Leveraging the holistic benefits of biosimilars in Europe - part 2: how payers can safeguard the future of a healthy biosimilar market environment.

INTRODUCTION: Biosimilars have improved access to biologic medicines; however, historical thinking may jeopardize the viability of future markets. AREAS COVERED: An expert panel of eight diverse European stakeholders provided insights about rethinking biosimilars and cost-savings, reducing patient access inequalities, increasing inter-market equity, and improving education. The insights reported here (Part 2) follow a study that provides perspectives on leveraging the holistic benefits of biosimilars for market sustainability based on independent survey results and telephone interviews of stakeholders from diverse biosimilar markets (Part 1). Directional recommendations are provided for payers. EXPERT OPINION: The panel's market maturity framework for biosimilars has three stages: 'Invest,' 'Expand' and 'Harvest.' Across market stages, re-thinking the benefits of biosimilars beyond cost-savings, considering earlier or expanded access/new indications, product innovations, and re-investment of biosimilar-generated cost-savings should be communicated to stakeholders to promote further engagement. During 'Expand' and 'Harvest' stages, development of efficient, forward-looking procurement systems and mechanisms that drive uptake and stabilize competition between manufacturers are key. Future biosimilars will target various therapy areas beyond those targeted by existing biosimilars. To ensure a healthy, accessible future market, stakeholders must align their objectives, communicate, collaborate, and coordinate via education, incentivization, and procurement, to maximize the totality of benefits.

Challenges to Human Papillomavirus Vaccine Acceptability among Women in South India: An Exploratory Study.

Cervical cancer is the second leading cause of cancer and one of the leading causes of cancer-related death in women in India. Human papillomavirus (HPV) vaccine uptake in India is low due to cost, low awareness of HPV, social stigma, and other factors. We assessed the awareness, attitudes, and beliefs regarding HPV and HPV vaccination and explored the barriers and challenges to HPV vaccine intent among women in Mangalore, India. An exploratory study was conducted using two focus group discussions (FGDs) and six in-depth one-on-one interviews. FGD-1 comprised nine women aged 18 to 26 years, and FGD-2 comprised seven women aged 27 to 45 years. The FGDs were recorded, transcribed, and analyzed using thematic content analysis. Themes identified were limited knowledge of HPV and vaccine, stigma associated with receiving HPV vaccine, vaccine safety concerns, and cost as a barrier to receiving vaccine. Participants expressed desire for physician and government recommendation of the HPV vaccine to validate vaccine intent. Contrasting themes between the two FGDs include support for vaccination at a younger age and lower perception of stigma and judgment in the 18- to 26-year-old group; however, participants in the 27- to 45-year-old group support vaccination at an older age and endorse greater fear of stigma and judgment associated with obtaining vaccination. Education regarding HPV-associated diseases and the HPV vaccine for the general public, physicians, and government officials in conjunction with lowering vaccine cost, improving vaccine access, and encouraging strong physician recommendations are key strategies to scale up HPV vaccine implementation in India.

Cost-effectiveness of Descemet stripping automated endothelial keratoplasty versus penetrating keratoplasty in patients with endothelial dysfunction in India.

PURPOSE: The aim of this study was to compare the cost-effectiveness and perform cost-utility analysis of Descemet stripping automated endothelial keratoplasty (DSAEK) vs. penetrating keratoplasty (PK) in Indian population. METHODS: This was an institutional, ambispective, observational study. Patients who underwent PK or DSAEK for endothelial dysfunction were included and followed up for 2 years; those with other ocular comorbidities were excluded. The analysis was performed from the patient's perspective receiving subsidized treatment at a tertiary care hospital. Detailed history, ophthalmic examination, total expenditure by patient, and clinical outcomes were recorded. The main outcome measures were best spectacle-corrected visual acuity (BSCVA), graft survival (Kaplan-Meier survival estimates), incremental cost-effectiveness ratio (ICER), and incremental cost-utility ratio (ICUR). Utility values were based on quality-adjusted life years (QALYs) associated with visual acuity outcomes. Statistical analysis was performed using SPSS software package, version 12.1; a value of P < 0.05 was considered statistically significant. RESULTS: A total of 120 patients (PK: 60, DSAEK: 60) were included. At 2 years, for a similar logMAR BSCVA, [PK (0.32 ± 0.02), DSAEK (0.25 ± 0.02); P = 0.078], the overall cost for PK (13511.1 ± 803.3 INR) was significantly more than DSAEK (11092.9 ± 492.1 INR) (difference = 1952.6 INR; P = 0.01). ICER of DSAEK relative to PK was -39,052 INR for improvement in 1 logMAR unit BSCVA. ICUR of DSAEK relative to PK was -1,95,260 INR for improvement in 1 QALY. CONCLUSION: DSAEK was more cost-effective than PK in patients with endothelial dysfunction at 2 years.

