[Ip-health] Loftus in WSJ: Cancer Drug Price Rises 1, 400% With No Generic to Challenge It

Peter Maybarduk maybarduk at gmail.com
Fri Jan 5 08:26:20 PST 2018

Apologies to IP-Health subscribers for the several late updates you are
about to receive .. we've had some email trouble.

---------- Forwarded message ----------
From: Peter Maybarduk <maybarduk at gmail.com>
Date: Tue, Dec 26, 2017 at 1:53 PM


Cancer Drug Price Rises 1,400% With No Generic to Challenge It - WSJ
with-no-generic-to-challenge-it-1514203201 1/3

Peter Loftus

Since 2013, the price of a 40-year-old, off-patent cancer drug in the U.S.
has risen 1,400%, putting the life-extending medicine out of reach for some

Introduced in 1976 to treat brain tumors and Hodgkin lymphoma, lomustine
has no generic competition, giving seller NextSource Biotechnology LLC
significant pricing power.

The U.S. Food and Drug Administration is seeking to encourage more
competition for drugs like lomustine, one of at least 319 drugs for which
U.S. patents have expired but which have no generic copies, according to a
list the agency published earlier this month.

The FDA says it will speed up review of any applications to market generic
copies of the drugs on its list, as part of a broader effort to encourage
lower drug prices. An FDA spokeswoman said the agency has received
inquiries from several companies about products on the list, but that it is
too soon to gauge overall interest in the products. But as the experience
with lomustine shows, attracting generic competition to some older drugs
can be hard to pull off.

For many years, lomustine was marketed under the brand name CeeNU by
Bristol-Myers Squibb Co., which charged about $50 a capsule for the highest
dose, before selling the product in 2013. Now, the same capsule costs about
$768, after nine price increases by a little-known Miami startup,
NextSource, which supplies lomustine in a deal with the drug’s new owner,
manufacturer CordenPharma. NextSource, which rebranded the drug as
Gleostine, most recently raised the price by 12% in November, on the heels
of a 20% increase in August, according to analyses drug-price tracker
Truven Health Analytics and Elsevier performed for The Wall Street Journal.
Prices also have increased significantly for other doses of the drug.

‘This is simply price gouging, period,’ said Duke University’s Henry
Friedman, pictured with nurse practitioner Christina Cone. Robert DiCrisci,
chief executive of NextSource, said in a statement the company bases its
pricing on product-development costs, regulatory-agency fees, and the
benefit the treatment delivers to patients. The company provides discounts
to uninsured patients and those with financial limitations, he said.

The price hikes after the change in ownership are similar to what some
other companies including Valeant Pharmaceuticals International Inc. and
Turing Pharmaceuticals have done in recent years. Normally, rising prices
for a product should attract more competition. But Rena Conti, an assistant
professor at the University of Chicago who studies health policy, said
generic-drug makers have to carefully choose which drugs to make because
there can be big entry costs and time commitments associated with obtaining
regulatory approval and dedicating manufacturing capacity.

“There still may be opportunities for entering other markets that would be
more enticing to firms than this market,” she said. Even for medicines that
have a generic version, about 40% have only one generic supplier, according
to a study she co-wrote this year.

Many of the drugs on the FDA’s list are for small patient populations, and
companies may decide it isn’t worth the investment to sell generic copies,
said Chip Davis, president and CEO of generic-industry trade group
Association for Accessible Medicines. He said the FDA’s steps, however,
could entice more companies to enter markets for older drugs.

Lomustine isn’t widely prescribed. In 2015, the most-recent year for which
data were available, Medicare Part D prescription-benefit plans paid for
1,694 prescriptions in the U.S., according to the Centers for Medicare and
Medicaid Services. But because of the price increase, Part D spending on
the drug jumped to about $608,000 in 2015 from $163,000 the year before.

The drug has gained renewed interest among oncologists because recent
government-funded studies show its use with other chemotherapies can
significantly prolong survival in patients with certain brain tumors, said
Ashley Sumrall, section chief of neuro-oncology with Carolinas HealthCare
System in Charlotte, N.C.

Some cancer doctors are taking notice of the price hike. “This is simply
price gouging, period,” said Henry S. Friedman, a neuro-oncologist and
professor of neurosurgery at Duke University School of Medicine. “People
are not going to be able to afford it, or they’re going to pay a lot of
money and have financial liability.” He co-wrote an editorial criticizing
lomustine’s pricing in The Cancer Letter newsletter in September.

Mallika Weant, a clinical pharmacist in Duke’s brain-tumor clinic, said
some of the clinic’s patients have opted for less-costly medications
because they can’t afford lomustine. The doses are based on body weight,
and some patients must take multiple capsules, adding to the cost.

Even insured patients often have to pay for a portion of their medicines
out of pocket. Andrea Gratzer of Denver, N.C., said her husband Gary, a
patient at Duke, was prescribed Gleostine in September to treat a brain
tumor. But a representative from a specialty pharmacy for their Medicare
drug-benefit plan, EnvisionRx, told them the out-of-pocket costs would be
$2,815 for a 30-day supply, Ms. Gratzer said.

EnvisionRx didn’t return a call seeking comment. When Ms. Gratzer told her
husband, he said that was too expensive, she said. She called Duke, and a
doctor changed the prescription to another drug, Temodar, that was more
affordable. “We really can’t afford the lomustine,” Ms. Gratzer said. “That
was the drug of choice. He wouldn’t do it.”

More information about the Ip-health mailing list