Friday, July 18, 2014 10:55:00 AM
http://blogs.wsj.com/pharmalot/2014/07/17/oregon-to-pharma-lets-make-a-deal-on-hepatitis-c-drugs/?mod=yahoo_hs
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This article contained a lot of "meat" for me, and served to reinforce what I have felt, what I have read.
The issue of pricing is looming larger and larger. This article does not convey who will win but shows some of the issues in play.
Some of the issues.....
Some coverage may become binary; all or nothing based upon price. At least that is the saber rattling push back the article relates. In the same manner that Gilead will strive to keep it's Sovaldi/ledipasvir price as high as possible, the states and other payors will push as hard as they can to keep the prices as low as possible. We are also seeing similar push back in the EU, where the prices paid will be publicized, compared between some countries.
Historically, Gilead has had premium prices, and whereas they also have a potentially shorter treatment, and some feel the best all around treatment it seems unlikely that they will cut prices deeply. This could mean a windfall for Abbvie/Enta.
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The article also conveys what I have wondered; the potential approval of the Abbvie 3D treatment by October. This article seems to suggest it is possible. One even wonders if the Abbvie NDA submission date arrived at a time that might make the 3D approval time come *nearly* as early as Gilead's, but not so early as to make it first to have to price the drug treatment. It could very well be that the second to approval will have an advantage of sorts. If the downside were to only be missing a few weeks of the first HCV DAA launch, it may well be worth it it gained revenues by the benefit of optimizing the pricing against Gilead's.
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(quote from the article)
"Oregon’s current coverage policy for Sovaldi usually requires that patients have significant liver scarring, or what’s known as stage-three or stage-four fibrosis. On July 31, an advisory committee of physicians will consider a recommendation by Oregon Medicaid staff to narrow the eligibility criteria to include only patients with stage-four fibrosis, the point at which liver damage starts to become irreversible, or cirrhosis, Burns says."
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This part speaks to what some of the early treatment groups may look like. They may be comprised of a larger group of cirrhotics, many of whom are past treatment failures.
This group should almost certainly require 12 weeks of treatment with ribavirin, without regard to whether it is the Abbvie or Gilead treatment. This is one area in which the Abbvie 3-D treatment may be better than Gilead's, will have comparable patient side effects and treatment duration.
It is also an area where Abbvie has perhaps betters stats, better dedicated trials and more clear outcomes. Abbvie had it's own dedicated cirrhotics trial. Gileads were mixed into other groups which to some degree may have obfuscated the results.
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There is a palatable lack of love for Gilead and it's pricing strategies, and this article also conveys that.
At the moment, Congress is looking for someone to blame for the high prices. I don't look down on Gilead for doing what all drug companies do, but I note that there is a lot of pressure on price, and it would not surprise me to see an earlier Abbvie 3D drug approval, so that the companies are brought to the table to compete. It would not take much for Abbvie to capture a larger than expected market share.
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Off topic, slightly, but I saw that Adam F supposed that ENTA might not be one of those small cap bubblicious biotechs opined by Yellen;
http://www.thestreet.com/story/12775982/1/biotech-stock-mailbag-acelrx-yellen-aftermath-nymox.html?puc=yahoo&cm_ven=YAHOO
(page 2 of this article)
(AF wrote)
"I wouldn't make a blanket statement that all small-cap biotech stocks are over-valued. Enanta Pharmaceuticals (ENTA_) hit an all-time high stock price this year, but I'd say that's justified given the potential for its hepatitis C drugs in partnership with Abbvie"
~W
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