Your browser doesn't support javascript.
loading
Show: 20 | 50 | 100
Results 1 - 20 de 135
Filter
1.
J Manag Care Spec Pharm ; 30(8): 773-781, 2024 Aug.
Article in English | MEDLINE | ID: mdl-38717044

ABSTRACT

BACKGROUND: Lupus nephritis (LN) is a severe manifestation of systemic lupus erythematosus; up to 30% of patients with LN will develop end-stage kidney disease (ESKD). One of the main treatment goals for LN is preservation of kidney function, with early decreases in proteinuria associated with improved long-term outcomes. Voclosporin, a second-generation calcineurin inhibitor, was approved in the United States in 2021 for the treatment of active LN combined with background immunosuppression. The AURORA 1 study found that the use of voclosporin with low doses of mycophenolate mofetil and glucocorticoids yielded significant reductions in proteinuria. The AURORA 2 study showed long-term efficacy and safety of voclosporin over a 3-year period with kidney function preservation. The Institute for Clinical and Economic Review (ICER) is a nonprofit organization that evaluates medical evidence to help improve patient outcomes and control costs. In 2021, ICER published an economic model to estimate the impact and cost-effectiveness of LN therapies. From a US health care perspective, voclosporin was cost-effective at $149,260 per quality-adjusted life-year (QALY) and $131,528 per equal value of life-years gained (evLYG). At the time of the LN cost-effectiveness model (CEM) development, voclosporin was not yet approved in the United States and the cost of treating patients with LN with ESKD was not captured in the literature. OBJECTIVE: To evaluate the cost-effectiveness of voclosporin given the emergence of new data. METHODS: The LN CEM uses a short-term trial-based Markov model and long-term extrapolation using partitioned survival modeling data assuming adults with LN start with active disease, transitioning to complete or partial renal response, kidney failure, or death. In the current analysis, clinical data for voclosporin, duration of voclosporin treatment for nonresponders, and drug costs reflecting the 2023 price of voclosporin were updated. Additionally, health care payer costs of disease management were incorporated based on real-world claims data on the costs of treating patients with LN. RESULTS: Using the LN CEM with inputs reflecting the latest and most relevant evidence, the incremental cost of voclosporin per QALY was $88,076 and per evLYG was $77,643. For a subpopulation of Black, Hispanic, and Latino patients, the incremental cost of voclosporin per QALY was $77,435 and per evLYG was $67,828. CONCLUSIONS: Following the inclusion of updated data in the cost-effectiveness analysis, voclosporin remains a cost-effective therapy for the treatment of active LN including in a Black, Hispanic, and Latino subpopulation, substantially below the ICER willingness-to-pay threshold of $150,000/QALY.


Subject(s)
Cost-Benefit Analysis , Cyclosporine , Immunosuppressive Agents , Lupus Nephritis , Humans , Cyclosporine/therapeutic use , Cyclosporine/economics , United States , Lupus Nephritis/drug therapy , Lupus Nephritis/economics , Immunosuppressive Agents/therapeutic use , Immunosuppressive Agents/economics , Quality-Adjusted Life Years , Models, Economic , Drug Costs , Treatment Outcome
2.
Value Health Reg Issues ; 42: 100983, 2024 Jul.
Article in English | MEDLINE | ID: mdl-38663057

ABSTRACT

OBJECTIVES: To evaluate cost-effective pharmacological treatment in adult kidney transplant recipients from the perspective of the Colombian health system. METHODS: A decision tree model for the induction phase and a Markov model for the maintenance phase were built. A review of the clinical literature was conducted to extract probabilities, and the life-years were used as the outcome. Costs were calculated using the administrative databases. The evaluating treatment schemes are organized by groups of evidence with direct comparisons. RESULTS: In the induction phase, anti-thymocyte immunoglobulin+ methylprednisolone is dominant, more effective, and less expensive, compared with basiliximab+methylprednisolone. In the maintenance phase, azathioprine (AZA) is dominant in contrast to mycophenolate mofetil (MFM) both with cyclosporine (CIC)+ corticosteroids (CE); CIC is dominant relative to sirolimus (SIR) and tacrolimus (TAC) (both with MFM+CE or AZA+CE), and TAC is dominant compared with SIR (in addition with MFM+CE or mycophenolate sodium [MFS]+CE); MFM is dominant in relation to MFS and everolimus, and SIR is more effective MFM but it does not exceed the threshold (in sum with TAC+CE); MFS and MFM are dominant relative to everolimus, and SIR is more effective than MFM, but it does not exceed the threshold (in addiction with CIC+CE); MFM is dominant in relation to TAC (in sum with SIR+CE), and CIC+AZA+CE is dominant in relation to TAC+MFM+CE. CONCLUSIONS: The base-case results for all evidence groups are consistent with the different sensitivity analyses.


Subject(s)
Cost-Benefit Analysis , Immunosuppressive Agents , Kidney Transplantation , Humans , Kidney Transplantation/economics , Colombia , Cost-Benefit Analysis/methods , Cost-Benefit Analysis/statistics & numerical data , Immunosuppressive Agents/economics , Immunosuppressive Agents/therapeutic use , Adult , Cyclosporine/therapeutic use , Cyclosporine/economics , Mycophenolic Acid/therapeutic use , Mycophenolic Acid/economics , Tacrolimus/economics , Tacrolimus/therapeutic use , Azathioprine/therapeutic use , Azathioprine/economics , Markov Chains , Decision Trees , Graft Rejection/prevention & control , Graft Rejection/economics , Sirolimus/therapeutic use , Sirolimus/economics , Transplant Recipients/statistics & numerical data , Adrenal Cortex Hormones/therapeutic use , Adrenal Cortex Hormones/economics , Cost-Effectiveness Analysis
3.
Clin J Am Soc Nephrol ; 17(3): 385-394, 2022 03.
Article in English | MEDLINE | ID: mdl-35115304

