
The government and pharmaceutical industry are showing polarizing views on the current situation and the cause of Korea Passing phenomenon.
As if they are speaking in different languages, their prospective and proposed solutions are like parallel lines never crossing each other’s path.
So what does pharmaceutical industry fear about in those two words of ‘Korea Passing’?
Daily Pharm conducted a survey on 21 Market Access experts from respective affiliation to get a better look into what the industry is trying to convey.
Korea Passing is not a myth, but a reality in global pharmaceutical companies First, the survey questionnaire asked if the experts have experienced Korea Passing either directly or indirectly.
Except one response, 20 said they have experienced directly or have heard of it.
For those have either experienced or heard of it, the survey questioned how many cases of Korea Passing they have come across with.
Nine said one case, and other nine said two to three cases.
Three answered five or more cases.
The average was about 4.2 cases.
Sorting by treatment type, chronic disease treatments faced Korea Passing the most with 12 cases (multiple responses allowed).
Rare disease and anticancer treatments followed with ten and nine cases, respectively.
Immune checkpoint inhibitor and infectious disease treatment each experienced once.
So far, allergic asthma treatment Xolair, antidiabetic treatment Victoza, amyotrophic lateral sclerosis (ASL) treatment Radicut, and immunotherapy Obdivo have been mentioned the most when talking of Korea Passing.
But the survey revealed more cases.
It hinted that more Korea Passing phenomena are happening behind the scenes.

Excluding indirect experience of the phenomenon from word of mouth, the questionnaire asked if they have received an order from global headquarters to drop application or negotiation with government body.
16 out of 21, or about 76 percent of the survey participants answered they have.
11 of them said there was one such case, and four said two or more cases.
One did not answer.
Apparently, the order was given for seven items before they applied for insurance reimbursement listing, eight during reimbursement feasibility evaluation, and four during drug pricing negotiation.
On the details of the ‘order’ regarding Korea Passing, 13 answered the headquarters specifically mentioned the word “withdrawal” or “defer” during a meeting.
One said their office was ordered to defer the Ministry of Food and Drug Safety (MFDS) approval application submission.
Three items received an order to suspend reimbursement listing application submission, and other three got an order to postpone processing after applying for reimbursement listing Three answered they were given an order to pull out from negotiation when negotiating pricing went under certain price.
Moreover, three said their headquarters ordered them to unilaterally withdraw from reimbursement listing.
Not a specific order, but even six of the participants said they had to read between the headquarters’ message implying withdrawal or suspension during meetings.
Taken at face value, there have been at least 16 cases where a global headquarters has given a direct order to either withdraw or suspend government processing.
Multiple responses aside, the survey confirmed many of global headquarters are sensitive about pricing in Korea and also go as far as to directly give an order.

Industry admits some of their contribution The participants suspected two major reasons were behind the Korea Passing phenomenon.
19 said drug pricing in different countries, and 16 said low reimbursed price in Korea, including multiple responses.
Questionnaire asked once again to see if Korean government or pharmaceutical company played any part.
None of them said pharmaceutical companies were either entirely or mostly responsible.
However, six of them said it was entirely because of the Korean government.
Majority of the participants, or ten of them said the Korean government is mostly responsible while pharmaceutical companies were also partially responsible.
Five answered the companies and government were responsible 50/50.
Majority of the participants, or 13 of them answered China played the biggest role in Korea Passing, as expected.
Other regions like the Middle East, A7 countries and others were mentioned by ten, three and two participants, respectively.
None of them said Australia.

The Chinese government has been completely reforming its pharmaceutical insurance benefit policy for last two years.
In the process, the government has decided to include Korea as one of their international reference pricing countries.
Previously, the country has been referencing drug prices in Korea unofficially.
But when China made it official was the tipping point for the global headquarters to make more drastic decisions.
The point in time matches with right around when Korea Passing has become a social issue.
Korean pharmaceutical industry is concerned of multinational drug maker headquarters making decisions to postpone or withdraw reimbursement listing application due to Chinese market.
Besides China, the Middle East was also played a crucial role in Korea Passing.
Among the Middle Eastern countries, Saudi Arabia is reportedly referencing Korean drug pricing.
“The notion of Korea Passing is not that new.
When Saudi government started referencing Korean pricing, the phenomenon occurred time to time.
But it became as big of an issue, because the impact it bring is comparatively more detrimental than before”, an industry insider explained.
“Especially after China officially added Korea as one of external reference pricing countries, the industry’s concern on Korea Passing has grown exponentially.
Figures may not yet show the impact, but the influence has been substantial”, they added.
All agree “Worried about future releases in Korea” All of the survey participants had a same answer for one part.
They all agreed they currently have at least one item in risk of Korea Passing.
Eight or the majority of them said there are two items.
And it was followed by five answering one item, four saying three items, and one saying four, and three saying five to ten items.
None of them said ten or more.
Then what’s next for Korea Passing?
Questioning about their views on the current administration capable of solving the issue, 14 of them answered negatively.
Clearly, they are afraid of Korea Passing setting in over the time.
But, six said the otherwise.
Still some are positive the issue would get resolved, despite their serious concern about Korea Passing.
They are hopeful the phenomenon is a temporary occurrence, and the Korean government and pharmaceutical industry would find a solution.

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