Big-name drugmakers want to profit from selling lower-priced copies of rivals' expensive biotechnology drugs. Patients and doctors want to pay less for medicine.
Getting those two sides together is harder than it looks. Part of the problem: a web of relationships between drug companies and insurers that shields incumbent drugs and often sidelines upstarts until the market becomes crowded.
Pfizer said this month that Inflectra, its version of the blockbuster Johnson & Johnson rheumatoid arthritis drug Remicade, brought in $94 million in the second quarter. Remicade, a biologic medicine made from living cells, booked $1.53 billion in sales in the period and had 2016 sales of $7 billion.
Ascension Health, a nearly 23,000-bed nonprofit hospital system based in St. Louis, spends $55 million a year on Remicade, more than any other drug. Using Inflectra, part of a new class of medicines called biosimilars, would save it at least $10 million annually, according to Ascension's chief pharmacist, Roy Guharoy. He met with Pfizer and planned to integrate Inflectra into care more often until learning that insurers preferred to stay with Remicade.
"This we did not expect," Guharoy said. "If the insurance companies force us to use the branded product, of course our hands are tied."
Pfizer says the playing field is tilted against its drug.
"Access for Inflectra has been substantially limited due to [Johnson & Johnson's] pursuit of exclusionary contracting with insurers and providers. Our lower-priced product has not received access at parity to Remicade and remains in a disadvantaged position despite recent price increases of Remicade," the company said in a statement.
Johnson & Johnson spokesman Caroline Pavis said in a statement that Remicade is sold in a highly competitive market and that health plans decide on coverage.
Biosimilars have faced a difficult path to market. Doctors and patients tend to be loyal to innovative drugs that have worked well; payers are cautious in adopting new alternatives; and biosimilars can't be swapped at the pharmacy because they aren't identical to the drugs they aim to replace.
Remicade, known as infliximab and first approved in the U.S. in 1998 for treating the digestive disorder Crohn's disease, was cleared for rheumatoid arthritis a year later. It marked a seismic shift for the 1.3 million patients who today suffer from swelling and pain in the joints. By 2008, it was the top-selling drug in Johnson & Johnson's pharmaceutical division.
"Most rheumatologists are very happy with the drugs we have. I wouldn't switch a patient if they were doing well on infliximab simply for the economics of it," said Susan Goodman, rheumatologist at Weill Cornell Medicine and New York-Presbyterian. "However, if a patient could only be given Inflectra, that would be a different argument."
Johnson & Johnson told analysts on a recent conference call that it has protected Remicade's turf by setting up its contracts with payers for the year. Johnson & Johnson has exclusive contracts in nearly half its market, according to analyst Ronny Gal of Sanford Bernstein & Co., meaning payers agree to cover only Remicade for rheumatoid arthritis. Johnson & Johnson also bundled drugs and devices with hospitals and gave discounts to infusion centers, Gal wrote.
"We view biosimilars as competitive entrants and we compete for continued access to Remicade for patients," said Pavis, the Johnson & Johnson spokesman. "Patients should have affordable access to medicines their health care providers determine are best for them."
UnitedHealth Group, the largest U.S. insurer, recently told providers that Remicade remains its preferred drug for coverage. Remicade is still on next year's list of preferred medicines at pharmacy-benefit managers Express Scripts Holding Co. and CVS Caremark, run by CVS Health Corp.
A Cigna Corp. spokesman declined to comment. Representatives for Anthem Inc., Aetna, and UnitedHealth Group didn't respond to requests for comment.
Pfizer began selling Inflectra in November at $946 a vial, a 15 percent discount to Remicade's then-price of $1,113. But Johnson & Johnson has retained its pricing power, boosting Remicade's price to $1,168, a 64 percent increase since 2011. Johnson & Johnson says discounts and rebates, among other factors, can lower the drug's actual sale price.
Other biosimilars have taken time to get traction. When Novartis division Sandoz launched white-blood-cell booster Zarxio, the first biosimilar approved in the U.S., two years ago, it cost 15 percent less than Amgen's Neupogen. Since then, Neupogen has gradually lost its dominance, with sales sliding from $1.4 billion in 2013 to $765 million last year. But another similar drug, Granix by Teva Pharmaceutical Industries, has been cleared, and Express Scripts earlier this month became the second pharmacy-benefit manager to exclude Neupogen from its list of covered medicines.
Remicade faces a similar turning point. Merck and Samsung Bioepis started selling a Remicade biosimilar this month at a 35 percent discount to Johnson & Johnson's medication. Some analysts say that could be enough to move more sales away from Remicade.
"The moment the second or third comes in, then you have a price war," said Pratap Khedkar, a consultant at ZS Associates who studies the biosimilar market.
Doctors are still waiting for that moment. Jonathan Kay, a rheumatologist at the University of Massachusetts Memorial Medical Center in Worcester, Mass., said he tried to prescribe Inflectra to a patient last year. He says Inflectra and Remicade are essentially equivalent and going with a cheaper alternative is the more "responsible" thing to do.
However, Kay's hospital found Inflectra cost $25 more than Remicade a vial, a discrepancy he attributes to pricing negotiations involving the supply chain.
"That was a hard stop," he said. "They didn't go any further."
Makers of name-brand drugs once opposed biosimilars, citing safety among other concerns, but now say they have the manufacturing muscle and experience to produce and distribute the drugs.
"For 20 years, until maybe this year, the brand industry's position was, 'Don't take a biosimilar, it's scary, it's dangerous," said Bruce Leicher, senior vice president and general counsel at Momenta Pharmaceuticals Inc., which sells generics and is developing biosimilars. "That's what doctors have been told. All of that has to be overcome, and it could take a year or two until this becomes routine, like generics are a routine presence."
At the same time, increasing competition to make drugs more affordable is a priority for policy makers. The Food and Drug Administration wants every off-patent medicine to have competition and it has been reviewing dozens of biosimilar applications.
A wave of biosimilars is expected to hit the market in coming years, including competitors for top-selling cancer drugs such as Amgen's bevacizumab, marketed as Avastin by Genentech, now a unit of Roche Holding, and Mylan's version of Herceptin from Genentech.
SundayMonday Business on 08/21/2017