QALYs in cancer: are they meaningfully counted?
New analysis has revealed that, in Canada, information concerning patients’ health-related quality of life changes is often not routinely documented in cancer clinical trials, or incorporated into the decision making process for a drugs' reimbursement.
Both the effectiveness and cost effectiveness of a new therapy are important parameters to assess with regards to determining the value and reimbursement status of a trial drug. A common evaluation method for this concerns determining the cost of the drug per quality-adjusted life year (QALY) the patient gains. A new analysis has revealed that drug manufacturers in Canada do not routinely document original information concerning patients’ health-related quality of life changes in cancer clinical trials or incorporate this data into the decision making process for a drugs' reimbursement.
In Canada, recommendations for reimbursement concerning new cancer therapies come from the pan-Canadian Oncology Drug Review department (pCODR) of the Canadian Agency for Drugs and Technologies in Health (CADTH; Ottawa, Canada). It is commonly accepted that a new technology or medical device that yields a cost per QALY of CA$50,000, or less, is likely to receive reimbursement.
Clinical trials were not originally designed to collect and report on information that is meaningful to patients regarding a trial drug or to address reimbursement decisions.
In an interview with The Evidence Base, Nancy Dreyer, Chief Scientific Officer for IQVIA Real World Solutions (NC, USA), explained: “Randomized controlled trials are considered the gold standard for evaluating whether a medical treatment can work, but not whether the treatment does work for diverse patients in real-world situations.”
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In this study, to determine to what extent cancer drug trials collect information that is meaningful to patients and relevant to reimbursement decision making, a team of researchers led by Adam Raymakers from the Canadian Centre for Applied Research in Cancer Control (Vancouver, Canada) assessed drug manufacturer reimbursement submissions received by the pCODR department during 2015–2108.
In all submissions reviewed, the drugs’ QALY gains were very small.
65% of submissions concerned drugs for which the cost effectiveness of the therapy was estimated to be greater than CA$100,000 per patient QALY gain.
Further, over 50% of submissions did not contain original data on patients’ health-related quality of life gains from the trial drug; most reports instead relied on evidence from previous studies concerning this.
Raymakers commented: “It is important to bring attention to the idea that when drug companies/manufacturers are talking about improvements from new and expensive drugs, they might not actually be meaningful improvements or they may not be improvements that are valued by patients.”
“Patients and the public should understand that it can often be the case that these drugs might confer little to no meaningful benefit, at a substantial cost. If drug prices continue to rise, and are to be reimbursed by insurance companies or publicly funded systems, these drugs must offer benefit relative to their costs. Benefit should not be an abstract measure but rather one that is valued by patients,” concluded Raymakers.
Raymakers AJN, Regier DA, Peacock SJ. Health‐related quality of life in oncology drug reimbursement submissions in Canada: A review of submissions to the pan‐Canadian Oncology Drug Review. Cancer. doi: 10.1002/cncr.32455. (Epub ahead of print) (2019);
A cost‐utility analysis utilizes data from preference‐based measures of patients' health‐related quality of life. The analysis assesses the effects of competing therapies with QALYs.
Calculating the QALY gain associated with a drug is a common way of assessing the health gains associated with that specific drug or medical technology. One QALY gain equates to a gain of one year in 'perfect' health for the recipient patient.