Evaluation of Appropriateness and Cost Savings of Pharmacist-Driven Palivizumab Ordering.

OBJECTIVES: Guidelines by the AAP for the use of palivizumab prophylaxis for respiratory syncytial virus (RSV) recommend administration within 72 hours prior to discharge for selected high-risk patient populations. Our institution historically administered palivizumab on a fixed-day schedule of Mondays and Thursdays, but adjusted the practice in fall 2017 to a pharmacist-driven flex-schedule based on anticipated discharge date. This review evaluated the effect of pharmacist-driven palivizumab ordering on the appropriateness of palivizumab administrations, based on AAP and institutional recommendations. Additionally, this review evaluated for effects on institutional cost. METHODS: This was a retrospective single-center evaluation including patients for whom palivizumab was ordered between July 1, 2016, and June 30, 2018. Patients in the 2016-2017 RSV season were in the fixed-day group, while patients in the 2017-2018 RSV season were in the flex-schedule group. RESULTS: A total of 142 palivizumab doses were evaluated. Overall, 97% of administrations were for an appropriate indication. All doses administered inappropriately (n = 4) occurred in the fixed-day group. In the fixed-day group, 48.6% of doses were given within 72 hours prior to discharge, which increased to 70.1% in the flex-schedule group (p = 0.01). The amount of drug saved by batching was 1 vial for every 4.9 patients in the fixed-day group, and 1 vial for every 4.8 patients in the flex-schedule group. CONCLUSIONS: There was a statistically significant improvement in compliance with AAP recommendations following the implementation of pharmacist-driven flex-schedule for palivizumab, compared to a fixed-day batching schedule. There was no significant difference in cost.

Financial Risk Protection and Hospital Admission for Trauma in Cameroon: An Analysis of the Cameroon National Trauma Registry.

BACKGROUND: Half of the global population is at risk for catastrophic health expenditure (CHE) in the event that they require surgery. Universal health coverage fundamentally requires protection from CHE, particularly in low- and middle-income countries (LMICs). Financial risk protection reports in LMICs covering surgical care are limited. We explored the relationship between financial risk protection and hospital admission among injured patients in Cameroon to understand the role of health insurance in addressing unmet need for surgery in LMICs. METHODS: The Cameroon National Trauma Registry, a database of all injured patients presenting to the emergency departments (ED) of three Cameroonian hospitals, was retrospectively reviewed between 2015 and 2017. Multivariate regression analysis identified predictors of hospital admission after injury and of patient report of cost inhibiting their care. RESULTS: Of the 7603 injured patients, 95.7% paid out-of-pocket to finance ED care. Less than two percent (1.42%) utilized private insurance, and more than half (54.7%) reported that cost inhibited their care. In multivariate analysis, private insurance coverage was a predictor of hospital admission (OR 2.17, 95% CI: 1.26, 3.74) and decreased likelihood of cost inhibiting care (OR 0.34, 95% CI: 0.20, 0.60) when compared to individuals paying out-of-pocket. CONCLUSION: The prevalence of out-of-pocket spending among injured patients in Cameroon highlights the need for financial risk protection that encompasses surgical care. Patients with private insurance were more likely to be admitted to the hospital, and less likely to report that cost inhibited care, supporting private health insurance as a potential financing strategy.

Identifying Strategies to Advance Health Equity through Action on Social Determinants of Health and Human Rights for Street-Connected Children and Youth in Kenya.

