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The use of comparative effectiveness research to inform policy decisions on the inclusion of bevacizumab for the treatment of macular diseases in Thailand's pharmaceutical benefit package.

ABSTRACT: There is increasing impetus to use pharmaceutical interventions, ie, ranibizumab or bevacizumab, for the treatment of particular macular diseases. This paper describes the evidence and decision-making of the National List of Essential Medicines Committee that recently announced the inclusion of bevacizumab for the treatment of macular diseases in its pharmaceutical benefit package. The findings of a systematic review and meta-analysis in this paper indicate that the intravitreal administration of bevacizumab is superior to nonpharmaceutical treatments for age-related macular degeneration (AMD) and diabetic macular edema (DME), but inconclusive for retinal vein occlusion, given the limited evidence. The study also failed to distinguish among the differences in terms of visual acuity improvement, reduction of central macular thickness, and response to treatment between AMD and DME patients treated with bevacizumab and those treated with ranibizumab. Although bevacizumab was not licensed for AMD and DME, the committee decided to include bevacizumab in the National List of Essential Medicines. It is expected that many patients who are in need of treatment but who are unable to afford the expensive alternative drug, ranibizumab, will be able to receive this effective treatment instead and be prevented from suffering irreversible loss of vision. At the same time, this policy will help generate evidence about the real-life effectiveness and safety profiles of the drug for future policy development in Thailand and other settings.

SUBMITTER: Anothaisintawee T

PROVIDER: S-EPMC3520463 | biostudies-literature | 2012

REPOSITORIES: biostudies-literature

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The use of comparative effectiveness research to inform policy decisions on the inclusion of bevacizumab for the treatment of macular diseases in Thailand's pharmaceutical benefit package.

Anothaisintawee Thunyarat T Leelahavarong Pattara P Ratanapakorn Tanapat T Teerawattananon Yot Y

ClinicoEconomics and outcomes research : CEOR 20121206

There is increasing impetus to use pharmaceutical interventions, ie, ranibizumab or bevacizumab, for the treatment of particular macular diseases. This paper describes the evidence and decision-making of the National List of Essential Medicines Committee that recently announced the inclusion of bevacizumab for the treatment of macular diseases in its pharmaceutical benefit package. The findings of a systematic review and meta-analysis in this paper indicate that the intravitreal administration o ...[more]

PMID: 23248574

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Project description:BACKGROUND:Non-Invasive Prenatal Testing (NIPT) is a technology which provides information about fetal genetic characteristics (including sex) very early in pregnancy by examining fetal DNA obtained from a sample of maternal blood. NIPT is a morally complex technology that has advanced quickly to market with a strong push from industry developers, leaving many areas of uncertainty still to be resolved, and creating a strong need for health policy that reflects women's social and ethical values. We approach the need for ethical policy-making by studying the use of NIPT and emerging policy in the province of Ontario, Canada. METHODS:Using an adapted version of constructivist grounded theory, we conducted interviews with 38 women who have had personal experiences with NIPT. We used an iterative process of data collection and analysis and a staged coding strategy to conduct a descriptive analysis of ethics issues identified implicitly and explicitly by women who have been affected by this technology. RESULTS:The findings of this paper focus on current ethical issues for women seeking NIPT, including place in the prenatal pathway, health care provider counselling about the test, industry influence on the diffusion of NIPT, consequences of availability of test results. Other issues gain relevance in the context of future policy decisions regarding NIPT, including funding of NIPT and principles that may govern the expansion of the scope of NIPT. These findings are not an exhaustive list of all the potential ethical issues related to NIPT, but rather a representation of the issues which concern women who have personal experience with this test. CONCLUSIONS:Women who have had personal experience with NIPT have concerns and priorities which sometimes contrast dramatically with the theoretical ethics literature. These findings suggest the importance of engaging patients in ethical deliberation about morally complex technologies, and point to the need for more deliberative patient engagement work in this area.

