Mike Gladstone is the global president of Inflammation and Immunology at Pfizer.

Mike Gladstone

As a society and a health care system, we have waited a long time for advancements in care that biologic medicines offer. These drugs, made from living cells, have dramatically changed how many serious conditions – which include certain cancers, diabetes, rheumatoid arthritis and others – are treated.

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

But for individual patients, the wait to access these advanced options continues. Payer policies mandate they must step through treatment with older, potentially less effective options before trying the treatments that may be better suited to the biology of their condition. While patients continue older treatments for months or even years, the disruptions to their quality of life and the disease-related burdens of anxiety and depression can deepen.

Some of the obstacles preventing quicker uptake of biosimilars can be eased through awareness and education – but not all. Policy and economic action are required to shorten the time patients spend waiting. Biosimilars already offer some financial benefits to payers, and they could offer more. Payers themselves can magnify that benefit by allowing broader use of biosimilars.

We are already seeing welcome steps to educate providers on biosimilars so they may integrate them into their therapeutic approach. With the December 2021 launch of its 

 for educators of health care professionals (HCPs), the FDA’s Center for Drug Evaluation and Research (CDER) took an important step toward supporting the integral role that biologic medicines should play in today’s health care system.



As a component of the agency’s Biosimilars Action Plan, the toolkit is designed to help students in HCP degree programs develop a deeper understanding of biosimilars. It provides a wealth of information to encourage the cultivation of informed perspectives about biosimilars. Students will learn how biosimilars relate to reference products, details about the approval process for biologic products, standards related to interchangeability and implications for substitution, and information related to prescribing. This important curriculum is particularly valuable to providers and can be especially indispensable to those caring for patients with immuno-inflammatory conditions.



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



We could take action to accelerate both the pace at which patients progress to the treatments that will serve them best, and the competition that could, over the longer term, drive down the overall cost of biologics. Policymakers could take several steps to help increase the uptake of biosimilars in the US. It can begin with a reduction of patient out-of-pocket costs for biosimilars to make these medicines more affordable and increase their usage. Adjusting add-on payment policies to increase reimbursement can provide more incentive for prescribing biosimilars. A shared savings model that includes prescribers can also drive better access. Finally, implementing a Star Rating system to measure biosimilar access can encourage Medicare Advantage programs to support their use.

Some of these measures have already been proposed in legislation being considered by Congress, such as 

. The sooner they are adopted, the more quickly patients’ wait for treatments that could help them will shorten.

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

In the short term, biosimilars have the potential to offer the efficiencies that payers need while allowing patients the opportunity to access advanced treatments. Taking a longer view, expanding the pool of patients who have access to biosimilars can spur competition among biosimilar manufacturers – and create economic incentives to further decrease the cost of biosimilars.

Payers can be our partners in accelerating this process by using the tools at their disposal to foster the changes that can shorten the time patients spend waiting for biologics, and by doing so, more quickly bring about cost savings that can benefit the entire health care system.

Articles

Despite improvements in biosimilar education efforts for future health care professionals, payer policies need a major revamp to ensure that biosimilar use is encouraged, according to Pfizer's Mike Gladstone.

Mike Gladstone

Opinion: Efforts to Improve Biosimilars Education Are a Start, but Payer Policies Must Catch Up