Vertex Urges CDC to Recommend Hep C Screening

[Guest guest]

Vertex Urges CDC to Recommend Hep C Screening, To Nudge " Second Tsunami " of

Patients

Luke Timmerman 2/2/11

If Vertex Pharmaceuticals gets its way in talks with U.S. public health

officials, most people over 50 could soon get blood tests to screen for

hepatitis C infections at the doctor's office. If the U.S. Centers for Disease

Control and Prevention (CDC) agrees this is a good idea, it could prompt another

1 million patients who don't realize they are infected to come out of the

woodwork and start clamoring for Vertex's new hepatitis C drug over the next few

years.

The Cambridge, MA-based biotech company (NASDAQ: VRTX), which has operations in

San Diego, has joined other drugmakers in supporting studies they hope will

persuade the CDC to recommend routine screening for hepatitis C, Vertex CEO Matt

Emmens said in a recent interview. The company is one of the sponsors of what's

called the Viral Hepatitis Action Coalition, a public-private partnership with

the CDC, which is conducting studies known as BEST-C. These studies could

determine how effective it is to screen patients for hepatitis C infection more

widely.

These studies, which are expected to cost a total of $3.6 million, could be

worth billions to Vertex if they show that screening random Baby Boomers is

worthwhile.

An estimated 600,000 patients in the U.S. are expected to seek treatment that

could include Vertex's drug, or a rival offering from Merck, if the FDA clears

the new drugs for sale as analysts expect in the middle of this year. The two

new protease inhibitors are being hailed as major steps forward, as they have

been shown to roughly double cure rates of hepatitis C, a viral infection that

damages the liver over many years. Vertex's drug, telaprevir, has shown it can

push the cure rate up as high as about 75 percent, while cutting the treatment

time in half to about six months. That means patients don't have to endure such

a long period of flu-like symptoms, which has traditionally discouraged many

patients from getting treatment.

The new advance from Vertex, demonstrated in a trio of pivotal clinical trials,

has created this huge wave of pent-up demand from patients and doctors. Knowing

this, many analysts have projected the product will be pretty much an instant

hit, topping $2 billion in U.S. sales after just a couple years. But then, some

expect sales to taper off, as many of the most motivated patients get cured, and

don't need the drug anymore. Essentially, they see Vertex possibly becoming a

victim of its own success.

Matt Emmens

That's not how it will play out, says Emmens, a marketing veteran who spent much

of his career at Merck. An estimated 3.2 million to 3.9 million people in the

U.S. have chronic hepatitis C infections. That's a lot more than the initial

wave of patients, which is mostly composed of people who sought treatment before

but relapsed. Besides those patients, many more candidates are Baby Boomers who

don't know they contracted the hepatitis C infection decades ago through

unprotected sex, IV drug use, or blood transfusions from contaminated supplies.

Many of these infections lie dormant for about 20 years or more, but are just

now starting to emerge over the decade to come, Emmens says. Some patients won't

see symptoms at all, and as the AP pointed out in this solid feature last month,

it's hard to tell which infected patients are likely to get the worst symptoms.

The unluckiest ones will end up suffering severe liver scarring (cirrhosis),

liver cancer, liver transplants, and ultimately, premature death.

Connecting with that massive crowd of patients, who aren't motivated to seek

treatment today because they don't see any really bad symptoms yet, is one of

the big marketing challenges Vertex faces. The company is planning to spend some

of its $1.3 billion cash hoard on a public awareness campaign designed to urge

people to get tested to see if they have the virus, Emmens says. But even more

important than the ad campaign, Vertex is hoping the CDC will recommend routine

hepatitis C screening, which would start turning up a lot more positive tests.

If it does, Emmens he predicts it could prompt another 1 million patients to

seek treat treatment around 2014 and later, right as the most people in the

initial wave of highly motivated patients go home having been cured.

" You have an estimated 2 million people out there who are not aware they are

infected, " Emmens says. " Some don't know, or just don't give a damn, or have

other problems, and won't seek treatment. But if you found 1 million new

patients over a two or three-year period, there's a second tsunami. "

As for analysts predicting telaprevir will rise and fall, Emmens shook his head.

" That's absurd. I understand they've got to do their job. But from a marketing

guy's perspective, that just doesn't happen unless you lose your patent, " Emmens

says. " Docs use what works. Patients will come in, and they will want the

highest chance they can get of a cure. That's what they really care about. " A

shorter treatment period, and more convenient twice-daily dosing instead of

thrice-daily are a couple of other features Vertex is hoping to incorporate into

hepatitis C treatment, he adds.

Vertex has clearly been spending a lot of time lately thinking about making its

case to insurers. The trick will be to persuade insurers that it's worth

spending quite a bit of money upfront on a potent new drug to attack a dormant

infection, as opposed to waiting to see if patients get sick years later and

rack up big hospital bills. Emmens notes that liver transplants cost around

$300,000, and, obviously, not everyone who wants a new liver actually survives

long enough to get to the top of the waiting list. Vertex, citing an actuarial

study it sponsored to try to measure the cost of future treatment, says medical

costs in the U.S. for people with hepatitis C are expected to more than double,

from $30 billion in 2009 to approximately $85 billion—presumably when factoring

in a lot of liver transplants.

I must say I'm personally wary of drugmakers who use their money and influence

to rewrite health guidelines that end up favoring their bottom line. Companies

that want to sell more drugs for high blood pressure, osteoporosis, and obesity

have been known to push for new health guidelines that classify many more people

as " Suddenly Sick " as a couple of my former Seattle Times colleagues wrote in a

terrific investigative story in 2005. Whether this aggressive new treatment is

really beneficial to people's health over the long run is often unknown.

This case strikes me as somewhat different, though, because today's available

hepatitis C treatment is really so poor. Vertex and Merck are essentially coming

along with drugs that represent a big leap ahead with potential to cure hundreds

of thousands, maybe millions, of people. It will probably cost taxpayers a few

billion dollars a year for many years to come, and it's always hard to say for

sure how many billions you might save down the road when people don't end up in

the hospital getting liver transplants. But you can be sure Vertex is working

hard behind the scenes right now to convince officials that an ounce of

prevention is worth a pound of cure.

Luke Timmerman is the National Biotech Editor of Xconomy, and the Editor of

Xconomy Seattle. You can e-mail him at ltimmerman@..., or follow him at

twitter.com/ldtimmerman.

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