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Articles

Researchers investigated the acceptability of community pharmacy-led influenza vaccination and patients’ willingness to return for future immunization.

Access to Community Pharmacies Increased Willingness to Receive Flu Vaccine

The main motivations for preferring vaccination included previous experience with an RSV infection and desire to protect the baby.

Pregnant Women Generally Prefer Maternal RSV Vaccine to Infant Injections

Researchers analyzed the association between adherence to a Mediterranean diet and obesity cancers, with a focus on the mediating role adiposity plays throughout the process.

Mediterranean Diet Adherence Reduced Risk of Obesity-Related Cancer

All dosages of semaglutide (Wegovy) under the new program will be available at $499 per month for patients that are uninsured or who do not have coverage for obesity medication.

Novo Nordisk to Provide Cash Options for Wegovy Through Online Pharmacy

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ASHP Midyear 

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Clinical

The Impact of Pharmacists and Pharmacy Technicians in Recognizing and Responding to Human Trafficking (Pharmacist Credit)

1.0 Credit / Law, Pain Management, Opioids


Ensuring Pharmacy Technicians’ Proficiency in Risk Evaluation and Mitigation Strategies

Denosumab-Bmwo is approved for all indications of the respective reference products, including osteoporosis and high-risk of fracture due to chemotherapy.

FDA Approves Denosumab-Bmwo as Biosimilar to Prolia, Xgeva

Yesintek from Biocon Biologics and Pyzchiva from Sandoz will have a patient assistance program that includes benefits verification and copay support.

Two New Stelara Biosimilars Now Available in US

Denosumab-dssb is approved as a 60 mg pre-filled syringe as a biosimilar for Prolia and 120 mg vial as a biosimilar for Xgeva.

FDA Approves Denosumab-Dssb as Biosimilar for Prolia, Xgeva

The drug is the first rapid-acting insulin biosimilar product approved for use by the FDA, marking a significant milestone in diabetes treatment.

FDA Approves Merilog as Biosimilar to Insulin Aspart for Diabetes

Chelsee Jensen, PharmD, BCPS, senior pharmacy specialist at the Mayo Clinic, discusses her career and how biosimilars will impact the pharmacy profession in the coming years.

Specialty Pharmacist Working to Improve Biosimilar Adoption

Chelsee Jensen, PharmD, BCPS, senior pharmacy specialist at the Mayo Clinic, discusses key benefits of incorporating biosimilars into a health system's formulary.

Benefits of Incorporating Biosimilars Into Health System Formularies

Biosimilars offer numerous benefits to patients, such as wider availability of treatment options and increased access to biological products. However, their adoption across various therapeutic areas has remained slow due to concerns over safety and efficacy and uncertainties about interchangeability.

But research has shown that health systems in particular can benefit from biosimilar adoption, as they offer significant costs savings.

, Chelsee Jensen, PharmD, BCPS, senior pharmacy specialist at the Mayo Clinic, sat down to discuss key benefits of incorporating biosimilars into a health system's formulary, potential challenges health systems face when integrating biosimilars, strategies health systems pharmacies can use to increase provider and patient confidence in biosimilars, and future trends in biosimilar development and utilization that health systems need to prepare for.

“I do foresee for biosimilars that when they are available, they continue to be utilized,” Jensen said. “That is super important to try to reduce the overall cost of health care in the United States. I will say that there are biologics out there that the patents have expired and we don’t have any biosimilar competitors entering the market. I would challenge health systems and manufactures to really dive into what the barriers are, where the opportunities are. How can we partner with industry to start developing biosimilars where there aren’t any competitors on the market?”

1. Edgar BS, Cheifetz AS, Helfgott SM, et al. Overcoming barriers to biosimilar adoption: real-world perspectives from a national payer and provider initiative. 

. 2021;27(8):1129-1135. doi:10.18553/jmcp.2021.27.8.1129

2. Kvien TK, Patel K, Strand V. The cost savings of biosimilars can help increase patient access and lift the financial burden of health care systems. 

