Biosimilar manufacturers have been desperate to obtain utilization for their products in the adalimumab marketplace, leading to some interesting arrangements with pharmacy benefit managers (PBMs). The first one implemented was CVS Health’s partnership with Sandoz under the banner of its subsidiary Cordavis. Boehringer Ingelheim signed a separate deal with Evernorth, including its PBM Express Scripts. What additional deals may arise I do not know, but I doubt this is the last of them.
Believe me, I am in favor of nearly any strategy that increases biosimilar utilization in the adalimumab marketplace (as well as others). Keep in mind that the PBMs are not entering into these arrangements because they are sudden believers in biosimilar products. They are making these deals to ensure they are not cut out of the action; that is, if plans and their clients want low-WAC versions of the biosimilars preferred on formulary, the PBMs need to ensure they can make up the rebate revenue lost from high-WAC products. In other words, they want a piece of the manufacturing action and still have a say as to which products are ultimately utilized.
Let’s not forget that the CVS Health initiative includes the preferred private-label version of Hyrimoz® as well as the preferred unbranded product from AbbVie and Hadlima® (Samsung Bioepis’ and Organon’s biosimilar). As I understand it, only the private-label version of Hyrimoz will come from Cordavis. Its website says “Cordavis will work with manufacturers to co-produce FDA-approved, high-quality products that are affordable and easy for patients to use.” As a “co-producer,” is Dublin, Ireland–based Cordavis positioning itself as a pseudomanufacturer, a distributor, marketing partner, or something else?
Under the Evernorth arrangement, Boehringer Ingelheim’s Cyltezo® and Alvotech’s Simlandi® will be produced under a private label and distributed by Evernorth’s pharmaceutical distributor, Cayman Islands–based Quallent Pharmaceuticals. According to the prescribing information for amlodipine, one of approximately 50 generics that Quallent lists as available products, the drug is manufactured by Cipla Ltd, for Quallent. The biosimilar offerings will likely be listed similarly.
This may position Express Scripts as a pseudomanufacturer as well. The one unique aspect to this particular arrangement is that the private-label biosimilars will be available to members without any cost sharing.
So Many Adalimumab Biosimilar Options, but for How Long?
Counting the reference unbranded product and the other unbranded offerings, we have 12 or so biosimilar adalimumab agents. We’ve reported recently that Hyrimoz, Sandoz’s biosimilar, has benefited greatly since the implementation of the Cordavis arrangement on April 1 to prefer it and exclude Humira®. Only time will tell how high the dispensing curve will go for branded or unbranded Hyrimoz (both of which are available at >80% discounts). Boehringer is crossing its fingers for a similar bump in utilization when its deal is implemented on June 1.
With increased scrutiny on the PBM industry, the moves by CVS and Evernorth are canny. It is unknown how revenues might be shared or royalties paid with their partners (or how much). Cordavis has intimated that this will not be the only biosimilar that it manufacturers and distributes. One can imagine scenarios in which other biosimilars covered under the pharmacy benefit can work out similar arrangements; let’s see what occurs with the launch of the Stelara® biosimilars next year.
We have not yet heard OptumRx’s plans in this area, but I doubt it will be left behind. Overall, is this a good thing? I’ve said often in this column their biosimilar sustainability is essential to the management of present and future high cost biologics. We need to be careful in that this is not biosimilar competition by new pseudomanufacturers—this is a reaction by PBMs who fear getting left out in the cold.
It is a lifeline of sorts to biosimilar makers if they can make their own individual deal, to gain a chance at some level of utilization. With so much competition in the adalimumab space, deals cannot be made with major PBMs to ensure all survive. Remember that the PBMs did not make a move in this area until low-WAC discounts were already greater than 80%. A private-label version of Hyrimoz is not less expensive. Therefore, I do not believe that this will enhance biosimilar competition in the long run. Some biosimilar makers will view these arrangements as their opportunity finally for a significant foothold into the market. The decision by the PBM to exclude Humira or at least have it as a nonpreferred product was not made prior to reaching this deal. And that is the major issue for biosimilar competition.
I am hopeful that at least the companies who have made this arrangement with the PBMs can gain significant revenues as a result, and that it might serve as an opening for several other manufacturers to finally see a few crumbs of revenue from what was a $18.6 billion pie in 2022.
