Evaluating the benefits of new medicines

Among the study’s strong design characteristics were its cross-country nature and second round of results validation.
- Aris Angelis
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An innovative methodology for evaluating the benefits of new medicines has been shown to be an effective decision support tool following new evidence from real world applications led by the Department of Health Policy at LSE.

Escalating drug prices have resulted in numerous ways of evaluating treatments, many of which are partly based on intuition and guesswork – giving cause for concern that they could potentially result in misleading policy recommendations. At the same time, scarce resources, the rising demand for health services, ageing populations and technological advances threaten the financial sustainability of many health care systems and render efficient and fair resource allocation an essential but difficult task.

The Advance Value Framework, developed by Aris Angelis and Panos Kanavos of the Department of Health Policy and LSE Health – Medical Technology Research Group, was tested in practice with national key experts and stakeholders in England, France and Germany to assess the value of new drug compounds under clinical development for non-alcoholic steatohepatitis (NASH), a liver disease without any effective treatments.

Besides testing the methodology as a support tool during drug development while considering payer-related value concerns, another objective of the study was to test the consistency of the results by repeating it with two different participant groups in each country. It enabled participants to reflect on certain value dimensions and incorporate these more explicitly, as part of a more transparent deliberation process. This is the first, cross-country, multiple-criteria decision analysis (MCDA) study of its kind during drug development, eliciting the value preferences of different national stakeholders and comparing the results, while also repeating the study to validate their consistency with different participants.

The study has been published in Medical Decision Making, the official journal of the Society for Medical Decision Making. It received financial support by a research grant from Novartis as part of 2-year project.

Aris Angelis said: “The empirical findings generated improve the knowledge in the field, aiming to support decision-making along the life-cycle of new biopharmaceutical compounds when assessing their value early on during clinical development. Among the study’s strong design characteristics were its cross-country nature and second round of results validation.”   

Panos Kanavos said: “Our findings, drawn from this comparative work, demonstrate that the Advance Value Framework captures a wide range of benefits in an open, transparent and deliberative manner and in this way contributes to efficient resource allocation. In addition, our Framework provides a meaningful option for early-stage assessment of compounds in development.”

To read the latest study:

To read an earlier empirical study tested in collaboration with HTA bodies in 4 EU countries: