New criteria set for flexible ICER threshold evaluations

Gov’t discloses amendment to "Criteria for a detailed evaluation of drugs subject to negotiation, such as new drugs"

Reviewed through DREC review on the 8th…Includes improvements to the Risk-Sharing Agreement scheme

The National Health Insurance Review and Assessment Service (HIRA) established new criteria for drugs that apply flexible ICER (incremental cost-effectiveness ratio) thresholds during the Drug Reimbursement Evaluation Committee (DREC) meeting that was held on the 8th.

 

The previous criteria only stipulated that a flexible ICER threshold could be applied, but specifics were established.

 

this time.

 

In February, DREC recognized reimbursement adequate for the breast and stomach cancer drug Enhertu (trastuzumab deruxtecan, Daiichi Sankyo Korea) by flexibly applying the ICER threshold.

 

On the 8th, HIRA disclosed the "Criteria for detailed evaluation of drugs subject to negotiation, such as new drugs" which was newly amended based on DREC deliberations.

 

                                                  The amendments include ▲ New criteria for flexible ICER threshold evaluation; ▲ Addition of severe diseases to the risk-sharing agreement scheme; ▲ Omission of the Drug Evaluation Committee review when expanding the reimbursement range of RSA drugs that claim less than KRW 1.5 billion; ▲ New conditions that require submission of clinical evidence such as RWD and RWE when renewing RSA schemes.

 

◆ New criteria for flexible ICER threshold evaluation=The existing regulations only stipulated that the ICER threshold “need not be explicit, and can be flexibly applied with regards to the results of previous deliberations in consideration of the severity of the disease, the burden of disease on society, the impact on quality of life, and innovativeness.” In the amendment, the 'innovativeness' requirement has been specifically established for the flexible evaluation of new drugs.

 

A new drug is regarded as ‘innovative’ when it satisfies all of the following criteria: ▲ there is no substitutable or therapeutically equivalent product or treatment ▲ has shown significant clinical improvement, such as prolonged survival, is recognized in the final outcome, ▲is a new drug is approved by the MFDS under Article 35(4)(2) of the Pharmaceutical Affairs Act through expedited review or is recognized as equivalent by the committee.

 

◆ Addition of severe diseases to the risk-sharing agreement scheme = In principle, anti-cancer drugs or rare disease drugs were subject to RSA.

 

However, the previous regulation had allowed drugs that are not necessarily anti-cancer or rare disease drugs to be applied to RSA if the committee recognizes the drugs as equivalent.

 

However, the amended regulations clarified the ‘equivalent disease’ condition.

 

The amendment stipulates that an ‘equivalent disease’ to a severe disease does not qualify for the currently recognized special calculations, but is difficult to cure, causes irreversible disability or organ damage due to the progression of the disease, and has a significant burden of disease.

 

DREC had already recognized reimbursement of severe atopic dermatitis drugs like Dupixent and severe asthma drugs as reimbursable using RSA.

 

◆ Omission of the Drug Evaluation Committee review when expanding the reimbursement range of RSA drugs that claim less than KRW 1.5 billion = The new amendment allows RSA drugs to skip DREC review if the expanded claims amount amounts to less than KRW 1.5 billion.

 

Specifically, if the expected additional claims of refund-type RSA drugs, excluding the mixed-type RSA drugs, is less than KRW 1.5 billion, DREC’s evaluation can be skipped and the insurance ceiling price and refund rate be re-negotiated through NHIS negotiations.

 

◆RWD, RWE, etc.

 

to be submitted when RSA is renewed =The new amendment also requires drugs with a certain condition to submit RWD, RWE, etc.

 

when renewing their RSA contract.

 

This is in line with how Ilaris (canakinumab, Novartis Korea) was recently approved for reimbursement based on the condition of submitting prospective clinical trial data.

 

As such, the amendment specifies that drugs that are listed under the condition of collecting clinical evidence, such as RWD and RWE, should collect and submit clinical evidence when renewing their RSA contract.

 

On the other hand, the new amendment does not include terms for the preferential treatment of homegrown new drugs.

 

The pharmaceutical industry had expected that the preferential treatment for domestic new drugs would be included by revising the ‘1.7.

 

Cases where necessary in consideration of the impact on healthcare' clause of the ‘Criteria for detailed evaluation of drugs subject to negotiation, such as new drugs.’ The industry expected that preferential treatment of non-inferior new drugs and domestically developed new drugs utilizing natural products would be added in the amendment, but were not included.

 

However, there are opinions that the condition for preferential treatment for domestic drugs may be included in other regulations.