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Journal of Market Access & Health Policy

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https://www.readbyqxmd.com/read/30479703/non-profit-drug-research-and-development-the-case-study-of-genethon
#1
Szymon Jarosławski, Mondher Toumi
Non-profit drug research and development (R&D) has the potential to deliver innovative treatments at affordable prices. Using the case study methodology, we discuss some ethical and economic issues, including the possible impact of non-profit companies on innovation efforts from for-profit firms. Like other non-profits, Genethon is willing to adopt an ethical attitude toward their donors by pricing their products affordably. It remains to be seen if the approach to internalize the marketing authorization, manufacturing and distribution activities prove to be efficient and sustainable...
2019: Journal of Market Access & Health Policy
https://www.readbyqxmd.com/read/30425804/patient-reported-outcome-claims-in-european-and-united-states-orphan-drug-approvals
#2
Szymon Jarosławski, Pascal Auquier, Borislav Borissov, Claude Dussart, Mondher Toumi
Purpose: We aimed to evaluate the rate of usage and the kind of patient-reported outcome (PRO) claims in orphan drug approvals from the European Medicines Agency (EMA) dated between 1/1/2012 and 31/12/2016 and to compare them to those from the US Food and Drug Administration (FDA). Methods: Orphan drug approval documentation was obtained from the EMA website. PRO-related language was extracted from the Summaries of Product Characteristics (SmPCs). Data were compared to a previously published analysis of the FDA approvals from the same time period...
2018: Journal of Market Access & Health Policy
https://www.readbyqxmd.com/read/30425803/budget-impact-of-antimicrobial-wound-dressings-in-the-treatment-of-venous-leg-ulcers-in-the-german-outpatient-care-sector-a-budget-impact-analysis
#3
Maria Gueltzow, Poroshat Khalilpour, Katharina Kolbe, York Zoellner
Background: Hard-to-heal wounds are associated with high treatment costs and, in Germany, are mostly treated in the outpatient care sector. Wound dressings are the main cost-drivers in venous leg ulcer (VLU) care which prescription is budget-restricted. Objective: To determine to what extent the choice of antimicrobial dressing affects the spending in outpatient care by investigating the budget impact of the bioburden-reducing dressing Cutimed Sorbact. Methods: The budget impact analysis was performed comparing three different scenarios of the intervention mix of antimicrobial dressings...
2018: Journal of Market Access & Health Policy
https://www.readbyqxmd.com/read/30364868/the-potential-price-and-access-implications-of-the-cost-utility-and-budget-impact-methodologies-applied-by-nice-in-england-and-icer-in-the-us-for-a-novel-gene-therapy-in-parkinson-s-disease
#4
Jesper Jørgensen, Spiros Servos, Panos Kefalas
Background : NICE in England, and ICER in the US both use cost-utility analyses (CUA) and budget impact analyses (BIA) to assess value for money and affordability, however the thresholds used differ greatly. Objective : To perform a cross-country comparison of the results of the CUA and BIA and detail the implications for reimbursed price and volumes, for a novel gene therapy for Parkinson's disease (PD). Methods : A Markov model was built to perform country-specific CUAs and BIAs Findings : The US ceiling price identified through CUA is ~ 1...
2018: Journal of Market Access & Health Policy
https://www.readbyqxmd.com/read/30275939/health-related-quality-of-life-in-patients-having-schizophrenia-negative-symptoms-a-systematic-review
#5
REVIEW
Chiraz Azaiez, Aurélie Millier, Christophe Lançon, Emilie Clay, Pascal Auquier, Pierre-Michel Llorca, Mondher Toumi
Background : Schizophrenia negative symptoms (SNS) contribute substantially to poor functional outcomes, loss in productivity and poor quality of life. It is unclear which instruments may be used for assessing quality of life in patients with SNS. Objective : The objective of this review was to identify instruments assessing health-related quality of life (HRQoL) validated in patients with SNS and to assess their level of validation. Data sources : We conducted a systematic literature review in Medline and the ISPOR database in March 2016 to identify studies on the quality of life in patients with SNS published by March 2016...
