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After years of false starts, stalls, and missteps, Congress may soon be ready to tackle the thorny question of how to regulate generic biologic pharmaceuticals, lawmakers noted at the Generic Pharmaceutical Association's 2006 Annual Policy Conference held recently in Washington, D.C.

Lawmakers seek standard for generic biologics

journal explores issues within pharmacy, from the impact advocacy can have in community pharmacies to staffing shortages across multiple sectors within pharmacy. This month’s issue also explored the importance of disease awareness months and how they are opportunities to maximize valued care. Check out a preview of this month’s issue here.

download the PDF of the Total Pharmacy August 2024 issue here

Don’t get left behind: Sign up today for our 

 and get the latest drug information, industry trends, and patient care tips delivered straight to your inbox.

See what’s trending in pharmacy with a preview of the Total Pharmacy August issue.

Total Pharmacy

In This Issue: Total Pharmacy August 2024

Combining sodium glucose co-transporter 2 inhibitors (SGLT2is) with glucagon-like peptide-1 receptor agonists (GLP-1RAs) may offer additional protection against cardiovascular and kidney disease in patients with type 2 diabetes (T2D), according to the results of a new meta-analysis published in 

 and presented at the 61st European Renal Association Congress in Stockholm, Sweden.

Separately, SGLT2is and GLP-1RAs have demonstrated cardiovascular benefits. However, little clinical literature has focused on outcomes associated with using the medicines together. Due to the growing prevalence of GLP-1RAs in the 

 and obesity landscape, accelerated by an increasing number of indications for the agent class, this is a crucial area for further study.

The SGLT2 Inhibitor Meta-analysis Cardio-Renal Trialists’ Consortium (SMART-C) is the largest assessment of outcomes for the combined therapeutic use of SGLT2is and GLP-1RAs. The study gathered data from 12 large-scale, placebo-controlled trials of SGLT2is involving 73,238 patients with diabetes. Of these, 3065 were already receiving GLP-1RAs.

Overall, SGLT2is lowered the risk of major adverse cardiovascular events by 11% and hospitalization for heart failure or cardiovascular death by 23% compared to placebo. Notably, this benefit was seen regardless of whether patients were also taking GLP-1RAs.

When used together with GLP-1RAs, SGLT2is reduced the risk of chronic kidney disease progression by 33% and slowed the annual loss of kidney function by nearly 60%.

The study found no additional safety concerns when SGLT2is were used in combination with GLP-1RAs.

Study Reveals Robust Benefits of Semaglutide in Protecting Against Kidney, CV Events in Patients With T2D

Current meta-analysis results build off positive results of the landmark FLOW trial (

). Published earlier in May, results of the international, double-blind, randomized, placebo-controlled phase 3 trial spotlighted semaglutide’s effectiveness in lowering the risk of kidney failure, decelerating worsening kidney function, and protecting against the risk of cardiovascular events and death, in patients with T2D.

“SGLT2 inhibitors have clear protective effects against heart failure and chronic kidney disease, while GLP-1 receptor agonists can reduce the risk of heart attack, stroke, and also kidney disease—as recently demonstrated in the landmark FLOW trial,” said Brendon Neuen, lead author, clinical associate professor, senior research fellow at The George Institute for Global Health, and director of kidney trials at Sydney’s Royal North Shore Hospital, in a news release.

 “Our findings support using this combination to further improve outcomes in patients with type 2 diabetes who meet guideline recommendations for both therapies.”

Elevated glucose from diabetes can damage blood vessels in the heart and kidneys, increasing the risk of 

 and kidney disease. In fact, diabetes is the most common cause of chronic kidney disease.

Moreover, estimates predicting that T2D prevalence will more than double in the next 30 years, surpassing 1 billion global cases by 2050, further strengthen the need for research into diabetes care.

 According to Neuen in an interview with 

 conducted over email, the current study offers valuable insights for developing global treatment strategies for the condition.

"These findings, which represent the largest and most comprehensive evaluation of the combined use of SGLT2i and GLP-1RA, provides the clearest evidence yet that combined use of both medicines can further reduce cardiovascular and kidney disease," said Neuen. "We anticipate that these findings will inform how people with diabetes are treated worldwide, including influencing major clinical practice guidelines.

Although current results suggest that using SGLT2is and GLP-1RAs in tandem may offer robust protection against cardiovascular and kidney disease, further research is needed to fully understand the long-term effects of the combination therapy.

Pharmacy practice is always changing. Stay ahead of the curve: Sign up for our 

 and get the latest drug information, industry trends, and patient care tips, straight to your inbox.

