The launch of new cancer pill Jakafi will require extensive education, said Incyte Pharmaceuticals, owing partly to low awareness levels among doctors.
“Don't expect a bolus of new patients based on pent-up demand,” cautioned Incyte's Pat Andrews, EVP and chief commercial officer. In addition to the usual need to educate on how the drug is used and who the appropriate patients are, she said, “The majority of physicians are not well informed about the drug.”
Jakafi is the first FDA-approved JAK inhibitor, a class of drugs which may be useful in oncology and rheumatology therapy. Close behind Incyte is Pfizer's JAK inhibitor tofacitinib, an oral product which has been widely viewed as having potential for unseating some of the injected rheumatoid-arthritis drugs. Physicians have been clamoring for an alternative to offer their needle-shy patients, raising expectations for tofacitinib. Pfizer hopes to get approval in the second half of 2012.
As the first drug specifically approved for myelofibrosis—a rare, life-threatening blood cancer—Jakafi (ruxolitinib) also represents an advance, yet has not generated a high awareness level. Andrews cited blinded research the firm conducted that showed more than 90% of hematology/oncology specialists were at least open to trying "a product like Jakafi" on one of their patients during the first six months after approval.
Launching through specialty pharmacies this week, Jakafi was sanctioned by the FDA for treating patients with intermediate or high-risk myelofibrosis. Incyte's marketing strategy includes a mix of direct and non-personal selling tactics.
“As with any new medication, especially one with a first-in-class mechanism of action in a disease where there have been limited therapies, we'll need to increase awareness and education in the communities, of availability and appropriate use,” said Andrews. “That will take a while, because the prescriber base is dispersed and the majority of physicians are likely to have only a handful of myelofibrosis patients each.”
The firm has a field force numbering 60 territory managers in place to cover about 6,500 treating physicians -- primarily specialists in hem/onc. Each rep averages 18 years of experience, including 11 in hem/onc, and many have established relationships with providers, Andrews said.
“We'll complement these direct educational efforts with a variety of non-personal, multichannel promotional activities that will help drive awareness and use of Jakafi,” she said. “Uptake will be gradual but steady."
While Incyte declined to give any sales guidance on a conference call about the approval, Collins Stewart's Salveen Richter estimated total sales reaching $773.5 million by 2016, if the drug works in additional indications. It's in Phase III testing for polycythaemia vera, which according to Richter is a more lucrative indication than myelofibrosis.
Incyte estimated that myelofibrosis affects about 16,000 to 18,500 people in the US. The firm said it would charge $7,000 a month ($84,000 a year) for the new pill. The Street had expected a per-patient premium of $40,000-$60,000 per year. Reimbursement support and educational resources will be provided for patients, the company said. Novartis is handling the ex-US launch.