Chronic wounds in a multiethnic Asian population: a cost of illness study.

OBJECTIVE: To estimate the 'cost of illness' arising from chronic wounds in Singapore. DESIGN: Incidence-based cost of illness study using evidence from a range of sources. SETTING: Singapore health services. PARTICIPANTS: We consider 3.49 million Singapore citizens and permanent residents. There are 16 752 new individuals with a chronic wound in 2017, with 598 venous ulcers, 2206 arterial insufficiency ulcers, 6680 diabetic ulcers and 7268 pressure injuries.Primary outcome measures expressed in monetary terms are the value of all hospital bed days lost for the population; monetary value of quality-adjusted life years (QALYs) lost in the population; costs of all outpatient visits; and costs of all poly clinic, use of Community Health Assist Scheme (CHAS) and emergency departments (EDs) visits. Intermediate outcomes that inform the primary outcomes are also estimated. RESULTS: Total annual cost of illness was $350 million (range $72-$1779 million). With 168 503 acute bed days taken up annually (range 141 966-196 032) that incurred costs of $139 million (range 117-161 million). Total costs to health services were $184 million (range $120-$1179 million). Total annual costs of lost health outcomes were 2077 QALYs (range -2657 to 29 029) valued at $166 million (range -212 to 2399 million). CONCLUSIONS: The costs of chronic wounds are large to Singapore. Costs can be reduced by making positive investments for comprehensive wound prevention and treatment programmes.

Pertinence de l'exigence d'un essai préalable avec un immunosuppresseur dans les indications de paiement des médicaments biologiques: gastroentérologie et dermatologie / Relevance of the prerequisite of the use of an immunosuppressant drug for the coverage of biologic agents (gastroenterology and dermatology)