ABSTRACT

BACKGROUND AND OBJECTIVES: Despite existing therapies, people with lupus nephritis progress to kidney failure and have reduced life expectancy. Belimumab and voclosporin are two new disease-modifying therapies recently approved for the treatment of lupus nephritis. DESIGN, SETTING, PARTICIPANTS, & MEASUREMENTS: A de novo economic model was developed to estimate the cost-effectiveness of these therapies, including the following health states: "complete response," "partial response," and "active disease" defined by eGFR and proteinuria changes, kidney failure, and death. Short-term data and mean cohort characteristics were sourced from pivotal clinical trials of belimumab (the Belimumab International Study in Lupus Nephritis) and voclosporin (the Aurinia Urinary Protection Reduction Active-Lupus with Voclosporin trial and Aurinia Renal Response in Active Lupus With Voclosporin). Risk of mortality and kidney failure were on the basis of survival modeling using published Kaplan-Meier data. Each drug was compared with the standard of care as represented by the comparator arm in its respective pivotal trial(s) using US health care sector perspective, with a societal perspective also explored. RESULTS: In the health care perspective probabilistic analysis, the incremental cost-effectiveness ratio for belimumab compared with its control arm was estimated to be approximately $95,000 per quality-adjusted life year. The corresponding incremental ratio for voclosporin compared with its control arm was approximately $150,000 per quality-adjusted life year. Compared with their respective standard care arms, the probabilities of belimumab and voclosporin being cost effective at a threshold of $150,000 per quality-adjusted life year were 69% and 49%, respectively. Cost-effectiveness was dependent on assumptions made regarding survival in response states, costs and utilities in active disease, and the utilities in response states. In the analysis from a societal perspective, the incremental ratio for belimumab was estimated to be approximately $66,000 per quality-adjusted life year, and the incremental ratio for voclosporin was estimated to be approximately $133,000 per quality-adjusted life year. CONCLUSIONS: Compared with their respective standard care arms, belimumab but not voclosporin met willingness-to-pay thresholds of $100,000 per quality-adjusted life year. Despite potential clinical superiority in the informing trials, there remains high uncertainty around the cost-effectiveness of voclosporin.


Subject(s)
Antibodies, Monoclonal, Humanized , Cyclosporine , Immunosuppressive Agents , Lupus Nephritis , Antibodies, Monoclonal, Humanized/economics , Antibodies, Monoclonal, Humanized/therapeutic use , Clinical Trials as Topic , Cost-Benefit Analysis , Cyclosporine/economics , Cyclosporine/therapeutic use , Female , Humans , Immunosuppressive Agents/economics , Immunosuppressive Agents/therapeutic use , Lupus Nephritis/drug therapy , Male , Quality-Adjusted Life Years , Renal Insufficiency , United States
4.
J Manag Care Spec Pharm ; 27(10): 1495-1499, 2021 Oct.
Article in English | MEDLINE | ID: mdl-34595943

ABSTRACT

DISCLOSURES: Funding for this summary was contributed by Arnold Ventures, California Health Care Foundation, The Donaghue Foundation, Harvard Pilgrim Health Care, and Kaiser Foundation Health Plan to the Institute for Clinical and Economic Review (ICER), an independent organization that evaluates the evidence on the value of health care interventions. ICER's annual policy summit is supported by dues from AbbVie, Aetna, America's Health Insurance Plans, Anthem, Alnylam, AstraZeneca, Biogen, Blue Shield of CA, Boehringer-Ingelheim, Cambia Health Services, CVS, Editas, Evolve Pharmacy, Express Scripts, Genentech/Roche, GlaxoSmithKline, Harvard Pilgrim, Health Care Service Corporation, HealthFirst, Health Partners, Humana, Johnson & Johnson (Janssen), Kaiser Permanente, LEO Pharma, Mallinckrodt, Merck, Novartis, National Pharmaceutical Council, Pfizer, Premera, Prime Therapeutics, Regeneron, Sanofi, Spark Therapeutics, uniQure, and United Healthcare. Pearson is employed by ICER. Through their affiliated institutions, Tice, Mandrik, Thokala, and Fotheringham received funding from ICER for the work described in this summary.


Subject(s)
Antibodies, Monoclonal, Humanized/economics , Cyclosporine/economics , Immunosuppressive Agents/economics , Lupus Nephritis/drug therapy , Antibodies, Monoclonal, Humanized/therapeutic use , Cost-Benefit Analysis , Cyclosporine/therapeutic use , Humans , Immunosuppressive Agents/therapeutic use , Models, Economic
6.
Br J Dermatol ; 179(6): 1297-1306, 2018 12.
Article in English | MEDLINE | ID: mdl-29727479

ABSTRACT

BACKGROUND: Oral systemic immunomodulatory medication is regularly used off-licence in children with severe atopic eczema. However, there is no firm evidence regarding the effectiveness, safety, cost-effectiveness and impact on quality of life from an adequately powered randomized controlled trial (RCT) using systemic medication in children. OBJECTIVES: To assess whether there is a difference in the speed of onset, effectiveness, side-effect profile and reduction in flares post-treatment between ciclosporin (CyA) and methotrexate (MTX), and also the cost-effectiveness of the drugs. Treatment impact on quality of life will also be examined in addition to whether FLG genotype influences treatment response. In addition, the trial studies the immune-metabolic effects of CyA and MTX. METHODS: Multicentre, parallel group, assessor-blind, pragmatic RCT of 36 weeks' duration with a 24-week follow-up period. In total, 102 children aged 2-16 years with moderate-to-severe atopic eczema, unresponsive to topical treatment will be randomized (1 : 1) to receive MTX (0·4 mg kg-1 per week) or CyA (4 mg kg-1 per day). RESULTS: The trial has two primary outcomes: change from baseline to 12 weeks in Objective Severity Scoring of Atopic Dermatitis (o-SCORAD) and time to first significant flare following treatment cessation. CONCLUSIONS: This trial addresses important therapeutic questions, highlighted in systematic reviews and treatment guidelines for atopic eczema. The trial design is pragmatic to reflect current clinical practice.


