For Ronit Zemel, a Washington, D.C.-based Jewish educator, the prescription medication Restasis—which she took to heal eye damage—was never affordable.
“I kept being told every time I went to the doctor’s office, ‘this is a constant problem,’ ‘look into getting it from Canada,’ ‘hopefully they’ll get a generic,’” said 25-year-old Zemel. When she found out the drug had a $605.50 copay, “I started to tear up at the pharmacy.”
Even with the help of a copay coupon, Zemel still needed financial assistance, which she got from her parents. After rationing the three-month supply of Restasis out over six months, she eventually stopped taking it, though it meant she had to give up contacts.
Yet, with her chronic condition, it’s possible that Zemel will have to take Restasis again at some point—and the prospect of it getting any cheaper seems even further away.
Last month, drugmaker Allergan PLC AGN, +0.19% announced that it has made a deal with a New York state American Indian tribe to help protect Restasis from competition, using the tribe’s sovereign immunity as a shield against patent challenges. The deal—the first such move by Allergan and, in the pharmaceutical industry, an unusual one at best—has unleashed a firestorm of criticism, including from lawmakers.
Restasis, a dry eye medication used for eye inflammation, is a powerhouse for Allergan. Last year, the medication brought in $1.4 billion in revenue, second only to Allergan’s top product, Botox.
Dry eye disease, characterized by chronic pain, dry eyes, eye discomfort and variable vision, is “maybe one of the most common reasons people seek eye care,” said Dr. Penny Asbell, director of the cornea and refractive surgery service at The Mount Sinai Hospital.
Restasis is synthesized from the anti-inflammatory cyclosporine, which has long been used to prevent organ rejection in transplant patients.
Unlike cyclosporine, which is used inside transplant patients’ bodies, Restasis is applied directly to the eye, where it’s thought to address underlying inflammation on the ocular surface. While inflammation is typically associated with pus and swelling, in dry eye the symptoms are now recognized as being more subtle, Asbell said.
Before Restasis was approved, in late 2002, lubrication was mainly used to alleviate dry eye disease, making Restasis, at the time, a “paradigm shift,” Asbell said.
Originally, patents on Restasis were set to expire in 2014. But Allergan filed more patents, covering the “specific formulation and the method of using” the product, that expire in 2024.
Restasis is expensive, with an average retail price of $574 for a 60-vial package, according to price comparison website GoodRx.
Although it has been around for a long time, until recently—with the FDA’s 2016 approval of Shire’s SHP, +0.08% lifitegrast—there were no direct competitors.
Doctors also prescribe topical steroids off-label for dry eye disease, Asbell said, but heavy use can cause a whole slew of other problems, including glaucoma, cataracts and risk of infection. Patients can also use various forms of lubrication, including eye drops, gels and ointments, Asbell said.
Patent experts say that the deal struck by Allergan could allow patents to endure until August 2024.
Lawmakers and patient advocates, meanwhile, are concerned not only about the implications for Restasis but whether this will set a pharmaceutical industry precedent.
The House Oversight committee wrote to Allergan Chief Executive Brent Saunders on Tuesday asking for documents and information regarding the deal.
The agreement “may impair competition across the pharmaceutical industry and ultimately dissuade companies from pursuing less-costly generic alternatives to brand drugs,” according to the letter.
Allergan said in a statement that it plans to comply with the information requests. But, the statement said, the Restasis deal does not fully shield the medication from patent litigation currently in federal district court.
“To be clear, if the district court ruling is adverse to Allergan’s patent position, and there is an FDA approval of a generic version of Restasis, that product could enter the market many years in advance of the listed patent expiry dates,” the statement said.
Lawmakers should focus instead on the inter partes review process, Allergan said, referring to another channel by which patents can be challenged and one that many drugmakers take issue with.
But patient advocates say they’re worried.
Allergan’s sham patent transfer is an effort to circumvent the law to prevent a cheaper generic of Restasis to come to market,” said David Mitchell, the co-founder and president of the non-profit Patients for Affordable Drugs. “Patients will be hurt by this. Patients are being hurt by this. And it’s an outrage.”
Mitchell’s group wrote a letter to industry group Pharmaceutical Research and Manufacturers of America’s President and Chief Executive Stephen Ubl, asking him to disavow the tactic. The group has not received a response, Mitchell said.