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Journal of Market Access & Health Policy

Nick Hicks, Keith Allan, Christoph Thalheim, Paul Woods
BACKGROUND: A key task for the pharmaceutical industry is to understand the compliance implications of engaging with a patient advocacy group (PAG). This presents challenges for the industry to negotiate the ethical and reputational issues that can arise when working with a PAG. OBJECTIVE: To gain the views of pharmaceutical industry executives on future compliance challenges when working with PAGs. STUDY DESIGN: We conducted two surveys among two sets of industry executives: one group focussed on market access roles and the other focussed on non-market access roles...
2016: Journal of Market Access & Health Policy
Donald R Ricci, Thomas R Marotta, Howard A Riina, Martina Wan, Joost De Vries
Training has been important to facilitate the safe use of new devices designed to repair vascular structures. This paper outlines the generic elements of a training program for vascular devices and uses as an example the actual training requirements for a novel device developed for the treatment of bifurcation intracranial aneurysms. Critical elements of the program include awareness of the clinical problem, technical features of device, case selection, and use of a simulator. Formal proctoring, evaluation of the training, and recording the clinical outcomes complement these elements...
2016: Journal of Market Access & Health Policy
Michael Schlander, Silvio Garattini, Peter Kolominsky-Rabas, Erik Nord, Ulf Persson, Maarten Postma, Jeff Richardson, Steven Simoens, Oriol de Solà-Morales, Keith Tolley, Mondher Toumi
BACKGROUND: In most jurisdictions, policies have been adopted to encourage the development of treatments for rare or orphan diseases. While successful as assessed against their primary objective, these policies have prompted concerns among payers about the economic burden that might be caused by an annual cost per patient in some cases exceeding 100,000 Euro. At the same time, many drugs for rare disorders do not meet conventional standards for cost-effectiveness or 'value for money'...
2016: Journal of Market Access & Health Policy
Semukaya Sendyona, Isaac Odeyemi, Khaled Maman
BACKGROUND: A change in the pharmaceutical environment has occurred from previously only needing to convince regulators of a product's safety and efficacy to obtain marketing authorisation to now needing to satisfy the value perceptions of other stakeholders, including payers, to attain market access for products. There is thus the need to understand the concept of market access that may be defined as 'the process that ensures the development and commercial availability of pharmaceutical products with appropriate value propositions, leading to their prescribing and to successful uptake decisions by payers and patients, with the ultimate goal of achieving profitability and best patient outcomes'...
2016: Journal of Market Access & Health Policy
Julie Dorey, Emilie Clay, Amine Khemiri, Anis Belhadj, Patricia Trigo Cubillo, Mondher Toumi
BACKGROUND AND OBJECTIVE: Huntington's disease (HD) is an inherited neurodegenerative disorder that heavily affects the patient's motor, cognitive, and psychological functions. Yet, very few studies have measured the impact of this disease on the patient's health-related quality of life (HRQoL) with specific and validated instruments. The aim of this study was to explore the impact of HD on the HRQoL of Spanish HD patients using the self-reported, Huntington Quality of Life Instrument (H-QoL-I) and the generic instrument EuroQoL five dimensions (EQ-5D-3L) and thereafter compare the results obtained with the two instruments...
2016: Journal of Market Access & Health Policy
Jesper Jørgensen, Panos Kefalas
OBJECTIVE: To explore the relationship between prices charged by manufacturers of proprietary pharmaceuticals in the US and in the UK in recent years (2013-2016), expressed as a multiplier, and to detail to what extent this relationship differs for high-cost therapies used in smaller patient populations, as compared to lower-cost drugs. METHODOLOGY: Therapies assessed by the Scottish Medicines Consortium (SMC) in the UK between 1 January 2013 and 1 June 2016 were identified; only in-patent therapies were included in the analysis (to avoid the impact of price erosion post patent expiry); results were grouped according to annual cost per patient (whether considered high-cost, i...
