GLG News by Oncology Reimbursement Experts (US)

The comprehensive clinical program will supplement the significant body of clinical data existing for ERBITUX in colorectal and head and neck cancers by exploring the use of ERBITUX in additional tumor types including brain, breast, bladder, gastric, lung, pancreas and prostate

The coverage restrictions placed on the FDA-approved indication have no scientific basis and are incompatible with good clinical practice," said Roger M. Perlmutter, M.D., Ph.D., executive vice president of Global Research and Development at Amgen. "We are concerned that inappropriately limiting coverage...

My understading id medicare need to cover all FDA indicated drugs. Here CMS violating FDA indication for Aranesp and procrit

Decrease use by 20-25% use of ESA. This may lead discounting and higher rebate from both amgen and orto-biotech to sustain market share. Since most of amgen contract with aranesp and neulasta use. It may effect use of neulasta. Next 6 month CMS may restrict use of Neulasta and neupogen for neutropenia...

-Brain cancer-or more specifically- glioblastomas- are uniformly fatal and treatment -radiation and chemo--is really not effective. -Many younger people are affected by this disease and a cure that is patient specific would be terrific. - This is not the first time that someone has tried to do this...

SAFETY- label should reflect the actual dosage, and the physician's instructions/we need to use DUR edits to monitor adherence and safety/ tablet pieces can become lodged in the esophagus, or ingested by a child or pet if they are misplaced. tablet splitting is not recommended by the ISMP

Decreased ESA usage benefits insurance companies.

The approval of Lybrel is likely to result in patient request for its use.  Most patient will be required to pay the most expensive patient cost share however, as the product really brings nothing new to the contraceptive armamentarium.  Gynecologists have been presribing other brand and generic...

3 day monitoring vs  7 day!  -  Competition for Medtronics Depending on cost structure and outcomes data - might be preferred by physicians/clinics and insurers to the 3 day medtronic monitoring systems. 

1) There are several generic "statins": lovastatin, pravastatin, simvastatin. 2) Lipitor is expected to be available later this year as generic (atorvastatin) 3) Medicare formularies have already been submitted for 2008. Lipitor could be added, but not easily.