Despite the fact that street-connected children and youth (SCY) in low- and middle-income countries experience numerous social and health inequities, few evidence-based policies and interventions have been implemented to improve their circumstances. Our study analyzed strategies to advance health equity through action on the social determinants of health (SDH) for SCY in Kenya based on General Comment 21 of the United Nations Committee on the Rights of the Child. To identify policies and interventions, we analyzed archival newspaper articles and policy documents and elicited ideas from a diversity of social actors across Kenya. Our results identified three types of policies and interventions: repressive, welfare oriented, and child rights based. We then situated these strategies within the World Health Organization's conceptual framework on SDH inequities to understand their mechanism of impact on health equity. Our results demonstrate that a child rights approach provides a strong avenue for advancing health equity through action on the SDH for SCY in Kenya. As a result of these findings, we developed a checklist for policy makers and other stakeholders to assess how their policies and interventions are upholding human rights, addressing needs, and working to advance health equity for SCY.

Social Support for Physical Activity for High Schoolers in Rural Southern Appalachia.

OBJECTIVE: Social support for physical activity (PA) has been shown to enhance PA levels in adolescents. Although social support has been examined extensively in the literature, less is known about the role of social support for PA for high school adolescents in rural southern Appalachia. PA is important because adolescent obesity is greater in Appalachia than in the rest of the United States. METHODS: This was a qualitative secondary analysis of focus groups conducted in 2013-2014 among parents, teachers, and high school students (N = 77) in 6 counties across rural southern Appalachia. Beets' typology of social support was used to categorize themes. RESULTS: Participants discussed instrumental supports, including providing transportation and paying fees, enrolling child in recreation/sports, and providing PA equipment at home. Performing PA with adolescents and modeling, watching/supervising, and prioritizing PA were identified as conditional supports. Several motivational supports were identified: encouragement, force, and the admiration of people who are active. Participants also identified key informational supports, including discussing the importance/health benefits of PA, how to be physically active, and general advice/information. Barriers to PA engagement (eg, body image issues, bullying, competitive nature of PA opportunities) and the role of referent groups (eg, family, peers, teachers) emerged as important concepts in the discussion. CONCLUSION: This study identifies opportunities and practical ways for families and schools to provide, build, and strengthen supports for PA among adolescents in rural Appalachia.

Considerations for neonatal and pediatric pain management.

PURPOSE: Current literature and clinical practice guidelines on pediatric pain management are reviewed. SUMMARY: Acute pain is commonly present in neonatal and pediatric patients due to underlying disease states or procedures. Especially in institutions with limited pediatric pain services, it is imperative to describe the appropriate management of pain and pharmacotherapy options that are effective and safe in pediatric patients. Despite the knowledge of pain being an important aspect in the management of children, barriers exist, leading to suboptimal treatment. Addressing these barriers through education of healthcare practitioners, families, and patients will lead to optimizing the patient pain experience. Tools for pain assessment vary depending on the type of pain, the child's age and understanding of pain, and the clinical situation. Pharmacotherapy options for pain management in neonates and pediatric patients include opioid and nonopioid agents. Efficacy and safety data on the use of medications for the treatment of pain in pediatric patients is described. The delivery of medication encompasses patient-specific factors and preferences. Strategies for opioid stewardship and management of iatrogenic withdrawal pose a unique challenge in pediatric patients. CONCLUSION: The management of acute pain in neonates and pediatric patients should be a priority for all practitioners caring for these patients. Use of age-appropriate pain assessment tools and understanding of the mechanisms of action and roles in therapy of various nonopioid and opioid therapies can help optimize treatment of pain in neonatal and pediatric patients.

Digital Platforms in the Assessment and Monitoring of Patients with Bipolar Disorder.

This paper aims to review the application of digital platforms in the assessment and monitoring of patients with Bipolar Disorder (BPD). We will detail the current clinical criteria for the diagnosis of BPD and the tools available for patient assessment in the clinic setting. We will go on to highlight the difficulties in the assessment and monitoring of BPD patients in the clinical context. Finally, we will elaborate upon the impact that diital platforms have made, and have the potential to make, on healthcare, mental health, and specifically the management of BPD, before going on to evaluate the benefits and drawbacks of the use of such technology.

Effectiveness and cost-effectiveness of mindfulness-based cognitive therapy compared with maintenance antidepressant treatment in the prevention of depressive relapse or recurrence (PREVENT): a randomised controlled trial.

