The drug reimbursement benefit would be improved throughout chronic disease treatment this year, centering hepatitis B and C virus treatment and antidiabetic combination drugs.

The already listed drug reimbursement reevaluation would be enforced from the latter half of the year, when the subjects are decided in the first half of the year. Moreover, the external reference pricing criteria, generic substitution incentive, also known as Rewards for Saving Drug Expenditure (RSDE), would be amended within this year.

South Korea’s Ministry of Health and Welfare (MOHW) is to unfold the ‘2021 Action Plan for the First National Health Insurance (NHI) Master Plan’ as scheduled.

These plans would follow the yearly flow of innovative NHI coverage enhancement initiative and the reimbursement quality and finance management programs.


Pharmaceutical coverage enhancement initiative—granting reimbursement on non-reimbursed drugs

The ‘Reimbursement Provision on Non-reimbursed Drug’ program that enhances coverage while keeping the positive listing system, would expand on chronic disease treatment as it did on musculoskeletal and pain clinic medication and anticancer treatment (adjuvant drug) last year.

So far, the government completed newly listing total 60 items (22 anticancer treatments and 38 general drugs) with high social and clinical demand, originally categorized as non-reimbursed drug.

An immunotherapy Tecentriq (January 2018), a multiple myeloma treatment Kyprolis (February 2018), a renal cell carcinoma treatment Cabometyx (February 2019) and an immunotherapy Imfinzi (April 2020) are now all covered by NHI.

General drugs, such as hepatitis C virus treatment Mavyret (June 2018), a new drug for spinal muscular atrophy (SMA) Spinraza (April 2019), a severe atopic dermatitis treatment Dupixent (January 2020), and a hemophilia treatment Hemlibra (May 2020), were also listed for reimbursement.

With the initiative to cover the listed drugs in non-reimbursed criteria, the coverage was applied on total 124 items, consisting of 15 anticancer treatment and 109 general drugs. A chronic lymphocytic leukemia treatment Imbruvica (April 2018), a breast cancer treatment Perjeta (May 2019), a hepatocellular carcinoma treatment Nexavar (January 2020), an acute lymphoblastic leukemia treatment Blincyto (April 2020) and a parenteral iron therapy Venoferrum (May 2020) received the NHI benefit.

The drug coverage expansion program is to continue this year as well, concentrating on non-reimbursed treatments for chronic disease, i.e. hepatitis B and C virus treatments and antidiabetic treatment.

The government plans to revise the pharmacoeconomic evaluation guideline within the first quarter, and reflect the external reference pricing changes on regulation by the second half of the year.

The government expects the patients’ treatment access would be improved and their financial burden would be lessened by the new coverage on drugs with high social and clinical demand.

NHI sustainability—reevaluating listed drugs

The government has been reassessing the reimbursement adequacy and feasibility on medical service, pharmaceutical, and medical treatment material, in the said sequential order.

In November 2019, Drug Post-listing Evaluation Subcommittee under the Drug Reimbursement Evaluation Committee was formed and selected choline alfoscerate to reevaluate the reimbursement from February through July and changed the benefit to selective reimbursement (copayment rate 80 percent) for using the drug in treating conditions other than dementia.

Also, the government is to initiate the reevaluation program this year after finalizing the process and revising the weighted drug pricing system since last February.

In particular, by integrating the current weighted pricings—‘one year plus infinite (number of companies supplying same substance drug less than three)’ for synthetics, and ‘two years plus one year (number of same substance drug suppliers less than three)’ for biologics—the government is to apply ‘one year plus two years (number of same substance drug suppliers less than three)’ for both synthetics and biologics and to extend two years after deliberation.

The weighted pricing reevaluation would be conducted within the first half of the year, and the actual full on reevaluation would start from the latter half of the year after selecting subject drugs with uncertainty.

The government anticipates the reevaluation to create a foundation for essential drug-centered coverage expansion.

NHI sustainability—improved management of pharmaceutical expense

To better manage the pharmaceutical expense, the government has been compiling long and mid-term drug reimbursement strategy so far based on the revised volume-pricing linkage system.

First, the RSDE program improvements would be established to control the drug use volume by referring to the previous researches. The government would review the plan in the first quarter, put together the improvements and finalize them by the end of the year.

As for pharmaceutical expense control, the detailed drug reimbursement-deciding principles and listing prioritization would be reviewed by the third quarter and finalized within the fourth quarter.

The final adjustment would be decided and finalized in the latter half of the year, after thoroughly analyzing the external reference pricing with the current pricing range for each chronic and senile disorder drugs in South Korea.