Objectives: This study examines the cost-effectiveness of the OPTI-SCRIPT intervention on potentially inappropriate prescribing in primary care.

Methods: Economic evaluation, using incremental cost-effectiveness and cost utility analyses, conducted alongside a cluster randomized controlled trial of twenty-one general practices and 196 patients, to compare a multifaceted intervention with usual practice in primary care in Ireland. Potentially inappropriate prescriptions (PIPs) were determined by a pharmacist. Incremental costs, PIPs, and quality-adjusted life-years (QALYs) at 12-month follow-up were estimated using multilevel regression. Uncertainty was explored using cost-effectiveness acceptability curves.

Results: The intervention was associated with a nonsignificant mean cost increase of €407 (95 percent CIs, −357–1170), a significant mean reduction in PIPs of 0.379 (95 percent CI, 0.092–0.666), and a nonsignificant mean increase in QALYs of 0.013 (95 percent CIs, −0.016–0.042). The incremental cost per PIP avoided was €1,269 (95 percent CI, −1400–6302) and the incremental cost per QALY gained was €30,535 (95 percent CI, −334,846–289,498). The probability of the intervention being cost-effective was 0.602 at a threshold value of €45,000 per QALY gained and was at least 0.845 at threshold values of €2,500 per PIP avoided and higher.

Conclusions: While the OPTI-SCRIPT intervention was effective in reducing potentially inappropriate prescribing in primary care in Ireland, our findings highlight the uncertainty with respect to its cost-effectiveness. Further studies are required to explore the health and economic implications of interventions targeting potentially inappropriate prescribing.

Objectives: In the past decade, there has been a growing interest in health technology disinvestment. A disinvestment process should involve all relevant stakeholders to identify and deliver the most effective, safe, and cost-effective healthcare interventions. The aim of the present study was to describe the state of the art of health technology disinvestment around the world and to identify parameters that could be associated with the implementation of disinvestment programs.

Methods: A systematic review of the literature was performed from database inception to November 2014, together with the collection of original data on socio-economic indicators from forty countries.

Results: Overall, 1,456 records (1,199 from electronic databases and 257 from other sources) were initially retrieved. After analyzing 172 full text articles, 38 papers describing fifteen disinvestment programs/experiences in eight countries were included. The majority (12/15) of disinvestment programs began after 2006. As expected, these programs were more common in developed countries, 63 percent of which had a Beveridge model healthcare system. The univariate analysis showed that countries with disinvestment programs had a significantly higher level of Human Development Index, Gross Domestic Product per capita, public expenditure on health and social services, life expectancy at birth and a lower level of infant mortality rate, and of perceived corruption. The existence of HTA agencies in the country was a strong predictor (p = .034) for the development of disinvestment programs.

Conclusions: The most significant variables in the univariate analysis were connected by a common factor, potentially related to the overall development stage of the country.

Objectives: Tackling ethical dilemmas faced by reimbursement decision makers requires deeper understanding of values on which health technology assessment (HTA) agencies are founded and how trade-offs are made. This was explored in this study including the case of rare disease.

Methods: Representatives from eight HTA explored values on which institutions are founded using a narrative approach and reflective multicriteria (developed from EVIDEM, criteria derived from ethical imperatives of health care). Trade-offs between criteria and the impact of incorporating defined priorities (including for rare diseases) were explored through a quantitative values elicitation exercise.

Results: Participants reported a diversity of substantive and procedural values with a common emphasis on scientific excellence, stakeholder involvement, independence, and transparency. Examining the ethical imperatives behind EVIDEM criteria was found to be useful to further explore substantive values. Most criteria were deemed to reflect institutions’ values, while 70 percent of the criteria were reported by at least half of participants to be considered formally by their institutions. The quantitative values elicitation highlighted the difficulty to balance imperatives of “alleviating or preventing patient suffering,” “serving the whole population equitably,” “upholding healthcare system sustainability,” and “making decisions informed by evidence and context” but may help share the ethical reasoning behind decisions. Incorporating “Priorities” (including for rare diseases) helped reveal trade-offs from other criteria and their underlying ethical imperatives.

Conclusions: Reflective multicriteria are useful to explore substantive values of HTAs, reflect how these values and their ethical underpinnings can be operationalized into criteria, and explore the ethical reasoning at the heart of the healthcare debate.

Objectives: The aim of this study was to investigate how the societal perspective is conceptualized in economic evaluations and to assess how intersectoral costs and benefits (ICBs), that is, the costs and benefits pertaining to sectors outside the healthcare sector, impact their results.

Methods: Based on a search in July 2015 using PubMed, Embase, CINAHL, and PsychINFO, a systematic literature review was performed for economic evaluations which were conducted from a societal perspective. Conceptualizations were assessed in NVivo version 11 using conventional and directed content analysis. Trial-based evaluations in the fields of musculoskeletal and mental disorders were analyzed further, focusing on the way ICBs impact the results of economic evaluations.

