How Useful Are Digital Health Terms for Outcomes Research? An ISPOR Special Interest Group Report.

OBJECTIVES: This study aimed to review definitions of digital health and understand their relevance for health outcomes research. Four umbrella terms (digital health, electronic health, mobile health, and telehealth/telemedicine) were summarized in this article. METHODS: PubMed/MEDLINE, Embase, Cochrane Library, and EconLit were searched from January 2015 to May 2020 for systematic reviews containing key Medical Subject Headings terms for digital health (n = 38) and synonyms of "definition." Independent pairs of reviewers performed each stage of the review, with reconciliation by a third reviewer if required. A single reviewer consolidated each definition for consistency. We performed text analysis via word clouds and computed document frequency-and inverse corpus frequency scores. RESULTS: The search retrieved 2610 records with 545 articles (20.9%) taken forward for full-text review. Of these, 39.3% (214 of 545) were eligible for data extraction, of which 134 full-text articles were retained for this analysis containing 142 unique definitions of umbrella terms (digital health [n = 4], electronic health [n = 36], mobile health [n = 50], and telehealth/telemedicine [n = 52]). Seminal definitions exist but have increasingly been adapted over time and new definitions were created. Nevertheless, the most characteristic words extracted from the definitions via the text analyses still showed considerable overlap between the 4 umbrella terms. CONCLUSIONS: To focus evidence summaries for outcomes research purposes, umbrella terms should be accompanied by Medical Subject Headings terms reflecting population, intervention, comparator, outcome, timing, and setting. Ultimately a functional classification system is needed to create standardized terminology for digital health interventions denoting the domains of patient-level effects and outcomes.

Treatment of bypass failure in patients with chronic limb threatening ischemia - open surgery vs. percutaneous mechanical thrombectomy.

Background: Lower limb bypass occlusion in patients with chronic limb threating ischemia remains a challenge. We can choose between different treatment options: open surgery, local thrombolysis, thrombectomy/atherectomy devices. In this pilot study, we compare clinical outcomes and treatment costs between open surgery (OS) and percutaneous mechanical thrombectomy (pMTH). Patients and methods: This pilot study represents a retrospective analysis of hospital data of 48 occluded bypasses admitted from 2013 to 2018. Only patients presenting with severe ischemia and recrudescence of symptoms (Rutherford 4-6) were included in the current analysis. Two cohorts of patients were analysed: patients who underwent OS and patients that underwent pMTH. Primary clinical outcomes were one-year cumulative patency and limb salvage rates. Total cost was calculated as a sum of intra- and post-operative costs. To weigh clinical benefits against the economic consequences of OS versus pMTH a cost-effectiveness framework was adopted. Results: We analysed a series of 48 occluded bypasses 17 treated with open surgery and 31 with pMTH. Procedural success was 100% in both groups. When comparing one-year death rates (p-value = .22) and re-occlusion rates (p-value = .43), no statistically significant differences were observed between the two cohorts. Mean patency duration in the surgery cohort was significantly shorter (p-value < .05). Primary patency (OS 41.2% vs. pMTH 48.4%) and limb salvage rate (OS 88.2% vs. pMTH 90.3%) at one year are similar in both groups. The total cost of surgery was substantially higher (OS 10,159€ vs. pMTH 8,401€) Conclusions: This pilot study, although limited to 48 occluded bypasses, demonstrates that endovascular treatment with pMTH is less invasive, less time consuming and less expensive, and produces greater health benefits than traditional OS.

Multicriteria Decision Analysis to Support Health Technology Assessment Agencies: Benefits, Limitations, and the Way Forward.

