Specialty Pharmacy Dispensing Process for Factor VIII and Emicizumab for Hemophilia A

EP: 1.The Role of Prophylactic Therapy in Hemophilia A

EP: 2.Considerations for Prophylaxis in Patients With Hemophilia A

EP: 3.Selecting Prophylactic Therapy in Hemophilia A

EP: 4.Ideal Candidates for Factor VIII and Emicizumab for Hemophilia A

EP: 5.Role of Specialty Pharmacies in the Management of Hemophilia A

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EP: 6.Specialty Pharmacy Dispensing Process for Factor VIII and Emicizumab for Hemophilia A

EP: 7.Financial Challenges Associated With Prophylactic Treatment for Hemophilia A

EP: 8.Overcoming Barriers in Specialty Pharmacy for Treatment of Hemophilia A

EP: 9.Reflections on the Evolving Space of Prophylaxis in Hemophilia A

Jonathan Ogurchak, PharmD, CSP: Dr. Abramson, I want you to weigh in too, coming from the specialty pharmacy perspective. Let’s talk a little bit about that dispensing process for both Factor as well as emicizumab. What does that dispensing process look like, including some of those things that Dr. Kuhn mentioned as it relates to education? There are definitely some factors that need to take place in the home for those patients that you really hope to bridge that gap. I’d love for you to be able to comment a little bit on what the role of the specialty pharmacy is in that dispensing process.

Anastasia Abramson, PharmD, MBA: Sure. Dr. Kuhn did a fantastic job covering the role of specialty pharmacy. Specialty pharmacists definitely provide patient medication management and care coordination while helping to maintain the cost effectiveness for the patients and also the payers. Also, specialty pharmacists definitely engage patients to help drive adherence and outcomes by providing education. That education piece is really critical for therapy and administration, and as well as, of course, assisting in the financial coverage for patient access. However, in terms of the dispensing process, for both types of prophy therapy, it’s pretty similar. We do have infusion care nurses who help onboard our patients and collect health history, review supplies needed for administration, and evaluate education needs. Then, on refills, they do make proactive outreach to help keep the patient on track with their therapy, as well as ongoing assessment for adherence, bleeding episodes, and administration needs.

The pharmacist team, of course, works very closely with this as well. I think one of the differences for prescription processing in particular and dispensing I can call out is that emicizumab comes in standard vial size strengths while on the Factor products, the actual Factor VIII units can differ between the lots. When we fill actual Factor prescriptions, there is a target dose that generally has an allowance of plus or minus 10%. Subsequently, the pharmacy works to dispense the closest possible variance to that target, which is really driven by market availability at the time of dispense and what we can order in. We really focus on handling these medications patient specifically so that we are as close as possible to each individual patient’s target. However, we often have to combine vial sizes to get to that target while keeping patient convenience in mind since this can impact adherence with having too many vials that he/she may need to mix and administer. Of course, this is certainly something that our nurses and pharmacists address during assessment and may sometimes even need to work with the physician to see if it’s appropriate to address the target one way or the other just so that we can fit into what those vial sizes are that are available.

In terms of education needs, some of the important pieces that we cover would be storage and administration. Patients should be educated on product specific storage requirements. And we advise on the manufacturer recommended storage, which most of the products can be kept refrigerated and protected from light until expiration. It’s…and some patient circumstances and most of the products have stability at room temperature actually ranging anywhere from 3 to 12 months. We also want to review the stability after reconstitution and how long the product is good for once it’s mixed or drawn up in the event that something does come up and the patient needs to step away. Then, in the case of emicizumab, it can be stored at room temperature and then returned to refrigeration as long as the combined time outside of the refrigerator is no longer than 7 days or 86 °F, which is pretty unique.

Then, for administration, the pharmacist is always available for counsel and to go over the review of mixing and administration procedures with the patients or even to help troubleshoot over the phone at time of administration if something comes up. We do want to ensure that the patients are made aware that the remainder of any unused dose should be discarded. In the case of emicizumab, we do review when 2 separate syringes should be used to administer. The product comes in 4 different vial sizes and 2 different concentrations. Thus, we want to ensure that the different concentrations are not mixed in the same syringe or injection. Also, patients do often receive administration training at their hemophilia treatment center for hands on learning. They can observe and then later on be observed to ensure proper technique. Lastly, if upon assessment with our nurses during the fill, we do identify that they need some follow up or in-home training, we do arrange for a nurse to come out to the home and review that with them as well.

Transcript edited for clarity.