a. Vascepa will be approved based on both of the following criteria:
1) Used for cardiovascular risk reduction -AND- 2) Documentation of positive clinical response to therapy -AND- 3) Patient is on an appropriate low-fat diet and exercise regimen -AND- 4) Patient is receiving maximally tolerated statin therapy -AND- 5) Prescribed by or in consultation with one of the following: a) Cardiologist b) Endocrinologist c) Lipid specialist
5.) This is hilarious so I as a FAMILY MD have been prescribing Vascepa for probably 8 years - sent letter to all my local cardiologist several times - who still think it s just fish oil and tell my patients as much and UHC thinks I am not qualified to prescribe the med !
2.) DOcumentation of clinical response ? The clinical response is reduction of coronary events so if they have a coronary event they dont get the med ??
Eclipsing Family DOcs will cut into the market significantly especially on the diabetic + two risk factor equation most of those patients are being treated by family docs - AMRN needs to fight this