About 180 clinics without IRB used diagnostic drugs

for precocious puberty

Using Avastin, about 230 clinics without IRB

Avastin and Decapeptyl, are drugs that allow the use of drugs beyond the scope of approval without the IRB.

 

How much is it used in front-line medical institutions?

 

About 230 macular degeneration treatment drugs Avastin and precocious puberty drug Decapeptyl injection were found to be using these drugs without IRB at 180 hospitals and clinics.

 

The Pharmaceutical Management Office of the Health Insurance Review and Assessment Service disclosed the current status at a meeting with the Special Press Association held on the 28th.

 

In 2019, the relevant notice was changed so that drugs exceeding the permitted scope could be used without reimbursement even without an IRB, but it was only last year that the system was actively applied to the field.

 

The first drug approved by an institution not implemented by the IRB is Avastin, which is used for ophthalmic diseases.

 

Avastin, as a targeted anticancer drug, has been used for various cancers, including colorectal cancer, breast cancer, non-small cell lung cancer, renal cell cancer, ovarian cancer, peritoneal cancer, and cervical cancer.

 

In February 2020, the Korean Academy of Ophthalmology applied for the use of Avastin over the permitted scope to the ophthalmologist, and the HIRA prepared guidelines after discussing infection control measures.

 

The guidelines include measures to prevent infection during the dispensing process.

 

The HIRA received applications for use from non-IRB organizations since February of last year, and until last year, about 230 places used Avastin for ophthalmologic diseases.

 

The second approved drug is Decapeptyl 0.1mg, which is used to diagnose precocious puberty.

 

Decapeptyl is a prescription drug approved for hormone-dependent prostate cancer, endometriosis, uterine fibroids, and central premature onset of puberty in girls under 9 years old and boys under 10 years old.

 

It was not approved as a diagnostic reagent for precocious puberty, but as the supply of the only diagnostic reagent was stopped, medical institutions are continuing to apply for approval for excessive use.

 

It was applied by the Korean Hospital Association in October 2021, and it was confirmed that about 180 hospitals and clinics without an IRB applied for use between July last year and just five months.

 

On the other hand, for the use of drugs over the scope of permission by institutions that have not implemented the IRB, the Korean Medical Association, the Korean Hospital Association, the Korean Dental Association, and related academic societies for each specialty apply for use over permission, and the HIRA reviews for approval.

 

▲ More than one-third of approved drugs compared to all drug clinical trial institutions for the same case, ▲approval of more than 3,000 drugs for the same case based on the previous year, ▲ Need for expansion Approval can be made if it meets at least one standard, such as medicines for rare diseases and pediatric diseases that are recognized.