Commentary
Pharma companies are getting too good a deal in Ireland, Irish Times, 26th April, 2021
Relevant comparator strategies are often omitted in cervical screening CEAs, leading to the underestimation of ICERs; 4-12-2015
We recently published a systematic review of cost-effectiveness analyses (CEAs) of HPV testing in cervical screening. It specifically addresses the choice of comparator strategies modelled. Published in Value in Health, it shows that of 30 studies reviewed, 21 appear to have included insufficient comparator strategies to reliably estimate the ICER of the most policy-relevant strategy from the CEA perspective. In many cases, the analyses do not include sufficient strategies with longer screening intervals between screens of 5 years or more. The consequence of which is that many of the estimated ICERs will be underestimates relative to what would probably be found had more potential comparator strategies have been included in the model.
The primary point of the paper can be understood from the example of the figure below. It shows results reported by Accetta et al.'s 2010 paper, Is human papillomavirus screening preferable to current policies in vaccinated and unvaccinated women? A cost-effectiveness analysis published in the Journal of Medical Screening. This study compared four different combinations of cervical screening technology, include some that used HPV testing. They compared these four strategies at two different screening intervals of 3 and 5 years. The figure shows the efficient frontier and ICER estimates over the efficient strategies. This analysis did not include screening intervals of 6, 7 or 8 years. We have added the possible position of estimates for such "hypothetical strategies" with longer screening intervals, shown with the green squares. If the costs and effects estimates of these hypothetical strategies did lie somewhere in the region shown, then the ICER estimate of €5,000/QALY is very likely to be a substantial underestimate. The likely omission of relevant comparator strategies is fairly obvious in this case once the possible position of hypothetical strategies have been included. Similar omissions were found in 20 other studies within the review, although not were all as obvious as that shown here.
The review draws particular attention to what it describes as the policy-relevant strategies from the CEA perspective. These are the most effective strategies with ICERs within the threshold, which therefore are optimal when attempting to maximise effectiveness from finite resources. Given that these are the most policy-relevant strategies, it is particularly important that their ICERs are estimated correctly. In the example from Accetta et al. shown here, using the threshold of €50,000/QALY stated within that study, the €5,000/QALY strategy is therefore the optimal strategy. Accordingly, it matters that the omission of likely relevant comparators means that this ICER is probably an underestimate. Of course no CEA can simulate all possible screening strategies, but analysts should take care when specifying comparators in order to ensure that the ICER of the most policy-relevant strategy has been estimated correctly.
Excessive Cost of Soliris Will Damage Irish Health Services; 6-02-2015
The HSE's decision to fund eculizumab, also known by its brand name Soliris, will be welcome among the small number of patients needing the drug and in the boardroom of its manufacturer, Alexion Pharmaceuticals. While it's good news for some, this decision should be recognised as bad news for everybody else. The reason being that the price of this drug is so grossly excessive that it represents exceedingly poor value to the Irish health system.
Ireland has an established framework for determining fair prices for new medicines. We employ highly-trained experts to judge which drugs should be adopted and at what cost. These decisions are made in reference to fair price limits previously agreed between the HSE, the Department of Health and the pharmaceutical industry. These limits are weighted to reward effectiveness, such that better drugs receive premium prices. Our current price limits are arguably already generous and offer ample compensation for innovative treatments.
The price demanded Alexion for eculizumab is reported to be €430,000 per patient annually. Adjusting this price into the standard measure of value used in cost-effectiveness analysis of healthcare gives an estimate of between €0.7 - €1.1 million per year of healthy life. This is between 15 and 25 times the accepted fair limits: it cannot be overstated how extraordinarily expensive eculizumab is.
Even though eculizumab is expected to bring very welcome potentially life-saving benefits to the few patients that will receive it, once we take the drug's cost into account these benefits become tiny relative to the potential alternative uses of money elsewhere in the health system. Indeed, there is a perverse paradox that although eculizumab will save some, it will result in net harm to the health of the Irish population, as the extreme cost of the drug means that far more health gains will have to be foregone by cutting or not adopting other better value services to find funding. Although this may seem somewhat abstract or hypothetical we have to realise that eculizumab has a real cost in terms of other services foregone that must not be overlooked.
