Will expedited listing be possible within the year?

for drugs that treat severe diseases

Was planned to be implemented in November, but expected to exceed the deadline and be implemented at the end of December at the earliest

May amend the PE evaluation exemption system that received criticism...system under discussion with the MOHW

The implementation of the measure that allows expedited listing for serious disease treatments is expected to be deferred somewhat.

 

Although the government started the opinion collection process with the goal of implementing the measure in November, government officials see the measure to be implemented at the end of December at the earliest.

 

According to industry sources on the 9th, the Health Insurance Review and Assessment Service and the National Health Insurance Service made a preannouncement on the proposed amendment to regulations that reduce the listing period of drugs related to life-threatening conditions and started the opinion collection process.

 

The amendment contains plans to reduce the reimbursement review period of treatments for life-threatening conditions by 60 days through concurrent operation of reimbursement evaluation and pricing negotiations.

 

Under the amendment, HIRA’s drug reimbursement evaluation period is set to be reduced from 150 days to 120 days, and the NHIS’s drug pricing negotiation period from 60 days to 30 days.

 

Severe and rare disease treatments and PE exemption drugs are eligible for the expedited listing.

 

The NHIS and HIRA will share data during HIRA’s review process and prepare a prior consultation process so as to establish a financial sharing plan.

 

For this, HIRA decided to amend the ‘Regulation on the standards and procedures to evaluate the eligibility of reimbursement of drugs’ and the ‘Detailed evaluation standards for drugs subject to negotiations such as new drugs, etc,’ and the NHIS to revise the drug pricing negotiation guideline, with the common goal of implementing the measures in November.

 

However, it is now November and the opinion collection process is now complete, but the amended regulations have not been announced yet.

 

The industry believes that the implementation is being delayed due to a delay in the review of HIRA's regulations, and preparations for revision of drug price negotiation guidelines on NHIS's part are complete.

 

HIRA’s proposed amendments to its regulations are now being discussed with the MOHW after completing the opinion collection process.

 

Some are speculating that HIRA's delay may be due to amendments being made to address the criticism that arose regarding drugs eligible for pharmacoeconomic evaluation exemptions.

 

In the proposed amendment to the regulations that are under review, the government added a clause allowing PE exemption for ‘drugs used to treat pediatric patients that are therapeutically equivalent or has no available treatment option and demonstrates improvement in quality of life or is otherwise approved by the committee.’ The industry has been voicing opposition to the system, saying that the amendment narrows the pathway for PE exemptions rather than expanding it.

 

The Korean Research-based Pharmaceutical Industry Association had issued a statement, pointing out that “Drugs that fall under Item 2(a) and 2(b) that have difficulty generating evidence were eligible for PE exemptions even if they were not used to treat a ‘small number of’ patients.

 

However, the amended regulation mandates the ‘small number’ condition to be met.

 

This will only reduce the scope of eligible subjects.

 

This rather reduced the scope of eligibility.” The same had been raised as an issue at the NA Audit.

 

Rep.

 

Sun-Woo Kang of the Democratic Party of Korea pointed out that the proposed system rather reduces the scope of eligible drugs by changing the standard of 'a small number of patients' that had been an ‘OR’ clause for PE exemptions into a requirement.” However, HIRA explained through a written response that “The ‘small number of patients’ standard is not absolute and drugs are evaluated for PE exemption through committee deliberations in consideration of the severity of disease, etc.” HIRA added that the ‘drugs used by pediatric patients’ mean drugs whose main indication is applied to pediatric patients, and recommended that companies prove the ‘meaningful improvement in quality of life’ through the use of Multi-Attribute Utility Instrument (MAUI) and that the drugs will be evaluated through committee deliberations in consideration of the characteristic of each disease.

 

As such, there is an opinion that the implementation of the system is being delayed in order to revise the relevant regulations due to constant issues raised by the pharmaceutical industry and the National Assembly.

 

An industry official said, “As the measure needs to be concurrently applied by HIRA and NHIS, implementation of the expedited listing system will inevitably be delayed if either side is less prepared.

 

Therefore, it seems unlikely that the amendment will be implemented in November, and most are expecting the amendment to be applied at the end of December at the earliest.”