NA audit talks about pre-listing coverage on anticancer

Professor Kang Jin-hyoung summoned as a witness, urged the government to improve access to expensive anticancer drugs

Lawmaker Lee Yongho “Patients can’t access new drug because of NHI finance”

NHIS-HIRA “Need to approach it carefully”

At the National Assembly annual audit, a healthcare provider suggested the ‘pre-listing reimbursement and post-evaluation’ should be implemented and ‘incremental cost-effectiveness ratio (ICER) threshold’ should be adjusted to practically improve access to new drugs.

 

Professor Kang Jin-hyoung at the Catholic University of Korea Seoul St.

 

Mary’s Hospital, treating cancer patients at the clinical treatment scene, elaborated about the patients struggling to receive treatment due the delayed new drug reimbursement listing.

 

However, the insurer, or the National Health Insurance Service (NHIS) and Health Insurance Review and Assessment Service (HIRA) expressed a reserved view on the suggestion.

 

At the NHIS-HIRA National Assembly annual audit session on Oct.

 

20, Professor Kang Jin-hyoung was summoned as a witness and stated, “A novel anticancer treatment takes a long time to receive NHI reimbursement even after getting approved for the market by the Ministry of Food and Drug Safety (MFDS),” and “Patients are in immense pain as an immunotherapy for lung cancer could not pass HIRA for three years.” Regardless of how greatly effective a new drug is, it is not easy for the patients to actually use those drugs without the reimbursement.

 

Professor Kang explained, “MOHW and HIRA say the anticancer treatment listing takes 350 days, but it excludes the time for requesting and submitting supplementary evidence.

 

The time should be shortened to within 180 days for the patients and healthcare providers to actually feel the improvement.” The professor also noted although the risk sharing agreement system (RSA) introduced in 2014 contributed in speeding up the new drug listing procedure initially, the effect of RSA implementation on shortening the time has been insignificant due to expensive anticancer treatment entering the market.

 

The professor stressed, “The social controversy is that most of immunotherapies can hardly get to RSA signing.

 

After RSA was implanted, a half of anticancer treatments were listed through RSA, but the actual effect of shortening the listing period was weak,” and “The new drug listing speed has slowed down due to scarce review meetings amid COVID-19.

 

If RSA were the only supplementary boost for the positive listing system, we need to pursue new options from now on.” Professor Kang recommended the following agenda to improve the new drug accessibility; providing pre-listing reimbursement and post-evaluation option, adjusting ICER threshold, and seeking means to secure additional source of NHI income to enhance public-private access.

 

Regarding the ICER threshold for severe and rare disease treatments, the professor noted the threshold should be flexibly adjusted in a ‘bracket’ range, instead of basing it on GDP per capita.

 

An independent Lawmaker Lee Yongho, who summoned Professor Kang, commented that “The patients would be desperate to access those new drugs,” and “Only controlling the NHI finance would not grant a solution.

 

We need a balanced approach.”

NHIS President Kim Yong-ik (left) and HIRA President Kim Sun-min (Source: National Assembly Correspondent Organization)

Instead of clearly giving their opinion, however, NHIS President Kim Yong-Ik and HIRA President Kim Sun-min both claimed implementing a new system should be approached, carefully..

 

President Kim stated, “We can only be cautious when listing a new drug.

 

Negotiating with a pharmaceutical company from a disadvantageous position can put NHIS and the government at risk when setting the drug pricing.

 

And higher drug price can then put the patients in a worse situation.

 

This is why the problem is difficult to solve.” On introducing the pre-listing reimbursement and post-evaluation, President Kim said, “We would review the suggestion, but we would not make any hasty decision as with have imminent issues regarding drug pricing and NHI finance.” HIRA President Kim Sun-min also said the accessibility issue is regrettable from the point of patients, but the suggested agenda would be difficult to execute without a social consensus.

 

President Kim explained, “ICER threshold has to be effective when adding more cost.

 

Recently listed anticancer treatments require cost of over 1 billion won to extend life expectancy by average one year,” so “We need to consider other patients and pursue the social consensus through thorough discussions.” “Although we would further make efforts to expand access to new drugs for severe and rare disease patients, we are already providing pharmacoeconomic evaluation exemption system and pricing negotiation exemption system,” nevertheless, “We would continue to improve the access,” said President Kim.

 

After hearing from Lawmaker Lee Yongho’s witness, People Power Party Lawmaker Lee Jongseong spoke to President Kim Yong-ik, “You sounded negative about providing support to access the novel immunotherapy, but the administration promised, with the Moon Care, that no one would be neglected from accessing treatments.

 

The government needs more forward-looking review.

 

It should consider making a cancer fund and other options.” President Kim then answered, “We are absolutely not negative about expanding access to new drugs.

 

Surely the alternative options should be considered, but the previous answer was concerned more of the pricing negotiation.”