GLG News by Oncology Reimbursement Experts (US)

The primary end point of the phase III trial "Imatinib Mesylate (Gleevec) in Treating Patients with Primary GIST that has been Completely Removed by Surgery" was recurrence free survival with the secondary endpoints of overall survival, efficacy, and safety. The study was closed early with the announcement...

Strong signals Congress will examine Medicare dialysis payments this year. Top three proposals under discussion are: (1) annual inflation update; (2) "bundled payment" reforms; and (3) longer "Medicare secondary payor."  Right now, most likely action is bundled payment reforms -- which could...

The authors once more underline the known limitations of phase II studies, originating from their uncontrolled design and limited statistical power. The proposed remedies will result in only minor improvements.

1. Herceptin is one of the favorite drugs used by oncologists2. Optimal schedule and length is not clear3. Role of additional testing is not established4. Competition is around the corner

Implications: 1. Drug will be delayed further2. Abraxane and Epothilone B will be approved. 3. If management understood that approach of early 80s does not work now, the drug would be available on market years ago.  

1. The first working drug will not be approved because it is too expensive.2. Narrow indication: never smoker, EGFR (+) would likely be approved if submitted, but that would establish the precedent and affect many other drugs3. US regulatory authorities may follow suite.