OBJECTIVE: Recent years have witnessed an increased interest in the use of multicriteria decision analysis (MCDA) to support health technology assessment (HTA) agencies for setting healthcare priorities. However, its implementation to date has been criticized for being "entirely mechanistic," ignoring opportunity costs, and not following best practice guidelines. This article provides guidance on the use of MCDA in this context. METHODS: The present study was based on a systematic review and consensus development. We developed a typology of MCDA studies and good implementation practice. We reviewed 36 studies over the period 1990 to 2018 on their compliance with good practice and developed recommendations. We reached consensus among authors over the course of several review rounds. RESULTS: We identified 3 MCDA study types: qualitative MCDA, quantitative MCDA, and MCDA with decision rules. The types perform differently in terms of quality, consistency, and transparency of recommendations on healthcare priorities. We advise HTA agencies to always include a deliberative component. Agencies should, at a minimum, undertake qualitative MCDA. The use of quantitative MCDA has additional benefits but also poses design challenges. MCDA with decision rules, used by HTA agencies in The Netherlands and the United Kingdom and typically referred to as structured deliberation, has the potential to further improve the formulation of recommendations but has not yet been subjected to broad experimentation and evaluation. CONCLUSION: MCDA holds large potential to support HTA agencies in setting healthcare priorities, but its implementation needs to be improved.

HEALTH TECHNOLOGY ASSESSMENT IN SERBIA.

OBJECTIVES: This study provides an overview of the Republic of Serbia healthcare system and describes the process of developing and conducting health technology assessment (HTA). METHODS: The authors performed pragmatic, nonsystematic literature review based on available statistical data, legislation, and studies. RESULTS: Healthcare law creates conditions that allow implementation of the principle "value for money." The institutions directly vested in the implementation of HTA are the National Health Insurance Fund (NHIF) and the Ministry of Health (MoH). There are some reflections of the efforts by NHIF and MoH toward achieving this goal. CONCLUSIONS: Despite the highly set objectives, there is still a lot of work to be done to build an adequate model to support decision-making processes to bridge the discrepancies between broadly defined rights to health care and limited resources in the country.

Health Technology Assessment for Molecular Diagnostics: Practices, Challenges, and Recommendations from the Medical Devices and Diagnostics Special Interest Group.

BACKGROUND: Health technology assessments (HTAs) are increasingly used to inform coverage, access, and utilization of medical technologies including molecular diagnostics (MDx). Although MDx are used to screen patients and inform disease management and treatment decisions, there is no uniform approach to their evaluation by HTA organizations. OBJECTIVES: The International Society for Pharmacoeconomics and Outcomes Research Devices and Diagnostics Special Interest Group reviewed diagnostic-specific HTA programs and identified elements representing common and best practices. METHODS: MDx-specific HTA programs in Europe, Australia, and North America were characterized by methodology, evaluation framework, and impact. Published MDx HTAs were reviewed, and five representative case studies of test evaluations were developed: United Kingdom (National Institute for Health and Care Excellence's Diagnostics Assessment Programme, epidermal growth factor receptor tyrosine kinase mutation), United States (Palmetto's Molecular Diagnostic Services Program, OncotypeDx prostate cancer test), Germany (Institute for Quality and Efficiency in Healthcare, human papillomavirus testing), Australia (Medical Services Advisory Committee, anaplastic lymphoma kinase testing for non-small cell lung cancer), and Canada (Canadian Agency for Drugs and Technologies in Health, Rapid Response: Non-invasive Prenatal Testing). RESULTS: Overall, the few HTA programs that have MDx-specific methods do not provide clear parameters of acceptability related to clinical and analytic performance, clinical utility, and economic impact. The case studies highlight similarities and differences in evaluation approaches across HTAs in the performance metrics used (analytic and clinical validity, clinical utility), evidence requirements, and how value is measured. Not all HTAs are directly linked to reimbursement outcomes. CONCLUSIONS: To improve MDx HTAs, organizations should provide greater transparency, better communication and collaboration between industry and HTA stakeholders, clearer links between HTA and funding decisions, explicit recognition of and rationale for differential approaches to laboratory-developed versus regulatory-approved test, and clear evidence requirements.

Comparison of economic and health implications from earlier detection of HIV infection in the United Kingdom and Poland.

