FDA recommends limiting use of simvastatin in 80-mg strength
SILVER SPRING, Md. — The Food and Drug Administration is seeking to limit the use of high doses of a drug for high cholesterol due to the risk of a muscle injury known as myopathy.
The FDA said it would recommend curtailing use of drugs containing 80 mg of simvastatin — the highest dosage approved by the FDA. The drug now is available as a generic, though Merck originally sold it under the brand name Zocor, and it’s one of the active ingredients of Merck’s Vytorin (simvastatin, ezetimibe and niacin). An estimated 2.1 million people were prescribed the 80-mg dose of the drug last year, according to the agency.
The agency said that only patients who have taken the drug for 12 months or longer without ill effect should take the 80-mg dose, and that prescribers should give it to patients only if they have been unable to adequately lower their cholesterol with the 40-mg dose.
“Our overall goal is to get doctors to not start patients on 80 mg of simvastatin,” FDA Division of Metabolism and Endocrinology Products deputy director Eric Colman said.
The FDA also said that all statins carry the risk of myopathy, characterized by unexplained weakness and pain in the muscles, but that 80-mg simvastatin carries especially high risk and that the muscle damage often results from interactions with other medications, while some patients are genetically predisposed to it. Other statins on the market include Pfizer’s Lipitor (atorvastatin) and AstraZeneca’s Crestor (rosuvastatin).
Moody’s gives CVS Caremark high rating among PBM competitors
NEW YORK — Moody’s Investors Service compared the three largest pharmacy benefit managers — CVS Caremark, Express Scripts and Medco Health Solutions — in a report issued Tuesday. While it maintained a positive view of all three, it gave CVS Caremark the highest credit rating.
"CVS Caremark has the highest credit rating of the three companies and is the only one with a retail pharmacy business, providing it with size and diversity that offset financial metrics that are weaker than the company’s PBM peers," the report stated.
Moody’s said the three PBMs have ratings in the "Baa" category, and while they do face similar far-reaching opportunities, such as an increased use of generic medications and a greater focus on curbing rising healthcare costs, there are differences that exist among them. Moody’s also stated that one of the biggest challenges facing PBMs is a reduction in commercial insurance membership.
"CVS Caremark is the only one of the three large PBMs with a retail pharmacy business. This business provides greater scale and diversification and offers CVS Caremark more protection from a downturn in the PBM segment. The company derives more than half of its revenues and almost 60% of its operating income from its retail pharmacy business. CVS Caremark has a strong market position in both of the competitive retail and PBM segments," Moody’s stated.
Moody’s also noted the fact that CVS Caremark now will handle the $3 billion mail-order and specialty prescription drug benefit for the Federal Employee Program starting January 2012, which for the last three years had been handled by rival Medco Health Solutions.
Statin users can save money if they adhere to therapies, Medco finds
FRANKLIN LAKES, N.J. — In a year and a half, patients taking statins to lower their cholesterol can save more than $900 when they take their medications as prescribed, according to a new study in the June 1 issue of the American Journal of Cardiology.
The study, conducted by pharmacy benefit manager Medco Health Solutions’ research subsidiary, the Medco Research Institute, found that patients who adhered to their therapies saved as much as $944 over 18 months because they experienced fewer cardiovascular problems leading to hospitalization.
The study was based on data from Medco’s pharmacy and medical claims for 381,000 patients ages 18 to 61 years who received statin therapy between January 2007 and June 2009. Patients who took their drugs 90% of the time had total healthcare costs of $10,162, compared with $11,106 for those who took them less than 60% of the time.