Implications abound for historic leader Amgen and newer companies with paradigm-shifting SGLT2 inhibitors (AstraZeneca [Farxiga], Vifor/Janssen [Invokana], Eli Lilly/Boehringer Ingelheim [Jardiance] and Merck [Steglatro])
EXTON, Pa., / December 7, 2021/ PRNewswire – Chronic kidney disease (CKD) patients experience a wide range of comorbidities and risks associated with their disease, such as hyperphosphatemia, secondary hyperparathyroidism (SHPT), diabetic complications, hyperkalemia, and metabolic acidosis. At the American Society of Nephrology (ASN) Fall 2021 Conference, continued endorsement of SGLT2 inhibitors for CKD patients with and without diabetes garnered significant attention, as did market expectations for the beleaguered HIF-PH inhibitor class and excitement around upcoming treatment options for glomerular diseases.
Results from the recently published chart audit included in Spherix’s RealWorld Dynamix™: Dialysis (US) service (an analysis of more than 1,000 dialysis patients) highlight challenges (and opportunities) for pharmaceutical companies, especially Amgen. Specifically, use of calcimimetics over the past year has shifted back towards Sensipar (cinacalcet) and away from Amgen’s Parsabiv (etelcalcetide), as Parsabiv was pulled into the general reimbursement bundle at the start of 2021. As a result, dialysis organizations have limited their use much more aggressively, most notably in Fresenius units, resulting in a substantial contraction of Parsabiv share.
However, some dialysis patients do remain on Parsabiv, and analysis reveals deeper insights into specific patient types that nephrologists have fought to keep on the therapy. To prepare and forecast effectively, companies looking to launch into the dialysis market, such as those developing HIF-PH inhibitors for anemia of CKD, can use Parsabiv as an example product as they go through the TDAPA reimbursement model lifecycle.
Evolving use of ESAs, especially as dialysis centers roll out increasingly strict protocols, is also included in this research. One particular piece of information all eyes will be watching as HIF-PH inhibitors potentially gain FDA approval is the true prevalence of ESA hypo-response, a metric strongly overestimated by physicians. Indeed, nephrologists report that approximately one-in-seven ESA-treated dialysis patients have a sub-optimal response to ESA therapy; however, within the chart audit, only one-in-fifty identified as ESA hypo-responders.
Later this week, Spherix will release its fifth annual chart audit included in the RealWorld Dynamix™: CKD Non-Dialysis (US) service, an analysis of more than 1,000 CKD non-dialysis patients. This report covers a range of disease areas faced by CKD non-dialysis patients, such as anemia, hyperkalemia, and hyperphosphatemia. It also includes enhanced analysis on diabetic kidney disease and the uptake of SGLT2 inhibitors, GLP-1 agonists, and Bayer’s Kerendia (finerenone).
More than four-in-ten CKD non-dialysis patients have type 2 diabetes, which represents a significant patient population and burden on nephrologists. Oftentimes, these patients progress rapidly and there is little nephrologists can do to slow their disease. However, a sea change is occurring in DKD patient care with the entry of SGLT2 inhibitors, most notably the approval of Farxiga (AstraZeneca) in CKD patients with and without diabetes earlier this year. Prescribing of SGLT2 inhibitors for patients with Type 2 diabetes increased by more than one-half in CKD Stage 3 patients and more than doubled in CKD Stage 4 patients from 2020 to 2021, with expected future growth.
Interestingly, as a result of increased SGLT2 inhibitor use, nephrologists’ use of other diabetes medications, such as GLP-1 agonists, is beginning to decelerate. Chart audit data reveals that use of the GLP-1 agents has contracted in CKD Stage 3 and 4 patients over the past year. As Novo Nordisk advances Ozempic (semaglutide) in CKD/DKD trials, this could have significant implications.
SGLT2 inhibitors are also making strong headway in CKD patients without diabetes. In 2020, only a handful of non-diabetic patients from the chart audit were on SGLT2 inhibitors; however, as of the latest data, nearly one-in-ten non-diabetic patients were on SGLT2 inhibitors. All eyes will be watching to see if treatment earlier in therapy with these effective agents may have longer term implications across the spectrum of disease.
While 7% of the patient population is on mineralocorticoid receptor antagonists (MRAs), prescribing of newcomer Kerendia (Bayer) is slowly starting to build. Nephrologists are excited about Kerendia and its significant potential in the DKD patient population; however, they are still determining their ideal treatment pathways and how SGLT2 inhibitors and Kerendia will be used, either together or separately, in their paradigms.
The fierce competition for prescriptions and access between Farxiga, Invokana (Vifor/Janssen), Jardiance (Eli Lilly/Boehringer Ingelheim), Steglatro (Pfizer/Merck), and Kerendia is likely to only intensify next year.
In 2022, markets will continue to evolve as care for kidney disease patients advances. Unfortunately, in Spherix’s post-ASN pulse report, Special Topix: ASN Kidney Week Coverage 2021, one-half of nephrologists strongly agree that “challenges from the FDA over the past year in getting products approved will ultimately hurt innovation for new nephrology therapies.” Assuming some of the more innovative products looking for approval over the next twelve months (including Nefecon [Calliditas], bardoxolone methyl [Reata], and vadadustat [Akebia/Otsuka]) get approved, nephrologists are ready to start prescribing new therapies.
About RealWorld Dynamix™
RealWorld Dynamix™ is an independent, data-driven service unveiling real patient management patterns through rigorous analysis of large-scale patient chart audits. Insights reveal the “why” behind treatment decisions, include year over year trending to quantify key aspects of market evolution, and integrate specialists’ attitudinal & demographic data to highlight differences between stated and actual treatment patterns.
Insights are based on patient level data gathered through collaboration with specialty physicians who provide details on clinical and non-clinical patient demographics, along with their rationale for treatment choices.
About Special Topix™
Special Topix™ is an independent service that includes access to a report or series of reports based on current events or topics of interest in specialty markets covered by Spherix.