PURPOSE: To model the financial and survival impact of early HIV infection detection versus late and compare results between the UK and Polish setting among the newly detected patients. PATIENTS AND METHODS: A Microsoft Excel decision model (SUNRISE) was designed to generate a set of outcomes for a defined population. Survival was modelled on the COHERE study extrapolated to a 5-year horizon as a constant hazard. Hazard rates were specific to age, sex and whether detection was early or late. The primary outcomes for each year up to 5 years were: annual costs, numbers of infected cases, hospital admissions and surviving cases. Total population was observed in UK and Poland. ISPOR Budget Impact Model - Principles of Good Practice were utilised in SUNRISE development. RESULTS: The projected cumulative cost-savings over 5 years in Poland and UK were 5,823,479 PLN (£1,109,234) and £21,608,562 respectfully. When including the value of life-years saved projected cumulative cost-savings in Poland and UK amounted to 8,374,018 PLN (£1,595,051) and £29,834,679 respectively. Savings were insensitive to transmission rates, but were sensitive in direct proportion to the percentage shift from late to early detection. In UK, savings were in higher proportion to Poland, due to much higher overall cost of HIV treatment (whether early or late HIV detected patient). CONCLUSION: Estimated cost savings that could be translated into identification of appropriate programmes (providing wider coverage of HIV testing, awareness building) that would lead towards higher proportion of early HIV detected patients are very sensitive to the cost of HIV test and overall HIV treatment cost.

Economic burden and dosing trends of buprenorphine buccal film and transdermal patch in chronic low back pain.

Aim: Exploring prescribing trends and economic burden of chronic low back pain (cLBP) patients prescribed buprenorphine buccal film (Belbuca®) or transdermal patches. Methods: In the MarketScan® commercial insurance claims (employees and their spouses/dependents, 2018-2021), the first film or patch prescription date was an index event. The observation covered 6-month pre-index and 12-month post-index periods. Results: Patients were propensity-score matched (708 per cohort). Buprenorphine initiation had stable cost trends in buccal film and increasing trends in transdermal patch cohort. Between-cohort comparisons of healthcare expenditures, cost trends and resource utilization showed significant differences, mostly in favor of buccal film. Buccal film also had higher daily doses and wider dosing range. Conclusion: Buprenorphine film is more cost-effective cLBP treatment with more flexible dosing.

What is this article about? This retrospective study included patients with chronic low back pain (cLBP) and commercial insurance in the USA. Only patients treated with Belbuca®, a buprenorphine buccal film, or a buprenorphine transdermal patch were included. Patients were observed 6 months prior to and 12 months after the first buprenorphine prescription. Healthcare costs, cost trends, resource use and buprenorphine treatment characteristics were explored.What were the results? Patients with cLBP on buccal film had lower costs, stable cost trends and less healthcare resources used. Also, they had higher buprenorphine daily doses.What do the results mean? The results imply that buccal film is less costly for cLBP patients than patches. The buccal film had more flexible dosing with higher daily doses, which might be associated with better pain control.

Treatment characteristics of chronic low back pain patients treated with buprenorphine buccal film or transdermal patch.

Aims: Retrospective insurance claims analysis exploring treatment characteristics in chronic low back pain patients prescribed buprenorphine buccal film (Belbuca®) or transdermal patches. Patients and methods: The first buprenorphine prescription (buccal film or transdermal patch) was an index event. Patients were observed over 6 month pre- and post-index periods. Propensity score matching minimized the selection bias. Results: Buccal film patients had a higher buprenorphine daily dose (501.7 vs 270.9 µg; p < 0.001). The patch-to-film switching rate was higher than vice versa (11.5 vs 3.8%; p < 0.001). The buccal film showed a greater reduction in opioid prescriptions (-1.1 vs -0.7; p = 0.012), daily morphine milligram equivalents (-12.6 vs -7.3; p < 0.001) and opioid treatment duration (-13.4 vs -7.6 days; p = 0.022). Conclusion: Buccal film was associated with higher buprenorphine doses and a greater reduction of opioid burden.

