Updated Cost-effectiveness Analysis of PCSK9 Inhibitors Based on the Results of the FOURIER Trial

Kazi, Dhruv S.; Penko, Joanne; Coxson, Pamela G.; Moran, Andrew E.; Ollendorf, Daniel A.; Tice, Jeffrey A.; Bibbins‐Domingo, Kirsten

doi:10.1001/jama.2017.9924

Cited by 137 publications

(179 citation statements)

References 2 publications

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“…24,25 In addition, some states have passed legislation requiring standardized PA forms across drug classes, which may also influence PA policies for PCSK9is in the future. Further research is needed to understand how PA requirements impact prescribing and initiation of PCSK9is and how this affects cardiovascular outcomes in this patient population.…”

Section: Discussionmentioning

confidence: 99%

Prior Authorization Requirements for Proprotein Convertase Subtilisin/Kexin Type 9 Inhibitors Across US Private and Public Payers

Doshi

Puckett

Parmacek

et al. 2018

Circ: Cardiovascular Quality and Outcomes

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BACKGROUND:Proprotein convertase subtilisin/kexin type 9 inhibitors (PCSK9is) are an innovative treatment option for patients with familial hypercholesterolemia or clinical atherosclerotic cardiovascular disease who require further lowering of low-density lipoprotein cholesterol. However, the high costs of these agents have spurred payers to implement utilization management policies to ensure appropriate use. We examined prior authorization (PA) requirements for PCSK9is across private and public US payers. METHODS AND RESULTS:We conducted an analysis of 2016 formulary coverage and PA data from a large, proprietary database with information on policies governing >95% of Americans with prescription drug coverage (275.3 million lives) within 3872 plans across the 4 major insurance segments (commercial, health insurance exchange, Medicare, and Medicaid). The key measures included administrative PA criteria (prescriber specialty, number of criteria in PA policy or number of fields on PA form, requirements for medical record submission, reauthorization requirements) and clinical/diagnostic PA criteria (approved conditions, required laboratories or other tests, required concomitant therapy, step therapy requirements, continuation criteria) for each of 2 Food and Drug Administration-approved PCSK9is. Select measures (eg, number of PA criteria/fields, medical record submission requirements) were obtained for 2 comparator cardiometabolic drugs (ezetimibe and liraglutide). Between 82% and 97% of individuals were enrolled in plans implementing PA for PCSK9is (depending on insurance segment), and one third to two thirds of these enrollees faced PAs restricting PCSK9i prescribing to a specialist. For patients with familial hypercholesterolemia, diagnostic confirmation via genetic testing or meeting minimum clinical scores/criteria was also required. PA requirements were more extensive for PCSK9is as compared with the other cardiometabolic drugs (ie, contained 3×-11× the number of PA criteria or fields on PA forms and more frequently involved the submission of medical records as supporting documentation). CONCLUSIONS:PA requirements for PCSK9is are greater than for selected other drugs within the cardiometabolic disease area, raising concerns about whether payer policies to discourage inappropriate use may also be restricting access to these drugs in patients who need them.

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Section: Discussionmentioning

confidence: 99%

Prior Authorization Requirements for Proprotein Convertase Subtilisin/Kexin Type 9 Inhibitors Across US Private and Public Payers

Doshi

Puckett

Parmacek

et al. 2018

Circ: Cardiovascular Quality and Outcomes

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“…This statin analysis was based on a lower-potency statin that was still patented; hence, a similar analysis performed today with high-potency generic statins would give even more favourable results. In a similar analysis involving the subsequent addition of ezetimibe to a statin, Kazi and colleagues 19 estimated a cost of US$199 000 per quality-adjusted life-year (QALY) compared to a statin alone. These results underscore the challenges associated with identifying cost-effective lipid therapies when compared with the low cost and demonstrated effectiveness of statins.…”

Section: Discussionmentioning

confidence: 99%

“…Arrieta and colleagues 20 published an updated model estimating a cost of US$337 729 per QALY and requiring a discount to $5459 per year to reach US$100 000 per QALY. Similarly, Kazi and colleagues 19 updated earlier estimates to US$339 000 per QALY, requiring a discount to US$4215 to achieve US$100 000 per QALY when comparing to the addition of ezetimibe. Importantly, those authors also confirmed that the estimated cost per life-year saved was lower than the cost per QALY.…”

Section: Discussionmentioning

confidence: 99%

Evaluation of the cost-effectiveness of evolocumab in the FOURIER study: a Canadian analysis

Lee

Kaouache

Grover

2018

cmajo

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“…More recently, results from the ODYSSEY cardiovascular outcome trial (CVOT) support these findings, demonstrating a 3.4% absolute risk reduction in MACE in patients treated with PCSK-9 antibody to mean LDL of53.3 mg/dl, compared with LDL of 101.4 mg/dl in the placebo group [17]. Given their high cost and difficult insurance approval process [18], PCSK-9 antibody use is currently limited to patients with heterozygous familial hypercholesterolemia who are statin intolerant, or who have clinical ASCVD requiring additional lowering of LDL. One interesting PCSK9 inhibitor effect that needs further investigation, and could broaden its role in dyslipidemia management, is its ability to lower Lp(a); the degree in lowering may vary from patient to patient [19].…”

Section: Combination Therapiesmentioning

confidence: 99%

Towards more specific treatment for diabetic dyslipidemia

Rodríguez

Newman

Schwartzbard

2018

Current Opinion in Lipidology

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Purpose of review Treatment of diabetic dyslipidemia is necessary because of its impact on cardiovascular disease, which is the leading cause of death in patients with diabetes. In the past, standard treatment of diabetic dyslipidemia focused only on correcting lipids. Although this remains the mainstay of treatment, because new antihyperglycemic treatments reduce cardiovascular events with minimal effect on dyslipidemia, a new approach is both timely and relevant. Recent findings LDL-lowering remains the focus of treatment for diabetic dyslipidemia, especially in patients with both diabetes and cardiovascular disease (CVD). Higher intensity statin therapy or lower LDL cholesterol goals are recommended in these patients. Combination therapy, especially with ezetimibe, fibrates, bile acid sequestrants, PCSK9 inhibitors and omega 3 fatty acids should be considered along with selected new agents to reduce glycemia. Summary As diabetic dyslipidemia plays a key role in CVD, aggressive treatment is indicated. New research targets include apo-CIII and lipoprotein(a) [Lp(a)]. In addition, new antihyperglycemic therapy is changing diabetes care and altering treatment guidelines. The most recent American Diabetes Association Standards of Care has expanded its recommendations for people with CVD and diabetes, suggesting that medications validated to improve cardiac health should be strongly considered.

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Updated Cost-effectiveness Analysis of PCSK9 Inhibitors Based on the Results of the FOURIER Trial

Cited by 137 publications

References 2 publications

Prior Authorization Requirements for Proprotein Convertase Subtilisin/Kexin Type 9 Inhibitors Across US Private and Public Payers

Prior Authorization Requirements for Proprotein Convertase Subtilisin/Kexin Type 9 Inhibitors Across US Private and Public Payers

Evaluation of the cost-effectiveness of evolocumab in the FOURIER study: a Canadian analysis

Towards more specific treatment for diabetic dyslipidemia

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