An exploratory study to estimate cost-effectiveness threshold value for life saving treatments in western Iran

Background: Cost-effectiveness analysis provides a crucial means for evidence-informed decision-making on resource allocation. This study aims to elicit individuals' willingness to pay (WTP) for one additional quality-adjusted life-year (QALY) gained from life-saving treatment and associated factors in Kermanshah city, western Iran. Methods: We conducted a cross-sectional study on a total of 847 adults aged 18 years and above to elicit their WTP for one additional QALY gained by oneself and a family member using a hypothetical life-saving treatment. We used a multistage sampling technique to select the samples, and the Iranian version of EQ-5D-3L, and visual analogue scale (VAS) measures to obtain the participants� health utility value. The Tobit regression model was used to identify the factors affecting WTP per QALY values. Results: The mean WTP value and standard deviation (SD) was US 862 (3,224) for the respondents. The mean utility values using EQ-5D-3L and VAS methods for respondents were 0.779 and 0.800, respectively. Besides, the WTP for the additional QALY gained by the individual participants using the EQ-5D-3L and VAS methods were respectively US 1,202 and US 1,101, while the estimated value of the family members was US 1,355 (SD = 3,993). The Tobit regression models indicated that monthly income, education level, sex, and birthplace were statistically significantly associated (p < 0.05) with both the WTP for the extra QALY values using the EQ-5D-3L and the VAS methods. Educational level and monthly income also showed statistically significant relationships with the WTP for the additional QALY gained by the family members (p < 0.05). Conclusion: Our findings indicated that the participants' WTP value of the additional QALY gained from the hypothetical life-saving treatment was in the range of 0.20�0.24 of the gross domestic product (GDP) per capita of Iran. This value is far lower than the World Health Organization (WHO) recommended CE threshold value of one. This wide gap reflects the challenges the health system is facing and requires further research for defining the most appropriate CE threshold at the local level. © 2020, The Author(s)

Using the health policy triangle framework to describe local, regional and national healthcare policy changes within Ireland's diverse healthcare settings

Introduction: Developed in the late 20th century, the conceptual descriptive framework for this thesis was inspired by Walt and Gilson’s health policy triangle (HPT). The HPT model is a policy analysis framework universally used and applied in the literature to analyse various health-related issues, mainly at national or international level. Robust research is required to seek a greater understanding of the application and utilisation of the HPT framework to describe smaller-scale health policy decisions under investigation at local and regional level. Such local and regional decisions may then inform both national and international decisions. The author’s directive was to retrospectively analyse local, regional and national health policy change within different Irish healthcare settings over the last decade with regard to (i) development processes, (ii) evidence generation, (iii) implementation, and (iv) outcomes using the HPT framework within the context of the current Irish Sláintecare reforms. Methods: Using diverse local, regional and national Irish healthcare settings, this thesis examined the generalisable nature of the HPT framework when applied to variety of health-related policy decisions at different stages in their life cycle. Methodologies such as literature reviews, economic evaluations (cost-effectiveness analysis and cost minimisation analysis), and qualitative analysis (using the Framework Approach) helped provide evidence on the health-related policy decisions. Results: The narrative literature review in Chapter 2 identified that the types of health policies analysed by the HPT framework were mainly positioned at national or international level in lower to upper-middle-income countries and were primarily focused upon public health topics. This research concluded that given its generalisable nature, future research that utilises the HPT framework in smaller scale health policy decisions investigated at local and regional levels, could also be beneficial. A subsequent literature review in Chapter 3 applied Walt and Gilson’s health policy triangle model, as a scaffolding framework, to help describe how emerging evidence was used by a large acute Irish teaching hospital to permit the introduction of biosimilar infliximab CT-P13, for the treatment of IBD, into routine care in a safe and timely manner. The review of this local policy decision found that there was a significant time lag of over three years between regulatory approval and clinical acceptance for biosimilar infliximab CT-P13 in this large local hospital’s switching process. The actors concluded that with the existential concern and uncertainty still surrounding biosimilar medicines, a distinct and individualised approach for biosimilar medicine implementation is required. The cost-effectiveness analysis in Chapter 4 demonstrated that on average, the intervention arm of a physician-led medication review programme was more costly but was also more effective. Compared with usual care, the intervention was associated with a non-statistically significant increase of €877 (95% CI −€1,807, €3,561) in mean healthcare cost, and a statistically significant decrease of −0.164 (95% CI −0.257, −0.070) in the mean number of adverse drug reaction events per inpatient. The HPT framework was used to describe how this local level policy decision concerning the physician-led STOPP/START intervention was not implemented but that the generated economic evidence contributed to the evolving STOPP/START criteria policy formation, growth and future evaluation. The cost minimisation analysis in Chapter 5 assessed which formulation of trastuzumab (injected via different administration routes) was more cost-effective and time saving in relation to active healthcare professional (HCP) time. Over a full treatment course of 17 cycles, average HCP time saved accumulated to 16.78 hours with an estimated direct cost saving of €1,609.99 in favour of the trastuzumab subcutaneous formulation. The HPT framework elaborated on various contributing components concerning this contemporary regional policy which ultimately led to the replacement of the trastuzumab intravenous formulation by the trastuzumab subcutaneous formulation in clinical practice. The qualitative interview study in Chapter 6 revealed that both community pharmacists and general practitioners (GPs) accepted the theoretical concept of a co-payment attached to the Irish public health insurance scheme as it prevents moral hazard. GPs independently suggested that a co-payment system introduced in their field of practice may inhibit moral hazard by publicly insured patients in the utilisation of GP services. The HPT framework was used to depict the interrelated factors which underpin this national pharmaceutical policy where going forward, both GP and pharmacy unions have expressed interest to be more involved in the policy formation stages, not the post-implementation stages. Conclusion: This research has illustrated how generalisable and adaptable the HPT framework is when applied to health-related policy decisions in various Irish healthcare settings. Given this advantage, it is proposed that the HPT framework should be used in Sláintecare reform policy. Using a common descriptive framework and standardising the approach to health policy analysis during this ten-year reform has the potential to increase the successful fruition of Sláintecare policy goals

Evidence Reversal: An exploratory analysis of randomized controlled trials from the New England Journal of Medicine

BACKGROUND: Evidence Reversal (ER) is the phenomenon whereby new and stronger evidence contradicts previously established evidence. OBJECTIVES: To quantify evidence reversals and to determine characteristics associated with reversibility. METHODS: Original articles from the New England Journal of Medicine (2000 to 2016) were screened for three inclusion criteria: tested a clinical practice; Randomized Controlled Trial design; and tested an established clinical practice. The proportion of RCTs that represented ER was determined. Association of trial characteristics with reversal was explored using logistic regression in order to inform a potential framework of reversibility. RESULTS: In total, 611 RCTs met the inclusion criteria, of which 54% were evidence reversals. Based on variables associated with ER, a reversibility framework was proposed, comprised of eight trial characteristics. CONCLUSION: More than 50% of RCTs published in the NEJM that test established practices are evidence reversals. The characteristics of RCTs that are associated with reversal will inform future research to further understand reversibility