7 research outputs found
Assessing the long-term effectiveness of interferon-beta and glatiramer acetate in multiple sclerosis: final 10-year results from the UK multiple sclerosis risk-sharing scheme
Background Because multiple sclerosis (MS) is a chronic disease causing disability over decades, it is crucial to know if the short-term effects of disease-modifying therapies reported in randomised controlled trials reduce long-term disability. This 10-year prospective observational study of disability outcomes (Expanded Disability Status Scale (EDSS) and utility) was set up, in conjunction with a risk-sharing agreement between payers and producers, to investigate this issue.
Methods The outcomes of the UK treated patients were compared with a modelled untreated control based on the British Columbia MS data set to assess the long-term effectiveness of these treatments. Two complementary analysis models were used: a multilevel model (MLM) and a continuous Markov model.
Results 4862 patients with MS were eligible for the primary analysis (mean and median follow-up times 8.7 and 10 years). EDSS worsening was reduced by 28% (MLM), 7% (Markov) and 24% time-adjusted Markov in the total cohort, and by 31% (MLM) and 14% (Markov) for relapsing remitting patients. The utility worsening was reduced by 23%–24% in the total cohort and by 24%–31% in the RR patients depending on the model used. All sensitivity analyses showed a treatment effect. There was a 4-year (CI 2.7 to 5.3) delay to EDSS 6.0. An apparent waning of treatment effect with time was seen. Subgroup analyses suggested better treatment effects in those treated earlier and with lower EDSS scores.
Conclusions This study supports a beneficial effect on long-term disability with first-line MS disease-modifying treatments, which is clinically meaningful. However the waning effect noted requires further study
Effectiveness and cost-effectiveness of interferon beta and glatiramer acetate in the UK Multiple Sclerosis Risk Sharing Scheme at 6 years:a clinical cohort study with natural history comparator
BACKGROUND: In 2002, the UK's National Institute for Clinical Excellence (NICE) concluded that interferon beta and glatiramer acetate would be cost effective as disease-modifying therapies (DMTs) for multiple sclerosis only if the short-term disability benefits reported in clinical trials were maintained. The UK Multiple Sclerosis Risk Sharing Scheme (RSS) was established to assess whether disability progression was consistent with a cost-effectiveness target of £36 000 per quality-adjusted life-year projected over 20 years. We aimed to evaluate the long-term effectiveness and cost-effectiveness of these DMTs by comparing a cohort of patients with relapsing-remitting multiple sclerosis enrolled in the UK RSS with a natural history cohort from British Columbia, Canada. METHODS: In our clinical cohort we included patients starting a DMT who were enrolled in the UK RSS who had relapsing multiple sclerosis at baseline and had at least one further clinical assessment. In our control cohort we included patients in the British Columbia multiple sclerosis database (BCMS; data collection 1980-96) who met the same eligibility criteria as for the RSS cohort. We compared disability progression at 6 years for RSS patients with untreated progression modelled from BCMS patients using continuous Markov and multilevel models. The primary outcomes were the progression ratio (treated vs untreated) measured both in Expanded Disability Status Scale (EDSS) score and utility. A ratio of less than 100% for EDSS implied slower than expected progression on treatment compared with off treatment; a utility ratio of 62% or less implied that the DMTs were cost effective. FINDINGS: 5610 patients starting a DMT were enrolled in the UK RSS between Jan 14, 2002, and July 13, 2005 (72 sites), of whom 4137 were included in our clinical cohort. We included 898 BCMS patients in the control cohort who met the RSS inclusion criteria and had at least one EDSS score after baseline. RSS patients had a mean follow-up of 5·1 years (SD 1·4). Both models showed slower EDSS progression than predicted for untreated controls (Markov model, 75·8% [95% CI 71·4-80·2]; multilevel model, 60·0% [56·6-63·4]). Utility ratios were consistent with cost-effectiveness (Markov model, 58·5% [95% CI 54·2-62·8]; multilevel model, 57·1% [53·0-61·2]). INTERPRETATION: Findings from this large observational study of treatment with interferon beta or glatiramer acetate provide evidence that their effects on disability in patients with relapsing-remitting multiple sclerosis are maintained and cost effective over 6 years. Similar modelling approaches could be applied to other chronic diseases for which long-term controlled trials are not feasible. FUNDING: Health Departments of England, Wales, Scotland, and Northern Ireland, Biogen Idec, Merck Serono, Bayer Schering Pharmaceuticals, Teva Pharmaceuticals Industries, UK National Institute of Health Research's Health Technology Assessment Programme
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Estimating the epidemiological impact of reaching the objectives of the Florida integrated HIV prevention and care plan in Miami-Dade County
The US Ending the HIV Epidemic (EHE) initiative aims to reduce national HIV incidence 90% by 2030 and to address the disproportionate burden of HIV among different racial/ethnic populations. Florida's state-wide 2022–2026 Integrated HIV Prevention and Care Plan outlines objectives for reaching EHE goals. In Miami-Dade County, we determined the epidemiological impact of achieving the integrated plan's objectives individually and jointly.
