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1.
Hum Vaccin Immunother ; 20(1): 2348124, 2024 Dec 31.
Article in English | MEDLINE | ID: mdl-38714332

ABSTRACT

South Korea's National Immunization Program administers the quadrivalent influenza vaccine (QIV) to manage seasonal influenza, with a particular focus on the elderly. After reviewing the safety and immune response triggered by the adjuvanted QIV (aQIV) in individuals aged 65 and older, the Ministry of Food and Drug Safety in Korea approved its use. However, the extensive impact of aQIV on public health is yet to be fully understood. This study assessed the cost-effectiveness of replacing QIV with aQIV in South Korean adults aged 65 years and older. A dynamic transmission model, calibrated with national influenza data, was applied to compare the influence of aQIV and QIV on older adults and the broader population throughout a single influenza season. This study considered both the direct and indirect effects of vaccination on the elderly. We derived the incremental cost-effectiveness ratios (ICERs) from quality-adjusted life-years (QALYs) and costs incurred, validated through a probabilistic sensitivity analysis with 5,000 simulations. Findings suggest that transitioning to aQIV from QIV in the elderly would be cost-effective, particularly if aQIV's efficacy reaches or exceeds 56.1%. With an ICER of $29,267/QALY, considerably lower than the $34,998/QALY willingness-to-pay threshold, aQIV presents as a cost-effective option. Thus, implementing aQIV with at least 56.1% efficacy is beneficial from both financial and public health perspectives in mitigating seasonal influenza in South Korea.


Subject(s)
Adjuvants, Immunologic , Cost-Benefit Analysis , Influenza Vaccines , Influenza, Human , Humans , Influenza Vaccines/economics , Influenza Vaccines/administration & dosage , Influenza Vaccines/immunology , Republic of Korea , Aged , Influenza, Human/prevention & control , Influenza, Human/economics , Aged, 80 and over , Adjuvants, Immunologic/economics , Adjuvants, Immunologic/administration & dosage , Male , Female , Quality-Adjusted Life Years
2.
Am J Trop Med Hyg ; 105(6): 1696-1697, 2021 09 27.
Article in English | MEDLINE | ID: mdl-34583329

ABSTRACT

Chromoblastomycosis is a chronic cutaneous fungal infection caused by dematiaceous fungi. It is a therapeutic challenge because of the lack of specific treatments. We describe a refractory case of chromoblastomycosis in which the lesion did not respond to initial treatment, but then use of topical imiquimod cured the lesion successfully.


Subject(s)
Adjuvants, Immunologic/administration & dosage , Chromoblastomycosis/drug therapy , Imiquimod/administration & dosage , Adjuvants, Immunologic/economics , Adjuvants, Immunologic/therapeutic use , Administration, Topical , Aged , Antifungal Agents/administration & dosage , Antifungal Agents/therapeutic use , Cost-Benefit Analysis , Humans , Imiquimod/economics , Imiquimod/therapeutic use , Male
3.
JAMA Netw Open ; 4(3): e213800, 2021 03 01.
Article in English | MEDLINE | ID: mdl-33787908

ABSTRACT

Importance: Management of high-risk non-muscle-invasive bladder cancer (NMIBC) represents a clinical challenge due to high failure rates despite prior bacillus Calmette-Guérin (BCG) therapy. Objective: To describe real-world patient characteristics, long-term outcomes, and the economic burden in a population with high-risk NMIBC treated with BCG therapy. Design, Setting, and Participants: This retrospective cohort study identified 412 patients with high-risk NMIBC from 63 139 patients diagnosed with bladder cancer who received at least 1 dose of BCG within Department of Veterans Affairs (VA) centers across the US from January 1, 2000, to December 31, 2015. Adequate induction BCG therapy was defined as at least 5 installations, and adequate maintenance BCG therapy was defined as at least 7 installations. Data were analyzed from January 2, 2020, to January 20, 2021. Exposures: Intravesical BCG therapy, including adequate induction BCG therapy, was defined as at least 5 intravesical instillations of BCG within 70 days from BCG therapy start date. Adequate maintenance BCG therapy was defined as at least 7 installations of BCG within 274 days of the start (the first instillation) of adequate induction BCG therapy (ie, adequate induction BCG plus some form of additional BCG). Main Outcomes and Measures: The Kaplan-Meier method was used to estimate outcomes, including event-free survival. All-cause expenditures were summarized as medians with corresponding interquartile ranges (IQRs) and adjusted to 2019 USD. Results: Of the 412 patients who met inclusion criteria, 335 (81%) were male and 77 (19%) were female, with a median age of 67 (IQR, 61-74) years. Follow-up was 2694 person-years. A total of 392 patients (95%) received adequate induction BCG therapy, and 152 (37%) received adequate BCG therapy. For all patients with high-risk NMIBC, the 10-year progression-free survival rate and disease-specific death rate were 78% and 92%, respectively. Patients with carcinoma in situ (Cis) had worse disease-free survival than those without Cis (hazard ratio [HR], 1.85; 95% CI, 1.34-2.56). Total median costs at 1 year were $29 459 (IQR, $14 991-$52 060); at 2 years, $55 267 (IQR, $28 667-$99 846); and at 5 years, $117 361 (IQR, $59 680-$211 298). Patients with progressive disease had significantly higher median 5-year costs ($232 729 [IQR, $151 321-$341 195] vs $94 879 [IQR, $52 498-$172 631]; P < .001), with outpatient care, pharmacy, and surgery-related costs contributing. Conclusions and Relevance: Despite adequate induction BCG therapy, only 37% of patients received adequate BCG therapy. Patients with Cis had increased risk of progression, and progression regardless of Cis was associated with significantly increased costs relative to patients without progression. Extrapolating cost figures, regardless of progression, resulted in nationwide costs at 1 year of $373 million for patients diagnosed with high-risk NMIBC in 2019.


