The term "long-listed drug" (長期収載品) has become far more visible in prescribing and front-desk work. The reason is that the selected treatment rule for long-listed drugs began in October 2024, and the charge was raised in June 2026.
A long-listed drug is, in short, an original brand-name drug for which a generic version is on the market. It refers to an originator product whose patent has expired and which has been listed on the drug price standard for a long time.
The term itself comes from drug pricing policy, but it now bears directly on how much you charge at the window. This article covers the definition, the scope of the selected treatment rule, how the charge is calculated, the exemptions, and what changes in clinic practice.
Disclaimer: This article is general information. Drug prices and the operation of the rules change with each revision. For actual billing and collection, please check the latest notifications and Q&A from the Ministry of Health, Labour and Welfare.
What Is a Long-Listed Drug—"An Original With a Generic"
Under the drug pricing system, medicines fall roughly into these groups.
| Category | Description |
|---|---|
| Original (new) drug | The first developed and approved product; protected by patent for a period |
| Long-listed drug | An original whose patent has expired and for which generics are sold |
| Generic drug | Approved as having the same active ingredient and indications as the original; priced lower |
So a long-listed drug is not a separate category from an original. It names a state an original moves into over time. Once a generic appears, that original becomes long-listed.
"Long" here means long listed on the drug price standard. Development costs have largely been recovered, and an alternative exists—so the premise for continuing to support the same price through insurance changes. That is the policy framing.
Why It Is in the News Now
Long-listed drugs have long been subject to price cuts, but a mechanism touching patient payments directly began in October 2024.
When a patient requests the brand-name version without medical necessity, part of the price gap with the generic is charged to the patient as a "special charge." This is the selected treatment rule for long-listed drugs.
The selected treatment framework itself is covered in What Is Selected Treatment?. Here we focus on long-listed drugs.
Which Long-Listed Drugs Are in Scope
Not every long-listed drug is covered. A product falls in scope if either of the following applies.
- Five or more years have passed since the generic was listed
- Even within five years, the generic substitution rate has reached 50% or more
The idea is not to place the burden of choice on patients while generic supply is still settling. The line is drawn so that a product enters scope only once generics are sufficiently established.
Conversely, an original with no generic is out of scope. Prescribing a new drug still under patent has nothing to do with this rule.
How Much Is the Special Charge
The calculation works as follows.
- Take the gap between the long-listed drug's price and the price of the highest-priced generic band
- Compute a set proportion of that gap as the "special charge"
- Treat the special charge as outside insurance coverage (fully paid by the patient); the remainder is covered as usual
That "set proportion" has changed since the rule began.
| Period | Special charge |
|---|---|
| From 1 October 2024 | One quarter of the price gap |
| From 1 June 2026 | One half of the price gap |
The increase came with the fiscal 2026 fee revision. The revision as a whole is summarized in Medical Fee Revision 2026.
Consumption Tax Applies
An easily missed point: consumption tax applies to the special charge. Insurance benefits are tax-exempt, but the portion collected as selected treatment is consideration for a service outside insurance.
In the accounting system, the insured portion and the selected treatment portion therefore fall under different tax treatments. If you cannot separate them, the totals may match while the tax calculation does not. How to separate insured and non-insured accounting is covered in Separating Insured and Private-Pay Accounting.
Exemptions—"Medical Necessity"
There are cases where a patient receives the brand-name drug and no special charge arises. The test is whether this is the patient's preference or a medical necessity.
Where the physician judges there is medical necessity, the charge does not apply. Situations include:
- The indication requires the original because efficacy differs with the generic
- Side effects or allergic reactions differ between original and generic, ruling the generic out
- The dosage form differs and the patient cannot take it, for example due to swallowing difficulty
- A previous switch to the generic produced worsening symptoms or adverse effects
Supply-side reasons also exempt the case: the pharmacy or clinic has no generic in stock, or it cannot be obtained given distribution conditions.
The important part is that this judgment must be documented. If you did not collect the special charge because medical necessity applied, the reason should be explainable from the record and the prescription.
What Changes in Clinic Practice
Explanation at prescribing. Patients who request the brand-name product need to be told that a difference arises versus choosing the generic. Who actually collects the charge depends on in-house versus outside dispensing, but the explanation starts with the prescriber.
In-clinic posting. Where selected treatment charges are collected, the content and amount must be posted in the clinic. Because the amount varies by product, posting the basis of calculation is more workable than listing every item.
Prescription notation. Where medical necessity applies, or where the patient declines the generic, the intent has to be expressed on the prescription. Without an agreed internal rule, practice varies by physician.
Billing and EMR configuration. Whether a product is in scope, and how large the charge is, changes at every price revision. Whether the system keeps up through master data updates is the practical dividing line. Run this by hand and the front desk stalls at every revision.
Relationship to electronic prescriptions. Electronic prescriptions also carry information on the brand/generic choice. For the overall picture see What Are Electronic Prescriptions?.
Common Misconceptions
"You must not prescribe long-listed drugs." Not so. Prescribing is allowed, and where medical necessity exists no special charge arises. The charge applies only when the choice rests on patient preference alone.
"All original drugs are in scope." Scope is limited to long-listed drugs with generics, five years from listing or 50% substitution. New drugs under patent are unaffected.
"The patient pays the whole difference." The patient pays a set proportion of the gap—one half from June 2026—not the whole of it. The remainder stays within insurance coverage.
"Set it up once and the operation is fixed." Prices are revised and substitution rates move. Build the operation on the assumption that the list of in-scope products keeps changing.
What the System Has to Do
Whether this works on the ground depends on whether master data and accounting are connected.
Three things are needed. In-scope determination must track the latest drug price master. The special charge must be calculated automatically and posted to accounting separately from the insured portion. Tax categories must split correctly and appear on the receipt.
If any of these is manual, front-desk load grows with every revision. The checking side, including consistency with claims, is covered in What Is Claim Review?.
Pottech's AI Karte is an AI-native EMR that handles the medical record and the billing system as one. For the design principle of separating insured and non-insured while connecting them on a single foundation, see What Is an AI-Native Electronic Medical Record?.
Conclusion
- A long-listed drug is an original brand-name drug for which a generic is sold
- Since October 2024, a "special charge" arises when a patient requests it without medical necessity
- Scope covers long-listed drugs five years from generic listing or at 50%+ substitution
- The charge is a proportion of the price gap—one half from 1 June 2026 (one quarter at introduction)
- The charge is outside insurance, fully patient-paid, and subject to consumption tax
- Medical necessity and inability to supply the generic are exemptions
- In practice, settle four things: explanation, posting, prescription notation, and master updates
- Because scope shifts with each revision, master-driven updating is a precondition
For details on AI Karte or to request a demo, please contact us.