While Alexion are free to ask for a steep price it is up to the HSE to decide what is fair to pay. The decision to adopt the drug at the reported price is extremely disappointing from a cost-effectiveness perspective. It demonstrates that healthcare decision makers are not adhering to their espoused commitment to providing cost-effective care and that expert advice is being ignored.
While eculizumab is certainly not the first drug in Ireland to be approved above agreed price limits, but the extent to which price limits have been smashed is significant. This decision reinforces the message to manufacturers that despite the work of our cost-effectiveness experts Ireland is not serious about setting sensible price limits. This can only further incentivise drug companies to demand exorbitant premiums as the Irish system looks hopelessly incapable of saying no.
While it is difficult not to overstate what poor value eculizumab is, it is important to keep the cost in perspective. The number of patients needing eculizumab is very small, so while the price of the drug is grossly excessive, the overall cost will be tiny compared to the HSE's total budget. Therefore, the damage to the Irish health system as a whole will be minor in those relative terms.
We should not be complacent however regarding high costs drugs for small patient groups. If we allow ourselves to routinely abandon sensible spending rules for drugs with small patient populations we will soon find that all the exceptions add up to an increasingly unsustainable burden. This has been the UK's experience with its Cancer Drugs Fund, a special fund established to finance cancer treatments that have not demonstrated sufficient value for money to be adopted under standard rules. The fund rapidly proved inadequate to satisfy demand for cost-ineffective treatments, despite growing to a massive £340 million this year.
Furthermore, we need to recognise that abandoning sensible spending limits for rare conditions means that there will be less and less money available to treat common illnesses that have large population health burdens. This will lead to the illogical consequence that very cost-effective services will not be available for the majority of patients as the necessary funds are expended to relatively poor effect on a minority of patients.
We can already see some aspects of this in current services. Ireland currently funds many of the newest drugs, which often come at huge costs and sometimes bring only very little benefit to dying patients. At the same time basic services are being cut and relatively simple and effective aspects of healthcare remain under-funded. The trolley crisis in emergency departments has not abated, patients remain on waiting lists for years and community care for older people is scant. We cannot ignore the connection between the financial burden of expensive new treatments and the chronic failure of other parts of our health service: to do so is simply reckless and willful self-deception.
Irish Cancer Society claims that breast check extension to ages 65-69 will save money incorrect; 1-10-2014
The Irish Cancer Society (ICS) is running an advocacy programme in advance of the 2014 Budget to get the national breast screening programme extended from age 65-69. The ICS claim the programme will save money: "The Irish Cancer Society wants to remind the government and the Minister for Health not to forget about women in this age group, highlight their broken promise, and convince them that the extension of this screening service will save lives and save money." However, it is highly doubtful that this claim that screening will be cost saving is true. Breast cancer screening programmes usually impose net health costs on health systems. Meaning that the costs of providing screening tend to more than outweigh the cost of any treatment savings realised through early detection. So while the ICS may be correct that screening will save some money somewhere in the system, it will cost the health system more overall. Hence the claim that extending screening will save money is misleading.
The ICS's efforts are a legitimate campaign to get the government to follow through on a policy pledge and they cannot be criticised for that. However, invoking an incorrect cost argument is not helpful. This can only serve to confuse the public. Telling people that a service is cost saving when it is not is likely to create a sense of anger among the public, as policy makers appear to be failing to adopt measures that appear to be a straightforward win-win. However, the reality is not as simple as this. The ICS has a responsibility to inform the public appropriately and not to ignore or dismiss the additional costs that will be borne by the health system if screening is extended.
If the ICS has good evidence for their claim that extending screening will reduce net costs then they should share it. If they don't, then they should change their campaign material to more reliably inform the public.
Update on ICS cost-saving claim; 2-10-2014
Following a positive discussion with the Irish Cancer Society, the claim that the extension of the breast screening service will save money has been removed. It is encouraging that the ICS were happy to change their advocacy material once they realised it was inaccurate. Clearly they do see the importance of reliable information as part of the public policy debate.