On November 6, Coherus Biosciences released information that sent its shares soaring over 17% higher by midday on the 7th. The company announced its third-quarter earnings, which boasted greater marketshare for its lead product as well as a broadened late-stage pipeline.
The company announced that its marketshare for its lead biosimilar product Udenyca® had reached 19% as of end of the third quarter. The company is hoping to crack 20% by the end of 2019. Coherus President Denny Lanfear mentioned on an earnings call that Udenyca share was gained at the expense of both Neulasta® prefilled syringe and On-Body Injector® prescriptions.
In other Coherus news, it disclosed a transaction that provides the company with exclusive rights to an investigational biosimilar version of ranizumab (reference product Lucentis®) from Bioeq. According to Coherus, it has secured exclusive rights to the product’s intellectual property. The big news is that Coherus intends to submit the 351(k) application for this agent before the end of 2019, with a potential launch in 2021. The product purchase likely means the discontinuation of Coherus’ own ranizumab biosimilar (CHS-3351), which was in preclinical development at the time of the acquisition. According to Mr. Lanfear, “This license pulls forward our previously anticipated Lucentis biosimilar launch in the US by about two years.”
Bioeq will earn an immediate payment from Coherus, and then milestone payments as commercialization advances. Under the agreement, Bioeq and Coherus will both receive a share of the profits postlaunch.
The secret is in the sauce that makes Kaiser Permanente a
truly integrated payer, and in its devout avoidance of the Achilles heel of
other payers.
At this week’s GRx+Biosims meeting, two sessions with KP’s executives made it startling clear—if you don’t accept rebates, the decision to move to biosimilars is simple.
Amy Gutierrez, PharmD
Amy Gutierrez, PharmD,Senior Vice President and Chief Pharmacy Officer, Kaiser Permanente
National Pharmacy Programs and Services, emphasized the organization, especially
its California regions (which account for 80% of its membership), is highly
integrated. The medical groups and Kaiser pharmacies “strongly collaborate,” coming
up with evidence-based reviews of formulary drugs.
At a separate session, Sameer Awsare, MD, Associate Executive Director, The Permanente Medical Group, elaborated, “Our drug information services are critical in doing the evidence-based review.” When an oncology clinician is part of the review, he said, “it’s hard for other oncologists to go against these recommendations. This results in widespread buy-in to the formulary decisions.”
Formulary
adherence is about 95%, according to Dr. Gutierrez, and in California, “the
plan does not require prior authorizations.”
The Looming Patent Cliff
“Biosimilars
are safe, and they have been shown to be as effective as innovator products,”
asserted Dr. Awsare. He listed the many reasons why uptake has been slow—pay-for-delay,
misinformation, patent litigation, and perverse incentives among the top
factors. “Biosimilars have reduced costs because of increasing competition.”
Dr. Gutierrez
stated that newer therapies can cost from $500,000 to $2 million. “How can we
afford these newer treatments? The abandonment rate for medications that cost
patients $250 or more is 69%, and 52% when the out-of-pocket costs are between
$125 and $250.” This has significant implications for Kaiser and its 12.3
million members.
With 71 drug
patents set to expire through 2023, representing $55 billion in costs, “We hope
to take advantage of this with biosimilars,” she said.
Kaiser Permanente’s Biosimilar Journey
The health
plan was an early adopter of Zarxio® (filgrastim-sndz). “We learned
the ropes with that one,” said Dr. Gutierrez.
Dr. Awsare explained
that when Zarxio first came out, the providers questioned the results of the
European studies. Kaiser performed a study with its own patients (the first 700
patients to receive the product). “It turned out we saw even less neutropenia
than with Neupogen—maybe it’s even a ‘biobetter’,” he stated. The result is
that Kaiser Permanente now has 98% uptake on Zarxio, according to Dr. Awsare.
Kaiser decided
in 2017 to cover Inflectra (infliximab-dyyb). “At that time, the professional [gastroenterological]
societies were inferring this was not the best course of treatment,” said Dr.
Gutierrez, and Kaiser Permanente delayed using the biosimilar for the inflammatory
bowel disease indications. Kaiser started a registry to ensure that no safety
signals were seen after the switch.
When Fulphila
(pegfilgrastrim-jmdb) was approved, Kaiser soon decided to cover it in
preference to the reference product. And when Amgen launched its biosimilar bevacizumab
(Mvasi®) and trastuzumab (Kanjinti®), Kaiser Permanente
jumped in with both feet. “The
oncology doctors were ready to move to biosimilar trastuzumab and bevacizumab
when they were launched,” said Dr. Awsare. “We went to 97% uptake on the
Avastin biosimilar in only a month.”
Kaiser also focuses on covering only one biosimilar in a class, to maximize its leverage.
Dr. Gutierrez
emphasized that the plan has the ability to get “immediate P&T decisions and
put coverage in place rapidly.” This has resulted in biosimilar uptake of 80%
to 95%, depending on the product. She explained, we’ve seen greater (and
faster) adoption rates with supportive care medications versus direct
treatment.” Overall, the plan has saved about
$200 million since we began covering our first biosimilar.”
In cases where
a product has a “skinny label,” Kaiser is open to approving off-label
indications, if the evidence supports it. “We’re working with our physician
groups to gain that evidence,” she said.
Dr. Gutierrez
advised that supply and stocking is important. “We might be ready to start
using the biosimilar immediately,” she said, “but the manufacturer may not be
ready to meet our supply needs. We’re getting better at that.”
“We work to minimize use of evergreening products whenever possible to maximimize the impact of the future biosimilars market,” added Dr. Gutierrez. “We are a leader in US biosimilar use. Manufacturers know that Kaiser Permanente can switch medication coverage fast, and this gives us significant leverage.”
Note: This post was updated and corrected on December 4, 2019. We had initially characterized Ruxience as being placed on Kaiser Permanente’s formulary. This is incorrect.
