Papers by Gary M Ginsberg
JAMA network open, Feb 23, 2023
IMPORTANCE New dosing options for immune checkpoint inhibitors have recently been approved by the... more IMPORTANCE New dosing options for immune checkpoint inhibitors have recently been approved by the US Food and Drug Administration (FDA), including fixed dosing with extended intervals. Although the dose intensity appears the same, there is expected to be some waste with extendedinterval dosing, as some drug remains in the bloodstream once a decision to stop treatment is made. The economic impact of extended-interval fixed dosing is unknown compared with standardinterval fixed dosing. OBJECTIVE To analyze the potential health care costs of using extended-interval fixed dosing instead of standard-interval fixed dosing. DESIGN, SETTING, AND PARTICIPANTS This economic evaluation used a pharmacoeconomic model to simulate 2 cohorts of patients with platinum-resistant metastatic urothelial cancer receiving pembrolizumab as second-line therapy at different dosing intervals using 2020 pricing data. Data were analyzed from 2020 to 2022. EXPOSURES The simulated patients received FDA-approved regimens of either 200 mg every 3 weeks or 400 mg every 6 weeks. MAIN OUTCOMES AND MEASURES The progression-free survival curve from the KEYNOTE-045 trial was used to estimate treatment duration. Drug, imaging, and administration costs were included in analyses. Sensitivity analyses were performed to assess how different imaging frequencies would affect the model results. The potential overall costs of using the 2 different dosing strategies were assessed. The base case was set in the US, while sensitivity analyses were set in several other countries. RESULTS In the base case analysis, dosing every 6 weeks instead of every 3 weeks resulted in an estimated 8.9% increase in pembrolizumab costs for the health care payer. Accounting for a decrease in infusion costs would result in an estimated net additional cost of $7483 per patient in the US (7.9% cost increase). In the US, this would amount to an increase of approximately $28 million annually for health care payers. Similar percentages in cost estimate increases were found for health care payers around the world, such as in Israel, where the net additional cost would be $5491 per patient. CONCLUSIONS AND RELEVANCE This economic evaluation assessed and quantified the potential increased costs related to extended-interval fixed dosing of pembrolizumab. The model method could be applied to other diseases and other drugs for which there has been a movement toward extended-interval dosing. Results may differ in other diseases owing to differing disease courses and patient profiles.
PLOS ONE, 2018
To investigate the impact of auditory stimulation on motor function in children with cerebral pal... more To investigate the impact of auditory stimulation on motor function in children with cerebral palsy (CP) and disabling hypertonia. Method 9 matched pairs (age: 7y5m, SD 4y1m; 13 boys; gross-motor-functional-classificationscale: median 4; manual-ability-classification-system: median 4) were randomized to receive either auditory stimulation embedded in music (study, n = 9) or music alone (sham, control, n = 9) for at least 10 minutes 4 times a week for 4 weeks. Goal-Attainment-Scale, Care-and-Comfort-Hypertonicity-Questionnaire, Gross-Motor-Function-Measure and Quality-of-Upper-Extremity-Skills-Test (QUEST) were assessed before and 5 months following intervention. Result Children receiving auditory stimulation attained more goals than children who listened to music alone (p = 0.002). Parents reported improved care and comfort in children in the study group compared to a slight deterioration in controls (p = 0.002). Upper extremity skills improved in the study group compared to controls (p = 0.006). Similar gross motor function changes were documented in both groups (p = 0.41). One participant reported increased seizure frequency; no other participants with epilepsy reported increased seizure frequency (n = 6/18) and no other adverse events were reported.
