Jacqueline Vanderpuye-Orgle

Impact of Oral Nutrition Supplements on Hospital Outcomes in Pediatric Patients

BACKGROUND Nutrition deficiency is common among hospitalized children. Although oral nutrition supplements (ONS) may improve malnutrition in this population, the benefits and healthcare costs associated with their use have not yet been fully explored. The objective of this study was to assess the effect of ONS use on inpatient length of stay (LOS) and episode cost in hospitalized children. MATERIALS AND METHODS Retrospective analysis of 557,348 hospitalizations of children aged 2-8 years in the Premier Research Database. The effect of ONS use on LOS and episode cost in a propensity score- matched sample was estimated in analyses with and without the use of instrumental variables (IVs) to reduce confounding from unobserved variables. RESULTS ONS were prescribed in 6066 of 557,348 inpatient episodes (1.09%). In IV analysis, using a matched sample of 11,031 episodes, hospitalizations with ONS use had 14.8% shorter LOS (6.4 vs 7.5 days; 1.1 days [95% CI, 0.2-2.4]). Hospitalizations with ONS use had 9.7% lower cost (

HIV Care Providers Emphasize the Importance of the Ryan White Program for Access to and Quality of Care

16,552 vs

Competition in the Age of Biosimilars

18,320;

Efficacy and safety of post-docetaxel therapies in metastatic castration-resistant prostate cancer: a systematic review of the literature

1768 [95% CI,

Reconsidering the economic impact of the EU manufacturing and export provisions

1924-

Competition and Biosimilar Products--Reply.

1612]). CONCLUSIONS ONS use was associated with lower LOS and episode cost among pediatric inpatients. ONS use in hospitalized pediatric patients may provide a cost-effective, evidence-based approach to improving pediatric hospital care.

Public-Private Partnership as a Path to Affordable Healthcare in Emerging Markets

With the implementation of the Affordable Care Act (ACA) under way, some policy makers have questioned the continued relevance of the Ryan White HIV/AIDS Program as a safety net for people living with HIV/AIDS. We surveyed HIV care providers to understand the role of the Ryan White Program and to identify concerns regarding the ACA implementation. We also addressed whether the program is still relevant after ACA implementation and, if so, what elements should be retained. We found that providers consider the Ryan White Program to be critical in facilitating high-quality care for people living with HIV/AIDS. Most of the providers highlighted the programs support for providing medical and nonmedical case management as especially valuable and important to the entire continuum of care and for all patient subpopulations. Whether care is supplied by the Ryan White Program, Medicaid, or other means, our findings suggest that case management services will remain critical in treating HIV/AIDS as the health care landscape continues to evolve.

Evaluating the economic burden of psoriasis in the United States

In March 2015, the US Food and Drug Administration (FDA) approved the first biosimilar in the United States, ushering in the age of biosimilar competition for biologics. A biosimilar is defined by the FDA as “[a] product that is highly similar to a US-licensed reference biological product notwithstanding minor differences in clinically inactive components, and for which there are no clinically meaningful differences between the biological product and the reference product in terms of the safety, purity, and potency of the product.”1 The FDA requires that a biosimilar product deliver the same dosage and strength as the reference product and be used for the same indications as the reference product. The approval of biosimilars was authorized by the Biologic Price Competition and Innovation Act (BPCIA), which is part of the Affordable Care Act.2 It allows biosimilar manufacturers to file an abbreviated application using the original producer’s data, provided that this producer has had at least 12 years of data exclusivity.2 The first approved biosimilar was the recombinant colony-stimulating factor filgrastim-sndz, made by Sandoz/Novartis, which is the biosimilar version of filgrastim, marketed by Amgen as Neupogen. Apotex has 2 biosimilar applications currently under active review by the FDA for filgrastim and pegfilgrastim, a biosimilar of Amgen’s Neulasta, a long-acting form of Neupogen. Celltrion has a biosimilar application under review for infliximab, marketed by Janssen Biotech as Remicade. More

The Relationship Between Adherence and Total Spending Among Medicare Beneficiaries With Type 2 Diabetes

Abstract Objective: Prostate cancer is a highly prevalent form of cancer in older men and is one of the leading causes of death from cancer in men across the globe. Many therapeutic agents have been approved for patients with metastatic castration-resistant prostate cancer (mCRPC), particularly as a post-docetaxel treatment strategy. The objective of this systematic literature review was to assess published efficacy and safety data for select mCRPC therapies – such as abiraterone, cabazitaxel, and enzalutamide – in the post-docetaxel setting. Methods: Database searches of MEDLINE, Embase, and Cochrane CENTRAL, in conjunction with hand searches of multiple congress abstracts, yielded 13 randomized studies and 107 non-randomized studies that met the inclusion criteria. Results: Randomized studies demonstrated significant improvements in median overall survival (OS) outcomes over placebo for abiraterone (15.8 vs. 11.2 months) and enzalutamide (18.4 vs. 13.6 months), and similar significant improvements were noted for cabazitaxel over mitoxantrone (15.1 vs. 12.7 months). Differences in progression-free survival (PFS) were similarly significant, although variance in the criteria for measuring PFS may limit the extent to which these outcomes can be compared between studies. Non-randomized evidence included multiple publications from several early access and compassionate use programs with a primary objective to report safety outcomes. Results from these studies largely reflected the findings in randomized trials. Conclusions: Overall, there is a growing body of evidence for post-docetaxel treatment options available in patients with mCRPC. Further head-to-head trials or indirect treatment comparisons may be a valuable method to assess the comparative efficacy of these therapies.

Does Patient Cost Sharing for HCV Drugs Make Sense

Background The European Commission is considering two provisions which would permit limited generic drug production in the EU prior to supplemental protection certificate expiration. A recent study by Vicente and Simões addressed the potential economic consequences of these provisions and concluded that the provisions could result in 178, 698 million (M) new units produced, 8,890 new direct jobs, 26,670–35,560 new indirect jobs, and 37 new medium-sized pharmaceutical enterprises over the period 2014–2022. This paper assesses the accuracy of these findings through a critical review of the Vicente and Simões analysis. Methods We replicated the Vicente and Simões model and applied a series of adjustments including (1) correction of an arithmetic error, (2) introduction of a counterfactual analysis, (3) substitution of evidence-based parameters and (4) accounting for statistical uncertainty. Like Vicente and Simões, we model effects on four key outcomes: units produced, medium-sized pharmaceutical enterprises launched, and direct and indirect jobs created. Given data limitations, we were unable to replicate the Vicente and Simões export provision model. Results Our adjustments yield estimates of the economic effects that are substantially smaller than those reported by Vicente and Simões. Our revisions suggest the provisions would lead to 124,992 M new manufactured units (a 30% reduction relative to Vicente and Simões), 1,898 new direct jobs (78% reduction), 6,642 new indirect jobs (75–81% reduction), and 14 new medium-sized pharmaceutical enterprises (62% reduction). When parameter uncertainty is considered, the estimate of the number of direct and indirect jobs created is not statistically distinguishable from zero. Conclusion The Vicente and Simões analysis contains several limitations, most notably a substantial arithmetic error. While difficult to assess, the study implicitly assumes that increased demand leads to job gains in the generic sector, but that reduced demand does not lead job losses in the branded sector. Addressing these limitations substantially reduces the estimated economic effects of the proposed EU provisions.