 Treatment Algorithms --
May 2008
 In This Issue...
Introduction:
Dyslipidemia is a highly prevalent condition offering
significant commercial potential to drug developers garnering even a small patient
share percentage of the treatable population. Statins dominate this market and
were the leading low-density lipoprotein (LDL) cholesterol modifiers in the United States in 2007. Pfizer’s Lipitor (atorvastatin) drives much of the sales in this
class; however, the genericization of Merck’s Zocor (simvastatin) in 2006 has
resulted in a steady stream of patients moving toward this lower-priced,
moderately effective statin. In addition, physicians have increasingly been
turning to agents from other antidyslipidemic drug classes over the past few
years, primarily Merck’s cholesterol absorption inhibitor Zetia (ezetimibe)
because of its benign side-effect/safety profile as well as the fixed-dose
combination (FDC) of simvastatin and ezetimibe (Vytorin), from Merck. Several new
FDCs and novel agents targeting various lipid subfractions are currently in
development, including a combination of AstraZeneca’s Crestor (rosuvastatin) and
Abbott’s ABT-335 (TriLipix; the follow-on agent to Abbott's fenofibrate [Tricor]),
and have the potential to launch within our 2008-2010 forecast window. Although
statins will continue to dominate the U.S. market, we believe that novel
therapies will garner considerable patient share both from statins and
traditional statin adjuncts (e.g., niacin derivatives, fibric acid derivatives)
due to these agents’ issues with safety, tolerability, and/or efficacy.
Questions Answered in This Report:
- Lines of therapy: Lowering LDL cholesterol is the main
goal delineated by the National Cholesterol Education Program Expert Panel on
Detection, Evaluation, and Treatment of High Blood Cholesterol in Adults (Adult
Treatment Panel III) (NCEP ATP III) treatment guidelines. Because of their
proven ability to aggressively lower LDL, statins are prescribed to the
majority of drug-treated patients. Within the statin class, individual drugs
are differentiated mainly by potency and price. What percentages of early-line
patient share are devoted to each statin and statin-containing FDC? How much has
the availability of generic simvastatin forced redistribution of first-line statin
patient share? What trends have been seen in first-line use of the relatively
new agents Zetia and Vytorin over the past year?
- Pathways to key therapies: 86% of newly treated patients
receive statin monotherapies and statin-containing FDCs as first-line therapy. Of
these agents, simvastatin has seen significantly increased patient share since
its genericization in 2006, though physicians must often turn to more potent
statins such as Crestor or combination therapy (adding Zetia or switching to
Vytorin) for refractory patients. What are the common pathways to more
potent statins and statin-containing combinations? How long does it take for
patients to switch over? Has the launch of generic simvastatin triggered
changes in the movement of patients to it from other statins?
- Physician behavior: Although surveyed primary care
physicians (PCPs) report that the majority (60%) of their dyslipidemia patients
are targets for primary prevention strategies, surveyed cardiologists report
that the majority of their patient pool (66%) comprises high-risk patients who
require more aggressive treatment strategies or secondary prevention. Do
PCPs and cardiologists differ in the percentage of newly diagnosed dyslipidemia
patients to whom they prescribe nonpharmacological regimens versus drug
therapy? Are specific subpopulations of patients more likely to be treated with
only nonpharmacological interventions? Do the reasons why physicians select one
statin over another differ significantly between cardiologists and PCPs? Are
there notable differences in the percentages of cardiologists and PCPs who
report that they are changing their prescribing of Zetia and/or Vytorin in the
wake of the release of Ezetimibe and Simvastatin in Hypercholesterolemia
Enhances Atherosclerosis Regression (ENHANCE) trial results?
- Forecast: Reductions in the average daily cost of statins
(due to generic uptake) will only be partially offset by price increases
related to the use of high statin dosages, more potent branded statins, FDCs,
or polypharmacy to meet increasingly aggressive LDL goals. Will the
emergence of novel FDCs change statins’ first-line patient share? What place
will emerging treatments such as Abbott’s Simcor (Niaspan/simvastatin) or
Merck’s Cordaptive (extended-release niacin/laropiprant) and MK-0524B (Cordaptive/simvastatin)
have within the dyslipidemia treatment algorithm, and will they hold
significant commercial potential? Will cardiologists and PCPs differ in their acceptance
of novel FDCs? Will physicians replace the use of current fibrate therapies
with any emerging treatment focused on reducing triglyceride (TG) levels?
Includes:
Primary research: Quantitative results from our
survey of 152 physicians (75 cardiologists and 77 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 55 million lives from more than 80
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,
simvastatin, lovastatin, pravastatin, Crestor, Lescol, Zetia, Vytorin, Caduet,
Advicor, fenofibrate, gemfibrozil, Niaspan, Welchol, cholestyramine, cholestyramine
light, and colestid.
- Flowcharts tracking the preceding therapy patterns for patients
taking each of the following key therapies: Lipitor, simvastatin, lovastatin,
pravastatin, Crestor, Lescol, Zetia, Vytorin, Caduet, Advicor, fenofibrate,
Niaspan, and Welchol.
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