Trends in avoidable mortality from cardiovascular diseases in the European Union, 1995-2020: a retrospective secondary data analysis.

Background: Certain causes of death can be avoided with access to timely prevention and treatment. We quantified trends in avoidable deaths from cardiovascular diseases for European Union (EU) countries from 1995 to 2020 and examined variations by demographics, disease characteristics, and geography.

Methods: Retrospective secondary data analysis of avoidable cardiovascular mortality using the WHO Mortality Database.

A Framework for Digital Health Policy: Insights from Virtual Primary Care Systems Across Five Nations.

Digital health technologies used in primary care, referred to as, virtual primary care, allow patients to interact with primary healthcare professionals remotely though the current iteration of virtual primary care may also come with several unintended consequences, such as accessibility barriers and cream skimming. The World Health Organization (WHO) has a well-established framework to understand the functional components of health systems. However, the existing building blocks framework does not sufficiently account for the disruptive and multi-modal impact of digital transformations.

Health technology assessment for cancer medicines across the G7 countries and Oceania: an international, cross-sectional study.

Background: Criticisms have emerged that cancer medicines offer modest benefits at increasingly high prices. Reimbursement decisions made by health technology assessment (HTA) agencies have become a complex endeavour for cancer medicines. Most high-income countries (HICs) use HTA criteria to identify high-value medicines for reimbursement under public drug coverage plans.

Post-Marketing Requirements for Cancer Drugs Approved by the European Medicines Agency, 2004-2014.

To address unresolved questions about drug safety and efficacy at the time of approval, the European Medicines Agency (EMA) may require that manufacturers conduct additional studies during the postmarketing period. As a growing proportion of new cancer drugs are approved on the basis of limited evidence of clinical benefit, timely completion of postmarketing requirements is important. We used publicly available regulatory documents to evaluate key characteristics of pivotal studies supporting EMA-approved cancer drugs from 2004-2014 and assessed completion rates of postmarketing data collection requirements after a minimum of 5 years.

Assessment of Coverage in England of Cancer Drugs Qualifying for US Food and Drug Administration Accelerated Approval.

Importance: Numerous cancer drugs have received accelerated approval from the US Food and Drug Administration (FDA) based on clinical trial outcomes that are otherwise not acceptable for traditional FDA approval; the accelerated approval process allows outcomes based on surrogate measures that are only reasonably likely to estimate clinical benefits. In England, the National Institute for Health and Care Excellence (NICE) evaluates the clinical benefits and cost-effectiveness of drugs after they have received regulatory approval and issues recommendations regarding their coverage in the National Health Service (NHS). However, the level of concordance between European and FDA decision-making in the context of drugs qualifying for FDA accelerated approval is unknown.

Cost-effectiveness of cancer drugs: Comparative analysis of the United States and England.

Background: England's National Institute for Health and Care Excellence (NICE) and the US' Institute for Clinical and Economic Review (ICER) both conduct cost-effectiveness evaluations for new cancer drugs to help payers make drug coverage decisions. However, NICE and ICER assessments have been noted to reach different conclusions. We aim to better understand the degree to which their recommendations diverge and what drives these apparent differences.

The 'Netflix plus model': can subscription financing improve access to medicines in low- and middle-income countries?

At present, pay for prescription models are insufficient at containing costs and improving access to medicines. Subscription financing through tenders, licensing fees and unrestricted or fixed volumes can benefit stakeholders across the supply chain. Pharmaceutical manufacturers can reduce the need for marketing expenses and gain certainty in revenue.