Imagine being told you’ll have to self-inject a medication – without instructions – that has only been FDA approved for provider-administration. Chances are, you may not use it at all, even though it means inviting dangerous symptoms.
That scenario could soon be a reality for many patients with severe asthma who are insured by Medicare.
Proposed Coverage Change Puts Patients at Risk
Many of the administrative functions of Medicare are managed regionally by private companies, Medicare Administrative Contractors. Several MACs recently proposed changing how tezepelumab is covered. They want the injectable medication moved to the “self-administered drug” list starting in July.
The medication’s FDA label and instructions specify that it is “intended for administration by a health care provider.” There is no patient-oriented guide explaining how tezepelumab should be stored or injected. Asking even the savviest patient to safely do either is both inappropriate and unrealistic.
It is also important for provider-administered injectable asthma medications like this one to be administered in a clinical setting so that patients can be observed for potential side effects. Having a doctor on hand to quickly address an adverse reaction is a valuable safeguard.
Exacerbating Access Challenges for Communities of Color
Beyond safety concerns, patient advocates fear that changing the rules for tezepelumab will diminish patients’ ability to manage their severe asthma using the innovative medication. This can lead to worse health outcomes for all patients and compound negative effect on patients of color.
Black Americans are nearly 1.5 times more likely to have asthma, five times more likely to visit the emergency room due to asthma and three times more likely to die from asthma compared to white Americans.
Making it harder for patients to get a treatment that controls their symptoms could further widen health inequities in the asthma community.
Calls for Action
In a letter to federal officials, the Alliance for Patient Access outlined several concerns about the policy change. Chief among them: Moving tezepelumab from being covered for physician administration under Part B to self-administration under Part D. This “is an inappropriate overstep by the Medicare Administrative Contractors,” the letter warned.
The patient advocacy organization urged the Centers for Medicare and Medicaid Services to review the contractors’ proposed change quickly so “our seniors have appropriate access to the treatment as FDA-approved and indicated.”