Celltrion Stekima Listed in Top 3 US PBM Formularies

Securing Coverage for 22% of the Entire Insurance Market

Celltrion's autoimmune disease treatment Stekima. Photo by Celltrion

Celltrion's autoimmune disease treatment 'Stekima' (active ingredient ustekinumab), which is currently being sold, was successfully listed on the formulary of one of the top three Pharmacy Benefit Managers (PBMs) in the United States on the 3rd of this month (local time), securing an early refundable market. This achievement came just about a month after its U.S. launch.

Through this, Stekima succeeded in securing all public and private insurance formularies operated by the PBM, and notably gained the status of a preferred drug with priority prescription. The public and private insurances managed by this PBM are known to cover about 22% of the entire U.S. insurance market. While there is usually a certain period between contract signing and actual formulary listing, Celltrion plans to expedite the listing timing by quickly advancing negotiations based on the negotiation capabilities built through sales of existing products.

The top three PBMs in the U.S. pharmaceutical market hold influence over about 80% of the entire insurance market. Typically, if a pharmaceutical company does not negotiate with a major PBM, its drugs cannot be listed on the formularies operated by insurance companies. In such cases, patients must purchase expensive treatments at full price without reimbursement, making actual sales practically impossible.

Celltrion demonstrated its sales competitiveness by achieving formulary listing with a major PBM just one month after Stekima’s launch. Stekima is directly sold by Celltrion’s U.S. subsidiary, and the personal networks established through sales of other autoimmune disease products such as Zimpenetra (active ingredients infliximab, U.S. product name Remsima SC) and Uplima (active ingredient adalimumab) played an important role in this contract process. Additionally, since Celltrion has actively engaged with key autoimmune disease medical professionals in the U.S. through sales of existing products, prescriptions of Stekima are expected to expand rapidly now that formulary listing is complete.

Prior to this contract, on the 22nd of last month (local time), Celltrion opened the door to market acquisition by signing a preferred drug listing contract with 'Costco Health Solutions,' a PBM affiliated with the U.S. mega-distributor Costco. This allows PBM members and Costco employees to enjoy reimbursement benefits at pharmacies located within Costco stores nationwide in the U.S.

This contract achievement is expected to positively influence ongoing Stekima listing negotiations with other PBMs. Celltrion is currently conducting smooth listing discussions with major PBMs, and with inquiries about Stekima rapidly increasing from small to medium and regional PBMs as well, additional listing achievements are anticipated.

Thomas Nussbickel, Chief Commercial Officer (CCO) of Celltrion’s U.S. subsidiary, said, "Following the preferred drug listing with the Costco-affiliated PBM last month, we have succeeded in securing a stable market where Stekima reimbursement can be realized by achieving public and private insurance listing with a major PBM. Stekima is rapidly expanding its results by leveraging the networks built by experienced professionals at the local subsidiary who have sold existing autoimmune disease treatments, and we will make every effort to continue securing additional PBM contracts."

Meanwhile, Stekima was launched in the U.S. market on the 12th of last month (local time) as a low wholesale acquisition cost (Low WAC) version, discounted by 85% from the original product’s wholesale acquisition cost (WAC). According to IQVIA, a pharmaceutical market research firm, the global ustekinumab market size was estimated at approximately $20.369 billion (about 28.516 trillion KRW) in 2023, with the U.S. market accounting for about $15.616 billion (about 21.862 trillion KRW), representing approximately 77% of the total.