[Reporter’s View] Industry suffers from ‘Re-eval Neurosis'

The era of reevaluations has dawned on Korea.

 

Reevaluation of reimbursement adequacy, clinical reevaluations, and generic drug pricing reevaluations are being carried out simultaneously.

 

The Ministry of Health and Welfare and its affiliated organizations appear to be scrambling to reevaluate and reduce drug pricing expenditures as if they have received orders from somewhere.

 

The reevaluation of the reimbursement adequacy began with choline alfoscerate preparations in 2020, and then reviewed 4 ingredients including silymarin and avocado-soya in 2021, then 7 ingredients including streptokinase in 2022, and then 8 ingredients including hyaluronic acid eye drops, and rebamipide this year.

 

In addition, the reimbursement adequacy of 7 ingredients, including sarpogrelate and mosapride will be reevaluated next year.

 

At the same time, the Ministry of Food and Drug Safety is conducting its clinical reevaluations.

 

Clinical safety and efficacy reevaluation of choline alfoscerate, acetyl L-carnitine, oxiracetam, streptokinase, and streptodornase has been conducted or is in progress.

 

Not long ago, reevaluations on the reimbursement ceiling price of drugs, also known as the reevaluation of generic drug prices, had been carried out.

 

This reevaluation was conducted to apply the new drug pricing system implemented in July 2020 to already listed generics.

 

More than 20,000 items were subject to reevaluation.

 

As a result, as of the 5th of this month, the prices of 7,355 generic drugs were reduced by up to 28%.

 

Due to so many items being reevaluated at the same time, much confusion has been occurring in the field.

 

The biggest problem pointed out was the redundancy of reevaluation targets.

 

Choline alfoscerate, streptokinase, streptodornase, acetyl L-carnitine, and oxiracetam were selected simultaneously as subjects for clinical reevaluation and the reevaluation of reimbursement adequacy.

 

As a result, acetyl L-carnitine and oxiracetam were withdrawn from the market after failing to prove clinical utility and were naturally excluded from receiving reevaluation on their reimbursement adequacy.

 

In the case of streptokinase, some indications that failed to prove clinical usefulness were removed, and there is a high possibility that the remaining indications will also be deleted following the other reevaluations.

 

Employees in charge of related affairs express extreme fatigue caused by the excessive and redundant reevaluations.

 

Although the government claims that the legal basis and purpose of each reassessment are clearly different, the pharmaceutical industry's criticism is that there is no significant difference in the methods each uses to select subject drugs, assess the adequacy of reimbursement, and prove clinical usefulness.

 

In addition, the officials had to painstakingly reevaluate the prices of 20,000 generic drugs.

 

Even though these drugs were legally approved and listed for reimbursement, the pharmaceutical industry had no choice but to conduct bioequivalence tests for the sole purpose of maintaining drug prices.

 

Even though the generic drug pricing re-evaluation is not complete, pharmaceutical industry officials say they have no time to rest.

 

This is because a bigger wave of ‘overseas drug price comparison reevaluation’ is expected to land soon.

 

The MOHW had announced that it will conduct a reevaluation and compare the price of listed drugs with their overseas prices next year.

 

The MOHW plans to finalize the reevaluation criteria within the year, report it to the Health Insurance Policy Deliberation Committee, and implement it in earnest next year.

 

This means that next year, in addition to the ongoing reimbursement adequacy reevaluations and clinical reevaluations, a reevaluation for comparison with overseas drug prices will also be carried out simultaneously.

 

In particular, anxiety appears to be rising as the scope and range of drug price cuts are expected to be larger than that made by the existing reevaluations.

 

In addition to anxiety, uncertainty is also rising due to repeated reevaluations every year and the various accompanying measures that follow.

 

But above all, constant reevaluations are serving as the largest barrier.

 

Complaints are rising constantly on how so many reevaluations are taking place simultaneously.

 

The data that must be submitted amounts to hundreds or thousands of pages.

 

Some have been cynically joking that a department dedicated to reevaluation should be established.

 

And so it seems fair to say that the pharmaceutical industry is indeed suffering from reevaluation neurosis.