Latebreakers: January 9, 2006

Most Part D plans use USP model guidelines

The voluntary drug classification system developed by USP for the Medicare Part D benefit was the basis for 74% of the formularies developed by drug plans for the 2006 benefit year. USP has proposed revisions to the Model Guidelines for 2007, which include an expansion of the formulary key drug types from the current 118 to 170. The increase was due to the inclusion of both Part D and Part B drugs and expansion for pharmacologic/clinical distinctions in areas such as oncology, cardiovascular, and hematological therapeutic categories. The revisions will be presented to CMS by Jan. 30.

Orencia gets FDA nod for treatment of rheumatoid arthritis

High price of meds drives patient coping strategies

American families are coping with the rising price of medications by engaging in a number of potentially risky behaviors, including skipping medication doses, taking less than the prescribed dose of medication, or deciding to stop taking prescription medications altogether, according to a new survey conducted by ASHP. The survey of 1,006 Americans found that a majority deal with rising drug costs by asking for generic medications rather than brand-name Rx drugs (90.5%). Respondents said they use several other tactics, some of which could be potentially dangerous, to fit medicines into their budgets, including requesting free medication samples from their physicians (27.1%), not having a prescription filled (13.7%), skipping medication doses or taking less than the prescribed dose of medicine (11.5%), or stopping prescription medications altogether (7.3%). Ten percent of the respondents said that they or a family member had been sick or had an illness worsen because they couldn't afford to fill their prescriptions.

FDA approves new treatment for advanced kidney cancer

The FDA has approved Onyx Pharmaceuticals' Nexavar (sorafenib tosylate), a new cancer medicine used to treat adults with advanced renal cell carcinoma, the most common type of kidney cancer. Two studies in patients with advanced kidney cancer showed that patients treated with sorafenib, which will be distributed and marketed by Bayer Pharmaceuticals, had more survival time before progression or death. In the larger study, most patients had previously received treatment with interleukin-2 or interferon. Common temporary side effects reported with sorafenib are rash; diarrhea; increased blood pressure; and redness, pain, swelling, or blisters on the palms of the hands or soles of the feet.

AHRQ: Medications as effective as surgery for GERD

Proton pump inhibitors (PPIs) are as effective as surgery at treating gastroesophageal reflux disease, according to a report by the Agency for Healthcare Research & Quality (AHRQ). The report is the first in a series of 10 studies mandated by the 2003 Medicare law that will compare the effectiveness and price of medical treatments. For the report, AHRQ researchers conducted an eight-month review of major medical studies and found that for most people with uncomplicated GERD, PPIs such as Nexium (esomeprazole, AstraZeneca) and Prilosec (omeprazole, AstraZeneca) can be as effective at relieving symptoms and improving the quality of life as surgery. The study also found that H₂ receptor antagonists, such as Pepcid (famotidine HCl, Merck) and Zantac (ranitidine HCl, GlaxoSmithKline) are not as effective as surgery but are less likely to cause side effects. In addition, the researchers found that although surgery sometimes is performed to end the need to take medications, between 10% and 65% of patients who receive the surgery must resume taking the drugs. The Pharmaceutical Care Management Association applauded the AHRQ report for "putting forward useful information that consumers, clinicians, and purchasers can all use to evaluate competing therapies and better utilize scarce healthcare dollars."