A partnership forum sponsored by the Academy of Managed Care Pharmacy (AMCP) yielded numerous ideas for improving access to biosimilars.
The Academy of Managed Care Pharmacy (AMCP) has kicked off an effort to promote biosimilar use by developing strategies and consensus at a 2-day summit involving various stakeholders.
“AMCP is dedicated to continue partnering with managed care pharmacy stakeholders to implement these strategies and advocate for biologic to be accepted as safe and effective therapeutic options, as well as increase access to them,” said AMCP CEO Susan Cantrell, RPh, CAE.
A Broad Agenda
Specifically, the group said it has resolved to improve education about biosimilars, agree on best practices regarding use, promote the collection of real-world evidence and postmarketing data on biosimilar adverse events, review policies for coverage of biosimilars under the pharmacy benefit, oppose anticompetitive practices, and bolster public support for FDA approvals.
“Some of the complexities from the health plan side, including contracting arrangements, may reduce or remove the anticipated cost savings of a biosimilar vs the reference biologic,” the group wrote in a summary statement.
They identified a need to overcome clinical and administrative barriers to biosimilar use that add to the difficulties of matching patients with biosimilars that would address their health needs. “With complexities around setting up the [electronic medical records] and order sets in each provider system, particularly given that each patient might be associated with different payers and formularies, it can be difficult for providers to determine the right biosimilar that will provide the right treatment at the right cost for a given patient, especially when the biosimilar is one drug in a multi-drug regimen.”
The summit participants also concluded that in some cases originator brand biologics may come with robust patient support programs, and taken as a whole these may supply compelling reasons to prefer reference products over biosimilars.
In addition, there’s a need to overcome pubic “mistrust of science in general and the drug approval process in particular,” and the group aims to work on this, too.
Getting all this done will be no easy task, they said. “A variety of factors cause the biosimilar landscape to be highly complex and diversified. These include different approval pathways due to the complexity of molecules, differing benefit types and sites of care, complex electronic medical record (EMR) systems and order sets, differences in administration routes and approved indications, confusion around terminology, physician clinical specialties, and the differing needs of patients depending on the disease state as well as whether they are treatment-naïve. All of these complexities present an overall challenge from which many other challenges flow.”
In mapping out its future path to accomplish these objectives, the group said it would publish a proceedings document with its findings and recommendations, support that dissemination with a webinar, construct other educational programs, find ways to incentivize biosimilar uptake, and recruit more participants and stakeholders to help with the overall process.
Biosimilars in America: Overcoming Barriers and Maximizing Impact
July 21st 2024Join us as we explore the complexities of the US biosimilars market, discussing legislative influences, payer and provider adoption factors, and strategies to overcome industry challenges with expert insights from Kyle Noonan, PharmD, MS, value & access strategy manager at Cencora.
FDA and Industry Experts Unpack Biosimilar Device Requirements
October 23rd 2024At the GRx+Biosims 2024 conference, a panel of industry experts and FDA officials discussed evolving device requirements for biosimilars and interchangeable biosimilars, highlighting new approaches to comparative use human factors studies, regulatory challenges, and alternative validation methods.
Exploring the Biosimilar Horizon: Julie Reed's Predictions for 2024
February 18th 2024On this episode of Not So Different, Julie Reed, executive director of the Biosimilars Forum, returns to discuss her predictions for the biosimilar industry for 2024 and beyond as well as the impact that the Forum's 4 new members will have on the organization's mission.
Revolutionizing Biopharmaceuticals: The EU's Biosimilar Success and Remaining Challenges
October 16th 2024The European Union's (EU) approach to biosimilars has revolutionized the biopharmaceutical market by driving innovation, lowering costs, and increasing adoption; however, there remains a need for more education, real-world evidence, and efforts to address challenges to enhance patient access and affordability.