1. Apperloo E, Neuen BL et al. Efficacy and safety of sodium glucose co-transporter 2 inhibitors with and without glucagon-like peptide-1 receptor agonists: A SMART-C collaborative meta-analysis of randomised controlled trials. 

. 2024. doi: 10.1016/S2213-8587(24)00183-9

2. Massaro L. Study reveals robust benefits of semaglutide in protecting against kidney, CV events in patients with T2D. 

https://www.drugtopics.com/view/study-reveals-robust-benefits-of-semaglutide-in-protecting-against-kidney-cv-events-in-patients-with-t2d

3. Combining popular diabetes drugs offers complementary heart and kidney benefits. News release. The George Institute for Global Health. July 9, 2024. Accessed July 10, 2024. 

https://www.georgeinstitute.org/media-releases/combining-popular-diabetes-drugs-offers-complementary-heart-and-kidney-benefits

4. Mayo Clinic Staff. Chronic kidney disease. Fact sheet. Accessed July 8, 2024. 

https://www.mayoclinic.org/diseases-conditions/chronic-kidney-disease/symptoms-causes/syc-20354521

5. Klein HE. Diabetes prevalence expected to double globally by 2050. 

https://www.ajmc.com/view/diabetes-prevalence-expected-to-double-globally-by-2050

When used together, sodium glucose co-transporter 2 inhibitors (SGLT2is) and glucagon-like peptide-1 receptor agonists (GLP-1RAs) were able to lower the risk of major adverse cardiovascular events and kidney disease by 11% and 33%, respectively.

Clinical

SGLT2i, GLP-1RA Combination Therapy Offers Robust Protection Against Cardiovascular, Kidney Disease

Kelly Malkamaki: Part 1

Kelly Malkamaki: Part 2

Kelly Malkamaki: Part 3

Kelly Malkamaki: Part 4

Community pharmacies have been dealing with a variety of financial pressures that have led to decreased profit margins. According to data from the 2024 NCPA Digest, gross profit margins fell to 19.7% this year for pharmacies, the lowest point in the report’s 10-year lookback window.

 A key reason for this decrease is low medication reimbursement rates by third-party payers.

Although dispensing prescription medications is a primary income source for most community pharmacies, the continued decrease in reimbursement rates necessitates a move towards other ways to increase the bottom line. Offering additional clinical services, such as vaccine programs, point-of-care testing, and long-term care services, are great ways to do this. Another innovation that can help independent pharmacies is incorporating technology into workflows, which can help improve business efficiency and increase the patient experience.

AssureCare, a population health management company, is working to provide software that connects payors, providers, and pharmacies. The company’s goal is to help these parties work efficiently and effectively together to improve patient outcomes by managing medication-related risks. AssureCare’s technology solutions automate complex tasks, optimize workflows, and offer deep analytics, enabling informed decisions and cost-effective care delivery. AssureCare offers a wide range of solutions for community pharmacies including medication management, ONC certified EHR medical billing, credentialing and revenue cycle management services.

, Kelly Malkamaki, senior product pharmacy analyst at AssureCare, discussed how pharmacies dealing with decreased medication reimbursement rates can incorporate different revenue streams into their business, what role technology plays in pharmacies today, and how AssureCare can assist pharmacies.

“Pharmacies are no longer able to solely just dispense prescription medications and survive in today’s world,” Malkamaki said. “We have to think of new streams of revenue to bring in the doors.”

“We as pharmacists are the only health care professionals over the years that give away free advice,” she added. “I’m here to tell you that we are worth more than that. With that being said, maybe you’re not charging for delivery. Maybe you’re not charging for smoking cessation counseling. I’m telling you, maybe you can…All of these additional streams of revenue can help you not only survive but thrive in your pharmacies.”

Click here to learn more about AssureCare.

1. NCPA Releases 2024 Digest Report. News Release. NCPA. October 27, 2024. Accessed October 31, 2024. 

https://ncpa.org/newsroom/news-releases/2024/10/27/ncpa-releases-2024-digest-report

Drug Topics talked with Kelly Malkamaki, pharmacist, former independent community pharmacy owner, and senior product pharmacy analyst at AssureCare, about how community pharmacies can continue to thrive with decreased medication reimbursement rates.

Total Pharmacy Interviews

Community Pharmacies Must Diversify Their Revenue Streams to Survive in Today’s Landscape

Gap in Biosimilar Knowledge Causes Barriers to Implementation 

Highlighting a lack of education as a key barrier to implementation, experts believe it’s crucial for providers and patients alike to seek a deeper understanding of biosimilar medications. As research and education regarding these drugs increase, the general public will possess greater knowledge on how to access valued but affordable care as key benefits of biosimilars.

Biosimilar medications were first introduced into the drug supply chain in 2015 and over 60 additional products have been approved since.

