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Journal of Market Access & Health Policy

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https://www.readbyqxmd.com/read/29034065/development-of-an-instrument-evaluating-the-impact-of-surgeon-patient-relationship-in-patients-on-sick-leave
#1
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
https://www.readbyqxmd.com/read/28839525/annuity-payments-can-increase-patient-access-to-innovative-cell-and-gene-therapies-under-england-s-net-budget-impact-test
#2
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
https://www.readbyqxmd.com/read/28839524/a-comparative-review-of-haute-autorit%C3%A3-de-sant%C3%A3-and-national-institute-for-health-and-care-excellence-health-technology-assessments-of-ikervis%C3%A2-to-treat-severe-keratitis-in-adult-patients-with-dry-eye-disease-which-has-not-improved-despite-treatment-with-tear
#3
REVIEW
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
https://www.readbyqxmd.com/read/28839523/quantifying-the-persisting-orphan-drug-shortage-public-health-crisis-in-the-united-states
#4
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
https://www.readbyqxmd.com/read/28804603/towards-a-more-transparent-hta-process-in-poland-new-polish-hta-methodological-guidelines
#5
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
https://www.readbyqxmd.com/read/28804602/balanced-assessment-systems-revisited
#6
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
https://www.readbyqxmd.com/read/28804601/policy-implementation-for-methicillin-resistant-staphylococcus-aureus-in-seven-european-countries-a-comparative-analysis-from-1999-to-2015
#7
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
https://www.readbyqxmd.com/read/28804600/analysis-of-health-economics-assessment-reports-for-pharmaceuticals-in-france-understanding-the-underlying-philosophy-of-ceesp-assessment
#8
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
https://www.readbyqxmd.com/read/28740623/patient-access-to-reimbursed-biological-disease-modifying-antirheumatic-drugs-in-the-european-region
#9
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
https://www.readbyqxmd.com/read/28740622/drug-pricing-and-reimbursement-information-management-processes-and-decision-making-in-the-global-economy
#10
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
https://www.readbyqxmd.com/read/28740621/direct-cost-analysis-of-the-second-year-post-allogeneic-hematopoietic-stem-cell-transplantation-in-the-bone-marrow-transplant-centre-of-tunisia
#11
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
https://www.readbyqxmd.com/read/28740620/use-and-cost-comparison-of-clobazam-to-other-antiepileptic-drugs-for-treatment-of-lennox-gastaut-syndrome
#12
Clément François, John M Stern, Augustina Ogbonnaya, Tasneem Lokhandwala, Pamela Landsman-Blumberg, Amy Duhig, Vivienne Shen, Robin Tan
Background: Lennox-Gastaut syndrome (LGS) is a severe form of childhood-onset epilepsy associated with serious injuries due to frequent and severe seizures. Of the antiepileptic drugs (AEDs) approved for LGS, clobazam is a more recent market entrant, having been approved in October 2011. Recent AED budget impact and cost-effectiveness analyses for LGS suggest that adding clobazam to a health plan formulary may result in decreased medical costs; however, research on clinical and economic outcomes and treatment patterns with these AED treatments in LGS is limited...
2017: Journal of Market Access & Health Policy
https://www.readbyqxmd.com/read/28740619/should-new-health-technology-be-available-only-for-patients-able-and-willing-to-pay
#13
REVIEW
Piet Calcoen, Albert Boer, Wynand P M M van de Ven
New health technology comes on the market at a rapid pace and - sometimes - at a huge cost. Providing access to new health technology is a serious challenge for many countries with mandatory health insurance. This article analyses access to new health technology in Belgium and the Netherlands, using eight concrete examples as a starting point for comparing the two - neighbouring - countries. Contrary to the Netherlands, out-of-pocket payments for new health technology are widely accepted and practiced in Belgium...
2017: Journal of Market Access & Health Policy
https://www.readbyqxmd.com/read/28740618/ethical-issues-associated-with-medical-tourism-in-africa
#14
REVIEW
John J O Mogaka, Lucia Mupara, Joyce M Tsoka-Gwegweni
Global disparities in medical technologies, laws, economic inequities, and social-cultural differences drive medical tourism (MT), the practice of travelling to consume healthcare that is either too delayed, unavailable, unaffordable or legally proscribed at home. Africa is simultaneously a source and destination for MT. MT however, presents a new and challenging health ethics frontier, being largely unregulated and characterized by policy contradictions, minority discrimination and conflict of interest among role-players...
