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Ole Henriksen: How health technology assessments transformed clinical development
Manage episode 382347596 series 3526489
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This week we speak to Ole Henriksen, Associated Partner of Nordic Healthcare Group and pharmaceutical market access expert. We speak about how health technology assessments (HTA) has impacted how we conduct clinical trials.
Health Technology Assessment (HTA) emerged first as a research area in decision aids. Later, during the 1990s, as a formal requirement for reimbursement.
Due to it being a requirement in many markets, it is often called “the 4th hurdle”. It should be understood in addition to regulatory requirements on efficacy, safety and quality, HTA poses a 4th requirement of therapeutic value or value for money.
The main purpose of conducting an assessment in the first place is to inform decision making. The research question or decision problem is: Should we include the technology as part of standard of care (and reimburse it)?
Historically clinical trials were used to gain market access by passing regulatory requirements – efficacy, safety and quality. The emergence of HTA meant that data and information on the technologies at time of marketing should also be used to assess the value of the technology vs. existing clinical practice and in clinical practice.
This is perhaps one of the big dilemmas in medical development today that we have regulatory authorities who grant priority review/fast track and so on, but HTA authorities asking for more certain effects to be documented at reimbursement.
Guest:
Ole Henriksen
https://www.linkedin.com/in/ole-henriksen-b911705/
Nordic Healthcare Group
https://nordichealthcaregroup.com/
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