Results: A total of 107 studies were assessed, of which 74 (69.1 percent) provided conceptualizations of the societal perspective. These varied in types of costs included and in descriptions of cost bearers. Labor productivity costs were included in seventy-two studies (67.3 percent), while only thirty-eight studies (35.5 percent) included other ICBs, most of which entailed informal care and/or social care costs. ICBs within the educational and criminal justice sectors were each included five times. Most of the trial-based evaluations analyzed further (n = 21 of 28) reported productivity costs. In nine, these took up more than 50 percent of total costs. In several studies, criminal justice and informal care costs were also important.

Conclusions: There is great variety in the way the societal perspective is conceptualized and interpreted within economic evaluations. Use of the term “societal perspective” is often related to including merely productivity costs, while other ICBs could be relevant as well.

Objectives: Japanese authorities have announced a plan to introduce a health technology assessment (HTA) system in 2016. This study assessed the potential impact of such a policy on the price of the antivirologic drug simeprevir.

Methods: Taking the antivirologic drug simeprevir as an example, we compared the current Japanese price with hypothetical prices that might result if a U.K. (cost-utility) or German (efficiency frontier) style HTA assessment was in place.

Results: The simeprevir unit price under the current Japanese pricing scheme is 13,122 Japanese yen (equivalent to 109.35 U.S. dollars as of April 2015). Depending on the selection of comparators and the pricing method, and assuming that HTA will be used as a basis for price setting, the estimated prices of simeprevir vary up to four times higher than under the current Japanese pricing scheme.

Conclusions: Although the analysis is based on only one drug, it cannot be taken for granted that a new HTA system would reduce public healthcare expenditure in Japan.

Objectives: The aim of this work was to provide a comprehensive overview of the evolution of the health technology assessment (HTA) concept in the scientific literature through a scientometric approach.

Methods: A literature search was conducted, by selecting publications, as well as news from the media, containing “health technology assessment” in their title, abstracts, or keywords. We then undertook a bibliometric and network analysis on the corpus of 2,865 publications thus obtained.

Results: Since a first publication in 1978, interest in HTA remained marginal until a turning point in the late 1980s, when growth of the number of publications took off alongside the creation of the U.K.’s NICE agency. Since then, publications have spread across several journals. The ranking of the organizations that publish such articles does not reflect any hegemonic position. However, HTA-related scientific production is strongly concentrated in Commonwealth and Nordic countries. Despite its transnational aspects, research on HTA has been framed within a small number of scientific networks and by a few opinion leaders.

Conclusions: The “career” of the HTA concept may be seen as a scientific-knowledge based institutionalization of a public policy. To succeed in a country, HTA first needs scientific prerequisites, such as an organized scientific community working on the health sector and health services. Then, it appears that the recognition of this research by decision makers plays a key role in the development of the field.

Objectives: Value assessments of marketed drug technologies have been developed through disinvestment frameworks. Components of these frameworks are varied and implementation challenges are prevalent. The objective of this systematic literature review was to describe disinvestment framework process components for drugs and to report on framework components, challenges, and solutions.

Methods: A systematic literature search was conducted using the terms: reassessment, reallocation, reinvestment, disinvestment, delist, decommission or obsolescence in MEDLINE, EMBASE, NLM PubMed, the Cochrane Library, and CINAHL from January 1, 2000, until November 14, 2015. Additional citations were identified through a gray literature search of Health Technology Assessment international (HTAi) and the International Network of Agencies for Health Technology Assessment (INAHTA) member Web sites and from bibliographies of full-text reviewed manuscripts.

Results: Sixty-three articles underwent full text review and forty were included in the qualitative analysis. Framework components including disinvestment terms and definitions, identification and prioritization criteria and methods, assessment processes, stakeholders and dissemination strategies, challenges, and solutions were compiled. This review finds that stakeholders lack the political, administrative, and clinical will to support disinvestment and that there is not one disinvestment framework that is considered best practice.

Conclusions: Drug technology disinvestment components and processes vary and challenges are numerous. Future research should focus on lessening value assessment challenges. This could include adopting more neutral framework terminology, setting fixed reassessment timelines, conducting therapeutic reviews, and modifying current qualitative decision-making assessment frameworks.

Objectives: The aim of this study was to examine submissions made to the Pharmaceutical Benefits Advisory Committee (PBAC) and assess whether the predicted financial impact was associated with a recommendation. The second objective was to assess whether the financial and utilization estimates for listing the proposed medicine were reliable.

Methods: Data were extracted from public summary documents of major submissions considered by the PBAC from 2012 to 2014. Information collected included whether submissions were accepted, rejected, or deferred; estimated use; and financial impact. For those submissions that were recommended in 2012 and listed on the Pharmaceutical Benefits Scheme (PBS) by January 2014, a comparison was made between predicted and actual use and cost in 2014, based on PBS utilization.

