Points of View Trends in the Calculation of New Drugs, Focusing on the Supplementary Drug Pricing -Survey including the three times of NHI listing after the reform of NHI drug price system in FY2024

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Research Institute for Pharmaceutical Industry Policy Research (RIPIPRI)

SUMMARY

1. Introduction

NHI (National Health Insurance) drug prices for new drugs in Japan are determined based on the rules stipulated in the "Standards for Calculating NHI Drug Prices " ¹⁾. 1 ⁾ The system for calculating NHI drug prices for new drugs has undergone various changes since the "Report of the Advisory Committee on the Calculation of NHI Drug Prices for New Drugs " ²⁾ was adopted in 1982 by the "Advisory Committee on the Calculation of NHI Drug Prices for New Drugs," a private consultative body of the Director of the Medical Affairs Bureau of the Ministry of Health and Welfare. In particular, the system of "supplemental cost" has changed over time as a system to evaluate the value and innovation of drugs, and has been expanded and improved in various ways in the NHI drug price reform in FY2024. In the NHI drug price reform of FY2024, various enhancements were ^made3).

This report examines and discusses the NHI drug price calculation for new drugs before and after the 2024 NHI reform based on publicly available information, focusing mainly on the "supplemental fee" system.

Survey Methodology

For drugs containing new active ingredients that were listed as new drugs from April 2018 to August 2024, information on NHI prices at the time of listing (NHI price calculation method, supplemental fee, and supplemental fee for promotion of new drug creation and resolution of off-label drug use (hereinafter referred to as "supplemental fee for new drug creation, etc.")) was obtained from the Central Social Insurance Medical Council's "List of New Medical Drugs " ⁴ The same ingredients and the same dosage form were obtained from ^the Central Social Insurance Medical Council (hereinafter referred to as the Chuikyo). The same ingredient and the same dosage form were counted as one.

The NHI drug price system is reformed every two years, and various changes are made each time. However, starting in FY2018, the same system of supplemental cost adjustment was introduced for the cost accounting method as for the similar drug effect comparison method, and the supplemental cost adjustment was added to the overall NHI drug price. In addition, the existing requirement that the "deviation rate (the difference between the actual market price and the NHI price) be below average" was abolished for the additional fee for new drug creation, etc., and the eligible items were limited to drugs for rare diseases, drugs that obtained an additional efficacy benefit when listed on the market, and drugs with a new mechanism of action, etc. ⁵⁾ The impact of the FY2018 overhaul has already been investigated and analyzed in previous Policy Research Institute ^News5), and in order to conduct a survey of the various supplemental systems, such as the supplemental price supplement, focusing on the FY2012 reform of the NHI drug price system, it was necessary to exclude changes due to the FY2018 overhaul by limiting the survey to drugs listed in FY2018 and later. Therefore, the period covered by this report is from April 2018 to August 2024.

In addition, since the NHI drug price system is subject to various changes after FY2018 due to biennial reforms, it is not possible to compare all drug prices for multiple fiscal years in many respects. In fact, the additional fee for the creation of new drugs has been subject to additional requirements each time the system is reformed, so this report compares the two-year period for each reform. On the other hand, the changes made to the supplemental drug price index in FY2020 and FY2022 were ^{limited6,7,8)}, and there were no changes to the additional drug price index for usefulness, marketability, and pediatric drugs in particular. However, there are still only three accessions in FY2024 (30 new active ingredient-containing drugs), which is fewer in number than the data before the reform (243 new active ingredient-containing drugs accessioned in FY 2018-2023). Therefore, it should be presented in advance that this paper is a tentative survey and analysis of the impact of the FY2024 NHI drug price reform on the calculation status, mainly the supplemental fee, based on the data available at this time.

Next, the analysis is presented in 2-1 to 2-3.

2-1. Calculation Method

The calculation methods applicable to drugs containing new active ingredients are mainly the comparable drug effect method and the cost accounting method (Figure 1). There are two types of similar drug effect comparison methods (I) and (II), but the similar drug effect comparison method (II) is not subject to the correction addition. Therefore, we investigated the overall trend of the percentage of drugs listed as new drugs containing new active ingredients that fell under the similar drug effect comparison method (I) and the cost accounting method, as well as the trend by dosage form.