. 2022 Feb;52:151939. doi: 10.1016/j.semarthrit.2021.11.009. Epub 2021 Dec 30. PMID: 35027243.

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Health System

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.

Gap in Biosimilar Knowledge Causes Barriers to Implementation | ASHP Midyear

A conversation with Chelsee Jensen, PharmD, BCPS, senior pharmacy specialist at the Mayo Clinic.

Specialty Pharmacist Paving the Way for Biosimilar Adoption

Chelsee Jensen, PharmD, BCPS, is a senior pharmacy specialist at the Mayo Clinic. Before she became a pharmacist, Jensen wanted to become a nurse. However, after helping her grandmother organize and stay on track with various medications, she decided to pursue a career in pharmacy.

At the Mayo Clinic, Jensen works in the supply chain and finance field as a pharmaceutical formulary manager. She began at the Mayo Clinic as an inpatient pharmacist, but switched positions in 2017. In her role, she has spearheaded a biosimilar implementation initiative across the entire Mayo Clinic. She said her role has been very interesting and that she has learned a lot so far.

“I think this supply chain role has so much value,” Jensen said. “My previous experience in the hospital in the inpatient setting gave me a ton of value. I also had exposure to our outpatient infusion area. I think all of that has tied in really nicely to the work I do now and I’m just super happy that I chose this profession and have had the opportunities that I’ve had.”

In a conversation with Drug Topics, Jensen discussed some of the rewards and challenges she faces in her setting, a specific program she implemented that exemplifies the value of pharmacists in patient care, what the biggest opportunities are for pharmacists to expand their role in patient care in today's health care landscape, and how biosimilars will impact the pharmacy profession in the coming years.

Our coverage of American Pharmacists Month continues all October. To view all of our interviews, 

visit our American Pharmacists Month landing resource center

Total Pharmacy

Farmer Biosimilars 4

Despite their clear benefits, regulatory issues hindering access and adoption to biosimilar therapies still persist. “The one…that stands out to me the most is that various states and payers still have not allowed pharmacist-level substitutions for biosimilars without the FDA-approved interchangeable designation,” said Lakesha Farmer, Senior Director, Strategic Accounts, ION Oncology Practice Network at Cencora.

In order to be granted interchangeable status, the FDA requires that a biosimilar agent undergo an extensive switch study, in which participants are alternated between treatment with the reference product and the biosimilar product to provide that the biosimilar is “highly similar in nature and noninferior to the reference product,” Farmer explained. The issue with these switch studies, though, is their cost: “As we know, drug studies are typically very expensive,” Farmer added. “These studies can cost millions of dollars. They can also further delay the market launch for biosimilar products.”

In July 2023, legislators introduced the Biosimilar Red Tape Elimination Act in an effort to eliminate the need for interchangeable designations by removing the switch study requirement—a requirement that only exists in the United States. Other countries, Farmer said, acknowledge all biosimilars as interchangeable on market approval: “If the interchangeability requirements are removed, this could positively impact the adoption of biosimilars and allow for automatic substitutions at the pharmacy level.” This change could lead to sustainability in the market, less expensive go to market strategies for manufacturers, and more affordable medications for both the health care system and patients.

 at AXS24, the Asembia Specialty Pharmacy Summit, held April 28 to May 2 in Las Vegas, Nevada. 

Click here for more of our coverage from AXS24.

Addressing requirements around FDA interchangeability designations can increase the adoption of biosimilar substitutions at the pharmacy level. 

Hurdles In Access: Costly Switch Studies Block Wider Biosimilar Use

Farmer Biosimilars 3

Biosimilar therapies might be here to stay, but the regulatory landscape around these products is still evolving, said Lakesha Farmer, Senior Director, Strategic Accounts, ION Oncology Practice Network at Cencora. “There are several legislative efforts currently in motion to address several perceived impediments to the biosimilar approvals and launches that we see today.”

