PPIs benefit from ranitidine’s market removal

“Should encourage use of lower-priced tidine class drugs that had no NDMA detected, as use of PPIs increase NHI expenditures"

Daily cost of PPIs are up to 3 times more expensive than H2 blockers

MFDS notice regarding ban on ranitidine drugs

With proton pump inhibitors (PPI) enjoying reflective interest in sales from the market removal of ranitidine, which was banned due to detection of the potentially carcinogenic substance NDMA(N-Nitrosodimethylamine), criticism is rising that national health insurance finances are being unnecessarily wasted.

 

The point is that PPIs cost on average twice to three times more than tidine-class H2 receptor blockers, and the increased use of the PPIs not only increases NHI expenditures but also increases the financial burden borne by the patients.

 

On the 17th, the pharmaceutical industry was been busy analyzing the changes in the peptic ulcer treatment market brought on by the banned sales of ranitidine drugs after the rise of its NDMA impurity issue in 2019.

 

After ranitidine was removed from the market due to the detection of NDMA impurities, a significant amount of prescriptions have moved from H2 receptor blockers to PPIs.

 

Annual prescription sales from 2018 to 2020 also show that prescription sales of PPIs have increased from ₩454.9 billion in 2018 to ₩523.4 billion in 2019, and ₩633.5 billion last year.

 

On the other hand, prescription of H2 receptor blockers decreased from ₩346.5 billion in 2018 to ₩296 billion in 2019 when NDMA impurities were detected and relevant products were banned from the market, then fell to ₩132.5 billion last year, to be reduced to 1/3 in just 3 years.

 

Numbers show that the size of the peptic ulcer prescription market has rather grown compared to 2018 due to an increase in PPI prescriptions despite the removal of the ranitidine ingredient.

 

The growth of the prescription market was influenced by the increased use of PPIs that cost on average twice to three time more than H2 receptor blockers.

 

More specifically, H2 blockers cost ₩276 to ₩360 a day at an average of ₩314/day, whereas PPIs cost from ₩527 to ₩1,300 at an average of ₩314/day.

 

Due to this, some have criticized that replacing ranitidine prescriptions with the high-priced PPIs that are of a different class when other lower-priced H2 blockers in the same class as ranitidine with no NDMA detected are available increases waste of NHI finances.

 

Their position is that changing prescriptions to higher-priced drugs not only increases NHI expenditures but also increases the financial burden borne by patients in the long term.

 

To resolve the issue, industry experts had suggested that the authorities should provide same-class drug prescription recommendations in the event inevitable recalls and substitution of drugs arise due to safety issues as in the NDMA case, Industry experts believe efforts such as introducing pop-up windows in the DUR system that show same-class drug recommendations when HCPs select and prescribe drugs should be made to prevent an unnecessary increase in NHI expenditures.

 

An official from a domestic pharmaceutical company said, “I am positive about the government’s decision to promptly recall and discontinue sales of the potentially harmful ranitidine substance, but it is unfortunate that there were no specific guidelines on its replacement and that it caused an increase in NHI expenditures.

 

It is a waste of NHI finances as well as an increased financial burden on the patients to substitute ranitidine to high-priced PPIs when there are other, lower-priced drugs available in the same class with the same indications.” He continued, “The replacement process for hazardous drugs should be further improved and advanced using the DUR system, etc.

 

It is the doctor’s responsibility to select or switch drugs due to their lack of effect in the treatment process, however, the use of same-class low-priced drugs should be prioritized for substitutions due to external factors."