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PREFER Report Summary

Project ID: 115966
Funded under: H2020-EU.3.1.7.

Periodic Reporting for period 1 - PREFER (Patient Preferences in benefit risk assessments during the drug life cycle - Sofia ref.: 115966)

Reporting period: 2016-10-01 to 2017-09-30

Summary of the context and overall objectives of the project

PREFER will determine how patient preferences can support decision-making across the medicinal product life cycle. PREFER will test different methods to elicit patient preferences. The project will make recommendations on which methods are best to use at the different points when decisions are made in the medical product lifecycle. PREFER recommendations will be for the companies developing medical products (Industry), the authorities that approve them (Regulators), the authorities that decide on pricing and reimbursement (Health Technology Assessment (HTA) bodies and/or Payers). PREFER will involve patients and other stakeholders during the project. Along with a scientific assessment of preference elicitation methods, the project will include recommendations on when and how to best ask for patient input.

Work performed from the beginning of the project to the end of the period covered by the report and main results achieved so far

In the first year, structures and resources to manage the project have been put in place. IT solutions for storing and sharing data have been put in place, along with binding plans to ensure this is done in a way that protects privacy (following legal regulatory frameworks, e.g. the new EU General Data Protection Regulation). A plan for communicating about PREFER was also made, along with support to inform patients and other external audiences. Scientific issues related to health preference elicitation have been discussed with experts outside the consortium at various international conferences in order to gain insights. To support the work and ensure the project recommendations are relevant, PREFER has formed three advisory groups: one for patients, one for regulatory authorities, and one for HTA bodies and Payers.

PREFER has reviewed the literature related to possible preference elicitation methods and held in-depth interviews with individual stakeholders outside the project. This work has allowed PREFER to identify the desires, expectations, concerns, and requirements stakeholders have about methods for patient preference elicitation, and when they could use patient preferences to make decisions on medicinal products. In all, 143 interviews were performed, recorded and transcribed. Those interviewed include patients, informal caregivers, patient representatives, physicians, regulators, reimbursement agency representatives, health technology assessment body representatives, industry representatives and academics. To capture cultural differences, interviews were carried out in Sweden, Romania, Italy, the United Kingdom, the Netherlands, Germany, France and the United States. The same methods were used in all interviews to identify culture-specific processes, conditions, and contextual factors that influence perceived advantages and possible roles that patient preference could have throughout medical product development.

PREFER used a three-step approach to identify preference elicitation methods. In the first step, the project looked at methods listed in previous preference methods reviews. The second step consisted of a systematic literature review. In the final step, PREFER consulted with international preference study experts outside the project. The result of these 3 steps was a list of 32 methods that can be considered for medical product decision making However, only 18 of them had been used in preference research looking at medical products.

Scoping reviews were used to identify, describe and assess the clinical feasibility of (1) using different ways to communicate risk, (2) educate patients, and (3) profile psychological variables that can affect the construction, elicitation, and interpretation of patient preferences. This work formed the basis for recommendations on how to present risks (unfavourable effects) in preference studies. Recommendations describe motivational factors for selecting different psychological constructs that can be used to measure preferences. Moreover, the recommendations describe educational components of preference studies. Criteria for assessing and selecting ways measure why patients have certain preferences were also developed. Recommendations include specific guidelines for educational tools that chart how the characteristics of a preference study relate to the selection of specific educational features. To help researchers select educational tools, PREFER has developed an Educational Feature-Identifier Grid along with recommendations.

PREFER identified candidate methodologies and criteria to assess both empirical clinical case studies and computer simulation studies. Furthermore, case study synopses and preliminary research questions were developed to be used in three disease areas: Rheumatology, Lung cancer and Neuromuscular disorders.

Progress beyond the state of the art and expected potential impact (including the socio-economic impact and the wider societal implications of the project so far)

Health preference studies have been performed both by the pharmaceutical industry and by academic institutions for different disease areas. However, this is the first time that an assessment of the methods used is made based on a comprehensive mapping of concerns and needs of all relevant stakeholders as well as on systematic and scoping reviews of the relevant literature. 14 methodologies have been identified that have hitherto not been used. The approach using psychological and educational expertise in order to in a systematic way attain well-informed and reflected preferences with identification of psychological instruments that may help profiling patients and thereby understanding reasons for heterogeneity is new to the field and of great implication for the possibility to address questions on representativeness and generalisability of results from health preference studies.

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