Reflections on national strategies for new medicines
2020-07-12 02:00:00
The accelerated pace of technological developments, increasingly complex therapies and the combination of different technologies is changing regulatory practice, influencing HTA as well as pricing and reimbursement.
Innovative medicines targeting a (high) unmet-medical-need often demand marketing authorisation through an expedited procedure based on much less robust evidence, leading to a higher uncertainty of effectiveness and safety.
In this changing environment, payers must still continue to ensure that decisions on access to safe and effective therapies are based on sufficient evidence and that prices reflect the actual added benefit to patients (and/or health systems). Thus, new products receiving marketing authorisation by way of expedited procedures present a challenge to current practices.
This paper is a reflection of how payer organisations in close cooperation with regulators, HTA, health professionals, patient organisations and marketing authorisation holders can implement changes to deal with these challenges.
To view the full reflection paper, click on the following link.
