Tasmina Hydery, PharmD, MBA, BCGP, assistant director of integrated technology solutions, AmerisourceBergen/Xcenda, Jennifer Snow, MPH, vice president of reimbursement policy insights, AmerisourceBergen/Xcenda, and Cate Lockhart, MS, PharmD, PhD, executive director, Biologics and Biosimilars Collective Intelligence Consortium presented a research update on biosimilar uptake and benefit design at AMCP Nexus 2021.

In the first portion of the session, Dr Hydery outlined the current therapeutic areas and biosimilar landscape dating from the first biosimilar’s launch in 2015—filgrastim-sndz (Zarxio)—to today’s current market which includes many FDA-approved biosimilars with even more launched by the manufacturer awaiting further approvals.

Some biosimilar class approvals currently include products for tumor necrosis factor blocker (including etanercept and adalimumab), insulin glargine (Semglee, Viatris/Mylan), and ophthalmology (ranibizumab).

Insulin glargine-yfgn, the biosimilar approved in July 2021 by the FDA as an interchangeable biosimilar via the 351(k) pathway is not currently available for use but the manufacturer forecasts it officially launching closer to the end of 2021.

Dr Hydery offered further insight on the state-specific biosimilar factors that could prevent approvals or launches, especially due to varying state regulations. Some of the questions that require answers in this area are:

• Does the FDA need to certify interchangeability first?
• Does the prescriber need to be notified? (What is the time frame for notification?)
• Do patients need to be notified?
• Does a prescriber notation of “brand medically necessary” or “dispense as written” block substitution?
• Do pharmacy records need to be retained?

Dr Hydery went on to share positive reactions to an interchangeable biosimilar via quotes from anonymous LinkedIn users who stated:

• “The first interchangeable biosimilar is now on the market, with more on the horizon. Let’s see if this helps translate into uptake!”
• “Now that the first biosimilar #insulin product (Semglee) has received the #FDA interchangeability designation, US pharmacists need to be informed about their state’s requirements for #interchangeability and pharmacy-level #substitution of biologics.”
• “New FDA-approved biosimilar interchange at the pharmacy can lead to cost savings.”

Another shared quote included a statement from acting FDA commissioner Janet Woodcock, MD, who said, “Approval of the first interchangeable biosimilar product furthers FDA’s longstanding commitment to supporting a competitive marketplace for biological products.”

These messages paint a picture of an industry that understands that biosimilars have a role to play in reducing costs and improving care and access for patients but there are still legislative hurdles to overcome.

An example of biosimilar legislation includes HR 2148, the Prescription Dug Price Relief Act of 2021. Under this act, the Department of Health and Human Services (HHS) must yearly review all brand name drugs for excessive pricing, as well as review when petitioned. If in this review any drug is found to be excessively prices, “HHS must (1) void any government-granted exclusivity; (2) issue open, nonexclusive licenses for the drugs; and (3) expedite the review of corresponding applications for generic drugs and biosimilar biological products. HHS must also create a public database with its determinations for each drug”

Also under HR 2148, drug manufacturers must report financial information for their brand name drugs, including any funding for research and advertising.

There are a number of other pieces of legislation in the works to address costs including S 1427/HR 2869—cosponsor of the Biosimilars Shared Savings Demo, which directs CMS to establish a voluntary, national demonstration project under Medicare Part B to evaluate the benefit of providing a shared savings payment for biosimilars; HR 2846—which is designed to improve access to low-cost generics to older adults and a cosponsor the Ensuring Access to Lower Cost Access for Seniors Act; and HR 2815—a cosponsor of the BIOSIM act, which would increase reimbursement for biosimilars at ASP+6% of the brand name.

On the US biosimilar pipeline, products are in the works for the following classes: targeted immunomodulators, insulins, supportive care, oncology, ophthalmology, immunosuppressants, bone health, growth hormones, and infertility.

In terms of current biosimilar coverage policies, the presenters stated, based on database of 535 coverage decisions, regarding 9 available biosimilars, at 17 of the largest commercial health plans in the United States, coverage decisions for biosimilars were 14% preferred, 53% on par, and 33% nonpreferred. For example, the biosimilar filgrastim-sndz was 51% preferred and biosimilars infliximab-abda and infliximab-dyyb were noted as nonpreferred 65% and 59%, respectively.

Presenters emphasized there are a lot of moving parts when it comes to biosimilar adoption and patients switching to lower cost options. This includes combatting a stigma that biosimilar products are just as safe and effective as the original reference product for patients.

Based on survey data collected, the majority of payers agree biosimilars provide meaningful cost savings (59% agree completely, 35% somewhat, 6% do not agree). In fact, when asked “Which of the following factors (if any) influence your decision to designate a preferred product (reference product or biosimilar) when 1 or more biosimilars are available?” 94% of payers responded that lower price is a primary influencing factor.

Other factors included contracting arrangement (75%), therapeutic area (49%), number of indications biosimilar is approved for vs reference product (39%), physician demand (24%), length of biosimilar on market (22%), and 6% marked other. In this same survey question, only 4% of payers responded that patient demand was the reason for a switch to a biosimilar.

Survey data showed that 75% of organizations are contracting with biosimilar manufacturers for select biosimilars, while 10% said they contract for all biosimilars. Other standout data points from the survey include:

• Formulary management occurs often through prior authorization (92%)
• FDA-approved indications are not the deciding coverage factor (55% reported that it is not)
• Switching to a biosimilar is seen as safe and effective (96% for treatment naïve, 92% for patients currently treated with a reference product)
• Payers emphasize need for improved substitution laws and real-world evidence on switching

In the final segment of the session, the presenters shared utilization management success data from Providence St Joseph Health (PSJH), a nonprofit health system comprised of 51 hospitals and more than 800 clinics on the western coast of the United States.

PSJH created tools within its electronic health record system which guided prescribers to preferred biosimilars, which in turn streamlined prescriber and pharmacist workflows, improved ordering processes, and increased overall efficiency. This utilization management tool implementation which increased switches to biosimilars saved PSJH nearly $10 million in 2019, proving that the cost saving potential is very real.

In conclusion, the presenters reiterated biosimilar uptake in the United States had a slower start compared with other countries, but the landscape is rapidly changing. Utilization is increasing but there are still regulatory complications that cause lags in adoption and approvals—including varying state laws that often cause confusion.

What the presenters emphasized in closing is “Managed care organizations are anticipating pharmacy-benefit biosimilars and identifying formulary strategies,” and further, “We now have examples of successful utilization strategies,” which will only improve over time.