INTRODUCTION: Au cours des dernières années, les médicaments biologiques se sont ajoutés à l'arsenal thérapeutique des maladies inflammatoires chroniques. Afin d'assurer un usage responsable de ces agents coûteux, leur paiement est actuellement autorisé suivant l'essai préalable de certains traitements conventionnels, notamment des immunosuppresseurs, à moins d'intolérances ou de contre-indications. Toutefois, des associations médicales en gastroentérologie et en dermatologie font état d'un décalage entre les indications de paiement des médicaments biologiques et les meilleures pratiques cliniques. Actuellement, lorsque l'utilisation des médicaments biologiques sans l'essai préalable des immunosuppresseurs est requise, une assistance par un programme de soutien aux patients et aux patientes pourrait être offerte par les fabricants des médicaments biologiques, selon certaines conditions. Dans le traitement des maladies inflammatoires de l'intestin, l'utilisation précoce des médicaments biologiques par le biais de ces programmes de soutien semble être une pratique bien établie et largement répandue depuis plusieurs années. Avec l'entrée en vigueur en avril 2021 de l'article 80.2 de la Loi sur l'assurance médicaments, lequel interdit le paiement ou le remboursement d'un médicament ou d'une fourniture dont le paiement est couvert par le régime général d'assurance médicaments, des associations médicales ont partagé des préoccupations quant à l'accès des médicaments biologiques sans l'essai préalable des immunosuppresseurs au ministère de la Santé et des Services Sociaux (MSSS). Notons que les médicaments biologiques, qu'ils soient de référence ou biosimilaires, font actuellement partie des exceptions prévues au règlement. Afin d'évaluer la pertinence des préalables de traitement dans les indications de paiement des médicaments biologiques, le MSSS a demandé à l'Institut national d'excellence en santé et en services sociaux (INESSS) de mobiliser les savoirs quant à la place des immunosuppresseurs et des médicaments biologiques dans les domaines de la gastroentérologie et de la dermatologie. MÉTHODOLOGIE: Tout d'abord, les indications de paiement des médicaments biologiques inscrits sur les listes de médicaments du Québec (ou dont la décision du ministre est en attente) ont été comparées à celles des autres provinces canadiennes. Ensuite, une revue rapide de la littérature a été réalisée pour répertorier notamment les recommandations des guides de pratique clinique (GPC) concernant la place des médicaments biologiques et des immunosuppresseurs dans la prise en charge de la maladie de Crohn chez l'adulte et l'enfant, de la colite ulcéreuse chez l'adulte et du psoriasis en plaques chez l'adulte. Finalement, les savoirs expérientiels et contextuels ont été recueillis par l'intermédiaire d'une invitation à recevoir des commentaires sur le plan de travail de l'INESSS et d'une consultation d'experts comprenant des gastroentérologues et des dermatologues. RÉSULTATS: Les GPC retenus dans les travaux relatent le manque d'étude de bonne qualité évaluant le moment optimal pour l'introduction des médicaments biologiques dans le traitement. Néanmoins, selon les données disponibles et le degré de valorisation de plusieurs autres facteurs, y compris les risques de complications, la gravité de la maladie, la réponse aux traitements antérieurs et les coûts, les sociétés savantes ont émis des recommandations concernant diverses séquences de traitement avec les médicaments biologiques, autant avant que suivant un traitement par les immunosuppresseurs. Pour le traitement des maladies inflammatoires de l'intestin, la plupart des GPC sélectionnés présentent des recommandations au sujet de l'utilisation des médicaments biologiques suivant un traitement conventionnel, lequel inclut l'acide 5-aminosalicylique (5-ASA) et (ou) les corticostéroïdes et (ou) les immunosuppresseurs. Plusieurs GPC font toutefois également état d'un changement de paradigme vers l'utilisation des médicaments biologiques en première intention de traitement, particulièrement chez les personnes qui ont des facteurs de risque de mauvais pronostic, afin de prévenir les complications, l'hospitalisation et le recours à la chirurgie. Très peu d'essais ont comparé l'efficacité des médicaments biologiques par rapport à celle des immunosuppresseurs, et ceux répertoriés ne sont pas représentatifs de la pratique clinique actuelle avec les médicaments biologiques. Les immunosuppresseurs sont généralement recommandés pour le maintien de la rémission et pourraient constituer une option de traitement acceptable suivant l'atteinte d'une rémission par les corticostéroïdes, mais leur utilisation suscite des préoccupations liées à leur innocuité, notamment le risque de lymphome T hépatosplénique associé aux thiopurines, telles l'azathioprine et la mercaptopurine. Pour le traitement du psoriasis en plaques, les recommandations issues des GPC sélectionnés concernant la place des médicaments biologiques dans le traitement sont peu nombreuses. Néanmoins, tous les GPC retenus s'accordent pour recommander l'utilisation des médicaments biologiques suivant un traitement par les agents de rémission systémiques conventionnels, lesquels incluent les immunosuppresseurs (principalement la cyclosporine et le méthotrexate) et l'acitrétine. Un GPC suggère également l'introduction précoce des médicaments biologiques dans des situations particulières. L'efficacité différentielle entre les médicaments biologiques et les agents de rémission systémiques conventionnels relève principalement de comparaisons indirectes. Une méta-analyse en réseau réalisée par le groupe Cochrane rapporte que la plupart des médicaments biologiques serait plus efficace que les agents de rémission systémiques conventionnels pour atteindre une réduction d'au moins 90 % sur le Psoriasis Area and Severity Index (PASI90). Par ailleurs, des enjeux d'innocuité sont liés aux agents de rémission systémiques conventionnels : le traitement continu par la cyclosporine n'est pas recommandé en pratique au-delà d'un an en raison des risques de néphrotoxicité, l'acitrétine pouvant causer des effets muco-cutanés et le méthotrexate, entraîner une hépatotoxicité. PERSPECTIVE DES EXPERTS ET AUTRES PARTIES PRENANTES: Pour le traitement des maladies inflammatoires de l'intestin, malgré l'absence de données de bonne qualité entre les immunosuppresseurs et les médicaments biologiques, les experts consultés estiment, selon leur expérience clinique, que les médicaments biologiques présentent une efficacité supérieure et un profil d'innocuité favorable par rapport aux immunosuppresseurs. Dans ce contexte, ils considèrent que l'essai des immunosuppresseurs avant l'autorisation des médicaments biologiques expose les patients à des risques de toxicité, de progression de la maladie et de complications. Afin d'éviter ces risques aux personnes qui en font usage, les cliniciens rapportent que l'utilisation des médicaments biologiques sans l'essai préalable des immunosuppresseurs par l'intermédiaire des programmes de soutien aux patients financés par les fabricants est une pratique bien établie au Québec depuis plusieurs années. En dermatologie, les cliniciens rapportent que les préalables de traitement dans les indications de paiement des médicaments biologiques pour le traitement du psoriasis en plaques pourraient forcer le choix d'options thérapeutiques souvent inappropriées pour les patients. Ils mentionnent que seul le méthotrexate dispose d'une réelle place dans le traitement du psoriasis en plaques modéré à grave. Les cliniciens reconnaissent que les délais engendrés par l'essai préalable d'au moins deux agents de rémission systémiques conventionnels, tel que requis actuellement dans les indications de paiement des médicaments biologiques, n'influencent pas le pronostic vital des patients. Toutefois, ils jugent important d'adapter le traitement à la condition particulière des personnes qui en font usage afin de réduire les plaques de psoriasis tout en limitant la survenue d'effets indésirables. CONCLUSIONS: Le moment optimal pour l'introduction des médicaments biologiques par rapport aux immunosuppresseurs dans les domaines de la gastroentérologie et de la dermatologie n'a pas été évalué dans des études de bonne qualité. Ainsi, les présents travaux démontrent une inadéquation entre la pratique clinique actuelle en gastroentérologie et les données probantes de bonne qualité disponibles. À ce propos, l'expérience clinique acquise au cours des dernières années avec les médicaments biologiques dans le traitement des maladies inflammatoires de l'intestin a mené les gastroentérologues à préconiser leur utilisation sans l'essai préalable des immunosuppresseurs. Les cliniciens estiment que l'exigence d'un traitement antérieur par les immunosuppresseurs dans les indications de paiement des médicaments biologiques pour le traitement des maladies inflammatoires de l'intestin devrait être retirée, principalement puisque les immunosuppresseurs retarderaient la guérison et exposeraient les patients à des risques de toxicité et de complications non négligeables, selon eux. Bien que la situation soit quelque peu différente en dermatologie, les cliniciens consultés soutiennent également le retrait de cette exigence pour le psoriasis en plaques.