2016: Journal of Market Access & Health Policy
Eve Hanna, Cecile Rémuzat, Pascal Auquier, Mondher Toumi
OBJECTIVE: Advanced therapy medicinal products (ATMPs) constitute a class of innovative products that encompasses gene therapy, somatic cell therapy, and tissue-engineered products (TEP). There is an increased investment of commercial and non-commercial sponsors in this field and a growing number of ATMPs randomized clinical trials (RCT) and patients enrolled in such trials. RCT generate data to prove the efficacy of a new therapy, but the discontinuation of RCTs wastes scarce resources...
2016: Journal of Market Access & Health Policy
Heather McDonald, Cathy Charles, Laurie Elit, Amiram Gafni
The pan-Canadian Oncology Drug Review (pCODR) makes recommendations to Canada's provinces and territories (except Quebec) to guide their cancer drug funding decisions. The objective of this paper is to explore, using an economic perspective and the pCODR as an example, the challenges associated with striving to simultaneously achieve the goals of maximizing health benefits with available resources and improving access to a more consistent standard of care across Canada. The first challenge concerns how to interpret the goals in order to determine how resources should be allocated to achieve each goal...
2016: Journal of Market Access & Health Policy
Siva Narayanan
It is important to evaluate how the value of medicine is assessed, as it may have important implications for health technology and reimbursement assessments. The value equation could comprise 'incremental benefit/outcome' (relative results of care in terms of patient health, comparing the innovation to best available alternative(s)) in the numerator and 'cost' (relative costs involved in the full cycle of care (or a defined period) for the patient's medical condition, incorporating the relevant cost-offsets due to displacement of best available alternative(s)) in the denominator...
2016: Journal of Market Access & Health Policy
Edward Gibson, Najida Begum, Federico Martinón-Torres, Marco Aurélio Safadi, Alfred Sackeyfio, Judith Hackett, Sankarasubramanian Rajaram
BACKGROUND: Influenza poses a significant burden on healthcare systems and society, with under-recognition in the paediatric population. Existing vaccination policies (largely) target the elderly and other risk groups where complications may arise. OBJECTIVE: The goal of this study was to evaluate the cost-effectiveness of annual paediatric vaccination (in 2-17-year-olds) with live attenuated influenza vaccination (LAIV), as well as the protective effect on the wider population in England and Wales (base)...
2016: Journal of Market Access & Health Policy
Craig Bennison, Stephanie Stephens, Benedicte Lescrauwaet, Ben Van Hout, Timothy L Jackson
BACKGROUND: If left untreated, vitreomacular traction (VMT) will infrequently improve through spontaneous resolution of vitreomacular adhesion (VMA), and patients remain at risk of further deterioration in vision. The mainstay of treatment for VMT is vitrectomy, an invasive procedure that carries the risk of rare but serious complications and further vision loss. As such, a 'watch and wait' approach is often adopted before this surgical intervention is performed. Ocriplasmin (microplasmin) is a potential alternative treatment for patients with symptomatic VMT that may remove the requirement for vitrectomy...
2016: Journal of Market Access & Health Policy
Katia Thokagevistk, Aurélie Millier, Leslie Lenert, Shamil Sadikhov, Santiago Moreno, Mondher Toumi
BACKGROUND: There is controversy as to whether use of statistical clustering methods to identify common disease patterns in schizophrenia identifies patterns generalizable across countries. OBJECTIVE: The goal of this study was to compare disease states identified in a published study (Mohr/Lenert, 2004) considering US patients to disease states in a European cohort (EuroSC) considering English, French, and German patients. METHODS: Using methods paralleling those in Mohr/Lenert, we conducted a principal component analysis (PCA) on Positive and Negative Syndrome Scale items in the EuroSC data set (n=1,208), followed by k-means cluster analyses and a search for an optimal k...
2016: Journal of Market Access & Health Policy
Mathias Flume, Marc Bardou, Stefano Capri, Oriol Sola-Morales, David Cunningham, Lars-Ake Levin, Nicolas Touchot
Indication value-based pricing (IBP) has been proposed in the United States as a tool to capture the differential value of drugs across indications or patient groups and is in the early phases of implementation. In Europe, no major country has experimented with IBP or is seriously discussing its use. We assessed how the reimbursement and pricing environment allows for IBP in seven European countries, evaluating both incentives and hurdles. In price setting countries such as France and Germany, the Health Technology Assessment and pricing process already accounts for differences of value across indications...
