“High pressure and hopes in the policy affairs at KRPIA"

Director Kim Minyoung at KRPIA

“To focus on strengthening KRPIA Policy Committee and open various communication channels”

“New reimbursement listing model needed with perks of South Korea”

Director Kim Minyoung

Some say this is the era where policy comes first than an academy, and pricing is more important than an approval.

 

The top priority for pharmaceutical companies in South Korea supplying new drug is the National Health Insurance (NHI) coverage.

 

The era of highly expensive drug has emerged, while the government and pharmaceutical industry are struggling to see eye-to-eye on drug pricing.

 

And now the reimbursement listing and its timing became the deciding factor for the success of a new drug.

 

The Korean Research-based Pharmaceutical Industry Association (KRPIA), representing the multinational pharmaceutical companies in South Korea, has appointed Kim Minyoung as a new Market Access and Policy Director after the position was vacant for about six months since a former Senior Director Sean Kim left the organization last April.

 

Kim was in charge of Market Access (MA) at Korean branch of Eli Lilly and Sanofi-Aventis, and until last year, he was leading the MA within JAPAC region at Amgen Asia.

 

Now at KRPIA, the director is to oversee internal and external activities in regards to the ‘adequate value of new drug’ the industry tries to resolve for a long time.

 

KRPIA’s MA committee and Policy Committee would be managed by Director Kim from now on.

 

“Started off with marketing and sales job, I have worked in policy and drug pricing related work at pharmaceutical companies for 25 years.

 

And I have finally joined KRPIA.

 

When I was working at Amgen Korea, I vaguely thought of drawing up a bigger picture of it all when I go back to South Korea, regardless of my humble experience.

 

And I feel now I have a grip on a good opportunity.

 

It’s burdening, but I also have big hopes for it.” But the pressure on Director Kim is real.

 

The pressure of increased drug price entails delay in listing.

 

Although the government is also trying to versatile with risk sharing agreement (RSA) and pharmacoeconomic evaluation (PE) exemption, their effort can hardly catch up with the speed of new drug development.

 

And it casts a dark shadow on multinational pharmaceutical companies.

 

Especially, at the movement KRPIA is considered to be missing personnel with former government affiliation.

 

“I am aware of the raised concerns.

 

But because we do not have staffs with previous government affiliation, it does not necessary mean the organization is incapable of operating policy related work.

 

The organization does not operate only with the office staff, but with incorporated participation by 44 member companies at respective committees.

 

Particularly, the Policy Committee consists of experts with various backgrounds from the National Assembly, government and media.

 

The committee can assert the variety of opinions by the stakeholders.” Besides the MA and Policy Committees, he noted the importance of the Government Affairs staffs.

 

Technically, the MA and GA within the industry have been ambiguously categorized, and the government affairs were limited to directly relevant institutes like the Ministry of Health and Welfare (MOHW), the Health Insurance Review and Assessment Service (HIRA), and the National Health Insurance Service (NHIS).

 

Many companies have their MA staffs to also cover GA tasks.

 

Director Kim said, “As the public’s interest is heightening not only in patients but also in new drugs, we are suddenly faced with more stakeholders to engage with like the National Assembly, civic groups and patient groups.

 

To reflect the needs, the Policy Committee must be invigorated.

 

This is one of our key agenda for the year.” If vitalizing the Policy Committee is the last piece of puzzle to achieve the goal, the policy recommendation would be outcome.

 

KRPIA has to be nimble to improve the industry’s access to pipeline currently concentrated to rare disease area.

 

Multinational pharmaceutical companies are taking steps to market targeted therapy, immunotherapy and gene therapy like CAR-T.

 

Director Kim carefully mentioned of HIRA and NHIS regarding the core process in reimbursement listing.

 

“As for HIRA, we could talk about the reimbursement standard expansion procedure.

 

Previously, the Expert Committee used to deliberate clinical adequacy of reimbursement anticancer treatments, but now the agency demands for financial impact evidences besides clinical efficacy report.

 

Financial impact can be reviewed once the clinical adequacy deliberation is completed.

 

It would be wonderful if they could streamline the committee operation and deliberation process.” “And for NHIS, the fundamental predicament the industry faces regarding the negotiation procedure is largely the asymmetry in financial impact related information.

 

NHIS has said the revised system would demand the negotiating company to confirm the financial impact evidences.

 

As an industry representative, we welcome the agency’s decision and hope the system works as expected.”