Points of View Topics related to care from a pharmaceutical industry perspective

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Minoru Ito, Senior Researcher, Pharmaceutical and Industrial Policy Research Institute

1. Introduction

We hear more and more about "integrated reform of medical and long-term care" and "seamless medical and long-term care delivery systems. However, it has already been argued that in a super-aged society, there is a limit to "medical treatment to cure" alone, and that "medical treatment to cure and support" is required, including medical treatment and nursing care in the final stage of life. 1) The pharmaceutical industry, whose primary focus is on the creation of innovative new drugs, also needs to consider "nursing care". 1) Even in the pharmaceutical industry, which is primarily concerned with the creation of innovative new drugs, the need to consider "nursing care" is likely to increase in the future. In recent years, cost-effectiveness evaluations of pharmaceuticals have begun to include public nursing care costs in their analyses.

The fiscal year 2024 is an important year in which the 8th Medical Care Plan and the 9th Long-Term Care Insurance Business (Support) Plan will be launched simultaneously, while the simultaneous revision of medical and long-term care fees is scheduled once every six years (Figure 1)2). ( Fig. 1) 2) Currently, discussions are being actively conducted toward FY2024. In light of this situation, we conducted a survey and research in order to organize the topics of "long-term care" that should be covered at this time.

Figure 1 Schedule related to medical care and long-term care

(2) Integrated reform of medical care and long-term care

Nationwide, the population aged 65 and over is expected to continue to increase until 2040, and the population aged 75 and over until 2050. In addition, as the aging of society progresses further, the number of patients and users with complex medical and nursing care needs will increase, and the need for medical and nursing care coordination will grow. 3) Figure 24) shows an image of medical and nursing care in the aging process. The image (Fig. 24) shows that medical care and long-term care are inextricably linked, suggesting the importance of coordination between the two.

Figure 2 Image of medical care and long-term care

In order to establish a seamless medical and long-term care provision system, it would be difficult to coordinate the medical plan and long-term care insurance plan if they are prepared separately. Therefore, the system has a "basic policy for comprehensively ensuring medical care and long-term care in the community" (hereinafter referred to as the "policy for comprehensive assurance"), which is a higher level concept and higher level guideline than both plans. Figure 34) shows the relationship between the Comprehensive Security Policy and the medical care plan and long-term care insurance business (support) plan.

Fig. 3 Organization of the relationship between the comprehensive assurance policy and other plans

The new Comprehensive Assurance Policy5) was publicly announced on March 17, 2023, clearly setting the direction for the 8th Medical Plan and the 9th Long-Term Care Insurance Business (Support) Plan. The significance and basic direction of the new policy when compared to the previous policy is shown in Figure 42).

Figure 4 Significance and basic direction of the comprehensive assurance policy

When looking at the new comprehensive security policy, one of the most distinctive points is that "in view of the subsequent decline in the working-age population" is clearly stated in the "Significance" section. Although the term "declining birthrate and aging population" has been used in the past, it would be desirable to distinguish between "aging" and "declining birthrate and population" as keywords when discussing social security in the future. In the report of the Council for the Establishment of an All-Generational Social Security System6) compiled in December 2022 prior to the Comprehensive Security Policy, three points are listed as "future directions of society to aim for," the first of which is "changing the trend of declining birthrates and population. The first of the three points is to "change the trend of declining birthrates and population decline." The report is rich in a sense of crisis, stating that the declining birthrate and declining population will lead to a "shrinking spiral" of the economy and society, including a contraction of production and consumption in economic activities and a decline in social security functions, leading many regional societies to the brink of extinction. The basic direction (2) of the new comprehensive security policy is "securing human resources to provide services and reforming work styles," which states the importance of securing the medical and long-term care human resources necessary for the medical and long-term care delivery system amid the rapid decline in the working-age population, suggesting that the impact of population decline is no longer a situation to be taken lightly. The new policy for securing medical and long-term care personnel is a clear indication that the impact of the declining population is no longer to be underestimated.