Numerous bills have been introduced since Congress passed the Biologics Price Competition Innovation Act of 2009, legislation that created “an abbreviated approval pathway to help provide patients with greater access to safe and effective biological products.”1 Farmer pointed to a recent bill introduced to Congress aimed at preventing product hopping, a practice where innovator product companies seek to extend exclusivity by switching patients to new or slightly changed versions of a reference product. “As we know, tactics like this can stall the ability to introduce new biosimilars to the market, as well as possibly hinders approved biosimilars from having full access to all of the originator product indications, which forces [these biosimilars] to have a skinny label approval,” Farmer said.

Skinny labels, she added, have demonstrated some benefits in the space due to their ability to avoid originator patent walls; however, these labels may also potentially hinder biosimilar adoption due to providers’ reluctance to prescribe a therapy that is not FDA approved for all indications.

“The good news is, although we are still making strides from a legislative standpoint, I believe that those strides are moving in the right direction,” Farmer said. “I am very hopeful and optimistic that we can expect to see even more legislative support of the biosimilar industry as it continues to grow in the coming years.”

1. Biological product innovation and competition. FDA. Reviewed April 10, 2024. Accessed May 1, 2024. 

https://www.fda.gov/drugs/biosimilars/biological-product-innovation-and-competition

A recent bill introduced to Congress is intended to prevent product hopping, a practice that extends exclusivity and hinders the adoption of biosimilar therapies. 

Expert: Biosimilar Legislation Making Moves in the Right Direction

Farmer Biosimilars 2

Biosimilar cost savings hinges on patient access. That’s why distributors—such as Cencora—work closely with biosimilar manufacturers to gain access to every biosimilar currently on the market in the United States, said Lakesha Farmer, Senior Director, Strategic Accounts, ION Oncology Practice Network at Cencora. “This ensures that our customers have access to every product that they need to provide their patients with these lower cost options,” she explained.

“From a GPO [group purchasing organization] perspective, our specialty GPO teams collaborate with all manufacturers to help negotiate and curate unique and competitive GPO contracts that provide lower cost options for biosimilars through invoice discounts [and] rebates,” Farmer added, while offering market access resources and services “to assist [partners] with the creation of patient assistance programs for biosimilar agents during the pre-commercialization process.”

While some biosimilars have been launched with both branded and non-branded versions, the “vast majority” of these products are marketed as branded products. “Most biosimilars suppliers offer robust patient access programs, similar to that of their reference products, which helps to level the playing field” in the competitive landscape, Farmer said. These patient access programs, which include co-pay assistance programs, free drug programs, and discount cards, can make the adoption of biosimilars more attractive—and affordable—to patients.

Distributors can help manufacturers create patient access programs that reduce costs, copays, and co-insurance. 

Distributors Play a Role in Patient Access Programs

Farmer Biosimilars 1

Cost savings is part of the promise of biosimilar medications. But in order to deliver on that promise, providers must prescribe them, and payers must cover them. Since their introduction, manufacturers have implemented a variety of unique pricing incentives and strategies to incentivize biosimilar adoption. “Most recently, we have seen manufacturers take a non-branded and branded approach to the launch of their biosimilars, which offers a low wholesale acquisition cost [WAC] and a high [WAC],” explained Lakesha Farmer, Senior Director, Strategic Accounts, ION Oncology Practice Network at Cencora. This new pricing strategy is being used across therapeutic areas, from insulin biosimilars to the many biosimilars to adalimumab (Humira) that have launched since the start of 2023.

The dual WAC strategy, Farmer added, “caters to all payers and plans based upon preference and increases coverage and access to biosimilars for patients.”

Farmer also highlighted the strategies being implemented by the Mark Cuban Cost Plus Drug Company, which also aim to reduce out of pocket patient costs. For adalimumab biosimilar adalimumab-aqvh (Yusimry), for $569. The average cash price for adalimumab, Farmer said, $7300. “By offering this biosimilar at a cash price of $569 to uninsured patients—as well as [to] commercially insured patients with high deductibles, high co-pays, and high co-insurance—this patient-centered approach can be a game changer.”

