This Is What We Know…The Latest On The New PPD Drug, Zulresso.
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For many women, having a baby is all they ever wanted. Pregnancy, and the promise of motherhood, will make you the happiest woman on earth. However, the reality for 1 in 5 women is a far cry from the what they always dreamed of. Postpartum depression, anxiety, OCD, and other perinatal mood and anxiety disorders become the new reality, and for these women options are scarce. Women suffer in silence. Mom guilt descends, screening is spotty, providers are untrained, treatment is sparse, and it’s one of the greatest causes of maternal mortality. So on March 19th when the FDA approved Zulresso, the first drug ever for postpartum depression, the game changed. But, initial reports of lengthy hospital stays and costs over 30K created a huge backlash from skeptics and hopefuls alike.
Lisa Tremayne is the Director Center of the Perinatal Mood and Anxiety Disorders in Long Branch, NJ. This center is one of only a handful across that country that is hospital based and provides support and treatment for women suffering from PMADs. Lisa has also been part of Sage Therapeutic’s (maker of Zulresso) advisory council and returns to the Bloom Foundation (she is also President) after meeting with the Sage team and other leaders in the PMAD field in Washington DC to discuss the next steps for Zulresso with COO, Shannon Hayes.
Shannon Hayes: When the announcement came that the FDA approved Zulresso, we were thrilled here at Bloom. I don’t think our phones stopped ringing for days. It was exciting, but then we started to see a backlash.
Lisa Tremayne: Yes, the pushback came pretty quickly.
SH: Because you are on the front lines, you see and treat women suffering from PMADs every day which is an unusual situation due to the limited number of resources around the country, you have a unique perspective on this issue. There are very few people like you and your team. You know what works and what doesn’t work…
LT: …and we see the collateral damages of waiting to get help. That is my number 1 frustration. So, here we have a breakthrough drug, the first drug ever for PPD and I wonder why anyone would feel anything other than – WOOHOO! Why, without the full answers, would one be against something so groundbreaking. I also assume this approval will open up a full new class of drugs. Every time there is a new allergy drug it is like, yay this is the best one! Why wouldn’t this be received the same way.
SH: I think you said it when you said “without full answers.” So let’s address that because we don’t have all the answers but let’s talk about what we do know. It has been reported that the treatment doesn’t come cheap—the average cost per patient is $34,000. Do you know anything more about that, how is that going to be addressed?
LT: The FDA approved this drug on March 19th, and now the process begins. The manufacturing, release, and launch looks to be about June. Again, I am not an FDA person, I am just telling you what I heard. Once the FDA approved it, Sage went to their insurance board and said – here is what we have, here is what it treats and what will be the reimbursement for this or what information do you need from this. As of day 8 from FDA approval, they have had no negative feedback from insurance companies. There is an out of pocket and deductible expense, as there is with any hospital treatment. Everyone reacted to the wholesale price that was reported, but that is not the price that will be passed on to the consumer.
SH: Another pushback that has garnered lots of discussion relates to the 60 hours of IV infusion needed. One of the first texts I received after the announcement was “What mom who has just had a baby is going to take the time away from their newborn to spend 60 hours in a hospital hooked up to an IV?”Do you feel this a valid push back?
LH: I feel this is an uneducated response. Zulresso is a tool in the breadth of drugs available, if needed, for a woman and for a family unit that is suffering the impacts of perinatal mood disorders. Say a mom scores off the charts for PMADs, hypothetically a 10 out of 10. Medication will work, but it will be 4-6 weeks before any real effects are seen, and that is if the correct med and dosage is given the first time. Can we help her with that now; absolutely? But, If you told me I could feel better from my allergies tomorrow instead of June, I choose tomorrow. Zulresso is the tomorrow choice. A woman who is going to be considered for this drug, or more likely will be suggested to receive this 3 day treatment after evaluation, is despondent. She is not intact in her family. She is not showering. She is probably not breastfeeding.
SH: Breastfeeding is another question that has been raised.
LT: If breastfeeding is a way mom is feeling attached to her baby, then she can pump and dump for 3 days. We do this when babies go into NICU, we do this if a mom gets into an accident and needs general anesthesia. This is not a bizarre request.
SH: So this is for the woman that is suffering so much that 3 days won’t matter because she is not engaged, she is not involved, because mom is sick.
LT: Exactly, mom is sick. I also did hear some questioning about the single mom. This is a valid question, and I think this is a wonderful opportunity for nonprofits and advocacy groups to step in and offer help. Help with child care, or financing so dad can take time off or for a nearby hotel for the family to stay… there are may ways to address this.
SH: Who exactly is this drug for?
LT: This is for the mom who is experiencing moderate to severe PMADs. A valid screening tool has been used and a team has made an evaluation and assessment of the mom. This is not a one size fits all. This is not a treat and street situation. This is not, okay you had your IV now off you go! There is a responsibility to say- Hey, we think this IV treatment is your best option right now and when mom is discharged, here is her follow up treatment plan. She can’t go home and start thinking – I can’t believe I left for 3 days, I stopped breastfeeding, what mother does that? So she has to be in a PMAD specific treatment plan.
Remember, they are coming in for treatment at a time when they feel despondent, lost, are experiencing intrusive thoughts, are not connected. Wouldn’t it be great to take that time mom is hooked up to IV and get her started on some nice self care as well. Have a therapist visit and maybe a survivor who can let her know she is not alone, how about a little aromatherapy and lots of sleep. The goal is to get the mom back to feeling like a human being, not a monster, not a failure, not disconnected.
SH: A lot of blog posts and comments addressed sleep. Many suggested that any new mom who got 60 hours of sleep and rest would feel better no matter what.
LT: Of course, if you put any mom with estrogen and progesterone anywhere for 3 days with protected sleep they would feel better just to get the mental load taken off their hands. My questions is would be how would they feel 3 days or a week later.
SH: So with this drug they still feel better 3 days later? A week? A month?
LT: Yes, but it is not 100%, it is around 70%. 70 works for me. I would a take 70% chance. If it doesn’t work, there are still other options such as medications and therapy.
SH: So hospitals that will be given the opportunity to provide this drug will also need to have in place a comprehensive PMAD therapy plan. Do you know if there are any physical side effects.
LT: The only one I know of is somnolence, which means sleepy. I think this is a really good side effect.
SH: I was going to wrap it up by asking what your feelings were on this drug, but I think that it is pretty apparent.
LT: I think it is amazing in my lifetime to see a first drug for something, that part of it blows me away. I can’t remember a first drug for anything.
SH: Viagra?
LT: Viagra was a very good invention….for some people. Maybe not women, hahaha just kidding.
SH: LOL, and Viagra is covered by insurance.
LT: So if erectile dysfunction pills are covered… this better be covered.
The bottom line is that postpartum depression and anxiety and OCD and psychosis and rage and all PMADs affect the health and welfare of the mom, their children, the family and society as a whole; and suicide is one of the leading causes of women after their first year postpartum. Our nationwide resources are abysmal and while there is no magic pill, Zulresso is one step closer to saving lives and THAT is worth celebrating.
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