[Ip-health] Times-Herald: Long wait for generic biologic drugs leaves some patients with few options when insurance expires

[Sarah Rimmington]

http://www.thetimesherald.com/article/20091101/NEWS01/911010312
The Times-Herald (Port Huron, MI)
November 1, 2009
High cost of living
Long wait for generic biologic drugs leaves some patients with few
options when insurance expires

By MAUREEN GROPPE
Gannett Washington Bureau
STEPHEN TAIT
Times Herald


Rob Day waited two decades for a cure to his rare blood condition.

For the 41-year-old Lexington man, the day never came.

"I went 20 years waiting for a miracle cure to come," he said. "Well, I
got the next best thing."

That next best thing is Soliris, a biomedic drug that allows Day to
function on a day-to-day basis. It is a drug that costs more than
$32,000 a month, a cost covered by his insurance plan.

The bad news is that, though he's been on the drug just two years, he
has only a few years of eligibility left before he reaches his insurance
plan's $2 million cap on benefits.

"I'm assuming I'm going to have to go off Soliris," said Day, who works
for the Times Herald as a graphic designer and multimedia technician.

Day said the medicine is the reason he has the energy to play with his
young daughters, Maddie, 8, and Gabby, 5. His blood condition --
paroxysmal nocturnal hemoglobinuria -- causes red blood cells to break
down prematurely and can lead to anemia, blood clots, shortness of
breath and severe pain.

Day can't switch to a cheaper, generic version of Soliris because there
isn't one.

Pharmaceuticals made from chemicals face competition from generics soon
after their patents expire, but the Food and Drug Administration doesn't
have a similar, streamlined approval process

for alternative versions of drugs that are made from living organisms,
as Soliris is.

Biologic drugs, a small but growing share of prescriptions, are
increasingly used to treat arthritis, cancer, diabetes and other
diseases. They're also expensive. The breast cancer drug Herceptin can
cost $48,000 a year, and the rheumatoid arthritis drug Remicade can cost
about $20,000.

The health care bills moving through Congress would create an easier
approval system for what are called "bio-similars." But they would give
brand-name inventors a longer period of market exclusivity than critics
say is justified.

Day spent two days this fall in Washington, D.C., in front of medical
leaders, lobbyists and aides to lawmakers telling his story as part of
Teva Pharmaceuticals' Year of Affordable Healthcare campaign.

He said once his insurance cap is hit, he has only a couple of options,
including costly independent plans.

Day spends an hour and half every two weeks at a Port Huron hospital
getting the medicine through intravenous drip, a process he can't skip
without fear of blood clots.

The outcome of the health care bills will make a difference not just to
patients such as Day, but also to taxpayers.

Brand-name drugs made from chemicals get five years of market
exclusivity after their patent expires before generic versions can be sold.

The 12-year period of market exclusivity for biologics that's in the
bills could save consumers and the government an estimated $25 billion
during the course of 10 years, according to the Congressional Budget
Office. A shorter exclusivity period would save more but also take more
out of drug makers' profits.

Critics say the issue is a prime example of how the drug industry isn't
contributing enough to the health overhaul, despite its commitment to
giving up
$80 billion during the course of 10 years.

"This is the low-hanging fruit," said Mark Merritt, head of the
Pharmaceutical Care Management Association, which represents companies
that manage drug benefit programs for employers. "If you can't get this
right in terms of cost control, what can you get right?"

The Federal Trade Commission has said biologic drugs don't need a longer
exclusivity period than regular drugs because biologics are more
difficult and costly to duplicate. That means makers of brand-name drugs
will keep much of their market share -- and profits -- even after facing
competition, according to the commission.

The brand-name drug industry argues it needs enough incentive to
continue researching and developing new drugs.

The Pharmaceutical Research and Manufacturers of America, the trade
association for the industry, also says its $80 billion commitment to
the health care reform effort isn't too low, because brand-name drug
makers won't gain as many new customers under the health reform plans as
the industry's critics say they will.

Because most people without health insurance are younger and relatively
healthy, they won't need many prescriptions, PhRMA argues. And the new
prescriptions that would be filled by the newly insured are more likely
to be generic versions. As a result, PhRMA says, the industry's revenues
won't grow more than 1% and could go down as much as 2%.

"Despite what critics say, coverage expansions are not expected to
generate a material upside for America's pharmaceutical research and
biotechnology companies," said Ken Johnson, senior vice president of
PhRMA. "Forcing the industry to provide additional sacrifices could lead
to catastrophic job losses."

Because the House and Senate bills both include the 12-year exclusivity
period favored by the industry, it will be difficult for opponents to
reduce that when a final version of the bill is being negotiated.

Difficult, but not impossible, according to former GOP Rep. Bill Thomas
of California, a main architect of the Medicare drug benefit Congress
created in 2003.

"If a lot of people believe they haven't played fairly in the game ...
there's a way to play the game better than they have," Thomas said of
pharmaceutical companies.

That means amending the bills with other provisions the industry doesn't
like, such as measures allowing drugs to be imported from other
countries or allowing the government to negotiate with drug companies
for cheaper Medicare drugs. House Democrats added the latter provision
to the revised version of the House bill released Thursday.

That change and others could be used as bargaining chips when
negotiators meet to resolve differences between the House and Senate bills.

"You've got to move amendments that put them at risk so when you close
the door and ... you want to deal with the 12 years, they don't thumb
their nose at you," Thomas said. "It's the only way you're going to be
able to resolve this at this late stage."

--
Sarah Rimmington
Attorney
Essential Action, Access to Medicines Project
Washington, DC
Tel: +1 (202) 387-8030
Cell: +1 (202) 422-2687
www.essentialaction.org/access/

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