INTRODUCTION: Over the past few years, biologic agents have been included in the therapeutic arsenal for treating chronic inflammatory diseases. To ensure responsible use of these costly drugs, their payment is currently only authorized following the use of conventional treatments (notably immunosuppressants), except in the presence of intolerances or contraindications. However, medical associations in gastroenterology and dermatology report a disconnect between coverage information for biologic agents and best clinical practices. At present, when biologic agents must be used without any prior trials of immunosuppressants, patients can, under certain conditions, receive assistance from biologic drug manufacturers for access through a patient support program. In the treatment of inflammatory bowel diseases, the early use of biologic agents through such support programs appears to be an established and widespread practice for several years. With the coming into force of section 80.2 of the Act respecting prescription drug insurance in April 2021, which prohibits the payment or reimbursement of a medication or supply covered by the Public Prescription Drug Insurance Plan, medical associations shared their concerns regarding access to biologic agents without any prior trials of immunosuppressants with the Ministère de la Santé et des Services sociaux (department of health issues and social services) (MSSS). It bears noting that biologic agents, whether they are reference products or biosimilars, are included in the exceptions provided for under the regulation. To assess the relevance of the prerequisite of the use of an immunosuppressant for the coverage of biologic agents, the MSSS asked the Institut national d'excellence en santé et en services sociaux (INESSS) to draw on the existing knowledge regarding the role of immunosuppressants and biologic agents in gastroenterology and dermatology. METHODOLOGY: First, coverage information for biologic agents listed on Québec drug formulary (or for which the Minister's decision is pending) was compared with that in other Canadian provinces. Then, a rapid review of the literature was performed to identify CPG (Clinical practice guidelines) recommendations regarding the place of biologic agents and immunosuppressants in the treatment algorithm of Crohn's disease in adults and children, ulcerative colitis in adults and plaque psoriasis in adults. Lastly, experiencebased and contextual knowledge was gathered through an invitation to receive feedback on the INESSS' work plan and from a consultation panel including gastroenterologists and dermatologists. RESULTS: The CPGs selected report a lack of quality studies on the best timing for incorporating biologic agents into a treatment plan. However, according to available data and the importance of several other factors, including the risk of complications, the severity of the illness, the response to previous treatments and the associated costs, learned societies made recommendations regarding various sequences of treatment with biologic agents, both before and after a treatment with immunosuppressants. For the treatment of inflammatory bowel diseases, most of the CPGs selected comprise recommendations as to the use of biologic agents following a conventional treatment that includes 5-ASA (aminosalicylic acids) and/or corticosteroids and/or immunosuppressants. Numerous CPGs, however, report a paradigm shift towards the use of biologic drugs as the front-line treatment, especially for persons at risk of a poor prognosis, to prevent complications, hospitalization and the need for surgery. Very few clinical trials have compared the efficacy of biologic agents and immunosuppressants, and the ones reported are not representative of current clinical practices with biologic agents. Immunosuppressants are generally recommended to maintain complete remission and could prove an acceptable treatment option once remission is achieved with corticosteroids; however, concerns associated with their safety have been raised, notably regarding the risk of hepatosplenic T-cell lymphoma due to thiopurines, such as azathioprine and mercatopurine. There are few recommendations in the selected CPGs regarding the role of biologic drugs in the treatment of plaque psoriasis. However, all of the CPGs selected agree in recommending the use of biologic drugs following a treatment with conventional systemic agents, which include immunosuppressants (primarily cyclosporine and methotrexate) and acitretin. One CPG also suggests resorting to the early use of biologic agents in special situations. The differential efficacy of biologic drugs and conventional systemic agents was mainly established through indirect comparisons. A network meta-analysis performed by Cochrane reports that most biologic drugs would be more effective than conventional systemic agents at achieving a decrease of at least 90% on the Psoriasis Area and Severity Index (PASI90). In addition, conventional systemic agents have certain safety issues: ongoing treatment with cyclosporine is not recommended beyond one year given the risks of nephrotoxicity, acitretin can cause mucocutaneous effects and methotrexate can induce hepatotoxicity. OPINIONS OF EXPERTS AND OTHER STAKEHOLDERS: For the treatment of inflammatory bowel diseases, despite the lack of quality data on immunosuppressants and biologic agents, the experts consulted believe, based on their clinical experience, that biologic agents offer a superior efficacy and a more favourable safety profile compared to immunosuppressants. Given this, they also consider that requiring a trial with an immunosuppressant before allowing the use of a biologic agent exposes patients to risks, among them toxicity, disease progression and complications. To avoid such risks, clinicians report that the use of biologic agents without the prior use of immunosuppressants through manufacturer-funded patient support programs is a wellestablished practice in Québec since many years. Clinicians in the field of dermatology report that the inclusion of preliminary treatments for the coverage of biologic agents in plaque psoriasis could result in patients being inappropriately treated. They mention that among the systemic drugs listed as prerequisite (acitretin, cyclosporin and methotrexate), methotrexate is the preferred agent for treating moderate to severe plaque psoriasis. The clinicians acknowledge that the delays resulting from the trial of at least two traditional systemic agents, as currently required in the coverage information for biologic agents, is not life-threatening for patients. However, they do believe that the treatment should be tailored based on the specific condition of the persons who benefit from it, to reduce psoriatic plaques while limiting the occurrence of adverse effects. CONCLUSIONS: The optimal timing for the introduction of biologics agents versus immunosuppressants in the field of gastroenterology and dermatology has not been assessed in good quality studies. Current research illustrates a discrepancy between actual clinical practices in gastroenterology and the quality evidence-based data available. The clinical experience using biologic drugs to treat inflammatory bowel diseases acquired over the past few years has led gastroenterologists to favour their use without a preliminary treatment with immunosuppressants. Clinicians consider that requiring such a prior treatment with immunosuppressants in the payment indications of biologic drugs for inflammatory bowel diseases should be ceased, mainly because immunosuppressants delay healing and expose patients to risks that include toxicity and non-negligeable complications. And while the circumstances are somewhat different in the field of dermatology, the clinicians consulted also support the removal of this requirement from payment indications of biologic drugs in the case of plaque psoriasis. Given a lack of data, this work did not evaluate the economic impact of withdrawing the requirement regarding prior treatment with immunosuppressants from the coverage information for biologic agents. This would likely generate a significant increase in costs, but the amounts involved should be compared to the cost of complications and other avoidable consequences. It should also be noted that a large portion of these costs are currently borne by the manufacturers, through patient support programs.

