Erin Mistry, chief commercial officer at CorMedix, can say firsthand how difficult it is to bring innovation to patients who need chronic hemodialysis.
Used to filter the blood of patients whose kidneys aren’t functioning properly, hemodialysis can be required up to three times a week. With about 80% of dialysis patients needing a catheter inserted directly into their heart for vascular access, infections are common.
To help prevent those infections, CorMedix developed a product called DefenCath, which cleans the catheter inside the patient’s body in between uses with a combination of taurolidine and heparin. But the marketing team has found themselves between a rock and a hard place when it comes to ensuring patients will have access to the product if the FDA gives it the go-ahead when a decision is expected in November.
CorMedix is a clinical-stage biotech that focuses on the application of taurolidine, a derivation of the amino acid taurine.
And although DefenCath is made for prevention, the FDA is classifying it as a drug. That makes reimbursement for the product — which could help hospitals administer fewer antibiotics and thus alleviate antimicrobial resistance — a prospect that isn’t well enough incentivized, Mistry said.
Dialysis is also a procedure administered disproportionately to people of color. Black Americans are about four times as likely to develop kidney disease and make up about 35% of hemodialysis patients, according to CorMedix.
"Investment doesn’t go into renal because of the way reimbursement works and there’s no reward for innovation at the end of the day in this particular therapeutic category."
Chief commercial officer, CorMedix
Here, Mistry describes the various complications that have arisen as the company nears the launch of DefenCath, the reimbursement “bundles” that keep innovation from happening in the dialysis space, and why clinical and financial incentives need to be better aligned in the renal therapeutic area.
This interview has been edited for brevity and style.
PHARMAVOICE: Can you tell me about the preparations your team is making before the November PDUFA date and launch?
ERIN MISTRY: Launching a product in today’s post-COVID environment is very difficult. Some of the preparations we’ve made are about understanding the way our customers work. For example, we have an inpatient opportunity where we go hospital to hospital to get on formulary, so it’s leveraging deep relationships with the hospitals and groups there. We’re looking at ways to commercialize that are much more customized than just hiring 40 sales reps or developing marketing support. We’ve shifted our marketing strategy to more public relations because we’re not a direct-to-consumer product. There are very few times in your career where you’re literally building a commercial infrastructure from scratch, and we’ve had to establish the revenue cycle management, order-to-cash systems, distribution, trade negotiations with group purchasing organizations that hospitals buy from — all of it. On the outpatient side, we have third parties like Fresenius and DaVita.
What are the biggest challenges of marketing DefenCath?
We need to focus on what it’s going to take for patients to get access to it, and the No. 1 way is to create clinical and financial alignment, which is very difficult to do in dialysis organizations. The majority of our work has been with the CMS on positioning our product as an infection prevention product, not a renal product. That’s important because that shows them we should be separately paid, and therefore the product will get used. So we’ve focused our efforts on the right reimbursement mechanics with the CMS, and surrounding that with advocacy and Hill support — the Congressional Kidney Caucus, the Black Caucus, the Senate Finance Committee, the House Ways and Means Committee. If you look at biotech and pharmaceutical companies, investment doesn’t go into renal because of the way reimbursement works and there’s no reward for innovation at the end of the day in this particular therapeutic category. Our first indication is renal, but we as a company are an infection prevention company.
What does your product bring to hospitals as they increasingly fight antimicrobial resistance?
Hospitals love a product like this because they’re doing so many things to combat infections without giving antibiotics to patients. Here we have an antimicrobial that is a simple solution that goes into a catheter between dialysis sessions. These catheters are attached to the patient’s heart, and if you get a bloodstream infection, it’s a massive problem. And so with regulators on board, it becomes a patient access problem because of the way the reimbursement works. No matter how good a product can be clinically, there has to be financial alignment in the system.
What are the particular problems you’re seeing as you look to get reimbursement for DefenCath?
If you look at where the most volume of this product would be, when folks are on dialysis, they stay on dialysis until they have a transplant. The way it works is currently the CMS has a bundle for dialysis where every time a patient is dialyzed, Medicare will pay $265 for the session. If you bring a new product in there, they’ve made it difficult to get out of that bundle because they want to save money. So if you’re looking at innovation and thinking about where you want to go to market first, it’s typically not where there are bundled payments — you either want an outlier payment or a separate payment, but renal is different. They’ve made it very difficult to do that.
When it comes to health disparities, we're providing an opportunity to give patients an innovative product. The standard of care is heparin, which was invented in 1965 for this, and there's not been any other product that has come into the space since then. So it's a great opportunity.
You’re caught between worlds somewhat, defying classification. How do you get past that?
We’re not a treatment — we’re prevention. The product doesn’t systemically enter the body. But the FDA has reviewed it as a drug, and the way it works for dialysis patients is everything gets rolled into the bundle. At the end of the day, dialysis organizations are caught holding the bag because anything they put as standard of care, they then have to pay over and above what they’re getting paid for by the CMS.