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Changing Dynamics in the Dyslipidemia Market: The Intrusion of Major Generic Statins

Authors
John S. Ensign, J.D., M.P.H.
PhysicianForum -- May 2006

  In This Issue...

In 2005, sales of HMG-CoA reductase inhibitors (or "statins") generated $12.8 billion in sales. Use of these antidyslipidemic agents is supported by a robust body of clinical research demonstrating their ability to reduce morbidity and mortality. The statin class is dominated by Pfizer’s Lipitor (atorvastatin), which generated U.S. sales of $7.4 billion in 2005. Several factors have driven Lipitor’s success: Lipitor was the first statin to be markedly more effective in reducing low-density lipoprotein (LDL) than other agents in the same class; in addition, it has been promoted in the United States for nearly a decade by Pfizer’s enormous sales force and marketing resources. More recently, an even more potent statin, AstraZeneca’s Crestor (rosuvastatin), was launched. Crestor’s sales gains have been slower than first expected, largely due to concerns about a rare but potentially lethal side effect (rhabdomyolysis) and also because Crestor’s greater potency was not targeted to a clear unmet need--existing agents are effective for most patients.

The high prevalence of dyslipidemia in the United States and high levels of lipid screening have led to very wide use of statins and, more recently, use of single-pill combinations of statins with other antidyslipidemic agents. In 2006, this market will undergo major upheaval when two formerly leading statins, Bristol-Myers Squibb’s Pravachol (pravastatin) and Merck’s Zocor (simvastatin), lose market exclusivity. Still widely prescribed, these agents are the first generic statins viewed as legitimate alternatives to Lipitor and Crestor.

Decision Resources’ Physician Forum survey entitled "Changing Dynamics in the Dyslipidemia Market: The Intrusion of Major Generic Statins" explores the current treatment of dyslipidemia, and examines the effect that the advent of major generic statin competition will have on future prescribing patterns and reimbursement policies. We surveyed 70 primary care physicians, 72 cardiologists and 20 HMO pharmacy directors and compared their responses to assess similarities and differences. This survey enabled Decision Resources to:

- Determine the magnitude of the impact of generic statins on the first- and second-line usage of branded statins and single pill combinations.

- Uncover alignments and dis-alignments in the attitudes and behaviors of clinicians versus HMO directors in factors that will influence the use of specific statins.

- Determine the secondary effects that patent expiry will have on prescribing behaviour, for example by gauging clinicians' impression of the role that the high cost of statins has on patient compliance.

- Describe the effect that Medicare reforms (including payment for lipid screening beginning in 2005 and the introduction of drug coverage in 2006) are having on the level of screening and price dynamics in the statin market.

- Analyze the current and future tier assignments of various antidyslipidemic agents, including the level of copayments associated with each tier, and the expectation of HMO PDs concerning generic substitution and therapeutic interchange.

- Compare various stepped-care approaches that HMOs expect to introduce following the availability of generic statins, and explore how patient level of risk will impact clinicians’ plans to switch patients to generics.

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