Patient characteristics associated with enrolment under voluntary programs implemented within fee-for-service systems in British Columbia and Quebec: a cross-sectional study.

BACKGROUND: There is a paucity of information on patient characteristics associated with enrolment under voluntary programs (e.g. incentive payments) implemented within fee-for-service systems. We explored patient characteristics associated with enrolment under these programs in British Columbia and Quebec. METHODS: We used linked administrative data and a cross-sectional design to compare people aged 40 years or more enrolled under voluntary programs to those who were eligible but not enrolled. We examined 2 programs in Quebec (enrolment of vulnerable patients with qualifying conditions [implemented in 2003] and enrolment of the general population [2009]) and 3 in BC (Chronic disease incentive [2003], Complex care incentive [2007] and enrolment of the general population [A GP for Me, 2013]). We used logistic regression to estimate the odds of enrolment by neighbourhood income, rural versus urban residence, previous treatment for mental illness, previous treatment for substance use disorder and use of health care services before program implementation, controlling for characteristics linked to program eligibility. RESULTS: In Quebec, we identified 1 569 010 people eligible for the vulnerable enrolment program (of whom 505 869 [32.2%] were enrolled within the first 2 yr of program implementation) and 2 394 923 for the general enrolment program (of whom 352 380 [14.7%] were enrolled within the first 2 yr). In BC, we identified 133 589 people eligible for the Chronic disease incentive, 47 619 for the Complex care incentive and 1 349 428 for A GP for Me; of these, 60 764 (45.5%), 28 273 (59.4%) and 1 066 714 (79.0%), respectively, were enrolled within the first 2 years. The odds of enrolment were higher in higher-income neighbourhoods for programs without enrolment criteria (adjusted odds ratio [OR] comparing highest to lowest quintiles 1.21 [95% confidence interval (CI) 1.20-1.23] in Quebec and 1.67 [95% CI 1.64-1.69] in BC) but were similar across neighbourhood income quintiles for programs with health-related eligibility criteria. The odds of enrolment by urban versus rural location varied by program. People treated for substance use disorders had lower odds of enrolment in all programs (adjusted OR 0.60-0.72). Compared to people eligible but not enrolled, those enrolled had similar or higher numbers of primary care visits and longitudinal continuity of care in the year before enrolment. INTERPRETATION: People living in lower-income neighbourhoods and those treated for substance use disorders were less likely than people in higher-income neighbourhoods and those not treated for such disorders to be enrolled in programs without health-related eligibility criteria. Other strategies are needed to promote equitable access to primary care.