What is this article about? The analysis explored treatment patterns in chronic low back pain patients treated with different buprenorphine drugs. The use of other pain medications was also evaluated. Buprenorphine buccal film (Belbuca^®) was compared with transdermal patches. This study used commercial insurance data of US patients. What were the results? The most relevant findings were: Patients using buccal film had about two-times higher buprenorphine daily doses. About 12% of patch patients switched to film, while approximately 4% of film patients switched to patch. Initiation of both buprenorphine drugs led to reduced usage of opioids and other pain drugs. Despite a shorter buprenorphine treatment, the film was associated with a greater reduction in opioid use than the patch. What do the results of the study mean? The results showed that patients prescribed buprenorphine buccal film would be able to achieve higher daily doses required for appropriate chronic low back pain management. The buccal film will also lead to a great reduction in concomitant opioid use. These advantages may explain why more patients switched from buprenorphine transdermal patch to buccal film than the other way around.

Real-world Medicare Healthcare Costs of Patients with Dupuytren's Contracture Treated with Collagenase or Fasciectomy.

Background: Our study aimed to compare real-world healthcare resource utilization (HRU) and healthcare cost (HC) of Medicare-insured patients (≥65 years old) with Dupuytren's contracture (DC) treated with Clostridium histolyticum (collagenase) or fasciectomy. Methods: DC patients treated with collagenase or fasciectomy between July 2011 and June 2017 were identified using the IBM MarketScan Medicare Supplemental Database. The index date was the date of the first procedure. Demographic characteristics were captured on the index date, and comorbidities were assessed during the 24-month preindex period. HRU and HC were analyzed throughout the 12-month postindex period. Patients were matched using propensity score weights. Gamma log-linked generalized linear models were used to evaluate HC drivers. Results: Out of 37,374 DC patients, 2911 received collagenase, while 6258 underwent fasciectomy. Postmatching, the total average annual HC was similar between collagenase and fasciectomy ($7271 versus $6220, P = 0.357). When HCs were stratified by the service provider, outpatient facility and physician office costs were lower in the collagenase cohort ($850 versus $1284, P = 0.047 and $546 versus $1001, P < 0.001). The costs of professional services were significantly higher than in the fasciectomy cohort due to the cost of collagenase injection ($1682 versus $629, P < 0.001). The HRU was similar between cohorts, except for more frequent outpatient facility visits in fasciectomy patients (12.3 versus 22.9, P < 0.001). Generalized linear model revealed Charlson comorbidity index, plan type, patients' residence region, sleep disorder, and hyperlipidemia as significant predictors of total HC. Conclusion: This study found comparable total annual HC and HRU between collagenase- and fasciectomy-treated Medicare patients.

A US Retrospective Claims Analysis Comparing Healthcare Costs of Patients Transitioning from Immediate-Release Oxycodone to Two Different Formulations of Extended-Release Oxycodone: Xtampza ER or OxyContin.

Purpose: Opioid therapy for managing chronic pain remains a challenge, as providers must weigh the medical benefit to the patient with the risk of adverse events. Manipulation of many extended-release (ER) opioid formulations may lead to increased serious medical outcomes or death. The economic burden of opioid use disorders due to opioid misuse and abuse may vary depending on which abuse deterrent opioid formulation is prescribed. The study aimed to compare demographic and clinical characteristics and healthcare costs of chronic pain patients treated with two different abuse-deterrent opioid formulations, Xtampza ER and reformulated OxyContin. Methods: The source of data was IBM® MarketScan® Commercial Claims and Encounters Medicare Supplemental database, from January 2016 through February 2020. Patients with chronic pain were assigned to either the Xtampza ER or the OxyContin cohort based on the initial ER opioid prescription set as the index date. Continuous healthcare coverage was required during a minimum 3-month pre-index and 9-month post-index periods. Pre-index patients' characteristics were analyzed. Healthcare costs of Xtampza ER vs OxyContin were assessed in the post-index period. Results: After applying selection criteria, 464 patients were observed in the Xtampza ER cohort versus 1927 patients in the OxyContin cohort. In unmatched patients, ER opioid costs were lower for Xtampza ER than OxyContin ($2645 vs $3141; p<0.001), which ultimately led to lower total prescription costs for the Xtampza ER cohort compared to the OxyContin cohort ($7492 vs $8754; p=0.016). In matched patients, the total healthcare costs were significantly lower in the Xtampza ER cohort than in the OxyContin cohort, $22,630 vs $28,386 (p=0.005), respectively. Conclusion: This study suggests that Xtampza ER may result in lower healthcare costs than OxyContin for a population of chronic pain patients switching from immediate release oxycodone based on real-world data.

