Regulatory niches: Diagnostic reform as a process of fragmented expansion. Evidence from the UK 1990-2018.

This paper analyses the politics of regulatory expansion within the diagnostics sector. Since 1990, an informal, clinician-led process of diagnostic innovation within the UK NHS has been challenged by new mechanisms for the evaluation of diagnostics. We describe these diagnostic reforms as a process of fragmented regulatory expansion. New governance mechanisms function as regulatory niches: discrete spaces within an overarching sociotechnical regime. The boundaries of regulatory niches are organisational and epistemological. Organisational boundaries map onto established communities of practice that constitute the regulatory target; epistemological boundaries are defined by distinctive evaluation frameworks. Niches are also distinguished by their outcomes (rate of positive decisions) and their origins. Niche formation was triggered by five drivers: public scandal; technological change; marketisation; institutional isomorphism; and transnational policy transfer. Each niche was triggered by a unique confluence of these drivers, but common to all were historic shifts in healthcare politics, as the rise of evidence-based medicine intersected with the centralising impulse of the regulatory state, which encroached on clinical autonomy in a contest for power that is increasingly mediated by influential non-governmental organisations.ERC 71668

What has health technology assessment ever done for us?

Health technology assessment (HTA) has over the past three decades become a well-established part of decisions about allocation of resources in many countries. Despite this, little is known about HTA's impact on health systems. Few studies have evaluated the benefits of HTA for health outcomes, for access to care or for public budgets. In contrast, HTA has relatively clear upfront costs, which could potentially discourage policy-makers from establishing HTA agencies, especially in low income countries with restricted resources. It may be premature, though, to dismiss this approach altogether, as less tangible modernizing goals are still significant

The Emerging Social Science Literature on Health Technology Assessment: A Narrative Review.

BACKGROUND: Social scientists have paid increasing attention to health technology assessment (HTA). This paper provides an overview of existing social scientific literature on HTA, with a focus on sociology and political science and their subfields. METHODS: Narrative review of key pieces in English. RESULTS: Three broad themes recur in the emerging social science literature on HTA: the drivers of the establishment and concrete institutional designs of HTA bodies; the effects of institutionalized HTA on pricing and reimbursement systems and the broader society; and the social and political influences on HTA decisions. CONCLUSION: Social scientists bring a focus on institutions and social actors involved in HTA, using primarily small-N research designs and qualitative methods. They provide valuable critical perspectives on HTA, at times challenging its otherwise unquestioned assumptions. However, they often leave aside questions important to the HTA practitioner community, including the role of culture and values. Closer collaboration could be beneficial to tackle new relevant questions pertaining to HTA

When health technology assessment is confidential and experts have no power: the case of Hungary.

Health technology assessment (HTA) is not simply a mechanistic technical exercise as it takes place within a specific institutional context. Yet, we know little about how this context influences the operation of HTA and its ability to influence policy and practice. We seek to demonstrate the importance of considering institutional context, using a case study of Hungary, a country that has pioneered HTA in Central and Eastern Europe. We conducted 26 in-depth, semi-structured interviews with public- and private-sector stakeholders. We found that while the HTA Department, the Hungarian HTA organisation, fulfilled its formal role envisaged in the legislation, its potential for supporting evidence-based decision-making was not fully realised given the low levels of transparency and stakeholder engagement. Further, the Department's practical influence throughout the reimbursement process was perceived as being constrained by the payer and policy-makers, as well as its own limited organisational capacity. There was also scepticism as to whether the current operational form of the HTA process delivered 'good value for money'. Nevertheless, it still had a positive impact on the development of a broader institutional HTA infrastructure in Hungary. Our findings highlight the importance of considering institutional context in analysing the HTA function within health systems

Half a Century of Wilson & Jungner: Reflections on the Governance of Population Screening.