Change in healthcare during Covid-19 pandemic was assessed through observational designs.

OBJECTIVE: Methodological challenges for investigating the changes in healthcare utilization during COVID-19 pandemic must be considered for obtaining unbiased estimates. STUDY DESIGN AND SETTING: A population-based study in the Lombardy region (Italy) measured the association between the level of epidemic restrictions (increasing exposure during pre-epidemic, post-lockdown, and lockdown periods) and the recommended healthcare (outcome) for patients with schizophrenia, heart failure, chronic obstructive pulmonary disease, breast cancer, and pregnancy women. Two designs are applied: the self-controlled case series (SCCS) and the usual cohort design. Adjustments for between-patients unmeasured confounders and seasonality of medical services delivering were performed. RESULTS: Compared with pre-epidemic, reductions in delivering recommended healthcare during lockdown up to 73% (95% confidence interval: 63%-80%) for timeliness of breast cancer surgery, and up to 20% (16%-23%) for appropriated gynecologic visit during pregnancy were obtained from SCCS and cohort design, respectively. Healthcare provision came back to pre-epidemic levels during the post-lockdown, with the exception of schizophrenic patients for whom the SCCS showed a reduction in continuity of care of 11% (11%-12%). CONCLUSION: Strategies for investigating the changes in healthcare utilization during pandemic must be implemented. Recommendations for taking into account sources of systematic uncertainty are discussed and illustrated by using motivating examples.

Association of Chronic Lower Respiratory Disease With County Health Disparities in New York State.

Importance: Chronic lower respiratory disease (CLRD) is the fourth leading cause of death in the United States, which imposes a considerable burden on individuals, families, and societies. The association between county-level health disparity and CLRD outcomes in New York state needs investigation. Objective: To evaluate the associations of CLRD outcomes with county-level health disparities in New York state. Design, Setting, and Participants: In this cross-sectional study, CLRD age-adjusted hospitalization for 2016 and mortality rates from 2014 to 2016 were obtained from the New York state Community Health Indicator Reports provided by the New York state Department of Health. County Health Rankings were used to evaluate various health factors to provide a summary z score for each county representing the county health status and how that county ranks in the state. Data analysis was performed from November 2020 to March 2021. Main Outcomes and Measures: The main outcomes were age-adjusted hospitalization and mortality rates for CLRD. The z score was calculated from the County Health Rankings, which includes subindicators of health behaviors, clinical care, social and economic factors, and physical environment. Pearson r and linear regression models were estimated. Results: During the study, 60 335 discharges were documented as CLRD hospitalizations in 2016 and 20 612 people died from CLRD from 2014 to 2016 in New York state. After adjusting for age, the CLRD hospitalization rate was 27.6 per 10 000 population, and the mortality rate was 28.9 per 100 000 population. Among 62 counties, Bronx had the highest hospitalization rate (64.7 per 10 000 population) whereas Hamilton had the lowest hospitalization rate (6.6 per 10 000 population). Mortality rates ranged from 17.4 per 100 000 population in Kings to 62.9 per 100 000 population in Allegany. County Health Rankings indicated Nassau had the lowest z score (the healthiest), at -1.17, but Bronx had the highest z score (the least healthy), at 1.43, for overall health factors in 2018. An increase of 1 point in social and economic factors z score was associated with an increase of 17.6 hospitalizations per 10 000 population (ß = 17.61 [95% CI, 10.36 to 24.87]; P < .001). A 1-point increase in health behaviors z score was associated with an increase of 41.4 deaths per 100 000 population (ß = 41.42 [95% CI, 29.88 to 52.97]; P < .001). Conclusions and Relevance: In this cross-sectional study, CLRD outcomes were significantly associated with county-level health disparities in New York state. These findings suggest that public health interventions and resources aimed at improving CLRD outcomes should be tailored and prioritized in health disadvantaged areas.

[Integrated care: the right way for the future?] / Integrated care: la strada giusta per il futuro?

Integrated Care (IC) is an "umbrella" term, under which numerous definitions are collected, which implies an attempt to coordinate and integrate fragmented and piecemeal health systems with new organizational arrangements. In fact, poor coordination of care is often a major obstacle for patients who access to health services. This adds on concern to the increasing demand for health and the greater proportion of healthcare expenditure induced by aging and chronic multiple comorbidity of patients. IC therefore sets itself the ambitious goal of harmonizing and optimizing patient care, both physical-mental and social, in order to obtain a continuous multi-organizational assistance. Although the principles on which IC is based are intuitive and simple, its extensive application is complicated and difficult to achieve. Within this article, we first try to define the concept of IC through a general review of the scientific literature on the subject. Then, we analyze the main economic and political criticalities of IC. Finally, we try to suggest recommendations about IC that can be extended to the health services of the member countries of the European Union.

