heartburn medicine Prilosec

[Guest guest]

Disturbing article.. especially for me, since B/C (Caremark)

only considers PREVACID a " preferred drug " and I can

not take it.. therefore, I pay for " off brand " .. meaning

$27 for one month or $54 for a 3 mo. mail order prescription

for Prilosec! I am very greatful that we have prescription

drug coverage. BUT, our co-pay for a 3 month supply of

medications was $470.21! (COBRA is an added

$769.79 PER MONTH!!!!!!)

Wonder if there is anything WE can do?

elaine

& & & & & & & & & & & & & & & & & & & & & & & & & & & & & & &

washingtonpost.com

http://www.washingtonpost.com/wp-dyn/articles/A12031-2002Mar24.html

Coalition Seeks to Curb Drug Patent Extensions

By Ceci Connolly

Washington Post Staff Writer

Monday, March 25, 2002; Page A01

When the heartburn medicine Prilosec hit the market 12 years ago, doctors

and patients couldn't get enough of it. By 2000, it was the best-selling

drug in the world and generated an estimated $4.7 billion in U.S. sales for

maker AstraZeneca.

But now the distinctive purple pill is giving the nation's governors,

private companies -- and other people who pay the medical bills --

heartburn.

Faced with tight budgets and rising medical costs, big health care consumers

were counting on the price to plummet last fall. That's when Prilosec's

20-year patent was set to expire and a cheaper generic version would have

been available. But through a series of legal and regulatory maneuvers,

AstraZeneca has kept its generic competitor off the market, and consumers

say they are paying the price.

Governors estimate a one-year delay would cost state Medicaid programs $300

million. At General Motors, where 346,000 Prilosec prescriptions were

written for employees last year, the carmaker loses $1.3 million every month

it cannot purchase the generic version, said the company's chief pharmacist,

Kirman.

AstraZeneca, on the other hand, collects $5.6 million in unanticipated

revenue every day Prilosec retains its monopoly.

AstraZeneca is far from alone. At least 12 drug companies have been using a

similar strategy to extend the patents on lucrative drugs. Federal law

grants an automatic 30-month extension each time a manufacturer simply

claims generic approval would infringe on its patent. The Food and Drug

Administration may also extend patents if the manufacturer asks to list a

new use of the drug, a new chemical property in it or even new packaging.

The law also provides an extra six months exclusivity if the drug maker

conducts safety trials for children.

The strategy has increasingly become a source of friction between drug

companies and those who foot the bill. In recent weeks, an unlikely

coalition of governors, corporate executives, union leaders and health care

advocates has emerged to fight the trend. With some backing from the generic

manufacturers, the Business for Affordable Medicine is lobbying Congress and

the Bush administration to close what it says are costly loopholes in drug

patent laws.

" These numbers are astronomical, " Vermont Gov. Dean (D) said. " This

is taking a terrible toll on state budgets, and we are all victimized. "

South Carolina Gov. Jim Hodges (D) has adopted the Prilosec nickname " purple

crack " because his state health plans " have become addicted to it. "

For their part, drug companies argue that they are simply protecting their

legitimate business concerns under the law.

Jeff Trewhitt, spokesman for the industry's lobbying arm, the Pharmaceutical

Research and Manufacturers of America, or PhRMA, emphasized that only a

fraction of prescriptions on the market are embroiled in patent fights and

that consumers must consider the savings a breakthrough drug can provide.

" In many cases, these drugs are keeping patients out of hospitals and

nursing homes, " Trewhitt said. " That is good not only from the standpoint of

their quality of life but it's also saving money. "

The fight stems from the Hatch-Waxman Act, which Congress passed in 1984 in

an attempt to strike a balance between the high cost of developing

life-saving drugs and the financial burden of purchasing those medications.

Pharmaceutical companies that spend hundreds of millions of dollars to bring

a new drug to market receive 20-year exclusive patents. By the time the

drugs make it onto the market, they generally end up with 12 years of market

dominance. The 30-month extensions, which can be obtained multiple times,

were designed to give companies time to prove their cases in court.

The industry's opponents say manufacturers abuse the system by filing

frivolous appeals that take advantage of the loopholes in the law to stretch

out patent protection months or years longer than intended.

" To me, profit is not a dirty word, but you've also got to play by the

rules, " said South Dakota Gov. J. Janklow, a Republican running for

Congress. " What the drug companies are doing is obvious. They get to the

very end of a patent, then change the color or throw in an inert ingredient

and claim they need a new patent. "

In the past two years, Bristol-Myers Squibb has stalled the market debut of

generic versions of its diabetes medication Glucophage, the anti-anxiety

drug BuSpar and cancer therapies Platinol and Taxol, say the researchers for

the Business for Affordable Medicine coalition.

