Imfinzi builds evidence for biliary tract cancer reimb

Will it be fully reimbursed in Korea?

Company failed to extend reimbursement of the Imfinzi+GenCis combination to the first-line for biliary tract cancer… makes reattempt this time

Expected to be represented at HIRA’s 7th Cancer Disease Review Committee meeting on October 2nd

Cost-sharing remains the main hurdle...how the CDDC will evaluate the Korean subgroup analysis evidence is important

AstraZeneca is reattempting to extend reimbursement of its immuno-oncology drug imfinzi (durvalumab) after announcing significant clinical outcomes in biliary tract cancer.

 

Amid the rising interest in Imfinzi’s reimbursement reapplication review, with patient petitions being posted on the National Assembly's e-petition website, the outcome of the Korean subgroup analysis has been recently announced, gaining attention.

 

임핀지 제품사진

According to industry sources, the Health Insurance Review and Assessment Service will hold the 7th Cancer Disease Deliberation Committee (CDDC) meeting on the 2nd of this month.

 

This time, AstraZeneca is knowingly reattempting to extend Imfinzi’s reimbursement after failing to extend its reimbursement as a first-line treatment for biliary tract cancer last year.

 

Last year, the company was not able to receive full coverage for the Imfinzi and GemCis (gemcitabine plus cisplatin) combination, and only GemCis was granted reimbursement at the time.

 

AstraZeneca has now reapplied to CDDC for full coverage based on several additional grounds.

 

Highlights include a Korean subgroup analysis of TOPAZ-1, Imfinzi’s Phase III study in patients with locally advanced or metastatic biliary tract cancer, which was presented at the Korean Society of Medical Oncology (KSMO) International Conference on October September 27th.

 

The 3-year follow-up of 120 South Korean patients who were enrolled in the TOPAZ-1 study showed that the Imfinzi combination improved median overall survival (mOS), 3-year OS rate, and clinical safety compared to conventional therapy.

 

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.

 

Another factor that can also influence the decision is patient demand.

 

A petition had been uploaded to the National Assembly on September 13 called for prompt insurance reimbursement of Imfinzi.

 

The petitioner, who described herself as the child of a patient with stage IV intrahepatic biliary tract cancer, said she had been paying more than KRW 10 million a month for Imfinzi as out-of-pocket cost because of its non-reimbursement, and that she was now unable to afford the treatment because she had exhausted her insured actual expense limit.

 

Despite Imfinzi’s proven effect, the petitioners believe that many patients have difficulty accessing the treatment due to financial reasons.

 

As of September 30, the petition had received 5,114 signatures.

 

Imfinzi is now recommended as a first-line standard of care in major biliary tract cancer treatment guidelines, including the National Comprehensive Cancer Network (NCCN) and the European Society for Medical Oncology (ESMO), and is reimbursed in major countries, including the United States and the United Kingdom.

 

However, there is also a view that the cost of Imfinzi, an immuno-oncology drug, is burdensome for Korea’s health insurance finances and that the company’s proportion of financial sharing will determine whether it passes CDDC review, regardless of the drug’s clinical performance.

 

The industry's view is that the fact that only GemCis was reimbursed in the Imfinzi combination regimen illustrates such government concerns.

 

The government had decided to not fully reimburse the Imfinzi-GemCis combination because this would require significant additional health insurance funding to cover its use as first-line treatment for biliary tract cancer.