Introduction: The introduction of diseasemodifying therapies (DMTs) for relapsing multiple sclerosis (RMS) over the last two decades has prompted the economic assessments of these treatments by reimbursement authorities. The aim of this systematic literature review was to evaluate the modeling approach and data sources used in economic evaluations of DMTs for RMS, identify differences and similarities, and explore how economic evaluation models have evolved over time. Methods: MEDLINEÒ, EmbaseÒ, and EBM Reviews databases were searched using OvidÒ Platform from database inception on 25 December 2019 and subsequently updated on 17 February 2021. In addition, health technology assessment agency websites, key conference proceedings, and gray literature from relevant

Objectives: Asthma is one of the most common long term medical conditions and an important contributor to the burden of illness. People with asthma experience poor life satisfaction and require a range of health services to manage their condition. There is a need to assess the instruments by disease concept and interpret the dimension scores. The aim of this systematic review is to assess the impact of severe asthma on the quality of life (QoL). MethOds: A systematic search was conducted of the relevant published evidence from Embase and MEDLINE. Search limits were: articles in English, in human and published since year 2005. Retrieved citations were screened by two independent reviewers according to inclusion criteria: severe asthma and baseline QoL data either measured on generic scale or disease-specific scale. Results: A total 29 studies met the inclusion criteria. The majority of studies were observational (14 studies) while seven studies had cross-sectional design. The majority of studies were conducted in adult population (18 studies) while few studies were conducted in children (5 studies). Asthma Quality of Life Questionnaire (AQLQ) was the most frequently used scale among the included studies, assessed in 13 studies followed by St. George's Respiratory Questionnaire (SGRQ) in six studies. Seven studies reported total AQLQ data with mean scores ranging from 3.1-4.8, which reflect poor QoL. Across these domains, scores assessed on AQLQ -symptoms and AQLQ -activity limitations were lower as compared to AQLQ -emotional function and AQLQenvironmental stimuli. Data also suggested that patients with severe asthma have rapid deterioration in overall health status as compared to patients with mildmoderate asthma. cOnclusiOns: Patients with severe asthma had lower total QoL scores as assessed through different scales, indicating worse QoL. Symptoms and activity limitations are the two main domains that potentially affect the QoL in patients with severe asthma.

Financial constraints versus public desire for more-generous healthcare create a difficult dilemma for countries globally. As each market strives to manage its prescription drug market, highly specific market access requirements and challenges abound for drugmakers. Innovative developers must engage with payers much earlier in the product development cycle in order to optimize trial design to satisfy specific MA and payer requirements on demonstrating innovation (e.g. selecting the appropriate comparator, targeting the correct/local patient population, gathering the most compelling head-to-head). By exploring how pricing and reimbursement (P&R) decisions are made in many major and developing markets around the world, we have developed a Country Archetypes model that identifies similarities among payer requirements, and, vitally, determines where product value messaging can be leveraged to optimize market access strategy. Data on payer type and drug review processes, payer fragmentation, percentage of individuals covered by a health insurance system, size of the pharmaceutical market, percentage of government and individuals in healthcare spending, and use as a reference country for other nations were collected for 27 of the largest pharmaceutical markets in the world. Considerations around free pricing, health technology assessment, and review of pharmacoeconomic and outcomes research data rules were made, and further segmentations on decision impact, size of reimbursable market, out-of-pocket costs, role of health insurance and market fragmentation applied. Ultimately, from the 27 nations examined, six groups emerged, each comprising countries with commonalities across all measures, albeit distinct profiles that affect P&R: Accountants, Pragmatists, Evidence seekers, Deal-makers, Ceiling setters, and Independents. Our Country Archetype model is intended to help multinational pharmaceutical companies prepare for local reimbursement evaluations, and pinpoint where decision-makers can be found. With classifications based on the most important set of reimbursement criteria necessary to attain favorable access in each market, the keys to access can be found and turned.

Objectives: The disease modifying therapies (DMTs) for multiple sclerosis (MS) are expensive and a burden on healthcare systems. Decisions driving the reimbursement of currently available DMTs can help prepare appropriate strategies for pricing and reimbursement submissions in future. The objective of this analysis was to understand recent health technology assessments (HTAs) for MS therapies in EU-5 nations and identify the factors driving their reimbursement decisions. Methods: European Commission (EC)-approved drugs for MS were identified via European public assessment reports. A surveillance of recent HTA decisions in the EU-5 regions, namely UK (NICE, SMC, AWMSG), France (HAS), Italy (AIFA), Spain (AEMPS, AETSA) and Germany (G-BA, IQWiG) was done using IQVIA TM 's proprietary platform 'HTA Accelerator' from 01/Jan/2015 to 01/06/2019. Results: Fourteen MS-specific DMTs have received EC approvals to date, with daclizumab being voluntary withdrawn post-approval for various safety reasons by the innovator. Forty-nine single drug assessments (SDAs) were carried out for these 14 drugs since 2015. Of these, the highest number of SDAs were for fingolimod (22.4%; n= 11) and ocrelizumab (20.4%; n= 10). Among the recently published 49 HTA decisions (SDAs), it was found that five negative recommendations were received for three DMTs in EU-5 [fingolimod (1 for G-BA), cladribine (1 for HAS and 1 for G-BA) and fampridine (1 for SMC and 1 for AWMSG)] owing to insufficient evidence justifying high cost or inability to demonstrate sufficient clinical effectiveness against the comparators. Conclusions: Despite approval of several DMTs for MS in the EU-5 region, DMTs have confronted negative recommendations from HTA agencies for not being able to justify their high cost against comparators. Hence, further emphasis on robust economic analyses justifying price vis-à-vis clinical benefits are warranted to drive positive HTA recommendations.