This week we have the second part of our two-art interview with Dr. Janice Smiell, CMO at Alliqua BioMedical, Inc. Dr. Smiell, and we delve a little deeper into the specifics of this new technology to heal chronic wounds using placental biomaterials.
Steve Freed: With all the testing that is done and the work involved in obtaining the placentas, is sounds like this could be a very expensive product.
Dr. Janice Smiell: This is why Medicare/Medicaid is very careful in determining and covering reimbursement. They want to see that there are some clinical data and some sort of comparative effectiveness before they will provide coverage. There is a lot of work that is going on, not only with our product, but other products like it. It is confusing because for the most part, if human tissue is processed properly, and nothing is introduced that would create an issue with it, then for the most part they all work toward supporting wound healing. The key has been looking at the ease of using them. Some of them come freeze-dried. Some of them, like ours, are dehydrated and have a longer shelf-life. Some of them keep the dead cells there. Ours happens to be decellularized completely. Some of them have living cells and are frozen, cryopreserved, so you have to thaw them in a special way before you can use them. It is a very confusing world. Our recommendation is simply look at price, look at ease-of-use, and look at the benefit from data that have been collected, and then it still may mean that you have to come down to trying it on a patient. That is the best you can do….
SF: Is using your product more cost-effective than other top-of-the-line wound products?
Dr. S: Many dressing-type products are less expensive, and those are the ones that should be tried first. No one will support going immediately to an expensive, more advanced therapy like Biovance. If you feel that you’re getting progress with more standard types of treatment, good. No matter what, you have to start by getting a good debridement; then get down to good, clean tissue; get rid of the infection; do the offloading of pressure, in the case of diabetic foot; or if it’s a venous ulcer, you are going to apply compression to combat the venous disease. You have to perform that good, standard care no matter what. A percentage of people will respond to that good, standard care. If, however, you provide the standard care and it is still not going anywhere, then you know you have an issue. You’ve already controlled their glucose, you’ve offloaded them, you’ve cleaned up the wound, you provided the moist environment, and it is not going anywhere— then you need to move to something more advanced. Which advanced therapy do you go to? If you are savvy, you are going to look at the evidence and still probably be confused, because there are a lot of products out there that have clinical studies backing them. Some clinical studies are better than others; you will have to make a decision. If you are working in a hospital, some of the decision is driven by what your hospital has on formulary, and what is reimbursed if you are in the outpatient office. What is reimbursed has to be part of your decision-making. You are going to decide based on a number of factors, not just the individual patient. I can tell you that with Biovance, we took it out there in a broad, registry-type study. We handed it off to 19 different sites and said, “Put this on wounds that you think need it, together with your good wound care, and tell us what you observe.” The only exclusion was you could not put it on an infected wound. In the all-comers scenario, we saw that 50 percent of the wounds closed in about a week. What does that mean? We’ve heard other products get 80 percent closed in a similar timeframe. Those were in clinical studies where they’ve controlled who can enter the study. You had to have certain hemoglobin A1c. You had to have no renal insufficiency. You couldn’t have this; you couldn’t have that. It was very controlled. Ours was with all controls off. In fact, when we looked at our population of 230 patients, we found that more than half of them would have been excluded from a prospective study. It was truly an all-comers scenario. We are now doing a prospective study in which we control who enters it. We will be able to show what the effect is in that situation as well, so there can be a direct comparison with other products. I feel comfortable predicting that in any scenario, our product will show benefit. Anecdotally, as it is out there now, we hear marvelous things about people who have had a non-healing wound for two years, four years, and are amazed how this product puts them back into healing mode and closes the wound. I put it on myself about 10 years ago and I, too, was amazed by how well it did. I can’t even find the site of my wound today. Cosmetically, I was quite pleased. If you have diabetes, your number one thought every day is, if I have a wound, am I going to lose this extremity? When you talk about cost, I know the average patient in my study used two pieces of Biovance over that eight-and-a-half-week period. The cost of two pieces was a very small price to pay to save a limb, or even to provide the peace of mind that comes when you see that your wound is healing. I got into this business because I had non-healing wounds. I had vasculitis. I knew what it felt like, the change of dressing every day, and hear people say, “Oh big deal! It’s a Band-Aid you are changing every day.” Well, it wears on you. When you can start to see that things are going in the right direction that is a huge relief. Wound closure means a lot. Everything is done nowadays by the vascular surgeon, the podiatrist, the physiatrist—everyone has come such a long way in providing the support and the elements that are needed for wound healing. It is rare to go to amputations so quickly. The shorter the time you have an open wound, the less you are at risk for infection, for further breakdown, for infection of the bone that can lead you toward that amputation. You know that in a diabetes patient, once you get to a certain level of amputation, you then have to be concerned about the extra work that puts on the heart—which has the same vascular disease that the leg did. Then you talk about losing a life not long after losing a limb. It’s a snowball effect that you want to avoid.
