HIRA unveils listed drug reevaluation guideline

Updating from previous reimbursed drug list adjustment procedure, comparing with 8 countries

Evaluation criteria to reflect usage frequency, billing ratio and social interest level of anticancer and rare disease treatments

Breaking down disclosed post-marketing pharmaceutical evaluation criteria and procedure

Chief Park Eun-Young of Pharmaceutical Evaluation Improvement Team at HIRA

The government unveiled the details of the post-marketing reevaluation criteria and procedure of reimbursed drug.

 

The scope of listed drug reevaluation mainly centers expensive drug items, such as anticancer and rare disease treatments, covered by insurance benefit despite their uncertainty in clinical efficacy.

 

The evaluation borrows the previous reimbursed drug list adjustment procedure, but the criteria are to be set in more intricately to cover different kinds of pharmaceutical benefit provided now.

 

Health Insurance Review and Assessment Service’ (HIRA) Chief Park Eun-Young of Pharmaceutical Evaluation Improvement Team under Pharmaceutical Department presented a post-marketing reevaluation plan on listed drug at a public hearing convened for the topic on Dec.

 

3 at the Ferrum Tower, Seoul.

 

For the reevaluation, applicable items are to be selected from the pool of high-cost drugs treating cancer and rare disease with uncertainty in clinical efficacy.

 

The selection procedure would take account of item’s insurance listing status in foreign countries, usage frequency, insurance billing ratio, namely pharmaceutical expenditure increase rate and billing amount.

 

Also levels of pharmaceutical and medical importance and social interest could also affect the procedure.

 

Initially selected list of drugs would then be evaluated by published literature, such as textbooks, guidelines and clinical literatures.

 

Basically, the structure of the listed-drug post-evaluation is to follow the footsteps of the Moon Jae-in Care.

 

Evaluation model the government used for adjusting reimbursed drug list from 2007 to 2011

◆ Updating listed drug post-evaluation from 12 years back: Evaluation on clinical efficacy was a key evaluation model in the previous reimbursed drug list adjustment.

 

Enforced from 2007 to 2011, the list adjustment procedure also made decisions on reimbursement listing cancellation or restriction based on literature review of related textbooks and guidelines, and verification of medically essential substances.

 

The Level A clinical efficacy evaluation indicated an item is “clinically effective”, as long as it met at least one of criteria, including Health Technology Assessment (HTA), World Health Organization (WHO) Model List of Essential Medicines (EML), shortage prevention drug, orphan drug, basic parenteral solution, and other essential drug.

 

Whereas, Level B evaluation indicated an item as “clinically effective” when it met all three criteria of confirming essential medicine recommendation by related academics, recognition by related committees, and usage status in foreign countries.

 

In the past, the Korean government used to refer to the U.S.

 

the U.K., France, Italy, Japan, Germany and Switzerland, also known as A7, for the status of reimbursement listing.

 

For the evaluation, an item had to be listed in more than two countries from the list.

 

A new drug developed from Korea or in Asia was considered ‘listed in two or more A7 countries.’ And now the government plans to apply the past experience in the reimbursed drug list adjustment procedure on to the new listed drug post-management.

 

Considering the diversified pharmaceutical benefits since then, the new post-management system is expected to be segmentalized and tightened even more.

 

New reimbursed drug post-marketing evaluation procedure model

◆ Evaluation details: From the overall list of reimbursed drug items, anticancer therapy, rare disease treatment and items with uncertainty in clinical efficacy would be selected as subjects for the evaluation.

 

Further selection criteria consist of substances requiring clinical efficacy validation by reevaluating effectiveness, requiring tightened management due to change in population structure and increased usage volume, and requiring Post-marketing Drug Reevaluation Subcommittee’s evaluation considering impacts on the society and other healthcare issues.

 

After the first phase of selection, HIRA would review foreign countries’ approval and reimbursement listing status on the subjects.

 

Besides the list of seven foreign countries used for the past reimbursed drug list adjustment, Canada is newly added.

 

Moreover, drug reimbursement billing amount, increased rate claims, billing frequency and its ratio are to be reviewed all around.

 

Other factors like levels of pharmaceutical and medical importance and social interest would be added as the evaluation criteria.

 

HIRA would then evaluate the filtered subjects with evenly chosen clinical literatures, such as related textbook, guidelines and HTA reports.

 

The agency explained alternative treatment options and special property of substances would be considered as well.

 

When choosing the textbooks and guidelines for the review, HIRA would extensively consider literature’s evidence basis, popularity, expertise, validity, publication period, language, and recognition based on academic society’s evidence evaluation.

 

Currently, the government and HIRA have not finalized the detailed list of literatures, such as basic list of textbooks from major search database, list of basic guideline from foreign guideline search database, government-related or not-for-profit performance assessment report, and list of published Cochran Reviews and HTA report.

 

In addition, HIRA is contemplating on taking account of substance demand from related academic societies, alternative feasibility based on available option with equivalent or different mechanisms, and special property of substance.

 

Restrictive use for pediatric patient, treatment for special patients with HIV-like conditions, and emergent medicine are categorized as special property of substance.

 

Clinical efficacy reevaluation procedure

◆ Procedure of clinical efficacy reevaluation: The government and HIRA are planning to select subject items with administrative review, Post-marketing Drug Reevaluation Subcommittee, and Drug Reimbursement Evaluation Committee (DREC), in the said order.

 

The literature-based evaluation would follow the selection, and then the government agency is to officially notify respective pharmaceutical companies.

 

The reevaluation can be repeated from the top, if need be, and the result is finalized after the second around.

 

The government plans to subdivide the reevaluation procedure into finance-based and performance-based post-marketing evaluation, and further enhance the reevaluation procedure.

 

Prospective plan for the reevaluation system