Subject(s)
BCG Vaccine/therapeutic use , Drug Costs , United States Department of Veterans Affairs/statistics & numerical data , Urinary Bladder Neoplasms/drug therapy , Veterans/statistics & numerical data , Adjuvants, Immunologic/economics , Adjuvants, Immunologic/therapeutic use , Aged , BCG Vaccine/economics , Disease-Free Survival , Drug Administration Schedule , Female , Follow-Up Studies , Humans , Male , Middle Aged , Retrospective Studies , Time Factors , United States , Urinary Bladder Neoplasms/diagnosis , Urinary Bladder Neoplasms/economics
4.
Farm. hosp ; 44(2): 68-76, mar.-abr. 2020. tab, graf
Article in Spanish | IBECS | ID: ibc-192390

ABSTRACT

OBJETIVO: Identificar y describir los estudios de costo-efectividad que evalúan las terapias modificadoras de la enfermedad en esclerosis múltiple recurrente-remitente. MÉTODO: Revisión sistemática de la literatura en MEDLINE, Embase, Cochrane Library, LILACS, Tufts Medical Center cost-effectiveness analysis registry, National Health Service economic evaluation database y Open Grey; búsqueda limitada entre enero de 2010 y diciembre de 2017, se ejecutó en enero de 2018. Se incluyeron modelos de costo-efectividad con perspectiva de pagador para interferón beta-1a, interferón beta-1b, acetato de glatiramero, teriflunomida, fingolimod, dimetilfumarato, natalizumab, alemtuzumab y rituximab. La herramienta Quality of Health Economic Studies fue usada para determinar la calidad de los estudios, el sesgo se evaluó sin una herramienta estandarizada, dada su no existencia. Se analizaron costos directos, años de vida ajustados por calidad y la razón de costo-efectividad incremental. La extracción de los datos y la evaluación de la información se realizaron por cada autor de forma independiente Resultados: Se encontraron 401 referencias, se incluyeron nueve estudios; hubo variabilidad en múltiples aspectos metodológicos. Según la razón de costo-efectividad incremental (costo), dos trabajos mostraron que ninguna terapia de primera línea fue costo-efectiva, un tercer estudio reporta al interferón beta-1b como dominante sobre placebo (-315.109,45 dólar estadounidense [US$]) y un cuarto artículo expone a teriflunomida como dominante sobre interferones y acetato de glatiramero (-121.840,37 US$). Respecto a las terapias de segunda línea, dimetil fumarato fue costo-efectivo en un estudio comparado con acetato de glatiramero e interferón beta-1a y fue dominante en otro trabajo frente a acetato de glatiramero (-158.897,93 US$) y fingolimod (-92.988,97 US$). En la tercera línea de tratamiento, natalizumab fue costo-efectivo sobre fingolimod en un artículo, y alemtuzumab fue dominante contra fingolimod (-49.221 US$) en un segundo estudio. En un tercer ensayo el alemtuzumab fue dominante sobre natalizumab (-1.656.266,07 US$). Muchos estudios tuvieron sesgo de patrocinador. Ocho artículos obtuvieron alta puntuación de calidad con la herramienta Quality of Health Economic Studies. CONCLUSIONES: Este trabajo demuestra que existe una gran variabilidad metodológica entre los estudios de costo-efectividad, y algunos de ellos tienen resultados contradictorios. No es posible determinar qué terapia modificadora de la enfermedad en esclerosis múltiple recurrente-remitente es costo-efectiva


