Newer Cardiovascular Drugs Are Being Incorporated Into Practice, but Access Remains a Challenge

Several key cardiovascular drugs are increasingly being used, although costs and access can still be challenging, according to presenters in a session at the American College of Cardiology 2023 Scientific Session.

First, presenter Joanna Joly, MD, reviewed the growing use of vericiguat, a novel oral soluble guanylate cyclase stimulator used in patients with heart failure following an acute decompensation event. Data from the VICTORIA trial found that death from cardiovascular cause or first hospitalization for heart failure occurred in 35.5% of patients receiving vericiguat compared with 38.5% of patients receiving placebo—a finding that led to the ongoing VICTOR trial.

The 2022 guidelines from the American Heart Association, American College of Cardiology, and Heart Failure Society of America gave vericiguat a 2b recommendation, saying it may be considered to reduce heart failure hospitalization and cardiovascular death.

Joly noted that this pharmacologic option is important given the growing number of patients with heart failure. Although it is challenging to estimate the proportion of advanced heart failure, the prevalence is likely to increase. Additionally, access to heart transplants and left ventricular assistance devices is limited, necessitating more effective pharmacologic options.

In a second presentation, panelist Lucianne West, PharmD, BCCP, discussed the implementation of finerenone, a mineralocorticoid receptor antagonist metabolized primarily by CYP3A4. The ARTS, ARTS-HF, and ARTS-DN trials investigated its use, raising questions about optimal dosing and whether it mitigates the risks of hyperkalemia commonly seen in cardiovascular drugs.

The FIDELIO-DKD and FIGARO-DKD trials aimed to answer this question and further understand finerenone’s efficacy and safety. The FIDELIO-DKD trial notably found that the drug did reduce the incidence of pre-specified composite cardiovascular outcomes. Investigators found similar outcomes in patients with and without a history of cardiovascular disease, suggesting it could be used for both primary and secondary prevention.

Importantly, finerenone is FDA-approved for patients with chronic kidney disease associated with type 2 diabetes, although cost is an issue with its modest price tag around $670 per month. Additionally, the FINEARTS-HF trial is underway evaluating morbidity and mortality outcomes in patients with New York Heart Association (NYHA) class 2 to 4 symptoms and left ventricular ejection fraction (LVEF) of 40% or greater.

Next, presenter Anjali Owens, MD, discussed the use of mavacamten, a first-in-class cardiac myosin inhibitor. The EXPLORER-HCM trial found that it significantly improved post-exercise left ventricular outflow tract (LVOT) and reduced LVOT gradient without significant decrement in LVEF. Similarly, gradient data from the VALOR-HCM study mirrored these results.

Mavacamten received FDA approval in April 2022 for NYHA functional class 2 or 3 obstructive hypertrophic cardiomyopathy, but questions remain about where it fits into the guidelines. Owens said the EXPLORER-HCM data suggest it could be used if patients remain symptomatic and obstructive after b-blockade or treatment with verapamil. Notably, it was approved with a REMS program due to the risk of systolic dysfunction and heart failure, and it must be closely monitored.

Hyperkalemia remains a significant issue in cardiovascular treatments, but novel potassium binders, such as sodium zirconium cyclosilicate and patiromer, are showing promise in this area, according to presenter Katherine Di Palo, PharmD, MBA, MS. Balancing guideline-directed medical therapy with proven morbidity and mortality benefits with the known risks of hyperkalemia is a major issue and is a key cause for the under-prescribing of guideline-directed cardiovascular treatments, according to Di Palo.

Importantly, experts have pondered whether potassium binders could help patients initiate and continue treatment with renin-angiotensin system (RAAS) inhibitors, thereby improving outcomes in heart failure. The DIAMOND trial aimed to answer this question with patiromer.

Notably, 85% of participants achieved optimal doses of RAAS inhibitor therapy while maintaining normokalemia and a greater proportion of patients maintained treatment with aldosterone receptor antagonists (MRAs). Despite these encouraging findings, the trial was not able to answer whether heart failure outcomes improved. However, guidelines currently note that this approach may be a useful strategy to initiate and maintain treatment with RAAS inhibitors.

Finally, presenter Mitchell Psotka, MD, PhD, reviewed tips for accessing and helping patients afford these drugs, which can be major challenges. Studies have found that utilization increases, and adverse events improve when medications are covered by insurance, with notably higher impacts for non-white and socioeconomically disadvantaged populations.

Psotka noted that prior authorization requests are more common among certain Medicare Advantage firms, and between 5% and 10% of all prior authorizations are denied. Only about 10% of these are eventually appealed, but, importantly, up to 90% of those are overturned, so Psotka urged clinicians to appeal prior authorization denials.

Additionally, he said pharmacists play a vital role in ensuring that patients can afford their medications, either by advising them on more affordable options or working with insurers and prescribers to find cheaper alternatives. Online pharmacies such as Mark Cuban’s Cost Plus Drugs may present options for generics, but these programs typically do not include specialty or brand name drugs.

REFERENCE

Psotka M, Di Palo K, Owens A, West L, Joly J. Practical Tips to Help Incorporate Newer Cardiovascular Drugs Into Practice. Presented at American College of Cardiology 2023 Scientific Session. March 5, 2023.