2016: Journal of Market Access & Health Policy
Eve Hanna, Cécile Rémuzat, Pascal Auquier, Mondher Toumi
BACKGROUND: Advanced therapy medicinal products (ATMPs) are innovative therapies that encompass gene therapy, somatic cell therapy, and tissue-engineered products. These therapies are expected to bring important health benefits, but also to substantially impact the pharmaceuticals budget. OBJECTIVE: The aim of this study was to characterise the ATMPs in development and discuss future implications in terms of market access. METHODS: Clinical trials were searched in the following databases: EudraCT (EU Drug Regulating Authorities Clinical Trials), ClinicalTrials...
2016: Journal of Market Access & Health Policy
Santiago G Moreno, Joshua A Ray
OBJECTIVE: The role of cost-effectiveness analysis (CEA) in incentivizing innovation is controversial. Critics of CEA argue that its use for pricing purposes disregards the 'value of innovation' reflected in new drug development, whereas supporters of CEA highlight that the value of innovation is already accounted for. Our objective in this article is to outline the limitations of the conventional CEA approach, while proposing an alternative method of evaluation that captures the value of innovation more accurately...
2016: Journal of Market Access & Health Policy
Yixi Chen, Shanlian Hu, Peng Dong, Åsa Kornfeld, Patrycja Jaros, Jing Yan, Fangfang Ma, Mondher Toumi
OBJECTIVES: In 2009, the Chinese government launched a national healthcare reform programme aiming to control healthcare expenditure and increase the quality of care. As part of this programme, a new drug pricing reform was initiated on 1 June 2015. The objective of this study was to describe the changing landscape of drug pricing policy in China and analyse the potential impact of the reform. METHODS: The authors conducted thorough research on the drug pricing reform using three Chinese databases (CNKI, Wanfang, and Weipu), Chinese health authority websites, relevant press releases, and pharmaceutical blogs and discussion forums...
2016: Journal of Market Access & Health Policy
Marc Massetti, Samuel Aballéa, Yann Videau, Cécile Rémuzat, Julie Roïz, Mondher Toumi
BACKGROUND: Health technology assessment (HTA) has been reinforced in France, notably with the introduction of economic evaluation in the pricing process for the most innovative and expensive treatments. Similarly to the National Institute for Clinical Excellence (NICE) in England, the National Authority for Health (HAS), which is responsible for economic evaluation of new health technologies in France, has published recommendations on the methods of economic evaluation. Since economic assessment represents a major element of HTA in England, exploring the differences between these methodological guidelines might help to comprehend both the shape and the role economic assessment is intended to have in the French health care system...
2015: Journal of Market Access & Health Policy
Vanessa Rémy, York Zöllner, Ulrike Heckmann
Vaccination has made an important contribution to the decreased incidence of numerous infectious diseases and associated mortality. In 2013, it was estimated that 103 million cases of childhood diseases in the United States had been prevented by the use of vaccines since 1924. These health effects translate into positive economic results, as vaccination can provide significant savings by avoiding the direct and indirect costs associated with treating the disease and possible long-term disability. A recent US study estimated that every dollar spent on childhood vaccination could save US$3 from a payer perspective and US$10 from a societal perspective...
2015: Journal of Market Access & Health Policy
Nathalie Largeron, Pierre Lévy, Jürgen Wasem, Xavier Bresse
The use of vaccines to prevent diseases in children, adults, and the elderly results in fewer medical visits, diagnostic tests, treatments, and hospitalisations, which leads to substantial savings in healthcare costs each year in Europe and elsewhere. Vaccines also contribute to reducing resource utilisation by preventing nosocomial infections, such as rotavirus gastroenteritis, which can increase hospital stays by 4-12 days. Vaccination also has an important role in the prevention of cancers with, for example, human papillomavirus or hepatitis B vaccines...
2015: Journal of Market Access & Health Policy
Vanessa Rémy, Nathalie Largeron, Sibilia Quilici, Stuart Carroll
No abstract text is available yet for this article.
2015: Journal of Market Access & Health Policy
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