Assessing HEOR in Patients With Central Disorders of Hypersomnolence

Abstracts presented at SLEEP 2021 include real-world data characterizing individuals with central disorders of hypersomnolence.

In a series of posters presented at Virtual SLEEP 2021, the 35th annual meeting of the Associated Professional Sleep Societies LLC, researchers used real-world data to highlight health economics and outcomes research (HEOR) of patients with central disorders of hypersomnolence, specifically idiopathic hypersomnia (IH) and narcolepsy. Abstracts were also published in an online supplement of the journal Sleep.

Diagnostic Sleep Testing, Comorbidities Prior to IH Diagnosis

Currently there are no approved treatments for IH, a rare and serious disorder. Using IBM MarketScan claims data, researchers conducted a retrospective analysis in an effort to characterize diagnostic sleep testing in the year leading up to IH diagnosis.1

In the current analysis, data between January 2014 and September 2019 were assessed for patients with newly diagnosed IH and those without an IH diagnosis. Demographic information, data on diagnosing physician specialty, and diagnostic sleep disorder testing—including claims for home sleep test, polysomnography and others—were also included in the study. Patients were divided depending on their diagnosis of overall IH or primary IH.

A total of 4980 (0.015%) patients with newly diagnosed IH were identified out of 32,948,986 eligible individuals. Mean patient age was 43 years and the majority (67%) were female. In addition, 2205 patients were diagnosed with primary IH (44% of overall IH) and these individuals tended to be younger, with a mean age of 39.

Analyses revealed:

  • Long sleep time was documented for 69% of the overall IH group and 67% of the primary IH group
  • The top 3 diagnosing physicians’ specialties were similar for overall IH/primary IH: pulmonology (23%/26%), neurology (14%/16%), and internal medicine (11%/10%)
  • Few patients (9% overall IH; 7% with primary IH) were diagnosed in family practice
  • Any sleep testing was performed in 44% of overall IH and 53% of primary IH patients
  • Polysomnography and multiple sleep latency test/maintenance of wakefulness test (MSLT/MWT), the most frequently used sleep tests, were less common in overall IH (39% and 22%) than in primary IH (48% and 32%)

Overall, utilization of objective sleep testing was low regardless of the definition of IH diagnosis. More research is needed to investigate clinicians’ use of sleep testing for IH diagnosis in the future, authors said.

In another effort to characterize newly diagnosed patients with IH, researchers used the same claims data from the IBM MarketScan database.2

“From this population, a cohort with newly diagnosed IH was identified, defined as ≥2 claims with an IH diagnosis code ≥1 day and ≤180 days apart, and without an IH diagnosis in the 12 months prior to cohort entry,” researchers wrote. Any patients with enrollment gaps of over 30 days were excluded from this analysis.

Specifically, researchers looked for claims with diagnoses for select morbid/comorbid conditions from 1 year prior to cohort entry. Of the 4980 patients with newly diagnosed IH identified, sleep-related morbidities included narcolepsy type 2 (17%) and hypersomnia (10%) for the IH cohort. In the general population cohort, these rates were 0.1% and 0.2%, respectively.

For the IH/general population cohorts, analyses revealed the following rates of additional comorbidities, respectively:

  • sleep apnea (50% vs 4%)
  • mood disorders (32% vs 8%)
  • depressive disorders (31% vs 7%
  • anxiety disorders (31% vs 9%)
  • hyperlipidemia (30% vs 20%)
  • headache/migraine (24% vs 7%)
  • diabetes or use of diabetes/obesity medication (20% vs 12%)
  • hypertension (15% vs 10%)
  • cardiovascular disease (14% vs 8%)

Among those with primary IH, common morbidities and comorbidities were similar to rates seen in the overall IH population. Because results indicate cardiovascular risk factors are so common upon diagnosis of IH, therapies that do not increase this risk are warranted for the condition, researchers wrote.

Cardiovascular Burden in Narcolepsy

Although narcolepsy, a rare lifelong disorder that requires long-term treatment, is associated with certain cardiovascular conditions, many available treatments carry cardiovascular-related warnings and precautions on labels.

To estimate the incidence of these comorbidities among US patients with narcolepsy, researchers again analyzed claims from the IBM MarketScan between January 2014 and September 2019.3 All patients included were at least 18 years old, while “The narcolepsy cohort was defined by ≥2 outpatient claims containing a diagnosis of narcolepsy type 1 or type 2 on separate days and no more than 6 months apart, with ≥1 non-diagnostic office-visit,” authors wrote.

Individuals without the disorder were matched 3 to 1 to patients with narcolepsy based on age, gender, US geographic region and other factors. A total of 12,816 and 38,441 individuals were included in the narcolepsy and matched non-narcolepsy cohorts. Mean age was approximately 38 years in each cohort and the majority (67%) were women.

Analyses showed “Incidence rates (per 1,000 person-years) for newly recorded cardiovascular comorbidities or events in narcolepsy/non-narcolepsy were: CVD without hypertension (13.29/7.99), major adverse cardiac events+ (11.75/6.86), heart failure (5.72/3.41), stroke (4.28/2.17), ischemic stroke (3.69/1.91), edema (9.84/4.22), and a composite of stroke, atrial fibrillation, and edema (17.73/8.88).”

Although more research is needed to understand treatment-specific risks for patients with narcolepsy, physicians ought to consider increased cardiovascular risk when providing risk modification strategies and treatment options for patients, authors concluded.

References

1. Saad R, Ben-Joseph R, Prince P, Stack C, Bujanover S, and Taylor B. Utilization of diagnostic sleep testing prior to idiopathic hypersomnia diagnosis among US adults: a real-world claims analysis. Presented at: Virtual SLEEP 2021; June 10-13, 2021; Virtual. Abstract 499.

2. Saad R, Ben-Joseph R, Prince P, Stack C, Bujanover S, and Taylor B. Clinical presentation prior to idiopathic hypersomnia diagnosis among US adults: a retrospective, real-world claims analysis. Presented at: Virtual SLEEP 2021; June 10-13, 2021; Virtual. Abstract 497.

3. Ben-Joseph R, Saad R, Dabrowski E, Taylor B, Gallucci S, and Somers V. Cardio-vascular burden of narcolepsy disease (CV-BOND): a real-world evidence study. Presented at: Virtual SLEEP 2021; June 10-13, 2021; Virtual. Abstract 503.