by Shannon Holden
Senior Clinical Manager, Center for Pharmacy Practice Excellence
It may give you heart palpitations to see the cardiology service line highlighted in the recent Pharmacy Market Outlook but take a breath and a beat – we’re going to break those changes down for you so both your heart and your pharmaceutical spend are better prepared for 2023.
As new medication approvals have been bursting out of the pipeline over the past decade for oncology; autoimmune diseases like rheumatology, dermatology and gastroenterology; and diabetes, among other diseases, cardiology hasn’t seen a robust pipeline until the past few years. And the change has been significant. In fact, cardiology saw changes in new indications for medications previously approved, first-in-class medications, and diseases with first-line treatments in just this year alone.
So, why now?
Despite all the effective drug therapies for cardiovascular diseases that are currently on the market, cardiovascular disease continues to be the leading cause of morbidity and mortality in the United States. Readmission rates for cardiology patients is a pain point for most hospitals despite continued work to keep patients at home and out of the hospital.
Cardiology also has traditionally been dominated by generic products, but with novel agents, greater cost and increased workload on clinic staff follow. In addition to new medications entering the market, updates in guidelines from the American College of Cardiology (ACC), the American Heart Association (AHA) and Heart Failure Society of America (HFSA)directly impact patients, pharmacy, clinic workload, and cost of therapy.
There are four main areas where we have seen changes that will impact spend and clinic operations: heart failure, cardiac amyloid, hypercholesterolemia and hypertrophic cardiomyopathy.
The 2022 ACC/AHA/HFSA updated guideline recommendations for heart failure were released in April with many recommendations that will impact pharmacy spend, cardiology clinic operations and patients.
First is the addition of the sodium-glucose cotransporter-2 (SGLT2) inhibitor class to the previously known triple therapy, now named quad therapy. Both empagliflozin and dapagliflozin were approved this past year for the treatment of heart failure patients with reduced ejection fraction (HFrEF). These recommendations will increase the number of medications and possible copays for patients on heart failure therapy. It also begs the question of whether SGLT2’s should be started while the patient is admitted. Patients admitted with heart failure previously were started on triple therapy while admitted and discharged to a cardiology clinic for titration. The addition of SGLT2s while the patient is admitted could increase hospital pharmacy spend, depending on the patient’s insurance and whether the prescribed product is different from what is preferred by the payer.
The second recommendation is the preference of utilization of an angiotensin receptor neprilysin inhibitor (ARNI) over an angiotensin converting enzyme (ACE) inhibitor or angiotensin receptor blocker (ARB). This recommendation doesn’t come as a surprise; however, it does increase the number of brand name products for this regimen, ultimately increasing the cost to the patient. Most payers require prior authorization for the SGLT2’s and some for ARNI, which puts a strain on clinical staff. In the past, triple therapy was predominantly generic agents where prior authorizations were rarely required. In addition, vericiquat also was recently approved and is indicated for a very specific population of patients with HFrEF. Patients who are on target dose or maximum tolerated doses of quad therapy and have either had recent hospitalization or requiring IV diuretics may be candidates for this medication. Prior to adding a fifth medication, patients should be assessed for adherence and affordability. Adding vericiquat to a patient’s regimen would bring their medications for heart failure up to five agents with likely three brand name products.
Recommendations for heart failure with comorbidities also are addressed in these updates and include the addition of iron screening and treatment in patients with HFrEF. Increased utilization of IV iron and infusion centers will follow as clinics adopt iron screening practices and will also lead to an increase in workload for clinics with care coordination and lab monitoring.
Lastly, heart failure with preserved ejection fraction (HFpEF) patients were previously lacking approved treatments, and now there are two new approved products added to the guidelines: sacubitril/valsartan and empagliflozin.
The story is a little different with cardiac amyloid. The 2022 ACC/AHA/HFSA guidelines now recommend screening and treatment of cardiac amyloid, which will impact pharmacy spend and clinical operations. Currently, there are 5,000-7,000 new cases of cardiac amyloid diagnosed each year, but with these new screening recommendations, we will likely see an increase in diagnosis. The screening for cardiac amyloid is rather expensive and the initial genetic screening is done in office. Unfortunately, most patients’ insurance coverages require prior authorizations for this costly treatment, and many patients may still need assistance to cover the copays. The increase in clinical staff workload due to screening, managing prior authorizations and supporting patient assistance programs also need to be considered as testing and diagnosis increase over the next few years.
The PCSK-9 inhibitors are the talk of the town when it comes to treating hypercholesterolemia. The first PCSK-9 agents to enter the market in 2015 were monoclonal antibodies: evolucumab and alirocumab. These are self-administered subcutaneous injectables that are given every 2-4 weeks depending on diagnosis and agent.
The new kid on the block is inclisirin, and it differs in many ways. For one, the mechanism of action – it’s a small, interfering RNA molecule, is different. Inclisirin dosing also is twice per year after initiation and has to be given in-clinic by a healthcare provider. The in-clinic administration adds initial operational challenges for the billing and purchasing of inclisirin as most clinics haven’t had to previously do this in the past. Since inclisirin is only administered in office, the medical benefit is utilized, and for some patients this may be preferred because compliance is easier to monitor and patients who don’t want to give themselves an injection have another option. As clinics work through these operational challenges and create new workflows for prescribing and administering inclisirin, utilization will increase.
Lastly, I think it’s important to recognize mavicamten. It was granted breakthrough therapy designation and approved in April 2022. It is a first-in-class cardiac myosin inhibitor and is the first agent to be approved for this indication. Even though most patients with hypertrophic cardiomyopathy have a low risk for sudden death. it is still the most common cause of sudden cardiac death in people under the age of 35. Prior to mavicamten entering the market, patients were prescribed a beta blocker and possible surgery. As with the other new agents on the market, mavicamten is rather expensive for our cardiology patients; however, with prior authorization and patient assistance, most patients should be able to afford it.
Looking into the future there are many agents in development for cardiology including more first-in-class medications. Continued work in this area is very important as we work to decrease mortality, help patients stay out of the hospital and increase patients’ quality of life. Just as we have seen with the recent approvals and changes in guidelines, these changes do impact clinical operations. These new medications will come at both a financial and operational cost, but the long-term benefits to patients and the health care system will outweigh the initial investment.
About the author
Shannon Holden, PharmD, is a Senior Clinical Manager with the Center for Pharmacy Practice Excellence. Prior to joining the Vizient team, Holden worked for MultiCare developing an ambulatory care pharmacy position in heart failure at the Pulse Heart Institute. However, most her ambulatory pharmacy work was done previously at Providence, expanding their ambulatory pharmacy services to include anemia, diabetes, neurology, gastroenterology and rheumatology. Holden holds a Pharm.D. from Washington State University, School of Pharmacy, and is Board-Certified in Ambulatory Care Pharmacy.