The continual evolution of new technologies requires on-going surveillance to improve health care. Countries around the world have established a range of early awareness and alert (EAA) systems implementing various methodologies to identify innovations and filter according to potential value and benefits (Reference Douw and Vondeling1).
There are innumerable sources of information to consider when identifying new technologies. Journal articles, internet scanning, news reports, expert opinion, inventors, and registries of clinical trials and patents are some of the most common sources of knowledge, as well as the industry (Reference Robert, Stevens and Gabbay12).
Planning the future usage of medical technologies is a challenge for decision makers worldwide (Reference Tal19). Since characteristics of health systems differ, as do values, the weight of criteria used to filter beneficial technologies is adjusted according to national and local needs (Reference Packer, Simpson and Stevens11). The developing EAA systems reflect these regional principles.
In Israel, there is obligatory universal coverage with a basic positive list of health services provided to all citizens without any discrimination in line with the National Health Insurance Law (NHIL) of 1994 (9). This law highlights principles of justice, equity, and solidarity. According to the NHIL, each new technology implemented requires an additional targeted budget, which in turn becomes an integral part of the overall budget for the National List of Health Services (NLHS) (Reference Shani, Klang, Haran and Shemer13). All publicly funded health services are registered in this positive list (NLHS). Primary care is provided by four insurers – health funds (health management organizations (HMOs). Other health services are provided by hospitals.
Hospitals in Israel are free to compete and adopt many new and emerging technologies, devices, procedures, and drugs (that are not available in community health services) even in the experimental stage, using their own resources. In comparison, pharmaceuticals and health services in the community are restricted within the NLHS. The insurers supplying services in the community have the option to adopt additional new technologies, but this is not often done due to budget limitations and rigid regulations. The most convenient mechanism for insurers to add such innovations is the supplementary insurance tier. New technologies can also be purchased by the individual through private insurance or directly out of pocket.
OBJECTIVES
This article aims to (i) describe the Israeli strategy for identifying new technologies worthy of adoption on a national level and (ii) raise dilemmas in decision making toward planning policy for innovations in different insurance layers.
Time Span
We would like to focus on three basic time spans in our emerging technology process. When relating to future planning, we can describe our scope relevant to different time periods: short-, medium-, and long-term.
The first time span is immediate to short-term (for the coming year); the second is a medium-term (a period of approximately 3 to 5 years that can be extended to a decade); and the third is long-term planning, 10–20 years or more.
Methodologies used by EAA systems are dynamic and may vary according to time spans and domestic health policy in different countries.
In Israel, the Department of Medical Technology Policy (DMTP, see Supplementary Table, which can be viewed online at www.journals.cambridge.org/thc2012039) at the Ministry of Health (MOH) and the Israeli Center for Technology Assessment in Health Care (ICTAHC) collaborate on horizon scanning to enhance insight into prospective health services for the future. Forecasting activities are conducted simultaneously on national, regional, local, and individual scopes for the three different time spans—short, medium, and long-term, each with unique features, and impact on future planning. Other countries such as England (Reference Packer10) and Austria (Reference Nachtnebel, Geiger-Gritsch, Hintringer and Wild8) focus on short-term EAA up to 3 years. In Israel, different approaches have been applied to operate and regulate these varying time span mechanisms (Table 1). These time-related forecasting pathways vary according to the type of adoption, participants’ involvement, fiscal allowance and the stage of technology lifecycle.
Table 1. Analyzing the Time Spans for Adopting New Health Technologies in Israel
Short-term Planning - Balancing Need With Budget Allocation
In the short-term, two different approaches are used side by side: extraction of emerging technologies from candidate health services presented to the MOH for updating of the NLHS (see appendix) and quarterly health scanning of publications and news on health innovations.
The predominant approach is enacted during the updating process of the NLHS. Immature technologies, which constitute the emerging phase, are identified and examined using criteria on issues of safety, clinical effectiveness, alternatives, pricing, social and ethical values, and national policy (Reference Greenberg, Siebzehner and Pliskin3) to wisely support future implementation within budget limitations.