2-2. additional compensation

The supplemental medicines that may be applicable to drugs containing new active ingredients when they are listed on the market are: the addition to the usefulness system, which is an addition to the evaluation of innovation and usefulness in terms of efficacy and safety (addition to the usefulness system, addition to the usefulness system (I), and addition to the usefulness system (II)); the addition to the evaluation of drugs with a small market size but high medical necessity (addition to the marketability system (I), addition to the marketability system (II)); and the addition to the costing system (II), which is a supplement to the evaluation of the effectiveness of the drug in terms of safety, efficacy, and other factors. ), additional fees to evaluate drugs with a small market size but high medical necessity (additional fee for marketability (I), additional fee for marketability (II), additional fee for specific uses, additional fee for pediatric use), and additional fees established as an incentive for early launch in Japan (additional fee for pioneering and additional fee for rapid introduction) (Table 1).

In the NHI drug price reforms of 2024, the evaluation of innovation was expanded to address the drug lag/drug loss that has emerged, and many changes were made to the system for the various additions (Table 2). Specifically, the addition of additional requirements to the Additional Allowance for Product Usefulness (Table 3), which is an addition to the Additional Allowance for Product Usefulness to evaluate the usefulness of drugs, the flexible use of additional allowances for marketability and pediatric drugs, the establishment of an additional allowance as an incentive for early introduction into Japan, and the addition of new drugs to be covered under the Additional Allowance for Drug Discovery, which is a system to maintain drug prices after listing on the market. Although it is undeniable that data may be insufficient for an accurate analysis since only three drug price revisions (April, May, and August) have been listed since the NHI price reform in FY2024, we investigated the extent of the impact of these system changes at this point in time.

2-3 Additional Factors in the Cost Accounting Method

As mentioned above, a system of supplemental cost accounting was introduced in the cost accounting system in FY2018, similar to the similar drug effect comparison system, but at the same time an addition factor system was also introduced. The addition factor is a coefficient set in the range of 0 to 1 according to the ratio of the amount that can be disclosed to the NHI drug price calculation ^{organization9,10)} out of the total product cost of a drug. If an item calculated using the cost accounting method falls under the addition factor, the value calculated by multiplying the rate of the assessed addition factor by this addition coefficient is the rate of addition reflected in the actual NHI price. In other words, if the addition factor is 0, even if the addition is evaluated, it will not be reflected in the NHI price. We investigated the status of the addition factor. Since there was no change in the addition factor system in the FY2024 NHI drug price reform, no comparison was made for this item between FY2024 and FY2023.

Results

3-1. Current Status of Calculation Method

(1) Ratio of calculation method (annual change)

Regarding the calculation methods used for drugs containing new active ingredients listed from FY 2018 to FY 2024 (April, May, and August for FY 2024), we investigated the number and ratio of drugs using the comparable drug effect method (I) and the cost accounting method. The results showed that although there were some fluctuations from year to year, the similar drug effect comparison method (I) was used more frequently, and in recent years, the similar drug effect comparison method (I) accounted for approximately 70% and the cost accounting method for approximately 30%. The ratio was the same as in the previous fiscal years (Figure 2).

(2) Ratio of calculation method (annual changes by mode of administration)

The results of the survey showed that the cost accounting method was used in some cases for injectable drugs, while the cost accounting method was used in others (Fig. 2). The same level has been observed after the NHI drug price reform in FY2024.

3-2. Current Status of Corrective Additions, etc.

(1) Types of supplementary fees and changes in the NHI drug price reform in 2024

The supplementary fee system has been expanded year by year as a system for evaluating the value of pharmaceuticals in response to changes in the drug discovery environment, the expansion of the value of pharmaceuticals, and changes in the pharmaceutical affairs system, etc. A pediatric supplement was introduced in 2006, a pioneer supplement in 2014, and a specific use supplement in 2022 (Table 1). In addition, the 2024 reform of the NHI drug price system will include the establishment of an additional fee for expedited introduction, the addition of requirements for the additional fee for usefulness (e.g., different drug discovery and manufacturing processes, limited patient population based on mechanism of action, improvement in secondary evaluation items such as quality of life), flexible application of the additional fee for marketability and pediatric use, and additional fees related to drug prices during patent term. Although only three new drugs have been listed since the NHI drug price reform in FY2024 (April, May, and August), 30 drugs containing new active ingredients have been listed so far, and the following table shows the status of the addition of new active ingredients for the purpose of evaluating the addition of new active ingredients. The following is a tentative survey of trends in the Supplemental New Drug User Fee, the Marketability/Pediatric Supplemental New Drug User Fee, and the New Drug Creation Supplemental New Drug User Fee, in order to see how they are faring.