Background: In their landmark report on the "Principles and Practice of Screening for Disease" (1968), Wilson and Jungner noted that the practice of screening is just as important for securing beneficial outcomes and avoiding harms as the formulation of principles. Many jurisdictions have since established various kinds of "screening governance organizations" to provide oversight of screening practice. Yet to date there has been relatively little reflection on the nature and organization of screening governance itself, or on how different governance arrangements affect the way screening is implemented and perceived and the balance of benefits and harms it delivers. Methods: An international expert policy workshop convened by Sturdy, Miller and Hogarth. Results: While effective governance is essential to promote beneficial screening practices and avoid attendant harms, screening governance organizations face enduring challenges. These challenges are social and ethical as much as technical. Evidence-based adjudication of the benefits and harms of population screening must take account of factors that inform the production and interpretation of evidence, including the divergent professional, financial and personal commitments of stakeholders. Similarly, when planning and overseeing organized screening programs, screening governance organizations must persuade or compel multiple stakeholders to work together to a common end. Screening governance organizations in different jurisdictions vary widely in how they are constituted, how they relate to other interested organizations and actors, and what powers and authority they wield. Yet we know little about how these differences affect the way screening is implemented, and with what consequences. Conclusions: Systematic research into how screening governance is organized in different jurisdictions would facilitate policy learning to address enduring challenges. Even without such research, informal exchange and sharing of experiences between screening governance organizations can deliver invaluable insights into the social as well as the technical aspects of governance

The Implementation of Managed Entry Agreements in Central and Eastern Europe : Findings and Implications

Funding Information: In Bosnia and Herzegovina, both The Federation of Bosnia and Herzegovina and the Republic of Srpska, also have special funds and budgets in place for the financing of expensive medicines, which are innovative and under patent. Similar earmarked funds are available in Scotland (the New Medicines Fund funded by the Pharmaceutical Price Regulation Scheme [PPRS] rebates) [35] and England (the Cancer Drugs Fund) [36]. However, support for such earmarked funds is mixed. While they facilitate access, critics raised issues about fairness towards other disease areas and patient groups that are not eligible for special funding [3, 39]. Further, the views of a Patient and Clinician Engagement meeting in Scotland [37] and the end-of-life criteria in England [38] offer opportunities for special considerations affecting medicines for end-of-life and very rare conditions to be taken into account in the health technology assessment process. Funding Information: The authors would like to acknowledge Dr. Jan Jones from the Scottish Medicines Consortium, Scotland, for contributing to the discussion with information on Scotland, Drs. Lyudmila Bezmelnitsyna and Anastasia Isaeva for contributing to data collection in Russia and Dr. Kate?ina Podrazilov? from SZP ?R for providing information on the Czech Republic. Alessandra Ferrario was a Research Officer at the LSE Health at the time this research was conducted. She is now a postdoctoral Research Fellow at the Department of Population Medicine, Harvard Medical School and Harvard Pilgrim Health Care Institute, Boston, USA. Email: [email protected] No sources of funding were used for this study. The authors declare they have no conflicts of interest. However, Di?na Ar?ja, Maria Dimitrova, Jurij F?rst, Ieva Grei?i?t?-Kuprijanov, Iris Hoxha, Arianit Jakupi, Erki Laidm?e, Vanda Markovic-Pekovic, Dmitry Meshkov, Guenka Petrova, Maciej Pomorski and Patricia Vella Bonanno work directly for national health authorities or are advisers to them. Alessandra Ferrario, Tomasz Bochenek, Ileana Mardare, Dominik Tomek, Luka Voncina, Alan Haycox, Panos Kanavos,?Olga L?blov?, and Brian Godman are academics and independent researchers also working with national and regional health authorities and others to improve the quality and efficiency of prescribing, and Tarik Catic, D?vid Dank?,and Tanja Novakovic are involved with pharmaceutical, pharmacoeconomics and outcomes research groups in their countries. Olga L?blov? has also carried out remunerated consultancy activities for A&R Partners, Baxter AG and Instytut Arcana and Ileana Mardare has signed a consulting contract with Ewopharma A.G. Romania. The content of the paper and the conclusions are those of each author and may not necessarily reflect those of any organisation that employs them. Publisher Copyright: © 2017, The Author(s).Background: Managed entry agreements (MEAs) are a set of instruments to facilitate access to new medicines. This study surveyed the implementation of MEAs in Central and Eastern Europe (CEE) where limited comparative information is currently available. Method: We conducted a survey on the implementation of MEAs in CEE between January and March 2017. Results: Sixteen countries participated in this study. Across five countries with available data on the number of different MEA instruments implemented, the most common MEAs implemented were confidential discounts (n = 495, 73%), followed by paybacks (n = 92, 14%), price-volume agreements (n = 37, 5%), free doses (n = 25, 4%), bundle and other agreements (n = 19, 3%), and payment by result (n = 10, >1%). Across seven countries with data on MEAs by therapeutic group, the highest number of brand names associated with one or more MEA instruments belonged to the Anatomical Therapeutic Chemical (ATC)-L group, antineoplastic and immunomodulating agents (n = 201, 31%). The second most frequent therapeutic group for MEA implementation was ATC-A, alimentary tract and metabolism (n = 87, 13%), followed by medicines for neurological conditions (n = 83, 13%). Conclusions: Experience in implementing MEAs varied substantially across the region and there is considerable scope for greater transparency, sharing experiences and mutual learning. European citizens, authorities and industry should ask themselves whether, within publicly funded health systems, confidential discounts can still be tolerated, particularly when it is not clear which country and party they are really benefiting. Furthermore, if MEAs are to improve access, countries should establish clear objectives for their implementation and a monitoring framework to measure their performance, as well as the burden of implementation.publishersversionPeer reviewe

