The COVID-19 pandemic posed many dilemmas for policymakers, which sometimes resulted in unprecedented decision-making.

BACKGROUND: The COVID-19 pandemic evolved through five phases, beginning with 'the great threat', then moving through 'the emergence of variants', 'vaccines euphoria', and 'the disillusionment', and culminating in 'a disease we can live with'. Each phase required a different governance response. With the progress of the pandemic, data were collected, evidence was created, and health technology was developed and disseminated. Policymaking shifted from protecting the population by limiting infections with non-pharmaceutical interventions to controlling the pandemic by prevention of severe disease with vaccines and drugs for those infected. Once the vaccine became available, the state started devolving the responsibility for the individual's health and behavior. MAIN BODY: Each phase of the pandemic posed new and unique dilemmas for policymakers, which resulted in unprecedented decision-making. Restrictions to individual's rights such as a lockdown or the 'Green Pass policy' were unimaginable before the pandemic. One of the most striking decisions that the Ministry of Health made was approving the third (booster) vaccine dose in Israel, before it was approved by the FDA or any other country. It was possible to make an informed, evidence-based decision due to the availability of reliable and timely data. Transparent communication with the public probably promoted adherence to the booster dose recommendation. The boosters made an important contribution to public health, even though their uptake was less than the uptake for the initial doses. The decision to approve the booster illustrates seven key lessons from the pandemic: health technology is key; leadership is crucial (both political and professional); a single body should coordinate the actions of all stakeholders involved in the response, and these should collaborate closely; policymakers need to engage the public and win their trust and compliance; data are essential to build a suitable response; and nations and international organizations should collaborate in preparing for and responding to pandemics, because viruses travel without borders. CONCLUSION: The COVID-19 pandemic posed many dilemmas for policymakers. The lessons learned from the actions taken to deal with them should be incorporated into preparedness for future challenges.

The Israeli Experience with the "Green Pass" Policy Highlights Issues to Be Considered by Policymakers in Other Countries.

In the first half of 2021, Israel had been ahead of other countries concerning the speed of its rollout and coverage of COVID-19 vaccinations. During that time, Israel had implemented a vaccine certificate policy, the "Green Pass Policy" (GPP), to reduce virus spread and to allow the safe relaxation of COVID-19 restrictions in a time of great uncertainty. Based on an analysis of GPP regulations and public statements compiled from the Israeli Ministry of Health website, we describe the design and implementation of the GPP. We also look back and discuss lessons learned for countries that are considering a GPP policy, given the current upsurge of the Delta variant as of summer 2021. To reduce equity concerns when introducing a GPP, all population groups should be eligible for the vaccine (contingent on approval from the manufacturer) and have access to it. Alternatively, health authorities can grant temporary certificates based on a negative test. We also highlight the fact that in practice, there will be gaps between the GPP regulations and implementation. While some places might require a GPP without legal need, others will not implement it despite a legal obligation. The GPP regulations should have standardised epidemiological criteria, be implemented gradually, remain flexible, and change according to the epidemiological risks.

The effects of continuous glucose monitoring system on patient outcomes and associated costs in a real-world setting.

AIMS: Continuous glucose monitoring system (CGMS) technologies may alert unaware hypoglycaemia or near hypoglycaemia events. However, costs are a significant concern in general CGMS use. This study describes the real-world effects of both clinical outcomes and associated costs in a major Health Maintenance Organization, 1 year following preauthorization of CGMS for each patient. METHODS: Cohort study. Type 1 diabetes patients who were preauthorized CGMS were identified, and their medical records during the year before preauthorization were compared to the following year. Data were collected for glucose control, medical services utilization and related costs. RESULTS: We identified 524 eligible patients, 57% males. Adherence to CGMS use was improved by age. The proportion of patients reaching HbA1c  < 7.5% (58 mmol/mol) increased in the high-adherence group and decreased in the low-adherence group. There were no significant changes in outpatient medical services utilization. However, there was a decrease in emergency room visit rates (30%-19%, p < 0.01) and hospitalization rates (22%-12%, p < 0.01) with the highest decrease among the high-adherence group. Hospitalization duration also decreased. However, the total costs per patient were higher as CGMS adherence increased. CONCLUSION: Continuous glucose monitoring system technologies have the potential of both improving blood glucose control and reducing inpatient utilization. However, CGMS technologies costs may put a significant burden on healthcare systems.

