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Actavis getting ready to launch at risk vs. Qsymia.

























Who is Mazur?

According to this group the generic approval of Qsymia is unlikely.

http://www.benzinga.com/news/13/10/...ceo-says-co-should-do-more-to-give-info-on-st


My thinking is that Actavis wanted to strike a deal with Vivus, but Vivus didn't like the terms. I think Actavis is bluffing. They do not want to spend $250 million in post clinical studies.
Aren't docs already prescribing the two agents individually already? I was at the AACE meeting and that seemed to be the prevailing thought. Also Belviq was a bit of a laugher...
 




can someone help me understand why that poor guy who writes about Arena/Belviq in Seeking Alpha tries so hard to spin every shred of info as if sales are good? Hope they pay him well to do that as it must be really hard.
 




Aren't docs already prescribing the two agents individually already? I was at the AACE meeting and that seemed to be the prevailing thought. Also Belviq was a bit of a laugher...

There is no question that doctors are prescribing generic phentermine and topiramate for patients. But what we are seeing is that doctors are only prescribing the generics if the patient has an issue with the cost and if only the patient brings it to the attention of the doctor. In general, we are seeing doctors prefer to prescribe Qsymia because of the some liability protection. Lets not forget that any off label use of a drug can place the doctor liable. With that being said, there are doctors who dispense generic phentermine and topiramate from their office. These particular doctors have their own "business model" and are unlikely to be converted to Qsymia prescribers.

What is interesting is that the average cost paid per script for Qsymia is $75 and Vivus said that will increase to $100 by the 4th quarter. I'm not 100% sure regarding the average price paid for Belviq because the company would not release specific information. Using some simple math it looks like about $30 per script.
 








$30 a prescription? What business are you in?

$200 for one month supply, 60 tabs.


You are correct, the cost of Belviq is $200, but that is not what the average patient is paying when you take into consideration free samples and discounts. Hopefully, patients will see the benefits of Belviq and be willing to pay retail price when those discounts are no longer available. Lack of insurance coverage is keeping the average price low.
 




You must own Arena stock. I'm not sure you understand the pharma/insurance company business relationships.

Either your insurance covers at some level of co-pay from the patient (then the insurance company is paying (WP $200 less co-pay less any Eisai rebate), or patient pays full retail out of pocket with samples/patient discount reducing the cost some. I don't believe they are aggressively sampling Belviq.

Somebody has to pay for the drug. You think Arena/Eisai can succeed with Belviq splitting revenue of $30 a month per prescription?

You need the government (Medicare, Medicaid, DOD, VA) or private insurance (United, WellPoint, etc.) to pay for it.
 




You are correct, the cost of Belviq is $200, but that is not what the average patient is paying when you take into consideration free samples and discounts. Hopefully, patients will see the benefits of Belviq and be willing to pay retail price when those discounts are no longer available. Lack of insurance coverage is keeping the average price low.

Free 14 day voucher is the sample being given to patients. They go to the pharmacy and receive two weeks free. After two weeks, the patient should know if they tolerate the drug..ie..side effects.

After the two week trial the patient then fills the prescription for 30,60, or 90 day supply. If Belviq is covered by managed care, co-pays are averaging $50-75 per month or 30 day supply..

If Belviq is not covered, then the patient pays cash price (minus $75 savings card) around $125-160 per month.

Around half of the weekly Trxs, since launch, for Belviq are free vouchers.
 




There is no question that doctors are prescribing generic phentermine and topiramate for patients. But what we are seeing is that doctors are only prescribing the generics if the patient has an issue with the cost and if only the patient brings it to the attention of the doctor. In general, we are seeing doctors prefer to prescribe Qsymia because of the some liability protection. Lets not forget that any off label use of a drug can place the doctor liable. With that being said, there are doctors who dispense generic phentermine and topiramate from their office. These particular doctors have their own "business model" and are unlikely to be converted to Qsymia prescribers.

What is interesting is that the average cost paid per script for Qsymia is $75 and Vivus said that will increase to $100 by the 4th quarter. I'm not 100% sure regarding the average price paid for Belviq because the company would not release specific information. Using some simple math it looks like about $30 per script.


The liability for off label use is almost nonexistent...their are many safe harbors like informed consent that absolve doc's off label liabilities. During the fen-phen lawsuits is was not due to combining two drugs that got doc's into trouble. As long as there is not a documented or well established contraindication there is very little to no risk. If anything what Q did was give an even brighter green light safety signal to write both drugs in combination.
 




The liability for off label use is almost nonexistent...their are many safe harbors like informed consent that absolve doc's off label liabilities. During the fen-phen lawsuits is was not due to combining two drugs that got doc's into trouble. As long as there is not a documented or well established contraindication there is very little to no risk. If anything what Q did was give an even brighter green light safety signal to write both drugs in combination.

Weight Loss specialist advertise generic Topamax and phentermine are available for weight loss!
 




The liability for off label use is almost nonexistent...their are many safe harbors like informed consent that absolve doc's off label liabilities. During the fen-phen lawsuits is was not due to combining two drugs that got doc's into trouble. As long as there is not a documented or well established contraindication there is very little to no risk. If anything what Q did was give an even brighter green light safety signal to write both drugs in combination.

Then why did the FDA impose a REMS for Vivus?
 








Weight Loss specialist advertise generic Topamax and phentermine are available for weight loss!

This is true, physicians are already using phentermine and generic Topamax for weight loss and a few weight loss clinics do advertise this generic combination.

Belviq is being written with phentermine in some cases.

I am not clear on why liability is part of the discussion.

If physicians were concerned about their financial health/liability, they would never write a prescription!

The concern about liability, for this discussion, is not relevant and shows a lack of business acumen.
 




Hey you big dummy, Drs rxing toperimate for weight-loss are playing Russian roulette. It's not indicated for that and if any little thing goes wrong, they are liable. The wt loss centers are big scams. All they did was be converted from pill mills to so called weight loss. You only see women go into these clinics because they are do Fn vain and stupid, they will try anything but proven rx meds to lose the cellulite from their big fat bodies.
 




Hey you big dummy, Drs rxing toperimate for weight-loss are playing Russian roulette. It's not indicated for that and if any little thing goes wrong, they are liable. The wt loss centers are big scams. All they did was be converted from pill mills to so called weight loss. You only see women go into these clinics because they are do Fn vain and stupid, they will try anything but proven rx meds to lose the cellulite from their big fat bodies.

Learn your industry jackass...many specialities use drugs routinely off label...it is a non issue other than diversion and abuse.