OBJECTIVE: To identify and describe cost-effectiveness studies that eva-luate disease modifying therapies in the context of relapsing-remitting mul-tiple sclerosis. METHOD: A systematic review of the literature was carried out by searching MEDLINE, Embase, the Cochrane Library, LILACS, the Tufts Medical Center Cost-Effectiveness Analysis Registry, the National Health Service Economic Evaluation Database and Open Grey. The search was performed in January 2018 and covered articles published between January 2010 and December 2017. The studies reviewed were payer-perspective cost-effectiveness analy-ses for interferon beta-1a, interferon beta-1b, glatiramer acetate, teriflunomide, fingolimod, dimethyl fumarate, natalizumab, alemtuzumab and rituximab. The Quality of Health Economic Studies instrument was used to determine the quality of the studies reviewed. Risk of bias was assessed without a standardized tool. An analysis was made of direct costs, quality-adjusted life-years and the incremental cost-effectiveness ratio. Data extraction and evaluation of information were conducted separately by each author. RESULTS: Four hundred one references were found; nine studies were included. A great degree of variability was identified for several methodological aspects. Two studies that applied the incremental cost-effectiveness ratio (cost) showed no first-line therapy to be cost-effective. A third study demonstrated dominance of interferon beta-1b over placebo (USD -315,109.45) and a fourth paper showed dominance of teriflu-nomide over interferons and glatiramer acetate (USD -121,840.37). As regards second-line therapies, dimethyl fumarate was cost-effective in a study that compared it to glatiramer acetate and interferon beta-1a and it was dominant in another study that compared it with glatiramer acetate (USD -158,897.93) and fingolimod (USD -92,988.97). In the third line of treatment, one study showed natalizumab to be cost-effective as compared with fingolimod, and another study showed alemtuzumab to be dominant over fingolimod (USD -49,221). A third trial demonstrated alemtuzumab to be dominant over natalizumab (USD -1,656,266.07). Many of the trials have sponsorship bias. Eight of the trials received a high QHES score. CONCLUSIONS: The present paper shows that cost-effectiveness studies have high levels of methodological variability, some of them reaching contradictory results. As a result, it is not possible to determine which disease-modifying therapy is really cost-effective in the context of relapsing-remitting multiple sclerosis


Subject(s)
Humans , Multiple Sclerosis/drug therapy , Multiple Sclerosis/economics , Cost Efficiency Analysis , Adjuvants, Immunologic/economics , Adjuvants, Immunologic/therapeutic use , Immunosuppressive Agents/economics , Immunosuppressive Agents/therapeutic use , Immunologic Factors/economics , Immunologic Factors/therapeutic use
5.
Front Immunol ; 11: 578715, 2020.
Article in English | MEDLINE | ID: mdl-33732227

ABSTRACT

Asiatic schistosomiasis caused by Schistosoma japonicum is a neglected tropical disease resulting in significant morbidity to both humans and animals - particularly bovines - in endemic areas. Infection with this parasite leads to less healthy herds, causing problems in communities which rely on bovines for farming, milk and meat production. Additionally, excretion of parasite eggs in feces perpetuates the life cycle and can lead to human infection. We endeavored to develop a minimally purified, inexpensive, and effective vaccine based on the 80 kDa large subunit of the calcium activated neutral protease (calpain) from S. japonicum (Sj-p80). Here we describe the production of veterinary vaccine-grade Sj-p80 at four levels of purity and demonstrate in a pilot study that minimally purified antigen provides protection against infection in mice when paired with a low-cost veterinary adjuvant, Montanide™ ISA61 VG. Preliminary data demonstrate that the vaccine is immunogenic with robust antibody titers following immunization, and vaccination resulted in a reduction of parasite eggs being deposited in the liver (23.4-51.4%) and intestines (1.9-55.1%) depending on antigen purity as well as reducing the ability of these eggs to hatch into miracidia by up to 31.6%. We therefore present Sj-p80 as a candidate vaccine antigen for Asiatic schistosomiasis which is now primed for continued development and testing in bovines in endemic areas. A successful bovine vaccine could play a major role in reducing pathogen transmission to humans by interrupting the parasitic life cycle and improving quality of life for people living in endemic countries.


Subject(s)
Adjuvants, Immunologic/pharmacology , Antigens, Helminth/pharmacology , Drug Development , Protozoan Vaccines/pharmacology , Schistosoma japonicum/pathogenicity , Schistosomiasis japonica/prevention & control , Veterinary Drugs/pharmacology , Adjuvants, Immunologic/economics , Animals , Antibodies, Helminth/blood , Antigens, Helminth/economics , Antigens, Helminth/immunology , Cattle , Cost-Benefit Analysis , Disease Models, Animal , Drug Costs , Female , Host-Pathogen Interactions , Immunogenicity, Vaccine , Mice, Inbred C57BL , Parasite Egg Count , Pilot Projects , Protozoan Vaccines/economics , Schistosoma japonicum/immunology , Schistosomiasis japonica/parasitology , Schistosomiasis japonica/transmission , Vaccination , Veterinary Drugs/economics
6.
Am J Manag Care ; 25(7): 335-340, 2019 07.
Article in English | MEDLINE | ID: mdl-31318506

