Re: Lipitor or Generic? Billion-Dollar Battle Looms
- From: "Jerry Okamura" <okamuraj005@xxxxxxxxxxxxx>
- Date: Sat, 15 Oct 2005 17:39:29 GMT
Two comments. In Hawaii, the pharmacy "must" offer you the choice of a
generic if a generic is available. Second, I have had around four or five
heart attacks (according to the doctors), quintuple bypass surgery, a
defiralator implanted after I had a severe heart attack after my bypass
surgery, and the doctors have not prescribed any cholesterol-lowering drug
for me on a regular basis.
"reeder" <reeder@xxxxxxxxxxxxxx> wrote in message
news:t121l1lvdvlig0knuon85vhqlm5mbib3cp@xxxxxxxxxx
> New York Times
> October 15, 2005
>
> Lipitor or Generic? Billion-Dollar Battle Looms
> By ALEX BERENSON
>
> The Lipitor war is about to begin.
>
> Starting next June, insurers and government agencies will have the
> opportunity to save billions of dollars by moving patients from
> Lipitor, a cholesterol-lowering drug by Pfizer that is the world's
> top-selling medication, to an inexpensive generic version of Zocor, a
> similar but less potent drug now made by Merck.
>
> Some insurers are already planning ways to move patients from Lipitor
> to generic cholesterol drugs after Zocor loses its patent protection.
> But Pfizer, which plans to use marketing muscle and clinical data to
> fight that migration, says that Lipitor has unique benefits and is
> worth a premium price, especially for patients at high risk of heart
> attacks.
>
> Both medicines belong to a class of drugs known as statins, which are
> the nation's best-selling medications, with almost 150 million
> prescriptions expected to be filled this year at a cost of $16
> billion. The insurers, and some cardiologists, say that switching
> patients from Lipitor to generic Zocor will be a safe way to cut costs
> in an era of skyrocketing pharmaceutical prices.
>
> In many cases, they say, patients who now take the most commonly
> prescribed dosage of Lipitor - 10 milligrams daily - can reduce their
> cholesterol just as much with Zocor. Lipitor costs $2 or more a day,
> while generic Zocor will probably cost 35 cents or less.
>
> "If I was taking a statin, I'd want to take the cheapest one, as long
> as I get to the goal that I wanted to get to," said Dr. Scott Grundy,
> a researcher who has consulted for both Merck and Pfizer. Dr. Grundy
> led a federal panel that in 2001 wrote guidelines for treating people
> with high cholesterol.
>
> But other doctors and epidemiologists say that Lipitor may be the best
> drug for many patients. "It would not be good medicine to go to a
> cheaper medicine that has less efficacy in our high-risk patients,"
> said Dr. Robert Vogel, a cardiologist at the University of Maryland,
> who has been paid by Pfizer to help conduct a clinical trial of
> Lipitor.
>
> Pfizer says it will fiercely defend Lipitor. "By taking any dose of
> Lipitor, you will reduce the risk of a cardiovascular event faster and
> to a greater degree than you will with any other medicine," said J.
> Patrick Kelly, Pfizer's president of United States pharmaceuticals.
>
> The fight over Lipitor involves a collision of fundamental forces in
> American health care. Spending on prescription drugs has jumped from
> $40 billion in 1990 to almost $250 billion this year, and continues to
> rise faster than overall inflation. But while many Americans say they
> believe that prescription drugs cost too much, they rarely want to
> accept generic medicines for themselves instead of more expensive
> drugs that may be only marginally better - especially since insurers
> or government agencies pay nearly 70 percent of all drug costs.
>
> Dr. JoAnne Foody, a practicing cardiologist and a professor at Yale
> University School of Medicine, said she expected to continue
> prescribing Lipitor for her high-risk patients, who need the maximum
> possible reduction in cholesterol.
>
> But she said she would be inclined to switch other patients off
> Lipitor onto generic Zocor, also called simvastatin, if the price
> difference was significant.
>
> "There are a very large portion of patients where the data for
> simvastatin are equivalent and sometimes better than the data for
> Lipitor," Dr. Foody said.
>
> But convincing American patients to give up a brand-name medicine and
> take a generic drug is not easy, said Albert Rauch, a drug industry
> analyst at A. G. Edwards, a regional brokerage firm based in St.
> Louis.
>
> For example, even though the antacid Prilosec is available in an
> inexpensive over-the-counter form, people prefer three very similar
> but higher-priced prescription antacids - Prevacid, Nexium and
> Protonix. Those three will have $10 billion in United States sales
> this year.
>
> "Therapeutic substitution - substituting one product for another in
> the same class - just hasn't happened yet," Mr. Rauch said.
>
> And Lipitor has more than Pfizer's marketing dollars working for it.
> Last month, an analysis of 14 clinical trials by Oxford University and
> the University of Sydney in Australia found that the more potent the
> statin and the greater the cholesterol reduction, the lower the risk
> of heart disease.
>
> Dr. Colin Baigent, who oversaw the analysis, did not directly endorse
> Lipitor but said he believed that statins were not interchangeable.
>
> "The aim should be to get their LDL cholesterol as low as possible,"
> Dr. Baigent said, referring to low-density lipoprotein, or LDL,
> cholesterol - commonly called bad cholesterol. "There is potential for
> many patients benefiting more."
>
> Statins work by interfering with the liver's ability to synthesize LDL
> cholesterol. All statins are chemically similar, although Lipitor,
> whose active ingredient is called atorvastatin, is more potent than
> Zocor, or simvastatin.
>
> The highest dosage of Lipitor (80 milligrams) can reduce cholesterol
> as much as 57 percent in an average patient, while the highest dosage
> of simvastatin lowers cholesterol 47 percent. But because most
> patients are not placed on the highest dosages, the two drugs can
> achieve comparable cholesterol-lowering results in many cases.
>
> Several large clinical trials have shown that statins reduce the risk
> of heart attacks and strokes. And statins appear to be safe for most
> patients, although they can cause muscle weakness in some people and
> occasionally lead to severe muscle damage.
>
> As a result, statins have become among the most commonly prescribed
> drugs. This year's forecast of 150 million statin prescriptions in
> this country is up from 82 million in 1999, according to IMS Health, a
> Pennsylvania company that compiles data about drug usage.
>
> About half of those prescriptions will be for Lipitor, which is taken
> by 12 million Americans a year, at a cost of about $8 billion.
> Worldwide, Lipitor sales are forecast to top $12 billion this year,
> making the drug by far the best-selling prescription medicine.
>
> Prescription drugs are protected by patents that give their inventors
> the exclusive right to sell them for up to 20 years, though they
> usually must spend part of that time gaining federal approval. The
> patent protection enables the drug maker that discovered the drug to
> earn back its development costs and make a profit. Otherwise, other
> companies could make and sell identical versions of the medicine,
> undercutting the company that invented it.
>
> But when a patent expires, the legal protection disappears. At that
> point any company can make the drug, as long as it proves to the Food
> and Drug Administration that its version is identical to the original.
> The patent on Lipitor is to expire in 2011, but that patent has been
> challenged.
>
> Zocor will lose its patent protection next June 23, and be opened to
> competition. Ivax, a generic drug company, has already said it will
> produce a generic version of the drug, and other companies plan to
> follow. As more generics enter the market, the price of generic
> simvastatin could fall to 35 cents a pill or less, compared with $3 or
> more now, according to Richard T. Evans, a drug industry analyst at
> Sanford C. Bernstein & Company.
>
> Merck will lose billions of dollars in annual sales and profits when
> Zocor loses its patent protection. To recoup its profits, Merck has
> introduced another anticholesterol drug, Vytorin, which combines Zocor
> with Zetia, a medicine from Schering-Plough that is not a statin but
> also reduces cholesterol.
>
> Vytorin is about as effective as Lipitor at lowering cholesterol, so
> both Merck and Pfizer have a stake in convincing doctors and insurers
> that they should pay extra for the increased potency their drugs offer
> over generic Zocor. But because Lipitor is so much more popular than
> Vytorin, Pfizer has more to lose than Merck and Schering-Plough if
> generic simvastatin becomes a standard treatment.
>
> Last week, Express Scripts, a Missouri company that helps companies
> design drug benefit plans, said it would drop Lipitor from its list of
> preferred drugs. Instead, Express Scripts has devised a plan that will
> offer patients taking generic simvastatin a much lower co-payment on
> their prescriptions.
>
> Steve Littlejohn, a spokesman for Express Scripts, said simvastatin
> was a viable alternative to Lipitor for most patients.
>
> At its minimum 10-milligram dose, Lipitor reduces bad cholesterol an
> average of 39 percent. In contrast, a 40-milligram dose of simvastatin
> cuts cholesterol by as much as 41 percent. For patients who need a
> higher-potency statin, Vytorin will be available, Mr. Littlejohn said.
> "Consumers and physicians and employers have seen the steady, almost
> inexorable rise in pharmacy costs, and said nothing can be done," Mr.
> Littlejohn said. "We're saying something can be done."
>
> Other insurers also say the Zocor patent expiration is an opportunity
> to reduce drug spending. Robert Seidman, the chief pharmacy officer
> for WellPoint, the nation's largest publicly traded health insurer,
> estimated that wide use of simvastatin could reduce the nation's drug
> costs by $2 billion or more a year. To encourage patients to switch
> from Lipitor, WellPoint plans to offer members four to six months of
> free simvastatin as soon as generic versions are available, he said.
>
> But Pfizer is fighting back. To demonstrate Lipitor's benefits in
> different kinds of patients, Pfizer has conducted 400 clinical trials
> on Lipitor, covering 80,000 people. Lipitor's edge over other statins
> goes beyond its superior ability to lower cholesterol, said Mr. Kelly.
>
> The data from those clinical trials has enabled Pfizer to repeatedly
> broaden Lipitor's label of approved uses, changes that must be
> approved by the F.D.A. Last month, the F.D.A. said Pfizer could begin
> to market Lipitor for the prevention of heart attacks and strokes in
> diabetics. To build brand loyalty, Pfizer also has thousands of sales
> representatives discussing Lipitor with doctors and spends at least
> $60 million annually to advertise Lipitor to consumers, according to
> Brandweek magazine. Pfizer declined to discuss how much it spends to
> market Lipitor.
>
> Dr. David Hyman, professor of medicine at Baylor College of Medicine
> in Houston, said he did not expect many patients to be switched off
> Lipitor. He pointed to drugs that lower blood pressure, where
> expensive branded medicines dominate cheaper generics despite
> extensive research showing the generics work as well. "So much of the
> market is really not price-responsive."
>
> But other experts on drug benefits said they believed that generic
> simvastatin might put a dent in Lipitor's sales, because companies,
> government agencies and patients had become so concerned about drug
> costs.
>
> "It's very likely that a large portion of the market, especially those
> covered by managed care organizations, will switch to generic Zocor,"
> said Albert Wertheimer, a professor of pharmacy at Temple University.
> "It seems like a reasonable thing to try."
>
.
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