The Race for COVID-19 Vaccines: Accelerating Innovation, Fair Allocation and Distribution.

Racing to develop and distribute a vaccine against COVID-19 has proven to be a challenging endeavor. Not only has there been the enormous scientific-technical challenge of developing the world's first vaccines against a coronavirus, the subsequent ethical issues involved in vaccine allocation have been equally complex. This contribution focuses on the policy and strategic aspects of accelerating innovation, fair allocation, and distribution.

Clinical and economic impact of HeartLogic™ compared with standard care in heart failure patients.

Aims: The implantable cardiac defibrillator/cardiac resynchronization therapy with defibrillator-based HeartLogic™ algorithm has recently been developed for early detection of impending decompensation in heart failure (HF) patients; but whether this novel algorithm can reduce HF hospitalizations has not been evaluated. We investigated if activation of the HeartLogic algorithm reduces the number of hospital admissions for decompensated HF in a 1 year post-activation period as compared with a 1 year pre-activation period.

Methods And Results: Heart failure patients with an implantable cardiac defibrillator/cardiac resynchronization therapy with defibrillator with the ability to activate HeartLogic and willingness to have remote device monitoring were included in this multicentre non-blinded single-arm trial with historical comparison.

Economic evaluation of an ultra-high density mapping system compared to non-ultra-high density mapping systems for radiofrequency catheter ablation procedures in patients with atrial fibrillation.

Purpose: Advanced non-fluoroscopic mapping systems for radiofrequency ablation (RFA) have shown to be an effective treatment of atrial fibrillation. This study analyzes the resource usage and subsequent costs associated with the implementation of an ultra-high density mapping system (UHDMS) compared to non-ultra-high density mapping systems (NUHDMS).

Methods: This retrospective observational study included 120 patients (18 years or older) with paroxysmal or persistent atrial fibrillation who underwent RFA for de novo pulmonary vein isolation guided either by an UHDMS (n=63) or NUHDMS (n=57) for their index procedure.

A report on the status of vaccination in Europe.

Vaccine policy, decision processes and outcomes vary widely across Europe. The objective was to map these factors across 16 European countries by assessing (A) national vaccination strategy and implementation, (B) attributes of healthcare vaccination systems, and (C) outcomes of universal mass vaccination (UMV) as a measure of how successful the vaccination policy is. A.

Cost-Utility Analysis of Lipegfilgrastim Compared to Pegfilgrastim for the Prophylaxis of Chemotherapy-Induced Neutropenia in Patients with Stage II-IV Breast Cancer.

Lipegfilgrastim (Lonquex®) has demonstrated to be non-inferior to pegfilgrastim (Neulasta®) in reducing the duration of severe neutropenia (SN) in patients with stage II-IV breast cancer. Compared to pegfilgrastim, lipegfilgrastim also demonstrated statistically significant lower time to ANC recovery in cycles 1-3, lower incidence of SN in cycle 2 and lower depth of absolute neutrophil count (ANC) nadir in cycles 2 and 3. The aim of this study was to quantify the cost utility of lipegfilgrastim compared to pegfilgrastim in stage II-IV breast cancer patients, taking the perspective of the Belgian payer over a lifetime horizon.

Making sense of big data in health research: Towards an EU action plan.

Medicine and healthcare are undergoing profound changes. Whole-genome sequencing and high-resolution imaging technologies are key drivers of this rapid and crucial transformation. Technological innovation combined with automation and miniaturization has triggered an explosion in data production that will soon reach exabyte proportions.

Pharmaceutical portfolio management: global disease burden and corporate performance metrics.

Background: Biopharmaceutical companies face multiple external pressures. Shareholders demand a profitable company while governments, nongovernmental third parties, and the public at large expect a commitment to improving health in developed and, in particular, emerging economies. Current industry commercial models are inadequate for assessing opportunities in emerging economies where disease and market data are highly limited.

Equity in Pharmaceutical Pricing and Reimbursement: Crossing the Income Divide in Asia Pacific.

Objectives: The article takes a three-dimensional approach (triangulation) in defining international pricing policy for pharmaceuticals using cost-effectiveness analysis (CEA), willingness-to-pay (WTP) analysis, and ability-to-pay (ATP) analysis. It attempts to find a balance between the various economic methods of which some focus on effectiveness while others are geared toward incorporating equity in the equation.

Methods: A critical review of the first two established economic methods and their ability to evaluate not only "efficacy" but also "fairness" in pricing decisions identifies a gap in the latter.

Delivering the promise of the Decade of Vaccines: opportunities and challenges in the development of high quality new vaccines.

The Decade of Vaccines (DoV) initiative, launched in 2010, has as its mission "to extend, by 2020 and beyond, the full benefits of immunization to all people, regardless of where they are born, who they are, or where they live". Through their life-saving vaccines, the research-based vaccine companies represented by the International Federation of Pharmaceutical Manufacturers & Associations (IFPMA) and the Biotechnology Industry Organization (BIO) make a major contribution toward this vision. In this article, we begin by summarizing progress made over the past three decades in research and development (R&D) of new and future vaccines, and identify the opportunities and challenges faced by the research-based vaccine industry.