From Specialty Pharmacy News

Most Health Plans Cover At Least One of Two Available Biosimilars (with Chart: Key Elements for Determining Biosimilar Coverage)

Reprinted from SPECIALTY PHARMACY NEWS, a monthly newsletter designed to help health plans, specialty pharmacies, pharma companies, providers and employers contain costs and improve outcomes related to high-cost specialty products. Subscribe today!

By Angela Maas, Managing Editor
July 2017Volume 14Issue 7

Almost two years after the first biosimilar became available in the U.S., the majority of health plans are covering at least one of these drugs, according to new research from Avalere Health. In addition, formulary coverage for the two available biosimilars is comparable to that of their competitors. And although neither drug has been designated as interchangeable with their reference products, plans seem to be comfortable with their use, which could help bring down payers’ spending on costly specialty drugs.

Two of the five FDA-approved biosimilars are available on the U.S. market: Zarxio (filgrastim-sndz), a granulocyte colony-stimulating factor (G-CSF) whose reference drug is Neupogen (filgrastim), and Inflectra (infliximab-dyyb), an intravenous anti-inflammatory biologic that is a biosimilar version of Remicade (infliximab). The FDA approved both biosimilars for all of the available indications of their reference drugs. Zarxio entered the U.S. market in September 2015 (SPN 9/15, p. 8), while Inflectra launched in November 2016 (SPN 12/16, p. 5).

Among the other FDA-approved biosimilars, two are embroiled in patent litigation: Erelzi (etanercept-szzs), a biosimilar Enbrel (etanercept) approved in August 2016 (SPN 9/16, p. 9), and Amjevita (adalimumab-atto), a biosimilar Humira (adalimumab) approved in September 2016 (SPN 10/16, p. 6). Renflexis (infliximab-abda), also an intravenous anti-inflammatory biologic, was approved in April 2017 (SPN 5/17, p. 10) and is expected to launch this year.

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Many industry experts anticipated biosimilar prices at 25% to 30% off those of the reference drugs. So far, Zarxio and Inflectra are priced at about 15% less. Still, 50 respondents to an Avalere survey, who were from 45 health plans representing 183 million covered lives, cited biosimilars’ cost relative to the reference drug as the top element they use to determine coverage of the drugs, with 95% citing this (see chart, below). The second and third most important elements were biosimilars’ efficacy, cited by 80%, and their safety, selected by 73% of respondents.

Avalere also reviewed how plans cover the biosimilars and found that 94% of employer-sponsored insurance plans say they are covering Zarxio, and 42% cover Inflectra.

The discrepancy could be due to a couple of reasons. According to Avalere’s Sung Hee Choe, vice president, and Gillian Woollett, senior vice president, “time could be a factor, as Inflectra has been on the market for approximately seven months, versus Zarxio’s approximately 22 months. Also, Zarxio has the benefit of extensive patient experience in Europe, which may have helped payers get comfortable with the product. Inflectra has also been on the market in Europe but [has] less experience than with Zarzio (as Zarxio is called in the EU).”

Zarxio is on the preferred brand tier for 42% of plans, compared with 45% for its competitors, which include Granix (tbo-filgrastim), Neulasta (pegfilgrastim) and Neupogen, according to an Avalere analysis based on data from Managed Markets Insight & Technology, LLC, which is the parent company of AIS Health. Thirty percent of plans have Zarxio on the non-preferred brand tier, compared with 23% for its competitors, while 22% have it on the specialty tier, compared with 21%. Only 6% of plans do not cover Zarxio, compared with 11% for its competitors.

Inflectra is on the preferred brand tier for only 7% of plans, compared with 36% for its competitors, which include Cimzia (certolizumab pegol), Enbrel, Humira, Orencia (abatacept), Remicade, Simponi (golimumab) and Xeljanz (tofacitinib citrate). Eighteen percent of plans have Inflectra on the non-preferred brand tier, compared with 28% for its competitors, while 17% have it on their specialty tier, compared with 21%. But while 14% of plans do not cover its competitors, 58% do not cover Inflectra.

It’s interesting to note that the numbers are based on coverage in the pharmacy benefit only, so use of the biosimilars could be much higher when the medical benefit is taken into account as well. According to the 2017 edition of the EMD Serono Specialty Digest, G-CSFs and intravenous anti-inflammatory biologics are two classes for which coverage under both the pharmacy and medical benefits is most likely.

Among 58 commercial health plans representing 173 million covered lives, 12% covered G-CSFs in the pharmacy benefit only, 28% in the medical benefit only, and 60% covered them in both benefits. For IV anti-inflammatory biologics, 12% of plans covered them in the pharmacy benefit only, 47% in the medical benefit only, and 41% covered them in both benefits.

Choe and Woollett tell AIS Health that there are four main takeaways from the data: “(1) the vast majority of employer health plans cover a biosimilar product; (2) coverage of Zarxio is high; (3) plans are placing biosimilars on their preferred brand tiers at rates in line with the brand products; and (4) biosimilars are gaining coverage despite their not having interchangeable status from FDA, which has been viewed as needed for biosimilar acceptance.”

The launch of the second Remicade biosimilar, Renflexis, is expected by October at the latest (SPN 6/17, p. 11). Asked how the anti-inflammatory category may change with the addition of a second biosimilar, Choe and Woollett say, “There is a lot of interest in this launch, both for the initial pricing of the second entrant, and also because they will be the first biologics to share HCPCS codes.”

Avalere noted that as of February, there were 64 drug development programs enrolled in the FDA’s Biosimilar Products Development Program, “and the Agency has received meeting requests to discuss the development of biosimilars for 23 different reference products. So far, manufacturers have publicly disclosed the submission of 14 biosimilar applications to the FDA (including those already approved).”

View the Avalere data at

Key Elements for Determining Biosimilar Coverage

Key Elements for Determining Biosimilar Coverage

SOURCE: Avalere Health, Avalere Policy 360, Biosimilars: U.S. Payer Perspective, released July 2017.

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