From a reimbursement perspective, “the most notable incentive is the add-on payment for physician administered biosimilars, which was introduced under the Inflation Reduction Act,” Farmer said. “Under this provision, biosimilar reimbursement is stated as [average sale price] plus 8% of the reference product’s [average sale price],” which is higher than the add-on of 6% for reference products.

One notable incentive includes the launch of biosimilars at both low- and high wholesale acquisition costs. 

Incentives Drive Provider, Patient Biosimilar Adoption

Gregory Biosimlars 2

Although biosimilar drugs are poised to save billions in health care spending, hesitancy remains around their uptake. In addition to provider and patient education, decision makers need to understand the financial implications of these therapies.

“Helping the administrative staff…understand the financial value of biosimilars to their institution is also a key area where pharmacists can really show value and show that there are opportunities that may be beyond what meets the eye for savings,” said Fran Gregory, PharmD, MBA, vice president of emerging therapies at Cardinal Health.

In the 2024 Cardinal Health Biosimilar Report,

 Gregory noted that US health care spending in 2022 reached $4.5 trillion, $252 billion of which was spent on biologic therapies. “When I think about the positive impact new treatments are having on patients, I also consider their potential impact on the health care economy,” Gregory wrote.

, that impact is key to creating a balance between spending on leading-edge treatments and finding the necessary savings to reduce the overall financial burden on the health care system.”

1. 2024 Biosimilars Report. Insights on a pivotal year of evolution and expansion. Cardinal Health. Accessed May 1, 2024. 

https://www.cardinalhealth.com/content/dam/corp/web/documents/Report/cardinal-health-2024-Biosimilars-Report.pdf

Pharmacists can help financial decision makers understand the value of biosimilar therapies.

Biosimilars Poised to Save Billions in Health Care Spending

Gregory Biosimilar Uptake 1

It’s no secret that medications are expensive. Biologic therapies account for only 2% of drugs on the market, but represent 46% of drug spending.

 Biosimilar medications are an answer to these high costs: As some of the most expensive—and most used—biologic drugs reach the end of their exclusivity window, biosimilars are projected to reach $181 billion in cost savings through 2027, according to Cardinal Health’s 2024 Biosimilars Report.

“It is more important than ever that all stakeholders of the health care ecosystem understand the significant benefits biosimilars offer to patients, providers, practices, and payers alike, said Fran Gregory, PharmD, MBA, vice president of emerging therapies at Cardinal Health, in a press release.

 “The savings generated by biosimilars will play an increasingly important part in creating a balance between funding innovative new treatments and reducing the overall financial burden on the health care system.”

 at AXS24, the Asembia Specialty Pharmacy Summit, to dive deeper into 

 and examine the important role that pharmacists play in their uptake.

“As a pharmacist myself, I think our role is critical in ensuring uptake of biosimilars in a few areas,” Gregory said. Education is one of those areas: In addition to educating themselves, pharmacists should be prepared to share that knowledge with other health care providers and patients. “The education coming from a health care provider to a patient is one of the most critical aspects of making sure that a patient accepts that treatment and believes that it’s as effective as the reference product.”

The Asembia Specialty Pharmacy Summit was held April 28 to May 2 in Las Vegas, Nevada. 

2024 Biosimilars Report. Insights on a pivotal year of evolution and expansion. Cardinal Health. Accessed May 1, 2024. 

Cardinal Health annual research report examines milestone year in biosimilars. News release. Cardinal Health. February 29, 2024. Accessed May 1, 2024. 

https://www.prnewswire.com/news-releases/cardinal-health-annual-research-report-examines-milestone-year-in-biosimilars-302075391.html

Savings associated with biosimilar uptake are projected to reach $181 billion through 2027.

Biosimilars

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