We adapted an HIV transmission model calibrated to Miami-Dade County adjusting access to HIV testing, pre-exposure prophylaxis (PrEP) and antiretroviral treatment to model the effects of each objective between 2022 and 2030. We compared two service scale-up approaches: (a) scale-up proportionally to existing racial/ethnic group access levels, and (b) scale-up according to new diagnoses across racial/ethnic groups (equity-oriented). We estimated reductions in new HIV infections by each objective and approach, compared to the EHE's incidence reduction target.
The single most influential strategy was reducing new HIV diagnoses in Hispanic/Latinx men who have sex with men through increased PrEP uptake, resulting in 907/2444 (37.1%) fewer annual new HIV infections in 2030. Achieving all objectives jointly would result in 1537/2444 (62.9%) and 1553/2444 (63.5%) fewer annual new HIV infections with the proportional and equity-oriented approaches, respectively.
Achieving the goals of Florida's integrated care plan would significantly reduce HIV incidence in Miami-Dade County; however, further efforts are required to achieve EHE targets. Structural changes in service delivery and a focus on effective implementation of available interventions to address racial/ethnic disparities will be crucial to ending the HIV epidemic.
This work was supported by the National Institutes of Health/National Institute on Drug Abuse grant no. R01-DA041747
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Estimating the epidemiological impact of reaching the objectives of the Florida integrated HIV prevention and care plan in Miami-Dade CountyResearch in context
Background: The US Ending the HIV Epidemic (EHE) initiative aims to reduce national HIV incidence 90% by 2030 and to address the disproportionate burden of HIV among different racial/ethnic populations. Florida's state-wide 2022–2026 Integrated HIV Prevention and Care Plan outlines objectives for reaching EHE goals. In Miami-Dade County, we determined the epidemiological impact of achieving the integrated plan's objectives individually and jointly. Methods: We adapted an HIV transmission model calibrated to Miami-Dade County adjusting access to HIV testing, pre-exposure prophylaxis (PrEP) and antiretroviral treatment to model the effects of each objective between 2022 and 2030. We compared two service scale-up approaches: (a) scale-up proportionally to existing racial/ethnic group access levels, and (b) scale-up according to new diagnoses across racial/ethnic groups (equity-oriented). We estimated reductions in new HIV infections by each objective and approach, compared to the EHE's incidence reduction target. Findings: The single most influential strategy was reducing new HIV diagnoses in Hispanic/Latinx men who have sex with men through increased PrEP uptake, resulting in 907/2444 (37.1%) fewer annual new HIV infections in 2030. Achieving all objectives jointly would result in 1537/2444 (62.9%) and 1553/2444 (63.5%) fewer annual new HIV infections with the proportional and equity-oriented approaches, respectively. Interpretation: Achieving the goals of Florida's integrated care plan would significantly reduce HIV incidence in Miami-Dade County; however, further efforts are required to achieve EHE targets. Structural changes in service delivery and a focus on effective implementation of available interventions to address racial/ethnic disparities will be crucial to ending the HIV epidemic. Funding: This work was supported by the National Institutes of Health/National Institute on Drug Abuse grant no. R01-DA041747
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"Ending the Epidemic" Will Not Happen Without Addressing Racial/Ethnic Disparities in the United States Human Immunodeficiency Virus Epidemic
We estimated human immunodeficiency virus incidence and incidence rate ratios (IRRs) for black and Hispanic vs white populations in 6 cities in the United States (2020-2030). Large reductions in incidence are possible, but without elimination of disparities in healthcare access, we found that wide disparities persisted for black compared with white populations in particular (lowest IRR, 1.69 [95% credible interval, 1.19-2.30])
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"Ending the Epidemic" Will Not Happen Without Addressing Racial/Ethnic Disparities in the United States Human Immunodeficiency Virus Epidemic.
We estimated human immunodeficiency virus incidence and incidence rate ratios (IRRs) for black and Hispanic vs white populations in 6 cities in the United States (2020-2030). Large reductions in incidence are possible, but without elimination of disparities in healthcare access, we found that wide disparities persisted for black compared with white populations in particular (lowest IRR, 1.69 [95% credible interval, 1.19-2.30])