Accuracy of Noninvasive Diagnostic Tests for the Detection of Significant and Advanced Fibrosis Stages in Nonalcoholic Fatty Liver Disease: A Systematic Literature Review of the US Studies.

BACKGROUND: The purpose of this systematic literature review (SLR) was to evaluate the accuracy of noninvasive diagnostic tools in detecting significant or advanced (F2/F3) fibrosis among patients with nonalcoholic fatty liver (NAFL) in the US healthcare context. METHODS: The SLR was conducted in PubMed and Web of Science, with an additional hand search of public domains and citations, in line with the PRISMA statement. The study included US-based original research on diagnostic test sensitivity, specificity and accuracy. RESULTS: Twenty studies were included in qualitative evidence synthesis. Imaging techniques with the highest diagnostic accuracy in F2/F3 detection and differentiation were magnetic resonance elastography and vibration-controlled transient elastography. The most promising standard blood biomarkers were NAFLD fibrosis score and FIB-4. The novel diagnostic tools showed good overall accuracy, particularly a score composed of body mass index, GGT, 25-OH-vitamin D, and platelet count. The novel approaches in liver fibrosis detection successfully combine imaging techniques and blood biomarkers. CONCLUSIONS: While noninvasive techniques could overcome some limitations of liver biopsy, a tool that would provide a sufficiently sensitive and reliable estimate of changes in fibrosis development and regression is still missing.

The burden of productivity loss of U.S. commercially insured patients diagnosed with Dupuytren's disease undergoing collagenase versus fasciectomy treatment.

Background: We conducted a comparative assessment of the productivity loss associated with the two different treatment options for Dupuytren's disease: collagenase and fasciectomy. Methods: The retrospective claims analysis was performed using the data from IBM MarketScan® Commercial (CD) and Health and Productivity Management (HPM) Databases over five years (2012-2016). We identified two cohorts of patients who underwent either collagenase or fasciectomy in the CD. Propensity-score matched patients were linked to their productivity loss claims in the HPM database. Productivity loss measures were assessed over a 12-month follow-up period. Results: Out of 702 collagenase and 999 fasciectomy propensity score-matched patients in the CD, there were 147 collagenase and 273 fasciectomy patients in the HPM database. Over the follow-up period, collagenase-treated patients were significantly less likely to use short-term disability (STD) leave (9.7% vs. 20.2%; P = 0.009), reflecting in the lower average number of absent STD days (mean, 2.8 vs. 8.1; P = 0.002) in comparison to fasciectomy-treated. The mean indirect STD cost was considerably lower in the collagenase vs. fasciectomy group ($375 vs. $1,108; P = 0.002). Conclusion: This study indicates that collagenase vs. fasciectomy treatment may be related to a lower rate of workplace absence and lower indirect cost in a year following the treatment.

Concomitant use of benzodiazepines in chronic pain patients adherent to extended-release tapentadol or oxycodone treatment-A retrospective claims analysis.

