[Reporter’s View] Can new drug listings really be accelerat

with the implementation of the accelerated listing process for new drugs

The measures to accelerate reimbursement listing of new drugs is expected to be implemented in earnest this year.

 

However, the practicality of the measure – on whether it will really accelerate drug listings – remains in question.

 

The health authorities made a preannouncement on the amendment of the pharmacoeconomic evaluation exemption guidelines and drug pricing negotiations to expedite the listing of anticancer drugs and severe disease treatments as promised by the Yoon Suk-Yeol administration for implementation next year.

 

Through this, the reimbursement listing of new drugs with no alternatives will be reduced by 60 days at most.

 

Reducing the reimbursement listing period of drugs has been a regular agenda that had been discussed every year.

 

With every discussion, the regulatory deadline was reduced incrementally.

 

This applies to both the evaluation and negotiation process conducted by the Health Insurance Review and Assessment Service and National Health Insurance Service.

 

However, this deadline is only the term set for the authorities to review reimbursement after someone (a pharmaceutical company) applies for reimbursement listing.

 

The fault is on both parts.

 

Quite a lot of pharmaceutical companies spend a considerable amount of time before applying for reimbursement after approval to discuss strategies with their headquarters.

 

In other words, the companies take their time to thoroughly calculate their strategies and options.

 

In the process, the companies weigh the timing of reimbursement to receive a higher price or forgo some indications in consideration of competition with other products.

 

Companies really deliberately defer pricing negotiations waiting to be included in the government’s coverage reinforcement measure or decided to cancel the introduction of their drugs determining that Korea's marketability is poor.

 

The decision to pass Korea, the ‘Korea passing’ phenomenon of “deciding to enter Korea after OO country” has become too common.

 

The government's stance to “take discussions to the Drug Reimbursement Evacuation Committee after addressing most issues in the front end” has also played a role.

 

When tracing back the listing process of drugs that have long exceeded the review deadline, applications for many of these drugs have been voluntarily withdrawn by the company after experiencing delays at the Drug Reimbursement Standard Subcommittee level.

 

However, many companies have spoken out on how this voluntary withdrawal is not so ‘voluntary.” The deferral decision is very common during drug pricing negotiations between the NHIS and pharmaceutical companies.

 

However, we need to remember that the 60-day deadline set for negotiations is a promise, and a deadline is a deadline.

 

Also, the NHIS has referred to the negotiation deadline as a sort of "benefit" when announcing its plan to shorten the deadline for new drugs.

 

The problem is that there is no transparency in the progress made in that 60-day period.

 

Nothing is disclosed on what happened to the drugs that exceeded the listing review deadlines.

 

As a result, only the patients are left to suffer in endless await.

 

No answer nor explanation on the direction of progress is provided to those that wait in dire need.

 

This new year, all the stakeholders involved should make collaborative efforts to reduce the period to actual reimbursement listing.