Telemedicine for Children With Medical Complexity: A Randomized Clinical Trial.

BACKGROUND: Telemedicine is widely used but has uncertain value. We assessed telemedicine to further improve outcomes and reduce costs of comprehensive care (CC) for medically complex children. METHODS: We conducted a single-center randomized clinical trial comparing telemedicine with CC relative to CC alone for medically complex children in reducing care days outside the home (clinic, emergency department, or hospital; primary outcome), rate of children developing serious illnesses (causing death, ICU admission, or hospital stay >7 days), and health system costs. We used intent-to-treat Bayesian analyses with neutral prior assuming no benefit. All participants received CC, which included 24/7 phone access to primary care providers (PCPs), low patient-to-PCP ratio, and hospital consultation from PCPs. The telemedicine group also received remote audiovisual communication with the PCPs. RESULTS: Between August 22, 2018, and March 23, 2020, we randomly assigned 422 medically complex children (209 to CC with telemedicine and 213 to CC alone) before meeting predefined stopping rules. The probability of a reduction with CC with telemedicine versus CC alone was 99% for care days outside the home (12.94 vs 16.94 per child-year; Bayesian rate ratio, 0.80 [95% credible interval, 0.66-0.98]), 95% for rate of children with a serious illness (0.29 vs 0.62 per child-year; rate ratio, 0.68 [0.43-1.07]) and 91% for mean total health system costs (US$33 718 vs US$41 281 per child-year; Bayesian cost ratio, 0.85 [0.67-1.08]). CONCLUSION: The addition of telemedicine to CC likely reduced care days outside the home, serious illnesses, other adverse outcomes, and health care costs for medically complex children.

Cost-minimization analysis comparing eltrombopag vs romiplostim for adults with chronic immune thrombocytopenia.

BACKGROUND: Promacta (eltrombopag; EPAG) and Nplate (romiplostim; ROMI) have not been compared in head-to-head trials for treatment of chronic immune thrombocytopenia (cITP); however, indirect treatment comparisons have indicated similar efficacy and safety outcomes, and the drugs are generally accepted as therapeutic alternatives. OBJECTIVE: To determine which of the 2 therapies would result in the lowest overall cost from a US health plan perspective, under the assumption of equivalent clinical efficacy and safety. METHODS: A cost-minimization model was developed in Microsoft Excel. The model incorporated only costs that differ between the treatments, including drug acquisition, administration, and monitoring costs, over a 52-week horizon. Average dosing for EPAG and ROMI was taken from the long-term EXTEND trial and from a published metaanalysis of 14 clinical trials, respectively. ROMI is injectable and EPAG is oral, so only ROMI had administration costs. The model assumed patients used 25 mg EPAG tablets and the 250 µg vial size of ROMI. ROMI wastage was included in drug acquisition costs by rounding up average dose to the nearest whole vial. Monitoring requirements were determined from US prescribing information, with platelet monitoring assumed equal, and hepatic panel testing every 4 weeks for EPAG. The model was adjustable to commercial, Medicare, and Medicaid plan perspectives, with optional inclusion of drug wastage, monitoring, or administration costs. RESULTS: The base case used a commercial plan perspective, with average dosing of 51.5 mg/day for EPAG and 4.20 µg/kg/week for ROMI. The analysis found a cost difference per treated patient of $64,770 in favor of EPAG on an annual basis. Breakdown by unique costs for EPAG included drug-acquisition cost of $123,135 and monitoring cost of $705. Breakdown by unique costs for ROMI included drug-acquisition cost of $183,234, with wastage of $63,179 and administration cost of $5,377. Based on a hypothetical commercial plan with 1 million members and an estimated 11 patients with cITP receiving ROMI, potential annual savings for switching all patients from ROMI to EPAG is $712,473 or $0.06 per member per month. EPAG remained the less costly option for all plan types and assumptions. A sensitivity analysis found that the result was most sensitive to drug pricing and wastage inputs. CONCLUSIONS: Because of lower drug-acquisition costs (including drug wastage) and administration costs, treatment of cITP with EPAG is associated with a lower net cost per patient than ROMI. DISCLOSURES: This study was funded by Novartis Pharmaceuticals Corporation. Proudman, Lucas, and Nellesen are employees of Analysis Group, Inc., which received funding from Novartis Pharmaceuticals Corporation to conduct this study. Patwardhan was employed by Novartis Pharmaceuticals Corporation at the time of this study; Allen is an employee of Novartis. This research was presented as an e-poster at the AMCP 2020 Virtual, April 2020.

Outcomes of a randomized quality improvement trial for high-risk Veterans in year two.

