PHARMACY

New drugs to alter HCV treatment, outcomes

BY Alaric DeArment

A phrase like “silent killer” sounds creepy enough on its own, but it’s an often-used one for a virus that, according to the Centers for Disease Control and Prevention, infects 1.3% to 1.9% of people in the United States.


New hepatitis C infections have fallen dramatically over the last decade, according to the CDC, from 28,000 in 2003 to 18,000 in 2008. However, the virus, which is mostly spread through unprotected sex and sharing of needles by drug abusers, remains dangerous, and as many as 3.2 million Americans may be infected. According to the C. Everett Koop Institute at Dartmouth Medical School, hepatitis B and C account for 75% of all cases of liver disease around the world, but unlike its cousin, more than 80% of infections by hepatitis C, also known as HCV, become chronic and lead to liver disease.


But HCV has one silver lining: It’s curable. The standard of care for HCV infection is a combination of the generic antiviral drug ribavirin with a biotech drug known as a pegylated interferon, usually Genentech’s Pegasys (peginterferon alfa-2a) or Merck’s PegIntron (peginterferon alfa-2b). The treatment can produce a sustained virologic response, or SVR, meaning that the virus is rendered at least undetectable and thus considered cured, though cure rates are lower in patients with genotype 1 of the virus, at 40% to 50%, while cure rates for genotypes 2 and 3 are much higher.


But in May, the Food and Drug Administration approved two drugs that could be the start of a new trend in HCV treatment: Vertex Pharmaceuticals’ Incivek (telaprevir) and Merck’s Victrelis (boceprevir), both protease inhibitors. “It’s going to have a major, huge, big impact — pick your favorite superlative,” analyst Seamus Levine-Wilkinson of healthcare market research firm Decision Resources told Drug Store News.


What’s significant about the two drugs is that, taken in combination with ribavirin-interferon alfa therapy, they greatly increase the cure rate for patients with genotype 1, bringing it up to 65% or more. “These drugs are a huge advance,” Levine-Wilkinson said. “They’ll really up the treatment rates.”


The drugs aren’t perfect, however, and they include side effects, such as rashes and anemia. But they could be a taste of the future of HCV treatment. Tibotec, a division of Johnson & Johnson, is developing TMC435, a protease inhibitor that may have fewer side effects than Incivek and Victrelis. Meanwhile, Pharmasset is working with Roche to develop RG7128 (mericitabine) and with J&J to develop PSI-7977. The latter two drugs are polymerase inhibitors, which differ from protease inhibitors in that they have the potential to work against all genotypes of the virus rather than just one. Levine-Wilkinson sees the new drugs launching as early as 2015. In addition, he said, they could even lead to the elimination of the need for interferons.


The development of new drugs is particularly significant for specialty pharmacy providers, for which genotypes are an important aspect of treatment. Recently, Accredo Health Group, the specialty pharmacy division of pharmacy benefit manager Medco Health Solutions, said it was able to drive down the cost of HCV treatment by $13,000 per patient by using genotype information, as well as by increasing medication adherence, as patients must be at least 80% adherent for their HCV treatment to be effective. 


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NACDS supports Affordable Medicines Utilization Act of 2011

BY Allison Cerra

ALEXANDRIA, Va. — Bipartisan legislation recently introduced to the Senate has received endorsement from a group representing the retail pharmacy industry.

The National Association of Chain Drug Stores said that the Affordable Medicines Utilization Act of 2011, introduced by Sens. Scott Brown, R-Mass.; Ron Wyden, D-Ore.; and John McCain, R-Ariz., "will provide incentives that will encourage state programs to efficiently use their healthcare dollars through increased use of more cost-efficient generic drugs while at the same time generating savings for not only the state but for the patient as well,” NACDS wrote in a letter.

NACDS did, however, caution against "evaluating spending on prescription drugs in a vacuum."

The bill seeks to offer states incentives to use generic drugs by allowing states to temporarily keep a portion of the savings, the senators said.

“With our nation in a financial crisis and as federal and state healthcare expenditures continue to rise, we must ensure that our healthcare programs are efficiently managed,” McCain said. “A recent study found that the federal/state Medicaid program potentially overspends by more than $300 million per year on brand-name drugs when a cheaper generic drug equivalent is available. This bipartisan proposal incentivizes state Medicaid programs to substitute generics for more expensive brand-name drugs, introducing real competition for reimbursement dollars and saving taxpayers’ hard-earned money.”

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Patients using mail-order pharmacy for new statin Rxs achieved better cholesterol control in study

BY Alaric DeArment

OAKLAND, Calif. — Patients in northern California using Kaiser Permanente’s services who received new prescriptions for statin drugs through mail-order pharmacy showed better control of their cholesterol in the first three to 15 months following the start of therapy than those who obtained them from Kaiser Permanente Northern California pharmacies, according to a new study.

The 100,298-patient study, published online in the Journal of General Internal Medicine, found that 85% of patients using mail-order pharmacy achieved their desired cholesterol levels, compared with 74.2% of those who used the local pharmacy.

“While the findings of this study should be confirmed in a randomized controlled trial, they provide new evidence that mail-order pharmacy use may be associated with improved care and outcomes for patients for risk factors with cardiovascular disease,” lead study author and Kaiser Permanente Division of Research investigator Julie Schmittdiel said. “Though mail order may not be right for all patients, this study shows that it is one possible tool in the broader healthcare system-level toolbox that can help patients meet their medication needs.”

Schmittdiel said the study was the first to examine whether mail-order pharmacy use is related to improved cardiovascular risk factor outcomes.

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