What to expect from the upcoming 2-day HIRA DREC meeting

which will be conducted for an unprecedented 2 days

HA eye drops and reimbursement adequacy review of Koselugo gain attention

The industry’s attention is focused on the Health Insurance Review and Assessment Service’s Drug Reimbursement Evaluation Committee meeting that is being held for an unprecedented 2 days this month.

 

The industry predicts that the 2-day term reflects the difficulty the committee will have in reaching a conclusion on the agendas set for DREC review.

 

In particular, the issues of interest are the reimbursement reevaluation of HA eye drops that have a market size of over KRW 200 billion and the review of reimbursement adequacy of the neurofibromatosis treatment ‘Koselugo Cap’ that was set to receive redeliberations.

 

According to industry sources on the 6th, DREC will hold its 9th meeting on the 6th and then its 10th meeting on the 7th.

 

In other words, the meeting will be held for two days.

 

In the 2-day meeting, the committee members will be deliberating the drug reimbursement adequacy reevaluation results on one day, and the other to deliberate on the decision on long-term care benefits and whether to approve reimbursement for prescription drugs.

 

The industry expects DREC will have difficulty making decisions this time, as the agendas are serious and important to the state and its deliberation requires 2 days.

 

◆Industry interest rises on whether the use amount of HA eye drops will be restricted In particular, whether the use amount of HA eye drops will be restricted as a result of reimbursement reevaluations remains an issue.

 

The authorities have also been reviewing whether to drop reimbursement for extrinsic diseases, but limiting its usage is the key focus of industry interest.

 

Moreover, the industry is concerned that if the annual limit is set at 4 boxes, their usage will be cut in half.

 

As for the other ingredients subject to reevaluations, their deliberation is expected to proceed without issue as their reimbursement status will not change significantly.

 

According to the industry, it is expected that reimbursement for rebamipide and levosulpiride may be maintained while reimbursement for limaprost alphadex, loxoprofen sodium, and epinastine hydrochloride may be restricted for secondary indications rather than primary indications.

 

◆Orphan drug Koselugo to be redeliberated for reimbursement, Will Leclaza’s competitor Tagrisso pass deliberations this time? Among newly deliberated drugs, whether Koselugo will pass review is the industry’s primary interest.

 

The committee had decided to rediscuss Koselugo’s reimbursement at the 8th DREC meeting.

 

As it has recently been reported that the HIRA and pharmaceutical companies have reached an agreement on a risk-sharing plan for this drug, attention is being paid to whether it will be able to pass the DREC review this time.

 

Koselugo is the only drug that was judged non-reimbursable by DREC last year.

 

On the 5th, the Korean Organization for Rare Diseases submitted a petition to the Human Rights Commission of the Republic of Korea, calling for coverage of 'Koselugo.’ After its reimbursement was discussed as an agenda item for DREC, patient groups have been strongly calling for its reimbursement.

 

Also, whether the plan to extend reimbursement for Tagrisso to the first line for non-small cell lung cancer, which passed review by the Cancer Disease Review Committee in March, will be reviewed by DREC is receiving attention.

 

The analysis is that if Tagrisso passes the DREC review this time, it could be listed for reimbursement faster than its competitor ‘Leclaza,’, which passed CDDC last month.

 

The results of the DREC meeting will be announced through a press release on the evening of the 7th, the day the 10th meeting is scheduled to end.