Largest-ever drug pricing reeval to be conducted this year

foreign reference countries increased to A8... fast-track approval pathway reinforced

Systems and projects to note in the health and pharmaceutical industry in 2023

Plans for evaluating the performance of high-priced drugs and legislation of public late-night pharmacies prepared

The health and pharmaceutical industry is busy preparing various systems and policies for the new year.

 

The reimbursement adequacy reevaluations for listed drugs that had been initiated as a pilot project on choline alfoscerate products settled as an annual policy project and are expected to start full-scale reevaluations on previously notified products.

 

High-priced drugs for pediatric patients will now be eligible for pharmacogenomic evaluation data exemptions (PE exemptions) and subjects for the special calculation system will also be expanded.

 

In addition, the 3rd Comprehensive Plan to Foster the Pharma and Bio Industry will be initiated, and the task force for the development of the service industry that includes the healthcare industry will also be launched within the month and impact the medical and pharmaceutical industry.

 

The National Assembly will discuss the abolition of the sunset clause on state funding for national health insurance and legislation for public late-night pharmacies.

 

Dailypharm prepared a summary of notable changes in the system as well as policy projects that will be made in 2023 in the pharmaceutical and biopharmaceutical industry.

 

First, the conversion factor for medical care facilities will be raised with the start of the new year.

 

The increase rate is 1.6% for hospitals, 2.1% for clinics, 3.0% for oriental medicine hospitals, and 3.6% for pharmacies.

 

Along with this, the health insurance rate will also rise to 7.09% based on those employed.

 

For drug pricing coverage and control, high-priced drugs for pediatric patients may be allowed PE exemptions starting this month.

 

PE exemption may be allowed for drugs used to treat pediatric patients that are therapeutically equivalent or has no available treatment option; and demonstrates improvement in quality of life or are otherwise approved by the committee.

 

The adjustment in the reference countries used to calculate the foreign adjusted drug price that raised concerns in the pharma and bio industry has been made.

 

The government added Canada to the existing A7 (Japan, France, Germany, Italy, Switzerland, the UK, and the US) to A8.

 

Australia, the country that the industry worried would be included as a reference country, was excluded.

 

The reimbursement reevaluations planned for the year are expected to be the largest ever.

 

The government announced that HIRA will be reevaluating reimbursement on a total of 8 ingredients - Rebamipide, Limaprost alpha-cyclodextrin, oxiracetam, acetyl L carnitine, loxoprofen sodium, levosulpiride, epinastine hydrochloride, sodium hyaluronate eye drops.

 

When adding the efficacy reevaluation set to be conducted on sterepto drugs that received conditional approval for 1 year, the number of drugs subject to reevaluation is increased to 9.

 

The discount rate for the drugs will be finalized in the coming December.

 

In February this year, ingredients subject to reimbursement reevaluations in 2024 will be decided upon and reviewed by the Health Insurance Policy Deliberation Committee.

 

Also, a performance evaluation procedure and management plan for high-priced drugs such as Kymriah and Zolgensma, the so-called 'one-shot treatments', will be prepared within the month.

 

Also, the negotiation period for drugs eligible for the Risk Sharing Agreement (RSA) among PE exemption drugs will be shortened by 30 days through the introduction of a prior discussion system, improving accessibility.

 

Also, the scope of drugs eligible for special calculations will be expanded.

 

A total of 42 new rare diseases and artificial kidney dialysis patients with chronic renal failure will also be applied to special calculations.

 

Also, the administrative dispositions used for the drug serial number reporting system will be raised.

 

From January, HIRA will raise the serial number reporting rate standard for administrative dispositions from 85% to 90% at the time of shipment by wholesalers (including manufacturers and importers that supply third-party licensed items).

 

Therefore HIRA will request administrative dispositions to be made to local governments if the reporting rate becomes less than 90%.

 

Also, the ‘ Regulation on Manufacture and Sales Management of Biological Products, Etc.’ that applied to all biological products will not be categorized into 3 product types.

 

The MFDS plans to make the amendments to the regulation before the 17 of this month.

 

The 3rd Comprehensive Plan to Foster the Pharma and Bio-Industry which had been set as a 5-year project will be implemented this year to support all areas ranging from R&D to business development, investment exports, job creation, and institutional infrastructure.

 

The 'Service Industry Development TF', which sets policy directions to revitalize the service industry, including the field of healthcare, will also be launched in earnest this month.

 

The Ministry of Economy and Finance that oversees the project plans to disclose its 5-year plan for innovating the service industry in March through the TF.

 

During the H1 of the year, a pilot project for the ‘Approval Evaluation-Negotiation Linkage System' will be carried out, and subject drugs will simultaneously undergo three tracks of the drug approval process – MFDS’ safety and efficacy evaluations for marketing authorizations, HIRA’s reimbursement adequacy evaluations, and NHIS’s drug pricing negotiations.

 

In the same period, the National Assembly will discuss whether to abolish the sunset clause for state support of health insurance finances and whether to legislate public late-night pharmacies.

 

Although the contract sales organization (CSO) reporting system is expected to be discussed at the plenary session in the H1 of the year, as the effective date for the law is 1 year and 6 months after the promulgation, its actual application is expected to be possible only in the 2024 2H at the earliest, even if the revisions are made rapidly.