HTA Quarterly
Fall 2024
In this special themed edition, our colleagues at Vintura, a Cencora company, explore the potential of value-based partnerships (VBPs). First outlining the principles, goals, and potential benefits of VBPs, this edition also provides two case studies that demonstrate how successful partnerships work in practice.
HTA Quarterly
Summer 2024
In this edition, we continue the series on preparations for European Union (EU) HTA now that the draft implementing act on procedural rules for Joint Clinical Assessment (JCA) of medicinal products has been published. Additionally, two country-specific analyses consider the impact of AMNOG benefit assessment on drug pricing in Germany, and the impact of participation in the UK’s Early Access to Medicines Scheme (EAMS) on recommendations from the National Institute for Health and Care Excellence (NICE).
HTA Quarterly
Spring 2024
In this edition, we continue our series on preparing for the introduction of European Union (EU) health technology assessment (HTA), consider how United States (US) drug pricing negotiations under the Inflation Reduction Act (IRA) compare with those in countries with an established price negotiation framework, and assess the strengths and limitations of artificial intelligence (AI) tools for literature reviews.
HTA Quarterly
Winter 2023
With EUnetHTA 21 coming to an end and details emerging of the timelines and evidence requirements that will govern the new Joint Scientific Consultation (JSC) and Joint Clinical Assessment (JCA) processes, the authors consider how biopharma companies, health technology assessment (HTA) bodies, patients, and clinicians can best prepare for the start of the European Health Technology Assessment Regulation (HTAR). Also in this edition, we review the latest changes to the Institute for Clinical and Economic Review (ICER)’s value assessment framework, and explore the National Institute for Health and Care Excellence (NICE)’s early value assessment approach to assessing MedTech, including digital health technologies.
HTA Quarterly
Winter 2024
In this edition, we look ahead to the introduction of the European Union (EU) Joint Clinical Assessment (JCA), with a focus on predicting likely PICOs (population, intervention, comparator, outcomes) mandated in the submission template. Two related articles review completed German AMNOG assessments in detail to evaluate how the stringent G-BA requirements translate into practice, considering how evidence requirements vary between orphan and non-orphan drugs, and acceptance – or not – of indirect comparisons when head-to-head evidence is not available.
HTA Quarterly
Fall 2023
With just 17 months until Joint Clinical Assessment (JCA) is implemented for oncology drugs and advanced therapy medicinal products (ATMPs) in the European Union, in this edition we consider what we know so far and what is still uncertain. The authors also reflect on the industry’s perception of the current UK Voluntary Pricing and Access Scheme and hopes for the new scheme scheduled to start in January 2024. Against the backdrop of increased payer interest in and use of US value assessment tools, we question whether ICER’s assessment framework is sufficiently rigorous to accurately capture the value of potentially transformational therapies.
HTA Quarterly
Summer 2023
Marking the 10th anniversary of HTA Quarterly, the editors reflect on the ever-changing face of market access, as biopharma companies, regulators, and payers unite in a common aim to improve outcomes for patients while directing funds to those products that offer the greatest value. We also look back at the first 3 years of Project Orbis, a collaborative program intended to standardize and streamline global approval of innovative oncology treatments, and consider the role of artificial intelligence in the future of HTA.
HTA Quarterly
Spring 2023
In this issue, our editors examine assessment of innovation in Italy; while the rules may be clear, the outcomes are not always black and white. Additionally, in a pair of articles focused on the rapidly growing biosimilars market, we consider the market dynamics and incentives that impact biosimilar adoption, pricing, and reimbursement, in both the US and Europe.
HTA Quarterly
Fall 2022
In this issue, our editors provide insights on the new European Union health technology assessment (HTA) regulation, an analysis of the use of health economics to respond to the COVID-19 pandemic, and a review of Germany’s newly adopted Statutory Health Insurance Financial Stabilization Act.
HTA Quarterly
Summer 2022
In this issue, our editors provide insights on the Institute for Clinical and Economic Review’s (ICER’s) recently published assessment of fair access criteria, a review of the lock system for orphan drugs in the Netherlands, and an analysis of the United Kingdom (UK) National Institute for Health and Care Excellence’s (NICE’s) new Health Technology Assessment (HTA) manuals.
HTA Quarterly
Fall 2021
In this issue, our editors examine ICER's approach to Unsupported Price Increase (UPI) assessments, how health disparities play a pivotal role in health outcomes of marginalized patient populations, and how the evolution of cancer therapeutics offers opportunities to gain insights from key opinion leaders in oncology.
HTA Quarterly
Summer 2021
In this issue, our editors
examine two new tools from the Institute for Clinical and Economic Review
(ICER), assess the value of vaccines from an HTA perspective, and provide an
update from our previously published infectious disease economic model on the COVID-19
pandemic.
HTA Quarterly
Spring 2021
In this issue, our editors examine how real-world evidence impacts regulatory decisions in the United States, the current state of reimbursement for Advanced Therapy Medicinal Products (ATMPs) in Germany, and a look at two value assessment frameworks Innovation and Value Initiative (IVI) and the Institute for Clinical and Economic Review (ICER).
HTA Quarterly
Summer 2019
In this issue, we review HTA frameworks for next-gen sequencing in precision oncology, how HTAs review tumor-agnostic therapies, and the rise of complex technologies and their reimbursement landscape. Read our special feature, Hot Topic, on the changes in France’s healthcare system on medicinal products.
HTA Quarterly
Spring 2019
In this issue, we examine the impact of the 21st Century Cures Act on stakeholders in the United States, explore the proposed rule from the Centers for Medicare & Medicaid Services on managed care value-based formulary decisions, and consider how patient input can help influence drug development.
HTA Quarterly
Winter 2019
In this issue, we take a closer look at the utilization of “multiple criteria decision analysis” (MCDA) in health technology appraisals, newer therapies for Cystic Fibrosis, and the regulatory pathways and complexity of health technology assessment (HTA) evidentiary hurdles for new diabetes drugs, devices, and combination technologies.
Our editors
Managing editor
Jayne Hurrell, MA
Director, Value & Access Communication
Editorial board
Tommy Bramley, PhD
Sr. Vice President | Global Consulting | United Kingdom
Josep Darbà, PhD
Professor | Department of Economics | University of Barcelona | Spain
Grant Perry, BPA(h)
Sr. Director | Innomar Strategies | Canada
Mike Drummond, PhD
Professor | Centre for Health Economics | University of York | United Kingdom
George Papadopoulos, BSc(Hons), GradDipEpi
Director & Partner | Lucid Health Consulting | Australia- Ken Redekop, PhD
Associate Professor I Erasmus University I The Netherlands - Eldon Spackman, BA, MA, PhD
Co-Director | Institute for Public Health | University of Calgary | Canada - Keith Tolley, BA, MPhil
Director | Tolley Health Economics | United Kingdom