OBJECTIVE: The Veterans Health Administration (VHA) conducted a randomized quality improvement evaluation to determine whether augmenting patient-centered medical homes with Primary care Intensive Management (PIM) decreased utilization of acute care and health care costs among patients at high risk for hospitalization. PIM was cost-neutral in the first year; we analyzed changes in utilization and costs in the second year. DATA SOURCES: VHA administrative data for five demonstration sites from August 2013 to March 2019. DATA SOURCES: Administrative data extracted from VHA's Corporate Data Warehouse. STUDY DESIGN: Veterans with a risk of 90-day hospitalization in the top 10th percentile and recent hospitalization or emergency department (ED) visit were randomly assigned to usual primary care vs primary care augmented by PIM. PIM included interdisciplinary teams, comprehensive patient assessment, intensive case management, and care coordination services. We compared the change in mean VHA inpatient and outpatient utilization and costs (including PIM expenses) per patient for the 12-month period before randomization and 13-24 months after randomization for PIM vs usual care using difference-in-differences. PRINCIPAL FINDINGS: Both PIM patients (n = 1902) and usual care patients (n = 1882) had a mean of 5.6 chronic conditions. PIM patients had a greater number of primary care visits compared to those in usual care (mean 4.6 visits/patient/year vs 3.7 visits/patient/year, p < 0.05), but ED visits (p = 0.45) and hospitalizations (p = 0.95) were not significantly different. We found a small relative increase in outpatient costs among PIM patients compared to those in usual care (mean difference + $928/patient/year, p = 0.053), but no significant differences in mean inpatient costs (+$245/patient/year, p = 0.97). Total mean health care costs were similar between the two groups during the second year (mean difference + $1479/patient/year, p = 0.73). CONCLUSIONS: Approaches that target patients solely based on the high risk of hospitalization are unlikely to reduce acute care use or total costs in VHA, which already offers patient-centered medical homes.

A Head-to-Head Comparison of the Standard Quality-Adjusted Life Year Model With the Annual Profile Model.

OBJECTIVES: The standard quality-adjusted life year (QALY) model (SQM) assumes time-utility independence within constant health states and additive independence when health varies over time. The validity of SQM has been challenged through reported violations of these assumptions. An alternative approach that relaxes these assumptions is to assign a single valuation to an entire health profile: an integral assessment of disease severity over time. Here, we compare SQM with the annual profile model (APM) and test SQM for additive independence. METHODS: Eighty-two respondents valued 6 episodic conditions, including 4 of short duration, with SQM and APM, using the time trade-off method. Inter-rater reliability was assessed using intraclass correlation coefficients. Face validity was tested by asking respondents how well they were able to imagine the health states under SQM and APM. We calculated SQM QALY values for a 1-year time period, allowing for a direct comparison with APM values. For the short-term conditions we expected higher QALY values for SQM, violating additive independence. RESULTS: APM showed higher interrater reliability (intraclass correlation coefficient of 0.53 vs 0.18, respectively) and better face validity than SQM, with 6% (APM) vs 21% (SQM) of all respondents reporting difficulties. Additive independence of SQM was violated in 5 of the 6 conditions (including the 4 short duration health states), with higher QALY values under SQM (mean difference 0.04). CONCLUSION: The impact of short-term conditions is systematically underestimated under SQM when compared to a health profile model. APM is a less restrictive model and demonstrates better validity.

Biomarkers-based personalized follow-up in chronic heart failure improves patient's outcomes and reduces care associate cost.

BACKGROUND: Heart failure (HF) is a major and growing medical and economic problem, with high prevalence and incidence rates worldwide. Cardiac Biomarker is emerging as a novel tool for improving management of patients with HF with a reduced left ventricular ejection fraction (HFrEF). METHODS: This is a before and after interventional study, that assesses the impact of a personalized follow-up procedure for HF on patient's outcomes and care associated cost, based on a clinical model of risk stratification and personalized management according to that risk. A total of 192 patients were enrolled and studied before the intervention and again after the intervention. The primary objective was the rate of readmissions, due to a HF. Secondary outcome compared the rate of ED visits and quality of life improvement assessed by the number of patients who had reduced NYHA score. A cost-analysis was also performed on these data. RESULTS: Admission rates significantly decreased by 19.8% after the intervention (from 30.2 to 10.4), the total hospital admissions were reduced by 32 (from 78 to 46) and the total length of stay was reduced by 7 days (from 15 to 9 days). The rate of ED visits was reduced by 44% (from 64 to 20). Thirty-one percent of patients had an improved functional class score after the intervention, whereas only 7.8% got worse. The overall cost saving associated with the intervention was € 72,769 per patient (from € 201,189 to € 128,420) and €139,717.65 for the whole group over 1 year. CONCLUSIONS: A personalized follow-up of HF patients led to important outcome benefits and resulted in cost savings, mainly due to the reduction of patient hospitalization readmissions and a significant reduction of care-associated costs, suggesting that greater attention should be given to this high-risk cohort to minimize the risk of hospitalization readmissions.

