INTRODUCTION: The COVID-19 pandemic can cause emotional distress, which can in turn lead to the development of mental and physical symptoms. AIM: We examined the association of the COVID-19 outbreak and the mental, physical and sexual health of the female Polish population. METHODS: Data were collected in an online survey distributed on social media from April 22, 2020 through to May 7, 2020. The data collection began one month after the start of lockdown in Poland. MAIN OUTCOME MEASURE: Women were asked to complete the Beck Depression Inventory (BDI) and the Female Sexual Function Index (FSFI) questionnaires. RESULTS: Overall, 1644 women (median age 23 years) took part in the survey. They reported a lower frequency of sexual activity (P < .001) and a lower libido level (P < .001) during the pandemic then before it. 57.5% of the study group (n = 944) strongly agreed or agreed that fear of the health condition of loved ones was a source of stress and depressed mood. The average BDI-II total score was 11 (range 0-51; IQR 5-18), which corresponds to minimal depression. The average FSFI total score was 27.01 ± 7.61 (range 2-36). The FSFI and BDI scores were significantly correlated (P < .001). The FSFI score was significantly correlated with the presence of any comorbid chronic disease, the intensity of the fear of infection and fear of health conditions, perceived loneliness, and the being up to date with media news. The BDI score was significantly correlated with age, the intensity of the fear of infection and fear of health conditions, perceived loneliness, being up to date with media news, and the more frequent use of stimulants. CONCLUSIONS: The COVID-19 lockdown setting was associated with a high occurrence of depressive symptoms and increased risk of sexual dysfunction with decreased libido and lower sexual frequency the most commonly reported issues. Szuster E, Kostrzewska P, Pawlikowska A, et al. Mental and Sexual Health of Polish Women of Reproductive Age During the COVID-19 Pandemic - An Online Survey. Sex Med 2021;XX:XXXXXX.

Summary The burden of visible skin diseases (VSDs) includes not only physical symptoms but also psychosocial consequences such as depression, anxiety, impaired quality of life and low self-esteem. Stigmatisation was shown to play a major role in people with skin diseases The aim of the study was to review the evidence for the components, drivers, and impacts of (self-) stigma, and to organise the data into a series of conceptual models. A targeted literature search was conducted to identify studies on (self-) stigma in relation to VSD. Conceptual models of stigma in VSDs were developed from existing generic conceptual models for VSD and of generic conceptual models of stigma and were refined after discussion with a board of experts, patient advocacy groups, clinicians and researchers. A total of 580 references were identified, of which 56 references were analysed and summarised. Two conceptual models of stigma were identified: one with external stigma and self-stigma dimensions, the other for self-stigma in mental health. These models were adapted to allow a complete description of stigma in VSDs. For this, a distinction was made between ‘discrimination’ and ‘impact’. Finally, five models were developed: Macro-overview; Stigma, Impact and Socio-demographics; Stigma, Impact and Disease Characteristics; Stigma, Impact and Quality of Life; and Stigma, Impact and Coping. Gaps were identified in available quantitative evidence. To our knowledge, this is the first conceptual model of stigma in VSDs. The model will help to standardise evaluation of stigma and to enhance empirical evaluation of anti-stigma interventions in VSDs. Further research should be conducted to develop a more complete model in stigma due to significant gaps in existing evidence, particularly including the stigma in others (external stigma) and also to cover a broader range of VSDs as their impact on particular dimensions of stigma differs.

Coronavirus 2019 (COVID-19) has caused significant disruption to the cell and gene therapy (CGT) industry, which has historically faced substantial complexities in supply of materials, and manufacturing and logistics processes. As decision-makers shifted their priorities to COVID-19-related issues, the challenges in market authorisation, and price and reimbursement of CGTs were amplified. Nevertheless, it is encouraging to see that some CGT developers are adapting their efforts toward the development of promising COVID-19-related therapeutics and vaccines. Manufacturing resilience, digitalisation, telemedicine, value-based pricing, and innovative payment mechanisms will be increasingly harnessed to ensure that market access of CGTs is not severely disrupted.

