Should PCSK9 inhibitors (PCSK9i) be classified as statin medications that are used in clinical measure calculation, given their shared ability to reduce LDL cholesterol levels?

Frequently Asked Questions (FAQ):

Q: Should PCSK9 inhibitors (PCSK9i) be classified as statin medications that are used in clinical measure calculation, given their shared ability to reduce LDL cholesterol levels?

A: Firstly, MNCM strives to align with applicable, similar measures in national programs and the specifications provided by measure stewards whenever possible. This alignment enhances cooperation with regional and national performance measurement and benchmarking initiatives. It's crucial to note that MNCM measures are designed for retrospective population-level analysis and are not intended to guide individual patient care decisions.

Secondly, from a clinical standpoint, although PCSK9 inhibitors effectively lower LDL levels, they are not recommended as solo first-line agents by ADA or ACA/AHA guidelines.

According to ADA (2023), individuals with diabetes and established atherosclerotic cardiovascular disease should initially undergo high-intensity statin therapy to achieve an LDL cholesterol reduction of ≥50% from baseline, with an LDL cholesterol goal of <55 mg/dL. If this goal is not met on maximum tolerated statin therapy, the addition of ezetimibe or a PCSK9 inhibitor is recommended.

The ACA/AHA (2018) suggests that in very high-risk ASCVD patients, adding ezetimibe to maximally tolerated statin therapy is reasonable when the LDL-C level remains ≥70 mg/dL (≥1.8 mmol/L). For patients at very high risk not achieving the LDL-C goal on maximally tolerated statin and ezetimibe therapy, adding a PCSK9 inhibitor is considered reasonable.

Both guidelines emphasize the addition of PCSK9 inhibitors to maximally tolerated statin therapy. It's important to highlight that patients who are intolerant to statins are excluded from the measure. If a patient, despite using statins, does not achieve adequate control and a PCSK9 inhibitor is added in combination, this will not impact their scoring within the measure.

We will continue to monitor clinical practice guidelines, evidence, and stakeholder feedback to consider potential future updates. Any future revisions to these measures will prompt MNCM to align specifications accordingly.