SF: So you have to be specially trained to use this product. Can you share with us the potential treatment cost for a standard chronic wound? What could the cost be if you don’t have medical insurance that covers it?
Dr. S: The special training for Biovance is considered a surgical application. A podiatrist or surgical healthcare provider will learn how to place and anchor it, and it can be anchored with tape or sutures or whatever the doctor feels is necessary. It requires a person who is trained and certified in wound care. As for the cost, the smallest pieces are available for around $300. The average expenditure is probably around $1,000 to $2,000. As far as payment goes, if Biovance is placed in the OR at the time of debridement, then that is not an out-of-pocket cost to the patient. If it is an outpatient scenario where there is no insurance coverage, there could be that cost. There is a patient assistance network (PAN) that a patient can go to if they can’t afford this or any treatment. If they qualify, the patient can ask for assistance to cover co-pays or their entire care.
SF: If a person comes into the office and they have a tiny little wound that some Bactine and a Band-Aid would take care of, you are not going to recommend this product, obviously.
Dr. S: Correct. You are going to see if it gets taken care of using traditional methods of treatment. If in four weeks it goes nowhere, and you’ve done everything you could with what you have on hand, then you might want to consider Biovance.
SF: So what you’re saying is that after four weeks of no improvement, it’s time to consider other alternatives.
Dr. S: Yes. There are very good data out there, in both diabetic and venous ulcers, that say that if you do not have 40 to 50 percent closure of the area of your wound in that four-week timeframe, that you need to do something with a big gun.
SF: Can medical professionals and patients both find relevant information about Biovance there?
SF: Thank you for your time—this was very informative and interesting. Clearly we’ve learned more in the last five years than we have in the last 50. I would like to be around for the next hundred, just out of curiosity!
Dr. S: I think everything is moving toward customized care. These fields are not any different than cancer, endocrinology and everything else.
SF: It’s fascinating what we are producing out there. It’s just exciting to be part of it, and to learn about it and to report on it. For me, it is truly exciting.
Dr. S: There’s work being done with the stem cells that come from a placental source so that they can decrease the kind of reactions you have for rejection of the tissue in pancreatic transplants and others.
SF: That’s very interesting. I guess one day we will live forever, but it won’t be today.
SF: Right. It’s going to be the next generation. Good for them. Thank you again for your time. I appreciate it. I learned a lot.
Dr. S: Thank you.
Dr. Janice M. Smiell, M.D., Chief Medical Officer, brings more than 20 years of wound care, regenerative medicine, and clinical development experience to Alliqua BioMedical. She is the former VP of Medical Affairs at LifeCell Corporation, where she oversaw clinical development and product safety programs from 2007 to 2011. LifeCell develops and markets tissue repair products for use in reconstructive, urogynecologic and orthopedic surgical procedures. Prior to joining LifeCell, Dr. Smiell was the Executive Director of Global Clinical R&D at Celgene, where she led the clinical development of biomaterials and stem cells at the Company’s Cellular Therapeutics Division. From 1994 to 2003, Dr. Smiell was the Senior Director of Global Clinical R&D at Johnson and Johnson where she was awarded the prestigious Johnson Medal in recognition of her development work on Regranex, a growth factor for wound healing. Before joining Johnson and Johnson, Dr. Smiell served as the Medical Director of the Wound Care Center at Morristown Memorial Hospital. Dr. Smiell received her M.D. from the Medical College of Pennsylvania in Philadelphia (now Drexel University School of Medicine).