Health Technology Assessments (HTA)

What is Health Technology Assessment (HTA)?

A health technology is an intervention developed to prevent, diagnose or treat medical conditions; promote health; provide rehabilitation; or organize healthcare delivery. This can include educational and screening programmes, diagnostics, devices, medicines, surgical procedures, vaccines, etc.

Health technology assessment, or HTA, is the process to determine value of a health technology. Value may be assessed by examining the intended and unintended consequences of using a health technology compared to existing alternatives across the following domains:

  • Clinical effectiveness

  • Safety

  • Costs and economic implications

  • Ethical and social implications

  • Cultural and legal issues

  • Organizational and environmental aspects

  • Wider implications for the patient, relatives, caregivers, and the population

Reference: O’Rourke B, Oortwijn W, Schuller T, the International Joint Task Group (2020). The new definition of health technology assessment: A milestone in international collaboration. International Journal of Technology Assessment in Health Care 1–4. https://doi.org/10.1017/ S0266462320000215 

To learn more about HTA in orphan products for rare diseases, visit here.

What is Patient Involvement In HTA?

The Patient and Citizen Involvement Interest Group of Health Technology Assessment International defines “involvement” to be a wide-ranging term with two distinct, but complementary approaches:

  1. Research to provide evidence about patient and citizen/public perspectives, needs, preferences and experiences to input to HTA

  2. Patient and citizen/public participation in HTA processes

For an overview of why patients can and should be included in HTA processes, see here.

HOW TO EVALUATE IMPACT OF PATIENT INVOLVEMENT?

I co-lead the work of the Patient and Citizen Involvement Interest Group to support characterizing and reporting the impact of patient involvement in HTA. Draft framework incorporates three domains of impact:

  • Impact on decision-making [Content and decision outcome]

  • Impact on patient stakeholders [Patient participatory experience vs (disease experience)]

  • Impact on HTA bodies [Process and organizational culture]

Reference: Ongoing work of Stakeholder Perspectives of Impact project under HTAi Patient and Citizen Involvement in HTA Interest Group (PCIG).

 

You can learn more about the ongoing work to evaluate impact of patient involvement, through the webinars:

When and how should patients be involved in HTA process?

Patients can and should be involved across all stages in the HTA process and even at the organizational level of HTA bodies. This includes:

  • Topic proposal, selection, and prioritization of HTA topics

  • Topic scoping

  • Assessment and appraisal

  • Shaping conclusions and recommendations

  • Participating in the decision-making structures and processes of HTA

  • Committee deliberations and decision-making processes

  • Developing and reviewing processes, methods and HTA resources

  • Responding to consultations on assessments and appraisals

  • Dissemination, implementation and adoption of HTA conclusions and recommendations

  • Plain language summaries

  • Standing groups or other structures

Adapted from: INAHTA position paper | Date of Issue: June 2021 | https://www.inahta.org/download/inahta-position-statement-on-patient-involvement/

 

different methods of involving patients in HTA processes

Patients can be engaged through a variety of methods depending on the goals and needs of the engagement.

 

To learn more about the difference between patient and citizen involvement, the different ways to engage, ongoing gaps in engagement, and the particularities of HTA in rare diseases, visit the following blogs:

Patient involvement in Early Dialogues

Early Dialogues are processes through which medicine developers can request to discuss their research plans and gain feedback on their planned approach with regulators and health technology assessment (HTA) bodies. This includes advice on the integration of HTA requirements (e.g. choice of comparators, relevant outcomes, quality of life, patient groups) in the study design (pivotal trials & post-launch studies) and the economic evidence generation plan.

The advice provided as part of an early dialogue process is not binding, meaning the medicine developer does not have to follow it, and the HTA agency is in no obligation to approve the medicine if the developer follows the advice given.

Early dialogues usually take place before the start of pivotal clinical trials (after feasibility / proof of concept study, before Phase 2 or 3 protocol has been finalized).

Patient engagement and involvement in these dialogues is needed to ensure that patient experience, perspectives and knowledge is captured as part of this dialogue.

Sources and references: