Statins going on sale as generics

Annual savings on co-payments for cholesterol medicine could surpass $200 a year

May 21, 2006|By BRUCE JAPSEN | BRUCE JAPSEN,CHICAGO TRIBUNE

CHICAGO -- Hailed for effectiveness at lowering cholesterol, the family of drugs known as statins in recent years has been the most costly U.S. brand-name prescription group for U.S. consumers and employers.

Retailing between $2 and $5 a pill, statins accounted for $16 billion in U.S. sales last year, the leading class of brand-name drugs, representing 6.4 percent of U.S. prescription sales, according to research firm IMS Health.

Now cholesterol pills are going on sale.

The second-most widely prescribed statin, Zocor, is expected to be available late next month as a generic. The third-most prescribed brand statin, Pravachol, became available as a cheaper generic, pravastatin, this month.

The availability of generic versions could mean annual savings on co-payments of more than $200 a year, depending on a person's prescription benefit plan, analysts say. Also, monthly drug co-payments could be cut in half to between $5 and $10 on average for a generic statin to $20 to $40 a month or more for a brand, employers and insurers said.

"When a big branded drug loses patent protection, there is always a huge opportunity for cost savings," said Lynn Rossetto, a pharmacist with consulting firm Hewitt Associates, which advises employers how to save on their medical costs.

"The branded statins are around $100 or more for a month's supply," Rossetto said. "Oftentimes, more than one of these drugs fall among an employer's [costliest] drugs."

There also might be ramifications for those who take the most widely used cholesterol drug, Lipitor.

While Lipitor has patent protection until 2011, doctors and pharmacists say the similarities in effectiveness between Lipitor and Zocor should give statin users an opportunity to switch to a generic and save $1 a pill or more at retail prices depending on dosage.

The generic version of Zocor, expected to be available by late June, is named simvastatin. Last year, Zocor's sales totaled $4.4 billion, IMS said.

The emergence of the generic cholesterol drugs could have even greater meaning this year. That's because millions of seniors who previously did not have drug coverage gained access to drugs in January under the Medicare health insurance program.

Already, health insurance plans and pharmacists are encouraging consumers to pick pravastatin, the generic, over the brand Pravachol, and they are planning to push generic versions of Zocor as well.

Pravachol, doctors contend, is not as effective as Lipitor, so those patients would likely keep using Lipitor. But doctors, pharmacists and health insurers say generic Zocor is an effective alternative to rivals Lipitor and Crestor, the nation's fourth-leading brand-name statin in annual sales, according to IMS figures.

"Zocor has the efficacy that compares to the higher-end statins like Lipitor and Crestor," said Dr. Matthew Sorrentino, a preventive cardiologist at the University of Chicago Hospitals.

"If generic Zocor is priced low enough that it can save substantial amounts of money for patients, then I think it can have an impact in the statin marketplace and take away from the branded statins," he said.

Although the expected price of generic Zocor has not been disclosed, a Food and Drug Administration analysis said generics usually fall to 52 percent of the brand-name price once a second generic manufacturer launches a copy.

Still, consumers without drug coverage are not going to save as much on generic Zocor in the first six months it is available because a federal court in Washington ruled this month that only two companies could have exclusive rights to the generic version for six months. Had the ruling gone the other way, several more firms would have been able to sell generic copies of Zocor, further driving down pricing.

Once the generic exclusivity expires, there could be several more copies of Zocor on the market by early 2007, adding to the downward pressure on pricing.

To prepare consumers for the introduction of generics, some pharmacy benefit managers this year began listing Zocor as a "preferred brand" in their preferred lists of drugs, known as formularies. As a way to encourage consumers to use Zocor while moving them away from Lipitor, giant pharmacy benefit manager Express Scripts of St. Louis earlier this year put Lipitor in the more expensive "non-preferred tier." That move can add $20 or more to the co-pay of the health plan enrollee, depending on the structure of the benefit plan.

"This whole strategy will help pharmacy benefit plans and the members of those plans take advantage of a historic opportunity with Zocor going generic," said Steve Littlejohn, vice president of public affairs at Express Scripts.

Pfizer Inc., Lipitor's maker, however, is fighting back, contending that Lipitor is more effective than Zocor. Pfizer also cites studies that show it has certain advantages over Zocor, including lowering risks of heart disease and stroke.

Bruce Japsen writes for the Chicago Tribune.

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