Afstyla will be reimbursed from June

₩625 per IU

Passed the Health Insurance Policy Committee of the amendment bill of the MOHW

SK Chemicals' self-developed hemophilia treatment Afstyla (Lonoctocog Alfa (blood coagulation factor VIII, genetic recombination) ) finally passed the Health Insurance Policy Committee.

 

It took 15 months after obtaining a domestic permit and one year after applying for insurance registration.

 

The start of benefits was set on June 1, when supply was available, and the price was set at ₩625 per IU.

 

The MOHW announced that the amendment (draft) of the Pharmaceutical Benefit List and benefit upper limit price table', which provides benefits for Afstyla, was submitted to the agenda of the Health Insurance Policy Committee during the day (30th), and that both deliberation and resolution were passed.

 

.This drug is a hemophilia A treatment developed by SK Chemicals, and it was exported to CSL in Australia in 2009

 

.This drug applied for insurance registration to the HIRA on April 29, about three months after obtaining approval from the MFDS on January 20 last year

 

.The HIRA held the Pharmaceutical Benefits Advisory Committee on December 3 of the same year for deliberation

 

.This drug was introduced as a gene recombination product among factor VIII replacement therapy in textbooks such as Hemostasis and Thrombosis Advisory and recommended for use in clinical guidelines

 

.In terms of cost-effectiveness, the weighted average price of the alternative drugs Blood Coagulation Factor VIII, Recombinant (ADVATE), Moroctocog Alfa (Xyntha Solofuse Prefilled Inj.), Beroctocog Alfa (Greengene F), Efmoroctocog alfa, and Rurioctocog alpha is less than ₩625 per IU

 

.It was judged to be cost effective

 

.In the case of biopharmaceuticals, if they accept the weighted average price or less, they are classified as drugs that omit drug price negotiations, so negotiations are exempted

 

.Related conferences such as The Korean Society on Thrombosis and Hemostasis and The Korean Society of Hematology also commented that the effect was comparable to that of conventional drugs and improved convenience by reducing the number of administrations

 

.When looking at the listing status of excluded countries, it was listed in the United States, Italy, Japan, Switzerland, and Germany in five of the A7

 

.The adjusted average prices in these countries range from ₩1274.72 to ₩1350.89 per IU

 

.

Accordingly, the Pharmaceutical Benefits Advisory Committee decided that if the alternative drug was accepted below the weighted average price, the company would accept it and skip the negotiation, and only negotiate the estimated billing amount with the NHIS from January 19th to 19th of this year

 

.As a result of the negotiations, the two sides agreed to an estimated billing amount of ₩5.6 billion, taking into account the market share reflecting clinical usefulness

 

.The NHIS predicted that there would be no additional fiscal requirements as alternative drugs exist

 

.The items are 250, 500, 1000, 2000, 3000 IU, and the price is ₩625 per IU

 

.The MOHW decided to apply insurance benefits as of June 1, taking into account the availability of supply from the company

 

.CSL Behring Korea Ltd will sell this product, and SK Chemicals is receiving royalties and sales milestones from global sales

 

.