Biosimilars Increasingly Being Added to PBM Formularies

With a new announcement from Cigna adding biosimilars to their formulary lists, a growing number of biosimilars are being included on pharmacy benefit manager (PBM) formularies, potentially increasing access and affordability for patients.

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On Monday, Express Scripts announced that they were adding new biosimilars to their formularies. Effective September 1, 2023, the PBM will prefer Cyltezo (Boehringer Ingelheim), adalimumab-adaz (Sandoz), and Hyrimoz (Sandoz) alongside Humira (adalimumab, AbbVie) on its national preferred, standard, performance, and legacy commercial formularies. The company is also adding both the high- and low-concentration formulations of Hadlima (Organon) as preferred alongside Humira on its value, advantage, and total savings formularies.¹

Notably, Cyltezo is the only Humira biosimilar currently approved with an interchangeability designation from the FDA, meaning it can be swapped out for Humira at the pharmacy. Individual state laws dictate how providers and patients must be notified of this switch.²

Biosimilars for inflammatory conditions could have a massive impact on the specialty medicine landscape. According to a press release from Express Scripts, inflammatory medications represented almost 25% of total drug spend across its commercial book of business in 2022, and competition created by biosimilars could save between $225 billion and $375 billion in total US pharmacy spend over the next decade.³

“In any industry, competition often leads to lower prices, and until recently, Humira had little competition. Since it was introduced, its list price increased by 470%, and by adding multiple clinically equivalent, cost-effective biosimilars to our formulary, we can now use the opportunity created by competition to drive greater savings for our clients and the nearly 100 million Americans we serve,” said Express Scripts President Adam Kautzner, PharmD, in the press release.³

The first Humira biosimilar, Amjevita, was launched by Amgen in February 2023, opening up new opportunities for cost savings and accessibility for patients needing this treatment.⁴ The citrate-free, low concentration formulation of Amjevita is currently preferred on the Express Scripts national preferred formulary and the National Preferred Flex Formulary for 2023, according to a press release.³

Data from IQVIA have supported the potentially massive impacts of biosimilars. Including the market for inflammatory conditions, the biologics market in the United States has grown 12.5% annually on average over the past 5 years and now comprises 46% of spending. Notably, recent biosimilars have reached more than 60% of the molecule drugs volume within the first 3 years.⁵

Interestingly, non-340B clinics have seen higher uptake of biosimilars than 340B clinics, which an IQVIA report said was likely due to reimbursement dynamics. Introducing biosimilars to a clinic often leads to higher utilization of the molecule as patients see lower costs and increased access. Expected launches and uptake are expected to increase overall spending on biosimilars to between $20 billion and $49 billion in 2027 and cumulative sales of $129 billion over the next 5 years, with at least 10 molecules facing biosimilar competition over that period.⁵

With this growing interest in biosimilars, PBM inclusion of biosimilars in formularies could play a major role in uptake. In the press release, Cigna said the addition of new biosimilars “will support greater patient access and choice while helping to drive greater affordability for clients and customers.”¹

“Our formulary decision process is guided by clinical effectiveness first and foremost, while also considering the needs and continuity of care for patients, in addition to competitive cost savings to our clients,” said Harold Carter, chief pharma trade relations officer at Express Scripts, in the press release. “Our decision to add the Sandoz products, as well as the interchangeable product Cyltezo, to our [national preferred formulary] supports greater affordability across this entire treatment class.”³

In June, Optum Rx announced the addition of Hyrimoz and adalimumab-adaz, both from Sandoz, as well as Cyltezo from Boehringer Ingelheim as alternatives to Humira. According to a press release, this was the first pharmacy services company to add a Humira biosimilar to its formulary at parity with the original product and the first to include both the high- and low-list options.⁶

“We gladly welcome new biosimilar options and pricing strategies that enable us to effectively lower net costs and deliver long-term value, whether it’s by lower list prices or deeper discounts for our clients and patients,” Carter concluded.³

References

1. Cigna Healthcare Adds New Biosimilars to Formularies to Expand Access, Advance Affordability. News release. Cigna Healthcare. July 10, 2023. Accessed July 12, 2023. https://newsroom.cigna.com/cigna-healthcare-adds-new-biosimilars-to-formularies
2. Cyltezo, first and only FDA-approved interchangeable biosimilar to Humira, now commercially available in the US. News release. Boehringer Ingeleheim Pharmaceuticals, Inc. July 1, 2023. Accessed July 12, 2023. https://www.prnewswire.com/news-releases/cyltezo-first-and-only-fda-approved-interchangeable-biosimilar-to-humira-now-commercially-available-in-the-us-301868465.html#:~:text=RIDGEFIELD%2C%20Conn.%2C%20July%201,as%20a%20biosimilar%20in%202017
3. Express Scripts Adds Three Biosimilars to Largest Formulary to Promote Competition and Advance Affordability, Choices for Patients. News release. Express Scripts. July 10, 2023. Accessed July 12, 2023. https://www.prnewswire.com/news-releases/express-scripts-adds-three-biosimilars-to-largest-formulary-to-promote-competition-and-advance-affordability-choices-for-patients-301872877.html
4. First Humira Biosimilar Launches in the United States. Pharmacy Times. February 1, 2023. Accessed July 12, 2023. https://www.pharmacytimes.com/view/first-humira-biosimilar-launches-in-the-united-states
5. Biosimilars in the United States 2023-2027. IQVIA. January 31, 2023. Accessed July 12, 2023. https://www.iqvia.com/insights/the-iqvia-institute/reports/biosimilars-in-the-united-states-2023-2027
6. Optum Rx Expands Choice, Improves Affordability for Patients With Two Additional Humira Biosimilars. News release. UnitedHealth Group. June 23, 2023. Accessed July 12, 2023. https://www.unitedhealthgroup.com/newsroom/2023/2023-06-23-optum-rx-expands-choice-humira-biosimilars.html#:~:text=The%20Optum%20Rx%20standard%20formulary,to%20its%20low%2Dlist%20version.