International journal of rehabilitation research. Internationale Zeitschrift fur Rehabilitationsforschung. Revue internationale de recherches de readaptation, Jan 19, 2016
Although caregiving for stroke survivors is usually long-term, most studies on caregivers have ge... more Although caregiving for stroke survivors is usually long-term, most studies on caregivers have generally involved only the first year following the event. We assessed and compared the long-term level of well-being measures among stroke survivors and their caregivers at more than 1 year following the stroke event and examined the associations between well-being, survivors' characteristics, and caregiver burden. We interviewed a convenience sample of 51 community-dwelling stroke survivors, at least 1 year after the last stroke event, and their primary caregivers. Disability of survivors was assessed using the Barthel index and the modified Rankin Scale; health-related quality of life by the SF-36 questionnaire; and depression and anxiety using the Hospital Anxiety Depression Scale. Caregivers filled the SF-36 questionnaire, Hospital Anxiety Depression Scale questionnaire, and the Zarit Burden Interview, which assesses caregiver burden. Caregivers reported low levels of health-rela...
Israel journal of medical sciences, 1996
The objective of this part of the first cross-section of the longitudinal study of a cohort of 70... more The objective of this part of the first cross-section of the longitudinal study of a cohort of 70 year olds in Jerusalem was to survey the gastrointestinal symptoms and signs of this heterogeneous population and thus contribute to the knowledge of the development of gastrointestinal diseases in this age group. A total of 605 persons replied to a home-visit questionnaire gathering data on socioeconomic and migration variables. Later on, 463 of these attended an examination at the Geriatric Research Institute where an in-depth anamnesis and physical examination were conducted. A battery of biochemical and hematologic blood tests were performed as well as urine analysis, ECG, and pulmonary function tests. At 3 year follow-up, the interviewed subjects, subjects examined in the hospital, and the control group consisting of 70 year olds who were not examined, were compared. By the measures of disease-specific mortality and hospital morbidity, the three groups were found to be similar, dem...
Israel Journal of Health Policy Research, 2014
Background: External cephalic version (ECV) is infrequently performed and 98% of breech presentin... more Background: External cephalic version (ECV) is infrequently performed and 98% of breech presenting fetuses are delivered surgically. Neuraxial analgesia can increase the success rate of ECV significantly, potentially reducing cesarean delivery rates for breech presentation. The current study aims to determine whether the additional cost to the hospital of spinal anesthesia for ECV is offset by cost savings generated by reduced cesarean delivery. Methods: In our tertiary hospital, three variables manpower, disposables, and fixed costs were calculated for ECV, ECV plus anesthetic doses of spinal block, vaginal delivery and cesarean delivery. Total procedure costs were compared for possible delivery pathways. Manpower data were obtained from management payroll, fixed costs by calculating cost/lifetime usage rate and disposables were micro-costed in 2008, expressed in 2013 NIS. Results: Cesarean delivery is the most expensive option, 11670.54 NIS and vaginal delivery following successful ECV under spinal block costs 5497.2 NIS. ECV alone costs 960.21 NIS, ECV plus spinal anesthesia costs 1386.97 NIS. The highest individual cost items for vaginal, cesarean delivery and ECV were for manpower. Expensive fixed costs for cesarean delivery included operating room trays and postnatal hospitalization (minimum 3 days). ECV with spinal block is cheaper due to lower expected cesarean delivery rate and its lower associated costs. Conclusions: The additional cost of the spinal anesthesia is offset by increased success rates for the ECV procedure resulting in reduction in the cesarean delivery rate.
