A coverage change that could have put asthma patients at risk has been reversed. The decision was walked back in part due to a concerted effort by the advocacy community to raise awareness about the harms that could have resulted.
Proposed Medicare Coverage Change
The issue involved an innovative medicine called tezepelumab. It’s been found to help people with severe, uncontrolled asthma experience fewer attacks, including fewer attacks that led to emergency room visits or hospitalization.
The medication’s FDA approved label and instructions state it should be injected by a health care provider in a clinical setting every four weeks. However, several private regional Medicare service managers – called Medicare Administrative Contractors – earlier this summer proposed to cover only tezepelumab as a self-administered drug. This would have forced patients to inject themselves with the medication.
Money Saving Move Draws Ire
Patient advocates and providers took issue with the proposed coverage change, highlighting several issues:
- Direct conflict with the label. Given that tezepelumab is intended for administration by a health care provider, it doesn’t come with instructions for storage or self-injection. It’s unrealistic, and potentially hazardous, to expect that patients would be able to treat themselves with a medication designed to be given by a medical professional.
- Discounting the importance of adverse event monitoring. Forcing patients to administer the medication at home also eliminates post-injection monitoring. Some asthma treatments have produced side effects that were not detected in clinical trials and didn’t surface until the drug was being used on patients. This raises the importance of having a health care provider available to monitor any potential negative reactions following administration.
- The potential to widen health disparities. Black Americans are 42% more likely to have asthma and asthma rates are significantly higher in people whose families live below the poverty threshold. Changing the coverage for tezepelumab could have negatively impacted access and further widened health disparities.
In a letter to the Administrator of the Center for Medicare and Medicaid Services, the Alliance for Patient Access expressed concern about the “inappropriate overstep” of the MACs. Meanwhile, the Allergy & Asthma Network and allied groups urged all Medicare administrators to follow the FDA’s recommendations for clinical administration “in order to ensure patient safety.”
On Behalf of Patients, Advocates Prevail
In addition to written comments, the pair of advocacy organizations hosted a webinar for other stakeholders. They also engaged key members of Congress, produced educational materials and amplified their concerns via social media.
After being on the receiving end of numerous calls and letters, all the regional Medicare contractors agreed to change course. Earlier this month, the MACs retracted their proposals to cover tezepelumab only as a self-administered drug.
This is a victory for asthma patients and a case study of advocacy in action.