What factors matter to patients and healthcare providers when deciding on PCSK9i therapy?

Both very high–risk patients and healthcare professionals prioritized efficacy when deciding to start PCSK9 inhibitors as add-on treatment, according to Dutch online surveys. However, they had different views on the need for shared decision-making.

This summary is based on the publication of Mulder JWCM, Galema-Boers AMH, Kranenburg LW, et al. - PCSK9 inhibitor experiences and preferences of patients and healthcare professionals in decision-making: A mixed methods study. Atherosclerosis. 2024 Dec 20;401:119101 [Online ahead of print]. doi: 10.1016/j.atherosclerosis.2024.119101

Introduction and methods

Background

Clinical guidelines on CVD prevention emphasize the importance of shared decision-making in clinical practice [1,2]. With the availability of more options for lipid-lowering therapy (LLT), such as PCSK9 inhibitors, it is essential for patients and their physicians to agree on the treatment plan. Although the perspectives and preferences of patients and healthcare professionals regarding the use of statin therapy have been studied [3-5], this is not the case for the initiation and use of PCSK9 inhibitors [6].

Aim of the study

The authors investigated the preferences and experiences among patients and healthcare providers with regard to the initiation and use of PCSK9 inhibitors as add-on LLT.

Methods

In a mixed-methods study with an exploratory sequential design, 25 consecutive patients from the Lipid Clinic of the Erasmus Medical Center in Rotterdam, the Netherlands who were considered to be at very high risk (i.e., they had ASCVD, LDL-c >1.8 mmol/L despite optimal oral LLT, and ASCVD risk factor such as T2D or current smoking) and who qualified for PCSK9 inhibitor reimbursement were interviewed about their experiences with and preferences for PCSK9 inhibitors. Subsequently, an anonymous online survey on patient experiences was disseminated via email to 284 patients treated at this clinic who were prescribed a PCSK9 inhibitor, of whom 170 completed the survey (response rate: 60%). In addition, 59 healthcare professionals providing CVD risk management care filled in an online survey about their PCSK9 inhibitor prescription preferences and perceived patient preferences.

Main results

Patients

• During the interviews, most patients (n=18; 72%) indicated efficacy was the most important factor in the decision to start add-on LLT, followed by side effects (n=4; 16%) and ease of use (n=3; 12%).

• When asked who should decide to start add-on LLT, 18 interviewees (72%) preferred shared decision-making, whereas 6 (24%) pointed to the healthcare professional and 1 (4%) said they wanted to make the decision themselves.

• The online survey showed 141 patients (83%) thought efficacy was the most important attribute in deciding on initiation of add-on LLT, followed by side effects (n=24; 14%) and ease of use (n=5; 3%).

• Almost all patients who filled in the online survey (n=153; 90%) favored shared decision-making in the decision to initiate PCSK9 inhibitor therapy, compared with 10 (6%) preferring the healthcare professional making the decision and 7 (4%) choosing the patient.

Healthcare professionals

• Of the healthcare professionals, 54 (92%) considered efficacy to be the most important factor in the decision to initiate add-on LLT and 5 (8%) believed this to be side effects. None of them valued ease of use.

• With regard to their patients’ preferences, 28 healthcare professionals (47%) expected patients to prioritize safety (side effects), followed by efficacy (n=25; 42%) and ease of use (n=6; 10%).

• For 16 healthcare professionals (27%), patient preferences were pivotal for the type of PCSK9 inhibitor they would prescribe. However, most (59%) preferred an anti-PCSK9 monoclonal antibody (evolocumab or alirocumab), 3% favored a PCSK9 siRNA (inclisiran), and 8% had no specific preference.

• Several healthcare professionals said patient characteristics influenced their prescription preferences. Most chose a monoclonal antibody for patients with statin intolerance or familial hypercholesterolemia, whereas needle phobia, nonadherence, and limited health literacy were reasons to opt for an siRNA.

Conclusion

In this mixed-methods study on the initiation and use of PCSK9 inhibitors as add-on LLT, efficacy was the most important aspect for both patients and healthcare professionals in the decision to initiate this add-on treatment. Almost all patients (90%) preferred shared decision-making regarding the initiation of PCSK9 inhibitor therapy. However, only 27 % of the healthcare professionals considered patient preferences when choosing the type of PCSK9 inhibitor. They did indicate that specific patient characteristics could affect this choice, such as statin intolerance or needle phobia. “To facilitate shared decision-making, future research should investigate the development and impact of a decision aid for patients,” according to the authors.

Find this article online at Atherosclerosis

References

1. F.L.J. Visseren, F. Mach, Y.M. Smulders, et al., ESC Guidelines on cardiovascular disease prevention in clinical practice: developed by the Task Force for cardiovascular disease prevention in clinical practice with representatives of the European Society of Cardiology and 12 medical societies with the special contribution of the European Association of Preventive Cardiology (EAPC), Eur. Heart J. 42 (2021) 3227–3337.
2. D.K. Arnett, R.S. Blumenthal, M.A. Albert, et al., ACC/AHA guideline on the primary prevention of cardiovascular disease, J. Am. Coll. Cardiol. 74 (2019) e177–e232.
3. S.T. Ahmed, J.M. Akeroyd, D. Mahtta, et al., Shared decisions: a qualitative study on clinician and patient perspectives on statin therapy and statin-associated side effects, J. Am. Heart Assoc. 9 (2020) e017915.
4. K.D. Valentine, S. Brodney, K. Sepucha, M.J. Barry, Predictors of informed people’s preferences for statin therapy to reduce cardiovascular disease risk: an internet survey study, J. Gen. Intern. Med. 38 (2023) 36–41.
5. S. Brodney, K.D. Valentine, K. Sepucha, et al., Patient preference distribution for use of statin therapy, JAMA Netw. Open 4 (2021) e210661.
6. Q. Hao, B. Aertgeerts, G. Guyatt, et al., PCSK9 inhibitors and ezetimibe for the reduction of cardiovascular events: a clinical practice guideline with risk-stratified recommendations, BMJ 377 (2022) e069066.