Projecting the potential impact of the Cap-Score™ on Clinical Pregnancy, Live Births, and Medical Costs in Couples with Unexplained Infertility.

Purpose The Cap-Score™ was developed to assess the capacitation status of men, thereby enabling personalized management of unexplained infertility by choosing timed intrauterine insemination (IUI), versus immediate in vitro fertilization (IVF) or intracytoplasmic sperm injection (ICSI) in individuals with a low Cap-Score™. The objective of this study was to estimate the differences in outcomes and costs comparing the use of the Cap-Score™ with timed IUI (CS-TI) and the standard of care (SOC), which was assumed to be three IUI cycles followed by three IVF-ICSI cycles. Methods We developed and parameterized a decision-analytic model of management of unexplained infertility for women based on data from the published literature. We calculated the clinical pregnancy rates, live birth rates, and medical costs comparing CS-TI and SOC. We used Monte Carlo simulation to quantify uncertainty in projected estimates and performed univariate sensitivity analysis. Results Compared to SOC, CS-TI was projected to increase the pregnancy rate by 1–26%, marginally reduce live birth rates by 1–3% in couples with women below 40 years, increase live birth rates by 3–7% in couples with women over 40 years, reduce mean medical costs by $4000–$19,200, reduce IUI costs by $600–$1370, and reduce IVF costs by $3400–$17,800, depending on the woman’s age. Conclusion The Cap-Score™ is a potentially valuable clinical tool for management of unexplained infertility because it is projected to improve clinical pregnancy rates, save money, and, depending on the price of the test, increase access to treatment for infertility

Nine years of comparative effectiveness research education and training: initiative supported by the PhRMA Foundation

The term comparative effectiveness research (CER) took center stage with passage of the American Recovery and Reinvestment Act (2009). The companion US$1.1 billion in funding prompted the launch of initiatives to train the scientific workforce capable of conducting and using CER. Passage of the Patient Protection and Affordable Care Act (2010) focused these initiatives on patients, coining the term ‘patient-centered outcomes research’ (PCOR). Educational and training initiatives were soon launched. This report describes the initiative of the Pharmaceutical Research and Manufacturers Association of America (PhRMA) Foundation. Through provision of grant funding to six academic Centers of Excellence, to spearheading and sponsoring three national conferences, the PhRMA Foundation has made significant contributions to creation of the scientific workforce that conducts and uses CER/PCOR

The clinical and cost burden of coronary calcification in a Medicare cohort: An economic model to address under-reporting and misclassification

AbstractBackgroundCoronary artery calcification (CAC) is a well-established risk factor for the occurrence of adverse ischemic events. However, the economic impact of the presence of CAC is unknown.ObjectivesThrough an economic model analysis, we sought to estimate the incremental impact of CAC on medical care costs and patient mortality for de novo percutaneous coronary intervention (PCI) patients in the 2012 cohort of the Medicare elderly (≥65) population.MethodsThis aggregate burden-of-illness study is incidence-based, focusing on cost and survival outcomes for an annual Medicare cohort based on the recently introduced ICD9 code for CAC. The cost analysis uses a one-year horizon, and the survival analysis considers lost life years and their economic value.ResultsFor calendar year 2012, an estimated 200,945 index (de novo) PCI procedures were performed in this cohort. An estimated 16,000 Medicare beneficiaries (7.9%) were projected to have had severe CAC, generating an additional cost in the first year following their PCI of $3500, on average, or$56 million in total. In terms of mortality, the model projects that an additional 397 deaths would be attributable to severe CAC in 2012, resulting in 3770 lost life years, representing an estimated loss of about $377 million, when valuing lost life years at$100,000 each.ConclusionsThese model-based CAC estimates, considering both moderate and severe CAC patients, suggest an annual burden of illness approaching $1.3 billion in this PCI cohort. The potential clinical and cost consequences of CAC warrant additional clinical and economic attention not only on PCI strategies for particular patients but also on reporting and coding to achieve better evidence-based decision-making

Assessing the value of orphan drugs using conventional cost-effectiveness analysis:Is it fit for purpose?

Conventional cost-effectiveness analysis-i.e., assessing pharmaceuticals through a cost per quality-adjusted life year (QALY) framework-originated from a societal commitment to maximize population health given limited resources. This "extra-welfarist" approach has produced pricing and reimbursement systems that are not well- aligned with the unique considerations of orphan drugs. This framework has been slow to evolve along with our increased understanding of the impact of rare diseases, which in turn has complicated the assessment of orphan drugs meant to treat rare diseases. Herein, we (i) discuss the limitations of conventional cost-effectiveness analysis as applied to assessing access to, as well as the pricing and reimbursement of, orphan drugs, (ii) critically appraise alternative and supplemental approaches, and (iii) offer insights on plausible steps forward

