Zilretta has several things going for it. It’s not an opioid painkiller—a plus at a time when opioid addiction is a nationwide issue. It appears to be safer in diabetics than standard-of-care steroid shots. And it’s a longer-acting version of those traditional injections, meaning relief lasts longer.
But so far, the drug’s launch hasn't exactly taken off: Analysts expect 2018 sales of just $28 million. How is Flexion going to steer Zilretta toward that $1 billion in peak sales pharma watchers are expecting?
A midyear rollout for direct-to-consumer advertising, for one thing. More progress on getting reimbursement deals with payers. And continuing its push to get the brand into doctors' minds as a new option for patients with osteoarthritis.
The latter has been tough going. When Zilretta was approved last October, Flexion told analysts its 103-rep sales team could reach more than 9,000 orthopedists and rheumatologists, covering more than three-quarters of the market. Now, more than five months into its launch, a physician survey shows Flexion has work to do to boost awareness. RBC Capital, which polled 38 orthopedic surgeons, found that 15 of them (39%) hadn't even heard of Zilretta.
Of course, it's still early days, and Flexion's commercial chief, Dan Deardorf, said in March that his team is focusing on "depth versus breadth of our interactions with prescribers." And until DTC ads launch in a few months—following the traditional six-month waiting period after a new drug launch—getting the word out to doctors will still be job one.
“We want to make sure that we’ve got a solid base of physicians out there utilizing the product, so that when we activate the patient [with advertising] they’ve got a significant likelihood of receiving Zilretta when they go to ask about it," CEO Mike Clayman said during the company's fourth-quarter earnings call.
Doctors aware of Zilretta have faced some reimbursement hurdles—namely, the lack of a specific reimbursement code that makes payers' payment processing easier and faster. Doctors have been testing the reimbursement waters by treating very few patients first, Flexion executives have said.
To help them along, Flexion hired sales reps experienced at handling reimbursement for buy-and-bill products, and the company trained them to walk physicians and staff through the now-laborious reimbursement process. A field access team offers additional support for reimbursement problems. And on top of that, Flexion has a copay program—FlexForward—that can get patients started on the med and offers support for them, too. More than 95% of claims processed through FlexForward have been covered, Clayman told FiercePharma.
More favorable reimbursement codes are coming, too. Optimism about easing the reimbursement process is likely why analysts have pegged Zilretta’s 2019 sales at $129 million—an enormous leap from that $28 million expected this year.
In RBC's survey, 14 of the 38 physician respondents said they were waiting for feedback from patients or peers before stepping up their prescribing. Given Zilretta’s 12-week treatment cycle, it takes time to get that feedback. But Clayman and Deardorf said they've heard anecdotes about patients experiencing some serious pain relief.
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“It’s the patient experience that will ultimately shape the prescribers’ decision-making, and it’s this type of feedback that physicians will share with their peers,” said Deardorf during the fourth-quarter call.
As RBC points out, that's key to revving up the launch. “Bottom line, we believe the need for awareness and desire for feedback from patients/physicians remain the biggest hurdle, but color from initial returning patients is encouraging,” wrote RBC analysts in a note last month.
Phase 3 data showed Zilretta delivered consistent improvement in pain, stiffness and function. “It is rare, if not unprecedented, for a product to show such advantages" on all three of those measures, assessed by a standard instrument in clinical trials, Clayman said.
What’s more, it doesn’t trigger a significant rise in blood sugar, often seen when patients with Type 2 diabetes get immediate-release steroid shots—and that's promising for Zilretta, because 20% of patients with OA in the knee are diabetic. The company is playing up that advantage in talks with physicians.
Flexion has its eye on new indications that could broaden Zilretta's market to patients with OA in the shoulder and hip. The company estimates about 5.3 million OA patients get injected into the knee each year, while the combined number for shoulder and hip is 1.5 million.