In a prior article titled: Relypsa's (NASDAQ:RLYP) Veltassa will be embraced by Physicians, I suggested and felt that the drug would be immediately embraced by both nephrologist and cardiologist and my feelings stand with both embracing the drug.
In a recent cover story in Cardiology Today, Jan 2016, titled: "New therapies change landscape of care for patients with HF (heart failure)." Veltassa is one of the drugs highlighted in this article and 2 prominent Heart Failure specialist have embraced Veltassa with a great deal of enthusiasm. These cardiologist are: Dr Douglas Mann, MD (professor of medicine and chief of cardiology at Washington University School of Medicine, St Louis) and Javed Butler, MD, MPH (chief of cardiology and professor of medicine at Stony Brook University, New York).
Butler is quoted as saying: "But for the heart failure population, the big news is not that it can lower potassium, but that it may enable patients to use drugs that help with heart failure but raise potassium levels." These would of course be the RAAS inhibitors. Butler goes on to say: "The place where there is an unmet need...is in chronic therapy for patients with heart failure and hyperkalemia who are unable to take RAAS (renin-angiotensin-aldosterone) inhibitors, and taking a chronic therapy (i.e. Veltassa) will lead to an increasing the use of RAAS inhibitor therapy." He also goes on to say, "To date, we have not been able to give RAAS inhibitors at all, or at least in recommended doses, because of this risk for hyperkalemia."
Dr Mann also comments a similar sentiment: "the drug (Veltassa) might be appropriate for patients with heart failure and impaired renal function, who we've not been able to get aldosterone antagonists into. When you put those patients on them, they retain potassium. For that group, it may expand the ability to use aldosterone antagonists, which are wonderful drugs and inexpensive. This has the potential to have an impact".
Butler goes on to conclude that we do not have an outcomes data yet for heart failure patients: "Although there are data out to a year that it is safe and well tolerated, we dont have HF-focused studies. We need to know whether putting patients with HF on this therapy so they can have RAAS inhibitor therapy will lead to improved outcomes." The latter is the likely next step for research studies on both Veltassa and ZS-9.
Both of these experts comments help to explain how slowly medicaly information filters down to the regular medical community. First, the heart failure specialist and nephrologist use these new drugs in select populations, then they begin to expand to more patients when newer studies are finalized and eventually these new drugs are embraced by the rest of the medical community.
One can think of how statins were initially only use by cardiologist on patients with heart disease and then expanded to be used by internist, family medicine doctors and the rest of the medical community. Now statins are recommended to patients who do not even have heart disease but are at risk for heart disease such as diabetics or those with a prior stroke or high family history of heart disease (with dyslipidemia).
The general flow of medical information and the adoption of new drugs is a top down approach. First its written about and presented by top academic institutions, then this slowly filters to the general medical community to a point where these recommendations change the standard of care for the management of a certain condition, in this case, hyperkalemia from chronic kidney disease (and end stage renal disease) and chronic heart failure. Finally, you will see guidelines change to incorporate these new drugs into therapeutic regimens.
The standard of care means that in the general medical community where one practices, what is the general accepted measure of treating certain patients, in this case, patients with hyperkalemia and chronic heart failure. Eventually, these top academic instiutions work on new guidelines. At times, this is even mandated by Medicare for certain pay for performance incentives.
Once the standard of care is officially or unofficially changed, it will become a medical liability not to practice in this way, but it may take years to change.
Veltassa is a new drug that will take time to reach the patients that need it most and eventually will reduce the disease burden of both heart failure and hyperkalemia. We know for a fact that hyperkalemia is dangerous and kills many patients every year, it will take time for doctors to realize we have a solution to this problem.
Where I practice, it is currently not even on the hospital formulary, but it is available in the outpatient setting. I have not prescribed the drug yet, but intend to do so in the near future. In a recent survey conducted by Spherix Global Insights (101 US nephrologists) in late January 2016 of doctors, about 40% of doctors said they have either used it or intend to soon: "In addition to the 20% of surveyed nephrologists who already have prescribed Veltassa to at least one patient, 17% report that they intend to start prescribing "right away." Nephrologists report a high unmet need with a large pool of patients who would be considered candidates for Veltassa."
Disclosure: I/we have no positions in any stocks mentioned, but may initiate a long position in RLYP over the next 72 hours.
I wrote this article myself, and it expresses my own opinions. I am not receiving compensation for it (other than from Seeking Alpha). I have no business relationship with any company whose stock is mentioned in this article.