Barriers to New Medications for Cardiovascular Disease: Insights from CardioSurve

Over the last decade, three new classes of drugs have joined the armamentarium for cardiologists to treat cardiovascular disease. The angiotensin receptor/neprilysin inhibitors (ARNIs), non–vitamin K antagonist oral anticoagulants (NOACs), and PCSK9 inhibitors are now evidence-based, guideline-directed medical therapy (GDMT). Yet, CardioSurve results support what many cardiologists feel during their daily clinical practice: persistent challenges and barriers to providing these therapies for their patients.

Cardiology

Overall, the survey of 151 FACCs found that most (89 percent) have favorable attitudes towards using the new drugs, and a large proportion had a high degree of familiarity and likelihood to prescribe these classes of drugs. But they are faced with a time-consuming process to obtain payer approval. In fact, the majority (55 percent) indicated it is difficult to gain approval from the payer. Only 6 percent indicated it is relatively easy to obtain access from the health plans and pharmacy benefits managers.

The top two barriers were cost issues (cited by 85 percent) and the requirement for preauthorization and the associated documentation and administrative burden (by 78 percent). Cost issues include the co-payment, co-insurance, and deductibles the patient must bear. Most of the other barriers are related to payer or administrative issues (Figure 1, gallery below).

“Cardiologists really want to do the best for their patients, and there is a lot of frustration when there are these barriers that seem arbitrary that prevent us from providing the best evidence-based care for our patients,” says Sean Pinney, MD, FACC. He notes that the survey responses align with his own experience and thus are reassuring.

"Cardiologists really want to do the best for their patients, and there is a lot of frustration when there are these barriers that seem arbitrary that prevent us from providing the best evidence-based care for our patients." Sean Pinney, MD, FACC

Seth Martin, MD, FACC, also finds that his personal experience is similar with the survey results, noting the top two barriers are very real. At the time the physician prescribes the medication, whether the insurance will pay for it and the financial burden for the patient is unknown. “There are real barriers to access to medications, beyond the patient going through the decision-making process with the physician to try a new drug, he says.” For PCSK9 inhibitors, the decision by the patient to try a new drug, and one that is an injectable, is the least of the barriers to optimal therapy, he says. And he notes the patients are often on an emotional rollercoaster during the approval process.

More than three of four cardiologists (77 percent) feel there is less time spent on patient care by the practice, clinician, or staff because of the time required for medical documentation and the prior authorization process. And nearly two of three (62 percent) also feel that patient confusion and treatment interruption occurs.

“The time for education and disease management, and even fully discussing the benefits and risks of the drug with the patient are sacrificed,” says Pinney, because of the time required to deal with insurance issues.

Formulary restrictions set by the insurance companies are thought by most cardiologists (71 percent) to lead to disparities in care related to income, elderly age, and underserved, diverse populations. Further, 64 percent think the formulary restrictions lead to patient confusion and a lack of understanding (Figure 2, gallery below).

In relation to actual treatment, 51 percent think these restrictions lead to increased discontinuation of medication and 46 percent that they reduce patient adherence and persistency to medications. Worse patient outcomes are thought to be a result of the formulary restrictions by 41 percent.

The process for insurance and formulary documentation consumes more than 8 hours a week in the practice of 16 percent of the cardiologists who responded, 1-2 hours for 24 percent and 3-4 hours a week for 17 percent. Nearly half said they do not have sufficient resources to properly manage this process.

The level of familiarity with the class of drugs was highest for NOACS, with 95 percent reporting being very or extremely familiar, and this was 69 percent and 65 percent for ARNIs and PCSK9 inhibitors. If there were no delays or denials, 74 percent indicated they would be more likely to prescribe a NOAC, and this was 83 percent for ARNIs and 81 percent for PCSK9 inhibitors.

Of the three new therapies, a delay in obtaining approval or receiving a denial was more likely for a PCSK9 inhibitor and this was the drug for which the cardiologist was most likely to appeal the decision. Of the cardiologists familiar with PCSK9 inhibitors, 64 percent often or always experience delays or denials, and this was 51 percent for ARNIs and 44 percent for NOACs.

The top two reasons cited for the delay or denial is the preauthorization process and documentation burden or the drug not being on formulary, although the rates for this varied somewhat between the classes of drugs (Table). The most common action when a patient is denied is to appeal or to prescribe the formulary-approved medication, although the rates of this also varied somewhat between the new therapies (Table 1, gallery below).

