RSA's collateral period was reduced by 3 months

The NHIS, briefing session on revisions to detailed operation guidelines for drug price negotiations

For expenditure cap, the standard changed from 130% to 100% of the estimated billing amount

The amount of collateral that pharmaceutical companies have to pay when signing an RSA drug is expected to decrease by 25%.

 

According to the 'Detailed Operation Guidelines for Drug Price Negotiation of the Risk Sharing Agreement' revised by The NHIS on October 8, the period of collateral has been changed from 12 months to 9 months.

 

This is because if the actual formula is substituted, the amount of collateral will decrease.

 

The NHIS held a 'RSA drug price negotiation system and follow-up management online briefing' for about 100 pharmaceutical companies from 2 pm on the 25th.

 

"Pharmaceutical companies have made a lot of requests to reduce the amount of collateral that is collectively entered at first," said Oh Se-rim, a team leader in the NHIS Drug Price Negotiation Department, who was in charge of announcing the revised matters.

 

Following that, Team leader Oh said, "It has been shown that the amount of collateral is arithmetically reduced by 25% by reducing the amount of collateral by three months from 12 months to 9 months." In the case of the Refund type, as the amount of collateral is reduced, it becomes 'estimated billing amount (maximum) x refund rate x 130%' to 'estimated billing amount (actual) x refund rate/1-refund rate x 9/12 x 130%'.

 

The reason that the estimated billing amount has changed from the upper limit (indicated price) to the actual price is that, while revising the guidelines, the 'actual fiscal impact criterion' was set in consideration of the refund of the estimated billing amount.

 

Based on the revised guidelines, if the amount of the collateral is calculated assuming a drug with a labeling price of ₩10,000, an actual price of ₩80,000, a refund rate of 20%, and an estimated billing volume of 1 million vials, it was previously '10 billion won (maximum amount) × 20% (refund rate) × It had to pay ₩2.6 billion as '130%', but '₩8 billion (actual) x 20%/(1-20%) (1-refund rate) x 9/12 x 130%' is applied as a change between collateral.

 

If so, it will reduce ₩650 million to ₩1.95 billion.

 

Team leader Oh explained, "The initial guideline was released and there was no change in the formula that was not in the refund rate part, but it was corrected by changing it to the actual price minus the refund rate.

 

There was a reduction in the amount of about 25%." Since its introduction in 2014, RSA has signed a total of 48 drugs and 85 items as of October 30.

 

By type, there are 13 Refund types (26 items), 18 Expenditure Cap types (29 items), 1 Refund type for initial treatment (2 items), and 3 Utilization Cap/Fixed Cost per Patient type (6 items), other type (1 item), and a combination of 12 items (21 items).

 

Expenditure Cap Change = According to the guidelines changed by The NHIS, the Expenditure Cap was changed from 130% to 100% of the estimated billing amount when negotiating the Article 6 risk sharing proposal.

 

At the time this guideline was published, the pharmaceutical industry was most opposed to it.

 

The team leader said, "The omission of Profitability Evaluation changed the total amount based on financial impact." The team leader said, "There is a lot of worries in the pharmaceutical industry.

 

As a result of analyzing Expenditure Cap-type drugs, most of them have reached the 100% standard.

 

It will not have a big impact as expected." In addition, the standard of the estimated billing amount was changed from the upper limit to the actual price.

 

Depending on the nature of the drug, it is possible to set the estimated billing amount based on the upper limit amount, and when monitoring the Price-Volume (PV), they can specify whether the refund amount is included in the agreement.

 

Nam-seon Choi, Director of Drug Price Negotiations, said, "If we assume that an estimated billing amount of ₩20 billion and a refund of ₩5 billion, whether for initial treatment Refund or Utilization Cap/Fixed Cost per Patient, we will set ₩15 billion as the estimated billing amount." "Pharmaceutical companies can decide whether to set it based on the actual fiscal impact excluding the amount of refund or the details of the claim.“

Nam-seon Choi is explaining the amendment to the RSA drug price negotiation guidelines

However, in principle, it is only stated in the guidelines that it is based on the actual price.

 

"In the past, only one type was applied," said Choi, "a part that changed as the guidelines were revised and various types were mixed and the standard for the total amount was set together." He explained, "The principle is based on the actual price, but if the actual price cannot be made according to various types, it can be discussed in the negotiation and entered in the agreement." Expenditure Cap contract obligation for phase III conditionally licensed drugs = As risk-sharing targets expanded in this guideline, conditional drugs in phase III clinical trial were also included.

 

This drug will sign an Expenditure Cap contract, and team leader Oh interpreted, "For these drugs, it is not easy to submit profitability evaluation data, but the possibility of benefit registration may have increased" However, the definition of conditional drugs in phase III was specified in accordance with the 'Examination Regulations for Declaration of Product Permission for Drugs', and limited to drugs that were approved by submission of data for phase II and approved under the conditions of clinical data for phase III.

 

Team leader Oh said, "The drugs that have only partially submitted data on conditional drugs in clinical III or whose overall survival rate (OS) is released after approval are not considered conditional, but only drugs according to the review regulations." Expiration of contract term = One of the biggest changes from the revision of this guideline in The NHIS is the treatment method after the RSA contract term expires.

 

In the past, before the expiration of the RSA contract period (4+1 years), the NHIS requested the evaluation of the risk-sharing system of existing RSA drugs in the Pharmaceutical Benefits Advisory Committee of the HIRA However, only the changed guidelines do not allow the Pharmaceutical Benefits Advisory Committee to determine whether or not to be eligible for a risk-sharing system.

 

The clinical usefulness and cost-effectiveness of drugs near the expiration of the RSA contract will be evaluated.

 

And the NHIS will be able to re-contract or terminate the contract by negotiating risk-sharing plans such as the upper limit amount of the drug, the estimated billing amount and the refund rate, and the cap based on the result.

 

The NHIS, the parties to the contract, will have the overall risk-sharing contract.

 

“In the past, the Pharmaceutical Benefits Advisory Committee evaluated whether or not to be eligible for RSA, and the contract was terminated because it was difficult to evaluate most of the risk-sharing when alternative drugs came in.” He added, "In the future, we will see the clinical utility and cost-effectiveness of RSA drugs, rather than evaluating whether the HIRA is subject to risk sharing." It means that if an alternative drug comes in or other issues arise, it will decide whether to continue the contract based on the cost-effective aspect.

 

Team Leader Oh said, “The Leader decides whether to re-contract or negotiate based on the evaluation results of the HIRA, and continues the contract considering the upper limit amount, estimated billing amount, and refund rate in consideration of changes in the clinical environment over the past 4 to 5 years.

 

We will discuss whether or not with a pharmaceutical company."