2017: Journal of Market Access & Health Policy
https://www.readbyqxmd.com/read/28740617/supply-side-and-demand-side-policies-for-biosimilars-an-overview-in-10-european-member-states
#15
Cécile Rémuzat, Anna Kapuśniak, Aleksandra Caban, Dan Ionescu, Guerric Radière, Cyril Mendoza, Mondher Toumi
This study aimed to provide an overview of biosimilar policies in 10 EU MSs. Methods: Ten EU MS pharmaceutical markets (Belgium, France, Germany, Greece, Hungary, Italy, Poland, Spain, Sweden, and the UK) were selected. A comprehensive literature review was performed to identify supply-side and demand-side policies in place in the selected countries. Results: Supply-side policies for biosimilars commonly include price linkage, price re-evaluation, and tendering; the use of internal or external reference pricing varies between countries; health technology assessment is conducted in six countries...
2017: Journal of Market Access & Health Policy
https://www.readbyqxmd.com/read/28740616/unlocking-the-potential-of-established-products-toward-new-incentives-rewarding-innovation-in-europe
#16
Gabrielle Nayroles, Sandrine Frybourg, Sylvie Gabriel, Åsa Kornfeld, Fernando Antoñanzas-Villar, Jaime Espín, Claudio Jommi, Nello Martini, Gérard de Pouvourville, Keith Tolley, Jürgen Wasem, Mondher Toumi
Background: Many established products (EPs - marketed for eight years or more) are widely used off-label despite little evidence on benefit-risk ratio. This exposes patients to risks related to safety and lack of efficacy, and healthcare providers to liability. Introducing new indications for EPs may represent a high societal value; however, manufacturers rarely invest in R&D for EPs. The objective of this research was to describe incentives and disincentives for developing new indications for EPs in Europe and to investigate consequences of current policies...
2017: Journal of Market Access & Health Policy
https://www.readbyqxmd.com/read/28473889/filling-the-gap-in-cns-drug-development-evaluation-of-the-role-of-drug-repurposing
#17
A Caban, K Pisarczyk, K Kopacz, A Kapuśniak, M Toumi, C Rémuzat, A Kornfeld
Background and objective: Background and objective: Drug repurposing has been considered a cost-effective and reduced-risk strategy for developing new drugs. Little is known and documented regarding the efficiency of repurposing strategies in drug development. The objective of this article is to assess the extent and meaning of this process in the CNS area. Methods: In order to identify repurposed drugs that target the CNS, an extensive search was performed. For each identified case, its initial and target indication, development status and the type of repurposing strategy (repositioning, reformulation or both) was recorded...
2017: Journal of Market Access & Health Policy
https://www.readbyqxmd.com/read/28473888/do-payers-value-rarity-an-analysis-of-the-relationship-between-disease-rarity-and-orphan-drug-prices-in-europe
#18
Goran Medic, Daria Korchagina, Katherine Eve Young, Mondher Toumi, Maarten Jacobus Postma, Micheline Wille, Michiel Hemels
Background and Objective: Orphan drugs have been a highlight of discussions due to their higher prices than non-orphan drugs. There is currently no European consensus on the method of value assessment for orphan drugs. This study assessed the relationship between the prevalence of rare diseases and the annual treatment cost of orphan drugs in France, Germany, Italy, Norway, Spain, Sweden, and UK. Methods: Approved orphan drugs and prevalence data were extracted from the European Medicines Agency website. Annual treatment costs were calculated using ex-factory price...
2017: Journal of Market Access & Health Policy
https://www.readbyqxmd.com/read/28473887/a-comparative-study-of-orphan-drug-prices-in-europe
#19
Katherine Eve Young, Imen Soussi, Michiel Hemels, Mondher Toumi
Background and Objective: This study assessed price differences by comparing annual treatment costs of similarly available orphan drugs in France, Germany, Italy, Norway, Spain, Sweden, and UK. Methods: Annual treatment costs per drug were calculated using ex-factory prices from IHS POLI and country price databases. The treatment cost in the comparator country was compared to the UK and ratios were analysed. Subanalyses were done on disease areas and UK cost quartiles. Results: 120 orphan drugs were included...
2017: Journal of Market Access & Health Policy
https://www.readbyqxmd.com/read/28321285/role-of-preliminary-registry-data-in-development-of-a-clinical-trial-for-an-innovative-device-a-small-but-integral-piece-of-a-health-policy-initiative
#20
Donald R Ricci, Joost de Vries, Raphael Blanc
Establishing a national health policy at a macro level involves the integration of a series of health initiatives across a spectrum of activities, including clinical care. Evaluation of the safety and efficacy of a new medical device ultimately evolves to testing in humans. The pathway to a formal prospective clinical trial includes a stepwise appreciation of pre-clinical data and detailed analysis of data obtained from preliminary registries, where information about appropriate patient selection and use of the device is obtained...
2017: Journal of Market Access & Health Policy
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