Sunday, 22 February 2015

Your meds are too expensive for their value Should NICE change its thresholds..meaning no drugs for You

Claxton K, Martin S, Soares M, Rice N, Spackman E, Hinde S, Devlin N, Smith PC, Sculpher M.Methods for the estimation of the National Institute for Health and Care Excellence cost-effectiveness threshold. Health Technol Assess. 2015 ;19(14):1-504

BACKGROUND:Cost-effectiveness analysis involves the comparison of the incremental cost-effectiveness ratio of a new technology, which is more costly than existing alternatives, with the cost-effectiveness threshold. This indicates whether or not the health expected to be gained from its use exceeds the health expected to be lost elsewhere as other health-care activities are displaced. The threshold therefore represents the additional cost that has to be imposed on the system to forgo 1 quality-adjusted life-year (QALY) of health through displacement. There are no empirical estimates of the cost-effectiveness threshold used by the National Institute for Health and Care Excellence.
OBJECTIVES:(1) To provide a conceptual framework to define the cost-effectiveness threshold and to provide the basis for its empirical estimation. (2) Using programme budgeting data for the English NHS, to estimate the relationship between changes in overall NHS expenditure and changes in mortality. (3) To extend this mortality measure of the health effects of a change in expenditure to life-years and to QALYs by estimating the quality-of-life (QoL) associated with effects on years of life and the additional direct impact on QoL itself. (4) To present the best estimate of the cost-effectiveness threshold for policy purposes.
METHODS:Earlier econometric analysis estimated the relationship between differences in primary care trust (PCT) spending, across programme budget categories (PBCs), and associated disease-specific mortality. This research is extended in several ways including estimating the impact of marginal increases or decreases in overall NHS expenditure on spending in each of the 23 PBCs. Further stages of work link the econometrics to broader health effects in terms of QALYs.
RESULTS: The most relevant 'central' threshold is estimated to be £12,936 per QALY (2008 expenditure, 2008-10 mortality). Uncertainty analysis indicates that the probability that the threshold is < £20,000 per QALY is 0.89 and the probability that it is < £30,000 per QALY is 0.97. Additional 'structural' uncertainty suggests, on balance, that the central or best estimate is, if anything, likely to be an overestimate. The health effects of changes in expenditure are greater when PCTs are under more financial pressure and are more likely to be disinvesting than investing. This indicates that the central estimate of the threshold is likely to be an overestimate for all technologies which impose net costs on the NHS and the appropriate threshold to apply should be lower for technologies which have a greater impact on NHS costs.
LIMITATIONS:The central estimate is based on identifying a preferred analysis at each stage based on the analysis that made the best use of available information, whether or not the assumptions required appeared more reasonable than the other alternatives available, and which provided a more complete picture of the likely health effects of a change in expenditure. However, the limitation of currently available data means that there is substantial uncertainty associated with the estimate of the overall threshold.
CONCLUSIONS: The methods go some way to providing an empirical estimate of the scale of opportunity costs the NHS faces when considering whether or not the health benefits associated with new technologies are greater than the health that is likely to be lost elsewhere in the NHS. Priorities for future research include estimating the threshold for subsequent waves of expenditure and outcome data, for example by utilising expenditure and outcomes available at the level of Clinical Commissioning Groups as well as additional data collected on QoL and updated estimates of incidence (by age and gender) and duration of disease. Nonetheless, the study also starts to make the other NHS patients, who ultimately bear the opportunity costs of such decisions, less abstract and more 'known' in social decisions.
FUNDING:The National Institute for Health Research-Medical Research Council Methodology Research Programme.

The Centre that funds research within the NHS has funded a piece of research to look at the costs of drugs. The take home message is that NICE has too high a threshold for accepting that a drug is cost-effective. The argument is that the threshold should be reduced by a half, meaning even less access to MS drugs if this threshold is accepted.  NICE use quality-adjusted life-year (QALY) as a measure of disease burden, including both the quality and the quantity of life lived. It is used in assessing the value for money of a medical intervention. 
The QALY is a measure of the value of health outcomes. Since health is a function of length of life and quality of life, the QALY was developed as an attempt to combine the value of these attributes into a single index number. The basic idea underlying the QALY is simple: it assumes that a year of life lived in perfect health is worth 1 QALY (1 Year of Life × 1 Utility value = 1 QALY) and that a year of life lived in a state of less than this perfect health is worth less than 1. In order to determine the exact QALY value, it is sufficient to multiply the utility value associated with a given state of health by the years lived in that state. QALYs are therefore expressed in terms of "years lived in perfect health": half a year lived in perfect health is equivalent to 0.5 QALYs (0.5 years × 1 Utility), the same as 1 year of life lived in a situation with utility 0.5 (e.g. bedridden) (1 year × 0.5 Utility). QALYs can then be incorporated with medical costs to arrive at a final common denominator of cost/QALY. This parameter can be used to develop a cost-effectiveness analysisof any treatment.

Drugs with a QALY over £30,000 will not get funded, so this is why Sativex has been struggling to be prescribed because a study suggested it was higher. However I have seen a study from Germany that favours cost effectiveness. However when cost-effectiveness is being calculated many I think there are some parameters do not come into the equation, e.g. effects on carers etc
If they reduce the cost per QALY some MS drugs will go. Beta interferons and Copaxone were not considered to be cost effective and a fudge was made "the Risk Sharing Scheme" to allow people access to them. 

An anonymous email comment on a BBC website said "As a Pharmacist in the NHS I've lost count of the number of times well funded pressure groups have been able to demand we divert money into unproven drugs that cost a fortune (and they do this through government pressure, where MPs/Ministers make medical decisions over the experts). This is all at the expense of medicine for conditions that don't have the pressure groups or funding"

Maybe we as a community need to develop generics that break the pharma price cartels. As pharma have developed the repurposing route, there is a good chance that the generics on which they are based will work too.  

This is why we should get behind the Jonathan Evans Repurposing Bill, maybe it is time to write to MP (eg. write to them) and say "Before the election (or for certain parties-before you loose your seat:-) do something useful and support the Repurposing Bill, 40 MPs to discuss the reading the Bill, which stalled because the lacklustre performance of your colleagues (MPs) on something that is of National importance. 

However with generics around you wouldn't need NICE, do you think NICE would want this.

What do you think, as being on the receiving end of these thoughts?

1 comment:

  1. It seems to me that the key missing factor with all MS treatments is the lack of being able to identify who will be a responder or a non-responder. If you cannot identify who will respond to any particular treatment and who will not, then time, money, and brain is being wasted. Some of the older drugs will still work well for some people, but unless you can identify who they will work for they are still a shot in the dark. The newer treatments all seem to come with more serious side effects, and if you knew you would be a responder to one of the older drugs why would you want to take one of the newer ones? The newer drugs are still firing off the ammo in the dark – it’s just heavier duty ammo, and that the numbers were better in clinical trials.

    Removing access to a drug which could be the right one for you is not helpful, but currently there does not exist any way of determining which drug is right for which patient (apart from avoiding Natalizumab if you are JC+). If you could identify responders/non-responders for any drug, then each medication becomes more cost-effective and able to be targeted at those who will derive benefits from it.


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