Biosimilars Help Support Members, Payors with Affordable Options

Specialty Pharmacy Pipeline | Drugs to Watch

Anticipated Launches | Q3 – Q4 2021

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Biological products (biologics) have helped to alter and improve the treatment of serious and complex conditions such as cancer, rheumatoid arthritis and inflammatory bowel disease. But biologics are expensive medications for payors and patients.https://doi.org/10.1007/s40265-020-01256-5 Prescription drug spending per capita is higher in the United States than most countries, with biologics accounting for $211 billion in 2019. Biosimilar drugs are alternatives to the U.S. Food and Drug Administration (FDA)-approved biologics with no clinically meaningful differences in safety and effectiveness.

The FDA has approved 29 biosimilar products.https://www.fda.gov/drugs/biosimilars/biosimilar-product-information As of May 25, 2021.

• Biosimilars are a growing class of therapeutic products in the United States. Since the first biosimilar was approved in the United States in 2015,https://journals.lww.com/ajnonline/Fulltext/2015/07000/First_Biosimilar_Drug_Approved.20.aspx the FDA has approved 29 biosimilar products.²
• In 2019, $5.2 billion was spent on biosimilars with that amount expected to increase to almost $27 billion in 2024.https://www.iqvia.com/-/media/iqvia/pdfs/institute-reports/iqvia-institute-biosimilars-in-the-united-states.pdf
• Many of the biosimilars in the United States have market shares below 50 percent, which is well below other countries where biosimilars have reached nearly 90 percent market share.https://www.bioprocessonline.com/doc/new-us-legislation-creates-momentum-for-biosimilars-0001
• Competition between biosimilars and a reference brand can reduce costs, while increasing patient access and quality of care.RAND Health Quarterly, 2018; 7(4):3

Biosimilar launches and approvals

There were five biosimilar drug launches in 2020

	Ruxience, a biosimilar to Rituxan (rituximab), treats adults with various conditions, including non-Hodgkin’s lymphoma and chronic lymphocytic leukemia
	Trazimera, Herzuma and Ontruzant, biosimilars to Herceptin (trastuzumab), which is used to treat certain cancers that are HER2 positivehttps://www.cancer.gov/publications/dictionaries/cancer-terms/def/trastuzumab
	Avsola, a biosimilar to Remicade (infliximab), which is used to treat autoimmune disorders and their symptomhttps://medlineplus.gov/druginfo/meds/a604023.html

Whereas only three biosimilars were approved** in 2020https://www.fr.com/biosimilars-2020-year-in-review/

	Riabni, a biosimilar to Rituxan (rituximab)
	Hulio, a biosimilar to Humira (adalimumab), for the treatment of several conditions, including rheumatoid arthritishttps://www.fda.gov/drugs/biosimilars/biosimilar-product-information
	Nyvepria, a biosimilar to Neulasta (pegfilgrastim), to decrease infections for patients receiving anti-cancer drugs

• Even though biosimilars often have less expensive manufacturer’s prices than reference brands, there are several barriers to more widespread acceptance. 
  • Up to a quarter of physicians claim unfamiliarity with biosimilars and, of those familiar, around two-thirds expressed concerns.Sarnola K, Merikoski M, Jyrkkä J, et al. Physicians’ perceptions of the uptake of biosimilars: a systematic review. BMJ Open 2020;10:e034183. doi:10.1136/ bmjopen-2019-034183
  • Of those providers who choose biologics before biosimilars, there are often financial incentives, including reimbursements aligned with a percentage of cost to the provider for a drug’s administration.Yazdany J. Failure to Launch: Biosimilar Sales Continue to Fall Flat in the United States. Arthritis & Rheumatology (Hoboken, N.J.). 2020 Jun;72(6):870-873. DOI: 10.1002/art.41203.
  • In addition, some biologics have continued to receive protected status, which provides the biologic with exclusivity in the drug market.https://www.iqvia.com/insights/the-iqvia-institute/reports/biosimilars-in-the-united-states-2020-2024 This has led to patent lawsuits and significant delays for FDA-approved biosimilars entering the market.Yazdany J. Failure to Launch: Biosimilar Sales Continue to Fall Flat in the United States. Arthritis & Rheumatology (Hoboken, N.J.). 2020 Jun;72(6):870-873. DOI: 10.1002/art.41203.
• Of the protected biologics with biosimilars approved or in development, two are the blockbuster biologics — Enbrel and Humira — that have biosimilars with planned launches in 2029 and 2023, respectively.https://www.iqvia.com/insights/the-iqvia-institute/reports/biosimilars-in-the-united-states-2020-2024
  • Biosimilars to the biologic Humira will be predominantly reflected as a pharmacy benefit, which may show an impact on client pharmacy spend.

Staying updated on biosimilars to help manage drug spend

• For nearly five years, our formularies have considered biosimilars to better manage and contain client drug spend. Our formularies utilize a lowest net cost strategy while ensuring clinical appropriateness.

• Sometimes the lowest net cost product is the reference brand and sometimes it is the biosimilar. Of biosimilars that have launched, we have some preferred biosimilars on our commercial template formularies.

• Our template formularies include new-to-market product reviews and regular evaluations to address changes in the rapidly evolving marketplace.

• By putting in place additional controls, such as realigning the physician reimbursement structure, starting patients on the right products at the point of prescribing and continuing to close education gaps around the safety of biosimilars, we help create an effective medical preferred drug strategy.

• As approvals, regulation and network acceptance gain momentum under the medical benefit, we help health plans utilize biosimilars. Medical preferred drug strategies can help clients address rising specialty medical pharmacy spend while aligning to their organizational philosophy, goals and lines of business. Novologix, our proprietary claims technology platform, can enable these strategies at the time of prior authorization. 

Thoughtful and strategic decisions are essential to delivering lower costs, and we help clients move on the right opportunities at the right time. As the market and client needs change, so do our strategies.

• As more biosimilars launch and become a larger portion of the pharmaceutical landscape, market competition will continue to increase, and drug costs will start to lower. At the same time, a balance between brand biologics and biosimilars is necessary to ensure patients continue to have access to the lowest cost appropriate therapy.

CVS Health will continue review of new drugs to evolve our formulary strategies to align with client needs and the changing pharmaceutical landscape.

This article was updated to remove specific product information and expand the formulary section.