ABSTRACT

OBJECTIVES: To assess the impact of a co-pay accumulator adjustment program (CAAP) on usage patterns of autoimmune specialty drugs, comparing health savings account (HSA) or preferred provider organization (PPO) plan enrollees before and after implementation of the CAAP. STUDY DESIGN: Retrospective cohort analysis. METHODS: Data on HSA and PPO patients with autoimmune specialty drug use were drawn from the Conduent pharmacy benefit manager for January 2016 to October 2017 from 15 self-insured employers initiating a CAAP in January 2017. Outcomes included monthly mean fills per person, therapy discontinuation, and proportion of days covered (PDC). Linear regressions, Kaplan-Meier survival curves, and Cox proportional hazards models assessed differences while adjusting for patient characteristics. RESULTS: There were 365 HSA and 238 PPO patients. After the CAAP implementation, for HSA versus PPO patients, adjusted trends in monthly fills per person decreased more rapidly, the risk of treatment discontinuation was significantly higher, and PDC was significantly lower. Prior to the CAAP, these metrics were not statistically different between groups except in 1 case. To help place the post-CAAP adjusted differences in trends in context, by the end of October 2017, 10 months after the CAAP start, HSA patients had 233 fewer autoimmune drug fills per 1000 patients, 20 percentage points higher treatment discontinuation, and 12 percentage points lower PDC. CONCLUSIONS: After the CAAP, HSA patients on autoimmune drugs had significantly lower monthly fill rates, higher risk of discontinuation, and lower PDC than did PPO patients, suggesting that CAAPs have the potential to negatively affect specialty drug use.


Subject(s)
Adjuvants, Immunologic/economics , Adjuvants, Immunologic/therapeutic use , Adjuvants, Pharmaceutic/economics , Adjuvants, Pharmaceutic/therapeutic use , Health Expenditures/statistics & numerical data , Medication Adherence/statistics & numerical data , Prescription Drugs/economics , Adult , Aged , Aged, 80 and over , Cohort Studies , Female , Humans , Male , Middle Aged , Retrospective Studies
7.
J Neurol Sci ; 404: 19-28, 2019 Sep 15.
Article in English | MEDLINE | ID: mdl-31323518

ABSTRACT

There are now over a dozen disease modifying therapies (DMTs) available to treat multiple sclerosis (MS). They vary in efficacy and safety as well as in cost. The literature on the cost effectiveness of these is often confusing and contradictory. There is a lack of quality evidence enabling the comparison of different DMTs. There are scarce randomized controlled trials which look at one DMT compared with another that is not IFN or GA. There is also a lack of systematic reviews comparing the efficacy and safety of different DMTs. This makes it difficult to perform good quality cost-effectiveness analyses (CEAs). Furthermore, CEAs in and of themselves are difficult to interpret or compare due to the variation in methods and cost estimations as well as the use of outcome measures which cannot be proven over a reasonable timeframe. This review looks at the different DMTs available for MS and attempts to draw some conclusions on their cost-effectiveness. It also considers the costs and benefits of front loading the cost of treatment for MS by using more expensive and effective treatment earlier on.


Subject(s)
Adjuvants, Immunologic/therapeutic use , Multiple Sclerosis/drug therapy , Adjuvants, Immunologic/economics , Cost of Illness , Cost-Benefit Analysis , Humans , Multiple Sclerosis/economics , Treatment Outcome
8.
Health Aff (Millwood) ; 38(2): 303-312, 2019 02.
Article in English | MEDLINE | ID: mdl-30715973

ABSTRACT

The high cost of multiple sclerosis (MS) disease-modifying therapies can negatively affect access for patients through increased payer restrictions and higher out-of-pocket spending. Our objective was to describe changes in pharmacy benefit coverage and cost-sharing amounts for MS disease-modifying therapies in the Medicare Part D program, using enrollment-weighted Prescription Drug Plan Formulary files for the period 2007-16. Among therapies available throughout the study period, the rate of prior authorization use increased from 61-66 percent of plans to 84-90 percent. The share of plans with at least one therapy available without limitations declined from 39 percent to 17 percent. The projected cumulative out-of-pocket spending for 2019 was $6,894. The therapy with the highest out-of-pocket spending was generic glatiramer acetate. Policy makers need to consider both access restrictions and a growing cost-sharing burden as potential consequences of high and rising drug prices for people with MS.


Subject(s)
Cost Sharing , Health Expenditures/trends , Medicare Part D/statistics & numerical data , Multiple Sclerosis/drug therapy , Prescription Drugs , Adjuvants, Immunologic/economics , Adjuvants, Immunologic/therapeutic use , Cost Sharing/economics , Cost Sharing/trends , Female , Glatiramer Acetate/economics , Glatiramer Acetate/therapeutic use , Humans , Insurance Coverage/statistics & numerical data , Insurance Coverage/trends , Male , Prescription Drugs/economics , Prescription Drugs/therapeutic use , United States
10.
BMC Med ; 16(1): 228, 2018 12 06.
Article in English | MEDLINE | ID: mdl-30518427

