How much is one year of your life worth? Is a year of your life worth more if it comes towards the end of your life?
These questions seem cold and harsh and it feels immoral to put a hard, calculated value on a life. But in the reality of an ever tightening NHS budget these are very real issues.
They are just some of the questions raised in a recent blog post “QALY – the cost to live” by Emma Warren. Here the author introduces the role of NICE, the National Institute of Health and Care Excellence, in approving which drugs or treatments will be available on the NHS.
I found myself asking who makes these decisions, and on what criteria are they based? Perhaps more importantly, what are the consequences of their decisions?
In 2009 a BBC documentary “Price of Life” followed the controversial case of Revlimid, a new form of treatment for a rare blood cancer. Including interviews with patients and their families, the program was at times heart-breaking as they fought for access to a drug which could potentially prolong their lives. However, the program also provided a unique insight into the decision process of NICE’s appraisal committee.
The committee consists of medical clinicians, patient representatives and other health care professionals who meet approximately 40 times a year to assess whether or not certain new drugs or treatments should be recommended on the NHS. The decision-making process is vigorous.
First, the manufacturer or drug company must submit their evidence. This includes detailed results of clinical trials in addition to the price and estimated cost of treatment for a patient. The committee must then review the evidence and figures, often complemented by NICE’s own calculations of estimated cost (which unsurprisingly often reveal that the manufacturers underestimate the true cost of treatment).
The aim is to assess the cost-effectiveness of a new treatment, compared to what is already available. However, what is considered to be “cost-effective”?
To assist in this decision the committee use QALYs, or Quality Assured Life Years. Based on a scale from 0-1 (0 being death and 1 being perfect health) a QALY is a measurement of how effective a certain drug will be at prolonging and improving the quality of life for a patient after treatment.
In answer to the first question, according to NICE your life is worth no more than £30,000 per QALY. This is the threshold at which NICE will decide that a drug is not cost effective enough to be recommended.
During the first committee meeting shown in the program NICE voted that Revlimid was not cost-effective enough to be recommended. Following such a decision there are 3 months in which patients can prepare an argument and the drug manufacturers can offer an alternative deal, before the committee meet again to review the decision.
In the case of Revlimid, however, the QALY measuring system came under fire and questions were raised regarding whether it was discriminatory against those suffering from terminal illnesses since in these cases, by definition, patients to do have a QALY.
For this reason, in 2009 NICE introduced an “end of life treatment protocol” by which the committee can recommend treatment which exceeds the £30,000 threshold. In other words they decided that, indeed, a year is worth more if it comes towards the end of your life. Due in part to this new protocol, in the conclusion of the program the drug was finally given a positive recommendation, at the price of £46,000 per QALY.
Throughout the process patients were understandably frustrated with NICE’s original decision not to approve Revlimid based on cost. However, for every decision the committee makes to approve a drug or treatment there must be a degree of re-allocation of resources. Would the £46,000 per year been better spent providing critical care in a paediatric unit? What if patients receiving Revlimid were told that the money being spent on their drug treatment meant someone else was losing out?
Of course it is unfair to ask such questions to someone staring death in the face. However, there will always be those who feel in some circumstances that the money could have been better spent elsewhere.
Who is really to blame?
In more recent news NICE came under criticism for their decision not to recommend various forms of breast cancer drug treatments (March 2014). Amongst these was Kadcyla, a drug which treats a specific form of breast cancer (HER2-positive) where the cancer has spread throughout the body and is inoperable. The drug has the potential to add an average of six months to the life expectancy of a patient. Despite the extra flexibility provided by the end of life protocol, Kadcyla still costs upwards of £166,000 per QALY. This is an extraordinary amount of money and comes largely due to the price the manufacturer, Roche, is proposing.
In NICE’s report, in which they outlined the decision not to recommend Kadcyla, they expressed their disappointment at Roche and stated “The company is well aware that we could not have recommended Kadcyla at the price it proposed.”
In addition to this, if we return to the case of Revlimid, another reason the drug was finally given a positive recommendation was due to the manufacturer agreeing to contribute to the cost of treatment. This, for me, highlights how NICE and the NHS are at the mercy of the drug manufacturers.
The price of the NHS
There is little the media enjoy more than “NHS bashing”. Open any tabloid and you will find an article stating the pitfalls in treatment, long waiting hours and stories of misdiagnosis. However, whilst as a patient you may be angry as you wish at the decisions made by the committee, I feel this anger is misdirected.
The pressure on both NICE and the NHS is fierce and comes from every angle. Drug companies want high profits, patients want the best treatment, and the NHS must stay within budget and allocated resources effectively.
The system has its drawbacks and the decisions can appear harsh and cold. But their role, however hard it may be, is to stand outside the emotion of ‘life and death’ and remain impartial. For us to be afforded free healthcare throughout our lives the needs of the many must outweigh those of the few.
(The date of the 2nd appraisal committee meeting regarding Kadcyla was originally scheduled for May 2014 but was cancelled due to the manufacturer proposing a new commercial agreement. The new date is TBC.)