- Sage Therapeutics plans to price its postpartum depression drug Zulresso between $20,000 and $35,000 per course of treatment, if the Food and Drug Administration approves the therapy as expected in December.
- Company CEO Jeff Jonas, speaking on an earnings call Tuesday, said Sage would disclose the final list price for Zulresso, along with details on a planned patient support program, following an FDA decision.
- The regulator is currently set to decide on the drug by Dec. 19. An approval looks likely after an advisory panel voted last week in support of the drug's risk-benefit profile. In Europe, discussions are ongoing with the European Medicines Agency.
If approved, Zulresso (brexanolone) would become the first drug approved by the FDA specifically for postpartum depression, the most common medical complication of childbirth.
Sage believes the therapy, administered intravenously over 60 hours, has the potential to act on symptoms within days, rather than weeks or months.
"[As a one-time infusion, we] believe Zulresso may set the stage for rethinking how psychiatric disorders are treated, as illnesses rather than chronic lifetime conditions," Jonas said.
However, there are some potential barriers to the drug's uptake if it hits market. The price could raise eyebrows, although Raymond James analyst Laura Chico believes rebates could bring Zulresso's net price down to $14,000 per treatment course.
Sage also noted its drug is a one-off treatment, rather than a chronic therapy.
"We've done extensive work to support that range of $20,000 to $35,000, including engagement with payers… [and] extensive pricing research," said Mike Cloonan, Sage's chief business officer, on an earnings call.
Zulresso will also likely come with a Risk Evaluation and Management Strategy due to issues with dizziness and loss of consciousness seen in clinical testing. That could restrict administration to only certain certified locations, raising practical issues given the long administration time.
Sage expects it could launch Zulresso in late March of next year, given reimbursement considerations and drug scheduling by the Drug Enforcement Agency that would need to take place following an approval.
"We're getting comfortable that there'll be multiple pathways to reimbursement in the hospital setting. We feel confident that with the high unmet need that exist[s] with PPD… those pathways to reimbursement will open up," said Cloonan. "We expect [the] REMS program will require administration of Zulresso and monitoring by a qualified trained staff in a healthcare setting that has been certified under the REMS program."
Home infusion is unlikely to be an option at time of launch, but will be discussed by Sage and the FDA. A patient registry will help to provide further safety data.
Sage has put in place a sales team of 180, and expects to focus on inpatient centers that can meet any REMS program imposed by the FDA.