Nearly 25% of patients with diabetes use less insulin than prescribed due to financial insecurity1, and this can result in poor glycemic control, increased complications and even death. Cost-related medication non-adherence remains a significant barrier to care, and addressing it is crucial for improving patient outcomes2.
Since insulin is considered a biologic rather than a small-molecule drug, there are stricter standards for approval; this can delay the marketing of generic products. Recently, however, the major insulin manufacturers have stepped up to offer some less-expensive alternatives, classified as biosimilar insulins.
Biosimilar insulins have the same amino acid sequence but may differ in the manufacturing processes, resulting in minor and not clinically relevant differences in molecular characteristics and clinical profiles3. An example is Basaglar insulin, which is a biosimilar insulin for Lantus (glargine) long-acting insulin analog. In March 2020, a new FDA policy was enacted to expedite the approval process for biosimilar insulins. Semglee is an example of a biosimilar insulin recently approved under the new FDA policy4. (Though less expensive, these biosimilar insulins may still not be affordable for many patients without health insurance coverage, especially in the setting of the COVID-19 pandemic and resultant economic consequences.) Insulin manufacturers are also offering “authorized generic” versions of some products, which are biochemically identical to name-brand products and can be substituted by pharmacists and sold at a lower cost.
The financial distress faced by many patients has worsened as the COVID-19 pandemic has resulted in unemployment and loss of medical coverage. The pandemic has also highlighted racial/ethnic disparities in access to health care among patients with diabetes5. Insulin manufacturers have responded with special COVID relief and patient assistance programs to provide insulin at a lower price. In addition, many states have enacted laws to limit monthly out-of-pocket costs for insulin.
Factors to consider
What can we and our patients do? As clinicians, we must consider the social determinants of health, including financial affordability, healthcare access and lack of adequate insurance coverage, which affect many of our patients. We must strive to understand and address challenges and consider options for insulin management, including use of older and less-expensive insulins (for example, U-100 regular and NPH) when appropriate. (Some studies have shown no additional benefit to newer insulins in type 2 diabetes.)6,7
The potential advantages of newer insulins must be considered in the context of cost and availability of patient assistance programs, which may be offered directly by the manufacturers. Changing the delivery system may also reduce patient costs. For example, a vial of insulin may be more affordable unit to unit than a pen device. Electronic resources such as GoodRx® and getinsulin.org, among others, may also be helpful for finding affordable options.
In addition to caring for patients, we must also support policy and legal changes to improve insulin access. Several current initiatives are underway, spearheaded by professional medical organizations and lawmakers. After the death of Alec Smith, a 26-year-old with type 1 diabetes who was unable to afford his insulin, the state of Minnesota passed the Alec Smith Emergency Insulin Act, creating statewide financial assistance for insulin for those in need. Some states (e.g. Colorado, Illinois, New York, Maine, Utah, Washington, West Virginia) have capped monthly out-of-pocket maximums ($30 to $100, depending on the state) for patients who depend on insulin.
Pharmaceutical companies may also offer additional patient assistance options. (The requirements for all financial assistance programs can vary and may not include undocumented or unregistered persons.) Medical organizations, including the American Diabetes Association, continue to actively lobby for decreased costs and increased insurance coverage for insulin, diabetes testing supplies and advanced diabetes technology (continuous glucose monitors and insulin pumps) to enable our patients to care for themselves and to prevent serious short- and long-term complications of diabetes.
During every patient encounter, we must be vigilant and ask about the ability to afford the medications and supplies that we prescribe. We must be aware of current legislative and regulatory actions and keep our patients informed. We must diligently help our patients explore options for financial assistance. We must meet the challenge head on, utilizing all available resources in a full team effort to improve insulin access for all.
Access additional resources and practical information designed to enhance the care and treatment of your diabetes patients.
About our experts:
Nancy J. Rennert, MD, FACE, FACP, CPHQ, System Chief of Diabetes Care, Western Connecticut Health Network, Nuvance Health, Chief of Endocrinology & Diabetes, Norwalk Hospital Associate Clinical Professor of Medicine, Yale School of Medicine, New Haven, Connecticut, University of Vermont Larner College of Medicine, Burlington, Vermont