 While still relatively new products in the marketplace, there is currently some subtle hesitation and a lack of understanding when it comes to choosing biosimilars over their original counterparts. But as more research is released, and infrastructure for implementation is created, experts argue that biosimilars could be a much more familiar type of medication.

“Educating patients and making sure that we address their concerns is key. A lot of providers have concerns to use biosimilars, especially for the non-medical switch. So, educating providers why this will be important clinically and financially for the health care system would be key,” Amanuel Kehasse PharmD, PhD, Director, Clinical Programs and Drug information, Clearway Health, told 

At the American Society of Health-System Pharmacists 2024 Midyear Clinical Meeting and Exhibition, held December 8 to 12 in New Orleans, Louisiana, Kehasse gave a presentation titled “Hot Sauce! Navigating the Spicy Landscape of Biosimilars in Specialty Pharmacy.” 

 caught up with him to discuss biosimilar implementation in the pharmacy and the main forces impeding it.

2024 ASHP Midyear Clinical Meeting and Exhibition here

1. Biosimilar Product Information. FDA. Published October 18, 2024. Accessed November 26, 2024. 

https://www.fda.gov/drugs/biosimilars/biosimilar-product-information

Amanuel Kehasse, PharmD, PhD, explored reasons why patients and providers may be avoiding the implementation of biosimilar medications.

Health System

Gap in Biosimilar Knowledge Causes Barriers to Implementation | ASHP Midyear

SGLT2 Inhibitors Recommended for Treating CKD

From glucagon-like peptide-1s (GLP-1s) to non-steroidal mineralocorticoid receptor antagonists (ns-MRAs), there are multiple variations of medications suited to treat chronic kidney disease (CKD). However, when it comes to the beginning of a CKD medication regimen, experts believe sodium-glucose cotransporter-2 (SGLT) inhibitors are the standard medications for patients with CKD and an estimated glomerular filtration rate (eGFR) equal to or greater than 20.

“Specifically, canagliflozin (Invokana) has been FDA approved for diabetic kidney disease. Empagliflozin (Jardiance) and dapagliflozin (Farxiga) have been approved for [CKD] in general,” Denise Kelley, PharmD, BCPS, FASHP, told 

At the American Society of Health-System Pharmacists 2024 Midyear Clinical Meeting and Exhibition, held December 8 to 12 in New Orleans, Louisiana, Kelley gave a presentation titled “Nephr Give Up: Pharmacologic Strategies for Slowing Chronic Kidney Disease Progression.” She discussed the various medications approved for CKD and the specific opportunities for when patients can benefit from them.

After her presentation, Kelley caught up with 

 to further discuss therapies that treat CKD. She also talked about the additional comorbidities that patients with CKD commonly experience, touching on the possible drug-drug interactions that accompany these patients.

Denise Kelley, PharmD, BCPS, FASHP, discussed the efficacy of medications designed to treat the progression of chronic kidney disease.

SGLT2 Inhibitors Recommended for Treating CKD | ASHP Midyear

How Pharmacists Can Help Patients Manage MASLD

Nonalcoholic fatty liver disease, now referred to as metabolic dysfunction-associated steatotic liver disease (MASLD), is prominent in nearly 25% of the US population, according to the American Liver Foundation.

 While many therapies have come to market to calm patients’ MASLD symptoms, some individuals need further attention in order to achieve the best outcomes.

Kathryn Litten, PharmD, clinical assistant professor at the University of Texas at Austin’s College of Pharmacy, met up with 

 at the American Society of Health-System Pharmacists 2024 Midyear Clinical Meeting and Exhibition, held December 8 to 12 in New Orleans, Louisiana. She discussed MASLD therapies in a presentation titled “Getting the Skinny on Existing and Emerging Therapies for Non-Alcoholic Fatty Liver Disease

“Using motivational interviewing strategies is so important for us as pharmacists to talk to our patients and to help encourage them to promote that weight-loss and promote those healthy outcomes,” said Litten.

She discussed how pharmacists are uniquely positioned to not only provide therapies for patients with MASLD, but also counseling. From their knowledge of medications to the efficacy of lifestyle behaviors, Litten believes pharmacists play a vital role as part of the health care team in treating liver disease.

1. Nonalcoholic fatty liver disease (NAFLD). American Liver Foundation. October 24, 2024. Accessed December 11, 2024. 

https://liverfoundation.org/liver-diseases/fatty-liver-disease/nonalcoholic-fatty-liver-disease-nafld/

Kathryn Litten, PharmD, joined Drug Topics to discuss how pharmacists can counsel patients with metabolic dysfunction-associated steatotic liver disease.

Todd Zwillich

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