April 2021 Edition Vol.13, Issue 4

Oncology Biosimilars: Cost Savings Offset by Challenges

By Aaron Tallent

Cost savings, lack of data, and overcrowded pharmacy shelves are some of the successes and challenges the cancer community is facing with in the growing biosimilars market. Oncology stakeholders discussed their experiences with prescribing biosimilars during a session at the recently held virtual Community Oncology Alliance’s (COA) annual meeting.

Biosimilars vs. Brand Name Cost Savings

“Biosimilars give us a huge opportunity for cost savings that should be passed down to the patient. If we can solve the issue of real-world evidence and data and supply that data back, I think that will support the use of biosimilars moving on,” said Sandeep Parsad, PharmD, MBA, BCOP, Assistant Director of Pharmacy for University of Chicago Medicine’s Hematology/Oncology and Investigational Drug Services.

Biosimilars have no clinically meaningful differences in the safety and effectiveness of specific US Food and Drug Administration (FDA)–approved biologics, also known as reference products. In 2015, the agency approved its first one, Zarxio (filgrastim-sndz), a biosimilar for Neupogen. To date, the FDA has approved 29 biosimilars, 16 of which are indicated for cancer treatments.

Given that 8 of the 10 most expensive drugs in the United States are cancer therapies, biosimilars allow for additional therapies to be made available and have already produced cost savings. The manufacturer of Zarxio, Sandoz, reports that the savings for filgrastim in the United States from 2016 through 2020 is more than $1 billion. Kaiser Permanente, one of the first to embrace biosimilars for Avastin (bevacizumab) and Herceptin (trastuzumab), has saved $200 million since 2015 and has reinvested the savings into patient care.

The average sales price of biosimilars when they launch is anywhere from 3% to 24% below the reference products’ average sales price.  Analysis by the Pacific Research Institute’s Wayne Winegarden, PhD, estimates that the current annual cost savings from biosimilars is $240.4 million, but that number could rise to $7 billion across federal and commercial programs if biosimilars cover 75% of the market share. Because the uptake of biosimilars has been relatively low, the full potential of reducing costs has yet to be reached.

“There’s almost a spectrum of ‘all in’ versus dipping your toes in the water,” said Sonia Oskouei, PharmD, BCMAS, DPLA, Vice President for Biosimilars at Cardinal Health.

Some oncology practices may be starting with supportive care agents or are focusing on new patients to build confidence and familiarity with utilizing biosimilars. Others, such as Blood & Marrow Transplant Specialist, OHC (Oncology Hematology Care, Inc.) in Ohio, are past that stage and have fully integrated biosimilars into their practice. They are now facing challenges that only data will solve.

“Once we have 8 different Herceptins, are they all the same and is it reasonable to pull a different one off the shelf than this same patient got 3 months ago?” asked E. Randolph “Randy” Broun, MD, a medical oncologist with the practice.

What are Biosimilars?

Biosimilars are not considered the same as generic drugs, which are exact replicas of their brand name products. Biosimilars are made from living cells and differ slightly from iteration to iteration during the manufacturing process. For example, the FDA has approved 5 different companies’ biosimilars for Herceptin and, although they match the safety and efficacy of their reference products, these biosimilars are not interchangeable. Data are needed to answer questions about long-term outcomes using a particular biosimilar or if there is any potential harm in switching a patient’s biosimilar midtherapy.

“Because we are seeing payers that are switching their biosimilar maybe every 3 months, you could be faced with questioning whether a patient can move from A to B to C and we just don’t have that data,” said Dr Parsad.

Insurance Coverage of Biosimilars

Insurance companies selecting different biosimilars as their preferred product are also exacerbating this dilemma. Dr Broun said that every insurance company seems to have their preferred version of Neulasta, so his practice has to stock 3 or 4 different biosimilars. A recent Health Affairs study analyzed coverage policies of Aetna, Cigna, United Healthcare, Anthem, and Blue Shield for the drug between October 2019 and March 2020. Between the 5 insurance companies, there was no consensus on whether the reference product or a specific biosimilar was the preferred therapy.

Dr Oskouei said that insurance policies run the gamut from covering all therapies equally to some preferring the reference product. Other companies cover any biosimilar, whereas some prefer specific ones. She noted this blend of payer policies “definitely creates a challenge for practices to carry multiple products.” The first obstacle may be building a bigger pharmacy.

“We may have pharmacies with just shelves and shelves of biosimilars to be able to give the appropriate agent to the appropriate patient at the appropriate time,” said Dr Broun.

If there is a positive side to these overcrowded shelves, it is that the competition appears to be driving down drug prices, as the net price of some reference products appear to decline by at least 7% after the first biosimilar is introduced. However, more data are needed on whether patients are truly benefiting from the reduced pricing. Even though biosimilars can cost much less than reference products, varying insurance policies and rebates offered by drug manufacturers have oncology professionals asking if the patient is truly seeing those savings.

“To answer that question is really tough because then you start looking at what are the rebates that are given by branded products,” said Dr Parsad. “If we are able to level set that, it may help us because it really muddies the water.”

Kathy Oubre, Chief Operating Officer of Pontchartrain Cancer Center in Louisiana, says that she has seen patients who received biosimilars in her practice benefit from the cost savings. Even with the early challenges, she believes the really young biosimilar market will produce long-term gains for cancer care.

“The US biosimilar market is still in its infancy. We just need to let it mature,” she said.

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