Subject(s)
Cost-Benefit Analysis , Cyclosporine/administration & dosage , Dermatitis, Atopic/drug therapy , Dermatologic Agents/administration & dosage , Methotrexate/administration & dosage , Administration, Oral , Adolescent , Child , Child, Preschool , Cyclosporine/adverse effects , Cyclosporine/economics , Dermatitis, Atopic/diagnosis , Dermatitis, Atopic/economics , Dermatitis, Atopic/genetics , Dermatologic Agents/adverse effects , Dermatologic Agents/economics , Female , Filaggrin Proteins , Humans , Intermediate Filament Proteins/genetics , Male , Methotrexate/adverse effects , Methotrexate/economics , Multicenter Studies as Topic , Pragmatic Clinical Trials as Topic , Randomized Controlled Trials as Topic , Severity of Illness Index , Treatment Outcome
7.
Br J Dermatol ; 177(6): 1527-1536, 2017 12.
Article in English | MEDLINE | ID: mdl-28391619

ABSTRACT

BACKGROUND: Pyoderma gangrenosum (PG) is a painful, ulcerating skin disease with poor evidence for management. Prednisolone and ciclosporin are the most commonly used treatments, although not previously compared within a randomized controlled trial (RCT). OBJECTIVES: To compare the cost-effectiveness of ciclosporin and prednisolone-initiated treatment for patients with PG. METHODS: Quality of life (QoL, EuroQoL five dimensions three level questionnaire, EQ-5D-3L) and resource data were collected as part of the STOP GAP trial: a multicentre, parallel-group, observer-blind RCT. Within-trial analysis used bivariate regression of costs and quality-adjusted life years (QALYs), with multiple imputation of missing data, informing a probabilistic assessment of incremental treatment cost-effectiveness from a health service perspective. RESULTS: In the base case analysis, when compared with prednisolone, ciclosporin was cost-effective due to a reduction in costs [net cost: -£1160; 95% confidence interval (CI) -2991 to 672] and improvement in QoL (net QALYs: 0·055; 95% CI 0·018-0·093). However, this finding appears driven by a minority of patients with large lesions (≥ 20 cm2 ) (net cost: -£5310; 95% CI -9729 to -891; net QALYs: 0·077; 95% CI 0·004-0·151). The incremental cost-effectiveness of ciclosporin for the majority of patients with smaller lesions was £23 374/QALY, although the estimate is imprecise: the probability of being cost-effective at a willingness-to-pay of £20 000/QALY was 43%. CONCLUSIONS: Consistent with the clinical findings of the STOP GAP trial, patients with small lesions should receive treatment guided by the side-effect profiles of the drugs and patient preference - neither strategy is clearly a preferred use of National Health Service resources. However, ciclosporin-initiated treatment may be more cost-effective for patients with large lesions.


Subject(s)
Cyclosporine/economics , Dermatologic Agents/economics , Prednisolone/economics , Pyoderma Gangrenosum/economics , Cost-Benefit Analysis , Dermatologic Agents/therapeutic use , Facilities and Services Utilization , Health Resources/economics , Health Resources/statistics & numerical data , Health Status , Humans , Prednisolone/therapeutic use , Pyoderma Gangrenosum/drug therapy , Quality-Adjusted Life Years , Single-Blind Method , State Medicine/economics , United Kingdom
8.
Australas J Dermatol ; 58(1): 30-34, 2017 Feb.
Article in English | MEDLINE | ID: mdl-26344939

ABSTRACT

BACKGROUND/OBJECTIVES: The use of high-cost, off-label, unsubsidised drugs has become valuable in the management of dermatology patients with challenging conditions unresponsive to conventional therapy. Currently, there is no dedicated funding and a paucity of evidence for such drugs. The aim of this audit was to review outcomes and costs. METHODS: A retrospective clinical audit of high-cost off-label dermatology drug applications to the High Cost Drug's Subcommittee was undertaken at a tertiary public hospital in Brisbane, Queensland, between 2002 and 2013. RESULTS: Of 28 applications, 25 were approved. The medications included thalidomide, mycophenolate mofetil, cyclosporin, infliximab, rituximab and adalimumab. Over 70% of patients responded to treatment. Individual annual costs for these medications ranged from $2068 to $36 984. Adverse effects resulted in drug withdrawal in five cases. CONCLUSIONS: Despite the absence of dedicated funding for high-cost drugs and a rigorous committee approval process, most applications were approved, of which >70% benefited from treatment. This audit provides useful clinical experience with off-label use of high-cost drugs in difficult dermatological conditions.


Subject(s)
Dermatologic Agents/economics , Dermatologic Agents/therapeutic use , Off-Label Use , Skin Diseases/drug therapy , Adalimumab/economics , Adalimumab/therapeutic use , Adult , Aged , Aged, 80 and over , Cyclosporine/economics , Cyclosporine/therapeutic use , Dermatology , Female , Humans , Infliximab/economics , Infliximab/therapeutic use , Male , Medical Audit , Middle Aged , Mycophenolic Acid/economics , Mycophenolic Acid/therapeutic use , Queensland , Retrospective Studies , Rituximab/economics , Rituximab/therapeutic use , Thalidomide/economics , Thalidomide/therapeutic use
9.
Lancet Gastroenterol Hepatol ; 1(1): 15-24, 2016 09.
Article in English | MEDLINE | ID: mdl-27595142

ABSTRACT

BACKGROUND: Infliximab and ciclosporin are of similar efficacy in treating acute severe ulcerative colitis, but there has been no comparative evaluation of their relative clinical effectiveness and cost-effectiveness. METHODS: In this mixed methods, open-label, pragmatic randomised trial, we recruited consenting patients aged 18 years or older at 52 district general and teaching hospitals in England, Scotland, and Wales who had been admitted, unscheduled, with severe ulcerative colitis and failed to respond to intravenous hydrocortisone within about 5 days. Patients were randomly allocated (1:1) to receive either infliximab (5 mg/kg intravenous infusion given over 2 h at baseline, and again at 2 weeks and 6 weeks after the first infusion) or ciclosporin (2 mg/kg per day by continuous infusion for up to 7 days, followed by twice-daily tablets delivering 5·5 mg/kg per day for 12 weeks). Randomisation used a web-based password-protected site, with a dynamic algorithm to generate allocations on request, thus protecting against investigator preference or other subversion, while ensuring that each trial group was balanced by centre, which was the only stratification used. Local investigators and participants were aware of the treatment allocated, but the chief investigator and analysts were masked. Analysis was by treatment allocated. The primary outcome was quality-adjusted survival-ie, the area under the curve (AUC) of scores from the Crohn's and Ulcerative Colitis Questionnaire (CUCQ) completed by participants at baseline, 3 months, and 6 months, then every 6 months from 1 year to 3 years. This trial is registered with the ISRCTN Registry, number ISRCTN22663589. FINDINGS: Between June 17, 2010, and Feb 26, 2013, 270 patients were recruited. 135 patients were allocated to the infliximab group and 135 to the ciclosporin group. 121 (90%) patients in each group were included in the analysis of the primary outcome. There was no significant difference between groups in quality-adjusted survival (mean AUC 564·0 [SD 241·9] in the infliximab group vs 587·0 [226·2] in the ciclosporin group; mean adjusted difference 7·9 [95% CI -22·0 to 37·8]; p=0·603). Likewise, there were no significant differences between groups in the secondary outcomes of CUCQ scores, EQ-5D, or SF-6D scores; frequency of colectomy (55 [41%] of 135 patients in the infliximab group vs 65 [48%] of 135 patients in the ciclosporin group; p=0·223); or mean time to colectomy (811 [95% CI 707-912] days in the infliximab group vs 744 [638-850] days in the ciclosporin group; p=0·251). There were no differences in serious adverse reactions (16 reactions in 14 participants receiving infliximab vs ten in nine patients receiving ciclosporin); serious adverse events (21 in 16 patients vs 25 in 17 patients); or deaths (three in the infliximab group vs none in the ciclosporin group). INTERPRETATION: There was no significant difference between ciclosporin and infliximab in clinical effectiveness. FUNDING: NIHR Health Technology Assessment programme.


