Pharmaceutical post-market management system to be enhanced

Penalties for violating agreements

A follow-up measure in response to criticism on failure to obligate the 'Drug Price-Reimbursement Agreement'

For new drugs, reporting requirements of efficacy·effectiveness and dosage addition will be streamlined

MOHW has suggested directives to the pharmaceutical post-market management system at the briefing session

The National Health Insurance Service (NHIS) plans to revise its drug price negotiation and post-market management systems next year, with a focus on stable pharmaceutical supply.

 

The NHIS will actively enforce penalties stipulated in its regulations if pharmaceutical companies discontinue drug supply without notification in violation of agreements reached during price negotiations.

 

This is a response to criticism raised during this year's parliamentary inspection that the agency was not adequately managing the supply obligation despite having the 'Drug Price-Reimbursement Agreement.'

Se-rim Oh, Head of the Negotiation and Post-Management Unit at the Department of Drug Management.

On November 11, the NHIS held a 'Drug Price Negotiation and Post-Market Management System Briefing' at its headquarters in Wonju, sharing the direction for management reinforcement with industry stakeholders for next year.

 

The NHIS emphasized that if a company must inevitably suspend supply in violation of the agreement, it must formulate patient protection measures and consult with the NHIS beforehand.

 

Se-rim Oh, Head of the Negotiation and Post-Management Unit at the Department of Drug Management, said, "The NHIS plans to strengthen management focusing on supply issues.

 

If a company withdraws approval and suspends supply, it must ask pharmaceutical associations and formulate patient protection measures." Starting next year, the NHIS will actively consider imposing penalties on companies that violate their supply obligations, based on a fixed formula.

 

The current formula sets the penalty amount per day of violation as: "(Previous Year's Annual Claim Amount of the Violating Drug) X 1/n X1/365X50%." Furthermore, companies will be required to submit data to the NHIS within 40 days of the end of each quarter to verify the fulfillment of their supply obligation (including monthly production volume, import volume, requested supply volume, and actual supply volume).

 

The existing clause requires a company to pay a KRW 1 million fine for failure to mee these requirements.

 

This is in response to criticism during the parliamentary inspection that the clause was not being enforced.

 

The NHIS plans to actively enforce this rule.

 

Oh explained, "If fulfilling the agreement is difficult, you must communicate and consult with the NHIS beforehand.

 

Some companies have already agreed to the penalty clause after prior consultation due to the circumstances of their contract manufacturers." Oh added, "Companies failing to submit (data) are supposed to pay KRW 1 million, but this hasn't been enforced.

 

The NHIS is aware of this.

 

Please comply with it going forward." Eliminating reporting requirements for new efficacy and effectiveness...will review streamlining the requirement to report dosage The current obligation for companies to report any additional efficacy and effectiveness secured overseas after signing a contract with the NHIS will be exempted starting in the first half of next year.

 

Reporting obligations when adding a new dosage will also be streamlined.

 

Instead, if the domestic introduction of the new strength is necessary, the details will be stated in the agreement.

 

Oh said, "The agreement includes the obligation to report when an indication is added.

 

We are reviewing the exemption of this reporting obligation starting in the first half of next year," and added, "We are also considering simplifying the reporting obligation for adding new dosage strengths.

 

However, if domestic introduction of a strength already listed for overseas reimbursement is necessary, we plan to address this by explicitly stating the details in the agreement.

 

We will be gathering opinions on this matter." The NHIS is also considering the partial disclosure of information regarding Risk-Sharing Agreement (RSA) drugs.

 

They are currently conducting consultations on disclosing a list of drugs subject to the refund-type RSA.

 

Oh said, "If a reimbursement decision application is made to HIRA, we will ensure that information about the refund rate can be provided.

 

However, a non-disclosure agreement must be signed," and added, "We are also conducting consultations on publicly disclosing the list of drugs subject to the refund-type RSA." PVA 'one-time refunds' will be allowed temporarily next year...new guidelines for negotiaing scope expansion will be established

Hae-hee Moon, Head of the Volume Management Unit at the Department of Drug Management.

The NHIS will also improve its drug utilization management plan next year.

 

The agency plans to restrict the operation of the "one-time refund" mechanism, which was implemented during the COVID-19 pandemic, and establish new guidelines for negotiating the expansion of a drug's usage scope.

 

Hae-hee Moon, Head of the Volume Management Unit at the Department of Drug Management, said, "We plan to limit the products eligible for the one-time refund contract starting next year.

 

We are currently discussing this with the Ministry of Health and Welfare (MOHW).

 

We plan to gather opinions from the pharmaceutical association afterward." Moon explained, "We are also preparing guidelines due to the need for written instructions in the process of negotiating the expansion of usage scope.

 

We plan to conduct consultations this week and will refine these guidelines next year." The NHIS is also reviewing plans for introducing a dual pricing system with the MOHW.

 

Moon said, "There is a request from pharmaceutical companies to introduce a dual pricing system due to the U.S.

 

MFN policy.

 

We are reviewing system improvements and implementation plans with the MOHW." Revision of price cap adjustment guidelines...separate adjustments for emergency imported drugs

Hyung-min Kim, Head of the New Drug Management Department.

The guidelines for adjusting the ceiling price during drug price negotiations will also be partially revised.

 

The consideration for the estimated claim amount, which was previously based on the 'claim volume and growth rate of the negotiated drug over the past 3 to 5 years,' will be changed to the 'claim amount generated by the negotiated drug over the past 3 to 5 years.' Furthermore, a clause will be added to ensure that drugs urgently imported through the Korea Orphan and Essential Drug Center (KODC) will have a separate price adjustment procedure.

 

In addition, the clause specifying 'when there is a need for public healthcare' as an exception to the three-year limit on price adjustment applications after the initial adjustment will be further specified.

 

Hyung-min Kim, Head of the New Drug Management Department, explained, "We will define the need for public healthcare as a request for cooperation from central administrative agencies, and revise the regulation to require the Pharmaceutical Benefit Evaluation Committee to notify the NHIS of a price readjustment application," and added, "A clause will be inserted requiring measures such as refunds if the contract falls short of the mandatory production volume agreement," emphasizing the ministry's commitment to stable supply.