then who said life is fair? I am pleased that NICE able to make these decisions. Not easy, and in someway NICE is like the GMC, damned if it does and damned if it doesn't. As doctors, we deal with human sufferings, pain, life and death situations and naturally these issues generate lot of passion and emotions. NHS must be efficient, effective and good value for money. It is not about being 'cheap' or clinically effective but cost effective. Competing interests: Passionate and Proud of NHS. |
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Jay Ilangaratne, Founder www.medical-journals.com
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When U Prabhu says "If, I am spending my own money then I should have the right to do so for anything I please", it sounds logical and fairly straightforward.However, when he says " If it is the public money then public must have a say..." and then goes on to argue that "NHS is publicly funded and it is wrong for patients or their relatives to say how the money should be spent", it sounds wrong and illogical.Has he dropped a clanger? Competing interests: Enjoys humour at times. |
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Nicholas D James, Professor of Clinical Oncology Cancer Research UK Institute for Cancer Studies, University of Birmingham, Edgbaston, Birmingham B15, Jennifer Pascoe, Abel Zachariah, Daniel Ray, Alice Oldroyd, Helen Parry, Helen Benghiat, Maria Karina, Stuart Collins, Emilio Porfiri
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The recent provisional NICE Guidance on drugs for renal cancer is, on their
own admission, compromised by the fact that all of the major trials are
confounded by cross-over from the control arm to the experimental therapy;
this will certainly lead to an under-estimation of benefit 1. Any estimate of
cost-per-QALY is thus highly suspect. In order to assess the possible survival
benefit from these new agents in a single tertiary referral centre for
urological cancer, we undertook an audit of survival in our centre according
to whether or not patients received either sorafenib or sunitinib. We obtained
details of all requests made for sorafenib and sunitinib since licence in 2006.
Seventy-nine patients were identified for whom funding requests had been made. Baseline characteristics were: age 59 (range 32 to 77) years; 79% male. The groups were similar with respect to prognostic factors (stage, haemoglobin, performance status, nephrectomy, calcium) and social deprivation index scores. Thirty-seven and 8 patients had funding approved for sunitinib and sorafenib, respectively; 21 and 13 were turned down. Seven patients ultimately self-funded the purchase of their treatment (6 sunitinib, 1 sorafenib). Fewer patients who received treatment with a drug for which funding was sought subsequently died: 8 out of 43 patients treated with sunitinib died compared with 10/15 who were not treated; for sorafenib the corresponding numbers of deaths were 3/9 versus 8/12. (overall hazard ratio from a time- dependent Cox regression analysis 0.46; 95% CI 0.21 to 1.01; ÷2 = 3.80; 1 d.f.; p=0.05); the advantage was similar for patients receiving sunitinib or sorafenib. This translates to a median survival from application of around 7 months for the non-funded patients to in excess of 22 months for those lucky enough to be treated. Overall NHS resource use, apart from funding for the renal cancer drugs, was similar for both groups, but was spread over a longer time interval for the treated group and so was lower per unit time. We believe this audit adds an important dimension to the current debate about treatment for kidney cancer patients in the UK for three reasons. Firstly, the trials comparing the new renal cancer drugs sunitinib and sorafenib are all compromised by crossover in the control arms, making accurate estimate of the survival benefit impossible, and making it likely that the published hazard ratios (0.6-0.8) underestimate the true survival benefit 2-4. Our audit has identified a group of patients who either received or were denied treatment on basis of postcode. Although not randomised, the groups have very similar clinical features but strikingly different survival, with a smaller estimated hazard ratio than the published trials and which we believe may be nearer the true estimate of benefit for these drugs. Secondly, the supportive care costs for the two groups (excluding the new drug costs) appears similar despite the longer survival times of the group receiving the newer treatments. Cost per unit time is thus lower. As these drugs are frequently self-funded (as was the case with 7 patients in our audit), this has an important bearing on the co-payment argument – patients were not sequestering additional NHS resources by self-funding drugs. Thirdly, our audit highlights the poor performance of NICE in respect of renal cancer therapy. The drugs were licenced in 2006 but final NICE guidance is not due until 2009. The provisional guidance just issued 1 has been widely criticised by oncologists as denying patients access to modern treatments of substantial benefit. Our audit underlines this opinion and also highlights the time wasted in the NHS trying to obtain funding for scores of patients via the exceptional cases route in the absence of NICE guidance, as we have been forced to do for our patients. In conclusion, compared to those receiving treatment, patients denied access to the latest cancer drugs for renal cell carcinoma had substantially worse survival, despite receiving treatment from the same clinical team in a tertiary referral centre. Access to the new drugs did not have an impact on overall use of NHS resources by funded patients. Modern treatments for advanced renal cancer should be available to all NHS patients with the disease. Competing interests: Clinical trial research funding from Bayer and Pfizer. Consultancy fees from Bayer and Pfizer 1. NICE, 2008, Renal cell carcinoma - bevacizumab, sorafenib, sunitinib and temsirolimus: evaluation report, http://www.nice.org.uk/guidance/index.jsp? action=folder&o=41474 2. Figlin RA, Hutson TE, Tomczak P, Michaelson MD, Bukowski RM, Negrier S, et al. Overall survival with sunitinib versus interferon (IFN)-alfa as first-line treatment of metastatic renal cell carcinoma (mRCC). J Clin Oncol 2008;26(May 20 Suppl):Abstract 5024. 3. Motzer RJ, Hutson TE, Tomczak P, Michaelson MD, Bukowski RM, Rixe O, et al. Sunitinib versus interferon alfa in metastatic renal-cell carcinoma. N Engl J Med 2007;356(2):115-24. 4. Escudier B, Eisen T, Stadler WM, Szczylik C, Oudard S, Siebels M, et al. Sorafenib in advanced clear-cell renal-cell carcinoma. N Engl J Med 2007;356(2):125-34. Figure 1. Survival analysis by drug type and treatment status
an=number of subjects, e=number of deaths Competing interests: Competing interests: Clinical trial research funding from Bayer and Pfizer. Consultancy fees from Bayer and Pfizer |
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