(2) Current status of additional fee for usefulness

First, we examined the applicability of the additions to the usefulness-based system by examining the percentage of drugs listed in FY2018 or later containing a new active ingredient that fell under the additions to the usefulness-based system, the additions to the usefulness-based system (I), and the additions to the usefulness-based system (II), by similar drug effect comparison method (I) and cost accounting method. The percentage of all usefulness-based additions was 42% (64/153) in FY2018-2023 for the similar drug effect comparison method (I), but 70% (14/20) in April-August 2024, and 70% (49/70) in FY2018-2023 for the cost accounting method, but 100% (10/10) in April-August 2024, showing a significant increase after the FY2012 NHI drug price reform. The figure increased significantly after the reform of the NHI drug price system in FY2024 (Figure 3-1, left). In particular, the change in the percentage of cases that fall under the "additional fee for usefulness (I)" is particularly significant for all calculation methods, increasing from 7% (11/153) to 20% (4/20) for the similar drug efficacy comparison method (I) and from 14% (10/70) to 40% (4/10) for the cost accounting method. The percentage of items that fell under the "additional fee for usefulness" tended to increase after FY2021 for all calculation methods, and the percentage of items that fell under the "additional fee for usefulness" was the highest during the survey period from April to August 2024 (Figure 3-1, right; similar drug effect comparison method (I): 70%, cost accounting method (I): 70%, cost accounting method (II): 40%). ): 70%, cost accounting method: 100%). The percentage of items that qualified for the "additional fee for usefulness" (i.e., the "additional fee for usefulness" and the "additional fee for usefulness (I)"), which have the highest percentage among the additional fee for usefulness, has been increasing since FY2023 for both calculation methods, and the percentage for the cost accounting method was the highest from April to August 2024 (Figure 3-1, right; similar drug effect comparison method (I): 20%; cost accounting method: 50%). (Figure 3-1, right, Comparable drug effect comparison method (I): 20%, Cost accounting method: 50%).

Next, we examined the addition rate of the additional benefit system, examining the average addition rate of the additional benefit system for drugs containing new active ingredients calculated by the similar drug effect comparison method (I) or the cost accounting method in FY 2018 and later. The average addition rate of the addition of usefulness system was higher in FY 2018 (18.3%) and FY 2024 (20.8%), when the addition of breakthrough efficacy was applicable, than in the other periods. Compared to the average of all items (the addition rate is calculated as 0% for items that do not qualify for the addition rate), the rate was less than 10% until FY2022, but exceeded 10% for the first time in FY2023 at 12.3%, and exceeded 15% for the first time in April to August 2024 at 16.7% (see Figure 3-2, top). Since the addition of the additional fee for staggered delivery has a particularly large addition rate and the presence or absence of applicable items has a large impact on the average value, we also examined the average value excluding the additional fee for staggered delivery to confirm the trend of the additional fee for usefulness (I) and (II). As a result, the average value after exclusion was the highest during the survey period in FY2024 (Figure 3-2, top, dashed line). By method of calculation, the comparable drug price method (I) showed similar levels in FY2023 and FY2024, while the cost accounting method showed higher values in FY2024 than in FY2023 (Figure 3-2, bottom middle line).

With regard to the requirements for the additional efficacy-based payment, which were expanded under the FY2024 NHI drug price reform, there have been cases of 1) -d (different drug discovery and manufacturing process), 1) -e (no new drug listed for a long time with a new mechanism of action in the target therapeutic area), and 3) -f (improvement in an important secondary endpoint) for 2 ^drugs11) (Table 4). ).

(3) Additional fee for marketability and additional fee for pediatric patients

First, we examined the status of additions for marketability and additions for pediatric patients: for drugs containing new active ingredients listed in FY 2018 or later, we surveyed the percentage of drugs that fell under additions for marketability ((I) or (II)) and additions for pediatric patients, by similar drug effect comparison method (I) and cost accounting method calculation method, and found that the percentage of drugs that fell under either of the above additions was The percentage of pharmaceuticals that fell under either of the above categories increased from 16% (24/153) in FY 2018-2023 to 45% (9/20) in April-August 2024 for the similar drug effect comparison method (I), and from 59% (41/70) in FY 2018-2023 to 70% (7/10) in April-August 2024 for the cost accounting method, A significant increase was observed before and after the FY2024 NHI price reform (Figure 4-1, left). However, when looking at each type of additions, the "Marketability Addition" (I) increased by 7% (11/153) to 10% ( ^10/10 ) for the "Marketability Addition" (I) in the "Comparison of similar drugs" method (I), while the "Pediatric Addition" (I) decreased by 7% (11/153) to 10% (10/10) for the "Comparison of similar drugs" method (I) (see Fig. 4-1 ^, left ⁾. In the case of the similar drug use comparison method (I), the marketability addition (I) increased slightly from 7% (11/153) to 10% (2/20), or almost the same level, while the pediatric addition increased from 9% (13/153) to 35% (7/20). In the costing method, marketability addition (I) showed an increasing trend from 52% (36/70) to 70% (7/10), while pediatric addition decreased from 6% (4/70) to 0% (0/10) (Figure 4-1).

