Insurance delays, denials negatively affect patients with hereditary angioedema

March 16, 2023

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Arora NS, et al. Abstract 414. Presented at: AAAAI Annual Meeting; February 24-27, 2023; San Antonio.

Disclosures: Arora reports no relevant financial disclosures.

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Key takeaways:

  • Patients who did not have access to medication reported up to four or more attacks per month.
  • Ninety percent of patients who did not have access to medication reported increased anxiety.

SAN ANTONIO — Insurance delays and denials for hereditary angioedema drugs have a negative impact on physical and mental health, according to data presented at the annual meeting of the American Academy of Allergy, Asthma and Immunology.

“Although modern therapies have dramatically improved quality of life, insurance delays and drug denials have become much more common.” Noni S. Arora, MD, MBA, resident physician, Department of Internal Medicine, University of Michigan, said during his presentation.

Data extracted from Arora NS, et al. Abstract 414. Presented at: AAAAI Annual Meeting; February 24-27, 2023; San Antonio.

Researchers surveyed 20 patients aged 18 and older with hereditary angioedema type I or II (HAE) who had had insurance problems related to their HAE medications in the previous 2 years. Also, 19 of these patients participated in a virtual follow-up focus group.

Noni S. Arora

“The survey and focus group addressed the impact of insurance challenges on health care utilization, work and school attendance, impact on family life and anxiety,” Arora said.

Using descriptive statistics, the researchers analyzed the survey results. Also, three independent reviewers used a thematic saturation approach to code each focus group transcript.

Quantitative results

Patients who did not have access to NAE medication reported having more frequent NAE attacks. For example, patients who had access to medication were more likely to have less than one seizure per month, while the only patients who had four or more seizures per month were those who did not have access to medication .

The study also included step therapy, where an older, cheaper drug must fail before a newer, more expensive drug is approved, in a higher number of attacks. In addition, patients reported being frustrated when they did not have access to previously effective medications.

Also, 16 (80%) of patients regained access to their medications and had a mean angioedema control test (AECT) score of 11.7 (SD [SD], 3.2). The four patients who did not regain access had a mean AECT score of 7 (SD, 3.6), indicating poor control of angioedema symptoms (P = 0.02).

More than half of those surveyed missed work or school due to an increase in attacks when they also did not have access to medication, with an average of 4 days missed. Also, 85% of patients called their allergist or primary care provider when they did not have access to medication.

Additionally, ED visits increased by 1.3 days per month (95% CI, 1.2-1.4) and ED visits increased by 3 days per month (95% CI, 2 ,8-3,2) for patients who do not have access, with significant associated costs.

Anxiety increased for 90% of patients when they did not have access to their medications, with delayed notification of insurance formulary changes exacerbating this anxiety. The financial impact of missing work or school on these patients’ families also worsened mental health.

Quality results

Five themes related to the impact these delays and denials have on patients emerged from the analysis:

  1. “negative emotions and increased anxiety;
  2. missed work and school and negative financial impacts;
  3. significant impact on family life and friends;
  4. avoiding a wide range of activities that can cause symptoms of angioedema; and
  5. more frequent HAE attacks leading to ED visits and hospitalizations.”

“Patients did comment that the fear and anxiety of losing access to their medication and going back to not having access was very difficult,” Arora said.

The swelling prevented one patient from being able to work at his physical, hands-on job, resulting in a loss of income. Because of the easy and frequent triggering, another patient likened being off medication to living “in a bubble.”

Similarly, five themes emerged relating to what patients had to endure to regain access to NAE medication:

  1. insurance company requirements to try alternative medications, which often don’t work, or step therapy;
  2. frequent need for prior authorization as well as repetitive laboratory work;
  3. an excessive amount of time communicating with insurance companies, pharmacies and doctors’ offices;
  4. minimum notice in case of insurance changes; and
  5. various sources of support, such as family, drug company programs, doctors’ offices, and the Hereditary Angioedema Association.

“It’s frustrating because it’s a genetic disease. My genes haven’t changed since the day I was born. So why am I doing this every 3 months?” said one patient.

Another patient likened the 40 hours a week spent on the phone to get approval as “a full-time job.”


“Insurance delays and denials of HAE drugs have had a significant impact on patients’ physical health, mental health, workforce productivity and family life,” Arora said. “The negative impact of delays and denials points to a need for change in insurance company policies and practices.”

The researchers urged insurance companies to set clinical criteria for drug approval, make those criteria transparent and provide them in an easily accessible format to prevent delays in care.

The researchers also urged insurance companies to streamline the insurance authorization process and improve clarity for patients and their care teams.

“It is especially important that patients and physicians receive sufficient advance notice of formulary changes to allow time to appeal or change therapy,” Arora said.

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