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American Diabetes Association Deeply Concerned With Recent Prescription Drug Formulary Trends

Following is a statement from the American Diabetes Association (August 15):


The American Diabetes Association (Association) is deeply concerned with recent trends in prescription drug formulary designs that result in frequent changes in drug coverage for individuals with diabetes. As pharmacy benefits managers (PBMs), insurers, and employers finalize their 2018 formulary lists, the Association urges them to focus on continuity of care for individuals with diabetes. Diabetes is a serious disease, and effectively managing it is not one-size-fits-all. The Association believes that every person living with diabetes should have access to the care, treatments, tools and information they need to successfully manage their diabetes.


Day-to-day management of diabetes is a heavy burden that rests squarely with the individual living with the disease. And, the complexities of managing diabetes are unique to each individual, based on health history, phenotype, co-morbidities, lifestyle, and other important factors. It is critical that people with diabetes have the opportunity to work with their healthcare providers to choose the most appropriate therapeutic option that best meets their individual needs at that particular time. Thus, a patient-centered approach, in consultation with a multidisciplinary diabetes care team, should be the guiding principle for making treatment choices.


Important considerations for deciding on a therapeutic option include efficacy, hypoglycemia risk, presence of complications, presence of cardiovascular risk factors or pre-existing cardiovascular disease, impact on weight, potential side effects, cost, and patient preferences. Agreements among insurers, manufacturers, and PBMs limiting therapeutic choice could impair a patient’s access to certain treatments and limit a provider’s choice of agents that are most effective for their patients, potentially adversely affecting patient outcomes.


Excluding a medication from the prescription drug formulary list can jeopardize the health of many patients with diabetes. In addition to the possibility that the replacement medication is not appropriate for the patient, formulary changes disrupt the continuity of care and burden patients with unanticipated, increased cost-sharing. These additional costs could result in individuals with diabetes being unable to afford medications essential to maintaining their health. 


Formulary changes made during the plan year are particularly troubling because most individuals do not have the option of changing to a different insurance plan that would cover his/her prescription medication. Therefore, the Association is strongly opposed to formulary changes such as removing medications from formularies or moving medications to a higher tier during the plan year. 


For patients negatively impacted by formulary changes, the Association strongly recommends PBMs, plans, and employers provide an expedited and standard process for gaining access to medications not included in the plan’s formulary. Responses to exception requests must be timely to ensure no delay in obtaining a needed medication, thereby preventing a gap in treatment. In addition, the Association recommends PBMs, plans, and employers temporarily cover non-formulary drugs as if they are on the formulary during the first 30 days after the formulary list is changed.


Finally, the Association believes all prescription drug coverage decisions made by PBMs, plans, and employers must be based on clinical evidence. Considering the strong clinical evidence obtained in recent years that supports new therapies and classes of agents and the positive effect on cardiovascular disease for people with diabetes and increased cardiovascular risk, in addition to the beneficial effect on unmet clinical needs such as hypoglycemia (a major factor that limits success for obtaining goals) and overweight/obesity, the Association urges PBMs, plans, and employers to minimize disruption of care when developing their 2018 formulary lists. 


Diabetes is a complex disease with many different treatment options. The Association remains committed to protecting people with diabetes—ensuring they have the access to medications that are effective for each of them individually.