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Journal of Market Access & Health Policy

Hirohisa Shimura
Background: One method for promoting drugs in Japan has been utilizing wholesalers for promotion; however, the effectiveness of the sales promotion has been brought into question. Methods: A total of 74,552 responses were collected from an internet survey of 511 prescribing doctors in hospitals with less than 19 beds, which recalled the visits by wholesalers' sales representatives (MS) in 2014. Each assessed the degree to which MS and/or sales representatives from a pharmaceutical company (MR) influenced a decision to prescribe each drug...
2018: Journal of Market Access & Health Policy
Borislav Borissov, Michael Urbich, Boryana Georgieva, Svetoslav Tsenov, Guillermo Villa
Background:  An elevated level of low-density lipoprotein cholesterol (LDL-C) constitutes one of the most important modifiable risk factors for cardiovascular disease (CVD). Individuals with heterozygous familial hypercholesterolaemia (HeFH) are particularly vulnerable to CVD events. The addition of evolocumab to statins has shown marked reductions in LDL-C levels. The objective of this analysis is to demonstrate the clinical and economic value of LDL-C lowering with evolocumab from the Bulgarian public health care perspective...
2017: Journal of Market Access & Health Policy
Andrea Aiello, Anna D'Ausilio, Roberta Lo Muto, Francesca Randon, Luca Laurenti
Background and Objective: Ibrutinib has recently been approved in Europe for Waldenström Macroglobulinemia (WM) in symptomatic patients who have received at least one prior therapy, or in first-line treatment for patients unsuitable for chemo-immunotherapy. The aim of the study is to estimate the incremental cost-effectiveness ratio (ICER) of ibrutinib in relapse/refractory WM, compared with the Italian current therapeutic pathways (CTP). Methods: A Markov model was adapted for Italy considering the National Health System perspective...
2017: Journal of Market Access & Health Policy
Karolina Badora, Aleksandra Caban, Cécile Rémuzat, Claude Dussart, Mondher Toumi
In Poland, two proposed amendments to the reimbursement act are currently in preparation; these are likely to substantially change the pricing and reimbursement landscape for both drugs and medical devices. Proposed changes include: alignment of medical device reimbursement with that of pharmaceuticals; relaxing the strict reimbursement criteria for ultra-orphan drugs; establishment of an additional funding category for vaccines; introduction of compassionate use, and a simplified reimbursement pathway for well-established off-label indications; appreciation of manufacturers' innovation and research and development efforts by creating a dedicated innovation budget; introduction of a mechanism preventing excessive parallel import; prolonged duration of reimbursement decisions and reimbursement lists; and increased flexibility in defining drug programmes...
2017: Journal of Market Access & Health Policy
A Millier, M Horváth, F Ma, K Kóczián, A Götze, M Toumi
Background : It is unclear if the burden associated with schizophrenia is affected by the type and severity of patient's symptoms. Objective : This study aims to quantify healthcare resource use associated with different profiles of schizophrenia symptoms. Study design : Post-hoc analysis of data from a naturalistic follow-up study. Setting : Secondary psychiatric services in France, Germany and the UK. Patients : EuroSC cohort:, representative sample of 1,208 schizophrenia patients Main outcome measure : We classified patients into eight health states, according to the Lenert classification (HS1-HS8), and estimated 6-month healthcare resource use (outpatient and day clinic visits, and hospitalisations) across the health states...
2017: Journal of Market Access & Health Policy
Clément François, Alice Guiraud-Diawara, Christophe Lançon, Pierre Michel Llorca, Ann Hartry, Lene Hammer-Helmich, Djamel A Zighed, Adrian Tanasescu, Mondher Toumi
Background : Adverse event (AE) reporting in clinical trials does not fully capture the patient-level perspective and comparing tolerability across treatments or among studies is difficult. Objective : This study was designed to develop a treatment tolerability index algorithm that combines AE reporting with physician- and patient-level AE information into a global burden score to allow comparison of the overall tolerability of antipsychotic medications used in treating schizophrenia. Study design : Data from a 4-arm, placebo-controlled clinical trial were used in the proposed tolerability index algorithm...