BACKGROUND: Individuals with a history of recurrent depression have a high risk of repeated depressive relapse or recurrence. Maintenance antidepressants for at least 2 years is the current recommended treatment, but many individuals are interested in alternatives to medication. Mindfulness-based cognitive therapy (MBCT) has been shown to reduce risk of relapse or recurrence compared with usual care, but has not yet been compared with maintenance antidepressant treatment in a definitive trial. We aimed to see whether MBCT with support to taper or discontinue antidepressant treatment (MBCT-TS) was superior to maintenance antidepressants for prevention of depressive relapse or recurrence over 24 months. METHODS: In this single-blind, parallel, group randomised controlled trial (PREVENT), we recruited adult patients with three or more previous major depressive episodes and on a therapeutic dose of maintenance antidepressants, from primary care general practices in urban and rural settings in the UK. Participants were randomly assigned to either MBCT-TS or maintenance antidepressants (in a 1:1 ratio) with a computer-generated random number sequence with stratification by centre and symptomatic status. Participants were aware of treatment allocation and research assessors were masked to treatment allocation. The primary outcome was time to relapse or recurrence of depression, with patients followed up at five separate intervals during the 24-month study period. The primary analysis was based on the principle of intention to treat. The trial is registered with Current Controlled Trials, ISRCTN26666654. FINDINGS: Between March 23, 2010, and Oct 21, 2011, we assessed 2188 participants for eligibility and recruited 424 patients from 95 general practices. 212 patients were randomly assigned to MBCT-TS and 212 to maintenance antidepressants. The time to relapse or recurrence of depression did not differ between MBCT-TS and maintenance antidepressants over 24 months (hazard ratio 0·89, 95% CI 0·67-1·18; p=0·43), nor did the number of serious adverse events. Five adverse events were reported, including two deaths, in each of the MBCT-TS and maintenance antidepressants groups. No adverse events were attributable to the interventions or the trial. INTERPRETATION: We found no evidence that MBCT-TS is superior to maintenance antidepressant treatment for the prevention of depressive relapse in individuals at risk for depressive relapse or recurrence. Both treatments were associated with enduring positive outcomes in terms of relapse or recurrence, residual depressive symptoms, and quality of life. FUNDING: National Institute for Health Research (NIHR) Health Technology Assessment (HTA) programme, and NIHR Collaboration for Leadership in Applied Health Research and Care South West Peninsula.

Awareness of, experience with, and attitudes toward buprenorphine among opioid users visiting a New York City syringe exchange program.

OBJECTIVE: To examine awareness of, experience with, and attitudes toward buprenorphine, to begin to understand why opioid users may not access buprenorphine treatment. Factors associated with attitudes toward buprenorphine were also explored. DESIGN: Cross-sectional study. SETTING: A community-based organization's syringe exchange program in mobile units at nine street-side outreach sites in New York City. PARTICIPANTS: One hundred eighty-six adult opioid users visiting a syringe exchange program. MAIN OUTCOME MEASURES: Awareness of, experiences with, and attitudes toward buprenorphine. RESULTS: Most (68.5 percent) participants were aware of buprenorphine, 27.8 percent had taken buprenorphine, and 58.6 percent knew someone who had taken buprenorphine. Of the 98 who had taken or knew someone who had taken buprenorphine, 85.7 percent endorsed positive attitudinal statements about its effectiveness, and up to 31.6 percent endorsed statements about its limited access. Participants' attitudes about the need for formal buprenorphine treatment were mixed. Current heroin users were more likely than nonusers to have heard of buprenorphine (76.0 percent vs 61.5 percent, p < 0.05), have taken buprenorphine (46.8 percent vs 9.6 percent, p < 0.01), endorse buprenorphine's effectiveness (96.3 percent vs 72.7 percent, p < 0.01), and believe that illicit and prescribed buprenorphine have similar benefits (35.2 percent vs 13.6 percent, p < 0.02) CONCLUSIONS: Most opioid users visiting a syringe exchange program had positive attitudes about buprenorphine's effectiveness, and few believed that buprenorphine was difficult to access. Attitudes about the benefits of illicit versus prescribed buprenorphine use were inconsistent. Understanding awareness of, experience with, and attitudes toward buprenorphine is important, as these factors are likely to influence opioid users' decisions about engaging in buprenorphine treatment.