Trumm Drug

July 2010 Drug News

ARBs Linked to Cancer?
There has been extensive media coverage of the possible link between angiotensin-receptor blockers (ARBs) and the development of cancer. The link was examined in a recent meta-analysis of 5 trials involving over 61,000 patients. Most patients (86%) took telmisartan (Micardis‘®’); the other patients received losartan (Cozaar®) or candesartan (Atacand®). The results suggested a small but significant increase in the risk of cancer occurrence in patients taking ARBs compared with those in control groups (7.2% vs 6.0%). Among the specific types of cancer examined (lung, breast, and prostate), a significant increase in risk was seen only for lung cancer.

In “real numbers”, the possible increase in risk amounts to about 1 one extra cancer case for every 105 people taking an ARB for about 4 years. A mechanism for the connection, and whether all ARBs may pose a risk, remain unknown. The manufacturer of telmisartan contested the results of the analysis, arguing that they are based largely on a study in which ramipril, an ACE inhibitor, was combined with telmisartan. In addition, other clinical trials and post-marketing exposure to telmisartan have not revealed any link to cancer development. While the evidence is preliminary and further study is needed, some experts stress a cautious approach to ARB use. Until more is known, the best advice may be to not stop taking ARBs. Reassure them that the cardiovascular benefits outweigh the possibility that cancer risk is modestly increased.

Checks in the mail: Part D gap begins closing
As a first step in closing the Medicare Part D coverage gap by 2020, beneficiaries who enter the doughnut hole this year and are not eligible for Medicare Extra Help are starting to receive a one-time, tax-free $250 rebate check from Medicare.

CMS and the pharmaceutical industry are ramping up for 2011 to implement the Medicare Coverage Gap Discount Program in the “Affordable Care Act” (the new health care reform law). A number of changes will occur that will affect pharmacists, once again putting pharmacists in the position of explaining the changes to patients next year.

Beneficiaries who reach the doughnut hole next year and are not eligible for the Medicare Extra Help program will receive a 50% discount on brand-name and some generic prescription drugs. The discount program, which will be effective January 1, 2011, represents the second step in closing the Medicare Part D coverage gap.

Congressional Hearings Sought on PBMs
Two members of Congress are seeking congressional hearings to explore the lack of government oversight of the PBM industry. Congress should consider regulating PBMs to require that they have a fiduciary responsibility to plan sponsors” and greater transparency of financial relationships, suggested Reps. Peter Welch (D-Vt.) and Bruce Braley (D-Iowa).

“The hearing Braley and Welch call for could create momentum for passing current legislative solutions to problematic PBM business practices or even spark the consideration of additional legislative solutions,” said Joseph H. Harmison, PD, NCPA president.

“A hearing will help shine a spotlight on several troubling questions that need answers if patients, pharmacies, and plan sponsors are going to be treated fairly. Is it fair for PBMs to contract with independent community pharmacies for access to patients, while steering some of those patients to mail order and retail pharmacies they own at higher cost to plan sponsors? Is it fair for PBMs to secretly receive rebates from drug manufacturers for favoring certain prescription drugs over others, and then pocket commissions as high as 50% before passing the rest on to patients and plan sponsors? Is it fair for PBMs to force independent community pharmacies into ‘take-it-or-leave-it’ contracts for access to patients that have onerous terms? The list of questions is seemingly endless, but a federal hearing is the right venue for some substantive answers to be found.”

Sunscreen Labeling Changes Expected After Summer
A new standard for sunscreen labels is likely, as FDA is working to finish by autumn new labeling rules years in the making. The current labeling system for sunscreen products is problematical, stated Dr. James Spencer, spokesman for the American Academy of Dermatology, and the rules would adopt a standard testing protocol and a proposed four-star UVA rating system indicating the protection level as “low,” “medium,” “high” or “highest.” The Associated Press

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