Project description:BackgroundGonorrhoea is one of the most common bacterial sexually transmitted infections in England. Over 41,000 cases were recorded in 2015, more than half of which occurred in men who have sex with men (MSM). As the bacterium has developed resistance to each first-line antibiotic in turn, we need an improved understanding of fitness benefits and costs of antibiotic resistance to inform control policy and planning. Cefixime was recommended as a single-dose treatment for gonorrhoea from 2005 to 2010, during which time resistance increased, and subsequently declined.Methods and findingsWe developed a stochastic compartmental model representing the natural history and transmission of cefixime-sensitive and cefixime-resistant strains of Neisseria gonorrhoeae in MSM in England, which was applied to data on diagnoses and prescriptions between 2008 and 2015. We estimated that asymptomatic carriers play a crucial role in overall transmission dynamics, with 37% (95% credible interval CrI 24%-52%) of infections remaining asymptomatic and untreated, accounting for 89% (95% CrI 82%-93%) of onward transmission. The fitness cost of cefixime resistance in the absence of cefixime usage was estimated to be such that the number of secondary infections caused by resistant strains is only about half as much as for the susceptible strains, which is insufficient to maintain persistence. However, we estimated that treatment of cefixime-resistant strains with cefixime was unsuccessful in 83% (95% CrI 53%-99%) of cases, representing a fitness benefit of resistance. This benefit was large enough to counterbalance the fitness cost when 31% (95% CrI 26%-36%) of cases were treated with cefixime, and when more than 55% (95% CrI 44%-66%) of cases were treated with cefixime, the resistant strain had a net fitness advantage over the susceptible strain. Limitations include sparse data leading to large intervals on key model parameters and necessary assumptions in the modelling of a complex epidemiological process.ConclusionsOur study provides, to our knowledge, the first estimates of the fitness cost and benefit associated with resistance of the gonococcus to a clinically relevant antibiotic. Our findings have important implications for antibiotic stewardship and public health policies and, in particular, suggest that a previously abandoned antibiotic could be used again to treat a minority of gonorrhoea cases without raising resistance levels.

Project description:BackgroundIn Thailand, pharmacists are responsible for all activities to ensure access to medicines throughout pharmaceutical supply chain. Competency framework (CF) is an important guidance for professional development and workforce planning.ObjectiveThis study aimed to explore needs for pharmacy services in pharmaceutical supply chain and competencies of pharmacists to serve those needs. It was the first step for developing evidence-based pharmacy CF within the context of Thailand in 2026.MethodsA qualitative method using in-depth interviews to gain rich data from practitioners and leaders in all area of practices. 99 key informants from 56 workplaces in Thailand were interviewed during January and March 2016. Data was transcribed verbatim, and thematic analysis was used. Competencies were extracted, followed by several rounds of group discussion among team members to develop an initial framework. The competencies and CF were presented, and recommendations were gained from professional leaders for refining the findings.ResultsThe key informants agreed that pharmacist's works and responsibilities have gradually been drifted to support changes in healthcare and pharmaceutical systems. The upcoming pharmaceutical services call for higher standards of practice, larger number of personnel, and skillful pharmacists who have strong foundation in pharmaceutical knowledge as well as an ability to integrate knowledge into practices. Two sets of CFs were established. The general CF comprises five core domains: product focus, patient focus, healthcare system focus, community focus, and personal focus for self-improvement. These general competencies allow practitioners to perform basic professional tasks, including providing information, dispensing, and compounding. The service-specific competency is the integration of general competencies tailored into specific area of practice.ConclusionsRegarding the professional goal to evolve pharmacists from generalists to specialists for providing higher quality of professional services, the pharmacists are required to demonstrate general competencies and service-specific competencies. The findings serve as the need-based evidence for developing a national CF for pharmacists in Thailand.

Project description:ImportanceLow- and middle-income countries have a high burden of respiratory syncytial virus lower respiratory tract infections. A monoclonal antibody administered monthly is licensed to prevent these infections, but it is cost-prohibitive for most low- and middle-income countries. Long-acting monoclonal antibodies and maternal vaccines against respiratory syncytial virus are under development.ObjectiveWe estimated the likelihood of respiratory syncytial virus preventive interventions (current monoclonal antibody, long-acting monoclonal antibody, and maternal vaccine) being cost-effective in Mali.DesignWe modeled age-specific and season-specific risks of respiratory syncytial virus lower respiratory tract infections within monthly cohorts of infants from birth to six months. We parameterized with respiratory syncytial virus data from Malian cohort studies, as well as product efficacy from clinical trials. Integrating parameter uncertainty, we simulated health and economic outcomes for status quo without prevention, intra-seasonal monthly administration of licensed monoclonal antibody, pre-seasonal birth dose administration of a long-acting monoclonal antibody, and maternal vaccination. We then calculated the incremental cost-effectiveness ratio of each intervention compared to status quo from the perspectives of the government, donor, and society.ResultsAt a price of $3 per dose and from the societal perspective, current monoclonal antibody, long-acting monoclonal antibody, and maternal vaccine would have incremental cost-effectiveness ratios of $4280 (95% CI $1892 to $122,434), $1656 (95% CI $734 to $9091), and $8020 (95% CI $3501 to $47,047) per disability-adjusted life-year averted, respectively.Conclusions and relevanceIn Mali, long-acting monoclonal antibody is likely to be cost-effective from both the government and donor perspectives at $3 per dose. Maternal vaccine would need higher efficacy over that measured by a recent trial in order to be considered cost-effective.

