Budget impact analysis of niraparib for first-line maintenance therapy in advanced ovarian cancer from a US payer perspective.

Ovarian cancer (OC) is the fifth leading cause of cancer death in women and has the highest mortality rate of gynecological cancers. Niraparib was recently approved by the FDA for the maintenance treatment of adult patients with advanced epithelial OC in complete or partial response to first-line platinum-based chemotherapy (PBC) regardless of biomarker status. To estimate the direct economic impact on US payers of adding niraparib as a first-line maintenance therapy for patients with advanced OC.

Real-world adverse events with niraparib 200 mg/day maintenance therapy in ovarian cancer: a retrospective study.

To assess real-world occurrence of common clinical trial-reported adverse events (AE) among patients with recurrent ovarian cancer initiating niraparib 200 mg/day. This retrospective observational study used physician-extracted anonymized medical record data of eligible patients initiating niraparib 200 mg/day after platinum-based chemotherapy. Of 153 patients, 57 (37%) experienced ≥1 of the three most common all-grade AEs within 3 months after niraparib initiation: nausea (16%; grade 3/4: 2%), thrombocytopenia (14%; grade 3/4: 3%) and fatigue (24%; grade 3/4: 3%).

Niraparib Maintenance Treatment Improves Time Without Symptoms or Toxicity (TWiST) Versus Routine Surveillance in Recurrent Ovarian Cancer: A TWiST Analysis of the ENGOT-OV16/NOVA Trial.

Purpose: This study estimated time without symptoms or toxicity (TWiST) with niraparib compared with routine surveillance (RS) in the maintenance treatment of patients with recurrent ovarian cancer.

Patients And Methods: Mean progression-free survival (PFS) was estimated for niraparib and RS by fitting parametric survival distributions to Kaplan-Meier data for 553 patients with recurrent ovarian cancer who were enrolled in the phase III ENGOT-OV16/NOVA trial. Patients were categorized according to the presence or absence of a germline mutation-gmut and non-gmut cohorts.

Budget impact of niraparib as maintenance treatment in recurrent ovarian cancer following platinum-based chemotherapy.

To estimate financial implications of adopting niraparib as maintenance treatment in recurrent ovarian cancer. A model was developed to estimate the budget impact of treating patients with niraparib compared with alternative maintenance treatment options (olaparib, rucaparib, bevacizumab or 'watch and wait') over 3 years. For a hypothetical plan with 1 million lives representative of US/Medicare-only populations, projected cost savings with niraparib were US$78,721/$293,723, $276,671/$1,009,729 and $353,585/$1,289,712 at years 1, 2 and 3, respectively.

A systematic literature review and network meta-analysis of treatments for patients with untreated multiple myeloma not eligible for stem cell transplantation.

In newly diagnosed multiple myeloma (MM), patients ineligible for front-line autologous stem cell transplantation (ASCT), melphalan and prednisone (MP) with thalidomide (MPT) or bortezomib (VMP) are standard first-line therapeutic options. Despite new treatment regimens incorporating bortezomib or lenalidomide, MM remains incurable. The FIRST study demonstrated significant improvement in progression-free survival (PFS) and overall survival (OS) for the combination of lenalidomide and low-dose dexamethasone (Rd) until progression vs.

The humanistic burden of head and neck cancer: a systematic literature review.

Background: Head and neck cancer (HNC) and its treatment can affect communication, nutrition, and physical appearance, and the global impact of this disease on patients' quality of life may be substantial.

Objective: The aim of this systematic literature review was to describe the impact of HNC and its treatment on the physical, emotional, and social well-being of patients over time, by examining longitudinal studies of patient-reported outcomes (PRO) evaluating these domains.

Methods: Databases (MEDLINE and Embase) were searched to identify studies published in English between January 2004 and January 2014 analyzing the humanistic aspects of HNC in adult patients.

Characteristics and temporal trends in patient registries: focus on the life sciences industry, 1981-2012.

