Can you speak to the benefits and opportunities around innovating in that IV at home space?
Around 30% of the compounds we'd like to move to subcutaneous delivery can't go for a variety of reasons. This may be because of the variable dosing, incompatibility, bioavailability, or other challenges. For those compounds that must remain IV, it would be great if we could make it easier for patients to receive these therapies. The opportunity is in drug preparation, IV access, administration, monitoring and follow up.
For many therapies right now, the patient has to travel to the clinic where we have all those things under expert care. This can really become a challenge if you’re dealing with a chronic therapy where you need to go in every two weeks. Going to the clinic can be very time consuming. There’s the commute. Clinics don’t start preparing medications until patients arrive which takes time. And if you’re talking about a multi-hour infusion plus time afterwards to monitor patients for reactions and then the commute home, you’ve committed basically a full day.
What are the first steps to making an IV therapy compatible with at-home administration?
You should first ask if you could make it subcutaneous. That would be most desirable because we have a good paradigm there. Assuming that won’t work, you should think about patient-burden. If you are working with a dosing frequency of quarterly treatment, is it worth it for patients to learn everything needed and take on extra work for at-home delivery? Once you’re dealing with weekly, biweekly or monthly treatment, it may be worth it.
Once you figure out the right treatment and patient group, you need to think about the complexity of the product. Well-designed technology may be able to remove potential errors if you have a very narrow therapeutic index or prepping the materials is difficult because there are multiple vials to combine into the IV bag. But there also may be instances where you need a trained person who does this all the time to oversee this. Maybe it can be overseen using remote monitoring but if not, you probably want to keep that in the clinic.
"As we pull more experts out of the process, we need to replace them with technology that can assure the proper steps are followed and safety and efficacy will be available at the end."
What are some of the obstacles to provide patients with that ability to administer IV at home?
There are definitely financial implications regarding who's getting paid to do what parts of the therapy, which means that shifting to at-home administration of IV is easier for some therapy classes than others. For example, if it's part of a doctor's regular practice and they have an infusion clinic, they're not going to be motivated to move those patients out of their clinic.
Of course, the patients themselves also have to be comfortable. One way to help can be to have experts or nurses come to their homes to administer these therapies.
Is the goal with at-home IV administration to be for patients to completely self-administer or is some kind of expert oversight required?
We've seen instances of both. In the US there are lots of home infusions where third-party nurses come in and perform all the steps. In some enzyme replacement therapies, patients do it all themselves. They may have a port that's already inserted and have access to the port so the patient or caregiver can prepare their medications themselves. That being said, the more you ask the patient to do, the more you'll find some patients not being comfortable or the technology needed to support the process not yet existing.
That's where the need would be for more automation. As we pull more experts out of the process, we need to replace them with technology that can assure the proper steps are followed and safety and efficacy will be available at the end.
How do we overcome different complexities that arise with at-home administration of IV therapies?
The technology is out there. In order to apply it, you have to evaluate the technology on a product-by-product basis and ask what that would look like. If you have to get three or four different drugs infused as part of your therapy, there may be challenges that make at-home administration unrealistic. If there is a potential for a severe side effect, like an anaphylactic reaction that requires you to then deliver epinephrine, you won’t want to move that therapy to the home where you probably don’t have that. You can set up a paradigm for what technology would be needed to address each of these.
Another example: venous access is common for every single infusion therapy, but some patients are harder than others and some disease states make it harder. You need to evaluate if certain segments will be able to administer the IV at home appropriately to make it worth investing in.
There’s also got to be a will to make a change. You don’t want to be fighting and investing against what patients or physicians want or what is unfeasible compared to the status quo.
"Like any technology, automation sounds great in theory, but the key is to evaluate whether automation can help you replace an expert with someone who feels comfortable learning and can be taught."
What role do connected devices play in this space?
If you're pulling the patients out of a clinic where they have a broader environment that provides all the necessary support, and now you want to do it remotely with a nurse providing oversight, you would need some kind of technology to provide some of that support. Connected devices can play a role in monitoring quality assurance in the medication preparation and recording how the drug was administered and any potential reactions to treatment.
Can automation improve patient experience?
Like any technology, automation sounds great in theory, but the key is to evaluate whether automation can help you replace an expert with someone who feels comfortable learning and can be taught. For example, BD just launched a product that uses ultrasound technology with a magnetized needle to provide an image of the needle relative to the vein to reduce first-stick failures. You could picture that technology perhaps evolving to the point where artificial intelligence overlays a real, clear picture over the ultrasound one so that even a layperson can insert a catheter, for example. I don’t see us jumping to automating everything but instead investing in incremental steps where we can add value to push the bar further.
What can the IV at-home space learn from the subcutaneous space?
One of the biggest experiences people had with subcutaneous was all of the human factors work that goes into it and evaluating the risks that emerge when you have non-healthcare providers using medical devices and combination products. We want to apply that same thinking to IV at-home early so that the products we put out there are used properly and are effective.
Where do you see IV at-home administration in ten years and how will we get there?
I think a decade from now we'll have more and more personalization in treatments: more biomarkers available, more feedback about how patients are responding to the treatment from both safety and efficacy perspectives, and maybe even more flexibility in how the dosing and treatment should be adjusted on a person-by-person basis.
For at-home treatment, this will mean gathering this information in parallel to treatment and being able to adjust things like dosing, rate of infusion, and frequency between therapies on a patient-by-patient basis. There is going to be much more feedback factoring into overall design.
Is there anything coming down the pipeline in this space that you're really excited about?
If we couple our large focus on patients with our increasing awareness on sustainability we can design and deliver a consistent and standardized system. Nowadays, when we think about a vial product, we think about the glass, rubber stopper, aluminum, box and drug components. But when you think about everything else patients get – from the tubing, syringes, diluent and everything else – there’s a substantial footprint that goes into one treatment. Many of those components come from specialty pharmacies which means they aren’t standardized. Sometimes a patient may receive a 10ml syringe and other times a 20ml syringe, for example.
If we started supplying systems to be used at home, including vials, diluent, injection method, etc in one package, we can both improve patient experience by providing them a consistent and complete package from one source and also reduce waste and the footprint of our therapies.
Anything else?
Similar to subcutaneous injection, IV is not a one company type of solution. We need all companies to work on it and build off of each other to continue striving for what’s best in patient care in this space.