During evaluation it is often found that scientific evidence needs reinforcement, diminishing the uncertainty parameter, and we therefore, wait another year to present the candidateship of this technology, while gathering additional information. This was the case for the drug eluting stent in 2002, Lucentis (Ranibizumab) for age-related macular degeneration in 2005, spinal neurostimulator for urinary incontinence in 2008, Yervoy (Ipilimumab) for melanoma in 2010, and bone marrow drill for elongation of bone as part of fracture repair (Fitbone) in 2011.
Different filtration criteria and scales are used for filtering beneficial technologies in the different time frames. Grading scale A is used in the short-term frame, and reflects the added value in clinical terms (e.g., life-saving, prolongation of life, improving quality of life) combined with the level of evidence (Table 2).
Table 2. Grading Criteria: Short Time Span (Scale A)
In cases of less mature candidate technologies, they will remain under the umbrella of pending entities, channeled for follow-up and future re-ranking (Reference Golan, Hansen, Kaplan and Tal2;Reference Ham and Locock5).
The second approach in the short-term relates to the scanning process conducted at ICTAHC, using key Internet sources and according to the guidelines as proposed in the EuroScan toolkit (Reference Simpson, Hiller and Gutierrez-Ibarluzea16). Findings from this scanning are integrated in the NLHS update process.
Medium-term Planning: Quality of Care, Professional Competition, and Regulation
Leading professionals identify promising innovations that may be future breakthroughs, and usually aspire to swiftly promote such advanced technologies. The MOH is involved in forecasting and regulating these technologies (especially devices or procedures) due to the economic burden entailed and preparedness required, because they are often dependent on intensive training and costly infrastructure. Other players collaborating in the medium-term process are specialist and professional organizations, providers of health services (such as hospitals and clinics), as well as insurers.
When analyzing medium-term adoption of emerging technologies the MOH has to consider morbidity and mortality trends, demographic changes (population size and characteristics such as age and socioeconomic status), and geographic parameters (that reflect accessibility) (Reference Tal, Sheffer and Vaknin18).
Examples of technologies analyzed using this preparedness strategy include planning for cerebral vascular accident (CVA) units in highly professional intensive care departments, the need for PET-CT in a medical center with specific expertise, and operating and locating an electron-beam center for cancer treatment. All of these assessments must take into account considerations of professional skills, performance ability, cost, and accessibility.
Grading scale B uses the added value of a new technology in comparison to current alternatives, (uniqueness, or complementary or add-on features) combined with costs or the need to invest in infrastructure or training of personnel. Grading scale C uses the added value for the individual (patient-centered technology) versus the benefit to the clinical community as a whole or the medical organization (clinic-centered), combined with cost (Table 3).
Table 3. Grading Criteria (“added value”) for Medium Time Span for Candidate Technologies (Scales B & C)
a Scale B indicates technologies involving infrastructure (e.g., MRI). Scale C indicates devices for individual use (patient-centered) vs. technologies that are part of the equipment located in the clinic available to all patients (clinic-centered) (e.g. glucometer vs. glucose monitoring halter).
Long-term Planning: Complexity of the Process and Uncertainty on the Horizon
Long-term planning of promising medical technologies was engineered in the “Health Israel 2020 Project”, as a part of the WHO agenda for preventive medicine for 2020. This national publicly funded project was created to cover twenty-three spectrums of health care for the entire population focusing on preventive medicine (including anti-hypertensive drugs, statins, etc.), vaccinations, combating obesity, and screening programs (Reference Tal, Marom, Applbaum and Rasooly17). Many stakeholders were involved in this process, headed by the MOH and including the four health funds, professional organizations, national councils, university departments of public health, and health research bodies accompanied by the Treasury (for potential future financial backing and control) and parliament committees (for legal aspects).
Tiers of Potential Loci for Identification of Medical Innovations:
The key features and tiers present in the identification and assessment of innovative technologies in Israel are presented in Table 4. The updating process of the NLHS in Israel is only the first point of intersection in the short-term phase. Other points of intersection in the early recognition of new technologies are the insurers, hospitals and the private sector. The perspectives of the different “actors” in the health scene can be divided into tiers representing the different levels of insurance. They differ in the proportion of the population encompassed, mechanism and frequency of update, mode of action, and contribution to the overall EAA system.