The second characteristic of the new policy is the frequent use of the word "region. In the basic direction (1), the policy states the "establishment of a regionally complete medical and long-term care delivery system," and in (5), the policy states the "creation of a regionally symbiotic society," with "region" as another keyword. The term "region" is thought to mean both the importance of ensuring a medical and long-term care delivery system that meets regional conditions, and the importance of local residents supporting each other, given that changes in population composition and trends in medical and long-term care demand differ from region to region. The "Future Direction of Society" in the report of the Council for the Establishment of an All-Generational Social Security System also states "strengthening mutual support in the community" as the third point, and indicates that each community is required to establish a comprehensive care provision system including medical care, long-term care, and welfare, and that it is necessary to strengthen mutual assistance functions in which residents help each other. The basic direction of the Comprehensive Assurance Policy has been separated from the basic direction of the Comprehensive Assurance Policy.

The "Vision of the Medical and Long-Term Care Provision System Post 2025" is presented as an attachment to the Basic Direction of the Comprehensive Assurance Policy. One of the three pillars to be realized is that, through cooperation between medical and long-term care providers, medical care that "heals and supports" people when they need it and flexible and diverse long-term care that attends to individual needs should be available in the community. If the goal is for people to be able to continue to live in their own neighborhoods even if their physical or mental condition deteriorates, this must be accomplished under the circumstances of increasing demand and compounding needs for medical and long-term care services due to the "aging" of the population and decreasing numbers of people with disabilities due to the "declining birthrate and shrinking population. Moreover, the situation is progressing in a speckled manner in each "region. In order to cope with this situation, it is desirable to reconsider the balance between self-help, mutual aid (community support), mutual assistance (mutual support through the insurance system), and public assistance (public burden through taxes). 1) In the past, emphasis tended to be placed on mutual aid (long-term care insurance), but it is expected that self-help and mutual aid will be given more weight in the future. Specifically, the importance of seamless cooperation between home medical care and long-term care is expected to increase. ( It has been pointed out that Western countries are also trying to shift their long-term care policies toward home care. 7) Figure 5 shows a bird's-eye view of the above trends.

Fig. 5 Overview of trends in medical care and long-term care

The pharmaceutical industry needs to consider these trends in its business operations. In drug discovery, it will become more important to develop drugs that also take into account the effects and contributions to nursing care. In addition to dementia, frailty, cardiovascular disease, diabetes8), and other diseases that are the main causes of the need for nursing care, back pain, arthritis, and eye diseases9) related to limitations in daily life are also desirable as specific diseases, and the development of dosage forms suitable for use in home healthcare is expected to become more welcome. Furthermore, given the decrease in the number of medical and nursing care providers, pharmaceuticals that can be administered at longer intervals and are easier to administer, thus reducing the burden on the providers, are also expected to be welcomed. Nakano et al. have examined the various values of pharmaceuticals, including the reduction of nursing care burden (mainly for family caregivers) and medical care burden (human and material). 10) It would be meaningful to consider drug discovery with an awareness that we are approaching a situation in which these values may become even more important.

3. possibility of evaluating "nursing care" in the value of pharmaceuticals

In the previous chapter, we mentioned the importance of drug development that also takes into account the effects and contributions to long-term care, and there is a movement to evaluate "long-term care" in the current system as well: in the "Guidelines for Analysis of Cost-Effectiveness Evaluation in the Central Social Insurance Medical Council, Version 311) " approved in January 2022 (hereinafter "Analysis Guidelines Version 3 In the "Guidelines for the Analysis of Cost-Effectiveness Evaluation in the Central Social Insurance Medical Council" (hereafter referred to as "Guidelines for the Analysis of Cost-Effectiveness Evaluation in the Central Social Insurance Medical Council", 3rd Edition11), it was added that if the impact on public care costs is important for the technology under evaluation, the analysis from the "public medical and nursing care standpoint" may be conducted and if actual data is available, the impact on QOL values on family members and other caregivers and nurses may be taken into consideration. Figure 6 shows an excerpt from the actual description of nursing care costs in the third edition of the Guidelines for Analysis.

Fig. 6 Excerpts from the Guidelines for Analysis of Cost-Effectiveness Evaluation, 3rd Edition, related to nursing care costs

As indicated in 11.2 of the Analytical Guidelines, Version 3, it is recommended that when including public long-term care costs in the cost, the costs should be aggregated by the level of care and support required. In this section, we would like to reexamine the level of care and support required and discuss the possibility of evaluation.

