LSE researchers propose more holistic method for evaluating new medicines

A new methodology to help decision-makers and stakeholders evaluate new medicines has been developed by London School of Economics (LSE) researchers^[1]
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The Advance Value Framework (AVF), funded by the European Commission’s programme for research, aims to address the pitfalls of current approaches to Health Technology Assessment (HTA) by taking a more holistic approach to the value assessment of medicines and medical technologies.

“Current methods for assessing the value of new medicines are largely based on economic evaluations, like cost-effectiveness analysis”, explained Aris Angelis from the LSE, who developed the methodology along with his colleague at the school, Panos Kanavos.

“A limitation of such methods is that they can formally incorporate only certain evidence relating to the benefits of medicines.

“Therefore, other types of benefit might be informally considered in parallel, which may result in less transparent or credible decisions regarding the reimbursement and coverage of these products.”

The AVF, which is based on Multiple Criteria Decision Analysis (MCDA), consists of three levels of criteria relating to five key domains that can be explicitly measured and assessed: burden of disease, therapeutic impact, safety profile, innovation level, and socioeconomic impact.

Angelis said that the multi-criteria method allowed for the explicit incorporation of multiple benefits and their relative importance in a structured and transparent way.

According to the paper, escalating drug prices have catalysed the generation of numerous “value frameworks” with the aim of informing payers, clinicians and patients on the assessment and appraisal process of new medicines, for the purpose of coverage and treatment selection decisions. However, it claims that because these frameworks are based on weak methodologies, the resulting recommendations may be misleading.

One example refers to the the use of cost utility analysis (CUA) and the incremental cost per quality adjusted life year (QALY), which has become the metric of choice for many HTA bodies when assessing and appraising value. The authors say that “by definition the latter only considers length of life in tandem with health-related quality of life, and does not adequately capture social value such as the wider innovation and socioeconomic impact”.

This AVF could be adopted and used by any body in the field of drug evaluation and more specifically in HTA, including academics and research institutions; government; national HTA bodies, such as NICE and insurance funds; and industry, at a global level.

“In theory NICE could adapt and use such a methodology in alignment with their remit, either alone or in combination with the current methods in place,” said Angelis.

He added that HTA bodies similar to NICE in other countries have expressed an interest or are already exploring multi-criteria approaches, either in Europe or in other areas of the world, such as Latin American and East Asia.