“The effort required to get a patient on a PCSK9 inhibitor is far and above what it is for any commonly used lipid-lowering drug,” Martin says. Working in a large health system, he has the advantage of working with a multidisciplinary team that includes a nurse practitioner and specialty pharmacist who assist with obtaining the initial preauthorization and with denials. Even still, it is an onerous process littered with denials, and he finds himself making phone calls to pharmacy benefit managers and enduring long wait times to help with obtaining approvals. A major frustration is not understanding the reason for the denial, because the established criteria for selecting the patient was followed diligently. “Ultimately, 90 percent of our patients receive approval, but it requires this resource-intensive team-based approach and a lot of persistence.”

Patient safety net programs may be available when the drug is cost prohibitive, because of co-pays and so forth, but this requires an office staff or team who knows the local programs and resources and can help the patient to navigate the process.

For the PCSK9 inhibitors, the lack of clinical outcomes data is cited as a reason for tightly restricting access. The first outcome results will come from the FOURIER trial that will be presented at ACC.17 in March, and Martin is hoping for a positive impact on obtaining approvals thereafter, at least for evolocumab.

The need for an infrastructure to facilitate the payer approval process to provide optimal care for patients was echoed by Geoffrey Barnes, MD, FACC. Like Martin and Pinney, he has support through his health system, and he suggests that cardiologists create their own local support system by engaging local clinical pharmacists to assist with the preauthorization and appeal process.

Barnes also notes concerns about patient confusion when they must go through a multi-day process to obtain preauthorization for a drug, during which they are unsure about what to do for their treatment. Many of his patients have been counseled that they need the NOAC to prevent a stroke, and this wait “creates unnecessary stress and anxiety for patients,” he says.

Unintended harm is another concern raised by Barnes. Most cardiologists must navigate many classes of drugs, and tend to become familiar with one or two of the NOACs, not all five of them. If a payer prefers a NOAC that the cardiologist is less familiar with, there is the potential of harm because of the nuances of dosing, interactions, side effects, and checking renal function. There is the potential to push cardiologists outside their comfort zone, which could raise some alarms.

The potential for increased disparity in providing evidence-based care to all patients because of payer issues was reinforced by Pinney. Sometimes the physician must make a calculation to prescribe a drug that is less expensive, even if it is less effective, if the patient must choose between paying their portion of the drug or food and other necessities. Barnes and Martin echo the concern of patients not taking their medications because of costs and not contacting their office for assistance.

The Role of the ACC

Nearly all (95 percent) of the cardiologists who responded to the survey would like the ACC to play a role in easing the burden of providing medication preauthorization and documentation and overcoming insurance denials. A leadership position for the ACC to help providers and patients to reduce the administrative burden of access to innovative new evidence-based therapies was cited by 75 percent.

The next two most commonly cited roles for the ACC were the development of standardized prior authorization forms by 62 percent and the communication and dissemination of guidelines and expert consensus pathways to better inform guideline-directed care and to satisfy the requirements for prior authorization by 56 percent.

"The physician’s role is to provide the best possible care for each patient, but there is a tension between current best evidence for care at the individual patient level and the concerns at the level of society, health systems, and payers." Seth Martin, MD, FACC

Acknowledging the need for standardization of the forms, Barnes also asks whether the requirement for preauthorization can be eliminated for drugs that are recommended as first-line therapy in the treatment guidelines. And currently there is an uncoordinated process for approvals that not only differs between payers, but differs within payers. Martin points out the frequent confusion about the correct form to be completed, with different staff members within the payer company requiring different forms for the same preauthorization. He even noted a recent case where his office was informed of a denial, while on the same day that patient received a notice of an approval.

Advocacy is one of the greatest strengths of the College. Leadership to address the current lack of transparency, consistency, and order is encouraged by these experts and the survey. Patients should be included in these efforts. “The physician’s role is to provide the best possible care for each patient, but there is a tension between current best evidence for care at the individual patient level and the concerns at the level of society, health systems, and payers,” says Martin.

Clinical Topics: Anticoagulation Management, Dyslipidemia, Heart Failure and Cardiomyopathies, Lipid Metabolism, Novel Agents, Statins, Heart Failure and Cardiac Biomarkers

Keywords: ACC Publications, Cardiology Magazine, Antibodies, Monoclonal, Anticoagulants, Anxiety, Cardiovascular Diseases, Consensus, Cytarabine, Decision Making, Deductibles and Coinsurance, Disease Management, Documentation, Lipids, Neprilysin, Nurse Practitioners, Patient Care Team, Patient Compliance, Patient Safety, Pharmacists, Physician's Role, Receptors, Angiotensin, Risk Assessment, Stroke, Ursidae, ACC Scientific Session Newspaper


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