Subject(s)
Colitis, Ulcerative/drug therapy , Cyclosporine/therapeutic use , Immunosuppressive Agents/therapeutic use , Infliximab/therapeutic use , Adolescent , Adult , Aged , Aged, 80 and over , Area Under Curve , Colitis, Ulcerative/economics , Cost-Benefit Analysis , Cyclosporine/economics , Drug Administration Schedule , Female , Follow-Up Studies , Humans , Hydrocortisone/therapeutic use , Immunosuppressive Agents/economics , Infliximab/economics , Infusions, Intravenous , Male , Middle Aged , Severity of Illness Index , Treatment Outcome , United Kingdom , Young Adult
10.
Health Technol Assess ; 20(44): 1-320, 2016 06.
Article in English | MEDLINE | ID: mdl-27329657

ABSTRACT

BACKGROUND: The efficacy of infliximab and ciclosporin in treating severe ulcerative colitis (UC) is proven, but there has been no comparative evaluation of effectiveness. OBJECTIVE: To compare the clinical effectiveness and cost-effectiveness of infliximab and ciclosporin in treating steroid-resistant acute severe UC. METHOD: Between May 2010 and February 2013 we recruited 270 participants from 52 hospitals in England, Scotland and Wales to an open-label parallel-group, pragmatic randomised trial. Consented patients admitted with severe colitis completed baseline quality-of-life questionnaires before receiving intravenous hydrocortisone. If they failed to respond within about 5 days, and met other inclusion criteria, we invited them to participate and used a web-based adaptive randomisation algorithm to allocate them in equal proportions between 5 mg/kg of intravenous infliximab at 0, 2 and 6 weeks or 2 mg/kg/day of intravenous ciclosporin for 7 days followed by 5.5 mg/kg/day of oral ciclosporin until 12 weeks from randomisation. Further treatment was at the discretion of physicians responsible for clinical management. The primary outcome was quality-adjusted survival (QAS): the area under the curve (AUC) of scores derived from Crohn's and Ulcerative Colitis Questionnaires completed by participants at 3 and 6 months, and then 6-monthly over 1-3 years, more frequently after surgery. Secondary outcomes collected simultaneously included European Quality of Life-5 Dimensions (EQ-5D) scores and NHS resource use to estimate cost-effectiveness. Blinding was possible only for data analysts. We interviewed 20 trial participants and 23 participating professionals. Funded data collection finished in March 2014. Most participants consented to complete annual questionnaires and for us to analyse their routinely collected health data over 10 years. RESULTS: The 135 participants in each group were well matched at baseline. In 121 participants analysed in each group, we found no significant difference between infliximab and ciclosporin in QAS [mean difference in AUC/day 0.0297 favouring ciclosporin, 95% confidence interval (CI) -0.0088 to 0.0682; p = 0.129]; EQ-5D scores (quality-adjusted life-year mean difference 0.021 favouring ciclosporin, 95% CI -0.032 to 0.096; p = 0.350); Short Form questionnaire-6 Dimensions scores (mean difference 0.0051 favouring ciclosporin, 95% CI -0.0250 to 0.0353; p = 0.737). There was no statistically significant difference in colectomy rates [odds ratio (OR) 1.350 favouring infliximab, 95% CI 0.832 to 2.188; p = 0.223]; numbers of serious adverse reactions (event ratio = 0.938 favouring ciclosporin, 95% CI 0.590 to 1.493; p = 0.788); participants with serious adverse reactions (OR 0.660 favouring ciclosporin, 95% CI 0.282 to 1.546; p = 0.338); numbers of serious adverse events (event ratio 1.075 favouring infliximab, 95% CI 0.603 to 1.917; p = 0.807); participants with serious adverse events (OR 0.999 favouring infliximab, 95% CI 0.473 to 2.114; p = 0.998); deaths (all three who died received infliximab; p = 0.247) or concomitant use of immunosuppressants. The lower cost of ciclosporin led to lower total NHS costs (mean difference -£5632, 95% CI -£8305 to -£2773; p < 0.001). Interviews highlighted the debilitating effect of UC; participants were more positive about infliximab than ciclosporin. Professionals reported advantages and disadvantages with both drugs, but nurses disliked the intravenous ciclosporin. CONCLUSIONS: Total cost to the NHS was considerably higher for infliximab than ciclosporin. Nevertheless, there was no significant difference between the two drugs in clinical effectiveness, colectomy rates, incidence of SAEs or reactions, or mortality, when measured 1-3 years post treatment. To assess long-term outcome participants will be followed up for 10 years post randomisation, using questionnaires and routinely collected data. Further studies will be needed to evaluate the efficacy and effectiveness of new anti-tumour necrosis factor drugs and formulations of ciclosporin. TRIAL REGISTRATION: Current Controlled Trials ISRCTN22663589. FUNDING: This project was funded by the NIHR Health Technology Assessment programme and will be published in full in Health Technology Assessment; Vol. 20, No. 44. See the NIHR Journals Library website for further project information.