2018: Journal of Market Access & Health Policy
https://www.readbyqxmd.com/read/30151078/establishing-the-cost-of-implementing-a-performance-based-managed-entry-agreement-for-a-hypothetical-car-t-cell-therapy
#6
Panos Kefalas, Omar Ali, Jesper Jørgensen, Nick Merryfield, Tim Richardson, Adam Meads, Laura Mungapen, Matthew Durdy
Background : Market access stakeholders consider the adoption of Managed Entry Agreements (MEAs), however a clearly described methodology to quantify their implementation burden is not available in the public domain. Objective : To quantify the cost of implementing a performance-based MEA at the hospital level. Methods : The analysis involved a hypothetical one-off therapy targeting Acute Lymphoblastic Leukaemia. Data collection from five NHS Hospital Trusts in England captured costs by task, job band, personnel time and capital investment...
2018: Journal of Market Access & Health Policy
https://www.readbyqxmd.com/read/30128087/systematic-review-of-pharmacoeconomic-models-for-schizophrenia
#7
REVIEW
Junwen Zhou, Aurélie Millier, Mondher Toumi
Background : Economic models are broadly used in the economic evaluation of antipsychotics in schizophrenia. Our objective was to summarize the structure of these models. Methods : Model-based economic evaluations of antipsychotics in schizophrenia were identified through Medline and Embase. General information was extracted including analysis type, model type, perspective, population, comparator, outcome, and timeframe. Model-specific structures for decision tree (DT), cohort- and patient-level Markov model (CLMM, PLMM), and discrete-event simulation (DES) models were extracted...
2018: Journal of Market Access & Health Policy
https://www.readbyqxmd.com/read/30034645/cost-effectiveness-of-edoxaban-compared-to-warfarin-for-the-treatment-and-secondary-prevention-of-venous-thromboembolism-in-the-uk
#8
Emilie Clay, Aurélien Jamotte, Peter Verhamme, Alexander T Cohen, Ben A Van Hout, Pearl Gumbs
Background : Venous thromboembolism (VTE), which includes pulmonary embolism (PE) and deep vein thrombosis (DVT), is the third most common acute cardiovascular disease and represents an important burden for patients and payers. Objective : The aim was to estimate the cost-effectiveness of edoxaban, a non-VKA oral anticoagulant vs. warfarin, the currently most prescribed treatment for VTE in the UK. Study design : A Markov model was built using data from the Hokusai-VTE randomised controlled trial to estimate the lifetime costs and quality-adjusted life years (QALYs) in patients with VTE treated with edoxaban or warfarin over a lifetime horizon, from the UK National Health Services perspective...
2018: Journal of Market Access & Health Policy
https://www.readbyqxmd.com/read/29915664/approaches-to-manage-affordability-of-high-budget-impact-medicines-in-key-eu-countries
#9
REVIEW
Mathias Flume, Marc Bardou, Stefano Capri, Oriol Sola-Morales, David Cunningham, Lars-Ake Levin, Maarten J Postma, Nicolas Touchot
Background:  The launch of hepatitis C (HCV) drugs such as sofosbuvir or ledipasvir has fostered the question of affordability of novel high budget impact therapies even in countries with high domestic product. European countries have developed a variety of mechanisms to improve affordability of such therapies, including 'affordability thresholds', price volume agreements or caps on individual product sales, and special budgets for innovative drugs. While some of these mechanisms may help limit budget impact, there are still significant progresses to be made in the definition and implementation of approaches to ensure affordability, especially in health systems where the growth potential in drug spending and/or in the patient contribution to health insurance are limited...
2018: Journal of Market Access & Health Policy
https://www.readbyqxmd.com/read/29785254/low-rates-of-patient-reported-outcome-claims-for-orphan-drugs-approved-by-the-us-food-and-drug-administration
#10
Szymon Jarosławski, Pascal Auquier, Borislav Borissov, Claude Dussart, Mondher Toumi
Background : Claims included in package inserts (PIs) for medicinal products approved by the US Food and Drug Administration (FDA) constitute the regulatory definition of drugs' benefits and risks. Objective : We sought to assess the usage of patient-reported outcome (PRO) claims in a comprehensive set of US FDA orphan drug approvals dated between 1/1/2012 and 31/12/2016, and characterize them. Study design : Orphan drug approval documentation was obtained from the US FDA website. Drug Package Inserts (PI) were analyzed to extract information on PRO-related language...
2018: Journal of Market Access & Health Policy
https://www.readbyqxmd.com/read/29686802/assessment-and-diffusion-of-medical-innovations-in-france-an-overview
#11
REVIEW
Amélie Dubromel, Loïc Geffroy, Gilles Aulagner, Claude Dussart
Background: In France, a significant part of health expenditure is publicly funding. This put a heavy burden on society. In an economic context requiring tight control of public spending, it seems relevant to control the diffusion of medical innovations. That is why health technology assessment is subject to an increasing interest at national level for management and approval decisions. This article provides an overview of the assessment and diffusion of medical innovation in France. Method: The data are extracted from French authorities or organisations websites and documents and from French legislative texts...