Results: In 2012 to 2014, the PBAC considered 142 unique major submissions; of those, 65 were recommended for listing. A higher financial cost to the government was a statistically significant factor in predicting rejection (p = .004 for cost > AUD 30 million Australian dollars [20.7 million Euros] compared with cost-saving). Of the submissions that were recommended in 2012 and listed by 2014, the actual use was higher than predicted for 5/19 medications. The estimated cost was outside the predicted bracket of cost for 10/19 medications, with 8/19 medications having threefold underestimated expenditure, and 2/19 items having lower than predicted expenditure.

Conclusions: This study highlights that the predicted financial impact of a medication to the PBS budget is associated with a PBAC recommendation and also highlights that predicted use may not reflect actual prescribing practices.

Objectives: We developed specific evaluation criteria to assess patient and public involvement in resource allocation decisions in health care.

Methods: We reviewed the literature from health and other sectors relevant to stakeholder involvement and conducted twenty-seven key informant interviews with stakeholders knowledgeable about patient and public involvement in Canadian drug resource allocation decisions. We used an inductive qualitative thematic approach to analyze the interviews with codes and categories developed directly from individuals’ interview transcripts.

Results: Integrating respondents’ comments and the literature review, we identified nine evaluation criteria of patient and the public involvement in healthcare resource allocation decision making: clarity regarding rationale and roles of patient and public members, sufficient support, adequate representation of relevant views, fair decision-making processes, legitimacy of committee processes, adequate opportunity for participation, meaningful degree of participation, noticeable effect on decisions, and considerations of the efficiency of patient and public involvement.

Conclusions: Our results will help to develop methods to evaluate patient and public involvement in healthcare decision making.

Background: Hospitals with health technology assessment (HTA) programs have reported its positive effects on the management of resources and costs. This study aimed to identify the barriers faced by hospital-based HTA (HBHTA) in Iran by inductive content analysis of stakeholders’ and decision-makers’ points of view.

Methods: The key individuals and organizations that could provide rich, relevant, and diverse data in response to the research question were purposively selected for the interviews and focus group discussion.

Results: Twelve stakeholders from seven public hospitals participated in the interviews. Another eighteen stakeholders from twelve HBHTA-related organizations took part in the focus group discussion. Most of the hospitals’ senior management team did not feel the need for HBHTA and believed that in Iran a systematic process like HTA faces many challenges.

Conclusions: The stakeholders participating in this study highlighted the significance of certain points that needed to be addressed before establishing HBHTA in Iran.

Objectives: Health technology financing is often based on randomized controlled trials (RCTs), which are often the same ones used for licensing. Because they are designed to show the best possible results, typically Phase III studies are conducted under ideal and highly controlled conditions. Consequently, it is not surprising that technologies do not always perform in real life in the same way as controlled conditions. Because financing (and price paid) decisions can be made with overestimated results, health authorities need to ask whether health systems achieve the results they expect when they choose to pay for a technology. The optimal way to answer this question is to assess the performance of financed technologies in real-world settings. Health technology performance assessment (HTpA) refers to the systematic evaluation of the properties, effects, and/or impact of a health intervention or health technology in the real world to provide information for investment/disinvestment decisions and clinical guideline updates. The objective is to describe the development and principal aspects of the Guideline for HTpA commissioned by the Brazilian Ministry of Health.

Methods: Our methods used include extensive literature review, refinement with experts across countries, and public consultation.

Results: A comprehensive guideline was developed, which has been adopted by the Brazilian government.

Conclusion: We believe the guideline, with its particular focus on disinvestment, along with the creation of a specific program for HTpA, will allow the institutionalization and continuous improvement of the scientific methods to use real-world evidence to optimize available resources not only in Brazil but across countries.

Objectives: The aim of this study was to examine the evidence payers cited in their coverage policies for multi-gene panels and sequencing tests (panels), and to compare these findings with the evidence payers cited in their coverage policies for other types of medical interventions.

Methods: We used the University of California at San Francisco TRANSPERS Payer Coverage Registry to identify coverage policies for panels issued by five of the largest US private payers. We reviewed each policy and categorized the evidence cited within as: clinical studies, systematic reviews, technology assessments, cost-effectiveness analyses (CEAs), budget impact studies, and clinical guidelines. We compared the evidence cited in these coverage policies for panels with the evidence cited in policies for other intervention types (pharmaceuticals, medical devices, diagnostic tests and imaging, and surgical interventions) as reported in a previous study.

Results: Fifty-five coverage policies for panels were included. On average, payers cited clinical guidelines in 84 percent of their coverage policies (range, 73–100 percent), clinical studies in 69 percent (50–87 percent), technology assessments 47 percent (33–86 percent), systematic reviews or meta-analyses 31 percent (7–71 percent), and CEAs 5 percent (0–7 percent). No payers cited budget impact studies in their policies. Payers less often cited clinical studies, systematic reviews, technology assessments, and CEAs in their coverage policies for panels than in their policies for other intervention types. Payers cited clinical guidelines in a comparable proportion of policies for panels and other technology types.

Conclusions: Payers in our sample less often cited clinical studies and other evidence types in their coverage policies for panels than they did in their coverage policies for other types of medical interventions.