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.
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Vera Bittner
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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
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Robert H. Eckel
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Generic atorvastatin is welcomed in the practice of CVD risk reduction
and should be popularized very quickly. I’ve 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 that’s often true of generics when they first come
out.
– Robert H. Eckel, MD
Professor of Medicine
University of Colorado Anschutz Medical Campus
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Rhonda Cooper-DeHoff
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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
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Michael Davidson
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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
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Rita F. Redberg
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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 Pfizer’s
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
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Paul L. Douglass
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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
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Roger S. Blumenthal
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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