Treatment Algorithms

August 2009

Treatment Algorithms in Dyslipidemia

Report Authors
Amanda Puffer, M.Sc.
Madhuri Borde, Ph.D.

Introduction:

Treatment for dyslipidemia is focused on the use of HMG-CoA reductase inhibitors (statins) to limit the synthesis of cholesterol and increase the clearance of low-density lipoprotein cholesterol (LDL-C) to reduce the risk of cardiovascular disease. Our analysis of newly diagnosed patients shows that Pfizer’s Lipitor (atorvastatin) and simvastatin lead all agents in patient share in the first three lines of treatment, while AstraZeneca’s Crestor (rosuvastatin) continues to gain ground following initial safety concerns at its launch in 2002. Adjunctive agents remain an important component of treatment for those patients who are not able to reach lower LDL-C targets or who have additional lipid abnormalities (i.e., low high-density lipoprotein cholesterol [HDL-C], elevated triglycerides). Until January 2008, Merck & Co./Schering-Plough’s Zetia was the preeminent adjunct therapy in early-line usage owing to its combination of synergistic efficacy with statins and good tolerability in lowering LDL-C. However, Zetia’s momentum has been halted following the publication of the ENHANCE trial, which called into question the efficacy of the agent in preventing clinical events. Our analysis integrates patient-level claims data and insight from 162 surveyed U.S. cardiologists and PCPs to determine how concerns over Zetia and Merck & Co./Schering-Plough’s Zetia/simvastatin FDC (Vytorin) have changed the dyslipidemia market through in-depth comparisons with our 2008 data. This report determines the share of each currently marketed drug by line of therapy, analyzes why key drugs are chosen over others, which agents have benefited from the ENHANCE trial fallout, and explains how physicians predict their behaviors and prescribing habits will change over the next two years with the recent launches of Abbott’s Simcor and Abbott/Solvay’s TriLipix and the impending launches of Abbott/AstraZeneca’s Crestor/TriLipix FDC and Kowa’s Livalo.

Questions Answered in This Report:

  *   Simvastatin has overtaken Lipitor as the single agent with the greatest patient share in newly diagnosed patients. What is the treatment initiation rate for newly diagnosed dyslipidemia patients, and what are the major barriers to initiating treatment? What are the retention rates for early-line treatments, including differences between Lipitor and simvastatin? When do physicians turn to adjuncts, and how does the early-line patient share for Zetia compare with Abbott’s Tricor and other fibrates? How has this share changed since the publication of ENHANCE?

  *   Pathways to key therapies: Longitudinal claims data reveal which agents of a given class are placed ahead of other agents in lines of therapy. How are Crestor and Lipitor positioned relative to each other in lines of therapy? When do physicians turn to fibrates, and what could limit the uptake of TriLipix in the dyslipidemia market? What drugs precede the use of Niaspan, and what does this say about how physicians use this agent?

  *   Physician behavior: Dyslipidemia patients are treated by both cardiologists and PCPs; the reasons physicians give for changing treatment from a given agent differ between the two types of treating physicians. What factors influence each specialty when making drug choices? What attributes are most critical in differentiating between Tricor and TriLipix, and between Tricor and Niaspan? What do surveyed cardiologists versus PCPs view as the differential advantages of Lipitor, Crestor, and simvastatin? What are physicians most likely to do upon failure of the leading statins (i.e., how many switch to a different agent before increasing the dose or adding an adjunct)?

  *   Forecast: Many surveyed physicians say they will increasingly strive for aggressive LDL-C targets and increase their use of agents to target HDL-C and triglycerides in second-line therapy. For which drug classes do physicians anticipate writing more prescriptions over the next two years? How do the anticipated changes of cardiologists differ from PCPs? Will ENHANCE continue to change prescribing habits over the next two years? What impact will the patent expirations of Lipitor and Tricor have on the dyslipidemia market? Will Kowa’s statin Livalo see significant uptake? How many physicians are anticipating prescribing Abbott/AstraZeneca’s Crestor/TriLipix FDC versus Kowa’s emerging statin Livalo?

Scope:

Primary research: Quantitative results from our survey of 162 physicians (80 cardiologists and 82 PCPs):

- Physician opinion on how drug use differs by patient severity.

- Most influential drug attributes when physicians choose between agents.

- Anticipated changes in the line of therapy in which physicians use key agents.

Primary patient-level data: Quantitative findings from our analysis of data covering 61 million lives from 98 geographically diverse U.S. health plans:

- Quantified lines of therapy analysis showing exact share of each agent in each line of therapy, including rate of progression between lines and length of time patients are on each line.

- Progression flowcharts through one year of treatment for newly diagnosed patients receiving each of the following first-line agents: Lipitor, Crestor, simvastatin, Novartis’s Lescol, lovastatin, pravastatin, Zetia, Abbott’s Tricor, Abbott’s Niaspan, Daiichi Sanko’s Welchol, Pfizer’s Colestid, Vytorin, Pfizer’s Caduet, Abbott’s Advicor, gemfibrozil, generic fenofibrate, other fenofibrate brands, cholestyramine, cholestryamine light.

- Flowcharts tracking the preceding therapy patterns for patients taking each of the following key therapies: Lipitor, Crestor, simvastatin, Lescol, lovastatin, pravastatin, Zetia, Tricor, Niaspan, Welchol, GlaxoSmithKline’s Lovaza, Vytorin, Caduet, Simcor.

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