[Ip-health] Oregon moves closer to limiting access on hepatitis C drugs as Senate investigation begins

Jamie Love james.love at keionline.org
Wed Jul 16 13:05:57 PDT 2014


Oregon moves closer to limiting access on hepatitis C drugs as Senate
investigation begins

on July 14, 2014 at 4:13 PM, updated July 15, 2014 at 9:00 AM

The state of Oregon appears to be nearing what could be a
first-in-the-nation stance limiting availability to Medicaid patients of
new hepatitis C treatments that offer great promise at a very high price of
$84,000 per 3-month treatment.

On July 31, a state committee will consider guidelines intended to limit
treatment only to patients who face serious liver damage without the drug.
If adopted later this year, the approach would reduce the state's costs
from an estimated $168 million in the coming year to about $40 million.

"We are still wrestling with how to address the fact that this is a drug
that is very expensive and that we simply can't afford," said Tom Burns,
director of pharmacy programs for the Oregon Health Authority. "We can't
afford to treat everybody."

The Oregon move would come in addition to an investigation launched Friday
by U.S. Sens. Ron Wyden, D-Ore., and Chuck Grassley, R-Iowa, upping the
pressure on the maker of one of the new hepatitis C drugs, called Sovaldi.

Wyden chairs the Senate Finance Committee and Grassley is one of the
committee's senior minority party members.

Their letter demands numerous documents from Gilead Sciences concerning why
the firm is charging $84,000 for a standard treatment, when the firm that
actually developed the drug planned to charge only $36,000 per treatment.

Pharmasset Inc. spent $62 million developing the drug, according to the
senators' letter. Sales of the drug generated as much as $3.3 billion in
the first quarter of this year. Gilead purchased Pharmasset for $11 billion
in 2012.

Gilead Sciences has in the past largely declined to discuss its pricing,
but defended Sovaldi's efficacy.

Private insurers, as well as state Medicaid programs, have been raising
concerns about the drug nationally. Oregon has more legal authority to
limit coverage because of a federal waiver exempting the state from many
federal regulations.

Oregon's hand was also bolstered recently by an evaluation of the drug by
Oregon Health & Science University researchers that questioned the evidence
showing Sovaldi's effectiveness, and noted many of the drug's early
reviewers had financial ties to Gilead.

Wyden and Grassley are following up on the financial ties, demanding Gilead
disclose its payments to researchers as well as to three professional
associations that issued guidelines concerning the drug that OHSU called

Burns said Oregon, too, continues to probe the science behind Sovaldi,
specifically potential shortcomings in tests' design. "The question we keep
asking is 'OK, you say these patients have been 'cured,' but you haven't
followed them after the end of the (drug) trial,'" to verify the cure, he
said. "And they won't answer the question."

While other drugs, such as Olysio, also offer a new, $1,000-a-pill cure for
hepatitis C that lacks the side effects of current treatment, Sovaldi has
drawn more attention since early trials indicate it is more effective.

-- Nick Budnick

James Love.  Knowledge Ecology International
http://www.keionline.org, KEI DC tel: +1.202.332.2670, US Mobile:
+1.202.361.3040, Geneva Mobile: +41.76.413.6584,   twitter.com/jamie_love

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