Estimating the costs of induced abortion in Uganda: A model-based analysis

<p>Abstract</p> <p>Background</p> <p>The demand for induced abortions in Uganda is high despite legal and moral proscriptions. Abortion seekers usually go to illegal, hidden clinics where procedures are performed in unhygienic environments by under-trained practitioners. These abortions, which are usually unsafe, lead to a high rate of severe complications and use of substantial, scarce healthcare resources. This study was performed to estimate the costs associated with induced abortions in Uganda.</p> <p>Methods</p> <p>A decision tree was developed to represent the consequences of induced abortion and estimate the costs of an average case. Data were obtained from a primary chart abstraction study, an on-going prospective study, and the published literature. Societal costs, direct medical costs, direct non-medical costs, indirect (productivity) costs, costs to patients, and costs to the government were estimated. Monte Carlo simulation was used to account for uncertainty.</p> <p>Results</p> <p>The average societal cost per induced abortion (95% credibility range) was $177 ($140-$223). This is equivalent to$64 million in annual national costs. Of this, the average direct medical cost was $65 ($49-86) and the average direct non-medical cost was $19 ($16-$23). The average indirect cost was$92 ($57-$139). Patients incurred $62 ($46-$83) on average while government incurred$14 ($10-$20) on average.</p> <p>Conclusion</p> <p>Induced abortions are associated with substantial costs in Uganda and patients incur the bulk of the healthcare costs. This reinforces the case made by other researchers--that efforts by the government to reduce unsafe abortions by increasing contraceptive coverage or providing safe, legal abortions are critical.</p

Evidence synthesis and linkage for modelling the cost-effectiveness of diagnostic tests : preliminary good practice recommendations

Objectives: To develop preliminary good practice recommendations for synthesising and linking evidence of treatment effectiveness when modelling the cost-effectiveness of diagnostic tests. Methods: We conducted a targeted review of guidance from key Health Technology Assessment (HTA) bodies to summarise current recommendations on synthesis and linkage of treatment effectiveness evidence within economic evaluations of diagnostic tests. We then focused on a specific case study, the cost-effectiveness of troponin for the diagnosis of myocardial infarction, and reviewed the approach taken to synthesise and link treatment effectiveness evidence in different modelling studies. Results: The Australian and UK HTA bodies provided advice for synthesising and linking treatment effectiveness in diagnostic models, acknowledging that linking test results to treatment options and their outcomes is common. Across all reviewed models for the case study, uniform test-directed treatment decision making was assumed, i.e., all those who tested positive were treated. Treatment outcome data from a variety of sources, including expert opinion, were utilised for linked clinical outcomes. Preliminary good practice recommendations for data identification, integration and description are proposed. Conclusion: Modelling the cost-effectiveness of diagnostic tests poses unique challenges in linking evidence on test accuracy to treatment effectiveness data to understand how a test impacts patient outcomes and costs. Upfront consideration of how a test and its results will likely be incorporated into patient diagnostic pathways is key to exploring the optimal design of such models. We propose some preliminary good practice recommendations to improve the quality of cost-effectiveness evaluations of diagnostics tests going forward

Principles of Economic Evaluation in a Pandemic Setting: An Expert Panel Discussion on Value Assessment During the Coronavirus Disease 2019 Pandemic

As the coronavirus disease 2019 (COVID-19) pandemic continues to generate significant morbidity and mortality as well as economic and societal impacts, the landscape of potential treatments has slowly begun to broaden. In the case of a novel disease with widespread consequences, society is more likely to place significant value on interventions that reduce the outsized economic burden of COVID-19. Treatments for severe disease will have a different value profile to that of large-scale vaccines because of their application in targeted and potentially small subsets of those with symptomatic disease vs broad deployment as a preventative measure. Where vaccines reduce transmissibility of COVID-19, use of therapeutics will target symptoms, up to and including death for infected individuals. This paper describes discussions from a virtual expert panel that met to attempt a consensus on how existing principles of economic evaluation should be applied to therapeutics that emerge in a pandemic setting, with specific focus on severe hospitalised cases of COVID-19. The panel concluded that the core principles of economic evaluation do not need to be drastically overhauled to meet the challenges of a pandemic, but that there are several additional elements of value such as equity, disease severity, insurance value, and scientific and family spillover effects that should be considered when presenting results to decision makers. The panel also highlighted the persistent challenges on how society should value novel therapies, such as the appropriate cost-effectiveness threshold to apply, which are particularly salient during a pandemic

International Society for Pharmacoeconomics and Outcomes Research Comments on the American Society of Clinical Oncology Value Framework

As members of the International Society for Pharmacoeconomics and Outcomes Research, we read with great interest the new American Society of Clinical Oncology (ASCO) conceptual framework to assess the value of cancer treatment options.1 We applaud the Value in Cancer Care Task Force for proposing a conceptual framework to support clinicians and patients in assessing the value of new cancer treatments. We acknowledge the challenges facing clinician–patient decision making, particularly concerning cancer treatments. Like ASCO, we recognize that the cost of treatments is increasingly being placed on patients through cost sharing and that engaging patients as part of making individual treatment decisions is of high importance. The ASCO framework highlights the growing tension among patients, insurance companies, and product manufacturers in a dynamic health care environment. In that light, the framework deserves a field test, and we look forward to seeing the outcome of that experience. We also appreciate the opportunity to offer comments and suggestions on the ASCO framework at this early stage, and our membership stands ready to support ASCO in future enhancements