Doctors caution that the usefulness of a new rheumatoid arthritis drug from AbbVie, while a welcome addition to their tool kits, will depend on how insurance companies decide to cover it.
On Friday, the Food and Drug Administration approved upadacitinib, which will be sold under the brand name Rinvoq, for adults with moderate to severe rheumatoid arthritis who either can't take or aren't responding to methotrexate. AbbVie set the annual list price for Rinvoq at $59,000.
Rheumatoid arthritis is the first of many indications AbbVie is targeting on the path to what executives are forecasting as $6.5 billion in Rinvoq sales by 2025. The company needs Rinvoq and its other recently approved immunology drug, Skyrizi, to do well as its mega-blockbuster Humira will lose patent protection in a few years, putting $20 billion of revenue at risk.
In the meantime, one of AbbVie's biggest goals is to move patients off Humira and onto the two newer drugs. Yet there are obstacles in its path.
Rinvoq and Skyrizi, a psoriasis medicine, operate in highly competitive markets. More than a half dozen rheumatoid arthritis treatments cleared the FDA in the past decade. They joined an already lengthy list of options that includes anti-TNF therapies like Humira and Enbrel, as well as more traditional DMARDs — short for disease-modifying antirheumatic drugs.
The competition has meant more negotiating power for payers as well as the ability to steer the treatment course for many patients. That could be a challenge for Rinvoq, which is part of a newer class of anti-inflammatory agents that inhibit enzymes called Janus kinases, or JAKs.
"I would like to start JAKs earlier on in more patients, but sometimes the insurance companies give us a hard time. So going down the DMARD and then the TNF route is probably easier to do," Priyanka Iyer, an associate of internal medicine at University of Iowa Health Care, said in an interview.
Iyer and other rheumatologists who spoke to BioPharma Dive agreed that having another marketed JAK inhibitor is a positive for patients, especially those who aren't responding to currently available options or those who are reluctant to get injections or infusions. JAK drugs like Rinvoq, Eli Lilly and Incyte's Olumiant and Pfizer's Xeljanz are all small molecules and taken orally.
But the doctors acknowledged they're mindful about whom they prescribe JAKs for in light of recent safety concerns.
Last month, the FDA issued a boxed warning on Xeljanz for increased risk of blood clots and death. The decision came a little more than a year after the FDA approved Olumiant, with the condition its label carry a warning for the risk of serious infections, malignancies and blood clots. Rinvoq's label highlights similar risks.
Still, physicians appear open to using JAK drugs, so long as a patient doesn't seem predisposed to the potential risks.
"I don't think we've had any changes in our prescribing patterns based on side effects, but I'm certainly very careful to monitor them," Nilanjana Bose, a rheumatologist with the Rheumatology Center of Houston, told BioPharma Dive.
Payers pose a bigger roadblock than safety.
Many rheumatoid arthritis drugs are expensive. The wholesale acquisition cost for Humira is $62,088. For Xeljanz it's $53,772. Olumiant looks relatively cheap at its launch price of $25,642, but the dose approved and its safety profile puts it at a competitive disadvantage.
Given their strong positions, payers can push back against these high-priced offerings and require patients fail on earlier, less expensive therapies before moving on to JAK inhibitors. It's a path many older patients find themselves on.
"Unfortunately, a lot of patients who are on stable injectable regimens, when it comes to that 65 age and insurance wants us switch them, sometimes they need to actually go down the infusion pathway before they come back to the orals," Iyer said.
"So that's just a long route to basically come back to what they could have been on earlier."
AbbVie says it's offering a patient support program and a co-pay card that could keep out-of-pocket costs for commercially insured patients who meet certain criteria at $5 per month. Patients with limited or no health insurance may qualify for another program called myAbbVie Assist to access Rinvoq.
"If this drug comes and it's well covered and it has a good support system with patient access, I think it will work fairly well in that case," Bose said. "When Xeljanz came out they had a really robust patient assistance program, so that helped the patients who could not afford it with regular insurance."
AbbVie shares were up 2.3% to $64.45 at market's close Friday.