Opinion
Video
Deciding Between Novel, Nonstatin Therapies
Author(s):
Panelists discuss how medical professionals consider PCSK9 inhibitors, bempedoic acid, and inclisiran in various clinical scenarios, their experiences with these newer therapies, the implications of the INCEPTION trial for treating patients with high-risk cardiovascular disease—particularly those who are statin-intolerant—the urgency of postcoronary event treatment, and emerging data on the broader impact of low-density lipoprotein cholesterol (LDL-C)–lowering therapies on quality of life.
Summary for Physicians: Challenges and Strategies for Nonstatin Lipid Therapies in Patients With Post-Cardiovascular Disease
Key Challenges in Implementing Nonstatin Therapies
- Cost barriers: Both actual and perceived cost concerns for patients
- Administrative burden: Navigating prior authorizations and appeals processes
- Time constraints: Limited appointment duration (15-20 minutes) restricts in-depth discussions about treatment options
- Patient follow-up issues: Some patients don't report medication access problems.
Practical Solutions and Strategies
- Utilize EMR tools: Implement cost analysis software embedded within electronic medical record (EMR) systems to preview medication costs
- Leverage support staff:
- Clinical pharmacists for detailed patient education and consultations
- Pharmacy technicians for insurance navigation (described as "underutilized resources")
- Midlevel providers for extended patient education sessions
- Care team members for patients needing additional support or with lower health literacy
Treatment Selection Approach
- Multipronged methodology based on:
- Patient preferences (particularly regarding oral vs injectable options)
- Required LDL level reduction percentage to reach target goals
- Recommended sequence based on LDL level lowering needs:
- 15% to 25% reduction: ezetimibe (oral, well tolerated, inexpensive)
- 40% to 50% or greater reduction: PCSK9-targeting therapies (eg, monoclonal antibodies or inclisiran)
- Bempedoic acid: Reserved for patients who are intolerant to other therapies or need an approximately 20% additional reduction
- Special considerations:
- Insurance coverage (e.g., Medicare patients may have better coverage for certain options)
- Patient adherence challenges
- Patients with elevated Lp(a) levels may benefit more from PCSK9 inhibitors (with a 20% to 25% Lp[a] lowering effect)
Emerging Trends
- Earlier implementation of intensive lipid-lowering therapies in post-acute phase
- Meds to beds programs that deliver medications before hospital discharge
- Focus on quality-of-life outcomes beyond major adverse cardiovascular event prevention
- Recognition of the "lower for longer is best" adage regarding LDL control
Future Developments
- Upcoming VICTORIAN-INCEPTION trial investigating inclisiran in ACS patients with target LDL level of 70 mg/dL
- Building on VICTORIAN-INITIATE data showing 82% target achievement with inclisiran vs 22% with standard care
