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Wednesday, April 24, 2024

Drug prices to plummet in wave of expiring patents

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The cost of prescription medicines used by millions of people every

day is about to plummet.

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The next 14 months will bring generic versions of seven of the

world’s 20 best-selling drugs, including the top two: cholesterol

fighter Lipitor and blood thinner Plavix.

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The magnitude of this wave of expiring drugs patents is

unprecedented. Between now and 2016, blockbusters with about $255

billion in global annual sales are set to go off patent, notes

EvaluatePharma Ltd., a London research firm. Generic competition

will decimate sales of the brand-name drugs and slash the cost to

patients and companies that provide health benefits.

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Top drugs getting generic competition by September 2012 are taken

by millions every day: Lipitor alone is taken by about 4.3 million

Americans and Plavix by 1.4 million. Generic versions of

big-selling drugs for blood pressure, asthma, diabetes, depression,

high triglycerides, HIV and bipolar disorder also are coming by

then.

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The flood of generics will continue for the next decade or so, as

about 120 brand-name prescription drugs lose market exclusivity,

according to prescription benefit manager Medco Health Solutions

Inc.

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“My estimation is at least 15 percent of the population is

currently using one of the drugs whose patents will expire in 2011

or 2012,” says Joel Owerbach, chief pharmacy officer for Excellus

Blue Cross Blue Shield, which serves most of upstate New

York.

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Those patients, along with businesses and taxpayers who help pay

for prescription drugs through corporate and government

prescription plans, collectively will save a small fortune. That’s

because generic drugs typically cost 20 percent to 80 percent less

than the brand names.

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Doctors hope the lower prices will significantly reduce the number

of people jeopardizing their health because they can’t afford

medicines they need.

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Dr. Nieca Goldberg, director of The Women’s Heart Program at NYU

Langone Medical Center in Manhattan, worries about patients who are

skipping checkups and halving pills to pare costs.

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“You can pretty much tell by the numbers when I check the patient’s

blood pressure or cholesterol levels,” that they’ve not taken their

medications as often as prescribed, she says.

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Even people with private insurance or Medicare aren’t filling all

their prescriptions, studies show, particularly for cancer drugs

with copays of hundreds of dollars or more.

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The new generics will slice copayments of those with insurance. For

the uninsured, who have been paying full price, the savings will be

much bigger.

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Daly Powers, 25, an uninsured student who works two part-time jobs

at low wages, says he often can’t afford the $220 a month for his

depression and attention deficit disorder pills. He couldn’t buy

either drug in June and says he’s struggling with his Spanish class

and his emotions. He looks forward to his antidepressant, Lexapro,

going generic early next year.

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“It’d make all the difference in the world,” says Powers, of Bryan,

Texas.

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Generic medicines are chemically equivalent to the original

brand-name drugs and work just as well for nearly all

patients.

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When a drug loses patent protection, often only one generic version

is on sale for the first six months, so the price falls a little

bit initially. Then, several other generic makers typically jump

in, driving prices down dramatically.

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Last year, the average generic prescription cost $72, versus $198

for the average brand-name drug, according to consulting firm

Wolters Kluwer Pharma Solutions. Those figures average all

prescriptions, from short-term to 90-day ones.

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Average copayments last year were $6 for generics, compared with

$24 for brand-name drugs given preferred status by an insurer and

$35 for nonpreferred brands, according to IMS Health.

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Among the drugs that recently went off patent, Protonix, for severe

heartburn, now costs just $16 a month for the generic, versus about

$170 for the brand name. And of the top sellers that soon will have

competition, Lipitor retails for about $150 a month, Plavix costs

almost $200 a month and blood pressure drug Diovan costs about $125

a month. For those with drug coverage, their out-of-pocket costs

for each of those drugs could drop below $10 a month.

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Jo Kelly, a retired social worker in Conklin, Mich., and her

husband Ray, a retired railroad mechanic, each take Lipitor and two

other brand-name medicines, plus some generic drugs. Both are 67,

and they land in the Medicare prescription “doughnut hole,” which

means they must pay their drugs’ full cost, by late summer or early

fall each year. That pushes their monthly cost for Lipitor to about

$95 each, and their combined monthly prescription cost to nearly

$1,100.

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Generic Lipitor should hit pharmacies Nov. 30 and cost them around

$10 each a month.

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“It would be a tremendous help for us financially,” she says. “It

would allow us to start going out to eat again.”

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For people with no prescription coverage, the coming savings on

some drugs could be much bigger. Many discount retailers and

grocery chains sell the most popular generics for $5 a month or

less to draw in shoppers.

