Over the last two and a half years those of us who work in the perinatal mental health field have been eagerly waiting for the release of brexanolone. Since Tuesday's FDA approval it has been a whirlwind of lovers and haters taken to media of all types to offer comments. I would like to offer some thoughtful feedback and point out some facts that have been missing in most interviews and articles.
First lets start with the cost, since that seems to be on the highlight of everyone's comments. $34,000 is a lot of money for a treatment of any kind. BUT lets compare this price tag to a few other quality of life changing infusions. IG or immunoglobulin treatments of autoimmune disorders costs $10,000 per infusion and a typical treatment cycles is 3 infusions. Remicade for Rheumatoid Arthritis cost up to $16,000 per infusion which requires 3 infusions to start plus 8 week maintenance infusions. The cost to get a drug to market and available to have as a treatment option here in the United States on average is 2.6 BILLION dollars. In order to continue to have new treatments as options, scientists and manufacturers require funding. Furthermore, a drug cost reported to the FDA is the cost before pharmaceutical benefits price negotiation and insurance coverage. The cost of this medication will be subject to the same copay/coinsurance as other treatments. If this is a treatment that is appropriate for a patient, the treatment team will work with her insurance company to get it covered.
Now lets talk about treatment response. The biggest study looking at antidepressant treatment response to date is the STAR D, which showed an average "response rate" - defined by a 50% reduction in symptoms, NOT remission of symptoms, was 34.7% after 6 weeks of treatment. Brexanolone showed a 70% REMISSION rate after 60 hours. This my friends, is what got it fast tracked through the FDA w/ 30 day follow ups indicating symptoms were still in REMISSION. To any mom that has suffered from postpartum depression and lost precious time bonding with her baby this is amazing.
The medication itself is an endogenous human hormone allopregnanolone, it is NOT a synthetic substance. The medication is truly offering the first of its kind treatment to treat the depression specifically related to 1 in 5 moms suffering from postpartum depression.
Access to this medication at least in Minnesota is the biggest hurdle. At this time there are NO facilities offering the infusion, closest for our MN patients at this time is Chicago.
No drug is perfect, there are side effects, treatment costs and even in this case time away from family (60 hours which is considerably less than a typical inpatient psychiatric stay by the way). This treatment is not for everyone and no one says you have to do it if you have postpartum depression. It is an option to be discuss as team with your providers. The biggest benefit of all the buzz over the last 5 days is that people are talking about PPD and all perinatal mood and anxiety disorders. Awareness, de-stigmatization and education are our best defense against these treatable conditions. If you or someone you know is experiencing depression, anxiety or any other mental health condition before, during and after pregnancy please contact [email protected], call/text 612-787-7776 and/or visit PPSUPPORTMN.org.
https://www.nytimes.com/2014/11/19/upshot/calculating-the-real-costs-of-developing-a-new-drug.html
https://www.sciencedirect.com/science/article/pii/S0140673617312643
https://www.sciencedirect.com/science/article/pii/S0140673618315514
First lets start with the cost, since that seems to be on the highlight of everyone's comments. $34,000 is a lot of money for a treatment of any kind. BUT lets compare this price tag to a few other quality of life changing infusions. IG or immunoglobulin treatments of autoimmune disorders costs $10,000 per infusion and a typical treatment cycles is 3 infusions. Remicade for Rheumatoid Arthritis cost up to $16,000 per infusion which requires 3 infusions to start plus 8 week maintenance infusions. The cost to get a drug to market and available to have as a treatment option here in the United States on average is 2.6 BILLION dollars. In order to continue to have new treatments as options, scientists and manufacturers require funding. Furthermore, a drug cost reported to the FDA is the cost before pharmaceutical benefits price negotiation and insurance coverage. The cost of this medication will be subject to the same copay/coinsurance as other treatments. If this is a treatment that is appropriate for a patient, the treatment team will work with her insurance company to get it covered.
Now lets talk about treatment response. The biggest study looking at antidepressant treatment response to date is the STAR D, which showed an average "response rate" - defined by a 50% reduction in symptoms, NOT remission of symptoms, was 34.7% after 6 weeks of treatment. Brexanolone showed a 70% REMISSION rate after 60 hours. This my friends, is what got it fast tracked through the FDA w/ 30 day follow ups indicating symptoms were still in REMISSION. To any mom that has suffered from postpartum depression and lost precious time bonding with her baby this is amazing.
The medication itself is an endogenous human hormone allopregnanolone, it is NOT a synthetic substance. The medication is truly offering the first of its kind treatment to treat the depression specifically related to 1 in 5 moms suffering from postpartum depression.
Access to this medication at least in Minnesota is the biggest hurdle. At this time there are NO facilities offering the infusion, closest for our MN patients at this time is Chicago.
No drug is perfect, there are side effects, treatment costs and even in this case time away from family (60 hours which is considerably less than a typical inpatient psychiatric stay by the way). This treatment is not for everyone and no one says you have to do it if you have postpartum depression. It is an option to be discuss as team with your providers. The biggest benefit of all the buzz over the last 5 days is that people are talking about PPD and all perinatal mood and anxiety disorders. Awareness, de-stigmatization and education are our best defense against these treatable conditions. If you or someone you know is experiencing depression, anxiety or any other mental health condition before, during and after pregnancy please contact [email protected], call/text 612-787-7776 and/or visit PPSUPPORTMN.org.
https://www.nytimes.com/2014/11/19/upshot/calculating-the-real-costs-of-developing-a-new-drug.html
https://www.sciencedirect.com/science/article/pii/S0140673617312643
https://www.sciencedirect.com/science/article/pii/S0140673618315514
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