ABSTRACT

BACKGROUND: The newly registered adjuvanted herpes zoster subunit vaccine (HZ/su) has a higher efficacy than the available live-attenuated vaccine (ZVL). National decision-makers soon need to decide whether to introduce HZ/su or to prefer HZ/su above ZVL. METHODS: Using a Markov model with a decision tree, we conducted a cost-effectiveness analysis of vaccination with HZ/su (two doses within 2 months) or zoster vaccine live (ZVL) (single dose, or single dose with a booster after 10 years) for cohorts of 50-, 60-, 70- or 80-year-olds in the Netherlands. The model was parameterized using vaccine efficacy data from randomized clinical trials and up-to-date incidence, costs and health-related quality of life data from national datasets. We used a time horizon of 15 years, and the analysis was conducted from the societal perspective. RESULTS: At a coverage of 50%, vaccination with two doses of HZ/su was estimated to prevent 4335 to 10,896 HZ cases, depending on the cohort age. In comparison, this reduction was estimated at 400-4877 for ZVL and 427-6466 for ZVL with a booster. The maximum vaccine cost per series of HZ/su to remain cost-effective to a willingness-to-pay threshold of €20,000 per quality-adjusted life year (QALY) gained ranged from €109.09 for 70-year-olds to €63.68 for 50-year-olds. The cost-effectiveness of ZVL changed considerably by age, with corresponding maximum vaccine cost per dose ranging from €51.37 for 60-year-olds to €0.73 for 80-year-olds. Adding a ZVL booster after 10 years would require a substantial reduction of the maximum cost per dose to remain cost-effective as compared to ZVL single dose. Sensitivity analyses on the vaccine cost demonstrated that there were scenarios in which vaccination with either HZ/su (two doses), ZVL single dose or ZVL + booster could be the most cost-effective strategy. CONCLUSIONS: A strategy with two doses of HZ/su was superior in reducing the burden of HZ as compared to a single dose or single dose + booster of ZVL. Both vaccines could potentially be cost-effective to a conventional Dutch willingness-to-pay threshold for preventive interventions. However, whether HZ/su or ZVL would be the most cost-effective alternative depends largely on the vaccine cost.


Subject(s)
Adjuvants, Immunologic/economics , Cost-Benefit Analysis/methods , Herpes Zoster Vaccine/economics , Herpes Zoster/drug therapy , Vaccines, Attenuated/economics , Adjuvants, Immunologic/pharmacology , Adjuvants, Immunologic/therapeutic use , Aged , Aged, 80 and over , Female , Herpes Zoster Vaccine/pharmacology , Herpes Zoster Vaccine/therapeutic use , Humans , Male , Middle Aged , Netherlands , Quality of Life , Vaccines, Attenuated/pharmacology , Vaccines, Attenuated/therapeutic use
11.
Pharmacoeconomics ; 36(11): 1321-1331, 2018 11.
Article in English | MEDLINE | ID: mdl-30047014

ABSTRACT

BACKGROUND: The place of disease-modifying osteoarthritis drugs (DMOADs) and intra-articular hyaluronic acid (IAHA) in the therapeutic arsenal for knee osteoarthritis (OA) remains uncertain. Indeed, these treatments have demonstrated symptomatic efficacy but no efficacy for disease modification. OBJECTIVE: This report reviews the cost effectiveness of IAHA and DMOADs used in the treatment of knee OA. METHODS: A systematic literature search of the MEDLINE, Scopus, EMBASE and Cochrane databases was performed independently by two rheumatologists who used the same predefined eligibility criteria to identify relevant articles. Papers without abstracts and in languages other than English or French were excluded. Extracted costs were annualised and converted to 2015 euros (€) using the Consumer Price Index of the relevant countries and the 2013 Purchasing Power Parities between these countries and the European Union average. RESULTS: A total of 95 abstracts were selected, and 13 articles were considered for the review: nine articles on IAHA and four on DMOADs. Only one article directly compared different IAHA compounds. Articles showed substantial heterogeneity in methodological approaches. The incremental cost-effectiveness ratios (ICERs) ranged from €4000 to €57,550 and from €240 to €53,225 per quality-adjusted life-year (QALY) gained for DMOADs and IAHA, respectively. CONCLUSIONS: This review highlights substantial heterogeneity between studies, ranging from a cost saving (or dominating) position to very high ICERs, far above the acceptability threshold of €50,000/QALY. Additional research is needed to determine reliable and robust ICER estimates for knee OA therapies.


Subject(s)
Antirheumatic Agents/administration & dosage , Hyaluronic Acid/administration & dosage , Osteoarthritis, Knee/drug therapy , Adjuvants, Immunologic/administration & dosage , Adjuvants, Immunologic/economics , Antirheumatic Agents/economics , Cost-Benefit Analysis , Humans , Hyaluronic Acid/economics , Injections, Intra-Articular , Osteoarthritis, Knee/economics , Quality-Adjusted Life Years
12.
Eur Urol Focus ; 4(4): 481-484, 2018 07.
Article in English | MEDLINE | ID: mdl-30005997

ABSTRACT

Bacillus Calmette-Guérin (BCG) is used as first-line intravesical therapy following tumor resection of non-muscle-invasive bladder cancer. Primary producers of BCG announced shortages within the last decade, leading to a worldwide shortage. We review the literature examining the BCG shortage and propose solutions to cope with this problem.


