But peramivir will soon have competition. The federal government said late Thursday that it had also ordered 10,000 treatment courses each of intravenous versions of Tamiflu and Relenza, with options to buy 30,000 more courses of each.
Those drugs could not be used, however, until they received emergency use authorizations from the F.D.A.
The government is paying an average of only $450 a course for those other drugs — only one-fifth of what it is paying for peramivir.
Right now, Dr. Lurie said, peramivir is the only drug that can be used intravenously so the government had to pay a high price. “I would say that one of the things that happens in the market when you have competition is that the price drops.”
It looks like the government wants to create competition and reduce the price of intravenous (IV) anti-virals. The problem is that Tamiflu IV and Relenza IV, have not even gone through Phase 1 or Phase 2 clinical trials yet, much less Phase 3. Receiving Emergency Use Approval (EUA) will prove to be a challenge, as BCRX receiving EUA for Peramivir has been challenging enough--even after years of clinical trials.
This is a case of two big foreign pharmaceutical companies fighting back to regain market share they've lost to an upstart US biopharmaceutical company. Tamiflu and Relenza are still effective in many cases against the novel H1N1 virus in their present form, oral and inhalant, respectively. But the seasonal flu is almost 100% resistant to Tamiflu, and starting to show resistance against Relenza.
IV Peramivir has shown to have 90% efficacy in saving lives of complicated cases of the H1N1 virus--when all other measures have failed. If and when Tamiflu IV and Relenza IV receive EUA, it remains to be seen whether they can show similar capability in saving lives.
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Sounds to me like IV Tamiflu and IV Relenza may be being sold at "dumped" prices (sold below normal value in order to obtain market share). How can a company sell such a small quantity of an experimental unapproved drug at such low prices? There is no way that $450/course reflects the normal value (all related costs, including R&D, clinical trials, plus a normal markup). No way.
ReplyDeleteAgain, a US prodcer is subjected to unfair foreign Big Pharma competition.
clawmann, you could be right. Although the prices of oral Tamiflu and the Relenza inhalant are much lower than IV Peramivir. The troubling aspect is that neither IV Tamiflu or IV Relenza have been through clinical trials, so ICU MD's are rolling the dice, assuming the IV versions will work when the oral and nasal compounds didn't--and hoping the IV versions are safe. When someone's life is on the line, trying to saving a few hundred dollars on a risky solution doesn't seem prudent to me.
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