Scientific Publications
OBJECTIVES: Point of care rapid diagnostic tests (RDTs) have demonstrated accurate and timely diagnosis across decentralized settings, broadening patient access in remote locations and improving pathways to diagnosis. This study aimed to synthesize published and other literature on the clinical, societal, and economic value of RDTs for infectious disease across Asia, Africa, and Latin America.
METHODS: A systematic literature review (SLR) was conducted using PubMed and Embase for publications dated 2017 to 2021 in accordance with PRISMA guidelines using RDT and infectious…
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Scientific Publications
OBJECTIVES: The European Medicines Agency’s in-vitro diagnostics (IVD) regulation (IVD-R) will roll out over the next 5 years; under IVD-R, Notified Bodies (NBs) will be required to review a larger proportion of IVDs (estimated increase from 8% to 80%). Under IVD-R manufacturers will not only have to demonstrate safety and equivalence of their IVD, but also scientific validity and analytical/clinical performance. Thought papers have hypothesized IVD-R’s impact on development timelines and evidence requirements. Key concerns include delays in approval timelines due…
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Scientific Publications
OBJECTIVES: As COVID-19 severely restricted patients’ ability to visit care settings in-person, the use of telehealth was impacted; the immediate and enduring impact on telehealth utilization is an unanswered question. This study aimed to identify medical conditions typically treated using telehealth and quantify trends in telehealth utilization through the COVID-19 pandemic.
METHODS: A retrospective analysis was performed using a 10 million-record random sample of patients with telehealth visits (with telehealth defined by CPT codes with telehealth modifiers or place-of-service codes).…
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Scientific Publications
OBJECTIVES: Cell and gene therapies (CGT) have prompted innovation in the life sciences landscape and captured national attention. However, the real-world use across this therapeutic class is not well quantified. This study aims to evaluate CGT uptake and quantify utilization patterns in the US, from 2015-2021.
METHODS: This study analyzed patient-level US claims data in the Komodo Healthcare Map™, a dataset including longitudinal medical and prescription claims encompassing adjudicated claims of >150 million unique enrollees from the US commercial, Medicare,…
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Scientific Publications
OBJECTIVES: Endogenous Cushing’s syndrome (CS) is a rare endocrine disorder characterized by chronic cortisol overproduction. Our objective was to summarize the economic and health-related (HR) quality of life (QoL) burden of CS and evaluate post-treatment burden.
METHODS: A systematic literature review (SLR) using the Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) checklist was conducted to identify peer-reviewed manuscripts and conference abstracts published in English from 2015 to December 4th, 2020, in PubMed, MEDLINE, and Embase.
RESULTS: Forty-five publications were included. Data…
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White Papers
The U.S. health economics and outcomes research (HEOR) field has seen many changes over the last decade, including significant growth driven by payers, regulators and clinicians who are increasingly looking to Real-World Evidence (RWE) as a valuable source for patient-level data. To understand the implications of this growth, the Trinity Life Sciences Evidence Strategy team sought to gain a multi-disciplinary view on where and how HEOR experts see the field evolving and to better understand how HEOR capabilities can be…
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Briefs
Learning and Development leaders within life sciences have led and managed change like never before. The global pandemic brought live customer engagements to a halt and an intense focus on using time for enhanced development. To deliver, Learning and Development (L&D) teams had to identify resources to meet the expectations of stakeholders while redesigning and virtually-delivering to learners. In most scenarios, L&D teams were learning at the same time as their audiences.
This study assesses the current landscape of L&D,…
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Blog
Published April 8, 2022
The Assessment Process of Innovativeness of a New Medicine in Italy
In April 2017, AIFA (Agenzia Italiana del Farmaco, Italian Medicines Agency) released an upgraded algorithm to assess and evaluate the level of innovativeness of new drugs seeking reimbursement from the EUR one billion innovative medicine fund made available by the Italian MoH (Ministero della Salute, Ministry of Health).
The algorithm introduced in 2017 provides a multi-dimensional approach: innovativeness will be judged by AIFA’s CTS (Commissione Tecnico-Scientifica, Technical and Scientific…
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Webinars
Available On Demand
Join Trinity Life Sciences for a webinar that explores the findings from our TGaS report entitled, ‘Commercial and Medical Affairs Leaders Landscape 2022’. The study is based on the responses of 35 Commercial leaders and 24 Medical Affairs leaders representing 56 separate biopharmaceutical companies.
Commercial and Medical Affairs teams continue to play an important role in healthcare innovation and the value of having cross-functional collaboration is more critical than ever.
Join us for a dynamic discussion as we cover the…
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Blog
Published March 29, 2022
Executive Summary
French president Emmanuel Macron announced a two-year trial that will allow pharmaceutical products that receive an ‘Amélioration du Service Médical Rendu’ (ASMR) rating of IV or better to get reimbursement immediately after the evaluation by the Transparency Committee (TC)
In these cases, price negotiations will start while the new therapies are already on the market
This new reform started in January 2022 as part of a two-year pilot project and is expected to significantly reduce the average time…
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