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A study found that patients with obesity who were diagnosed with type 2 diabetes aged 50 or younger had the highest risk of dementia.

Type 2 Diabetes Diagnosis at Younger Age Linked with Increased Dementia Risk

On the most recent episode of Over the Counter, Steve Callahan, Senior Director of Advisory & Insights at MMIT, talked with us about biosimilars and the Inflation Reduction Act.

Impact of the Inflation Reduction Act on Biosimilar Pricing, Dispensing 

TaQuina Warren, PharmD, owner of Focus Pharmacy in Smyrna, Delaware, discussed her career journey and why pharmacists are so crucial to the interoperability of health care.

Q&A: An Independent Pharmacy Owner’s Perspective on Pharmacists in Health Care

A recent study showed that cognitive behavioral therapy could help reduce fatigue and improve concentration with moderate certainty.

CBT, Rehabilitation May Improve Symptoms of Long COVID

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Developing innovative solutions for women with depression, accounting for differences in gender and sex, are critically important

Mind-Body Resilience for Women: A Focus on Depression

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

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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

Amongst declining reimbursements and increasing prescription drug prices, pharmacists and patients alike have recently looked to biosimilars to alleviate some financial pressures at the pharmacy counter. With federal legislation—namely the Inflation Reduction Act (IRA) of 2022—intervening to the benefit of prescription drug beneficiaries, biosimilars could arise as even better options for cheaper, alternative medications.

“[The IRA’s provisions are] meant to continue to incentivize manufacturers to create biosimilars because they want competition,” said Steve Callahan, Senior Director of Advisory & Insights at MMIT. “They don't want to [disincentivize] any manufacturer from coming out with a biosimilar.”

Biosimilars, which are alternatives to generic and brand-name prescription drugs, are newer products to the drug supply chain and are designed to increase competition amongst manufacturers. Callahan sat down with 

 to discuss how biosimilars are intertwined with the provisions of the IRA and what their prices will look like going into next year.

Amgen Gains FDA Approval for First Interchangeable Biosimilar to Eculizumab

: What are the IRA’s key provisions that are set to make the biggest impact on the distribution of biosimilars?

 IRA had a number of provisions focused on the pharma industry. Medicare is now going to negotiate on prices. That's something that is starting to roll out in the near future. In 2026, the first set of drugs are going to come out at these new list prices. This is the first time that Medicare is actually negotiating on the drugs themselves. Of course, there's been negotiations in the past about rebating, etc., but this is the first time that the actual list price of drugs are being negotiated. That certainly has a very big impact. I think another big impact is there's this new inflation-based rebate. The rate of inflation is also known as a CPI. This is the CPI penalty, where if a drug's price increases faster than the rate of inflation, the manufacturer of that drug actually has to pay that money back to Medicare. Whatever that differential is above the inflation rate, they have to pay that amount that was paid above that back to CMS as a rebate for that drug.

Those are 2 key provisions that have an impact overall. But a couple things about the biosimilar were also mentioned in the IRA. There is proposed to be more beneficial biosimilar reimbursements. I believe the reimbursement rate is 106% of the ASP (average sales price) for traditional drugs. For biosimilars, they've actually increased that 2%, so they'll get 108% instead of 106%. There is some incentive to prescribe biosimilars because there is a slightly better reimbursement rate from CMS. Also, I had touched on the fact that Medicare is now negotiating on prices. How that works is CMS looks at the top spend of drugs overall, so it's the price of the drug multiplied by the number of patients using it. From that list, they identified the drugs that they're going to negotiate the price on.

But there's actually an exclusion where if a product is expected to have a biosimilar come out within 2 years, they can actually be excluded from that list. What's interesting is that it's not automatic, where a biosimilar manufacturer has to request that; they have to request that exclusion. It is there, and it's meant to continue to incentivize manufacturers to create biosimilars because they want competition. They don't want to disincentivize any manufacturer from coming out with a biosimilar. That provision is there to actually help biosimilars coming out by allowing that product to be excluded from the Medicare price negotiations. Really interesting is that Stelara was on that list, and there's actually a number of Stelara biosimilars that are set to launch next year. I was surprised to see Stelara was on the list of products that CMS negotiated with because, in theory, those biosimilar manufacturers could have petitioned for that product to be excluded, but that didn't happen.