Subject(s)
BCG Vaccine , Drug Utilization , Urinary Bladder Neoplasms , Adjuvants, Immunologic/economics , Adjuvants, Immunologic/pharmacology , Adjuvants, Immunologic/supply & distribution , Administration, Intravesical , BCG Vaccine/economics , BCG Vaccine/pharmacology , BCG Vaccine/supply & distribution , Drug Utilization/economics , Drug Utilization/statistics & numerical data , Drug Utilization/trends , Drug and Narcotic Control , Humans , Neoplasm Invasiveness , Urinary Bladder Neoplasms/drug therapy , Urinary Bladder Neoplasms/pathology
14.
Int J Immunopathol Pharmacol ; 32: 2058738418757925, 2018.
Article in English | MEDLINE | ID: mdl-29442526

ABSTRACT

Actinic keratosis (AK) is a clinical condition characterized by keratinocytic dysplastic lesions of the epidermis, affecting individuals chronically exposed to sunlight. Topical therapies allow the treatment of a whole area of affected skin and currently include diclofenac sodium gel, 5-fluorouracil cream, 5-fluorouracil and acetylsalicylic acid solution, imiquimod cream, and ingenol mebutate gel. Due to the comparable efficacy of 3% diclofenac, ingenol mebutate, and 3.75% imiquimod in treating AK multiple lesions, a pharmacoeconomic evaluation of cost-effectiveness of the three treatments was needed. A cost-efficacy analysis comparing 3% diclofenac sodium with ingenol mebutate and 3.75% imiquimod was performed. In this analysis, efficacy data were combined with quality-of-life measurement derived from previous studies as well as the costs associated with the management of these lesions in Italy. Patients' demographics and clinical characteristics were assumed to reflect those from the clinical studies considered.


Subject(s)
Aminoquinolines/economics , Cost-Benefit Analysis/methods , Diclofenac/economics , Diterpenes/economics , Keratosis, Actinic/drug therapy , Keratosis, Actinic/economics , Adjuvants, Immunologic/administration & dosage , Adjuvants, Immunologic/economics , Aminoquinolines/administration & dosage , Anti-Inflammatory Agents, Non-Steroidal/administration & dosage , Anti-Inflammatory Agents, Non-Steroidal/economics , Clinical Trials, Phase III as Topic/economics , Decision Trees , Diclofenac/administration & dosage , Diterpenes/administration & dosage , Drug Compounding , Humans , Imiquimod , Multicenter Studies as Topic/economics , Randomized Controlled Trials as Topic/economics , Treatment Outcome
15.
Ann Saudi Med ; 37(6): 433-443, 2017.
Article in English | MEDLINE | ID: mdl-29229891

ABSTRACT

BACKGROUND: Promising clinical and humanistic outcomes are associated with the use of new oral agents in the treatment of relapsing-remitting multiple sclerosis (RRMS). This is the first cost-effectiveness study comparing these medications in Saudi Arabia. OBJECTIVES: We aimed to compare the cost-effectiveness of fingolimod, teriflunomide, dimethyl fumarate, and interferon (IFN)-b1a products (Avonex and Rebif) as first-line therapies in the treatment of patients with RRMS from a Saudi payer perspective. DESIGN: Cohort Simulation Model (Markov Model). SETTING: Tertiary care hospital. METHODS: A hypothetical cohort of 1000 RRMS Saudi patients was assumed to enter a Markov model model with a time horizon of 20 years and an annual cycle length. The model was developed based on an expanded disability status scale (EDSS) to evaluate the cost-effectiveness of the five disease-modifying drugs (DMDs) from a healthcare system perspective. Data on EDSS progression and relapse rates were obtained from the literature; cost data were obtained from King Faisal Specialist Hospital and Research Centre, Riyadh, Saudi Arabia. Results were expressed as incremental cost-effectiveness ratios (ICERs) and net monetary benefits (NMB) in Saudi Riyals and converted to equivalent $US. The base-case willingness-to-pay (WTP) threshold was assumed to be $100000 (SAR375000). One-way sensitivity analysis and probabilistic sensitivity analysis were conducted to test the robustness of the model. MAIN OUTCOME MEASURES: ICERs and NMB. RESULTS: The base-case analysis results showed Rebif as the optimal therapy at a WTP threshold of $100000. Avonex had the lowest ICER value of $337282/QALY when compared to Rebif. One-way sensitivity analysis demonstrated that the results were sensitive to utility weights of health state three and four and the cost of Rebif. CONCLUSION: None of the DMDs were found to be cost-effective in the treatment of RRMS at a WTP threshold of $100000 in this analysis. The DMDs would only be cost-effective at a WTP above $300000. LIMITATIONS: The current analysis did not reflect the Saudi population preference in valuation of health states and did not consider the societal perspective in terms of cost.