OBJECTIVE: To compare concomitant benzodiazepine (BZDs) use among chronic pain patients adherent to extended-release tapentadol (TapER) or oxycodone (OxnER) and estimate the number of lives potentially saved by switching pa-tients to the less BZD coprescribed treatment. DESIGN: Retrospective database study. SETTING: Patients were identified using the IBM MarketScan® Commercial Database. The opioid overdose death esti-mates were obtained from the US national mortality register and were used to estimate the number of lives potentially saved by switching patients to the opioid treatment with lower rates of BZD coprescribing. PATIENTS, PARTICIPANTS: The authors identified 30,213 chronic pain patients between October 2012 and March 2016. Af-ter propensity score matching, N = 2,355 and N = 6,761 patients were adherent (proportion of days covered ≥80 percent) to TapER and OxnER, respectively. INTERVENTIONS: TapER versus OxnER, during the 180-day treatment. MAIN OUTCOME MEASURE(S): Proportions of BZD coprescribing, BZD dosing patterns in matched patients, and the esti-mated number of lives potentially saved by the opioid treatment switch. RESULTS: TapER patients were less coprescribed BZDs during the treatment period (38.9 percent versus 49.2 percent, OR = 0.659, p < 0.001), and had fewer days of BZD supply per patient (mean: 49.6 versus 70.2 days, p < 0.001) with similar BZD average daily dose. Due to less frequent coprescribing of BZDs with TapER, it is estimated that ~800 deaths may have been avoided in the U.S. as a result of switching patients from OxnER to TapER. CONCLUSIONS: Among treatment-adherent patients, TapER patients had fewer BZD coprescriptions than OxnER pa-tients had. Moreover, when BZDs were coprescribed, those BZD prescriptions were for shorter periods of time. Pro-spective studies are warranted to explore rates and consequences of BZD coprescribing among opioids.

Healthcare Costs and Resource Use of Patients with Dupuytren Contracture Treated with Collagenase Clostridium Histolyticum or Fasciectomy: A Propensity Matching Analysis.

OBJECTIVE: Studies examining differences in US healthcare resource utilization (HCRU) and associated healthcare costs between collagenase clostridium histolyticum (CCH) and fasciectomy for Dupuytren contracture (DC) are limited. This study evaluated US HCRU and direct healthcare cost for the treatment of DC in privately insured patients using insurance claims. METHODS: This retrospective observational cohort study analyzed data from large nationwide insurance claims databases; it included individuals diagnosed with DC between July 1, 2011, and June 30, 2017, who were adults at index date (date of first treatment: CCH or fasciectomy). Participants had continuous health plan coverage 24 months pre-index and 12 months post-index date. All-cause and DC-related HCRU and healthcare costs from the payers' perspective were compared between propensity score-matched cohorts. Generalized linear models assessed factors associated with all-cause total healthcare costs. RESULTS: Of 83,983 patients diagnosed with DC, 1932 adults receiving fasciectomy and 953 adults receiving CCH were included. The mean ± standard deviation total all-cause healthcare cost was significantly lower with CCH than with fasciectomy (US$11,897 ± US$14,633 versus US$15,528 ± US$22,254, respectively; P<0.001). After propensity score matching, 702 and 999 patients remained in the CCH and fasciectomy cohorts, respectively. In this analysis, all-cause and DC-related total costs were significantly lower in the CCH cohort versus the fasciectomy cohort (all-cause: US$11,044 ± US$12,856 versus US$12,912 ± US$19,237, respectively, P=0.02; DC-specific: US$3417 ± US$3671 versus US$5800 ± US$4985, P<0.001), mainly due to the lower frequency of outpatient visits. CCH treatment and the use of a consumer-driven healthcare plan were associated with lower healthcare costs. CONCLUSION: Based on matched cohort data, adjusted 1-year healthcare costs for CCH-treated individuals were significantly lower compared with costs for fasciectomy-treated individuals.

Future of Data Analytics in the Era of the General Data Protection Regulation in Europe.