Purpose: Patient registries are used to monitor safety, examine real-world effectiveness, and may potentially contribute to comparative effectiveness research. To our knowledge, life sciences industry (LSI)-sponsored registries have not been systematically categorized. This study represents a first step toward understanding such registries over time.

Major depressive disorder in Africa and the Middle East: a systematic literature review.

With major depressive disorder (MDD) associated with significant clinical, economic and health-related quality of life impact, we sought to systematically review and synthesize information relevant to the burden of MDD in Africa and the Middle East, from which published evidence is slim. Our literature search identified 54 publications assessing epidemiological (43), humanistic (5), clinical/treatment (7) or economic outcomes (2). General population MDD prevalence and that among chronic disease populations were similar in Africa and the Middle East.

Burden and management of chronic kidney disease in Japan: systematic review of the literature.

Background: Chronic kidney disease (CKD) is a common disorder with increasing prevalence worldwide. This systematic literature review aims to provide insights specific to Japan regarding the burden and treatment of CKD.

Methods: We reviewed English and Japanese language publications from the last 10 years, reporting economic, clinical, humanistic, and epidemiologic outcomes, as well as treatment patterns and guidelines on CKD in Japan.

Humanistic and economic burden of generalized anxiety disorder in North America and Europe.

Background: To review the humanistic and economic burden of generalized anxiety disorder (GAD).

Methods: MEDLINE, EMBASE and the Cochrane Library, limited to articles published in English, between 1987 and 2010, in North America, Europe and Australia. The key focus was humanistic or functional outcomes, cost of illness and economic outcomes.

Integrating Escherichia coli antimicrobial susceptibility data from multiple surveillance programs.

Collaboration between networks presents opportunities to increase analytical power and cross-validate findings. Multivariate analyses of 2 large, international datasets (MYSTIC and SENTRY) from the Global Advisory on Antibiotic Resistance Data program explored temporal, geographic, and demographic trends in Escherichia coli resistance from 1997 to 2001. Elevated rates of nonsusceptibility were seen in Latin America, southern Europe, and the western Pacific, and lower rates were seen in North America.

Review of assessments of the human health risk associated with the use of antimicrobial agents in agriculture.

To our knowledge, no comprehensive risk assessment of agricultural uses of antimicrobial agents has been published. The published risk assessments of antimicrobial use in farm settings are all subject to multiple, serious limitations in scope, including (1) limitation to one species of microorganism; (2) limitation to one or a very few related antimicrobial agents; (3) limitation to a single outcome (death, hospital days, number of illnesses, etc.); (4) limitation to one species of farm animal (e.

Morbidity of infections caused by antimicrobial-resistant bacteria.

Antimicrobial resistance can have 2 effects on the outcome of infection: there can be an accompanying change in the virulence of the organism, and there can be a poorer response to treatment because of the empiric choice of an antimicrobial to which the organism is resistant. We have reviewed published studies relating antimicrobial resistance to the outcomes of infection caused by enteric pathogens. The data for Salmonella and Campylobacter infections suggest that antimicrobial-resistant strains are somewhat more virulent than susceptible strains-that is, they cause more prolonged or more severe illness than do antimicrobial-susceptible strains.

Excess infections due to antimicrobial resistance: the "Attributable Fraction".

Antimicrobial use causes a transient decrease in an individual's resistance to colonization by noncommensal bacteria ("competitive effect") and increases the likelihood of infection upon exposure to a foodborne pathogen. The additional "selective effect" of antimicrobial resistance results in a >3-fold increase in vulnerability to infection by an antimicrobial-resistant pathogen among individuals receiving antimicrobial therapy for unrelated reasons. Combining the increase in vulnerability to infection with the prevalence of taking an antimicrobial agent, it is possible to estimate the attributable fraction, or the number of excess infections that occurred as a result of the unrelated use of an antimicrobial agent to which the pathogen was resistant.