Generic atorvastatin has long-ranging clinical, financial implications
Cardiology Today asked the Editorial Board what this means for physicians, patients and the management of CVD.
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On Nov. 30, the first generic version of atorvastatin calcium tablets entered the market. The widely used statin is FDA approved to reduce elevated total cholesterol, LDL and triglycerides, as well as increase HDL levels.
Experts said availability of the generic may bring potentially lower costs and availability for more patients.
Everything, ultimately, boils down to cost. One of the biggest issues has been that many formularies did not have Lipitor at all or had it as a Tier 3 drug, making it difficult for patients to access the drug. Now, assuming that the price goes down, I would expect formularies to make atorvastatin generic more broadly available to the patients. Having a non-branded, high-potency statin is particularly important now that simvastatin (Zocor, Merck) was relabeled. There are many patients on high doses of simvastatin who take other drugs in addition and mandate a simvastatin dose reduction; hopefully, these patients will have an alternative now.
Vera Bittner, MD, MSPH
Cardiology Today Editorial Board member
Generic atorvastatin is welcomed in the practice of CVD risk reduction and should be popularized very quickly. Ive been alerted that, during the first 6 months, the cost of the generic is not going to be that much cheaper than Lipitor. I think thats often true of generics when they first come out.
Robert H. Eckel, MD
Professor of Medicine
University of Colorado Anschutz Medical Campus
Atorvastatin going generic has the potential to impact heart health in the same way the Walmart $4 generic program positively impacted overall health. Many patients who should be taking a statin, and specifically atorvastatin, do not. For those whose reason is they simply cannot afford it, the availability of a generic product should really help. Patients who took the drug sparingly before the drug went generic to save money (for example, they only took it every other day or half a tablet a day instead of a whole tablet) may now start taking the drug as directed since it is less expensive and so there is the potential for better efficacy of the drug. If more patients start taking the drug as prescribed, there is also the chance of more adverse effects starting to appear. Typically, when big drugs go generic, in some ways they fall off the radar screen there is less money available / invested to study the drug and more resources are put into the next big nongeneric drug in a company's pipeline. There may still be important questions to ask from a research perspective, but it gets harder to find support.
Unfortunately, cost is not the only reason patients who should be taking a statin aren't. We still have work to do regarding education about the safety and benefits of the statin class to have maximal impact on primary and secondary prevention strategies.
Rhonda Cooper-DeHoff, PharmD
Cardiology Today Editorial Board member
A generic atorvastatin will continue the trend to broaden the utilization of statins in moderate-risk patients. Clinical trials have shown that statins reduce the risk for CHD events by 30% to 50%. Therefore, cost-effectiveness based on cost of quality-of-life years saved will be improved with increased generic statin utilization. The clinical questions going forward now relate more to who should be treated rather than the cost of care.
Michael Davidson, MD
Cardiology Today Editorial Board member
The implications for patients and physicians from atorvastatin going generic depend somewhat on their current drug insurance benefits. Clinically, generics are as effective as brand-name drugs. Many pharmacy plans have tiered co-pay, and so patients will see lower costs with generics. Going generic may encourage physicians to prescribe atorvastatin over more expensive formulations. The transition to generic has been clouded by Pfizers recent agreements with several pharmacy-benefits managers designed to maintain its market share and attempt to prevent generic makers from competing as effectively. In the long run, these business tactics could have a negative long-term effect on generic drug makers and, thus, on patients and physicians.
Rita F. Redberg, MD
Cardiology Today Editorial Board member
The introduction to the market of a generic, high-potency statin has the potential for providing a well-proven pharmaceutical with potent lipid-lowering and anti-inflammatory properties at a low cost. Although the potential cost savings may not address the difficult issue of compliance, it does remove a significant barrier for lower socioeconomic populations. This is particularly welcomed during this time of economic downturn, which challenges many Americans. However, our primary focus must always be on CV prevention strategies and the adoption of healthy lifestyles, which I believe is a much more potent weapon in the battle against excessive morbidity and mortality from CVD.
Paul L. Douglass, MD
Cardiology Today Editorial Board member
Prescriptions of generic atorvastatin will assume a majority of the market. The latest clinical advisory on simvastatin restricts dosing of the drug to 20 mg when a patient is on a calcium channel blocker. Since niacin was a huge disappointment in AIM-HIGH (despite showing such promise in ARBITER 6 with a mean 0.014-mm improvement in common carotid intima media thickness), and fenofibrate only showed benefit in the low HDL and high triglyceride group in the ACCORD study, most clinicians will focus on monotherapy with a generic, potent statin. Moreover, managed care will likely encourage atorvastatin use over the more expensive brand name rosuvastatin or pitavastatin.
Roger S. Blumenthal, MD
Cardiology Today Editorial Board member