Value in Health, 2013
A533 Objectives: SHIFT examined the effect of adding ivabradine, a heart rate lowering therapy, t... more A533 Objectives: SHIFT examined the effect of adding ivabradine, a heart rate lowering therapy, to optimised standard therapy in chronic heart failure (HF) patients (n= 6505). This study reports methods and results for an analysis of SHIFT patient quality of life data used to inform the UK cost-effectiveness analysis for ivabradine. MethOds: EQ-5D quality of life data were collected for patients in countries with a validated questionnaire (n= 5313). EQ-5D data were analysed using regression techniques appropriate for repeated observations across individuals over time. Results: Ivabradine was associated with a significant gain in patient quality of life (utility). Utility values were estimated to range between 0.82-0.46 [standard care, New York Heart Association (NYHA) class I-IV] and between 0.84-0.47 (ivabradine, NYHA I-IV). Hospitalisations were strongly associated with a reduction in utility, this reduction varied according to NYHA class from-0.07 (NYHA I) to-0.21 (NYHA IV). Patients with more severe heart failure symptoms (NYHA III and IV), were found to suffer a greater loss in utility given a hospitalisation than patients with milder symptoms (NYHA I and II). cOnclusiOns: Ivabradine was associated with a significant improvement in quality of life. In addition, hospitalisation was found to significantly reduce patient quality of life; ivabradine is consequently expected to convey further quality of life benefits by avoiding the temporary utility loss associated with hospitalisations. Cumulatively, over a patient's life time, this may generate important gains in quality of life for ivabradine versus standard care.
Obesity is a serious risk factor for many chronic diseases. It is also quite an expensive one, ge... more Obesity is a serious risk factor for many chronic diseases. It is also quite an expensive one, generating direct health service costs of approximately NIS 1.14 billion, which is equivalent to 0.16% of Israel's Gross Domestic Product – or 2% of the country's health expenditure. The objective of the study was to assist Israeli policymakers in their efforts to prioritize interventions to prevent and treat obesity in Israel by calculating cost-effectiveness ratios of relevant interventional modalities. Cost-utility ratios of three interventional modalities for the prevention and treatment of obesity – dietary counseling, pharmaceutical interventions and bariatric surgery – were calculated by building a model using primary Israeli data for dietary counseling interventions, as well as by adapting data from the published literature to epidemiological and economic parameters characterizing Israel for all three interventional modalities. Public health interventions such as those deli...
International Journal of Public Health, 2016
Objectives Using cost-utility analysis, to evaluate whether or not to adopt a Neisseria meningiti... more Objectives Using cost-utility analysis, to evaluate whether or not to adopt a Neisseria meningitidis serogroup B vaccination programme for Israeli children. Methods Epidemiological, demographic, health service utilisation and economic data were integrated into a spreadsheet model to calculate the cost per averted disability-adjusted life year (DALY) of the intervention. Results Assuming 78 % vaccine efficacy with no herd immunity, vaccination will prevent 223 cases and 22 deaths over a 100-year period.
Journal of Autism and Developmental Disorders, 2006
There are few well-standardized measures of conversational breakdown in Autism Spectrum Disorders... more There are few well-standardized measures of conversational breakdown in Autism Spectrum Disorders (ASD). The study's objective was to develop a scale for measuring pragmatic impairments in conversations of individuals with ASD. We analyzed 46 semi-structured conversations of children and adolescents with high-functioning ASD using a functional linguistic paradigm. Five constructs were developed that assessed difficulties related to the pragmatics of conversation: atypical intonation; semantic drift; terseness; pedantic speech; perseveration. The scale shows good inter-rater reliability and variation in the scales is not simply a reflection of IQ or language competence. This tool represents a way of characterizing language use in ASD and is an initial step towards developing a tool to evaluate change in degree of social impairments in conversation.
Digestion, 2002
Background and Aims: Padma Lax, a complex Tibetan herbal formula for constipation was evaluated f... more Background and Aims: Padma Lax, a complex Tibetan herbal formula for constipation was evaluated for safety and effectiveness in treating constipation-predominant irritable bowel syndrome in a 3-month double-blind randomised pilot study. Methods: Patients were recruited from Hadassah Hospital's Gastroenterology clinic, using the Rome I Criteria for irritable bowel syndrome, and the international consensus criteria for constipation. Symptom severity was evaluated monthly by patients and gastroenterologist, using categorical and numerical rating scales. A patient diary recorded daily stool habit and trial medication. Results: In 61 patients, (34 Padma Lax, 27 placebo), significant improvement was demonstrated after 3 months in the Padma Lax group compared to placebo in constipation, severity of abdominal pain, and its effect on daily activities, incomplete evacuation, abdominal distension and flatus/flatulence. A global assessment indicated that significantly more Padma Lax patients, compared to placebo, rated the current treatment superior to previous therapies tried for irritable bowel. Laboratory parameters displayed no clinically significant changes. Side effects, primarily loose stools in 7 Padma Lax patients responded well to lowering treatment dosage from 2 to 1 capsule/day. Conclusions: Padma Lax is a safe and effective treatment for constipation-predominant irritable bowel syndrome and may offer an alternative to the current multi drug approach.
