Php315 - How Frequently Is Patient Experience Formally Assessed in Health Technology Assessments? Results From a Systematic Literature Review

Sarri, Grammati; Kenny, Juliet; Freitag, Andreas; Mountian, Irina; Szegvari, Boglarka; Brixner, Diana I.; Maniadakis, Nikos

doi:10.1016/j.jval.2018.09.1209

Cited by 2 publications

(3 citation statements)

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“…Currently, patient-based evidence is still not reported sufficiently in pharmaceutical company submission dossiers, as reported by the Canadian HTA agency (CADTH) when they reviewed dossiers submitted between December 2012 and June 2014 (21). Examples of HTAs formally assessing patient-based evidence or product labels incorporating patient data and patient value elements are still, sadly, few and far between (22, 23). However, to be fully involved in decisions related to their health is considered important by patients.…”

Section: Discussionmentioning

confidence: 99%

“…Despite the growing emphasis on patient-centeredness in healthcare and also in HTA assessments, there is to date few examples of where patient preferences have informed the decision-making process (22). Yet, patient preferences identified and quantified during early development can feed into early dialog or scientific advice consultations between pharmaceutical manufacturers and regulators/HTA agencies (https://www.eunethta.eu/early-dialogues/), typically conducted in advance of finalizing phase 3 design.…”

Section: Discussionmentioning

confidence: 99%

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Patient Preference Studies During Early Drug Development: Aligning Stakeholders to Ensure Development Plans Meet Patient Needs

Cook

Cave

Holtorf³

2019

Front. Med.

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Although patient preferences have been studied broadly for marketed products or around the time of submission to authorities and launch, patient preference studies have rarely been used during the early drug development phases. In this paper, we formulate three hypotheses supporting the use of patient preference studies in early product development: (1) integration of the patient perspective into the development process from phase 1 onwards will result in healthcare solutions with outcomes that best address patients' needs; (2) a structured process to build patient-based evidence involving partnerships between patients and other key stakeholders will improve alignment of development activities with the needs of patients; (3) quantitative patient preference research built on robust qualitative insights is necessary to strengthen development decisions in the interests of patients. To illustrate such a structured process, we describe qualitative insights research (social media analysis and online bulletin boards) and quantitative patient preference studies in dry eye disease and non-alcoholic steatohepatitis conducted during early product development by a pharmaceutical company to generate patient-based evidence. The outputs from such early patient preference studies are being used to inform patient reported outcome strategies, clinical development strategies, product design and delivery features, and form the basis for early dialog with regulators, health technology assessment (HTA) bodies and payers to ensure focus and alignment on patient-relevant endpoints. Furthermore, to discuss and theoretically substantiate our hypotheses, we review how different groups and organizations are working to embrace fully the patient perspective in product development and healthcare decision-making. The hypotheses are commensurate with the general trend toward patient-centered healthcare and the activities initiated by regulators, HTA agencies, and patient organizations. We advocate that all healthcare players should actively contribute to aligning on best practices concerning choice of methodologies and engage in multi-stakeholder dialog along the entire product development chain, to realize health technologies that best meet the needs of patients.

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Section: Discussionmentioning

confidence: 99%

Section: Discussionmentioning

confidence: 99%

Patient Preference Studies During Early Drug Development: Aligning Stakeholders to Ensure Development Plans Meet Patient Needs

Cook

Cave

Holtorf³

2019

Front. Med.

View full text Add to dashboard Cite

show abstract

“…The same applies to complementary, patient-reported experience measures (PREMs) which aim to capture elements such as route of administration of treatment, impact on caregivers and burden of disease. A recent literature review on use PREMs in 12 HTA bodies uncovered that only 11% of HTA reports published after 2012 considered these measures to some extent [16].…”

Section: Incorporating Patient-reported Measures In the Development Omentioning

confidence: 99%

Should health technology assessment be more patient centric? If so, how?

2020

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Php315 - How Frequently Is Patient Experience Formally Assessed in Health Technology Assessments? Results From a Systematic Literature Review

Cited by 2 publications

References 0 publications

Patient Preference Studies During Early Drug Development: Aligning Stakeholders to Ensure Development Plans Meet Patient Needs

Patient Preference Studies During Early Drug Development: Aligning Stakeholders to Ensure Development Plans Meet Patient Needs

Should health technology assessment be more patient centric? If so, how?

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