Domestic companies attempt at hemophilia treatment market

SK Plasma introduces Afstyla after JW Pharmaceuticals’ Hemlibra…will the new releases bring change to the market that is led by GC Pharma?

Received with less enthusiasm, “as in other drugs of similar classes, reimbursement standards will be the biggest barrier”

Domestic pharmaceutical companies have thrown their hats into the domestic hemophilia treatment market, forewarning a change in the prescription market.

 

The attempts will mainly target the large major hospitals that treat hemophilia, but the possibility of any significant change in the treatment market is considered low in the field.

 

According to industry sources on the 2nd, SK Plasma was found to have started domestic sales and marketing activities for Afstyla (lonoctocog alfa) in large major hospitals as the drug started receiving reimbursement benefits as a hemophilia A treatment.

 

SK Plasma is a spin-off of SK Chemical that specializes in blood products.

 

Afstyla is based on SK Chemical’s original candidate substance NBP601 and was developed into the finished product after a technology export to CSL Behring in 2009.

 

Contrary to existing hemophilia treatments that are composed of two separate protein chains, Afstyla’s single-chain molecule structure joins combines two protein chains into one to extend circulation time and improve safety.

 

SK Plasma is the second company to throw a hat into the market following JW Pharma’s introduction of Chugai Pharmaceutical’s Hemlibra (emicizumab-kxwh) that made its way into the market in May last year after receiving reimbursement approval.

 

In particular, expectations and interest is rising for Afstyla as Hemlibra is having trouble making its place in the treatment market.

 

Recently, insurance cutbacks that were made on prescriptions for pediatric hemophilia patients aged 12 or younger had been in much dispute.

 

Also, whether the drug can survive the competition in the ₩230 billion market dominated by GC Pharma is a key area of interest.

 

In addition to their own products ‘GreenMono’ and ‘Greengene F,’ GC Pharma has also been jointly marketing Takeda’s ‘Advate’ and ‘Advonate,’ which, as a whole, accounts for over 60% of the hemophilia treatment market.

 

Also, the industry is keen on whether Afstyla may survive the competition of similar-class drugs that are already in the market, including Sanofi’s ‘Eloctate’ and Takeda’s ‘Adynovate.’ The insured drug price set by NHI for these drugs is 675 won per 1IU.

 

On this, Chuhl Joo Lyu, professor of Pediatric Hematology and Oncology at the Yonsei University Severance Hospital, said, “Large hospitals are currently using Eloctate and Adynovate, which have similar MOAs with Afstyla.

 

However, even these are not prescribed much at hospitals because the dose and administration set under Korea’s reimbursement standards differ from those set overseas.” Lyu continued, “Basically, the drugs are approved abroad in higher doses but are restricted in Korea.

 

To increase the dose and administration level to meet the standards overseas, the insurance fee setting process must be conducted again at a lower price.” In fact, the approved dose for Eloctate as routine prophylaxis is 25~65 IU/kg based on the patient’s clinical response.

 

Pediatric patients under 12 years of age may require more frequent doses or a dose increase to 80 IU/kg Under the Health Insurance Review and Assessment Service’s reimbursement standards, a single dose of administration is 20-25 IU/kg, and for moderate or higher forms of bleeding, up to 30 IU/kg is allowed at the doctor’s discretion.

 

The basic approved dose for severe conditions is twice weekly, 8 times every 4 weeks.

 

For on-demand treatment of bleeding after administration, two injections per hospital visit are approved.

 

Therefore, with Afstyla’s price set at the same level, unless the reimbursement criteria are improved, the drug will not have competitivity in the prescription market.

 

A member of the Korean Society of Pediatric Hematology-Oncology who wished to remain anonymous said, “Afstyla’s efficacy is equivalent rather than superior to other long-acting agents.

 

That was why its insurance fee was set at the same level as Eloctate and Adynovate.

 

The price should be adjusted for the drug to have competitivity.”