Next, we examined the addition rates of the additions to the Marketability Additions and the Pediatric Additions: we examined the average rates of the additions to the Marketability Additions (I) and the Pediatric Additions for drugs containing new active ingredients that were calculated using the comparable drug effect method (I) or cost accounting method in FY 2018 and later. The average value of the applicable items for each addition was 11.1% in FY2024, exceeding 10% for the first time (Figure 4-2, top left), while the value for the addition for marketability (I) was consistently 10.0% before the FY2024 reform. The average value of the addition for children was generally 5-6% except in FY2020, when only one item was applicable, but in FY2024, the average value was 10% (Figure 4-2, top left). Compared to the average of all items (the addition rate is calculated as 0% for items that do not qualify for the addition rate for marketability (I) or for items that do not qualify for the addition rate for children), the addition rate for children showed an increasing trend in FY2024, with the average rate increasing to 2.3% in FY2024 from less than 1% in all periods before the FY2024 drug price reform (Figure 4-2 upper right).

Two out of nine (22.2%) marketability additions (I) and three out of seven pediatric additions (42.9%) fell under the "flexible application of addition rates" introduced in the FY2024 NHI drug price reform (Table 4). In addition, the number of other additions to the drug price index as an incentive for early introduction into Japan (pioneer additions and rapid introduction additions) was too small to analyze in this report, but there were two items by August that qualified for the rapid introduction additions newly established under the FY2024 drug price reforms (Table 4).

(4) Current status of additional drug creation benefits

For drugs containing new active ingredients that were calculated by the Comparable Drug Efficacy Comparison Method (I) or the Cost Accounting Method in FY 2018 or later, the percentage of drugs that fell under the Additional Allowance for New Drug Creation, etc. was surveyed. Since the requirements for the Additional Allowance for New Drug Creation, etc., have been added with each reform of the system, a comparison was made for each reform (every two years). As a result, the percentage of drugs covered by the "Additional Drug Creation Allowance" was 48% (25/52), 56% (24/43), and 64% (37/21) for the "Comparable Drug Value Comparison Method I" and 50% (9/18), 59% (16/27), and 76% (19/25) for the "Cost Accounting Method", showing a 10-15% increase trend before the 2024 reforms. In FY2024, however, they increased by another 25% to 90% (18/20) and 100% (10/10), respectively (Figure 5 left). In terms of annual trends, although there was a large year-to-year variation in costing methods with a small number of cases, there was a general increasing trend in all calculation methods, with the largest value in FY2024 during the survey period (Figure 5 right).

The cases to which the requirements introduced by the FY2024 NHI drug price reform applied were 4 out of 28 items for which the additional fee for new drug creation, etc. was applied (14.3%; pediatric addition: 3 items; composition efficacy product sales identical: 1 item) (Table 4).

3-3. Current Status of Additional Factors in Cost Accounting Method

The current status of the addition factor for items calculated using the cost accounting method, which was introduced in FY2018 at the same time as the system of supplemental payments, was investigated with a focus on orphan drugs, which are considered to be one of the drugs with particularly high unmet medical needs among pharmaceutical products. The results of the survey on the addition factor for orphan drugs from April 2018 to August 2024 showed that approximately 70% of the drugs had the lowest addition factor (0.2 until the drug is listed on the market on April 1, 2022, and 0 thereafter) (Figure 6, left). Next, a survey of the addition factor evaluated for orphan drugs and the actual addition factor reflected in the NHI price by modality revealed that while many items fell under the 15-20% or higher correction factor regardless of modality, the actual correction factor reflected in the NHI price was 20% or lower for many items regardless of modality (Figure 6 middle (Figure 6 middle right).