: What is the future of biosimilars within the prescription drug market, and what is the industry seemingly pushing to do with these products 10 to 20 years down the line?

 I think in the recent years, biosimilars have just become a lot more known. Now, this is something that's occurring in the market by maybe more everyday patients who aren't as in tune with the pharma industry. There's been products like insulin or HUMIRA. These are big-name products that had biosimilars launch that were newsworthy events. I think just the fact that this is a term that's being more understood, and since they've been in the market for longer, there's just a lot more acceptance of biosimilars that these are similar products to what a patient has been receiving.

Also in recent years, there's been biosimilars that came out [with] this interchangeable designation. One thing that separated the initial biosimilars from generics is that a generic has this interchangeable designation. [This means] if a physician prescribes you the brand name, at the pharmacy, they can just switch it to a generic product that's a lower cost. Because they've been shown to be the same, that's allowed at the pharmacy. With the first biosimilars, that wasn't the case; a physician had to actually write specifically for a biosimilar. If they put the original brand name on it, that's what the pharmacy was allowed to give. They couldn't switch it to anything else. But now that there's this interchangeable designation, I think that's eased a lot of the concern that maybe some patients who would otherwise be hesitant have had because now [it’s] showing that this is indeed the same output, the same outcomes a patient was already receiving.

I think that the factors that are making more acceptance are just the fact that there's more awareness of biosimilars, that there's more data, more overall public experience showing that the outcomes haven't changed for patients who've taken a biosimilar versus an originator over the past 10 years. There's been this new interchangeable designation, and then just some very high-profile products to get biosimilars. And there's a lot more in the works that are going to get biosimilars in the near future. I think that really this is just leading to more and more public awareness and acceptance of biosimilars, and that we're going to continue to see this be a space that just grows as time goes on.

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Steve Callahan, Senior Director of Advisory & Insights at MMIT, discussed out-of-pocket costs and the impact biosimilars are predicted to have for patients in the future.

Q&A: The Future of Biosimilar Pricing at the Pharmacy Counter

Throughout 2024, the US has experienced an unprecedented outbreak of avian influenza A(H5)—otherwise known as the bird flu—impacting dairy herds and poultry farms across the country. The current risk of humans contracting the virus remains low and no human-to-human transmission has been reported. Despite this, the bird flu has made its way from birds and cows to a total of 53 humans in 7 states,

 raising alarms to public health officials and infectious disease experts in fear of a future pandemic situation. [

Editor’s note: These numbers are accurate as of the time of publication.

“We've seen sporadic human cases, somewhere in between 5 and 10 cases in California. There were a couple of cases in Missouri earlier this year. There have been cases in Michigan and in Texas in humans, but to this point, no evidence of human-to-human transmission, which is a plus,” said Robert H. Hopkins, Jr., MD, medical director of the National Foundation for Infectious Diseases (NFID).

The first human case of the bird flu in the US was reported in April 2022 in a poultry worker from Colorado.

 After being examined and treated with the influenza antiviral oseltamivir (Tamiflu), the patient recovered; no human cases were reported in the US for nearly 2 years. Then, on March 27, 2024, a dairy farm worker in Texas reported conjunctivitis in their eyes and later tested positive for highly pathogenic avian influenza (HPAI) A(H5N1), making them just the second human living in the US to contract the bird flu virus.

The bird flu has since infected poultry in 49 states and wild birds in 50 jurisdictions,

 with human cases gradually increasing amid reports in various states. One of the key factors for the bird flu possibly developing into a larger public health threat is human-to-human transmission, which has not yet occurred. However, with one of the more recent cases in Missouri being the first to report no contact with infected animals,

 the bird flu virus is noticeably progressing, despite public health sentiments regarding little to no risk.

“These highly pathogenic avian influenza viruses were first detected in wild waterfowl in China in 1996, and in 1997, they were first found in a person causing infection” in Hong Kong, said Sonja Olsen, PhD, associate director for preparedness and response at the CDC’s Influenza Division, in a presentation sponsored by the NFID.

