Imfinzi passes first step to reimb in KOR… key is the price

How will the company successfully complete pricing negotiations?

Imfinzi has set reimb standards as a first-line treatment for biliary tract cancer after failing to establish standards last year

AZ proposes a new plan regarding the drug’s price… data on Koreans positively affect the reimb decision

Cost burden hurdle remains...how its expanded scope of use in biliary tract and liver cancer will affect the government's decision gains attention

With the reimbursement standard set for the immuno-oncology drug Imfinzi (durvalumab), which is under review for reimbursement extensions, how the discussions will develop thereafter is gaining attention.

 

Although the first step has been taken, attention is being paid to the future process as the matter was mentioned during the National Assembly’s Health Insurance Review and Assessment Service National Audit.

 

The drug price is the key issue.

 

Consensus on the cost is expected to be crucial amid the rising health insurance expenses being spent on anticancer drugs.

 

Pic of Imfinzi

According to industry sources on the 18th, the Health Insurance Review and Assessment Service recently held the 8th Cancer Disease Deliberation Committee (CDDC) meeting in 2024 to deliberate on whether to establish reimbursement standards for major anticancer drugs.

 

As a result, Imfinzi was set reimbursement standards in combination with gemcitabine and cisplatin for the first-line treatment of patients with locally advanced or metastatic biliary tract cancer.  In addition, AstraZeneca's Imjudo (tremelimumab) has also been set reimbursement standards in combination with Imfinzi in liver cancer, raising expectations for further coverage of the drug.  In a response to a written inquiry during the NA Audit, HIRA had said, “As a result of the CDDC review that was held in November last year, the committee decided Imfinzi’s cost should fully be borne by patients due to its high price and high financial spending compared to clinical benefits.” However, the CDDC changed its decision and recognized Imfinzi’s clinical benefits this time around.

 

In fact, a Korean subgroup analysis of TOPAZ-1, Imfinzi’s Phase 3 trial in biliary tract cancer, which was presented at the Korean Society of Medical Oncology (KSMO) International Conference in September, showed improved median overall survival (mOS) and 3-year OS rate in Korean patients.

 

Korean patients treated with the Imfinzi combination showed an mOS of 16.6 months, compared to the 11.3 months found in Korean patients treated with conventional therapy, which is a 5.3-month extension in overall survival.

 

The OS rate at 3 years also improved over twofold, being 21.0% in the Imfinzi combination arm and 8.8% in the conventional therapy arm.

 

 ▲ Key Results of the TOPAZ-1 overall patient and Korean subgroup analysis

The industry also believes that AstraZeneca's improved financial proposal to the government for Imfinzi would have played a role during the CDDC review.

 

The key question is whether it will pass the next stage, the Drug Reimbursement Evaluation Committee review.

 

Although the company has succeeded in expanding the reimbursement standard for Imfinzi and setting the reimbursement standards for Imjudo in biliary tract cancer and liver cancer, respectively, there is also the burden of increased use for Imfinzi that would affect the drug’s price.

 

Currently, Imfinzi costs around KRW3.34 million per bottle, and the cost of administering the drug is even higher for liver cancer patients who receive the drug in combination with Imjudo.

 

In the end, it will be important to find a compromise between the fact that Imfinzi has become the global standard of care for biliary tract cancer in 12 years and its increasing burden on health insurance finances.

 

In the U.S., U.K., and Japan, Imfinzi was reimbursed within a year of its approval.

 

The industry believes the U.K.’s case would provide clues for Korea’s implementation.

 

During reimbursement discussions, the U.K.

 

used a quality-adjusted life years (QALYs) weight of 1.2 and a flexible ICER in recognition of the fact that Imfinzi was the first immuno-oncology drug approved for the first-line treatment of biliary tract cancer.

 

However, as Imfinzi’s ICER does not meet the criteria for the Korean government's 'preferential treatment for innovative new drugs', it remains to be seen how the discussions will unfold.

 

The industry analyzes that it will come down to what the pharmaceutical companies will propose in terms of financial sharing and whether the government will accept the proposal.

 

“AstraZeneca Korea is committed to providing innovative treatment options for biliary tract cancer patients in Korea.

 

We will continue to do our best in the coming process,” said an AstraZeneca official.