Table 4. Tiers of Potential Loci for Identification of Medical Innovations
a Supplementary insurance.
b Private or additional insurance.
c Note that in some cases, citizens may purchase three different kinds of health insurance simultaneously – the basic health basket + supplementary insurances by the HMO and additional private insurance to top it all up.
NE/ NS, not established/not systematic; ND, non defined; AGA, adoption-geared assessment.
The first tier, based on the annual updating process focuses on identifying, filtering, and comprehensively assessing candidate technologies, and is relevant for the entire population (Reference Ham and Locock5).
Insurers operate on behalf of members of their fund and operate on three levels. The first is part of the MOH updates; the second is the supplementary insurance; and the third is an additional insurance to supply promising emerging technologies that were not yet adopted through the MOH mechanism. These supplementary technologies may be promoted by each insurer on their own initiative (second and third tiers based on age and risk, respectively).
Hospitals operate on a regional basis. Their inspiration to promote new technologies is only partially directed by the MOH, and they are free to innovate within their budgets. They are positively encouraged to compete on quality and innovativeness on the healthcare market. Private healthcare providers have even more opportunities for innovation for their clients. Naturally, their scope is profit-based and customer oriented.
Further filtering scales are warranted to classify the innovativeness and importance (added value) of the technologies investigated at each tier, referring to the different tiers, budget limitations and time perspectives.
DISCUSSION
One of the most important variables in evaluating emerging technologies is timing. There are many points during the development of an innovation when decision makers may become aware of its potential value. An analysis of the EuroScan International Network (www.euroscan.org.uk) database indicates that over a third of the technologies in the database were identified at the investigational phase III stage (Reference Ibargoyen-Roteta, Gutierrez-Ibarluzea, Benguria-Arrate, Galnares-Cordero and Asua6). A quarter of them were identified when they were already established, with another fifth being identified when they were nearly established. This indicates that most innovations in the database are recognized later in the technology's lifecycle, showing that uncertainty leads us to focus on more mature technologies. In this registry, the actual time gap between identification and potential implementation of many of the technologies is relatively short.
The three time spans presented in this article merge into the more distant future, although naturally highlighting the shorter-term perspective.
Identifying and filtering the most beneficial health technologies is critical in planning improvements in health services on a national level. We are confronted by public pressure to provide more advanced health services and caution is needed to overcome uncertainty in the early warning (EAA) process. We, therefore, need to be wise in using the scales mentioned in striving to filter relevantly, reducing uncertainty, and preparing the platform for identifying promising technologies.
In the medium-term, hospitals are leaders in the promotion of advanced devices and procedures. The EAA system aims to assist the government in balancing between two major roles: encouraging the adoption of highly expensive medical devices in hospitals while safeguarding accountability for promoting equity in accessibility to health services for populations residing in geographically peripheral areas and low socioeconomic groups.
Long-term planning is in general a complex feat in all fields. Prophecy was given to the simple “Ever since the fall of the holy temple, it has come to be that prophecy was taken away from the prophets, and given to the infants and the fools” (Talmud, Baba Batra chap. 12, line 2).
Uncertainty is a frail foundation for future decision making. General global trends must be taken into account but carefully adjusted according to Israeli data. For example, adjustments to general Western trends need to be amended due to the fact that the proportion of young people in Israel is higher than in many European countries. Notably, in Israel there are clusters of disease that are ethnic, genetic and specific, requiring unique focused attention by EAA system (Reference Tamary, Bar-Yam and Shalmon20). The shortage of healthcare personnel (nurses and physicians) may also influence the choice of technology for broad future usage.
As in other Western countries, priority setting for budget allocation is a constant source of turmoil. Budget conflicts prevail, challenging policy makers in attempts to divide funds between defense needs, education, health and national infrastructure and also within the realm of individual needs. There is conflict between social and health needs, although they are interrelated. In 2009, the national expenditure allocated for health issues was 7.9 percent of GDP, while for social affairs it was 16.3 percent of GDP (21).
In long-term planning all stakeholders share the burden, responsibility, and accountability. The dilemma entails the balance of influence in the roles of the different participants. Empowering patients and the public as well as private insurers in this process will change the equilibrium. Involvement of the public will integrate values, culture, and habits, and may influence compliance and dissemination (Reference Guttman, Shalev and Kaplan4). These are all concepts that must be considered in EAA activities.