 The earliest reports of bird flu in 1997 resulted in 18 human infections and 6 deaths in Hong Kong. The virus would go on to infect over 850 individuals with nearly a 50% mortality rate in various parts of the world.

According to the NFID’s presentation, the virus continued to spread elsewhere in the world in the 21st century and beyond. Further outbreaks appeared in several Asian countries by 2003. With those outbreaks mainly occurring in wild birds, the virus eventually spread to Africa, the Middle East, and Europe by 2005. Once the virus began spreading to other continents, it also began to genetically diversify.

From 2014 to 2016, gene-swapping of wild birds and poultry led to the appearance of H5N6 and H5N8 virus subtypes, eventually reaching birds in the US. Between 2018 and 2020, these virus subtypes became prevalent across the world. Since then, further human cases have been reported while the virus persists in birds all around the world, with 2024 seeing the largest outbreak of its kind in the US.

“Flu of all types—bird flu, human flu—is transmitted by bodily fluids,” Hopkins explained. “If you cough or sneeze, you aerosolize the virus. It can then be breathed in by somebody else, and that can make them catch the flu. You can also get it from touching infected and dead animal tissue. You can also get viruses secreted in other bodily fluids…and so if you're in contact with an animal's diet of fluid, you can potentially catch flu from that animal.”

First Human Bird Flu Case Without Exposure to Infected Animal Discovered in Missouri

There are currently 16 known hemagglutinin (HA) and 9 known neuraminidase (NA) subtypes of influenza A viruses that have been discovered in various bird species. Outside of the H17N10 and H18N11 subtypes, only found in bats, bird species are susceptible to all subtypes of influenza A viruses.

“HA and NA are the 2 major surface glycoproteins, essential for virus entry and release and are the major targets for neutralizing antibodies. Mutations that occur in the HA and NA genes can lead to changes in the protein and facilitate evasion of host humoral immune responses. A subset of avian influenza A viruses are commonly found in domestic poultry, and numerous incidental hosts, including humans, have been described,” wrote authors of a study published in the 

The virus has been detected in over 10,600 wild birds and over 109 million poultry, and to a much lesser extent compared with cows and humans.

 While these infections begin in birds, they carry the slight—but very real—possibility of evolving and subsequently affecting mammals.

“Infected birds shed avian influenza viruses through their saliva, mucous, and feces. Other animals infected with avian influenza viruses may have virus present in respiratory secretions, different organs, blood, or in other body fluids, including animal milk. Human infections with avian influenza viruses can happen when [the] virus gets into a person's eyes, nose, or mouth, or is inhaled,” according to the CDC.

While it is uncertain how the virus ended up in the US, experts learned about the 2024 outbreak when the bird flu began appearing in dairy cattle, which subsequently infected the first human patient since 2022. Since then, officials in 15 states have reported a bird flu outbreak amongst cows, with a total of 612 herds infected.

In fact, the outbreak across America’s dairy herds was so concerning that a veterinary epidemiologist experimented with grocery store milk in the Midwest and found viral bird flu RNA in 58 samples. Despite samples of the virus appearing in pasteurized milk, there was no harm of humans contracting the bird flu because the virus would have been killed before the milk was placed on the grocery store shelf.

However, this finding opened the eyes of public health experts to the more widespread nature of the potential bird flu threat than had been previously understood. For the past few months, government organizations have been putting forth a concerted effort to maintain the spread of the bird flu in the US, hoping to use lessons learned from the COVID-19 pandemic.

“When people get it, it's almost always been confirmed to be directly from animals to humans; the virus, in its current state, isn't evolved to readily spread from human to humans,” said David G. Hill, MD, director of clinical research at the American Lung Association. “That dual infection, where it changes to become more biologically designed to spread human to human, is where [an] epidemic or pandemic could occur. The reason for that is we don't have a lot of natural immunity to this virus, as opposed to the typical H1N1 flu that circulates where people have been exposed.”