Risk sharing or risk shifting? On the development of patient access schemes in the process of updating the national list of health services in Israel.

Background: Agreements between payers and pharmaceutical/medical device companies are widely implemented to address financial and clinical uncertainties. We analyzed the main characteristics of these agreements in Israel from 2011-2018.Research design and methods: We reviewed all agreements implemented during the study period. Information regarding the type of agreement, therapeutic indications, its time frame and the total budget involved are presented.Results: A total of 56 agreements were signed since 2011, of which 53 (95%) were financial-based and 50 (89%) referred to pharmaceuticals. The annual number of agreements increased from one in 2011 to 21 in 2018. The main therapeutic areas covered were: oncology (41%), hepatitis C (16%), neurology (11%), respiratory (9%), and cardiovascular (7%). The proportion of the annual budget allocated subject to these agreements increased accordingly from 3% in 2011 to 73% in 2018. The majority (63%) of the agreements were signed for 5 years, 9% were shorter-term and 20% have no time-limit. In 14 (44%) of the financial-based agreements implemented through 2017, the actual utilization exceeded the pre-specified threshold and the companies reimbursed the health-plans accordingly.Conclusions: The number of agreements and the allocated budget subject to these agreements increased substantially in recent years. Most agreements are financial-based that, in many cases, shifted the short-term financial risk from health-plans to the industry.

PCSK9 inhibitors may improve cardiovascular outcomes-Can we afford them?

BACKGROUND/OBJECTIVES: Proprotein convertase subtilisin/kexin type 9 inhibitors (PCSK9i) can significantly lower low-density lipoprotein (LDL) cholesterol levels. Early evidence suggests that use of PCSK9i also reduces the incidence of major adverse cardiovascular events (MACE). Our objective was to determine preliminary economic implications of PCSK9i use to avoid MACE, based on the current data from major phase III clinical trials. METHODS: Outcome data of the 4529 patients treated with PCSK9i in the OSLER and ODYSSEY LONG TERM trials were collected from the published reports. Cost of preventing MACE was evaluated based on the existing outcome data and current US prices of PCSK9i. The pooled results were compared to the cost of curing Hepatitis C Virus (HCV) patients with novel HCV drugs. RESULTS: PCSK9i treatment in the OSLER and ODYSSEY LONG TERM trials resulted in prevention of 35 MACE in a total of 4903 patient-years: 8 cardiovascular deaths, 22 myocardial infarctions, 0 strokes and 5 unstable anginas. The cost of PCSK9i drugs consumed during the trial's current follow-up period, could have reached $70,172,141. Therefore, the cost of preventing any MACE would be $2,004,918 and the cost of preventing one death would be $8,777,518. These figures are one hundred fold higher than the cost of curing one HCV patient (~$84,000). CONCLUSIONS: According to the current published data, using PCSK9i to prevent MACE seems to be a very expensive strategy. If upcoming outcome trials will demonstrate similar results, it seems that at current prices, using these drugs would not be affordable for most healthcare systems.

The association between adherence to cardiovascular medications and healthcare utilization.

