Lodi News-Sentinel

U.S. remains the world’s most expensive market for ‘biologic’ drugs

- By Sarah Jane Tribble

Europeans have found the secret to making some of the world’s costliest medicines much more affordable, as much as 80 percent cheaper than in the U.S.

Government­s in Europe have compelled drugmakers to bend on prices and have thrown open the market for socalled biosimilar­s, which are cheaper copies of biologic drugs made from living organisms. The brand-name products — ranging from Humira for rheumatoid arthritis to Avastin for cancer — are highpriced drugs that account for 40 percent of U.S. pharmaceut­ical sales.

European patients can choose from dozens of biosimilar­s, 50 in all, which have stoked competitio­n and driven prices lower. Europe approved the growth hormone Omnitrope as its first biosimilar in 2006, but the U.S. didn’t follow suit until 2015 with cancertrea­tment drug Zarxio.

Now, the U.S. government stops short of negotiatin­g and drugmakers with brand-name biologics have used a variety of strategies — from special contractin­g deals to overlappin­g patents known as “patent thickets” — to block copycat versions of their drugs from entering the U.S. or gaining market share.

As a result, only six biosimilar­s are available for U.S. consumers.

European countries don’t generally allow price increases after a drug launches and, in some cases, the national health authority requires patients to switch to less expensive biosimilar­s once the copycat product is proven safe and effective, said Michael Kleinrock, research director for IQVIA Institute for Human Data Science.

If Susie Christoff, a 59-yearold who suffers from debilitati­ng psoriatic arthritis, lived in Italy, the cost of her preferred medicine would be less than quarter of what it is in the U.S., according to data gathered by GlobalData, a research firm.

Christoff tried a series of expensive biologics before discoverin­g a once-a-month injection of Cosentyx, manufactur­ed by Swiss drugmaker Novartis, worked the best.

Without the medicine, Christoff said, her fingers can swell to the size of sausages.

“It’s 24/7 constant pain in, like, the ankles and feet,” said Christoff, who lives in Fairfax, Va. “I can’t sleep, (and) I can’t sit still. I cry. I throw pillows. It’s just ... awful.”

At first, Christoff ’s copay for Cosentyx was just $50 a month. But when a disability led her to switch to a Medicare Advantage plan, her out-of-pocket costs ballooned to nearly $1,300 a month — more than three times her monthly car loan.

Christoff, with the help of her rheumatolo­gist, Dr. Angus Worthing, tried Enbrel, Humira and other drugs before finding Cosentyx, the only drug that provides relief.

Christoff ’s case is “heartbreak­ing,” Worthing said.

Novartis declined to respond to questions about Cosentyx’s price. Instead, like other pharmaceut­ical companies, Novartis says it offers patient assistance programs for those who can’t afford the drug. Christoff said she doesn’t qualify for financial assistance.

Like other biologics, Cosentyx costs thousands of dollars per month. The annual cost of Christoff ’s treatment runs about $65,000 in the U.S. In Italy, where competitio­n and price negotiatio­ns play a bigger role, it would run about $15,000, according to GlobalData.

In England, Dr. Christophe­r Griffiths, a lead researcher at the National Institute for Health Research who treats patients with Cosentyx, said the National Health Service would pay about 10,000 pounds, or less than $13,000.

And those drastic price difference­s are true even though there is no biosimilar version of Cosentyx yet available in Europe, and might not be for years.

The cost of the drug is taking a toll on Christoff. This past summer, her progressiv­e disease made it difficult to enjoy the annual family vacation with her three grown children and their kids in Virginia Beach, Va.

“I can’t get down on the sand to play with my kids without help. I can’t get up without help,” Christoff recalled. “I’m not ready to stop trying. But I’m also not ready to go through my entire retirement fund to walk.”

Unlike Cosentyx, rival drugs — Humira, Enbrel and Remicade — all face biosimilar competitio­n in Europe. Only Remicade has competitio­n from a lower-cost biosimilar in the U.S., and Humira isn’t expected to have a copycat competitor in the U.S. market until 2023. Humira, made by AbbVie, is the world’s top-selling drug.

 ?? SARAH JANE TRIBBLE/KAISER HEALTH NEWS ?? Food and Drug Administra­tion Commission­er Scott Gottlieb takes questions on biosimilar developmen­t during a September public hearing at the agency’s White Oak campus.
SARAH JANE TRIBBLE/KAISER HEALTH NEWS Food and Drug Administra­tion Commission­er Scott Gottlieb takes questions on biosimilar developmen­t during a September public hearing at the agency’s White Oak campus.

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