2017: Journal of Market Access & Health Policy
Clément François, Adrian Tanasescu, François-Xavier Lamy, Nicolas Despiegel, Bruno Falissard, Ylana Chalem, Christophe Lançon, Pierre-Michel Llorca, Delphine Saragoussi, Patrice Verpillat, Alan G Wade, Djamel A Zighed
Background and objective : Automated healthcare databases (AHDB) are an important data source for real life drug and healthcare use. In the filed of depression, lack of detailed clinical data requires the use of binary proxies with important limitations. The study objective was to create a Depressive Health State Index (DHSI) as a continuous health state measure for depressed patients using available data in an AHDB. Methods: The study was based on historical cohort design using the UK Clinical Practice Research Datalink (CPRD)...
2017: Journal of Market Access & Health Policy
K E Young, I Soussi, M Toumi
Objective : The study compared the relative cost differences of similar orphan drugs among high and low GDP countries in Europe: Bulgaria, France, Germany, Greece, Hungary, Italy, Norway, Poland, Romania, Spain, Sweden, UK. Methods : Annual treatment costs per patient were calculated. Relative costs were computed by dividing the costs by each economic parameter: nominal GDP per capita, GDP in PPP per capita, % GDP contributed by the government, government budget per inhabitant, % GDP spent on healthcare, % GDP spent on pharmaceuticals, and average annual salary...
2017: Journal of Market Access & Health Policy
Julia I Drake, Juan Carlos Trujillo de Hart, Clara Monleón, Walter Toro, Joice Valentim
Background and objectives:   MCDA is a decision-making tool with increasing use in the healthcare sector, including HTA (Health Technology Assessment). By applying multiple criteria, including innovation, in a comprehensive, structured and explicit manner, MCDA fosters a transparent, participative, consistent decision-making process taking into consideration values of all stakeholders. This paper by FIFARMA (Latin American Federation of Pharmaceutical Industry) proposes the deliberative (partial) MCDA as a more pragmatic, agile approach, especially when newly implemented...
2017: Journal of Market Access & Health Policy
Thierry Dubert, Cedric Girault, Alexandre Kilink, Marc Rozenblat, Yves Lebellec, Anne-Lise Vataire, Myriam Vilasco, Gregory Katz
Background : To date, no specific instruments exist to measure the quality of the patient-surgeon relationship despite its potential to influence clinical and economic outcomes in patients undergoing surgery for musculoskeletal disorders (MSDs). Objective : The objective was to develop and validate an instrument to assess the quality of the patient-surgeon relationship, taking into account the return to work after functional restoration surgery. Methods : The instrument development was based on literature review, cognitive interviews and expert examinations...
2017: Journal of Market Access & Health Policy
Jesper Jørgensen, Panos Kefalas
Background: Cell and gene therapies have the potential to provide therapeutic breakthroughs, but the high costs of researching, developing, manufacturing and delivering them translate into prices that may challenge healthcare budgets. Various measures exist that aim to address the affordability challenge, including reducing price, limiting patient numbers and/or linking remuneration to product performance. Objective: To explore how the net budget impact test recently introduced in England can affect patient access to high-value, one-off cell and gene therapies, and how managed entry agreements can improve access...
2017: Journal of Market Access & Health Policy
Yasmina Iffet Eroglu
Background: In 2015, Ikervis® became the only EMA-approved cyclosporine A (CsA) eye-drop for the treatment of severe keratitis in adult patients with dry eye disease, which has not improved despite treatment with tear substitutes. Since the 1980s, CsA has been used empirically for ocular conditions in veterinary medicine then in humans. However, its extremely low aqueous solubility led to its administration in vegetable oils, which is characterized by low ocular availability, poor intraocular penetration, poor tolerability and short shelf-life...
2017: Journal of Market Access & Health Policy
Szymon Jarosławski, Chiraz Azaiez, Daria Korchagina, Mondher Toumi
Background: Orphan drugs (ODs) are pharmaceuticals manufactured for rare conditions that affect less than 200,000 people in the US. ODs are therefore produced in small quantities to meet sparse demand. Since 2010, OD shortages have become frequent, but no comprehensive, quantitative studies exist. Objective: The objective of this study is to assess the rates of OD shortages per therapeutic class and their trends over time in the United States. Study design: OD approvals were collected from publicly available information on the US Food and Drug Administration (FDA) website on 13 June 2016...