2018: Journal of Market Access & Health Policy
https://www.readbyqxmd.com/read/29686801/cost-effectiveness-of-solifenacin-compared-with-oral-antimuscarinic-agents-for-the-treatment-of-patients-with-overactive-bladder-in-the-uk
#12
Zalmai Hakimi, Con Kelleher, Samuel Aballéa, Khaled Maman, Jameel Nazir, Colette Mankowski, Isaac Odeyemi
Objective: To evaluate the cost-effectiveness of solifenacin 5 mg/day versus other oral antimuscarinic agents used for overactive bladder (OAB) from a UK National Health Service (NHS) perspective. Study design: In a Markov model, hypothetical patients received solifenacin 5 mg/day or a comparator antimuscarinic, after which they could switch to an alternative antimuscarinic. The model estimated incremental cost-effectiveness ratios (ICER), expressed as cost per quality-adjusted life year (QALY) over a 5-year period...
2018: Journal of Market Access & Health Policy
https://www.readbyqxmd.com/read/29372018/sales-promotion-by-wholesalers-affects-general-practitioners-prescription-behaviours-in-japan
#13
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
https://www.readbyqxmd.com/read/29785253/3-how-comprehensive-can-we-be-in-the-economic-assessment-of-vaccines
#14
REVIEW
Baudouin Standaert, Rino Rappuoli
In two previous papers we argued on current vaccines economic assessment not fully comprehensive when using the incremental cost-utility analysis normally applied for treatments. Many differences exist between vaccines and drug treatments making vaccines economic evaluation more cumbersome. Four challenges overwhelmingly present in vaccines assessment are less important for treatments: requirements for population, societal perspectives, budget impact evaluation, and time focused objectives (control or elimination)...
2017: Journal of Market Access & Health Policy
https://www.readbyqxmd.com/read/29785252/2-how-is-the-economic-assessment-of-vaccines-performed-today
#15
REVIEW
Baudouin Standaert, Rino Rappuoli
This paper describes how the economic assessment of vaccines is performed today. It discusses why it may be incomplete and explores potential approaches to adjust the analysis to be more comprehensive. Besides helping protect against serious disease, vaccines also help avoid mild disease episodes that may not receive medical attention but which have important societal consequences. They also benefit unvaccinated individuals by reducing disease transmission. Wider societal benefits may extend beyond a decrease in disease incidence, as lower transmission rates reduce the risk of epidemics, which in turn reduces the pressure on healthcare providers, and may improve the quality of care for patients with unrelated diseases...
2017: Journal of Market Access & Health Policy
https://www.readbyqxmd.com/read/29785251/towards-a-more-comprehensive-approach-for-a-total-economic-assessment-of-vaccines-1-the-building-blocks-for-a-health-economic-assessment-of-vaccination
#16
REVIEW
Baudouin Standaert, Rino Rappuoli
​Since we were born, we all take preventative actions to avoid unpredictable adverse conditions. Some actions are done automatically. Others require a conscious choice , either for personal or social benefit. A distinction can therefore be drawn between non-active and active prevention, and between individual and social prevention. Active prevention requires making a choice in time, effort, and cost. We call it an economic choice. Vaccines belong to the group of active and social prevention. Because a vaccination program is an economic social choice, how should it be valued, and what cost should we pay for? To date, the economic evaluations developed for treatment have been applied to vaccines...
2017: Journal of Market Access & Health Policy
https://www.readbyqxmd.com/read/29321830/cost-effectiveness-of-evolocumab-in-treatment-of-heterozygous-familial-hypercholesterolaemia-in-bulgaria-measuring-health-benefit-by-effectively-treated-patient-years
#17
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
https://www.readbyqxmd.com/read/29201288/cost-effectiveness-analysis-of-ibrutinib-in-patients-with-waldenstr%C3%A3-m-macroglobulinemia-in-italy
#18
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
https://www.readbyqxmd.com/read/29081924/proposed-changes-to-the-reimbursement-of-pharmaceuticals-and-medical-devices-in-poland-and-their-impact-on-market-access-and-the-pharmaceutical-industry
#19
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
https://www.readbyqxmd.com/read/29081923/healthcare-resource-use-in-schizophrenia-eurosc-findings
#20
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
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