Subject(s)
Adjuvants, Immunologic/administration & dosage , Immunosuppressive Agents/administration & dosage , Interferon beta-1a/administration & dosage , Multiple Sclerosis, Relapsing-Remitting/drug therapy , Adjuvants, Immunologic/economics , Administration, Oral , Cohort Studies , Cost-Benefit Analysis , Crotonates/administration & dosage , Crotonates/economics , Dimethyl Fumarate/administration & dosage , Dimethyl Fumarate/economics , Disease Progression , Fingolimod Hydrochloride/administration & dosage , Fingolimod Hydrochloride/economics , Humans , Hydroxybutyrates , Immunosuppressive Agents/economics , Interferon beta-1a/economics , Markov Chains , Multiple Sclerosis, Relapsing-Remitting/economics , Nitriles , Quality-Adjusted Life Years , Saudi Arabia , Tertiary Care Centers , Toluidines/administration & dosage , Toluidines/economics
16.
J Med Econ ; 20(10): 1056-1065, 2017 Oct.
Article in English | MEDLINE | ID: mdl-28703659

ABSTRACT

AIM: To conduct a cost-effectiveness analysis to compare ocrelizumab vs subcutaneous (SC) interferon beta-1a for the treatment of relapsing multiple sclerosis (RMS). METHODS: A Markov cohort model with a 20-year horizon was developed to compare ocrelizumab with SC interferon beta-1a from a US payer perspective. A cohort of patients with relapsing-remitting MS (RRMS) and Expanded Disability Status Scale (EDSS) scores of 0-6, who initiated treatment with ocrelizumab or SC interferon beta-1a, were entered into the model. The model considered 21 health states: EDSS 0-9 in RRMS, EDSS 0-9 in secondary-progressive multiple sclerosis (SPMS), and death. Patients with RRMS could transition across EDSS scores, progress to SPMS, experience relapses, or die. Transition probabilities within RRMS while patients received ocrelizumab or SC interferon beta-1a were based on data from the two SC interferon beta-1a-controlled Phase III OPERA I and OPERA II trials of ocrelizumab in RMS. Transitions within RRMS when off-treatment, RRMS-to-SPMS transitions, transitions within SPMS, and transitions to death were based on the literature. Utilities of health states, disutilities of relapses, costs of therapies, and medical costs associated with health states, relapse, and adverse events were from the literature and publicly available data sources. The model estimated per-patient total costs, incremental cost per life year (LY) gained, and incremental cost per quality-adjusted LY (QALY) gained. Deterministic sensitivity analyses (DSA) and probabilistic sensitivity analysis (PSA) were conducted to evaluate the robustness of the model results. RESULTS: Ocrelizumab was associated with a cost savings of $63,822 and longer LYs (Δ = 0.046) and QALYs (Δ = 0.556) over a 20-year time horizon. The results of the model were robust in the DSA and PSA. LIMITATIONS: The model did not consider subsequent treatments and their impact on disease progression. CONCLUSIONS: The results suggest that ocrelizumab is more cost-effective than SC interferon beta-1a for the treatment of RMS.


Subject(s)
Adjuvants, Immunologic/therapeutic use , Antibodies, Monoclonal, Humanized/therapeutic use , Immunosuppressive Agents/therapeutic use , Interferon beta-1a/therapeutic use , Multiple Sclerosis, Relapsing-Remitting/drug therapy , Adjuvants, Immunologic/adverse effects , Adjuvants, Immunologic/economics , Adult , Antibodies, Monoclonal, Humanized/adverse effects , Antibodies, Monoclonal, Humanized/economics , Cost-Benefit Analysis , Female , Health Expenditures , Health Resources/economics , Health Resources/statistics & numerical data , Humans , Immunosuppressive Agents/adverse effects , Immunosuppressive Agents/economics , Injections, Subcutaneous , Interferon beta-1a/adverse effects , Interferon beta-1a/economics , Male , Markov Chains , Models, Econometric , Multiple Sclerosis, Relapsing-Remitting/mortality , Quality-Adjusted Life Years
18.
J Med Econ ; 20(3): 297-302, 2017 Mar.
Article in English | MEDLINE | ID: mdl-27822961