2017: Journal of Market Access & Health Policy
Krzysztof Lach, Michal Dziwisz, Cécile Rémuzat, Mondher Toumi
Introduction: Health technology assessment (HTA) in Poland supports reimbursement decisions via the Polish HTA Agency (AOTMiT), whose guidelines were updated in 2016. Methods: We identified key changes introduced by the update and, before guideline publication, analysed discrepancies between AOTMiT assessments and the submitting marketing authorisation holders (MAHs) to elucidate the context of the update. We compared the clarity and detail of the new guidelines versus those of the UK's National Institute for Health and Care Excellence (NICE)...
2017: Journal of Market Access & Health Policy
Dávid Dankó, Márk Péter Molnár
In 2014, balanced assessment systems (BAS) were proposed as a resource-conscious, 'fit-for-purpose' form of health technology assessment for middle-income countries which lack resources and competences necessary for resource-intensive health technology assessment models. BAS has undergone extensive policy debate in the period since its publication but it has not been critically assessed in a structured form yet. This article aims to describe both the contributions and the weak spots of the original framework and to reflect on them with the intention of further developing the model...
2017: Journal of Market Access & Health Policy
Takuya Kinoshita, Hironobu Tokumasu, Shiro Tanaka, Axel Kramer, Koji Kawakami
Background: Policies to reduce methicillin-resistant Staphylococcus aureus (MRSA) infections, both healthcare-acquired (HA-MRSA) and livestock-associated (LA-MRSA) are implemented Europe-wide, but evaluations are difficult for countries yet to implement such policies. A descriptive study was conducted, describing multinational MRSA rates and policy implementation, focusing on MRSA mandatory surveillance. We also investigated antibiotic use and MRSA rates and the use of veterinary antibiotics. Methods: This study used Europe-wide surveillance data on infectious diseases (EARS-Net), antibiotic consumption (ESAC-Net), and veterinary medicine (ESVAC)...
2017: Journal of Market Access & Health Policy
Mondher Toumi, Anastasiia Motrunich, Aurélie Millier, Cécile Rémuzat, Christos Chouaid, Bruno Falissard, Samuel Aballéa
Background: Despite the guidelines for Economic and Public Health Assessment Committee (CEESP) submission having been available for nearly six years, the dossiers submitted continue to deviate from them, potentially impacting product prices. Objective: to review the reports published by CEESP, analyse deviations from the guidelines, and discuss their implications for the pricing and reimbursement process. Study design: CEESP reports published until January 2017 were reviewed, and deviations from the guidelines were extracted...
2017: Journal of Market Access & Health Policy
Zoltán Kaló, Zoltán Vokó, Andrew Östör, Emma Clifton-Brown, Radu Vasilescu, Alysia Battersby, Edward Gibson
Background & Objectives: Biological disease-modifying antirheumatic drugs (bDMARDs) for the treatment of rheumatoid arthritis (RA) are not always accessible to all patients in accordance with international guidelines, partly owing to their high direct costs against a background of restricted healthcare budgets. This study compares the size of RA patient populations with access to reimbursed bDMARDs across 37 European countries, Russia, and Turkey, according to their treatment eligibility defined by European League Against Rheumatism (EULAR) recommendations and national reimbursement criteria...
2017: Journal of Market Access & Health Policy
Dimitrios Tsourougiannis
Background: Cost-containment initiatives are re-shaping the pharmaceutical business environment and affecting market access as well as pricing and reimbursement decisions. Effective price management procedures are too complex to accomplish manually. Prior to February 2013, price management within Astellas Pharma Europe Ltd was done manually using an Excel database. The system was labour intensive, slow to update, and prone to error. An innovative web-based pricing information management system was developed to address the shortcomings of the previous system...
2017: Journal of Market Access & Health Policy
Myriam Razgallah Khrouf, Leila Achour, Asma Thabti, Mohamed Ali Soussi, Nour Abdejelil, Olfa Lazreg, Chema Drira, Aida Zahaf, Saloua Ladab, Tarek Ben Othman
Background: Hematopoietic stem cell transplantation (HSCT) is a medically complicated therapy with a long recovery time. In Tunisia, the National Health Insurance Fund (CNAM) covers only the first year post-transplantation, after which the costs are borne by the hospital. Objective: Describe complications that can occur during the second year post-allogeneic HSCT and calculate direct costs in different groups of patients. Methods: In this pharmacoeconomic study, medical records of the second year post-allogeneic HSCT were collected...
2017: Journal of Market Access & Health Policy
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