BACKGROUND: Despite the burden of varicella, there is no universal varicella vaccination (UVV) programme in the United Kingdom (UK) due to concerns this could increase herpes zoster (HZ) incidence. This study assessed the cost-utility of a first-dose monovalent (V) or quadrivalent (MMRV) followed by a second-dose quadrivalent (MMRV) UVV programmes. GSK and MSD varicella-containing vaccines (VCVs) were considered. METHODS: A dynamic transmission and cost-effectiveness models were adapted to the UK. Outcomes measured included varicella and HZ incidences, the incremental cost-utility ratio (ICURs) over a lifetime horizon. The payer and societal perspectives were evaluated. RESULTS: The impact of V-MMRV and MMRV-MMRV UVV programmes on varicella incidence was comparable between both VCVs at equilibrium. HZ incidence increased by 1.6%-1.7% over seven years after UVV start, regardless of the strategies, then decreased by >95% at equilibrium. ICURs ranged from £5,665 (100 years) to £18,513 (20 years) per quality-adjusted life year (QALY) gained with V-MMRV; and from £9,220 to £27,101 per QALY gained with MMRV-MMRV (payer perspective). MMRV-MMRV was cost-effective in medium- and long-terms with GSK VCV, and only cost-effective at long-term with MSD VCV at £20,000 per QALY gained threshold. Without the exogenous boosting hypothesis, HZ incidence decreased through UVV implementation. ICURs were most sensitive to discount rates and MMRV price. CONCLUSIONS: A 2-dose UVV was demonstrated to be a cost-effective alternative to no vaccination. With comparable effectiveness as MSD VCV at lower costs, GSK VCV may offer higher value for money.

ABSTRACT Background Morbidity and mortality associated with non-valvular atrial fibrillation (NVAF) imposes a substantial economic burden on the UK healthcare system. Objectives An existing Markov model was adapted to assess the real-world cost-effectiveness of rivaroxaban and apixaban, each compared with a vitamin K antagonist (VKA), for stroke prevention in patients with NVAF from the National Health Service (NHS) and personal and social services (PSS) perspective. Methods The model considered a cycle length of 3 months over a lifetime horizon. All inputs were drawn from real-world evidence (RWE): baseline patient characteristics, clinical event and persistence rates, treatment effect (meta-analysis of RWE studies), utility values and resource use. Deterministic and probabilistic sensitivity analyses were performed. Results The incremental cost per quality-adjusted life year was £14,437 for rivaroxaban, and £20,101 for apixaban, compared with VKA. The probabilities to be cost-effective compared with VKA were 90% and 81%, respectively for rivaroxaban and apixaban, considering a £20,000 threshold. In both comparisons, the results were most sensitive to clinical event rates. Conclusions These results suggest that rivaroxaban and apixaban are cost-effective vs VKA, based on RWE, considering a £20,000 threshold, from the NHS and PSS perspective in the UK for stroke prevention in patients with NVAF. This economic evaluation may provide valuable information for decision-makers, in a context where RWE is more accessible and its value more acknowledged.

A limited number of gene therapy medicinal products (GTMPs) have received marketing authorization (MA), of which some have been withdrawn, and even less have gained reimbursement. Many challenges that complicate GTMP market access can occur across multiple jurisdictions and decision-making contexts, but some reimbursement challenges are specific to jurisdictions. The importance of these challenges vary according to the specific therapy being developed, the country where market access is sought, and the efforts made by developers, regulators and payers to implement solutions to overcome these barriers. This review could alert developers to challenges associated with GTMP MA and how to address them.

Objectives: Inclusion of patient preference (PP) data in decision making has been largely discussed in recent years. Healthcare decision makers-regulatory and health technology assessment (HTA)-are more and more conscious of the need for a patient-centered approach to decide on optimal allocation of scarce money, time, and technological resources. This literature review aims to examine the use of and recommendations for the integration of PP in decision making. Methods: A literature search was conducted through PubMed/Medline in May 2019 to identify publications on PP studies used to inform benefit-risk assessments (BRAs) and HTAs and patient-centered projects and guidelines related to the inclusion of PPs in health policy decision making. After title and abstract screening and full-text review, selected publications were analyzed to retrieve data related to the collection, use, and/or submission of PPs informing BRA or HTA as well as attempts and initiatives in recommendations for PPs integration in decision-making processes. Results: Forty-nine articles were included: 24 attempts and pilot project discussions and 25 PP elicitation studies. Quantitative approaches, particularly discrete choice experiments, were the most used (24 quantitative elicitation studies and 1 qualitative study). The objective of assessing PPs was to prioritize outcome-specific information, to value important treatment characteristics, to provide patient-focused benefit-risk trade-offs, and to appraise the patients’ willingness to pay for new technologies. Moreover, attempts and pilot projects to integrate PPs in BRAs and HTAs were identified at the European level and across countries, but no clear recommendations have been issued yet. No less than seven public and/or private initiatives have been undertaken by governmental agencies and independent organizations to set guidance targeting improvement of patients’ involvement in decision making. Conclusion: Despite the initiatives undertaken, the pace of progress remains slow. The use of PPs remains poorly implemented, and evidence of proper use of these data in decision making is lacking. Guidelines and recommendations formalizing the purpose of collecting PPs, what methodology should be adopted and how, and who should be responsible for generating these data throughout the decision-making processes are needed to improve and empower integration of PPs in BRA and HTA.