BACKGROUND: Poor adherence to medications for cardiovascular disease (CVD) is associated with adverse health outcomes, but little is known about its association with healthcare utilization (HCU). OBJECTIVE: To examine whether adherence is associated with a long-term decrease in HCU. METHODS: This is a retrospective cohort study of 1582 patients with CVD who enrolled in Maccabi Healthcare Services in Israel, initiating CVD medication therapy in 2006. Adherence was assessed by the proportion of days covered (PDC) with medications. Patients were defined as: non-adherent (PDC <0.4), partially adherent (0.4 ≤ PDC < 0.8), and fully adherent (PDC ≥0.8). HCU was estimated for 4 years following treatment initiation. Multivariable GEE models were used to analyze predictors of HCU. Model I included total adherence during the entire follow-up period as well as the interaction between this measure and the follow-up year. Model II included previous and current year's adherence as well as previous year's HCU cost. Both models were adjusted for potential confounders including: patient's age, gender, socioeconomic status, ownership of voluntary supplementary health insurance, and comorbidities. RESULTS: The median age of patients was 63 (69 % males). Fifty-four percent of patients (n = 860) were defined as adherent, 24 % as partially adherent and 22 % as non-adherent. Model I: the annual HCU costs of adherent patients decreased by 10 % following treatment initiation [rate ratio (RR) = 0.90, 95 % confidence interval (CI) 0.86-0.94, P < 0.001]. This decrease stemmed predominantly from reduction in hospitalization costs. No significant changes in annual costs following treatment initiation were observed among partially adherent (RR = 1.00, 95 % CI 0.90-1.10, P = 0.935) and non-adherent (RR = 0.98, 95 % CI 0.87-1.10, P = 0.681) patients. Model II: no temporal association was found between adherence and HCU. CONCLUSIONS: Adherence to CVD medications is relatively low. Adherence is associated with long-term decrease in healthcare expenditure. Exploring reasons for the high non-adherence and ways to improve adherence may optimize utilization of health systems' scarce resources.

Determinants of Cost-Related Nonadherence to Medications among Chronically Ill Patients in Maccabi Healthcare Services, Israel.

BACKGROUND: The effectiveness of value-based insurance design is based on nonadherence, which derives solely from patients' economic constraints. OBJECTIVE: Our objective was to examine the extent of cost-related nonadherence to chronic medications and to analyze its potential determinants. METHODS: We conducted a telephone survey among a representative sample of Maccabi Healthcare Services chronically ill patients aged 55 years or older (n = 522). We developed a 12-month recall questionnaire that included demographic and socioeconomic characteristics, out-of-pocket expenditure on prescribed medication, physician's provision of explanation regarding prescribed therapy, adherence, and reasons for nonadherence. Respondents were defined as nonadherent if they reported that they did not purchase prescribed medications in the previous year because of their cost. We applied the multivariable logistic regression model to examine predictors of nonadherence. RESULTS: Median (interquartile range) age of the study sample was 69 (13) years (53% males). One hundred sixty-five patients (31.6%) reported not purchasing prescribed medications mainly because of medications' adverse effects and/or cost. Fifty respondents (9.6%) reported cost-related nonadherence. The multivariable logistic regression model revealed that cost-related nonadherence was associated with respondent's income lower than 4600 New Israeli shekel (odds ratio [OR] = 10.86; 95% confidence interval [CI] 1.45-81.12), unemployment (OR = 4.32; 95% CI 1.47-12.66), lack of physician explanation about the prescribed medication (OR = 2.38; 95% CI 1.18-4.78), and age (OR = 0.95; 95% CI 0.91-0.99). CONCLUSIONS: Cost-related nonadherence to chronic pharmaceuticals is self-reported among nearly 10% of the chronically ill patients and is strongly affected by low socioeconomic status, even under universal health insurance coverage and with relatively low co-payments as applied in Israel. Lack of information provided by physicians regarding the therapy is associated with a higher likelihood of cost-related nonadherence.

[Can linking co-payment for drugs to evidence on treatment value improve health outcomes and contain healthcare costs?].

Co-payment strategies are frequently used by health insurers as a measure of containing healthcare costs. However, co-payments may reduce the use of essential drugs in chronically-ill patients. Recently, value-based insurance designs, where co-payments rates are determined by the value of the treatment, have been introduced in the United States. This review summarizes the results of recent studies in the United States, suggesting that reducing co-payments for highly valued treatments and raising co-payments for less effective treatments can lead to better compliance and better outcomes, with the potential of reducing long-term costs. Further research is needed to examine the feasibility of this approach and the long-term impact on quality of care and treatment costs in other healthcare systems, including Israel.