The certification of persons requiring long-term care begins with a certification survey (basic survey) conducted by a municipal certification surveyor. Based on the results of this survey and the attending physician's written opinion, a primary determination is made, followed by a secondary determination by the Long-Term Care Accreditation Board, and certification is then granted by the municipality. 13) (Figure 7)

Fig. 7 Process of certification of long-term care (support required)

In principle, both the primary and secondary determinations are based on the "Standard Time for Certification of Needs for Long-Term Care. The "standard time for certification of persons requiring long-term care, etc." indicates the time required for nursing care (nursing care effort) estimated based on statistical data from the results of the certification survey (ability of the person to be certified, method of assistance, and existence of disabilities or phenomena), in units of "minutes". It is important to note that the standard time required for caregiver certification does not indicate the actual time required for care, but rather indicates the relative degree of caregiving effort required. The level of care required (classification of care required, etc.) is classified as shown in Table 114).

Table 1 Relationship between categories of long-term care status, etc. and standard time for certification of long-term care needs, etc.

The standard time required for caregiving is the sum of the time (nursing care effort) for "direct daily living assistance (subdivided into eating, toileting, moving, and keeping clean)," "indirect daily living assistance," "BPSD-related activities," "functional training-related activities," and "medical-related activities" for each of the eight daily living situations, with the time for each activity category The time for each activity category is calculated based on eight tree models. 15)

The tree model is designed so that the time for each activity category can be obtained by following the cascade. The cascade is determined by the results of the certification survey and the intermediate assessment item scores (calculated from the certification survey results), and the total time of the eight tree models is the standard time for certification of the person in need of care, etc., which determines the level of care required (classification of care status, etc.). In other words, the level of care required is determined based on the standard time required to be certified as needing care, etc., which is operationally estimated from the results of the certification survey. In practice, the primary judgment is made by computer.

Table 2 below shows the eight action categories (tree model names) and time ranges, Figure 8 shows an example of a tree model for "eating," and Figure 9 shows an image of the care requirement certification based on the tree model. 14)

Table 2 Action classification (tree model name) and time display range

Fig. 8 Example of tree model (meal)

Figure 9 Image of the certification of care required by the tree model

In order to tabulate costs by level of care and support required, the key point seems to be the possibility of capturing the impact of pharmaceuticals on the level of care and support required. When we look at the details of the way the nursing care needs are certified, the level of care and support needs are classified by the standard time required for the certification of nursing care, etc. The standard time required for the certification of nursing care can be operationally estimated from the results of the certification survey, which is affected by the effects of pharmaceuticals on symptoms. In other words, it is possible to estimate the impact of the effect of pharmaceuticals on the symptoms on the items of the certification survey by replacing the standard time for certification of long-term care with a numerical value, and to capture changes in the level of care and support required. Therefore, there was no small possibility of evaluating "care" in terms of the value of pharmaceuticals.

On the other hand, it should be noted that there are limitations, such as the large number of basic items in the certification survey (74 items) and the long validity period (review period) for certification (6 months in principle for applications for change of classification and 12 months in principle for renewal applications17).

4. the burden on caregivers

As the third topic related to caregiving, the person providing care (hereinafter referred to as "caregiver. The third topic related to caregiving is the "Basic Survey of Social Life" conducted by the Statistics Bureau of the Ministry of Internal Affairs and Communications, which examines the estimated population of caregivers (hereafter referred to as "caregivers"; family caregivers are considered to be mainly applicable), the time they spend caring for their families, and the extent of their burden. The Basic Survey on Social Life is a statistical survey to compile the Basic Statistics on Social Life based on the Statistics Law, and its purpose is to obtain basic data to clarify the actual status of social life of the population, such as the distribution of living time and the status of major activities during leisure time. The survey has been conducted every five years since 1976, and the 2021 survey is the 10th. The survey targets approximately 190,000 household members aged 10 and over in 91,000 households randomly selected from the households in the designated survey areas (approximately 7,600 survey areas nationwide), making it a sufficiently large scale survey. ( Note that persons residing in social welfare facilities were excluded from the survey. 18)

For this survey, due to data accessibility reasons, the five Basic Social Surveys from 2001 to 2021 were used to compile the results regarding the duration of life (duration of life section, nationwide). 19)

Figure 10 shows the estimated population of caregivers ("caregivers") and non-caregivers ("non-caregivers"), as well as the average daily activity time per person for those who provide care and nursing (average daily activity time per person for those who provide care and nursing only).

