Only hope for pancreatic cancer Onivyde seeking for coverage

Requested for reimbursement last July, DREC talks to commence from April

Unexpected issue found for seeking coverage on second and later-line treatment

The pancreatic cancer with highly unmet medical needs may welcome a newly listed drug.

 

The pharmaceutical industry sources reported Servier Korea’s Onivyde (Irinotecan Hydrochloride) would be deliberated by the Health Insurance Review and Assessment Service (HIRA) Drug Reimbursement Evaluation Committee (DREC).

 

Requested for the National Health Insurance (NHI) reimbursement last July, the drug is finally starting the practical discussion on the listing after about six months.

 

Onivyde has requested for reimbursement on an indication to treat patients, who have failed a first-line gemcitabine-based treatment, as second-line 5-FU/LV combination therapy.

 

But Onivyde faces an unexpected challenge.

 

The South Korean government has recently decided to significantly reform the anticancer treatment reimbursement standard used for pancreatic cancer.

 

As a result, HIRA is to enforce the revised notification of drugs prescribed and administered to cancer patients reflecting the details from Apr.

 

1.

 

According to the change, the division between the first and second tier anticancer treatments has been removed, and the first tier anticancer therapies (10 items including cisplatin monotherapy) were delisted, while gemcitabine plus paclitaxel combination, previously categorized as a second tier anticancer treatment for first-line palliative therapy with reimbursement, can be now also prescribed for second-line therapy.

 

As patients with pancreatic cancer had extremely limited option for a first-line therapy so far, the patients would greatly appreciate the government’s new reimbursement expansion decision.

 

But the latest change can be burdening for Onivyde.

 

As many of anticancer treatments initially not listed for reimbursement as second-line or later therapy are now listed, the government’s standard on reviewing the reimbursement feasibility, such as ICER, could get tougher.

 

Medical experts complain the government should have included Onivyde, when discussing about the reimbursement listing reform.

 

Professor Yoo Chang-hoon of Oncology Department at Asan Medical Center noted, “To this date, we talk about the second and third-line treatment with a lot of pancreatic patients.

 

Because they do not get coverage, we also check on their private medical expense insurance.

 

It is regrettable that Onivyde has not gotten reimbursement, yet, even it has global Phase III trial and Asian subset analysis data and Korean RWE.” The global multicenter Phase III trial NAPOLI-1 study has confirmed Onivyde, in combination with a standard second-line treatment option '5-FU/LV,' significantly improved the treatment outcome on patients, who did not respond to first-line gemcitabine-based treatment.

 

The drug raised awareness of the importance of sequential combination strategy in treating metastatic pancreatic cancer.

 

It is the only treatment recommended as a Category 1 by NCCN guideline when second-line gemcitabine-based anticancer therapy is used to treat patients with metastatic pancreatic cancer.