Conclusion and Discussion

In this report, we surveyed the calculation status of the price of drugs containing new active ingredients listed from April 2018 to August 2024, with a focus on the supplemental price adjustment. The calculation method consistently favored the similar drug effect comparison method (I), although there were some fluctuations from year to year, and in recent years, the similar drug effect comparison method (I) accounted for 60-70%, while the cost accounting method accounted for 20-30% (Figure 2). On the other hand, the ratio of the cost accounting method tends to be higher for injectable drugs than for internal use drugs, but in 2022-2023, the similar drug effect comparison method (I) was 60-70% and the cost accounting method was 20-30%, and no significant difference in levels was observed in FY2024. This point is considered consistent with the fact that no changes were made to the calculation method in the FY2024 NHI price reform.

The supplementary fee has been reviewed in response to changes in the drug discovery environment and changes in the pharmaceutical affairs system as a system for evaluating the value of pharmaceuticals, with the introduction of the additional fee for children in FY2006, the additional fee for pioneering work (additional fee for the system for designating pioneering examinations) in FY2014, and the additional fee for specific uses in FY2022. In addition, in the FY2024 NHI drug price reform, several changes were made to evaluate innovation, including the addition of a requirement for an additional fee for usefulness and the establishment of an additional fee for rapid introduction, in order to address the drug lag/drug loss that has emerged (see Table 2).

Although only three times listed, FY2024 had the highest coverage rate during the survey period for the addition to the usefulness system, the addition to the marketability system, the addition to the pediatric system, and the addition to the system for new drug creation (Figures 3-1, 4-1, and 5). The addition rate was also found to be high in FY2024 (Figures 3-2 and 4-2).

In addition, there are already some items that are subject to changes in the FY2024 NHI drug price reform, such as the newly established Additional Allowance for Product Usefulness and Additional Allowance for New Drug Creation (Table 4), as well as "flexible application of the additional fee rate" (Table 4), indicating that the reformed system has actually begun to be applied. The four items that have so far qualified for the new requirements for the additional utility system (two items for the additional utility system (I) and two items for the additional utility system (II)) would have satisfied the requirements for the additional utility system (I) or (II) that have been applicable this time even if the new requirements had not been institutionalized. Therefore, at present (August 2024), the impact of the FY2024 NHI drug price reform on the usefulness-based additions is mainly the contribution to the addition rate, and the impact on the applicable rate for each addition (breakthrough, usefulness (I) and (II)) seems to be small.

On the other hand, looking at annual trends, it is possible that the number of drugs with value that should be evaluated is increasing, given the fact that the number of supplementary fees had been on the rise even until last fiscal year, when there were no major changes in the supplementary fee system. For example, there were no "special-purpose drugs" added in FY2022 that were applicable at the time of listing on the New Drug List as of August 2024, suggesting that the FY2022 NHI drug price reform will have no impact on the number of applicable items. Therefore, it is considered that the NHI price reform in FY2022 will have no impact on the number of applicable items. In addition, the MHLW data also shows that there have been no cases of "pioneering drugs" and "drugs for the treatment of drug-resistant bacteria," which are requirements added in FY2020, falling under the Additional Allowance for New Drug Creation based on these requirements alone. ¹³⁾ Therefore, the impact of changes in the system up to last fiscal year on the number of applicable items is considered to be very limited. Therefore, the impact on the number of applicable items due to changes in the system up to last fiscal year is considered to be very limited. Based on the above, it is possible that the fact that the percentage of applicable items for both the Additional Allowance for Drug Use and the Additional Allowance for New Drug Creation showed an increasing trend by FY2023 is due to an increase in the number of drugs with value that should be evaluated. Under these circumstances, the fact that the percentage of applicable items in the "Supplementary Information" and "Supplementary Information for New Drug Creation" categories increased in FY2024 suggests that, in addition to an increase in the number of drugs that should be evaluated, innovation of drugs may be being evaluated more highly as a result of the FY2024 NHI price reforms. At the September 25, 2024 meeting of the Special Committee on Drug Prices of the Chuikyo, the secretariat explained that the number of applicable drugs and the percentage of new drugs in FY2024 tended to increase compared to FY2023, mainly by using charts showing the application status of the additional fee for usefulness and the results of the additional fee for marketability and pediatric use for ingredients listed as new drugs. ^The secretariat explained that the number of applicable cases and the rate of addition are increasing in FY2024 compared to FY2023.) The results of this survey, which focused on drugs with new active ingredients, showed a similar trend, and the results are consistent with this trend.

