Background New lipid-lowering therapies with excellent results on LDL cholesterol (LDL-C) levels came to market at more than five times the cost of the most effective statin regimen. We need strategies to put these treatments into practice and ensure their cost effectiveness.
Purpose In December 2016 the regional autonomic pharmacy and therapeutic committee published the authorisation criteria for the treatment with proprotein convertase subtilisin/kexin type 9 (PCSK9) inhibitors. Here we review our initial clinical experience with the use of these therapies.
Material and methods Descriptive study. Drug utilisation review of PCSK9-inhibitors in a secondary level hospital from December 2016 to September 2017. Demographics, prescription data and the authorisation process were assessed. In patients who began treatment, their effectiveness and tolerance were evaluated. Electronic medical records, prescription program and authorisation request files were used as data sources.
Results Twenty-five requests for authorisation of PCSK9-inhibitors were received. Median age 64 years (43–77), 37% female. Prescriber: cardiology 13, internal medicine 14. Three cases of familial hypercholesterolaemia, the others had atherosclerotic cardiovascular disease with the need for additional LDL-C lowering. Statin intolerance was claimed in 67%.
Forty per cent of treatments were initially denied, due to lack of supporting documentation: an adequate trial of statin therapy one, adherence to statin therapy two and statin intolerance one. One patient was denied, awaiting another medical issue to be resolved first. Two requests were reassessed and approved after additional documentation was provided.
Seventeen treatments were finally authorised, 13 have been initiated. LDL levels ranging from 115 to 309 mg/dL. Adherence was 100%, and no medication-related problems were observed. Twelve were assessed for effectiveness within the first 3 months of treatment: 32.9% to 74.2% decrease in LDL values.
Outpatient pharmacists intervened on three occasions, reminding the prescriber about the need for a follow-up.
Conclusion Our small series confirms the effectiveness and good tolerance of treatment with PCSK9-inhibitors.
Given the high cost of these treatments, patient selection and their routine follow-up are crucial. The pharmacist, as the professional who most frequently sees these patients, is in an ideal position to ensure compliance with follow-up recommendations and to assess the adherence, effectiveness and safety of these new treatments.
No conflict of interest
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