ABSTRACT

BACKGROUND: The safety and efficacy of disease-modifying therapies (DMTs) for relapsing-remitting multiple sclerosis (RRMS) has been established; however, it is not clear which provides optimal value, given benefit-risk profiles and costs. AIMS: To compare the cost-effectiveness of current DMTs for patients with RRMS in the US. MATERIALS AND METHODS: A Markov model predicting RRMS course following initiation of a DMT was created comparing outcomes (e.g. relapses, disease progression) and costs of natalizumab (NTZ), dimethyl fumarate (DMF), and peginterferon beta-1a (PEG) with fingolimod (FIN), glatiramer acetate (GA, 20 mg daily), and subcutaneous interferon beta-1a (IFN, 44 mcg), respectively, over 10 years. RRMS and secondary-progressive MS (SPMS) EDSS state transitions were predicted in 3-month cycles in which patients were at risk of death, relapse, or discontinuation. Upon DMT discontinuation, natural history progression and relapse rates were applied. Incremental cost-effectiveness ratios (ICERs) were estimated for the cost per relapse avoided, relapse-free years gained, progression avoided, and progression-free years gained. The impact of model parameters on outcomes was evaluated via one-way sensitivity analyses. RESULTS: Costs ranged from $561,177 (NTZ) to $616,251 (GA). NTZ, DMF, and PEG were dominant (less costly and more effective) compared to FIN, GA, and IFN, respectively, for all ICERs. Variability in drug costs and parameters that affected drug cost accrual (e.g. discontinuation rates and the decision to drop out after SPMS conversion) had a considerable impact on ICERs. LIMITATIONS: Several simplifying assumptions were made that may represent potential limitations of this analysis (e.g. a constant treatment effect over time was assumed). CONCLUSIONS: The results from this analysis suggest that the NTZ, DMF, and PEG are cost-effective DMT choices compared to FIN, GA, and IFN, respectively. The actual impact on a particular plan will vary based on drug pricing and other factors affecting drug cost accrual.


Subject(s)
Adjuvants, Immunologic/administration & dosage , Adjuvants, Immunologic/economics , Immunologic Factors/administration & dosage , Immunologic Factors/economics , Multiple Sclerosis, Relapsing-Remitting/drug therapy , Outcome Assessment, Health Care/economics , Adult , Cost-Benefit Analysis , Disease Progression , Disease-Free Survival , Female , Humans , Male , Markov Chains , Outcome Assessment, Health Care/methods
19.
Rev Esp Geriatr Gerontol ; 52 Suppl 2: 1-14, 2017 11.
Article in Spanish | MEDLINE | ID: mdl-29628113

ABSTRACT

Flu is a major public health problem, particularly for older people, and creates an important clinical and economic burden. A high mortality rate was reported in Spain during the period 2015 to 2016; 3,101 serious cases were hospitalised with a confirmed diagnosis of flu, of which 11% died (352 cases). Furthermore, financial and health costs are greatly increased by the complications of flu; people aged over 65 years represent approximately 64% of the total costs. Seasonal flu vaccination is the fundamental strategy, as demonstrated by cost-benefit and cost-effectiveness studies. A priority objective is to improve the vaccine's immune response and the search for and inclusion of adjuvants and immunostimulants in vaccines is a major line of research. This positioning report evaluates vaccination for older people and the importance of the adjuvanted vaccine in the elderly in strengthening immunogenicity, by means of a critical review of the literature based on the best evidence available on its immunogenicity and effectiveness, and an economic assessment.


Subject(s)
Adjuvants, Immunologic/administration & dosage , Influenza Vaccines/administration & dosage , Influenza, Human/prevention & control , Adjuvants, Immunologic/adverse effects , Adjuvants, Immunologic/economics , Aged , Humans , Immunogenicity, Vaccine , Influenza Vaccines/adverse effects , Influenza Vaccines/economics , Influenza Vaccines/immunology , Seasons
20.
Pharmacoeconomics ; 34(11): 1133-1144, 2016 11.
Article in English | MEDLINE | ID: mdl-27282692

ABSTRACT

OBJECTIVES: This study responds to a request in the National Institute for Health and Care Excellence (NICE) guidance to assess the impact of using alternative sources of utility values, applied to multiple sclerosis (MS). METHODS: Incremental cost-effectiveness ratios (ICERs) were calculated using utility values based on UK and Dutch values of EQ-5D, two UK mappings and one Dutch mapping of EQ-5D and two condition-specific instruments: the UK eight-dimensional Multiple Sclerosis Impact Scale (MSIS-8D) and the Dutch Multiple Sclerosis Impact Scale Preference-Based Measure (MSIS-PBM). Deterministic and Monte-Carlo simulation-based ICERs were estimated for glatiramer acetate versus symptom management using a lifetime Markov model. RESULTS: For both UK and Dutch perspectives, mapped and condition-specific utility values expressed significantly higher quality of life for the worst health state of the model than did EQ-5D. The ICER of glatiramer acetate with EQ-5D was US$182,291 for The Netherlands and US$153,476 for the UK. Ratios for mapped and condition-specific utilities were between 20 and 60 % higher. CONCLUSION: The overestimation of quality of life of patients with MS by mapped EQ-5D or condition-specific utility values, relative to observed EQ-5D, increases the ICER substantially in a lifetime Markov model.


Subject(s)
Adjuvants, Immunologic/therapeutic use , Glatiramer Acetate/therapeutic use , Multiple Sclerosis/economics , Quality of Life , Adjuvants, Immunologic/economics , Cost-Benefit Analysis , Glatiramer Acetate/economics , Health Status , Humans , Markov Chains , Multiple Sclerosis/physiopathology , Multiple Sclerosis/therapy , Netherlands , Quality-Adjusted Life Years , Severity of Illness Index , Surveys and Questionnaires , United Kingdom
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