Project description:BackgroundAround 18% of the population in Chile has disabilities. Evidence shows that this population has greater healthcare needs, yet they face barriers to accessing healthcare due to health system failures. This paper aims to assess the inclusion of people with disabilities in health policy documents and to explore the perceptions of key national stakeholders regarding the policy context, policy processes, and actors involved.MethodsA policy content analysis was conducted of 12 health policy documents using the EquiFrame framework, adapted to assess disability inclusion. Documents were reviewed and rated on their quality of commitment against 21 core concepts of human rights in the framework. Key national stakeholders (n = 15) were interviewed, and data were thematically analysed under the Walt and Gilson Policy Analysis Triangle, using NVivo R1.ResultsCore human rights concepts of disability were mentioned at least once in nearly all health policy documents (92%). However, 50% had poor policy commitments for disability. Across policies, Prevention of health conditions was the main human rights concept reflected, while Privacy of information was the least referenced concept. Participants described a fragmented disability movement and health policy, related to a dominant biomedical model of disability. It appeared that disability was not prioritized in the health policy agenda, due to ineffective mainstreaming of disability by the Government and the limited influence and engagement of civil society in policy processes. Moreover, the limited existing policy framework on disability inclusion is not being implemented effectively. This implementation gap was attributed to lack of financing, leadership, and human resources, coupled with low monitoring of disability inclusion.ConclusionsImprovements are needed in both the development and implementation of disability-inclusive health policies in Chile, to support the achievement of the right to healthcare for people with disabilities and ensuring that the health system truly "leaves no one behind".

Project description:BACKGROUND:Lifestyle modifications represent the first line of treatment in obesity management; however, many adolescents with obesity do not meet lifestyle recommendations. Given that adolescents are rarely consulted during health policy development and in the design of lifestyle interventions, their first-hand experiences, preferences, and priorities may not be represented. Accordingly, our purpose was to explore adolescents' lifestyle treatment recommendations to inform policy and program decisions. METHODS:Conducted from July 2017 to January 2018, this study adhered to a qualitative, crosslanguage, patient-oriented design. We recruited 19 13-17-year-old adolescents (body mass index [BMI] ?85th percentile) seeking multidisciplinary treatment for obesity in geographically and culturally diverse regions of Canada. Adolescents participated in one-on-one, in-person, semi-structured interviews in English or French. Interviews were audio-recorded, transcribed verbatim, managed using NVivo 11, and analyzed using quantitative and qualitative content analysis by two independent researchers. RESULTS:Adolescents' recommendations were organized into five categories, each of which denotes health as a collective responsibility: (i) establish parental support within limits, (ii) improve accessibility and availability of 'healthy foods', (iii) limit deceptive practices in food marketing, (iv) improve accessibility and availability of varied physical activity opportunities, and (v) delay school start times. Respect for individual autonomy and decision-making capacity were identified as particularly important, however these were confronted with adolescents' partial knowledge on nutrition and food literacy. CONCLUSIONS:Adolescents' recommendations highlighted multi-level, multi-component factors that influenced their ability to lead healthy lifestyles. Uptake of these recommendations by policy-makers and program developers may be of added value for lifestyle treatment targeting adolescents with obesity.

Dataset Information

The use of comparative effectiveness research to inform policy decisions on the inclusion of bevacizumab for the treatment of macular diseases in Thailand's pharmaceutical benefit package.

Publications

The use of comparative effectiveness research to inform policy decisions on the inclusion of bevacizumab for the treatment of macular diseases in Thailand's pharmaceutical benefit package.

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