Faslodex’s price stays as is…supply instability concerns

AZ applies for suspension of price reduction, court provisionally accepts

Government adhered to the principle of removing the premium upon generic drug entry, but patient harm is inevitable if supply issues arise

Generic versions are available, but short-term replacement is difficult due to the characteristics of the anticancer drug market

The breast cancer drug Faslodex (fulvestrant, AZ Korea), was facing a price cut due to the expiry of its premium pricing period, but this was prevented by the pharmaceutical company's request for a stay of execution.

 

On the 31st of last month, the MOHW announced that the court had temporarily suspended the execution of the disposition to reduce the insurance price ceiling for Faslodex until August 31.

 

The expiration of the premium pricing period for Faslodex was scheduled following the entry of generic drugs.

 

Although the one-year price adjustment period expired in 2023, it was extended for an additional 2 years because three or fewer companies were producing the same drug.

 

The price of AstraZeneca's Faslodex Inj was scheduled to be reduced from KRW 376,724 to KRW 288,194, while Boryung’s Fulvet Inj’s price was set to decrease from KRW 357,888 to KRW 288,194 as a Korean innovative pharmaceutical company’s product.

 

At the time, AstraZeneca and Boryung requested an extension of the premium pricing period, citing supply issues prior to its expiration.

 

However, with the emergence of Hankook Korus Pharm’s “Elbracan inj,” a domestically produced generic version of the drug, the insurance authorities decided in February to end the premium pricing as planned.

 

Boryung Fulvet's price was reduced as planned, while AZ Faslodex's price remained unchanged due to the suspension of the administrative disposition.

 

The Faslodex issue unexpectedly came up during Minister of Health and Welfare Eun-kyung Jeong’s confirmation hearing last month.

 

In a written Q&A, the then-candidate exchanged with the NA before the confirmation hearing, multiple members of the National Assembly raised concerns about potential supply disruptions due to the termination of the premium pricing.

 

At the time, Jeong, “Two identical drugs (substitutes) from other companies are currently listed, so the Drug Reimbursement Evaluation Committee (DREC) decided to terminate the preimium pricing for Faslodex,” adding, “We will manage generic drug prices at an appropriate level and strengthen domestic production and supply bases to ensure a stable supply of essential drugs.” The original manufacturer and patient groups argue that Faslodex, which was designated as a national essential medicine in November last year, requires price protection measures.

 

The multinational pharmaceutical company AZ is reportedly considering withdrawing from the Korean market if Faslodex’s prices are reduced due to the end of the premium pricing period.

 

However, domestic insurance authorities maintain that they decided to end the price adjustment period in accordance with principles, as domestic generic drugs are now available and there are no supply issues with the generic versions.

 

AZ appears to have planned to continue domestic supply while maintaining its drug’s price through the lawsuit.

 

However, if the court ultimately rejects the request for a stay of execution or if AZ loses the lawsuit, there is a possibility that the company’s global headquarters could decide to withdraw the drug from the domestic market.

 

If the supply of the original anticancer drug is discontinued, its impact on the market could be significant, even if generic drugs are available.

 

Given the nature of anticancer drugs, there is a strong preference for the original product, and with the original drug already holding a 90% market share, it would be difficult to immediately switch to generics.

 

Accordingly, while the insurance authorities have upheld the principle of ending the premium pricing for Faslodex, the analysis is that special management would be necessary to prevent future supply issues.

 

An industry insider explained, “Compared to AstraZeneca's withdrawal of the diabetes treatment drug Forxiga from the domestic market last year, the situation with Faslodex is not as straightforward.

 

While Forxiga is a chronic disease treatment that can be replaced by generics, Faslodex is a life-saving drug for cancer patients, and cannot be immediately substituted with its generic versions.”