In addition, compared to the "additions tied one-on-one to new regulatory designation systems," such as the "pioneer additions" and the "special use additions," which were newly established in recent years, the new additions for expedited introduction this fiscal year are related ^only to existing regulatory systems and priority ^{review14) , which is} relatively common among special measures in the pharmaceutical affairs, and therefore, cases that fall under the additions are more likely to occur early. Therefore, the addition to the NHI system may be more likely to be effective as an incentive in terms of NHI prices at an early stage. The additional fee for the NHI system is, by its nature, dependent on the status of designation in the NHI system. In many cases, it takes a certain period of time after the introduction of a new system for a newly designated drug to be approved and listed on the market, i.e., for a case to become eligible for the newly added incentive, and the number of cases eligible for the added incentive depends on the number of designated drugs in the relevant regulatory system. In fact, the additional payment for the Pioneering Review and Designation System (currently the Pioneering Drug Designation System), which was initiated by the pharmaceutical affairs system in FY2015, began operating in FY2016 as the "Additional Payment for Pioneering Review and Designation System (currently the Additional Payment for Pioneering Drugs) ^{15, 16)}, but was first applied in March ^201817). In terms of the number of applicable cases, while the Marketability Addition (I), which is linked to orphan ^drugs18) (about 10 to 30 ingredients are designated each year), has about 10 cases each year, the Pioneer Addition (I), which is linked to pioneering drugs (only 5 or fewer ingredients are designated each year after ^FY202019 ), has been applicable to a number of items for years until FY2022. The additional fee for the designation of drugs for specific uses, which was introduced by the pharmaceutical affairs system in FY2020 (only one product had been designated by August ^202420), was introduced in FY2022 as an additional fee for specific uses, but by August 2024, there had been no cases of this fee being applied to any new drug at the time of its launch. However, by August 2024, there had been no cases of such additions at the time of new drug listing, and only one case of such additions at the time of revision. On the other hand, the ^only relevant pharmaceutical affairs system for the additional fee for expedited introduction, which was newly established in FY2024, is the existing priority review ^{system21) , which} was considered to have the potential to generate applicable cases early. In fact, two items have already fallen under this category by the time of the third listing after the reform. It is expected that the system will continue to be effective from the early stage of introduction as an incentive in terms of drug prices.

One of the issues to be addressed in the future is the addition factor for the cost accounting method, which was introduced in the cost accounting method in FY 2018 and has been the subject of various discussions regarding its appropriateness as well as the level of disclosure on which it is based. However, the results of this survey, focusing on drugs for rare diseases, suggest that approximately 70% of these drugs have the lowest addition factor (0.2 until the product is listed on the market on April 1, 2022, and 0 thereafter), and that the impact of the addition factor on the actual NHI price is limited. The results also suggest that the impact of the supplemental fee on the actual drug price is limited (Figure 6). In addition, with regard to the usefulness-based addition, the most recent case was that in May 2024, for the first time in six years, an item was added to the usefulness-based addition with the highest addition rate, but the addition coefficient was 0, so a total of 90% of the evaluated addition was not reflected in the NHI ^price22). This was the first time in six months in May 2024 that the additions were not reflected in the NHI drug price because the coefficient of addition was zero.22 ⁾ Some members of the medical side of the Chuikyo expressed concern about this issue. The appropriateness of the disclosure of total product cost, which is the basis for setting the addition factor, and measures to improve it have been discussed in the Chuikyo and other medical associations for some time, but it is possible that corporate efforts have reached their limits due to the globalization of the pharmaceutical industry and the increasing complexity of supply chains resulting from the sophistication of ^{modalities24)}. In fact, considering the ^situation25) where the degree of disclosure has not improved after the systemic ^change8) of the addition factor aimed at improving the degree of disclosure, it is considered that some other measures are necessary.

The above suggests that the system of the addition factor remains an issue in the context of the expansion of the supplemental fee as a system to evaluate innovation in pharmaceutical products. As for the degree of disclosure, there is no change in the FY2024 NHI drug price reform and it is still under discussion (Table 2), so further discussion is expected in the future.

Conclusion

This paper reports on the latest NHI drug price calculations for drugs containing new active ingredients, including the information on the three times listed in FY2024, with a focus on the supplemental drug price adjustment. Although the issue of the addition factor remains, it has been expanded as a system, and it was found that changes were made in the direction of evaluating innovation in the FY2024 NHI drug price reform, and that these changes have already been applied to several drugs listed for the third time and are beginning to have an impact. On the other hand, the results for the years when there were no systemic changes suggest that the percentage of drugs with value that can be evaluated may be increasing. The results of this study suggest that there are high expectations for future trends toward the realization of a virtuous cycle of appropriate evaluation of pharmaceutical innovations and the sustained creation of innovative new drugs.

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