Announcement of drug price reform is delayed

Ministry of Health, confirmation notice and administration notice plan in order of enforcement this year

Complement of the positive list system, such as improving the economic evaluation exemption system and expanding the scope of subsidiary agreements

The reform of the drug price system, which the government plans to announce last month, is delayed somewhat.

 

The pharmaceutical industry is all on edge because of the reorganization of generic drug prices, improved risk-sharing contract (RSA), economic exemption system, and insurance policy supplementary agreement (sub-contract).

 

◆Generic price restructuring= Among the many cases where drug price restructuring is expected, the focus of the industry is on the final revision of the 'Determination and Adjustment Criteria for Drug Price Revision', which contains the generic price restructuring.

 

The government planned to announce the final announcement no later than last month, but it was slightly delayed, with some revisions to the earlier this month.

 

It is essential to calculate this system by linking the MFDS' item permission to the Ministry of Health and Welfare’s drug price system.

 

It is largely divided into generic cascade drug price reform and cut line system.

 

The requirement for a cascading drug price reform is to conduct its own bioequivalence test and to meet the registered use of the Drug Master File (DMF).

 

If both criteria are met, the price is estimated at 53.55% of the cost of the original drug (before generic listing).

 

However, if one or not met, then the price is multiplied by 0.85 based on 53.55%, depending on the level of fulfillment of the criteria.

 

They are cut by 15%.

 

In addition, the 'cut line system' is a price condition that is lowered separately from the permit linkage.

 

Starting from the 21st order of health insurance, the drug price is estimated at 85% of the lowest price regardless of whether the criteria are met.

 

For example, the 21st generic is estimated at 85% of the lowest price in 20 products, while the 22nd generic is 85% of the 21st generic price.

 

The government has announced that the drug price reform will be finalized by the middle of this month and planned to be implemented in July.

 

◆Completion of RSA, reimbursement decision, the economic evaluation exemption system and additional contract creation subjects=In the current drug price system, issues that require expansion or reorganization of the reimbursement gateway stage are also overhauled.

 

The government has continually improved the drug price system without changing the fundamentals of the system since the implementation of the positive list system.

 

However, as the groundbreaking reinforcement of security continued, the awareness of the need to reorganize and upgrade the positive list system continued.

 

The improved drug price system can be divided into: ▲expanding the scope of RSA coverage ▲complementary details of reimbursement determination ▲complement of economic evaluation exemption system ▲expansion of generics for writing subsidies when reimbursement listed.

 

First of all, in the case of RSA improvement, one of the new drug listing tracks, it is important to expand the gateway to be able to apply the RSA target criteria that could be applied only to the current selection drugs.

 

In the meantime, drugs that have the same therapeutic position but have not been covered by RSA just because of late-release drugs will have a wider benefit opportunity.

 

In addition, high-priced drugs that are subject to phase III conditional approval are considered to have greater uncertainty, and thus, improvements are made in the direction of raising benefits by reimbursed them within the framework of the RSA.

 

In the case of reimbursement determination, some socially disturbing reimbursed priorities are supplemented.

 

The government is currently making reimbursement in consideration of medically feasible or medically significant materiality and treatment effects, as well as patient costs and social benefits.

 

In the future, it will be added to determine detailed principles or priorities in consideration of the financial status of health insurance.

 

In other words, it reflects the decision of reimbursement to the financial level that health insurance can cover, along with the characteristics of pharmaceuticals and the necessity of the times.

 

The economic evaluation exemption system will also be supplemented.

 

The government plans to improve the system by adding antibiotics, tuberculosis treatment, and emergency detoxification drugs, which are difficult to evaluate, to reflect the voice of expanding the scope of drugs that are difficult to evaluate.

 

Lastly, it is a revised plan that includes a generic agreement that is included when insurance is listed.

 

The contracting parties are the Korea Health Insurance Corporation and pharmaceutical companies.

 

The main contents of the contract are to fulfill supply obligations and accept price cuts when disposing of rebates.

 

The government aimed to implement the midterm this year after outlined this month's reorganization plan based on improving the positive list system and promoting administrative notice.

 

Evaluation adopted by the government during the maintenance of the list of registered agreements from 2007 to 2011

◆Re-evaluation of listed drugs=The government is currently setting up a 'post-evaluation of pharmaceuticals', that is, a re-evaluation guideline for already listed reimbursed drugs and collecting expert opinion.

 

The evaluation is based on the revised List of Contracts, which was carried out 12 years ago, but the standard is expected to be more detailed.

 

Reevaluation targets are selected from anti-cancer drugs, rare disease drugs, and drugs of uncertain clinical usefulness.

 

Of these, ▲drugs that need to confirm clinical usefulness through effects re-evaluation ▲drugs that need to be managed due to increase in population structure and usage ▲other drugs that require evaluation taking into account social impacts and other effects on health care at ex post evaluation Sub-committees become standards.

 

The government plans to announce the final reassessment soon and finalize the system within the year.