Subject(s)
Colitis, Ulcerative/drug therapy , Cyclosporine/economics , Cyclosporine/therapeutic use , Immunosuppressive Agents/economics , Immunosuppressive Agents/therapeutic use , Infliximab/economics , Infliximab/therapeutic use , Adult , Colitis, Ulcerative/mortality , Colitis, Ulcerative/surgery , Cost-Benefit Analysis , Cyclosporine/administration & dosage , Cyclosporine/adverse effects , Female , Humans , Immunosuppressive Agents/administration & dosage , Immunosuppressive Agents/adverse effects , Infliximab/administration & dosage , Infliximab/adverse effects , Male , Middle Aged , Models, Econometric , Quality of Life , Quality-Adjusted Life Years , State Medicine , United Kingdom
11.
J Med Econ ; 19(10): 995-1002, 2016 Oct.
Article in English | MEDLINE | ID: mdl-27172118

ABSTRACT

BACKGROUND: Calcineurin inhibitors (CNIs) represent the cornerstone of immunosuppressive therapy after liver transplantation. A recent network meta-analysis (NMA) evaluated the relative efficacy of CNIs ciclosporin, prolonged-release (PR) tacrolimus, and immediate-release (IR) tacrolimus in adult liver transplant recipients based on randomized and large observational trials published since 2000. Based on the NMA findings, the present study evaluated the cost-utility of PR tacrolimus relative to ciclosporin or IR tacrolimus in liver transplant recipients in the UK. METHODS: A Markov model was developed to evaluate the cost-utility of immunosuppressive regimens in liver transplant recipients, capturing costs associated with immunosuppression, retransplantation, acute rejection (AR), and cytomegalovirus infection. Mortality, graft loss, and AR odds ratios were derived from the NMA. Costs were taken from the British National Formulary and the NHS National Tariff and expressed in 2016 pounds sterling. Future costs and effects were discounted at 3.5% annually. RESULTS: Over 25 years, PR tacrolimus resulted in increased life expectancy and quality-adjusted life expectancy (QALE) relative to IR tacrolimus and ciclosporin. Relative to ciclosporin, QALE increased by 1.17 quality-adjusted life years (QALYs) with PR tacrolimus while costs increased by GBP £4645, yielding an incremental cost-effectiveness ratio (ICER) of £3962 per QALY gained. Relative to IR tacrolimus, QALE increased by 0.78 QALYs and costs by £1474, resulting in an ICER of £1889 per QALY gained. Sensitivity analysis showed the analysis to be most sensitive to dosing assumptions. CONCLUSIONS: Based on a UK-specific analysis of the projected cost-utility of PR tacrolimus relative to IR tacrolimus and ciclosporin, PR tacrolimus was cost-effective, improving life expectancy and QALE relative to both IR tacrolimus and ciclosporin, yielding ICERs below £20 000 per QALY gained. The main limitations of the study were data source heterogeneity and omitting the economic and clinical effects of treating aspects of recurrent liver disease.


Subject(s)
Cost-Benefit Analysis , Cyclosporine/economics , Cyclosporine/therapeutic use , Delayed-Action Preparations/economics , Graft Rejection/drug therapy , Immunosuppressive Agents/economics , Immunosuppressive Agents/therapeutic use , Liver Transplantation , Tacrolimus/administration & dosage , Tacrolimus/economics , Drug Therapy, Combination , Humans , Models, Economic , Quality-Adjusted Life Years , State Medicine
12.
Rev Esp Salud Publica ; 90: E15, 2016 Apr 13.
Article in Spanish | MEDLINE | ID: mdl-27073006

ABSTRACT

OBJECTIVE: The objective was to evaluate the efficiency (relation between the cost and the results in health) of the treatments in psoriasis, seeking a higher quality of economic evaluations, consistency and transparency in these studies. METHODS: We developed a model of economic evaluation in psoriasis collecting all the many direct and indirect costs of each treatment. The effectiveness indicator used was Psoriasis Area Severity Index [PASI 75] which is generally acceptable in studies of psoriasis. The effectiveness indicator was a PASI 75.Subsequently we calculated the Incremental Cost-Effectiveness Ratio (ICER) for the period of 12 weeks and PASI 75, ordering treatments by level of effectiveness at the expense of treatment costs. RESULTS: The most cost effective treatment was methotrexate (ICER -7.5) followed by acitretin (ICER 29.5). The least cost has proved effective PUVA (ICER 4,651), followed by UVB narrow band (2,886.1). CONCLUSIONS: when taking into account both direct and indirect costs together with efficiency, methotrexate is the most cost effective treatment.


OBJETIVO: Los nuevos tratamientos biológicos, si bien mejoran la calidad de vida del paciente, incrementan los costes exponencialmente en relación al resto de tratamientos. El objetivo fue calcular el tratamiento más coste efectivo de los existentes para la psoriasis. METODOS: Se desarrolló un modelo de evaluación económica en psoriasis recogiendo todos los costes directos e indirectos de cada tratamiento. El indicador de efectividad que se utilizó fue Psoriasis Area Severity Index (PASI 75), que es el aceptable de manera general en estudios de psoriasis. Posteriormente se realizó un análisis de incremento coste efectividad (ICER) para el periodo de 12 semanas y PASI 75, ordenando los tratamientos por nivel de efectividad en detrimento de los costes de los tratamientos. RESULTADOS: El tratamiento más coste efectivo fue el metotrexato (ICER -7,5) seguido de acitretina (ICER 29,5). El menos coste efectivo resultó ser PUVA (ICER 4.651) seguido de UVB de banda estrecha (2.886,1). CONCLUSIONES: Aunque el tratamiento más económico teniendo en cuenta solo los costes directos sería el UVBbe, al tener en cuenta los costes indirectos y ajustarlos por la efectividad, el tratamiento más coste efectivo es el metotexato.