Geographic Variations in Healthcare Utilization and Expenditure for Chronic Rhinosinusitis: A Population-Based Approach.

OBJECTIVES/HYPOTHESIS: Chronic rhinosinusitis (CRS) is a common and costly health problem in the United States. A better understanding of healthcare resource utilization (HCRU) and healthcare expenditure (HCE) pertaining to CRS is required. The objective of this study is to investigate geographic variations in HCRU and HCE for CRS. STUDY TYPE/DESIGN: Retrospective study of administrative database. METHODS: Patients meeting pre-defined diagnostic criteria for CRS with continuous 1-year pre-index and 2-year post-index data were identified on IBM® Marketscan Research Databases over a 5-year period (2013-2017). Data pertaining to demographics, HCRU, and HCE were analyzed according to geographic region. Multivariable generalized linear models accounted for age, sex, baseline medication utilization, and co-morbidities. RESULTS: About 237,969 patients were included. Antibiotics were the most commonly prescribed medication (95%). Surgery rate (11%), immunotherapy (9.2%), oral steroid use (66%), and antibiotic utilization (mean 6.3 prescriptions) were highest in the South. However, visits with an otolaryngologist were considerably higher in the Northeast (62%). The Northeast region had the highest mean HCE ($2,449), which was 13% greater than HCE for the North Central region ($2,172). HCRU and HCE were higher in urban areas across all metrics, with 2-year HCE being 18% greater in urban areas ($2,374 vs. $2,019). Significant geographic variation in HCE was observed even after adjusting for covariates. CONCLUSION: Significant geographic variations in HCRU and HCE exist for CRS even after adjusting for covariates. Future studies are needed to help direct quality improvement and cost-saving efforts as well as efficient resource allocation in an era of value-based care. LEVEL OF EVIDENCE: 4 Laryngoscope, 131:2641-2648, 2021.

Translation and validation of the Traditional Chinese version of the COmprehensive Score for financial Toxicity-Functional Assessment of Chronic Illness Therapy (Version 2).

BACKGROUND: Cancer patients often experience severe financial distress due to the high cost of their treatment, and strategies are needed to objectively measure this financial distress. The COmprehensive Score for financial Toxicity-Functional Assessment of Chronic Illness Therapy (COST-FACIT) is one instrument used to measure such financial distress. This study aimed to translate the COST-FACIT (Version 2) [COST-FACIT-v2] instrument into traditional Chinese (COST-FACIT-v2 [TC]) and evaluate its psychometric properties. METHODS: The Functional Assessment of Chronic Illness Therapy (FACIT) translation method was adopted. The translated version was reviewed by an expert panel and by 20 cancer patients for content validity and face validity, respectively, and 640 cancer patients, recruited from three oncology departments, completed the translated scale. Its reliability was evaluated in terms of internal consistency and test-retest reliability. Confirmatory factor analysis has been used to evaluate the one- and two-factor structures of the instrument reported in the literature. The convergent validity was examined by the correlation with health-related quality of life (HRQoL) and psychological distress. Known-group validity was examined by the difference in the COST-FACIT-v2 (TC) total mean score between groups with different income levels and frequency of health care service use. RESULTS: The COST-FACIT-v2 (TC) showed good content and face validity and demonstrated high internal consistency (Cronbach's alpha, 0.86) and acceptable test-retest reliability (intraclass correlation coefficient, 0.71). Confirmatory factor analysis showed that the one- and two-factor structures of the instrument that have been reported in the literature could not be satisfactorily fitted to the data. Psychological distress correlated significantly with the COST-FACIT-v2 (TC) score (r = 0.47; p < 0.001). HRQOL showed a weak to moderate negative correlation with the COST-FACIT-v2 (TC) score (r = - 0.23 to - 0.46; p < 0.001). Significant differences were seen among the COST-FACIT-v2 (TC) scores obtained in groups of different income level and frequency of health care service use. CONCLUSIONS: The COST-FACIT-v2 (TC) showed some desirable psychometric properties to support its validity and reliability for assessing cancer patients' level of financial toxicity.

Accountable Care Organizations during Covid-19: Routine care for older adults with multiple chronic conditions.

The COVID-19 pandemic threatens the health and well-being of older adults with multiple chronic conditions. To date, limited information exists about how Accountable Care Organizations (ACOs) are adapting to manage these patients. We surveyed 78 Medicare ACOs about their concerns for these patients during the pandemic and strategies they are employing to address them. ACOs expressed major concerns about disruptions to necessary care for this population, including the accessibility of social services and long-term care services. While certain strategies like virtual primary and specialty care visits were being used by nearly all ACOs, other services such as virtual social services, home medication delivery, and remote lab monitoring were far less commonly accessible. ACOs expressed that support for telehealth services, investment in remote monitoring capabilities, and funding for new, targeted care innovation initiatives would help them better care for vulnerable patients during this pandemic.