Soliris follow-on Ultomiris conditionally listed

HIRA discloses deliberation outcomes from the second DREC meeting of the year

Praluent listed, Pentosin to get listed when accepting pricing lower than evaluated price

Handok’s paroxymal nocturnal hemoglobinuria (PNH) treatment Ultomiris (ravulizumab) is getting closer to the National Health Insurance (NHI) reimbursement.

 

On Mar.

 

4, the Health Insurance Review and Assessment Service (HIRA) convened a second meeting of the year for the Drug Reimbursement Evaluation Committee (DREC) and deliberated listing six items, such as Ultomiris, Sanofi-Aventis Korea’s Praluent (alirocumab) pen injection 75 mg and 100 mg, Kuhnil, Penmix, Boryung Pharmaceutical and Yungjin Pharm’s Pentosin (daptomycin) injection 350 mg and 500 mg.

 

As a result, the reimbursement for Praluent injection was cleared, but Ultomiris and Pentosin were conditionally passed, where the companies would have to accept a pricing lower than the evaluated price.

 

Ultomiris shares the same active ingredient with one of the most expensive new drugs Soliris (eculizumab).

 

The follow-on drug was authorized by the U.S.

 

Food and Drug Administration (FDA) in December 2018, and European Medicines Agency (EMA) in July 2018.

 

The South Korean health authority approved of the drug on May 21, 2020.

 

The upper limit pricing on Soliris is at 5,132,364 won per vial (30 ml), costing a patient approximately 400 million won a year for administering three vials biweekly.

 

Meanwhile, Ultomiris administers maintenance load once every eight weeks for two weeks after the initial load.

 

The long interval in administration would help lowering the cost per patient even if it is priced similarly to Soliris.

 

However, Handok would win the reimbursement only if it accepts a pricing lower than the DREC’s evaluated price, as it proposed a pricing higher than what DREC evaluated as.

 

All six items containing daptomycin—either approved as domestically manufactured or imported as a complete product of Cubicin authorized in 2003 by an American-based Cubist Pharmaceuticals in 2003—also applied for the listing but received conditional approval.