Australia, excluding drug price reference countries

including Canada Only

The HIRA revised the detailed evaluation standards for drugs subject to negotiation, such as new drugs

Australia's addition to the drug price reference country, which faced opposition from the pharmaceutical industry, failed.

 

The HIRA initially decided to take a step back from adding Australia and Canada to the drug price reference country and add only Canada to the reference country.

 

The HIRA released the "Detailed Evaluation Standards for Drugs Subject to Negotiation, including New Drugs" on the 28th on the work portal of nursing institutions.

 

The evaluation criteria include the contents of PE drugs announced by the HIRA in August and the expansion of drug price reference countries announced in November.

 

According to the revised detailed evaluation criteria, Canada was included in the existing countries of Japan, France, Germany, Italy, Switzerland, the United Kingdom, and the U.S.

 

A7 countries, making it A8.

 

Australia, which was announced in November, was not included in the reference country.

 

In the case of Australia, the domestic pharmaceutical industry strongly protested, saying that the price of generic drugs could be lowered if they are used for re-evaluation of post-registration materials due to low generic drugs.

 

The KRPIA also issued a statement of opposition, fearing that the price of new drugs would be lowered.

 

The HIRA includes Canada, which is acceptable to all stakeholders, to secure the validity of the amendment, and Australia is eventually excluded.

 

The HIRA official said, "Australia was added to the drug price reference country due to similar geographical access and economic conditions, but as the pharmaceutical industry's opinion, we decided to exclude it in terms of industrial similarity." If it is possible to omit the submission of PE data, it will be evaluated as the lowest among the national adjustment prices of eight foreign countries of similar drugs when registered in more than three A8 countries.

 

In addition, even if it is difficult or possible to select foreign similar drugs, 10% of the highest price of alternative drugs is added to the list of less than A83 countries, and the adjustment price of countries excluding similar drugs is used for evaluation.

 

The drug A8 is also referred to in RSA drugs.

 

The detailed evaluation criteria also reflected that "a small number of target patients" were among the requirements for the omission of submission of PE data.

 

The number of patients is judged based on the expected number of patients subject to benefits (in Korea) of the indication, but the current status of the expected number of patients at the time of evaluation of the drug, which has been considered essential for treatment, is considered.

 

For drugs that can be used for both adults, the submission of PE data can be omitted only if the main indication is children.

 

This reflects the HIRA's prediction in August.

 

In this regard, there were many objections, saying that the PE exemption system has retreated to limit the number of patients and exempt PE only from pediatric indication treatments.

 

However, the HIRA applied the original plan as it is, saying that these regulations can be flexibly applied in the evaluation process.