In the case of Prilosec, AstraZeneca argues it is strictly following the

provisions of the law, first taking advantage of the pediatric exclusivity

and then suing Andrx Corp. for what it believes are patent violations. " We

have not taken advantage of any loopholes in Hatch-Waxman, " company

spokeswoman Bloom-Baglin said. The case is pending in a New York

court.

More broadly, the brand-name makers say the generic drug industry has fared

well under the rules of Hatch-Waxman, which award a six-month exclusive

patent to the first generic to go on the market.

" Generics have almost tripled in sales, from [controlling] 19 percent of the

market in 1984 to about 47 percent in 2001, " said PhRMA's Trewhitt.

Insured Americans, for the most part, are unaware of the Prilosec

phenomenon. Premiums and co-payments rise each year, but the price

difference between a brand name and generic is rarely known. But states and

private employers have been busy tallying the costs.

If New Hampshire Gov. Jeanne Shaheen (D) could switch Medicaid patients to

the generic versions of those drugs, the state would save about $2.4 million

annually, she said.

" That would provide Meals on Wheels for 57,000 seniors five days a week, "

she said. " It would buy dental care for 8,000 children or well-child

checkups on 43,000. "

Shaheen, who is running for the Senate, said senior citizens who do not have

drug coverage face higher costs. In the bucolic town of Heniker, N.H., a

30-day supply of Prilosec sells for $152. Shaheen said the generic would

likely cost half that much.

" That's real money, " she said. " That $76 a month adds up. "

Just as Shaheen sees the equation in medical trade-offs, the corporate world

copes by shifting costs. If drug spending is up, companies find other places

to trim, such as the employee's benefits package or salary, said Bruce

Bradley, head of health policy at General Motors.

" We do not have unlimited health care dollars, " he said. " Spending money on

a brand name when a generic drug would work just as well is not spending

wisely. At the end of the day, the consumer gets hurt. " GM spent $55 million

on Prilosec last year.

Prilosec is not the only budget buster. A Business for Affordable Medicine

survey of 46 states found the Medicaid programs expect to spend $1.3 billion

annually on 17 drugs scheduled to go off patent within three years. These

include the antibiotic Augmentin, the antidepressant Zoloft and the

arthritis drug Relafen. If the generic versions become available

immediately, states expect to trim $600 million from their budgets.

Some are looking to Washington for a solution. Eighteen governors have

written to Health and Human Services Secretary Tommy G. and

officials at the FDA asking the government to exert its authority over

unnecessary patent extensions. The bipartisan National Governors Association

also passed a policy calling on Congress to convene hearings.

Some are lobbying for legislation drafted by Sens. McCain (R-Ariz.) and

E. Schumer (D-N.Y.) that would eliminate many of the extensions and

streamline the approval process for generics.

A few states, pessimistic that Washington will act, have devised other cost

controls.

Florida's Medicaid program, for example, covers only prescriptions on its

" preferred " drug list. If the state finds several drugs that work equally

well, it will generally list the cheaper one. Physicians who wish to

prescribe a more expensive version must get " prior authorization " from the

state.

Prilosec, which cost the state $55.4 million in 2000, is not on the list,

said Kitchens, bureau chief of Medicaid pharmacy services. Instead,

most patients receive Protonix or Prevacid. " There is no significant

clinical difference in what they bring, " he said. " It really comes down to

price. "

Missouri requires doctors to first prescribe generic heartburn medications

such as Zantac and Pepcid. If those fail, a physician can request Prilosec,

said Oestreich, director of the Medicaid pharmacy program. The switch

saved Missouri more than $26 million in Prilosec costs.

California, with its 2.5 million Medicaid recipients, negotiates its own

deals with drug companies. The competitive bidding saves the state about

$270 million in a drug budget of $3.8 billion, said Stan Rosenstein,

assistant deputy director of medical care.

Despite the success in reducing their expenditures on the original purple

pill, those states are worried about AstraZeneca's latest heartburn

prescription, Nexium. Physicians, including Vermont's Dean, say there is no

significant difference between Prilosec and Nexium.

But AstraZeneca persuaded the FDA to issue a 20-year patent for Nexium, and

the company is racing to switch patients to the new brand. Turn on the

television today or click on heartburn on the Internet and there's no

mention of the original purple pill.

According to the new marketing campaign: " Today's purple pill is Nexium. "

© 2002 The Washington Post Company