Indeed, natural immunity to any infectious disease is what public health experts aim to target when population-wide health concerns appear. As was procedure during the COVID-19 pandemic, the immediate response of the federal government is to tame the spread of the bird flu and develop processes for how to manage the virus if it were to reach human-to-human transmission; the latter portion being the development of a bird flu vaccine.

“We rapidly created vaccines to a completely novel virus for COVID-19,” said Hill. “H5N1 bird flu is [an] influenza virus where we've had vaccine technology for decades. There are vaccines in development. There have been vaccines made in the past, so there are some bird flu vaccines in the national defense stockpile, but I think they could ramp up production of a vaccine relatively quickly.”

Like the COVID-19 pandemic, vaccines would be a saving grace for public health in the US if the bird flu escalates. While officials are prepared to address the bird flu should it become a larger threat to public health, experts are concerned about vaccine uptake, something that created yet another hurdle during the COVID-19 pandemic.

“The struggle we face in clinical care and in public health right now is there is so much misinformation about vaccination,” said Hill.

According to NFID survey data from September 2024, US adults’ concerns about getting vaccinated against respiratory viruses have decreased in recent history. Just 38% of survey respondents said they definitely plan to get a flu vaccine, 26% for the updated COVID-19 vaccine, 21% for the respiratory syncytial virus (RSV) vaccine, and 24% for the pneumococcal disease vaccine.

While experts have seen a noticeable shift in vaccination rates, they are seemingly pointing at the COVID-19 pandemic for its part in exacerbating medical misinformation and skewing the trust patients have for their providers. As US vaccination rates decrease and the bird flu virus continues to infect humans, experts are hoping to stunt the spread of the virus before there is even a need for vaccination.

Unlike COVID-19, however, the bird flu is something medical experts within the US are much more familiar with: it has been observed in birds for the past 30 years, and the virus has similar strands as one of the most prominent infectious diseases, making the federal government’s current clinical infrastructure much more well-suited to address the bird flu than it was able to address the novel SARS-CoV-2 virus. With public health concerns remaining low at the time, right now, experts are aiming to address the bird flu at its source and amongst the humans most susceptible to interacting with the virus.

“There's a low risk to the average American out there. The people who should be concerned are those who work in an occupation that puts them at risk. People working on poultry farms or with close contact to livestock should be listening to their public health authorities and wearing appropriate protective equipment and reporting symptoms, should they get [the virus],” said Hill. For the general public, he urged to stay away from dead or injured birds and wild birds in general.

The CDC and US Department of Agriculture are working around the clock to assist workers at risk of contracting bird flu while also dedicating millions of dollars to support businesses impacted by the outbreak. Today, the escalation of the H5 bird flu to pandemic status is still considered unlikely and vaccination options are being prepared before the virus has even reached 100 people. But human-to-human transmission is key; it’s something experts and the general public should keep an eye out for to ensure they are playing their parts in keeping the population safe from this virus.

“If we're seeing H5 influenza viruses, local health departments can investigate that and make sure that this is coming from potentially animal sources, as opposed to something that’d make us worry about more human contact,” said Hopkins. “[There’s] lots of activity going on, but if we see human-to-human transmission, that's when we have to step things up to another level.”

Everything You Need to Know About the US Bird Flu Outbreak

1. H5 bird flu: current situation. CDC. November 1, 2024. Accessed November 1, 2024. 

https://www.cdc.gov/bird-flu/situation-summary/index.html

2. U.S. case of human avian influenza A(H5) cirus reported. News Release. CDC. Published April 28, 2022. Accessed November 1, 2024. 

https://www.cdc.gov/media/releases/2022/s0428-avian-flu.html

3. Health Alert Network (HAN) - 00506 | Highly pathogenic avian influenza A(H5N1) virus: identification of human infection and recommendations for investigations and response. News Release. CDC. April 5, 2024. Accessed November 1, 2024. 

https://emergency.cdc.gov/han/2024/han00506.asp

Public health and infectious disease experts offered their perspectives on the 2024 US bird flu outbreak and its potential of becoming a greater public health crisis.

Sandra Bond Chapman, PhD

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