Subject(s)
Cost-Benefit Analysis , Psoriasis/drug therapy , Acitretin/economics , Acitretin/therapeutic use , Adalimumab/economics , Adalimumab/therapeutic use , Cyclosporine/economics , Cyclosporine/therapeutic use , Etanercept/economics , Etanercept/therapeutic use , Health Care Costs , Humans , Immunosuppressive Agents/economics , Immunosuppressive Agents/therapeutic use , Infliximab/economics , Infliximab/therapeutic use , Methotrexate/economics , Methotrexate/therapeutic use , Models, Economic , PUVA Therapy/economics , Severity of Illness Index , Spain , Time Factors , Treatment Outcome , Ultraviolet Therapy/economics , Ustekinumab/economics , Ustekinumab/therapeutic use
13.
Transplant Proc ; 48(2): 609-11, 2016 Mar.
Article in English | MEDLINE | ID: mdl-27110013

ABSTRACT

Renal transplantation is the best therapeutic option for end-stage chronic renal disease. Assuming that it is more advisable if performed early, we aimed to show the clinical, social, and economic advantages in 70% of our patients who were dialyzed only for a short period. For this purpose, we retrospectively collected data over 28 years in 142 kidney transplants performed in patients with <6 weeks on dialysis. 66% of our patients were 30-60 years old; 98% of the patients had living donors. At transplantation, 64% of our patients had no public support; however, 64% of them returned to work and got health insurance 2 months later. Full rehabilitation was achieved in all cases, including integration to the family, return to full-time work, school and university, sports, and reproduction. Immunosuppression consisted of 3 drugs, including steroids, cyclosporine, and azathioprine or mycophenolate. The cost in the 1st year, including patient and donor evaluation, surgery, immunosuppression, and follow-up, was $13,300 USD versus $22,320 for hemodialysis. We conclude that preemptive renal transplantation with <6 weeks on dialysis is the best therapeutic option for end-stage renal failure, especially in developing countries such as Bolivia, where until last year, full public support for renal replacement therapy was unavailable.


Subject(s)
Kidney Failure, Chronic/therapy , Kidney Transplantation/statistics & numerical data , Adult , Aged , Azathioprine/economics , Azathioprine/therapeutic use , Bolivia , Costs and Cost Analysis , Cyclosporine/economics , Cyclosporine/therapeutic use , Developing Countries/economics , Developing Countries/statistics & numerical data , Female , Humans , Immunosuppression Therapy/economics , Immunosuppression Therapy/statistics & numerical data , Immunosuppressive Agents/economics , Immunosuppressive Agents/therapeutic use , Kidney Failure, Chronic/economics , Kidney Transplantation/economics , Living Donors/statistics & numerical data , Male , Middle Aged , Mycophenolic Acid/economics , Mycophenolic Acid/therapeutic use , Renal Dialysis/economics , Renal Dialysis/statistics & numerical data , Renal Replacement Therapy/statistics & numerical data , Retrospective Studies , Transplantation, Homologous/economics , Transplantation, Homologous/statistics & numerical data
14.
Ann Transplant ; 21: 1-11, 2016 Jan 05.
Article in English | MEDLINE | ID: mdl-26729299

ABSTRACT

BACKGROUND: Increasing immunosuppressant utilization and expenditure is a worldwide challenge as more people successfully live with transplanted organs. Our aims were to characterize utilization of mycophenolate, tacrolimus, cyclosporin, sirolimus, and everolimus in Australian transplant recipients from 2007 to 2013; to identify specific patterns of usage; and to compare Australian utilization with Norwegian, Danish, Swedish, and the Netherlands use. MATERIAL AND METHODS: Australian utilization and expenditure data were captured through national Pharmaceutical Benefits Scheme and Highly Specialized Drug administrative databases. Norwegian, Danish, Swedish, and the Netherlands utilization were retrieved from their healthcare databases. Utilization was compared as defined daily dose per 1000 population per day (DDD/1000 population/day). Data on kidney transplant recipients, the predominant patient group prescribed these medicines, were obtained from international transplant registries. RESULTS: From 2007-2013 Australian utilization of mycophenolic acid, tacrolimus and everolimus increased 2.7-fold, 2.2-fold, and 2.3-fold, respectively. Use of cyclosporin and sirolimus decreased 20% and 30%, respectively. Australian utilization was significantly lower than European utilization (2013) but was increasing at a faster rate. Total Australian expenditure increased approximately AUD$30 million over the study period to almost AUD$100 million in 2013. Kidney transplantation rates increased across each country over this time, with Australia having the lowest rate. CONCLUSIONS: Immunosuppressant usage and subsequent expenditure are rising in Australia and Northern Europe. With increased numbers of people living with transplants, and the observed growth potential predicted from Northern European data, this class of medicines can be expected to continue consuming an increasing share of Australian pharmaceutical expenditure into the future.


Subject(s)
Drug Utilization/trends , Immunosuppressive Agents , Organ Transplantation , Australia , Cyclosporine/economics , Databases, Factual , Denmark , Drug Utilization/economics , Drug Utilization/statistics & numerical data , Everolimus/economics , Health Expenditures/statistics & numerical data , Health Expenditures/trends , Humans , Immunosuppressive Agents/economics , Kidney Transplantation/statistics & numerical data , Kidney Transplantation/trends , Mycophenolic Acid/economics , Netherlands , Norway , Organ Transplantation/statistics & numerical data , Organ Transplantation/trends , Registries , Sirolimus/economics , Sweden , Tacrolimus/economics
15.
Am J Ther ; 23(3): e810-24, 2016.
Article in English | MEDLINE | ID: mdl-25299636

ABSTRACT

Tacrolimus and cyclosporine are the major immunosuppressants for renal transplantation. Several studies have compared these 2 drugs, but the outcomes were not consistent. The aim of this study was to evaluate the efficacy, safety, and pharmacoeconomics of cyclosporine and tacrolimus in the treatment of renal transplantation and provide evidence for the selection of essential drugs. Trials were identified through a computerized literature search of PubMed, EMBASE, Cochrane Controlled Trials Register, Cochrane Renal Group Specialized Register of randomized controlled trials, and Chinese Biomedical database. Two independent reviewers assessed trials for eligibility and quality and then extracted data. Data were extracted for patient and graft mortality, acute rejection, and adverse events. Dichotomous outcomes were reported as relative risk with 95% confidence intervals. A decision tree model was populated with data from a literature review and used to estimate costs and quality-adjusted life years gained and incremental cost-effectiveness. Altogether, 6137 patients from 27 randomized controlled trials were included. The results of our analysis were that tacrolimus reduced the risks after renal transplantation of patient mortality, graft loss, acute rejection, and hypercholesterolemia. Nevertheless, tacrolimus increased the risk of new-onset diabetes. Pharmacoeconomic analysis showed that tacrolimus represented a more cost-effective treatment than does cyclosporine for the prevention of adverse events following renal transplant. Tacrolimus is an effective and safe immunosuppressive agent and it may be more cost-effective than cyclosporine for the primary prevention of graft rejection in renal transplant recipients. However, new-onset diabetes should be closely monitored during the medication period.


