title: Cholesterol-lowering drugs: science and marketing.
abstract: Long-term use of statin therapy is essential to obtain clinical benefits, but adherence is often suboptimal and some patients are also reported to fail because of 'statin resistance'. The identification of PCSK9 as a key factor in the LDL clearance pathway has led to the development of new monoclonal antibodies. Here we critically review the economic evaluations published in Europe and focused on statins. We searched the PubMed database to select the studies published from July 2006 to June 2016 and finally selected 19 articles. Overall, the majority of studies were conducted from a third-party payer's viewpoint and recurred to modelling. Most studies were sponsored by industry and funding seemed to play a pivotal role in the study design. Patients resistant to LDL-C level reduction were considered only in a few studies. The place in therapy of the new class of biologic should be considered a kind of 'third line' for cholesterol-lowering, after patients have failed with restricted dietary regimens and then with current drug therapies. Otherwise they could result in hardly sustainable expenses even for developed countries.
authors.affiliation: CESAV, Centre for Health Economics, IRCCS Institute for Pharmacological Research 'Mario Negri', 24020 Ranica, Italy.
authors.forename: Livio
authors.initials: L
authors.lastname: Garattini
authors.affiliation: CESAV, Centre for Health Economics, IRCCS Institute for Pharmacological Research 'Mario Negri', 24020 Ranica, Italy.
authors.forename: Anna
authors.initials: A
authors.lastname: Padula
mesh_terms: D000911:Antibodies, Monoclonal / Q000191:economics* / Q000494:pharmacology / Q000627:therapeutic use; D000924:Anticholesteremic Agents / Q000191:economics* / Q000494:pharmacology / Q000627:therapeutic use; D002318:Cardiovascular Diseases / Q000188:drug therapy / Q000191:economics*; D008078:Cholesterol, LDL / Q000097:blood*; D016527:Drug Costs; D004351:Drug Resistance / Q000187:drug effects*; D005060:Europe; D006801:Humans; D018579:Patient Selection; D000071449:Proprotein Convertase 9 / Q000097:blood*
chemical_list: D000911:Antibodies, Monoclonal; D000924:Anticholesteremic Agents; D008078:Cholesterol, LDL; C472125:PCSK9 protein, human; D000071449:Proprotein Convertase 9
keywords: cardiovascular medicine; drugs; health economics; health policy