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Dr. Ambrose:
This is CME on ReachMD. I am Dr. Stephanie Ambrose, and I am joined today by Dr. Jenny McDaniel. Today, we'll be talking about how to integrate new therapies into clinical practice. Dr. McDaniel, what are some steps you take in your practice when new therapies are approved?

Dr. McDaniel: 
It is such an exciting time to be taking care of patients with hemophilia, with a lot of new therapies and novel mechanisms being employed. However, with this certainly comes some increasing complexity in introduction, and patient selection, and management.

So when thinking about these new therapies, of course, I first want to make sure that as the physician I am informed about the mechanism, the potential side effects, the implications of this therapy on how we're going to treat and manage the patient, and then extending that education to our treatment team and making sure that we all feel informed and capable with new therapies.

For some treatments, there may also be special facility considerations that need to be taken into consideration. We may need to, as a center, create workflows and procedures for how we implement and deliver these new treatments, and that would involve a lot of different aspects of our clinical care, staff, pharmacy, nursing, our social worker, our providers. A lot of different aspects of the treatment team will need to be involved in the planning and discussion for implementing some of these new therapies.

We also want to make sure that we implement new therapies as safely as possible, and I think we still have a lot to learn about how we may transition between different therapies, especially in the factor mimetic and rebalancing agent categories. With clotting factor concentrate, we have measurable levels.

As we highlighted in an earlier episode, with these novel therapies, there may be adjustments needed in the treatment for breakthrough bleeds, and creating an individualized emergency bleeding plan is going to be critical to try to deliver these treatments safely and reduce the risk of complications.

Dr. Ambrose, can you expand on anything additional that you might consider when thinking about integrating these new therapies into practice?

Dr. Ambrose: 
Absolutely. One of the things that I really kind of want to highlight that you just pointed out, Dr. McDaniel, is the importance in the shared decision-making process with these patients and families. The landscape has rapidly evolved within the world of hemophilia. And to go from only having factor replacement as a treatment option to having so many more tools to use, we really have a responsibility to our patients and their families to make sure that they understand what each of these therapies are and to help them walk through what their goals are for treatment and management and in helping to guide them reach a decision for which treatment option may be best for them.

So in doing this, creating a plan for transitioning patients from one therapy to another, helping patients through that process, what it looks like, what will they need to do, what will need to be monitored, is extremely important. Assessing laboratory parameters. So it's very important to know which lab tests are going to be affected by some of these therapies, and understanding that this is a challenge that can arise, particularly whenever patients may not be within our institution. And so helping patients to walk through the fact that lab tests can be affected and that should they get any lab parameters that just don't make sense, that they should always reach out to us as their healthcare team to help them navigate the appropriate ways to manage the medications that they're on.

As always, it's so important to monitor joint health. Our goal for treatment for any patient with hemophilia is to decrease the number of bleeds that they're having. And in particular, we really want to decrease the number of joint bleeds that they're having, because this is so debilitating over time for patients. And so with any therapies monitoring patients’ joint health to ensure that when they transition from one therapy to the next, that they truly are not having increased bleeding events will be so important.

As we discussed previously, we really have to watch for signs of thromboembolic events. And so with that, really becomes the need to teach patients who have lived their entire life with a bleeding disorder, and they have tended towards bleeding, that if they are starting one of these newer therapies that can increase their risk of thromboembolic events, to ensure that patients know, ‘What do I monitor for? I've always known what it was like to bleed, but I guess I've never really thought about what it would be to over-clot.’ And so I think it's very important to make sure that patients understand what that looks like.

So to emphasize with the rebalancing agents, and really just with all of the emerging therapies, what patients will need to do, how their treatment schedule will change, how their monitoring schedule will change. All of those are educational points that will be very important to ensure that patients understand when they're making an informed decision about whether or not a therapy may be right for them.

Well, this has been a great bite-sized discussion. Make sure to tune in to the rest of the microlearning activities in this series for more information. Thanks for listening. 

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