Security elaboration/ ultra-high-priced new drug coverage

Prospects of 2022 National Audit Issues

Enhancing and Monitoring of Registration Process

The government will prepare a series of follow-up measures, such as improving mechanisms for referring to overseas drug prices

In order to strengthen accessibility to new drug patients, the government has steadily increased coverage by opening a benefit gateway.

 

However, due to the development of innovative new drugs, limited funding of health insurance is a problem to catch up with the ultra-high price trend of anticancer drugs and rare disease treatments.

 

The challenge of overcoming the sustainability issue remains a challenge.

 

As Zolgensma, a treatment for Spinal Muscle Atrophy (SMA), called "ultra-high-priced one-shot treatment," was listed on the benefit starting this month, the government considered ways to improve accessibility from the basic definition of expensive new drugs.

 

The procedure for registering new drug benefits in Korea is carried out sequentially by applying for benefits from pharmaceutical companies, deliberating and evaluating the HIRA, negotiating drug prices between the NHIS and companies, and deliberating and voting by the Health Insurance Policy Review Committee.

 

However, it has been pointed out that the accessibility of drugs requiring urgent benefits is disrupted as HIRA deliberation and evaluation usually takes 120 days, 150 days for RSA targets, 60 days for drug price negotiations, and 30 days for review by the Health Insurance Policy Review Committee.

 

The biggest problem is by far the price.

 

The problem of price has been a constant obstacle even in the 2010s, when social needs were not heavily reflected.

 

Since the government and the insurance authorities judged whether or not the salary was paid and the price was the top priority, there were many problems with the appearance of high-priced new drugs.

 

Starting with the introduction of RSA in 2014, the government introduced a permit-evaluation linkage system in the same year and introduced a new economic evaluation data submission system and a drug price negotiation system in 2015 to improve accessibility to high-priced new drugs.

 

With the listing of Zolgensma, the government announced plans to create a definition of expensive drugs that it has been preparing and expand the mechanism for shortening negotiations, while strengthening follow-up management and monitoring.

 

The government will actively adopt a patient-level performance-based model by improving RSA, which used to be a financial base, but strengthen follow-up monitoring to utilize a payment method suitable for treatment effects and improve PVA in operation.

 

In addition, it was decided to prepare a pre-approved standard operating procedure (SOP) before taking ultra-high-priced drugs.

 

In addition, the National Assembly's legislative investigation office says it is desirable to discuss the introduction of a "pre-entry and post-evaluation" method as a new benefit pharmaceutical companies by paying the cost or evaluating the effectiveness of treatment after administration when claiming treatment expenses exceeding the set total benefit.

 

This is the way that related academia and patient organizations have suggested so far, and it can be said that it belongs to the same context in the large framework as RSA's performance-based model.

 

In order to make it common, the authorities and insurers should consider weakening the insurer's bargaining power and devices for effective operation in the process of negotiating drug prices.

 

In addition, the National Assembly also suggested the need to set up a separate fund to solve financial problems that will be affected by strengthening the guarantee of expensive new drugs.

 

This can be referenced in that advanced insurance countries such as the United Kingdom operate various types of drug funding systems as a mechanism for salary exceptions in consideration of uncertainties that arise when there is not enough data to evaluate the value of drugs.

 

The government plans to subdivide the management method and registration process by lowering the speed and evaluation barrier of the benefit entry stage, increasing follow-up monitoring and evaluation, and improving the reference criteria for foreign drug price adjustment in the future.

 

It is important to pay attention to how much more sophisticated the new drug guarantee policy will become in the future, so it is also important to pay attention to the parliamentary audit in the second half.