Article | January 29, 2024

That Price Is WAC: Boehringer's Push For Access To Humira Biosimilars

Source: Life Science Leader
Ben Comer_2022_1

By Ben Comer, Chief Editor, Life Science Leader

Stephen Pagnotta Headshot_6.29.23
Stephen Pagnotta

For Boehringer Ingelheim’s (BI) first foray into biosimilars, the company went straight to the top, developing an interchangeable biosimilar for AbbVie’s Humira, one of the best-selling pharmaceutical drugs of all time. BI’s experience with Humira biosimilars illustrates the strange market dynamics inherent to making cheaper, biosimilar products available to patients. “The U.S. healthcare system today sometimes doesn’t make sense when you look at how products are priced,” says Stephen Pagnotta, biosimilar commercial brand leader at BI.

Cyltezo, BI’s interchangeable Humira biosimilar, was first approved by the FDA in August of 2017. However, an agreement with AbbVie kept BI’s Humira biosimilar off the market for six years, due to various Humira patents held by AbbVie. Pagnotta says the agreement with AbbVie stipulated a launch date – in July of 2023 – that wouldn’t incur any legal actions or patent challenges from AbbVie.   

At launch, BI priced Cyltezo at a 5% discount to branded Humira, a relatively high Wholesale Acquisition Cost (WAC). “The WAC price is not indicative of what the net price is on the product when negotiated with PBMs,” says Pagnotta. “Our price point at initial launch – the WAC we chose – was really to optimize the availability of the drug to patients.” Two of the three largest PBMs in the U.S., Express Scripts and Optum Rx, currently cover Cyltezo, says Pagnotta.

In addition to the discounts extracted from the biosimilar WAC price, BI presented an overall package for Cyltezo to large PBMs, which Pagnotta believes was an important aspect of securing formulary coverage. “What we presented to the PBMs was a brand, not a biosimilar,” he says. “We presented Cyltezo as a product with patient support services, clinical educators, a dedicated field force, manufacturing from A to Z in the U.S., and a reliable supply that PBMs can count on, throughout the time period when we’re working with them.”

High WAC Vs Low WAC
Although a high WAC price helped secure patient access among some PBMs and insurers, others wanted a low WAC price in exchange for formulary coverage. “We started to see patients in plans that would only cover a low WAC option, and we weren’t getting access with the high WAC price in those plans,” says Pagnotta. “The flip side of that is plans that won’t cover a low WAC option and will only cover the high WAC product.”

Three months after its initial Cyltezo launch, BI announced the launch of an unbranded, low-WAC version of Cyltezo priced at an 81% discount to branded Humira. The unbranded second option, called adalimumab-adbm, is also interchangeable, and features the same brand colors and the same pen delivery device endorsed by the Arthritis Foundation, and is exactly the same drug as Cyltezo. “The only difference is the name on the label,” says Pagnotta. “Hopefully, a lower cost alternative will lower premiums and enable more access to patients.” Patients with commercial insurance can receive copay assistance from BI directly, notes Pagnotta. “We offer a $0 copay to commercially insured patients, regardless of the pricing model chosen by their PBM.”

New Competition
Cyltezo was the first Humira biosimilar for which FDA granted the interchangeable designation; last October, Pfizer announced that its Abrilada biosimilar had also received an interchangeable designation, making it the second Humira biosimlar product to receive the formal FDA designation. There are now nine Humira biosimilars on the market in the U.S., and yet, six months after the July 2023 launch of seven additional Humira biosimilar products, adoption rates for biosimilars have remain stagnant, at just 2% of total Humira prescriptions, according to a Samsung Bioepsis Biosmilar Market Report for Q1 2024.

Five companies are now offering two pricing tiers with branded and unbranded versions of their own Humira biosimilars, according to the Samsung Bioepsis report: BI’s Cyltezo, Amgen’s Amjevita, Sandoz’s Hyrimoz, Pfizer’s Abrilada, and Biocon Biologics’ Hulio. The four other approved biosimilars have opted for either a high WAC price (Fresenius Kabi’s Idacio and Celltrion’s Yuflyma), or a low WAC price (Organon’s Hadlima and Coherus Biosciences’ Yusimry), but not both.  

Given the additional costs required to conduct the trials necessary to gain an interchangeable designation from the FDA, combined with low uptake of all Humira biosimilars generally in the market, and the FDA’s recent draft guidance on removing the interchangeability label on products – is interchangeability still worth it to sponsors? Yes, says Pagnotta, for two key reasons. “Patients need to be accepting, and feel comfortable, about receiving a biosimilar, and the extra studies that are done to achieve that designation can help give patient peace of mind that the biosimilar will have the same efficacy and safety profile as Humira.” The second reason, per Pagnotta, is that interchangeable biosimilars can be substituted for branded Humira at the pharmacy (in certain states), without the involvement of a prescriber. “Fewer administrative hurdles can potentially help patients get their medications faster,” he says.

Regarding the FDA’s ongoing guidance process on interchangeability, Pagnotta says regardless of whether the FDA goes forward with removing the interchangeable language from drug labels, the designation – and the clinical studies that justify it – will remain in the FDA’s Purple Book. “We’ll still communicate that Cyltezo is interchangeable to physicians, and the studies we conducted will be available to those physicians to share with patient,” says Pagnotta. “Patients will still get those assurances regardless of whether they are in the label or not.”

“Humira is a $20 billion [a year] drug, and if we can’t make biosimilars successful in that market, then I question the feasibility of biosimilars going forward in the United States,” says Pagnotta. Clinicians should adopt them, PBMs should incentivize their use, and government agencies should encourage more biosimilar usage, he says. If they don’t do that soon, it will “seriously jeopardize the advancement of biosimilars in the U.S.”