Subject(s)
Cyclosporine/therapeutic use , Immunosuppressive Agents/therapeutic use , Kidney Transplantation , Tacrolimus/therapeutic use , Cost-Benefit Analysis , Cyclosporine/economics , Drug Costs , Graft Rejection/economics , Graft Rejection/prevention & control , Health Care Costs , Humans , Immunosuppressive Agents/economics , Kidney Transplantation/methods , Kidney Transplantation/mortality , Tacrolimus/economics
16.
Rev Saude Publica ; 49: 13, 2015.
Article in English | MEDLINE | ID: mdl-25741648

ABSTRACT

OBJECTIVE To analyze the cost-effectiveness of treatment regimens with cyclosporine or tacrolimus, five years after renal transplantation. METHODS This cost-effectiveness analysis was based on historical cohort data obtained between 2000 and 2004 and involved 2,022 patients treated with cyclosporine or tacrolimus, matched 1:1 for gender, age, and type and year of transplantation. Graft survival and the direct costs of medical care obtained from the National Health System (SUS) databases were used as outcome results. RESULTS Most of the patients were women, with a mean age of 36.6 years. The most frequent diagnosis of chronic renal failure was glomerulonephritis/nephritis (27.7%). In five years, the tacrolimus group had an average life expectancy gain of 3.96 years at an annual cost of R$78,360.57 compared with the cyclosporine group with a gain of 4.05 years and an annual cost of R$61,350.44. CONCLUSIONS After matching, the study indicated better survival of patients treated with regimens using tacrolimus. Moreover, regimens containing cyclosporine were more cost-effective [corrected].


Subject(s)
Cost-Benefit Analysis/economics , Cyclosporine/economics , Immunosuppressive Agents/economics , Kidney Failure, Chronic/surgery , Kidney Transplantation/economics , Tacrolimus/economics , Adult , Cohort Studies , Cost Savings , Cyclosporine/therapeutic use , Drug Administration Schedule , Female , Graft Survival , Humans , Immunosuppressive Agents/therapeutic use , Kidney Failure, Chronic/drug therapy , Kidney Failure, Chronic/economics , Male , Quality-Adjusted Life Years , Tacrolimus/therapeutic use
17.
Eur J Health Econ ; 16(4): 377-90, 2015 May.
Article in English | MEDLINE | ID: mdl-24728542

ABSTRACT

OBJECTIVES: Standards of immunosuppression in renal transplantation have changed dynamically in recent years. We here provide a refined advanced pharmacoeconomic model which uses state-of-the-art methods including a mixed treatment comparison (MTC) analysis. The aim was to assess the cost-effectiveness of current immunosuppressive therapy regimens (TR): "sirolimus + early withdrawal of cyclosporine + steroids" (TR1), "sirolimus-early transition" (TR2), "everolimus-early transition" (TR3) and "tacrolimus low dose + mycophenolate mofetil (MMF) + steroids" (TR4). METHODS: An up-to-date Markov model with current source data was employed to assess the cost-effectiveness of modern immunosuppressive regimens over 12-month and 10-year time periods. Transition probabilities for the occurrence of events for the first year were based on an MTC analysis. The robustness of the model was tested in extensive sensitivity analyses. RESULTS: Within the 12-month time period TR2 yields the highest life years (0.987 LY), generating costs of 17,500 . In terms of years with functioning graft (FG), TR4 yields the best efficacy over the 12-month model duration (0.970 years with FG). For the 10-year time period, TR2 yields the lowest costs (107,246 ) and dominates both TR3 and TR1, as it is simultaneously more effective. Within the 10-year model duration, TR4 reaches slightly higher effects compared with TR2 (6.493 vs. 6.474 LY) resulting in an incremental cost-effectiveness ratio of 387,684 per LY gained. CONCLUSIONS: The early transition to sirolimus provides long-term efficiency results comparable with a tacrolimus-based regimen, which represents a common treatment standard after kidney transplantation. Both are superior to other investigated immunosuppressive regimens.


Subject(s)
Immunosuppressive Agents/economics , Kidney Transplantation/economics , Cost-Benefit Analysis , Cyclosporine/administration & dosage , Cyclosporine/economics , Cyclosporine/therapeutic use , Drug Administration Schedule , Drug Costs/statistics & numerical data , Everolimus/administration & dosage , Everolimus/economics , Everolimus/therapeutic use , Germany/epidemiology , Graft Rejection/economics , Graft Rejection/prevention & control , Health Care Costs/statistics & numerical data , Humans , Immunosuppressive Agents/administration & dosage , Immunosuppressive Agents/therapeutic use , Kidney Transplantation/methods , Markov Chains , Mycophenolic Acid/administration & dosage , Mycophenolic Acid/analogs & derivatives , Mycophenolic Acid/economics , Mycophenolic Acid/therapeutic use , Sirolimus/administration & dosage , Sirolimus/economics , Sirolimus/therapeutic use
18.
Rev. saúde pública ; 49: 1-9, 27/02/2015. tab
Article in English | LILACS | ID: lil-742284

ABSTRACT

OBJECTIVE To analyze the cost-effectiveness of treatment regimens with cyclosporine or tacrolimus, five years after renal transplantation. METHODS This cost-effectiveness analysis was based on historical cohort data obtained between 2000 and 2004 and involved 2,022 patients treated with cyclosporine or tacrolimus, matched 1:1 for gender, age, and type and year of transplantation. Graft survival and the direct costs of medical care obtained from the National Health System (SUS) databases were used as outcome results. RESULTS Most of the patients were women, with a mean age of 36.6 years. The most frequent diagnosis of chronic renal failure was glomerulonephritis/nephritis (27.7%). In five years, the tacrolimus group had an average life expectancy gain of 3.96 years at an annual cost of R$78,360.57 compared with the cyclosporine group with a gain of 4.05 years and an annual cost of R$61,350.44. CONCLUSIONS After matching, the study indicated better survival of patients treated with regimens using tacrolimus. However, regimens containing cyclosporine were more cost-effective. .


