How Trodelvy was applied flexible ICER for innovativeness

ICER threshold was quite high... but the drug’s reimbursement adequacy was recognized considering its innovation

Satisfied all 3 innovation requirements established in August last year

The ADC breast cancer drug Trodelvy (sacituzumab govitecan, Gilead), which was reimbursed in June for triple-negative breast cancer, was the first case in which the ICER (incremental cost-effectiveness ratio) threshold was flexibly applied in recognition of its innovation.

 

So how did the Drug Reimbursement Evaluation Committee (DREC) of the Health Insurance Review and Assessment Service at the time evaluate the innovativeness of this drug?

 

According to the recently released evaluation results, Trodelvy was found to satisfy all criteria for innovative treatment, including the absence of alternative treatments, clinical improvement, and the criteria for expedited review.

 

According to industry sources on the 11th, in the recently released DREC evaluation results for Trodelvy, the committee members recognized its reimbursement as appropriate despite the high cost-effectiveness ratio, taking into account the drug’s innovativeness." In August last year, the Health Insurance Review and Assessment Service established new requirements for the innovation of drugs subject to flexible ICER threshold assessment.

 

According to the newly established criteria, the innovation of a new drug is recognized when ▲there are no substitute products or treatments with equivalent therapeutic positions, ▲significant clinical improvement can be recognized in the final outcome indicators, such as prolonged survival, ▲the new drug is a new drug approved by the Ministry of Food and Drug Safety through an expedited review process in accordance with Article 35-4, Paragraph 2 of the Pharmaceutical Affairs Act, or a drug recognized by the committee as equivalent to such a drug.

 

All three requirements must be met for a new drug to be recognized as innovative.

 

Trodelvy became the first drug to be recognized as innovative under these criteria.

 

At the time, the DREC members evaluated that Trodelvy satisfied all three requirements.

 

First, they determined that it satisfied the first requirement as the first antibody-drug conjugate (ADC) approved for triple-negative breast cancer, with no products or treatments with equivalent therapeutic positions.

 

In addition, they evaluated that the second requirement was also satisfied, as clinical improvement (mOS HR=0.51) was recognized in the final outcome indicators, such as prolonged survival.

 

Finally, considering that it was approved by the FDA as a breakthrough therapy and designated as a Global Innovative product for Fast Track item by the MFDS, the committee deemed that the third requirement was also satisfied.

 

In terms of cost-effectiveness, the committee concluded that Trodelvy is significantly more cost-effective than existing anticancer drugs and breast cancer drugs that have been reviewed in the past.

 

However, considering that it is a drug used for diseases that threaten survival in the third or further line of administration, that it has been recognized for improving the social burden of disease and quality of life, and that it is the first antibody-drug conjugate (ADC) approved for triple-negative breast cancer, the committee accepted its reimbursement as adequate.

 

In other words, the high price was accepted in recognition of its innovation.

 

Another factor was that the number of patients eligible for treatment was small, so the drug’s financial impact was not significant.

 

According to the DREC evaluation results, Trodelvy is a drug used by approximately 200 patients, and the decision was made after comprehensive consideration of factors such as the number of patients eligible for treatment and the financial impact.

 

In the end, Trodelvy was listed for reimbursement under two types of risk-sharing agreements (RSA) with the National Health Insurance Service.

 

Among the types of RSA contracts that were applied, one was a Refund-Type agreement, where the pharmaceutical company reimburses a certain percentage of the claimed amount to the NHIS, and the other was the Utilization Cap/Fixed Cost per Patient Refund Type agreement, where the usage limit per patient is set in advance, and a certain percentage of the excess amount is reimbursed to the NHIS if the limit is exceeded.

 

The listed price (maximum amount) is KRW 1,052,300 per vial, but due to the dual pricing system applied under the reimbursement-type contract, the actual price is higher.

 

The estimated number of patients receiving Trodelvy annually is approximately 282, with an estimated fiscal expenditure of approximately KRW 12.5 billion.

 

However, the actual fiscal expenditure is expected to be lower if the risk-sharing agreement is applied.

 

At a 5% coinsurance rate, patients will only need to pay approximately KRW 2.21 million per year for its administration.