Health Technology Assessment and Health Care Reimbursement in the European Union: Permissive Dissensus and the Limits of Harmonization through the Backdoor.

Member states have consistently limited the European Union's competences in the area of health care reimbursement. Despite these efforts, there has been a slow but steady tendency toward harmonization of a key tool in reimbursement decision-making: health technology assessment (HTA), a multidisciplinary evaluation of "value for money" of medicines, devices, diagnostics, and interventions, which provides expert advice for reimbursement decisions. This article examines the origins of this paradoxical appetite for harmonization as well as of the dissensus that has, at the moment, somewhat stalled further integration in HTA. It finds that the prointegration neofunctionalist "permissive dissensus" is still present in decision making on HTA but potentially offset by dissensus or outright opposition from key actors, including member states and the medical device industry. These actors are able to decipher the potential consequences of highly technical issues, such as HTA, for national systems of social protection. Despite that, they have little interest in politicizing the issue, potentially opening the door to integrative policy solutions in the future

Who's afraid of institutionalizing health technology assessment (HTA)?: Interests and policy positions on HTA in the Czech Republic.

This article identifies the interests and policy positions of key health policy stakeholders regarding the creation of a health technology assessment (HTA) agency in the Czech Republic, and what considerations influenced them. Vested interests have been suggested as a factor mitigating the diffusion of HTA bodies internationally. The Czech Republic recently considered and discarded establishing an HTA agency, making it a good case for studying actors' policy positions throughout the policy debates. Findings are based on in-depth, semi-structured expert and elite interviews with 34 key Czech health policy actors, supported by document analysis and extensive triangulation. Findings show that the HTA epistemic community of 'aspiring agents' was the only actor strongly in favor of an HTA body. Payers and the medical device and diagnostics industry were against it; patients and clinicians had no clear preferences. Original decision-makers were in favor but a new minister of health opted for a simpler policy alternative to solve his need for expertise. Existing institutions, policy alternatives and the institutional design of a future HTA body influence domestic actors' preferences for or against an HTA agency. Domestic and international proponents of HTA should give serious thought to their concerns when advocating for HTA bodies