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The impact of the coming wave of generics will be widespread – and

swift.

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Insurers use systems that make sure patients are switched to a

generic the first day it’s available. Many health plans require

newly diagnosed patients to start out on generic medicines. And

unless the doctor writes “brand only” on a prescription, if there’s

a generic available, that’s almost always what the pharmacist

dispenses.

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“A blockbuster drug that goes off patent will lose 90 percent of

its revenue within 24 months. I’ve seen it happen in 12 months,”

says Ben Weintraub, a research director at Wolters Kluwer Pharma

Solutions.

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The looming revenue drop is changing the economics of the

industry.

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In the 1990s, big pharmaceutical companies were wildly successful

at creating pills that millions of people take every day for common

conditions, from heart disease and diabetes to osteoporosis and

chronic pain. Double-digit quarterly profit increases became the

norm.

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But the patents on those blockbusters, which were filed years

before the drugs went on sale, last for 20 years at most, and many

expire soon.

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In recent years, many drug companies have struggled to develop new

blockbuster drugs, despite multibillion-dollar research budgets and

more partnerships with scientists at universities and biotech

companies. The dearth of successes, partly because the “easy”

treatments have already been found, has turned the short-term

prognosis for “big pharma” anemic.

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“The profit dollars that companies used to reinvest in innovation

are no longer going to be coming,” warns Terry Hisey, life sciences

leader at consultant Deloitte LLP’s pharmaceutical consulting

business. He says that raises “long-term concerns about the

industry’s ability to bring new medicines to market.”

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But pharmaceutical companies can save billions when they stop

promoting drugs that have new generic rivals, and U.S. drug and

biotech companies are still spending more than $65 billion a year

on R&D.

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The 20 new drug approvals in the U.S. this year, and other

important ones expected in the next few years, eventually will help

fill the revenue hole.

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For now, brand-name drugmakers are scrambling to adjust for the

billions in revenue that will soon be lost. Many raise prices 20

percent or more over the last couple years before generics hit to

maximize revenue. Some contract with generic drugmakers for

“authorized generics,” which give the brand-name company a portion

of the generic sales.

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Brand-name companies also are trimming research budgets, partnering

with other companies to share drug development costs and shifting

more manufacturing and patient testing to low-cost

countries.

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Pharmaceutical companies have cut about 10 percent of U.S. jobs in

four years, from a peak of about 297,000 to about 268,000,

according to Labor Department data. Nearly two-thirds of the cuts

came in the last 1 1/2 years, partly because of big mergers that

were driven by the need to shore up pipelines and boost profit in

the short term by slashing overlap.

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Drug companies also are trying to stabilize future sales by putting

more sales reps in emerging markets such as China and India, and

diversifying into businesses that get little or no generic

competition. Those include vaccines, diagnostic tests, veterinary

medicines and consumer health products.

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As the proportion of prescriptions filled with generic drugs jumped

to 78 percent in 2010, from 57 percent in 2004, annual increases in

prescription drug spending slowed, to just 4 percent in 2010.

According to the Generic Pharmaceutical Association, generics saved

the U.S. health care system more than $824 billion from 2000

through 2009, and now save about $1 billion every three

days.

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The savings are only going to get greater as our overweight

population ages. People who take their medicines regularly often

avoid costly complications and hospitalizations, says AARP’s policy

chief, John Rother, bringing the system even bigger savings than

the cheaper drugs.

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In addition, many patients taking a particular brand-name drug will

defect when a slightly older rival in the same class goes

generic.

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Global sales of Lipitor peaked at $12.9 billion in 2006, the year

Zocor, an older drug in the statin class that reduces bad

cholesterol, went generic. Lipitor sales then declined slowly but

steadily to about $10.7 billion last year. That still makes Lipitor

the biggest drug to go generic.

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For patients, it’s a godsend.

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Douglas Torok, 59, of Erie, Pa., now spends nearly $290 every three

months for insulin for his Type 2 diabetes, plus four daily pills,

including Lipitor, Plavix and two generics, for his blood pressure

and cholesterol problems. The $40,000-a-year foundry supervisor

fears not being able to cover the out-of-pocket costs when he

retires and doesn’t have a generous prescription plan.

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In the meantime, once Lipitor and Plavix get generic competition

his copayment will plunge from the current $1 per day for

each.

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“I will pay $16 for 90 days” for both, says Torok, who hopes to

travel more. “It’s a big deal for me on my income.”

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Brand-name drugs going off patent through 2015:

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Brand-name and generic drug price comparisons:

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