Study suggests erectile dysfunction medications can improve heart health

Despite fears of increased risk of serious heart complications and death, erectile dysfunction (ED) medications appear to have a positive effect on heart health.

Enterprise Analytics Core domain(s): Value of integrated benefits, CarelonRx

Summary

Background

Phosphodiesterase type 5 inhibitors (PDE-5i) are a group of medications commonly used to treat ED. In the past there has been concern over risk of cardiovascular events in people taking these medications, but recent studies suggest little risk in addition to benefits beyond improvements to sexual function. In this study, researchers measured the association between these medications and major adverse cardiovascular events (MACE) and mortality among men with ED.

Methods

Researchers used administrative claims data to compare the rates of MACE and mortality among men with ED taking these medications with the rates of MACE and mortality among men with ED not taking these medications.

Results

Compared to men with ED not taking PDE-5i, men with ED taking these medications (n=23,816) had a 13% reduction in MACE (Hazard Ratio [HR]=0.87; 0.79-0.95) and a 25% reduction in overall mortality (HR=0.75; 0.65-0.87) over a median follow up of 18 and 24 months (Figure 1).
Compared to men in the lowest quartile of exposure to PDE-5i, men in the highest quartile had the greatest reductions in MACE (HR=0.45; 0.37-0.54) and overall mortality (HR=0.51; 0.37-0.71).
Other subgroups of men using PDE-5i – those with cardiovascular risk factors, those with coronary artery disease, and those with type 2 diabetes – experienced similar benefits.

Figure 1. Matched and adjusted hazard ratios comparing rates of outcomes among men exposed vs. unexposed to PDE-5i

Key takeaways

This study was one of the largest cohort studies to demonstrate associations between PDE-5i exposure and significant, clinically meaningful reductions in MACE and mortality.
It may support FDA review of the prescription to over-the-counter switch for PDE-5i.
It may also lead to additional studies designed to evaluate the use of PDE-5i to prevent cardiovascular disease.

Publications

Kloner RA, Stanek E, Crowe CL, Singhal M, Pepe RS, Bradsher J, Rosen R. (in press). The Effect of PDE-5 inhibitors on Major Adverse Cardiovascular Events and Overall Mortality in a Large, Nationwide Cohort of Men with Erectile Dysfunction and Cardiovascular Risk Factors: A Retrospective, Observational Study based on Healthcare Claims and National Death Index Data. J Sex Med.

Poster presented at American Heart Association’s Quality of Care & Outcomes Research (QCOR) conference on May 13, 2022.

Carelon Research project team: Christopher Crowe, Rebecca Pepe*, Mukul Singhal*, Eric Stanek

*Carelon Research Associate at the time of the study.

For more information on a specific study or to connect with the Actionable Insights Committee, contact us at [email protected].

This study was conducted by Carelon Research, Inc., a subsidiary of Elevance Health, and funded by Sanofi, in collaboration with Huntington Medical Research Institute. Dissemination and sharing of the Newsletter is limited to Elevance Health and its subsidiaries and included findings and implications are for Elevance Health and its affiliates’ internal use only.

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Highlighted Studies

A real-world study of immunoglobulin (IG) reveals multiple cost-saving opportunities

Hub Domain(s): Immunology, oncology, costs of care, IngenioRx, policy guidance
Summary:

Background: Immunoglobulins (IG) are costly blood-derived products accounting for more than $500m in annual spending in the Anthem membership
Methods: HealthCore examined IG utilization using claims data to evaluate appropriateness of use, the extent of site-of-care optimization and non-preferred IG use.
Results: The findings revealed significant off-label use of IGs (30%), including 22% for indications that were neither approved by FDA nor covered by Anthem, but were accepted by other health plans; and 8% for indications that were neither approved by FDA nor covered by any health plan

Additionally, 25% of the IG use was observed in the most expensive site of administration of hospital outpatient (HOPD) and non-preferred IG use accounted for 71% of the total IG use

Key Takeaways: Examining the IG uses from various dimensions presents several opportunities to IngenioRx and Anthem:

Reducing off-label IG use represented an estimated $27.8m annual savings opportunity
Shifting IG utilization from HOPD to a less expensive site of care could drive a further estimated $6.3m in annual savings
The study also identified opportunities to increase the share of preferred IG products used by our patients.

Major depressive disorder (MDD) patients highly impacted by COVID-19 face daunting challenges

Hub Domain(s): COVID, member experience
Summary:

Background: Disruption to daily life and lockdown measures that were imposed in an attempt to contain the spread of COVID-19 presented new hurdles for at-risk populations, such as patients with major depressive disorder (MDD)
Methods: Conducted a 2020 internet survey to understand reasons for antidepressant continuation, switching and discontinuation in patients with MDD; COVID-19 pandemic questions were developed and added to survey.

COVID-19 Pandemic Impact (CPI) score was calculated and, based on their CPI scores, patients were categorized as experiencing low (LPI), medium (MPI) or high pandemic impact (HPI).

Results: Compared with LPI and MPI patients, HPI patients reported:

Significantly more problems accessing healthcare; few reported not having health insurance benefits due to loss of/reduced health insurance coverage (Figure 1).
More challenges obtaining depression prescription medications in terms of:

Filling new/current prescription(s)
Receiving samples from healthcare providers
Paying for prescription(s) due to loss of/reduced health insurance coverage and/or pharmacy benefits

Since start of COVID-19 pandemic engaged in significantly more:

Alcohol, drug, and tobacco use
Unhealthy mindless eating
Sedentary behavior

Key Takeaways: Our findings are consistent with literature showing that traumatic events, e.g. pandemics, can negatively impact health behaviors.

More research is needed to explore the COVID-19 impact in other patient populations.
Education opportunities exist for health plans to increase awareness among providers and patients of possible short and long-term COVID-19 effects on health behaviors.

Figure 1: Impact of COVID-19 pandemic on accessing healthcare/mental healthcare

Publications: Poster presented at the Virtual American Society of Clinical Psychopharmacology (ASCP) Annual Meeting, June 1-4, 2021

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Actionable Insights Newsletter
Translating research to power whole health

Issue 4 | November 2022