“Neglecting cost-effectiveness is dereliction of duty"

Interview on the new Director of Pharmaceutical Benefits Division Yang Yoon Seok

Unlike MFDS’ policy, selecting choline alfoscerate for reevaluation was adequate for a ‘positive listing system’

Answering to the criticism that National Health Insurance (NHI) coverage enhancement initiative is toughening the barrier of pharmaceutical reimbursement listing and standard, Korean health authority officials urged the cost-effectiveness should be further reinforced.

 

Recently appointed Director Yang Yoon Seok of the Pharmaceutical Benefits Division at Ministry of Health and Welfare (MOHW) hinted, “We want to put more filters, if possible.” The ministry officials also noted the government would pay a close attention to what pharmaceutical and bio industry, as well as patient groups, have to say, but they are planning to make policies weighing more on rationality and predictability.

 

Regarding the listed drug reevaluation pilot program announcing last week that choline alfoscerate would be the first, the government officials stressed unlike the approval system, the cost-effectiveness comes first in listed drug reevaluation.

 

On the questions directed to the final outcome of reevaluation—reimbursement removal or reduction, the officials shortly commented adequate actions would be taken and avoided providing further details.

 

Director Yang elaborated during a press conference held immediately after the Health Insurance Policy Deliberation Committee (HIPDC) meeting on May 15.

 

Appearing for the first time at an official press conference, Director Yang expressed his philosophy in insured drug policy, prospective approach, and his commitment to them.

 

Senior Deputy Director Lee Seon-joo and Deputy Director Choi Kyung-ho, playing significant roles in the Pharmaceutical Benefits Division, also joined Director Yang during the question and answer session.

 

(From left) Senior Deputy Director Lee Seon-joo, Director Yang Yoon Seok and Deputy Director Choi Kyung-ho

▶The Ministry of Food and Drug Safety (MFDS) is reportedly considering on reevaluating the approval standards on choline alfoscerate.

 

Has the listed drug reevaluation been discussed with MFDS?

 

If not, then it could cause confusion when reevaluations each conducted by MFDS and MOHW (Health Insurance Review and Assessment Service, HIRA) result in contrasting outcomes.

 

Deputy Director Choi Kyung-ho (“Choi”) “MFDS’ approval evaluation and MOHW’s reimbursement listing evaluation are different.

 

The previous negative listing system used to list most of the approved drugs, but the current positive listing system reviews cost-effectiveness.

 

The listed drug reevaluation is to be introduced within the framework, and such reevaluation, specifically for the price, is nothing new.” ▶Can the listed drug reevaluation ultimately result in reimbursement standard reduction or removal?

 

Director Yang Yoon Seok (“Yang”) “Depending on the outcome, adequate actions would be taken accordingly.” ▶The reevaluation mentioned in the first NHI Comprehensive Plan was about introducing more general drug reevaluation covering clinical efficacy, financial impact and contract compliance.

 

While selecting choline alfoscerate for the pilot program does not exactly explain how it is covering the said factors.

 

Is there a possibility that the pilot program could include other subject drugs during or after the first pilot program?

 

And what is the reason behind only selecting choline alfoscerate?

 

Yang “The lawmakers and media have raised issues over choline alfoscerate last year, and even civic health organizations have requested for an audit.

 

As we have already promised for a reevaluation, it cannot be delayed anymore.

 

The actual regulation would be set down based on the pilot program, but the pharmaceutical industry seems to be concerned about the [government policy] being spontaneous or arbitrary.

 

[By understanding those concerns] the Ministry intends to enhance predictability.” Choi “A number of pharmaceutical substances were listed up as the pilot program candidates.

 

Selecting the urgently demanded choline alfoscerate seemed appropriate.

 

In fact, differentiating the pilot evaluation and the actual evaluation would be meaningless.” ▶According to the information from HIPDC, the pharmaceutical expenditure saved from the reevaluation would be used for listing severe and rare disease treatments.

 

The previous director of Pharmaceutical Benefits Division mentioned about opening an account for pharmaceutical expenditure on severe disease treatment.

 

Has it been reviewed any further?

 

Choi “The limited resources, despite so many expenditures to cover, is our concern for the system.

 

So basically, the talk came about as a means to accumulate resources for coverage on severe disease treatment by cutting out expenditure on drugs with weak efficacy or unnecessary reimbursement.

 

Regardless, if the pharmaceutical expenditure can be saved, the ministry would have more resource to utilize on much needed reimbursement to cover severe disease treatments.

 

The issue is still under review.” ▶Again, the HIPDC information explains the reason behind choosing choline alfoscerate for the pilot program, which referred to A8 external pricing reference countries.

 

Does this mean that the existing list of A7 countries would be updated to A8 countries including Canada?

 

Choi “[The external pricing reference countries] is set by HIRA.

 

The A8 mentioned here is not so significant.

 

The eight countries were picked as reasonable references.

 

It would be better to interpreted like that.” ▶Some criticize that the financial issue of anticancer treatment reimbursement listing or expansion have been evaluated through ‘triple-filtering (Cancer Deliberation Committee, DREC and drug pricing negotiation)’ as the Cancer Committee started reinforcing financial impact management.

 

Some even go further and say the triple-filtering is deferring deliberation on many of anticancer treatment coverage and affecting the patient’s access to treatment.

 

Yang “They call it the ‘triple-filtering,’ but to be honest, we want more filtering if possible.

 

For this time around, we had the applicant company to submit a financial impact management plan on their immunotherapy.

 

Nevertheless, we would need to construct a system for the patients to receive more benefits.”

Choi “It does not mean the previous evaluations were insufficiently done.

 

Anyway, healthcare reimbursement review has to take account of cost-effectiveness at each step.

 

“In some cases, HIRA first projects comparatively lower cost, when NHIS projects the cost higher.

 

As a health authority, such cases should be prevented.

 

Neglecting cost-effectiveness is as irresponsible as dereliction of duty.

 

“Attempting to catch a mosquito with a sword would be nonsensical, but the related experts can talk about it at every step.

 

And if each step can be a filter, we expect the next step would be able to bring even better outcome.

 

“Pharmaceutical companies may feel these steps are excessively straining them, but demanding the health authority to review listing without the filtering would mean they are demanding us to work blindly.

 

And in clinical scene, doctors judge the use of a drug, and these doctors are part of the committees.

 

Financial experts are there to add more on the financial aspect.

 

We are definitely not putting down one-fifth resource for the necessary expenditure.”