To CER with Love
WellPoint has released guidelines for the submission and evaluation of comparative effectiveness research that it will use in reviewing drugs for its formulary.
The guidelines state that, "while randomized, controlled clinical trials remain the gold standard for producing reliable efficacy and safety data, WellPoint recognizes that there are circumstances in which RCTs may not be sufficient alone for decision-making. Accordingly, a well-conducted CER or observational study may complement RCT-based information by providing effectiveness data, or data on outcomes achieved in a 'real-world' setting."
The guidelines explain that "observational studies provide information regarding product safety, cost-effectiveness, budget impact, and the validation of key assumptions used in cost-effectiveness and budget impact models. Furthermore, WellPoint may want to gain more insight regarding drug comparisons not found in the literature, such as off-label use and use in sub-populations."
Should a drug sponsor desire to submit results of a CER study, the guidelines list 20 specific criteria relating to the study for which information should be included. These are to include not only details of the study design, patient population and results, but a discussion of potential bias, the limitations and validity of the conclusions, and the relevance of the findings to WellPoint's patient population.
Food for Thoughtless
From CQ: "Sen. Byron L. Dorgan of North Dakota has his eye on the food safety bill as a vehicle to revive his proposal to allow the importation of US-made prescription drugs from Canada and other countries." Dorgan "says he is determined to press for another floor vote on the 'reimportation' issue when the food safety measure (S 510) moves to the floor. The bill was slated for possible action this month, but has been nudged aside in the rush to complete a fiscal 2010 war supplemental bill and a package of tax cuts and social spending by the Memorial Day recess." Notably, "Majority Whip Richard J. Durbin of Illinois says he's concerned that the Dorgan proposal could complicate the food safety bill." Um, yeah.
And a Pair of Tube Socks
Via AFP comes the report that British supermarket chain Asda plans to sell cancer drugs at cost price and called on its peers who make massive profits on the treatments to follow suit.
The group, owned by the world's biggest retailer US supermarket giant Wal-Mart, said its initiative follows the success of a similar scheme by Asda for in-vitro fertility (IVF) treatments.
"The crippling cost of paying privately for cancer treatment has forced many people to spend their savings or even re-mortgage their house to pay for these essential drugs," said John Evans, superintendent pharmacist at Asda.
"We are the first retailer to recognise this injustice and to do something about it and we are calling on other retailers to follow our lead."
