Patient access to new cancer drugs in the EU involves centralised licensing decisions by regulators as well as reimbursement recommendations in the context of national healthcare systems. Differences in assessment criteria and evidence requirements may result in divergent decisions at central and national levels, ultimately compromising effective access to patients. Early access decisions are p...

Researchers have made great strides in understanding and treating alcoholics with co­occurring psychiatric disorders. Improved diagnostic criteria are available, and research has demonstrated that both disorders must be addressed if the dually diagnosed patient is to have the best chance for a good outcome. The best type of treatment program is an integrated approach, assuring that treatments w...

383 Implantable cardioverter-defibrillator (ICD) and cardiac resynchronization therapy (CRT) have become mainstays of clinical cardiology practice for high-risk patients supported by persuasive clinical trial data. Yet, areas of certainty are offset by considerable uncertainty about the criteria for implantation and for reimbursement. This article reviews selected elements of the clinical trial...

To identify and analyse the global early access program (EAP) landscape, assessing different national framework’s applicability for cell gene therapies. A targeted systematic literature review was conducted to EAPs across markets: Africa; Asia; Europe; North America; Australia South America. National healthcare agency websites were used compile information relating guidelines, laws criteria of ...

INTRODUCTION Doubts have been expressed about whether standard methods of health technology assessment are suitable for the evaluation of drugs for rare diseases. Under conditions of rarity, it may be more difficult to conduct large randomized trials in order to gather adequate evidence on efficacy, and the standard methods of economic evaluation may not adequately reflect societal preferences ...

BACKGROUND Because of recent changes in criteria for coverage for inpatient hospital stays, most nonacute percutaneous coronary intervention (PCI) procedures are reimbursed on an outpatient basis regardless of underlying patient risk. Downstream effects of these changes on the risk profile of patients undergoing outpatient PCI have not been evaluated. METHODS AND RESULTS Using the American Co...

BACKGROUND To ensure rapid access to new potentially beneficial health technologies, obtain best value for money, and ensure affordability, healthcare payers are adopting a range of innovative reimbursement approaches that may be called Managed Entry Agreements (MEAs). METHODS The Health Technology Assessment International (HTAi) Policy Forum sought to identify why MEAs might be used, issues ...

OBJECTIVE To review the use of evidence in the market approval process, reimbursement, and price control mechanisms for medicines and medical devices in China, Japan, and Singapore. METHODOLOGY Documentary reviews relevant to public health policy and management by government authorities. RESULTS Drug regulatory authorities play a vital role in the market authorization process of medical tec...

AIM To perform a comparative analysis of the pharmaceutical pricing and reimbursement systems in Croatia and the 27 European Union (EU) Member States. METHODS Knowledge about the pharmaceutical systems in Croatia and the 27 EU Member States was acquired by literature review and primary research with stakeholders. RESULTS Pharmaceutical prices are controlled at all levels in Croatia, which i...