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Journal of Market Access & Health Policy

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https://www.readbyqxmd.com/read/29915664/approaches-to-manage-affordability-of-high-budget-impact-medicines-in-key-eu-countries
#1
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
#2
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
#3
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
#4
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
#5
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
#6
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
#7
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
#8
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
#9
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
#10
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
#11
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
#12
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
https://www.readbyqxmd.com/read/29081922/a-tolerability-burden-index-in-schizophrenia-incorporating-patient-perspective-in-clinical-trial-adverse-event-reporting
#13
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
https://www.readbyqxmd.com/read/29081921/creating-an-index-to-measure-health-state-of-depressed-patients-in-automated-healthcare-databases-the-methodology
#14
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
https://www.readbyqxmd.com/read/29081920/the-perverse-impact-of-external-reference-pricing-erp-a-comparison-of-orphan-drugs-affordability-in-12-european-countries-a-call-for-policy-change
#15
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
https://www.readbyqxmd.com/read/29081919/utilization-of-multiple-criteria-decision-analysis-mcda-to-support-healthcare-decision-making-fifarma-2016
#16
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
https://www.readbyqxmd.com/read/29034065/development-of-an-instrument-evaluating-the-impact-of-surgeon-patient-relationship-in-patients-on-sick-leave
#17
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
#18
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
#19
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
#20
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
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