CNN
—
Pharmaceutical companies Sage Therapeutics and Biogen are still weighing how much the newly approved postnatal depression drug zranolone will cost if it hits the US market this year.
Zranolone will be marketed under the brand name Zurzuvae and is expected to launch in the fourth quarter of 2023, with the companies’ goal being to prescribe it in patients with postpartum depression (PPD), according to Sage Therapeutics spokesman Matt Henson. The aim is to make the drug available to anyone who is being treated. he said in an email on Tuesday.
“We plan to facilitate this through our Patient Access Program, which includes co-payment assistance for eligible PPD adults with commercial insurance,” Henson wrote. “We look forward to discussing these efforts and other planned support for PPD women closer to launch.”
The U.S. Food and Drug Administration on Friday approved zranolone for the treatment of postpartum depression, making it the first U.S. pill specifically for the condition estimated to affect about 1 in 8 new mothers. . Zranolone is a tablet taken daily for two weeks.
Questions remain as to what that price will be and when an announcement about that price will be made.
“Regarding the timing of pricing, as we get closer to launch, we will be discussing access strategies and other aspects of commercialization,” Sage Therapeutics CEO Barry Green said at a conference call. . company webcast with analysts on Monday. “It will be closer to launch.”
When Sage Therapeutics and Biogen applied for FDA approval of zranolone, they also submitted an application for the treatment of major depressive disorder in adults as well as postpartum depression.
they announced last week In its letter, the FDA said the drug’s application did not provide substantial evidence to support approval of zranolone for the treatment of major depressive disorder, which requires more research.
“As part of the final preparations, Sage and Biogen are currently working to determine how to adjust pricing thinking in light of the PPD label, as zranolone is only approved for the treatment of postpartum depression. As we get closer to the product launch, we plan to provide more clarity on our overall thinking,” said Chris Benecki, chief business officer at Sage Therapeutics, during a webcast Monday.
“Today, we can say that approximately 55% of births in the United States are covered by commercial insurance. We have a goal of making Zurzvae accessible to the majority of women in the country with minimal out-of-pocket costs,” Beneki said. “The rest of the birth will be covered through Medicaid, requiring little or no financial responsibility from the patient.”
Benecki said a payer’s decision on the coverage of the dart fly is expected within months of the U.S. Drug Enforcement Administration’s decision to schedule zranolone as a controlled substance, and is expected to be determined within 90 days. added.
Sage and Biogen are expected to price Zurzvae three times higher, according to Salim Saeed. The reason is that it has not been able to get approval for major depressive disorder, which affects 15 million people in the United States, and about 500,000 people are approved for postpartum depression. Wei Year, an analyst at Wall Street firm Mizuho, said:
Said said in an email Tuesday, referring to another sage drug for PPD that is administered via an IV drip and costs about $35,000, and wrote that he hopes “they will come close to Zlesso’s pricing.” rice field. Analysts noted that Sage said it would price Zurzvae below $10,000 if it also cleared for major depressive disorder, a key criterion for coverage through Medicare. wrote Mr.
Stacey Dusetsina, a professor of health policy at Vanderbilt University Medical Center, said the idea that companies should charge higher prices for drugs when patient numbers are low is not new.
“This is very similar to how the industry claims pricing works,” she said. “There is a strong argument that, for example, in the rare disease space, the price per person must be very high because the number of people using it is small.”
It is estimated that more than 400,000 babies are born to depressed mothers in the United States each year. Left untreated, postpartum depression can last for months or even years, according to the National Institute of Mental Health.
“The approval of zurzvae for the treatment of postpartum depression is a major milestone for the hundreds of thousands of women experiencing this underdiagnosed and untreated condition,” Biogen said. President and Chief Executive Officer Christopher A. Wiebacher said in a news release on Friday.
“We would like to thank our patients, patient advocates and researchers for their support in helping us reach this milestone,” Wiebacher said. “We believe zurzvae will be an important option for the treatment of PPD, and we will thoroughly review the feedback from the FDA regarding the use of zranolone in MDD to determine our next steps.”
CNN’s Meg Tyrrell contributed to this report.
