Reimbursement negotiation on track for Bimzelx

Where will Bimzelx position itself as a latecomer drug in psoriasis?

Was conditionally approved by DREC 7 months after the company applied for reimbursement at the end of August last year

Industry expected to finalize the price negotiation for Bimzelx in the first half of the year

Landing process is on track... Expected to be prescribed to new and resistant patients.

As the reimbursement negotiations process for Bimzelx (bimekizumab), a new psoriasis treatment, is picking up speed, the drug is soon expected to enter the market in earnest.

 

Pic of Bimzelx

According to industry sources on the 10th, UCB Korea is in drug price negotiations for Bimzelx's entry into the reimbursement list.

 

After receiving approval for Bimzelx on August 29, UCB Korea applied for reimbursement to the Health Insurance Review and Assessment Service (HIRA) the very next day, with the aim of entering reimbursement within this year.

 

The company passed HIRA’s Drug Reimbursement Evaluation Committee review in February, which paved the way for its drug pricing negotiations 7 months after receiving approval.

 

The industry predicts that Bimzelx will complete negotiations as early as June and that reimbursements will be applied at the latest in the second half of the year.

 

Bimzelix is the first biologic therapy to dual inhibit interleukin-17A and interleukin-17F (IL-17A and IL-17F).

 

IL-17A and IL-17F are key cytokines that trigger the inflammatory process in psoriasis, and Bimzelix selectively and directly targets and inhibits them simultaneously.

 

In BE READY trial, the global Phase 3 clinical study that became the basis for the approval, 90.8% of patients in the Bimzelx group achieved PASI 90 at Week 16, and 68.2% of patients achieved PASI 100.

 

In a clinical trial that compared Bimzelx with another biological agent, there was a clear difference in the percentage of patients who achieved complete clearance of skin lesions at Week 16, which is referred to as 'PASI 100'.

 

Specifically, ▲BE VIVID: Bimzelx 59%, ustekinumab (Stelara) 21% ▲BE SURE: Bimzelx 60%.

 

8%, adalimumab (Humira) 23.9% ▲BE RADIANT: Bimzelx 61.7%, secukinumab (Cosentyx) 48.9%, etc.

 

“It's been a long time since biologics have been available on the market, and there are still patients suffering despite having tried all biologics,” said Professor Ki Hun Jeong, Department of Dermatology at Kyung Hee University Hospital.

 

”The emergence of a new treatment option that is highly effective for patients with severe psoriasis is very meaningful in that aspect.” Currently, UCB Korea signed a distribution agreement with Geoyeong to prepare for Bimzelx’s launch, and some hospitals are reportedly working on landing the drug through their respective drug committees (DCs).

 

The company will act in earnest once the drug is reimbursed in Korea.

 

This is because there are already several reimbursed psoriasis treatment options on the market and a drug cannot exert any influence in Korea as a non-reimbursed drug.

 

 

Reimbursement status of major psoriasis treatments

So, where would Bimzelix fit in among the many available psoriasis treatment options in Korea?

 

Experts predict that it will be prescribed more often to patients who have developed resistance to other treatments or new patients.

 

Professor A of the Department of Dermatology at a tertiary hospital in Seoul said, “Some patients have already developed resistance to several of the major treatments and are using the last treatment.

 

In such cases, the emergence of new options is welcome news.

 

However, considering the situation of resistance and other factors, I don't think patients who were previously using existing treatments will switch to Bimzelx.” He also emphasized that “Bimzelx will likely be prescribed to new patients, on the condition that it is reimbursed.

 

Due to the nature of psoriasis, there are issues of resistance, so there is also a complementary role between treatments, despite the competition.” Considering these points, it seems that Bimzelx’s earlier reimbursement than drug price, which was initially the concern, will be a key factor in market competition.

 

The burden of treatment costs for patients with severe psoriasis has been reduced in general with the eased criteria for special calculation of reimbursement.

 

At the previous meeting, Shim Il, Managing Director of UCB Korea, said, “We are aware of the drug price as there are already other available treatments.

 

We will do our best to ensure prompt reimbursement of our drug.”