The development of evidence to demonstrate 'value for money' is regarded as an important step in facilitating the search for the optimal allocation of limited resources and has become an essential component in healthcare decision making. Real-world evidence collected from de-identified individuals throughout the continuum of healthcare represents the most valuable source in technology evaluation. However, in the European Union, the value assessment based on real-world data has become challenging as individuals have recently been given the right to have their personal data erased in the case of consent withdrawal or when the data are regarded as being no longer necessary. This act may limit the usefulness of data in the future as it may introduce information bias. Among healthcare stakeholders, this has become an important topic of discussion because it relates to the importance of data on one side and to the need for personal data protection on the other side, especially when it comes to "personal data related to the physical or mental health of a natural person, including the provision of health care services, which reveals information about his or her health status". At the forefront of these discussions are data protection issues as well as the population's trust in digital services. It seems that the new era has begun, where citizens and patients will have the ability to manage their personal or self-generated data. The European Commission has laid the groundwork for this paradigm shift that will steadily emerge in the coming years. To prepare for this change, we believe attention should be given to data security and other rules of data privacy. It has become increasingly important to ensure that individuals are properly introduced into complex environments with multiple sources of Big Data for clinical and behavioral purposes to provide an optimal balance between societal and individual benefits. In this article, a number of issues are considered and discussed, based upon the authors' experience, with the aim of helping the reader better understand the implications of the use of Big Data and the importance of data protection in the coming years.

Healthcare Costs And Resource Utilization In Chronic Pain Patients Treated With Extended-Release Formulations Of Tapentadol, Oxycodone, Or Morphine Stratified By Type Of Pain: A Retrospective Claims Analysis, 2012-2016.

PURPOSE: Chronic pain treatment imposes a substantial economic burden on US society. Treatment costs may vary across subgroups of patients with different types of pain. The aim of our study was to compare healthcare costs (HC) and resource utilization in musculoskeletal (MP), neuropathic (NP), and cancer pain (CaP) patients treated with long-acting opioids (LAO), using real-world evidence. PATIENTS AND METHODS: We compared total HC and resource utilization in subgroups of chronic pain patients (MP, NP or CaP) treated with three LAO alternatives: morphine-sulfate extended-release (MsER), oxycodone ER (OxnER) and tapentadol ER (TapER). Retrospective claims data were analyzed in the IBM Truven Health MarketScan® Commercial Claims Database (October 2012 through March 2016). All patients were continuously health plan enrolled for at least 12 months before the index date (first LAO prescription date) and during the LAO-treatment period. The cohorts were propensity-score matched. RESULTS: A total of 2824 TapER-treated patients were matched to 16,716 OxnER-treated patients, while 2827 TapER patients were matched to 16,817 MsER patients. The average monthly total HC were lower in the TapER than in the OxnER cohort ($2510 vs. $3720, p<0.001), reflecting significantly lower outpatient, inpatient and emergency department visit rates in the TapER cohort. Similarly, the TapER cohort exhibited a lower average monthly total HC ($2520 vs. $2900, p<0.05) than MsER cohort, with significantly fewer inpatient and outpatient visits in the TapER cohort. TapER demonstrated significantly lower total HC than OxnER in patients with NP and MP, and similar to OxnER in CaP patients. TapER costs were similar to MsER costs in all pain-type subpopulations. CONCLUSION: Based on real-world evidence, the TapER treatment for chronic pain was associated with significantly lower HC compared with MsER or OxnER. When categorized by type of pain, TapER remained a less costly strategy in comparison with OxnER for MP and NP.

How can multi criteria decision analysis support value assessment of pharmaceuticals? - Findings from a systematic literature review.