Fig. 10 Estimated population by caregiver status and caregiver's hours of care/nursing

The estimated population of caregivers has been increasing since 2001, reaching a high of 6,987,000 in 2016, representing an increase of about 50% in the 15 years since 2001. On the other hand, the time spent by caregivers for nursing and caregiving reached its highest value of 155 minutes in 2001, but has shown a downward trend since then, reaching its lowest value of 139 minutes in 2011, a decrease of about 10% over a 10-year period. In 2021, it was 143 minutes.

In order to continue to take a closer look at how the situation of caregivers is affected by whether or not they are employed, the estimated population was divided into employed persons (those who continue to work for income; helpers in their own businesses are included if they continue to work even if unpaid) and unemployed persons (those who are not employed), as well as those who are not employed. hours of care/nursing care implementation were surveyed. The results are shown in Figure 11.

Fig. 11 Estimated population by employment status of caregivers, and caregiving/nursing time of caregivers

The estimated population of those who provide care has been increasing since 2001, reaching a high of 3,968,000 in 2016, an increase of about 40% in the 15 years since 2001. On the other hand, the estimated population of caregivers without work also showed an increasing trend since 2001, reaching a high of 3,053,000 in 2011 and increasing by about 60% in the 10 years since 2001. The ratio of the employed to the unemployed was 2.501 million in 2021. The ratio of employed to non-employed was about 1:0.68 to 0.78.

The time spent by the employed caregivers for caregiving/nursing was 128 minutes, the highest value in 2001, and showed a decreasing trend thereafter, reaching a low of 105 minutes in 2011; it increased again to 120 minutes in both 2016 and 2021, and could be seen as a flat trend of about 2 hours over the past 20 years. On the other hand, the highest value of 176 minutes was recorded in 2001 for caregivers without a job, but since then it has shown a decreasing trend, reaching its lowest value of 161 minutes in 2021. Comparing the employed and unemployed caregivers, the unemployed tended to spend 1.34 to 1.54 times longer in caregiving and nursing than the employed caregivers.

Continuing with the goal of looking in detail at the differences in the way time is spent (especially time spent on work, leisure, etc., which is a large percentage of time spent) between care providers and non-care providers, we examined the average time spent by actors in work (work with income) and tertiary activities20) (leisure, sports, socializing, etc.) by care providers and non-care providers. The results are shown in Figure 12.

Figure 12 Average duration of work and tertiary activities by caregiving status

The time spent at work showed a slight increase from 430 minutes in 2001 for care providers, but remained mostly in the 440 minute range since 2011; in 2021, it was 441 minutes; in 2021, it was 441 minutes; in 2022, it was 441 minutes; in 2023, it was 441 minutes; in 2024, it was 441 minutes. In 2021, it was 441 min. On the other hand, the time spent on tertiary activities (20) has been increasing slightly from 366 min. in 2001 to a high of 387 min. in 2016 for caregivers. In 2021, it decreased slightly to 377 minutes. In 2021, it was 397 minutes. Comparing caregivers and non-caregivers, the time spent at work was about 40 minutes shorter and time spent on tertiary activities was about 30 to 20 minutes shorter throughout the 20-year period.

These results confirm that there are approximately 3.9 million employed caregivers who spend about 40 minutes less time at work than those who are not employed as caregivers. This result suggests that reducing the burden of caregiving may increase the productive activities of those who are paid caregivers. When converted to the time spent at work by those who do not provide care (approximately 480 minutes), this translates into the creation of productive activities for approximately 325,000 people, which is a burden on a scale that should not be underestimated.

On the other hand, it is assumed that the number of caregivers who are not working includes those who have left the workforce due to caregiving, and it was thought important to examine the extent of this burden. The "Basic Survey of Employment Structure" conducted by the Statistics Bureau of the Ministry of Internal Affairs and Communications was used in the study. The purpose of the survey is to obtain basic data on the employment structure of the nation and by region by examining the status of employment and non-employment among the population. The survey has been conducted every five years since 1982. 21) Although the 2022 survey is the latest survey, the results have not yet been released (as of May 2023), so we used the results of the 2017 survey22) and earlier. Trends in the number of unemployed persons who left their previous job in the past year for nursing/caregiving (2007-2017) are shown in Figure 13.