CONCLUSION AND THE FUTURE
Health planning in Israel matches world trends in the field, while being unique in certain aspects. In the Israeli health system the adoption of medical technologies is considered in the short-, medium-, and long-term and incorporates a variety of perspectives and stakeholders. Several different players have an interest in various innovations in different implementation loci (hospitals, community care), for different populations (national, regional, local, individual) and in different tiers of insurance (obligatory, supplementary, private).
Furthermore, the MOH has to deal with regulatory aspects and harmonize dilemmas of need, equity and cost containment. In the long-run, the horizon is cloudy, inhibiting focused decision making and budget tugs-of-war between different sectors of the economy—education, defense, welfare, and health continue. An increased number of stakeholders are involved, each swaying the balance of power in their direction.
An effective EAA system should identify innovations that are likely to have a significant impact (Reference Murphy, Packer, Stevens and Simpson7). To adequately evaluate information, the EAA system needs to establish consistent methodology (Reference Douw and Vondeling1). Ideally, this would help to ensure that important technologies are not overlooked and, conversely, that time is not wasted evaluating unimportant technologies. This methodology should take into account maintaining the system's objectivity while encouraging the flow of information, the feasibility of implementation and sufficient funding (9;Reference Shani, Siebzehner, Luxenburg and Shemer14;Reference Shemer, Shani, Tamir and Siebzehner15). Moving forward, global collaboration between EAA systems would be useful for streamlining processes.
Our crystal ball is immersed with uncertainty. Israel should highlight this subject of preparedness for future needs, initiating comprehensive action toward identifying emerging technologies, prioritizing and filtering on the basis of national values and policy. Caution is needed to balance regulatory control while monitoring quality of care versus the freedom to seek and adopt beneficial innovations. Another possible pathway open to us is enhancing the impact of international collaborations among specialists in the field deliberating on these issues.
SUPPLEMENTARY MATERIAL
Supplementary Table 1: www.journals.cambridge.org/thc2012039
CONTACT INFORMATION
Orna Tal, MD, MHA, Head, Division of Medical Technology Policy, Ministry of Health; Head, Emerging Technology Unit, Israeli Center for Technology Assessment in Health Care (ICTAHC), Gertner Institute to Epidemiology and Health Policy Research, Tel Hashomer, Israel
Nina Hakak, BA, The Israeli Center for Technology Assessment in Health Care, Tel Hashomer, Israel
CONFLICTS OF INTEREST
Orna Tal has received a grant from the National Institute of Health Policy Research, Israel. The other author reports she has no potential conflicts of interest.
APPENDIX
Health Funds – Health services in Israel are delivered by the four healthcare insurance companies (the health funds, also called Health Management Organizations - HMOs) according to reasonable medical judgment, within a feasible time span ensured by reasonable accessibility and within the framework of a restricted budget.
The updating process of the National List of Health Services
The annual appraisal of approximately 400–600 new candidate technologies submitted for public funding by manufacturers, healthcare professionals and organizations, patients and patient organizations, and the general public is performed at the MOH. A professional team of physicians, nurses, pharmacists, and medical engineers supported by a legal advisor and economists, ranks the evidence, and filters each technology, on the basis of safety, effectiveness, and appropriateness according to national needs and values. Grading criteria are detailed in Table 1.
There is an annual timeline for the prioritization process beginning with filtering, grading, and ranking added value, gathering epidemiological data and pricing with final deliberations and recommendations by the Public Committee for legal implementation and funding.
The Public Committee is composed of sixteen to twenty-one members appointed by the Ministers of Health and Finance. The members include at least: four physicians, four economists, the four medical managers of the insurers (HMOs), and four representatives of the public including an ethicist and a cleric. Other representatives may be added such as the medical professional union and the ombudsman. The Committee uses clinical, economic, social, legal and ethical principles in a transparent consensus process. Clinical aspects involve life-saving, prolonging life, or improving quality of life; economic parameters reflect the added value for investment; social aspects include preferences in consideration of large populations or low socioeconomic groups; while ethical dilemmas relate to allocation of resources according to solidarity and equity.
The final recommendations of the Public Committee are approved by the government at the end of the fiscal year, matched to specific budget appropriations and scheduled to be implemented early in the following year.
