A review of Health Technology Assessment (HTA) recommendations for drug therapies issued between 2007 and 2009 and their impact on policymaking processes in Poland

Kolasa, Katarzyna; Schubert, Sebastian; Manca, Andrea; Hermanowski, Tomasz

doi:10.1016/j.healthpol.2011.05.001

Cited by 22 publications

(21 citation statements)

References 15 publications

(17 reference statements)

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“…This has resulted in one reimbursement list which is divided into three categories (Box 2), with an economic analysis (typically either a cost-effectiveness analysis or cost-utility analysis) required to assess the potential reimbursement for new expensive medicines alongside a budget impact analysis (146) were appraised and reimbursed, 117 were appraised and not reimbursed and 29 were reimbursed and not appraised. Even when new medicines are reimbursed in Poland, there can be restrictions, e.g.14 of medicines had major restrictions, 11 had minor restrictions and 5 without restrictions  The most common restriction was recommendations for prescribing at a lower price and restrictions to specific sub-populations.…”

Section: Iii) Capped Budgets and Other Mechanisms To Potentially Optimentioning

confidence: 99%

Are new models needed to optimize the utilization of new medicines to sustain healthcare systems?

Godman

Malmström

Diogène³

et al. 2014

Expert Review of Clinical Pharmacology

115

132

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Are new models needed to optimise the utilisation of new medicines to sustain healthcare systems?Godman B 1,2,3 , Malmström RE 4 , Diogene E 5 , Gray A 6 , Jayathissa S 7 , Timoney A 8 , Acurcio FA 9,10 , Alkan A 11 , Brzezinska A 12 , Bucsics A 13 , Campbell S 14,15 AbstractIntroduction: Medicines have made an appreciable contribution to improving health. However, even high income countries are struggling to fund new premium-priced medicines. This will grow necessitating the development of new models to optimise their use. Objective: Review case histories among health authorities to improve the utilisation and expenditure on new medicines. Subsequently, use these to develop exemplar models and outline their implications. Challenges and proposed models: A number of issues and challenges have been identified including the limited innovation level of new medicines alongside increasing requested prices for their reimbursement especially for oncology, orphan diseases, diabetes and HCV. Models centre on the three pillars of pre-, peri, and post-launch including critical drug evaluation and multi-criteria models for valuing medicines for orphan diseases alongside potentially capping pharmaceutical expenditure Discussion: Proposed models which involve all key stakeholder groups are critical for the sustainability of healthcare systems or enhancing universal access. The models should help stimulate debate as well as restore trust between key stakeholder groups.

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Section: Iii) Capped Budgets and Other Mechanisms To Potentially Optimentioning

confidence: 99%

Are new models needed to optimize the utilization of new medicines to sustain healthcare systems?

Godman

Malmström

Diogène³

et al. 2014

Expert Review of Clinical Pharmacology

115

132

View full text Add to dashboard Cite

show abstract

“…So have the Eastern European countries (7)(8)(9)(10)(11). Nevertheless, challenges remain when it comes to the role of HTA in public health decision-making as well as to human resource capacities of these countries (11).…”

Section: Drug Reimbursement Decision-making -An Even Bigger Problem Imentioning

confidence: 99%

Criteria for Drug Reimbursement Decision-Making: An Emerging Public Health Challenge in Bulgaria

Искров

Стефанов

2016

Balkan Med J

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Background: During times of fiscal austerity, means of reimbursement decision-making are of particular interest for public health theory and practice. Introduction of advanced health technologies, growing health expenditures and increased public scrutiny over drug reimbursement decisions have pushed governments to consider mechanisms that promote the use of effective health technologies, while constraining costs. Aims: The study's aim was to explore the current rationale of the drug reimbursement decision-making framework in Bulgaria. Our pilot research focused on one particular component of this process -the criteria used -because of the critical role that criteria are known to have in setting budgets and priorities in the field of public health. The analysis pursued two objectives: to identify important criteria relevant to drug reimbursement decision-making and to unveil relationships between theory and practice. Study Design: Cross-sectional study. Methods: The study was realized through a closedended survey on reimbursement criteria among four major public health stakeholders -medical professionals, patients, health authorities, and industry. Empirical outcomes were then cross-compared with the theoretical framework, as defined by current Bulgarian public health legislation. Analysis outlined what is done and what needs to be done in the field of public health reimbursement decision-making. Results: Bulgarian public health stakeholders agreed on 15 criteria to form a tentative optimal framework for drug reimbursement decision-making. The most apparent gap between the empirically found preferences and the official legislation is the lack of consideration for the strength of evidence in reimbursement decisions. Conclusion: Bulgarian policy makers need to address specific gaps, such as formal consideration for strength of evidence, explicit role of efficiency criteria, and means to effectively empower patient and citizen involvement in public health decision-making. Drug reimbursement criteria have to be integrated into legitimate public health decision support tools that ensure the achievement of national public health objectives. These recommendations could be expanded to all Eastern European countries who share common public health problems.

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“…Many factors, such as safety, efficacy, clinical outcomes, and pharmacoeconomic evidence, as well as ethical, legal, and societal issues, will affect the decisionmaking processes related to the health insurance coverage of particular nanotherapeutic products. Thus, there is much to learn from the literature on health technology assessment methods/criteria/institutions 83,84 and their roles in the uptake of a new drug therapy in Poland 85,86 or Germany. 87 In addition, some countries have established "horizon scanning systems" to support their decision-making processes using reliable data about new health technologies.…”

Section: Nanotherapeutic Translation and Commercializationmentioning

confidence: 99%

Nanotherapeutics in the EU: an overview on current state and future directions

Hafner¹,

Lovrić²,

Lakoš³

et al. 2014

IJN

108

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The application of nanotechnology in areas of drug delivery and therapy (ie, nanotherapeutics) is envisioned to have a great impact on public health. The ability of nanotherapeutics to provide targeted drug delivery, improve drug solubility, extend drug half-life, improve a drug’s therapeutic index, and reduce a drug’s immunogenicity has resulted in the potential to revolutionize the treatment of many diseases. In this paper, we review the liposome-, nanocrystal-, virosome-, polymer therapeutic-, nanoemulsion-, and nanoparticle-based approaches to nanotherapeutics, which represent the most successful and commercialized categories within the field of nanomedicine. We discuss the regulatory pathway and initiatives endeavoring to ensure the safe and timely clinical translation of emerging nanotherapeutics and realization of health care benefits. Emerging trends are expected to confirm that this nano-concept can exert a macro-impact on patient benefits, treatment options, and the EU economy.

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A review of Health Technology Assessment (HTA) recommendations for drug therapies issued between 2007 and 2009 and their impact on policymaking processes in Poland

Cited by 22 publications

References 15 publications

Are new models needed to optimize the utilization of new medicines to sustain healthcare systems?

Are new models needed to optimize the utilization of new medicines to sustain healthcare systems?

Criteria for Drug Reimbursement Decision-Making: An Emerging Public Health Challenge in Bulgaria

Nanotherapeutics in the EU: an overview on current state and future directions

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