INTRODUCTION: Currently, 15-20% of individuals with coronary artery disease (chronic coronary syndrome [CCS]) or peripheral artery disease (PAD) receiving routine treatment experience cardiovascular events (CVEs) within 3-4 years. Using PICOSTEPS (Patients-Intervention-Comparators-Outcomes-Setting-Time-Effects-Perspective-Sensitivity analysis) reporting, we evaluated the cost-effectiveness of recently approved rivaroxaban 2.5 mg twice daily in combination with acetylsalicylic acid 100 mg daily (RIV + ASA) for the prevention of CVEs among Finns with CCS or symptomatic PAD. METHODS: Myocardial infarction, ischemic stroke, intracranial hemorrhage, acute limb ischemia, amputations, major extracranial bleeding, venous thromboembolism, and cardiovascular deaths were modeled in a Markov model examining a cohort of patients with CCS or symptomatic PAD. Relative effects of the intervention (RIV + ASA) and comparator (ASA) were based on the COMPASS trial. The primary outcome was 3%/year discounted incremental cost-effectiveness ratio (ICER), defined as cost (2019 euros) per quality-adjusted life year (QALY) gained in the Finnish setting over a lifetime horizon. In addition to nonfatal and fatal CVEs, the effects factored Finnish non-CVE mortality, quality of life, and direct costs from a public payer perspective. Disaggregated costs and QALYs, costs per life year gained (LYG), and ischemic strokes avoided, net monetary benefit (NMB), expected value of perfect information (EVPI), economic value-added (EVA), cost-effectiveness table, and acceptability frontier were examined. Probabilistic and deterministic sensitivity analyses were conducted. RESULTS: In the deterministic comparison with ASA over a lifetime horizon, RIV + ASA resulted in a benefit of 0.404 QALYs and 0.474 LYGs for an additional cost of €3241, resulting in an ICER of €8031/QALY. The probabilistic ICER was €4313/QALY (EVPI €1829/patient). RIV + ASA had positive NMB (€8791/patient), low EVPI (€88/patient), high EVA (€8703/patient), and 91% probability of cost-effectiveness using the willingness-to-pay of €25,254/QALY. The primary result was conservative and robust for RIV + ASA. CONCLUSION: RIV + ASA was a cost-effective treatment alternative compared with ASA in patients with CCS or symptomatic PAD in Finland.
Finland lacks published evidence on the cost-effectiveness of approved interventions for the prevention of cardiovascular events among individuals with chronic coronary syndrome (stable coronary artery disease) or symptomatic peripheral artery disease at risk of cardiovascular complications. Rivaroxaban 2.5 mg twice daily plus acetylsalicylic acid 100 mg once daily is indicated and reimbursed in Finland for the prevention of cardiovascular events for patients with stable coronary artery disease or symptomatic peripheral artery disease. We assessed the effectiveness and costs of treatment with rivaroxaban plus acetylsalicylic acid in comparison with treatment with acetylsalicylic acid. That is, we examined whether rivaroxaban is cost-effective when prescribed in combination with acetylsalicylic acid.Cardiovascular events with their associated costs and impact on quality of life were modeled over the lifetime of patients. The main effectiveness outcome was quality-adjusted life years (modeled survival multiplied by the expected quality of life), and costs included those relevant to the Finnish public payer in 2019. Extensive sensitivity analyses were carried out to evaluate the impacts of different model inputs and rationale.Rivaroxaban plus acetylsalicylic acid had high probability of being cost-effective, compared with acetylsalicylic acid. By valuing quality-of-life benefit with a plausible willingness-to-pay, net cost savings of €8791 per patient could be gained or economic value added by €8703 per patient if rivaroxaban was used.
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