Israel Journal of Health Policy Research, 2018
Background: Passive immunization against RSV (Respiratory Syncytial Virus) is given in most weste... more Background: Passive immunization against RSV (Respiratory Syncytial Virus) is given in most western countries (including Israel) to infants of high risk groups such as premature babies, and infants with Congenital Heart Disease or Congenital Lung Disease. However, immunoprophylaxis costs are extremely high ($2800-$4200 per infant). Using cost-utility analysis criteria, we evaluate whether it is justified to expand, continue or restrict nationwide immunoprophylaxis using palivizumab of high risk infants against RSV. Methods: Epidemiological, demographic, health service utilisation and economic data were integrated from primary (National Hospitalization Data, etc.) and secondary data sources (ie: from published articles) into a spread-sheet to calculate the cost per averted disability-adjusted life year (DALY) of vaccinating various infant risk groups. Costs of intervention included antibody plus administration costs. Treatment savings and DALYs averted were estimated from applying vaccine efficacy data to relative risks of being hospitalised and treated for RSV, including possible long-term sequelae like asthma and wheezing. Results: For all the groups RSV immunoprophylaxis is clearly not cost effective as its cost per averted DALY exceeds the $105,986 guideline representing thrice the per capita Gross Domestic Product. Vaccine price would have to fall by 48.1% in order to justify vaccinating Congenital Heart Disease or Congenital Lung Disease risk groups respectively on pure costeffectiveness grounds. For premature babies of < 29 weeks, 29-32 and 33-36 weeks gestation, decreases of 36.8%, 54.5% and 83.3% respectively in vaccine price are required. Conclusions: Based solely on cost-utility analysis, at current price levels it is difficult to justify the current indications for passive vaccination with Palivizumab against RSV. However, if the manufacturers would reduce the price by 54.5% then it would be cost-effective to vaccinate the Congenital Heart Disease or Congenital Lung Disease risk groups as well as premature babies born before the 33rd week of gestation.
BMC Public Health
Background Between 2011 and 2015, Men who have sex with men (MSM) accounted for nearly half of ne... more Background Between 2011 and 2015, Men who have sex with men (MSM) accounted for nearly half of new HIV cases among men in Israel. This study carries out a cost-utility analysis of PrEP (HIV Pre Exposure Prophylaxis), an antiretroviral medication that can protect against the acquisition of HIV infection, whose incidence rate in Israel is around 1.74 per 1000 MSM. Method Epidemiological, demographic, health service utilisation and economic data were integrated into a spread-sheet model in order to calculate the cost per averted disability-adjusted life year (DALY) of the intervention from a societal perspective, in mid-2018 US$ using a 3% discount rate. Cost utility analyses were performed for both types of PrEP delivery (continuous regimen and on-demand), together with sensitivity analyses on numbers of condom users who take up PrEP (baseline 25%) and subsequently abandon condom use (baseline 75%), PrEP efficacy (baseline 86%), PrEP prices and monitoring costs. Results Around 21.3% o...