OBJETIVO Analisar custo-efetividade de regimes terapêuticos com ciclosporina ou tacrolimo cinco anos após transplante renal. MÉTODOS Análise de custo-efetividade com base em dados de coorte histórica 2000-2004, com 2.022 pacientes tratados com ciclosporina ou tacrolimo e pareados 1:1 segundo sexo, idade, tipo e ano de transplante. A sobrevida do enxerto e os custos diretos de cuidados médicos a partir das bases de dados do Sistema Único de Saúde foram utilizados como medida de resultado. RESULTADOS A maioria dos pacientes era do sexo feminino e média de idade de 36,6 anos. O diagnóstico mais frequente de insuficiência renal crônica foi a glomerulonefrite/nefrite (27,7%). Em cinco anos, o grupo tacrolimo obteve uma expectativa de vida média de 3,96 anos de vida ganhos ao custo anual de R$78.360,57 ante 4,05 anos de vida ganhos e de R$61.350,44 para ciclosporina. CONCLUSÕES Após o pareamento, o estudo não mostrou melhor sobrevida dos pacientes com regimes que usam tacrolimo. Além disso, regimes contendo ciclosporina foram mais custo-efetivos. .


Subject(s)
Humans , Male , Female , Adult , Kidney Transplantation/economics , Tacrolimus/economics , Cyclosporine/economics , Cost-Benefit Analysis/economics , Immunosuppressive Agents/economics , Kidney Failure, Chronic/surgery , Drug Administration Schedule , Cohort Studies , Tacrolimus/therapeutic use , Cyclosporine/therapeutic use , Cost Savings , Quality-Adjusted Life Years , Graft Survival , Immunosuppressive Agents/therapeutic use , Kidney Failure, Chronic/economics , Kidney Failure, Chronic/drug therapy
19.
Prog Transplant ; 24(3): 257-62, 2014 Sep.
Article in English | MEDLINE | ID: mdl-25193726

ABSTRACT

BACKGROUND: Kidney transplant improves quality of life and survival compared with dialysis. Despite advances in immunosuppressant regimens and the prevention and treatment of acute rejection, graft survival rates have not improved significantly in the past decade. Although the clinical effectiveness of these regimens has been studied, the impact of changes over time on cost has not. METHODS: Costs of kidney transplant were compared between 2 periods demarcated by a programmatic change from cyclosporine (early) to tacrolimus (late) and from nonroutine induction (early) to routine induction (late) therapy in adult patients receiving a first kidney-only transplant in Calgary, Alberta, Canada, in an 8-year period. RESULTS: Complete costs for 3 years after transplant was available for 344 patients, including 161 adult recipients in the early period (April 1, 1998-December 31, 2001) and 183 adult recipients in the late period (January 1, 2002-March 31, 2006). The mean total 3-year cost of transplant for recipients was Can$100 034 in the early period and Can$144 712 in the late period largely attributed to increases in the cost of immunosuppressants (P< .001). CONCLUSIONS: Given that the cost of transplant has increased significantly over time, the cost-effectiveness of these and other immunosuppressive regimens should be evaluated carefully.


Subject(s)
Health Care Costs , Immunosuppressive Agents/economics , Kidney Transplantation/economics , Alberta , Antibodies, Monoclonal/economics , Cyclosporine/economics , Female , Graft Rejection/economics , Humans , Male , Middle Aged , Tacrolimus/economics
20.
Eur J Gastroenterol Hepatol ; 26(11): 1240-6, 2014 Nov.
Article in English | MEDLINE | ID: mdl-25171024

ABSTRACT

BACKGROUND: Cyclosporine and infliximab (IFX) seem equally effective as rescue therapy in hospitalized patients with severe ulcerative colitis (UC), although associated hospital stay and costs may differ. AIM: The aim of this study was to compare the duration of hospital stay and associated costs from initiation of rescue therapy to time of discharge in hospitalized patients with corticosteroid-refractory UC receiving cyclosporine or IFX. Colectomy rates after 6 months were used as the outcome parameter for treatment success. PATIENTS AND METHODS: Hospital records of patients admitted between November 2003 and August 2012 at a tertiary referral center were analyzed. RESULTS: Forty-two patients were included (cyclosporine group: 26 patients; IFX group: 16 patients). Patient characteristics were comparable, with the exception that cyclosporine-treated patients more often had a pancolitis (89 vs. 63%, P=0.046). The median length of hospital stay was 11.0 (interquartile range 7.75-13.25) versus 4.0 days (interquartile range 4.0-5.75) in the cyclosporine and IFX group (P<0.01), respectively. The mean in-hospital costs were significantly higher in the cyclosporine-treated versus IFX-treated patients (6121 vs. 4853 euros, P<0.05), whereas the total costs up to 3 months after initiation of rescue therapy were significantly higher in the IFX group (6787 vs. 9983 euros, P<0.01). There were no significant differences in colectomy rates at 6 months (23 and 31% for cyclosporine and IFX, P=0.50). More side-effects were observed during treatment with cyclosporine. CONCLUSION: Length of hospital stay and in-hospital costs have been reduced significantly since the introduction of IFX as rescue therapy for severe UC instead of cyclosporine. However, the total treatment costs are higher in IFX-treated patients.


Subject(s)
Antibodies, Monoclonal/therapeutic use , Colitis, Ulcerative/drug therapy , Cyclosporine/therapeutic use , Hospital Costs/statistics & numerical data , Length of Stay/statistics & numerical data , Adult , Antibodies, Monoclonal/adverse effects , Antibodies, Monoclonal/economics , Colectomy/statistics & numerical data , Colitis, Ulcerative/economics , Colitis, Ulcerative/surgery , Cyclosporine/adverse effects , Cyclosporine/economics , Drug Costs/statistics & numerical data , Female , Gastrointestinal Agents/adverse effects , Gastrointestinal Agents/economics , Gastrointestinal Agents/therapeutic use , Health Services Research/methods , Hospitalization/statistics & numerical data , Humans , Immunosuppressive Agents/adverse effects , Immunosuppressive Agents/economics , Immunosuppressive Agents/therapeutic use , Infliximab , Kaplan-Meier Estimate , Length of Stay/economics , Male , Netherlands , Treatment Outcome , Young Adult
SELECTION OF CITATIONS
SEARCH DETAIL