Will combination therapies for cancer be reimbursed in KOR?

Whether the discussions will further expand gains attention

HIRA starts preparing review principles for high-priced drugs

‘New anticancer drug+currently reimbursed drug’ combo the major focus of discussions…seeks to simplify the procedure

‘New drug+new drug’ combination excluded from discussions… new drug combinations remain in need for discussions

As the government has begun to prepare the principles for the reimbursement review of combination therapies that use new anticancer drugs, attention is being paid to whether the discussion will progress further.

 

According to industry sources, the Health Insurance Review and Assessment Service recently held a Cancer Disease Deliberation Committee meeting and decided to prepare deliberation principles to discuss whether to approve benefits for major combination therapies.

 

The decision is in line with the growing calls for a change in the reimbursement paradigm for prescribing anticancer drugs based on accumulated evidence on ‘combination therapies’ between treatments from various clinical studies.

 

Recently, multinational pharmaceutical companies have been seeking the reimbursement of combination therapies using new anticancer drugs, calling for an institutionalized process.

 

When considering reimbursement for combinations of non-reimbursed new drugs and reimbursed chemotherapy drugs, the industry has suggested that discussions on previously reimbursed drugs should be reserved and only the non-reimbursed drugs should be discussed.

 

A case in point is AstraZeneca's immuno-oncology drug Imfinzi (durvalumab), the reimbursement of which had been discussed for biliary tract cancer last year.

 

At the time, CDDC only approved gemcitabine and cisplatin in combination with chemotherapy (the GemCis regimen) for first-line treatment of biliary tract cancer, while leaving Imfinzi non-reimbursed.

 

The government will discuss setting a deliberation principle where a drug, which is already reimbursed, is used with a non-reimbursed new drug as part of combination therapy and should continue to be reimbursed without further discussions.

 

This can be observed in the results of the 7th CDDC Review, which reviewed the combination of ‘endocrine therapy’ and ‘Verzenio (abemaciclib)’ for the treatment of early breast cancer.

 

The outcome of the deliberations was to keep the previously reimbursed adjuvant endocrine therapy as is and make the newly added Verzenio available on a ‘100% coinsurance’ basis, reducing the cost burden on the patients.

 

In other words, it means that the process will be simplified by allowing the reimbursement of existing treatments within the combination to be recognized.

 

However, these principles are not automatically applicable to all new combination therapies, and as it leaves the existing framework in place, it is far from the improvements to the new drug approval approaches the industry had hoped for.

 

Nevertheless, it is positive as it has opened the door to further discussions.

 

There are also expectations that such discussions will lead to solutions for ‘new drug+new drug’ combination therapies.

 

A pharmaceutical industry official said, “It is still a drug-by-drug approach, so it's not a one-size-fits-all approach, but it's positive that the discussions have been officially made.

 

We understand that KRPIA and others are also having discussions on what kind of processes will be required for the reimbursement of new drugs for combination therapies in the future,’ “With the number of combination therapy cases increasing, there is currently no set process for how applications should be submitted for listing and how they should be reviewed.

 

We are looking forward to the various approaches that may be developed through discussions as individual cases have come to light.”