Sutent...Not covered on insurance

[justcurious4]

Can anyone out there please give me some advice on what to tell a patient that has just recently been diagnosed with advanced renal cell carcinoma? His doctor prescribed Sutent 50mg and it will cost him $7500.00 out of pocket since insurance companies aren't yet covering it. Any help would be appreciated!!! Thanks

[TimTam]

If Sutent is not covered on insurance for RCC is because Nexavar was approved based on Phase III data and it was approved with a valid clinical benefit endpoint: Progression Free Survival. Besides the FDA approved Nexavar with no conditions. Whereas, Sutent is approved based on two small phase II studies with only response data and with conditional approval (ie. pending or subject to verification in Phase III study results-conditional approval). Everyone in the cancer field knows that response data does not correlate with overall survival. Plus look at all the bolded precautions in the Sutent label below (courtesy of someone on this board):
Ventricular Dysfunction (LVEF), Hemorrhage/bleeding, cardiovascular deaths, Skin discoloration (drug for Mikael Jackson?), Seizures, hair color changes,fatal gastrointestinal complications ...on and on on on, on, on......where's the end???These poor cancer patients will die a horrible death ...Thanks to Sutent
Comapre this to Nexavar....
Why would anyone take Sutent for Renal cell cancer when the label says NO RANDOMIZED TRIALS??? "indicated for the treatment of advanced renal cell carcinoma. Approval for advanced renal cell carcinoma is based on partial response rates and duration of responses. There are no randomized trials of SUTENT demonstrating clinical benefit such as increased survival or improvement in disease-related symptoms in renal cell carcinoma."
Sutent
http://www.fda.gov/cder/foi/label/2006/021968lbl.pdf
Nexavar
http://www.fda.gov/cder/foi/label/2005/021923lbl.pdf
No randomized trial for RCC and NO clinical benefit???? Bizarre!!!
"SUTENT is indicated for the treatment of advanced renal cell carcinoma. Approval for advanced renal cell carcinoma is based on partial response rates and duration of responses. There are no randomized trials of SUTENT demonstrating clinical benefit such as increased survival or improvement in disease-related symptoms in renal cell carcinoma."
Check the following headers in Sutent label..

PRECAUTIONS
Left Ventricular Dysfunction
Hemorrhagic Events

"Tumor hemorrhages were observed as early as cycle 1 and as late as cycle 6"

"Serious, sometimes fatal gastrointestinal complications including gastrointestinal perforation, have occurred rarely in patients with intra-abdominal malignancies treated with SUTENT."

Skin Discoloration Sutent 33% Placebo 0%
Hair color changes Sutent 17% Placebo 0%
Hemorrhage/bleeding Sutent 26% Pacebo 1%
Check under...on and on and on it keeps going....Cardiovascular
Venous Thromboembolic Events
Seizures

Over dosage
OVERDOSAGE
No overdose of SUTENT was reported in completed clinical studies. In non-clinical studies mortality was observed following as few as 5 daily doses of 500 mg/kg (3000 mg/m 2 ) in rats. At this dose, signs of toxicity included impaired muscle coordination, head shakes, hypoactivity, ocular discharge, piloerection and gastrointestinal distress. Mortality and similar signs of toxicity were observed at lower doses when administered for longer durations.

Diarrhea Sutent 55% Placebo 5%
Nausea Sutent 54% Placebo 2%
Mucositis/stomatitis 53% Placebo 4%

[MrPoop]

You're just a detailing machine! Nice response, try that one on Dr. Who-gives-a-shit.

[justcurious4]

Thanks for the info... insurance approved it Friday 3/3 and it was added to their formulary this morning. Patient will be paying only a $50 copay.

Signed,
Dr. Who-Gives-A-Shit

[TimTam]

Bayers product Nexavar is now being considered for GIST due to its better safety profile than Sutent...

http://www.gistsupport.org/BAY_43-9006.html

[TimTam]

Sutent : Dose interruptions occurred in 48 patients (45%) on Study 1 and 45 patients (71%) on Study 2; one or more dose reductions occurred in 23 patients (22%) on Study 1 and 22 patients (35%) on Study 2."

Based on the lousy clinical trial design, we can't really tell how good the drug might be. Regardless, not many people can benefit from it because they can't keep taking it.
(from Yahoo message board)

Bayer??? Fucking BAYER??? You Nazi bastards need to stick to what you do best, which is gassing innocent men, women, and children. Fucking nazi shithead fucks. Die, every last fucking one of you, including your goddamn little Quisling sales reps in the USA. (look it up, retard).

Intelligent reply. Typical Pfizer approach... no substance to your argument thus you resort to character assassination. And by the way, you're implying that Bayer is more Nazi-like in the 21st Century than PFIZER? You gotta be fucking kidding me. What a whitewashed zombie!