New educational guidelines for biosimilars from payers are needed to ensure real change


As a society and as a healthcare system, we have long awaited advances in care that biologic medicines provide. These drugs, made from living cells, have dramatically changed the treatment of many serious diseases – including certain types of cancer, diabetes, rheumatoid arthritis and others.

For example, while older treatments for autoimmune diseases can reduce symptoms, biologics work differently. They are designed to modulate the immune responses that lead to conditions such as rheumatoid or psoriatic arthritis in joints, atopic dermatitis in the skin, ulcerative colitis in the gut, and more. These immune responses trigger inflammation in certain organ systems and are difficult to treat effectively. In the 40 years since the first biologic drug was approved in 1982, innovative biologics and related, lower-cost biosimilars have fundamentally expanded existing options to treat many different diseases.

But for individual patients, the wait to access these advanced options continues. Payer guidelines dictate that they must progress through treatment with older, potentially less effective options before trying treatments that may be better suited to the biology of their condition. As patients continue older treatments for months or even years, the impairments in their quality of life and the disease-related burden of anxiety and depression can deepen.

Some of the barriers preventing faster uptake of biosimilars can be broken down through awareness and education—but not all. Political and economic measures are needed to reduce patient waiting times. Biosimilars already offer some financial benefits to payers, and they could offer more. Payers themselves can increase this benefit by allowing more widespread use of biosimilars.

Learn the next step

We are already seeing welcome steps to educate vendors about biosimilars so they can incorporate them into their therapeutic approach. With the launch of its Curriculum Toolkit for Healthcare Professionals (HCPs) in December 2021, the FDA’s Center for Drug Evaluation and Research (CDER) took an important step in support of the integral role biologic drugs should play in today’s healthcare system.

As part of the agency’s Biosimilars Action Plan, the toolkit aims to help students in HCP programs develop a deeper understanding of biosimilars. It offers a wealth of information to encourage the cultivation of informed perspectives on biosimilars. Students will learn how biosimilars relate to reference products, details of the biologics approval process, interchangeability standards and implications for substitution, and prescribing information. This important curriculum is especially valuable for healthcare providers and can be especially indispensable for those caring for patients with immune-inflammatory diseases.

Act Informed

However, understanding biosimilars and how they can be used in the treatment of chronic diseases will only improve care if patients actually have access to these medicines. Unfortunately, even with more than 30 biosimilars approved in the US, the adoption rate has lagged behind other countries.

We could take action to both accelerate the pace at which patients get to the treatments that serve them best and competition, which could reduce the overall cost of biologics in the long run. Policymakers could take several steps to increase biosimilar acceptance in the US. It can start with reducing patient outlays for biosimilars to make these medicines more affordable and increase their use. Adjusting supplemental payment policies to increase reimbursement may provide a greater incentive to prescribe biosimilars. A shared savings model involving prescribing physicians can also encourage greater access. Finally, implementing a star rating system to measure access to biosimilars can encourage Medicare Advantage programs to support their use.

Some of these measures have already been proposed in legislation under consideration by Congress, such as: B. S1427 and HR2869. The sooner they are accepted, the faster patients will have to wait for treatments that could help them.

Given that biologics account for a large portion of total medical spending, patients, payers, and industry would all benefit from policies that expand the market for these drugs and increase competition to encourage lower costs.

how long will we wait

In the near term, biosimilars have the potential to provide the efficiencies that payers need while allowing patients to access advanced treatments. In the longer term, expanding the patient population who have access to biosimilars can increase competition among biosimilar manufacturers – and create economic incentives to further reduce the cost of biosimilars.

Payers can be our partners in accelerating this process, using the tools at their disposal to drive the changes that can reduce the time patients wait for biologics, thereby delivering faster cost savings that can benefit the entire healthcare system.

Mike Gladstone is Pfizer’s Global President of Inflammation and Immunology.


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