Impact of reimbursement restriction on drug market sales under the National Health Insurance in Japan

Figures & data

Figure 1. The process from application to listing in the NHI.

Table 1. Characteristics of each reimbursement restriction.

Reimbursement restriction	Examples
(1) Physician requirements	It must be performed under the guidance of a physician with sufficient knowledge and experience in XX treatment or his/her guidance. A minimum of XX years of clinical training in XX treatment after obtaining a medical license.
(2) Facility requirements	The product should be used in a medical facility that can sufficiently respond to emergencies, and under a system where appropriate measures, such as management by clinical tests, are taken.
(3) Patient requirements	It should be considered only for patients with an established diagnosis of XX. It cannot be used for patients with XX disease.
(4) Dosing period limitation	The duration of administration should be determined at an appropriate time to determine whether continued administration of the product is necessary, and should be limited to the minimum period necessary for the treatment of the disease.
(5) Removal of dosing period limitation	As the active ingredient of this drug product is the same as that of XX, which has been on the NHI drug price list for more than one year, the medication period restrictions for new drugs do not apply.
(6) Additional entries in the receipt (health insurance claim of medical fees)	In the remark’s column of the medical fee statement, the date of implementation of the test that confirmed that XX is positive should be described.
(7) Compliance with package insert	In the precautions for use of XX in the package insert, “YY” is listed, so be careful when using this product.
(8) Diagnostic testing	Confirmation of XX lesion by endoscopy. Confirmation of positive YY antigen.
(9) Prioritizing other medicines	This product should only be administered to patients who have had an inadequate response with other medications.
(10) Explanation of technical fees that can be charged together	When guidance and management is provided to patients who are self-injecting this product, the medical fee schedule category number “C101” (Home self-injection guidance and management fee) can be calculated.

Figure 2. The result of selecting drugs for our study.

Table 2. Results of the univariate analysis: association between percentage rate and covariates.

Variables	N	Mean percentage rate	Standard deviation	p-Value
(1) Physician requirements
Yes	2	30.85	4.97	.402
No	209	97.04	192.00
(2) Facility requirements
Yes	2	31.42	26.82	.442
No	209	97.04	192.00
(3) Patient requirements
Yes	6	72.11	39.52	.400
No	205	97.13	193.84
(4) Dosing period limitation
Yes	6	55.20	51.30	.592
No	205	97.62	193.69
(5) Removal of dosing period limitation
Yes	4	557.50	1023.13	.620
No	207	87.51	133.47
(6) Additional entries in the receipt
Yes	8	31.26	26.40	.082
No	203	98.98	194.43
(7) Compliance with package insert
Yes	25	136.73	410.45	.560
No	186	91.00	139.25
(8) Diagnostic testing
Yes	7	22.99	17.74	.022
No	204	98.93	193.94
(9) Prioritizing other medicines
Yes	8	112.63	150.66	.516
No	203	95.78	192.89
(10) Explanation of technical fees that can be charged together
Yes	21	67.77	94.58	.679
No	190	99.58	198.92
Total	211	96.42*	191.20

*Total percentage rates in the 25th, 50th, and 75th percentiles are 21, 47, and 100%, respectively.

Table 3. GLMM regression analysis (with family = gamma, link = log).

Categorical variables	Coef.	Standard error	95% Conf. interval	p-Value
Intercept	4.34	0.16	[4.03, 4.65]	<.001
Physician requirements	1.15	1.22	[−1.24, 3.53]	.345
Facility requirements	−0.26	0.88	[−1.75, 1.70]	.976
Patient requirements	0.40	0.53	[−0.64, 1.45]	.449
Dosing period limitation	−0.09	0.62	[−1.30, 1.11]	.879
Removal of dosing period limitation	1.84	0.79	[0.30, 3.38]	<.05
Compliance with package insert	−0.39	0.29	[−0.97, 0.18]	.176
Diagnostic testing	−1.30	0.64	[−2.56, −0.04]	<.05
Explanation of technical fees that can be charged together	−0.24	0.28	[−0.78, 0.31]	.394

Data availability statement

All necessary data used for this study are included in the manuscript.