Figure 13: Unemployed who left their previous job in the past year for nursing or caregiving

The number of unemployed persons who left their previous job in the past year for care/nursing (care leavers) has been decreasing from about 116,000 in 2007 to about 75,000 in 2017; the number decreased by about 32,000 from 2007 to 2012, but the decrease from 2012 to 2017 was only about 0.9 thousand, indicating that the decrease The trend toward a slower decline was evident. The results of the 2022 survey, to be released soon, were thought to warrant close attention.

The burden of caregiving, including those who provide paid care and those who leave care, is thought to be equivalent to the productive activities of about 400,000 people, suggesting that a social burden that should not be underestimated is being generated.

5. summary

Three topics related to long-term care were discussed. First, in the integrated reform of medical care and long-term care, he mentioned that the importance of cooperation between medical care and long-term care is likely to increase in the future, based on three keywords: "aging," "declining birthrate and population," and "community.

The aging of the population is not simply a matter of an increase in the number of people eligible for long-term care; it is also assumed to mean an increase in the complexity of medical and long-term care needs. The "declining birthrate and population" will lead to a decline in the social security function, and it will be difficult to secure the necessary personnel to provide medical and long-term care services. Furthermore, population composition and trends in demand for medical care and long-term care services will vary from one "region" to another. In order to cope with this situation, the importance of self-help and mutual assistance (mutual support in the "community") will increase in the future, and the importance of home medical care and long-term care is expected to grow. As a contribution of the pharmaceutical industry, the development of pharmaceuticals that address not only the main causative diseases that require nursing care, such as dementia, frail, cardiovascular disease, and diabetes, but also back pain, arthritis, and eye diseases that limit daily life, as well as pharmaceuticals that reduce the burden on the patient and formulations suitable for home use would be welcomed. The next question was "What is the value of a pharmaceutical product?

Next, the possibility of evaluating "care" in the value of pharmaceuticals was examined based on the Analytical Guidelines, 3rd Edition. Focusing on the current certification of long-term care needs, we confirmed that the level of care needed (classification of long-term care status, etc.) is determined by the standard time required for certification of long-term care, etc., which is estimated operationally and quantitatively based on a tree model from the results of certification surveys. We believe that it is possible to estimate the effect of pharmaceuticals on the results of certification surveys by converting the effect of pharmaceuticals on symptoms into a numerical value for the standard time required for the certification of long-term care, and to capture changes in the level of care required and the level of support required. Although further study is needed for a more concrete method, we believe that there is no small possibility to evaluate "care" in terms of the value of pharmaceutical products.

Finally, the burden on caregivers was examined based on the Basic Survey of Social Life and the Basic Survey of Employment Structure. As a result, it was confirmed that in 2021, the total estimated population of caregivers will be over 6.5 million, of which approximately 3.9 million will be employed caregivers. In addition, the paid caregivers spent about 40 minutes less time at work than the unpaid caregivers, which was thought to translate into productive activity for about 325,000 people. On the other hand, it was estimated that approximately 75,000 (in 2017) care leavers who left their previous jobs to take care of family members or nursing care were included among the non-working caregivers, which may have affected the productive activities of a total of approximately 400,000 people. In the analytical guideline 3rd edition11), it is stated that productivity loss of family members and others "may be included as an expense under the same conditions and treatment as productivity loss of the individual, if it is clear that productivity of others is lost due to nursing or caregiving" and that the value of pharmaceutical products for productivity loss of care providers We hope that the value of pharmaceuticals in relation to the loss of productivity of caregivers will be fully evaluated in the future.

One of the objectives of the pharmaceutical industry is to contribute to the extension of healthy life expectancy. In the Policy Research Institute News No.658 ), the author introduced that it is inappropriate to judge "health" only by the presence or absence of injury or disease, that it is a comprehensive concept that includes mental and social factors in addition to physical factors, and that the use of long-term care insurance data is considered most appropriate as a complementary indicator for healthy life expectancy. In other words, healthy life expectancy is affected by the state of society and social security supporting the subject, or in other words, the state of the medical and long-term care provision system. Long-term care is also considered important as a complementary indicator to measure healthy life expectancy. The pharmaceutical industry may have many opportunities to think about medical care, but not so many opportunities to think about long-term care. It is clear that the distance between medical care and long-term care will continue to shrink. The pharmaceutical industry should also develop new drugs and businesses with nursing care in mind. 2.

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