Dyslipidemia and PCSK9 inhibitors – practical focused update of indication and reimbursement criteria
Authors:
Vladimír Soška
Authors‘ workplace:
Oddělení klinické biochemie, Fakultní nemocnice u sv. Anny v Brně
Published in:
Vnitř Lék 2022; 68(3): 191-194
Category:
In Brief
Overview
PCSK9 inhibitors are modern and effective hypolipidemic drugs for lowering LDL-cholesterol, which belong to the „biological therapy“. Their prescription is limited to specialized centers and to the fulfillment of other conditions set by SÚKL. This article lists the current valid criteria under which they can be indicated for reimbursement from public health insurance, and comments conditions and limitations in terms of the possibility of their fulfillment in clinical practice.
Keywords:
cardiovascular diseases – familial hypercholesterolemia – PCSK9-inhibitors – LDL‑ cholesterol
Sources
1. Protocol for a prospective collaborative overview of all current and planned randomized trials of cholesterol treatment regimens. Cholesterol Treatment Trialists‘ (CTT) Collaboration. Am J Cardiol. 1995;75:1130-1134.
2. Visseren FLJ, Mach F, Smulders YM et al. 2021 ESC Guidelines on cardiovascular disease prevention in clinical practice. Eur Heart J. 2021;42:3227-3337.
3. Ceska R, Taborsky M, Vrablik M. Consensus statement of professional associations on prescribing of PCSK9-inhibitors. Vnitr Lek.64:1131-1136.
4. Ling H, Burns TL, Hilleman DE. An update on the clinical development of proprotein convertase subtilisin kexin 9 inhibitors, novel therapeutic agents for lowering low‑density lipoprotein cholesterol. Cardiovasc Ther. 2014;32:82-88.
5. Navarese EP, Kolodziejczak M, Schulze V et al. Effects of Proprotein Convertase Subtilisin/ Kexin Type 9 Antibodies in Adults With Hypercholesterolemia: A Systematic Review and Meta‑analysis. Ann Intern Med. 2015;163:40-51.
6. Schwartz GG, Bessac L, Berdan LG et al. Effect of alirocumab, a monoclonal antibody to PCSK9, on long‑ term cardiovascular outcomes following acute coronary syndromes: rationale and design of the ODYSSEY outcomes trial. Am Heart J. 2014;168:682-689.
7. Sabatine MS, Giugliano RP, Keech AC et al. Evolocumab and Clinical Outcomes in Patients with Cardiovascular Disease. N Engl J Med. 2017; 376:1713-1722.
8. Praluent. https://www.sukl.cz Rozhodnutí F‑CAU- 003-02R/31. 8. 2018, 20. 08. 2020.
9. Repatha. https://www.sukl.cz/ Rozhodnutí F‑CAU- 003-02R/31. 8. 2018, 7. 1. 2021.
10. SÚKL. Rozhodnutí o změně podmínek úhrady léčivého přípravku Repatha 140MG INJ SOL 2x1ML, správní řízení sp. zn. SUKLS29290/2019, č. jedln. sukl4530/2021 ze dne 7. 1. 2021.
11. SÚKL. Rozhodnutí o změně podmínek úhrady léčivého přípravku Praluent 75 mg, F‑CAU- 003-02R/31. 08. 2018, Sp. zn. SUKLS85942/2019, č. jedn. sukl209748/2020, ze dne 20. 8. 2020
Labels
Diabetology Endocrinology Internal medicineArticle was published in
Internal Medicine
2022 Issue 3
Most read in this issue
- Differential diagnosis of chronic lower limb edema
- Hypertension and dyslipidemia treament in stroke
- Use of telemedicine in patients with heart failure
- Beta‑blockers after myocardial infarction and chronic coronary heart disease