INTRODUCTION: As budget constraints become more and more visible, there is growing recognition for greater transparency and greater stakeholders' engagement in the pharmaceuticals' pric-ing&reimbursement (P&R) decision making. New frameworks of drugs' value assessments are searched for. Among them, the multi-criteria decision analysis (MCDA) receives more and more attention. In 2014, ISPOR established Task Force to provide methodological recommendations for MCDA utilization in the health care decision making. Still, there is not so much knowledge about the real life experience with MCDA's adaptation to the P&R processes. AREAS COVERED: A systematic literature review was performed to understand the rationale for MCDA adaptation, methodology used as well as its impact on P&R outcomes. EXPERT COMMENTARY: In total 102 hits were found through the search of databases, out of which 18 publications were selected. Although limited in scope, the review highlighted how MCDA can im-prove the decision making processes not only regarding pricing & reimbursement but also contribute to the the risk benefit assessment as well as optimization of treatment outcomes. Still none of re-viewed studies did report how MCDA results actually impacted the real life settings.

Revealed preferences towards the appraisal of orphan drugs in Poland - multi criteria decision analysis.

BACKGROUND: A Multi Criteria Decision Analysis (MCDA) technique was adopted to reveal the preferences of the Appraisal Body of the Polish HTA agency towards orphan drugs (OMPs). RESULTS: There were 34 positive and 23 negative HTA recommendations out of 54 distinctive drug-indication pairs. The MCDA matrix consisted of 13 criteria, seven of which made the most impact on the HTA process. Appraisal of clinical evidence, cost of therapy, and safety considerations were the main contributors to the HTA guidance, whilst advancement of technology and manufacturing costs made the least impact. CONCLUSIONS: MCDA can be regarded as a valuable tool for revealing decision makers' preferences in the healthcare sector. Given that only roughly half of all criteria included in the MCDA matrix were deemed to make an impact on the HTA process, there is certainly some room for improvement with respect to the adaptation of a new approach towards the value assessment of OMPs in Poland.

Economic and health implications from earlier detection of HIV infection in the United Kingdom.

PURPOSE: To model the budget and survival impact of implementing interventions to increase the proportion of HIV infections detected early in a given UK population. PATIENTS AND METHODS: A Microsoft Excel decision model was designed to generate a set of outcomes for a defined population. Survival was modeled on the Collaboration of Observational HIV Epidemiological Research Europe (COHERE) study extrapolated to a 5-year horizon as a constant hazard. Hazard rates were specific to age, sex, and whether detection was early or late. The primary outcomes for each year up to 5 years were: annual costs, numbers of infected cases, hospital admissions, and surviving cases. Three locations in the UK were chosen to model outcomes across a range of HIV prevalence areas: Lambeth, Southwark, and Lewisham (LSL), Greater Manchester Cluster (GMC), and Kent and Medway (K&M). RESULTS: In LSL, the projected cumulative cost savings over 5 years were £3,210,206 or £5,290,206 when including the value of the 104 life-years saved. Savings were insensitive to transmission rates, but sensitive in direct proportion to the percentage shift from late to early detection. In GMC, savings were in a similar proportion to LSL, but the magnitude was smaller, as a consequence of the lower base-case HIV prevalence. In K&M, with a smaller population and lower HIV prevalence than GMC, savings were commensurately smaller (£733,202 cumulatively over 5 years). CONCLUSION: The results strengthen the rationale for implementing increased testing in high prevalence areas. However, in areas of low prevalence, it is unlikely that costs will be returned over a 5-year period.

The use of non-economic criteria in pricing and reimbursement decisions in Central and Eastern Europe: issues, trends and recommendations.

INTRODUCTION: According to some experts, there is still room for improvement with regard to the inclusion of ethical considerations in Health Technology Assessment (HTA). AREAS COVERED: The pros and cons of the introduction of non-economic criteria in the HTA process in Central and Eastern Europe (CEE) are discussed. In comparison to Western Europe, financial considerations are even more important in CEE settings; however, it could also be said that attachment to equity and justice is part of CEE's heritage. Therefore, the trade-off between conflicting principles is evaluated. Expert commentary: To ensure the right balance between equity and efficiency in decision making, the current HTA framework has to be further augmented to allow all conflicting criteria to be addressed to a satisfactory degree. Following other examples, the applicability of multi criteria decision analysis technique to CEE settings should be further investigated.