The level of price discounting for Stelara biosimilars has hit a new low (or high), depending on your point of view. Hikma Pharmaceuticals USA announced on November 6 that it has launched Starjemza, its ustekinumab biosimilar, manufactured by Bio-Thera Solutions. Yesterday, Mark Cuban’s Cost Plus Drug Company announced the availability of Starjemza’s low monthly price of $360 per 90-mg dose, for cash-paying patients. This translates to a 98.8% price cut—the wholesale acquisition cost (WAC) of the reference product Stelara is $29,000 per month.
It is unclear if Hikma will be using Cost Plus as its sole pharmacy distributor and whether there will be a higher cost for patients with insurance coverage. The discount that Mark Cuban is offering is available to patients without insurance coverage. This brings up a relevant point in direct to patient dispensing of specialty drugs like biologics. It is clear that $360 per dose for any drug paid out of pocket is not exactly conducive to long-term adherence by the patient, although this would be paid every 8 weeks for a patient with Crohn’s disease receiving chronic injections. Most specialty pharmaceutical coverage in commercial health plans use a flat copay of $100 to $150 per dispensing or a coinsurance of 10% to 30% up to some maximum ceiling (perhaps $225).
Consider that WAC pricing for most of the ustekinumab biosimilars is an average of $3200 per dose. A 10% co-insurance would result in patient out-of-pocket cost of $320 (or likely lower, depending on the plan’s maximum cost sharing). The Cost Plus pricing for Starjemza roughly brings patients without coverage into the same cost-sharing range as patients with insurance coverage.
It does seem that by bypassing health insurance and PBMs to bring these patients the same out-of-pocket costs that insured patients pay after plans receive rebates and discounts, it is a positive. However, is the appeal of direct-to-patient dispensing greater for drugs like GLP-1s or insulins, where the starting costs are much lower than for monoclonal antibodies such as anti-TNF inhibitors and interleukin antagonists?
From the manufacturer’s standpoint, this net pricing brings this particular ustekinumab biosimilar in line with the adalimumab biosimilars. As we reported earlier this year, there is somewhat limited opportunity for a biosimilar company to earn profits when it has to split that $360 q8wk with its manufacturer (Bio-Thera) and pay any royalties that it might have agreed to when signing a marketing arrangement with the reference manufacturer. We do not know if that is the case for Hikma, but it is consistent with previous agreements).
This news still sets the bar far lower on ustekinumab biosimilar pricing; the lowest previously announced available price was for Accord’s Imuldosa at a 92% WAC discount or $2332.00 per month.
Samsung Bioepis Now Under Samsung Epis Holdings
Samsung Bioepis is the subject of a new corporate structure. On November 3, Samsung Epis Holdings Co., Ltd. announced the establishment as a new investment holding company, following the spin-off of Samsung Bioepis Co., Ltd. from Samsung Biologics.
Kyung-Ah Kim, currently President and CEO of Samsung Bioepis, will also take on the same roles for the holding company. In a press release, Ms. Kim said, “By establishing an independent decision-making structure, we see the potential for further growth and investment. Progress is being made to secure next-generation therapeutic technology on the back of the capabilities accumulated through our biosimilar business. With the spin-off, we expect to have more opportunities to explore next-generation growth drivers.”
