What are HTA processes and methods?
These are the decision-making processes and decision-making criteria used by different jurisdictions and their respective HTA and reimbursement authorities, to assess health technologies. These are important as they drive evidence requirements and these specifications are usually set out in process & methods guidance and available to download on the websites of the responsible agencies.
You may notice there are plenty of similarities between jurisdictions but they also reflect the needs and context of a particular healthcare system, therefore you will also see significant differences in approaches taken and subsequent implications of different outcomes.
Differences are driven by the structural differences across health systems such as history, structure, funding, treatment practices and the role of stakeholders. Obvious examples are differences between health systems with universal health care and those without, so UK and US. There are however significant differences between jurisdictions that are often considered to be of a similar archetype, so have similar health systems and use similar methods.
From an evidence perspective, what impact do these differences have in practice?
There may be a need to focus on different patient populations, measure different outcomes, generate comparative data in different ways, generate comparative data versus different comparators or use different approaches to economic evaluation.
It is therefore important to understand the rules for decision-making and adapt evidence generation to the different evidence requirements; the difficult part is deciding the most appropriate way of doing this; from a global perspective this introduces complexity as the differences can be far reaching and numerous and feasibly, you are going to have to compromise somewhere.
An additional consideration: processes and methods change; therefore, one has to adapt and also keep up with a constantly evolving set of expectations.
In summary process and methods are the decision-making processes and criteria used by HTA and reimbursement authorities. There are many similarities but also striking differences. These have an implication on evidence requirements and the choices required for evidence generation.
- AMCP, 2020. AMCP Format for Formulary Submissions Guidance on Submission of Pre-approval and
2. Post-approval Clinical and Economic Information and Evidence CADTH-pOCDR. Procedures for the CADTH pan-Canadian Oncology Drug Review. Canadian Agency for Drugs and Technologies in Health; 2020
3. NICE, 2014. Guide to the processes of technology appraisal. National Institue of Health and Care Excellence; 2014
4. NICE, 2022. NICE health technology evaluations: process and methods (PMG36)
5. PBAC. Guidelines for preparing submissions to the Pharmaceutical Benefits Advisory Committee. Pharmaceutical Benefits Advisory Committee; 2016.
6. PBS. Procedure guidance for listing medicines on the Pharmaceutical Benefits Scheme. Australian Government Department of Health – Pharmaceutical Benefits System; 2020.