Israel Journal of Health Policy Research, 2016
Background: The present permanent deferral policy in Israel for MSM was established in 1977 and w... more Background: The present permanent deferral policy in Israel for MSM was established in 1977 and was based on the previous (now outdated) USA Food and Drug Administration standards. This study analyses epidemiological data regarding blood donations among MSM, in order to estimate the risk for HIV transfusion transmitted infection (TTI) if the policy is changed to allow at-risk MSM to donate blood. Methods: An Excel based spreadsheet model integrated demographic, epidemiological data from the HIV National Register, laboratory, blood donation and testing data in order to calculate TTI due to false-negatives in known HIV+ donors, windows period donations, asymptomatic carriers and laboratory misclassification errors. A sensitivity analysis of our estimated TTIs for deferral periods for MSM was performed based on a literature review regarding this overall policy issue worldwide. Results: MSM in Israel have a considerably higher relative risk (RR) of both prevalence (115) and incidence (143) of being HIV+ than persons without a risk factor. Allowing MSM to donate blood, without any deferral period, will add an additional five HIV TTI cases over the next decade. Imposition of a 1 or 5 years deferral of abstinence will increase the number of HIV TTI cases only by 0.10 and 0.05 cases, respectively. Conclusion: A 1 year deferral period for blood donations from MSM in Israel is recommended.
Background: Obesity is a major risk factor for many diseases. The paper calculates the economic i... more Background: Obesity is a major risk factor for many diseases. The paper calculates the economic impact and the cost per Quality-Adjusted Life Year (QALY) resulting from the adoption of eight interventions comprising the clinical and part of the community components of the National Prevention and Health Promotion Program (NPHPP) of the Israeli Ministry of Health (MOH) which represents the obesity control implementation arm of the
BACKGROUND Standardized mortality ratios (SMRs) are used internationally to compare health status... more BACKGROUND Standardized mortality ratios (SMRs) are used internationally to compare health status across regions and to identify high risk areas for investigation of specific diseases, for funding determination, and for planning purposes. OBJECTIVE To ascertain regional differences in SMRs by sub-District in Israel for 1987-1994. METHOD The indirect method of standardization of mortality rates with adjustment for age, gender, and continent of birth was used to calculate SMRs by major cause of death, by sub-District of residence for the Jewish population of Israel. RESULTS SMRs for all causes of death ranged from regions with low rates (Petah Tikva, Sharon, Rehovot, Ashkelon, and Jerusalem) to those with high rates (Zefat/Golan, Hadera, Yizreel, Ramla, Haifa, Tel Aviv, and Be'er Sheva) (all p<0.0001). Zefat's SMRs are elevated for acute myocardial infarction, stroke, diabetes, and motor vehicle accidents (MVAs). Haifa's SMRs are high for all cardiovascular diseases, li...
Israel Journal of Health Policy Research, 2016
Background: The present permanent deferral policy in Israel for MSM was established in 1977 and w... more Background: The present permanent deferral policy in Israel for MSM was established in 1977 and was based on the previous (now outdated) USA Food and Drug Administration standards. This study analyses epidemiological data regarding blood donations among MSM, in order to estimate the risk for HIV transfusion transmitted infection (TTI) if the policy is changed to allow at-risk MSM to donate blood. Methods: An Excel based spreadsheet model integrated demographic, epidemiological data from the HIV National Register, laboratory, blood donation and testing data in order to calculate TTI due to false-negatives in known HIV+ donors, windows period donations, asymptomatic carriers and laboratory misclassification errors. A sensitivity analysis of our estimated TTIs for deferral periods for MSM was performed based on a literature review regarding this overall policy issue worldwide. Results: MSM in Israel have a considerably higher relative risk (RR) of both prevalence (115) and incidence (143) of being HIV+ than persons without a risk factor. Allowing MSM to donate blood, without any deferral period, will add an additional five HIV TTI cases over the next decade. Imposition of a 1 or 5 years deferral of abstinence will increase the number of HIV TTI cases only by 0.10 and 0.05 cases, respectively. Conclusion: A 1 year deferral period for blood donations from MSM in Israel is recommended.
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Papers by Gary M Ginsberg