Frequently news stories feature headlines such as ‘Doctors’ despair as NICE rejects another breast cancer drug that can extend life: ‘Treatment is eighth to be turned down by watchdog in three years’ or ‘NICE rejects pancreatic cancer regimen over cost concerns.’ While naturally rejections disappoint many, there is an essential evaluation process, largely based on the concept known as ‘Quality of Life’ (QOL) that ensures the clinical utility and return on investment from a new treatment. This and other measures are used by bodies such as, NICE to evaluate new medical technologies, some treatments unfortunately simply fail to address quality of life.
QOL is a term in regular use that can be hugely subjective as the general well being of individuals and societies, clearly the ultimate customer requirement. Aside from the general statement, it has a specific meaning in the world of healthcare, both in terms of assessment of patient wellbeing – Health-Related Quality of Life (HRQL) – and in terms of the benefit claims for a given treatment – QOL Claims. These two factors have a huge impact on whether a drug is accepted or rejected into general use.
HRQL measures are used to assess a patient’s status and can take the form of various questionnaires, some generic and some disease specific, the aim being to make assessment of quality of life less subjective. The questionnaires cover physical, social and emotional aspects to determine the current state and evaluate treatment options, and are often used during clinical trials.
Drugs, biologics and medical devices are often accompanied by QOL claims. These statements are based on the patient’s evaluation of the product’s impact on relevant aspects of life (e.g. supports urinary control 10 days after surgery). These QOL claims are important in determining if a new treatment will be adopted and reimbursed by a healthcare body. Organisations such as The National Institute of Health and Care Excellence (NICE) use scales such as quality and QOL and QALY, to determine the benefits to patients, survival rates and fundamentally cost/benefit analysis.
In reality NICE approve the majority of drugs they assess, however rejected treatments will still be a challenge both for healthcare practitioners, patients and the medical technology industry. It is important for medical technology developers to become aware of these parameters and adapt, to reduce waste wherever possible in development, testing and manufacture to set the balance of cost/benefit in a strong direction, while assuring quality and minimising risk.
NICE are likely to still make the headlines as new drugs are rejected, however it is important to be aware, just as with any customer decision, return on investment and good use of the facts are key throughout the supply chain.
Hannah Murfet is a medical biochemist turned quality professional, and Vice-Chair of the CQI’s Next Generation Network.