EMSOP Chronicles Vol.16 Issue 2 Part 1 (Spring 2025)

VOL 16 ISSUE 2 PART 1

SPRING 2025

EMSOP CHRONICLES

ERNEST MARIO SCHOOL OF PHARMACY VOL.16 ISSUE 2 APRIL 2025

EMSOP

CHRONICLES x brought to you by Pharmacy Governing Council

Value-Based Care: Why Make the Switch?

by Amrita Tejwani, P2 Value-based care is a hotly debated topic with a wide array of viewpoints. On the whole, value-based care is “doctors and other health care providers working together to manage a person’s overall health, while considering an individual’s personal health goals.”1 This contrasts with fee-forservice infrastructure, where “healthcare providers are reimbursed for each service they deliver to a patient,” which is the primary method to compensate for healthcare currently used throughout the US.2 In value-based care, healthcare providers are compensated according to overall patient outcomes, preventing unnecessary costs from accruing, since healthcare providers are no longer performing unnecessary actions to increase their overall compensation. The main argument against valuebased care is that healthcare professionals will not adopt it as “nobody is going to ever do population health because that requires compensating people for when they're tak-

Table of Contents Forget Me Not, Humira ..............2 505(b)(2), Oncology..................... 3 YCT-529, Value-Based ................. 4 Behavioral, YCT-529.................... 5 HoEMSOP.................................6-9 Cleanser, Humira ....................... 10 Art/Meme Wall ........................... 11 Credits........................................ 12

Photo Credit: https://www.nelsonmullins.com/insights/blogs/healthcare_essentials/corporate_and_transactional/using-a-value-based-enterpriseto-integrate-specialists-and-primary-care-taking-value-based-care-to-the-next-level

ing care and preventing disease to start off with.”3 It is evident that switching to valuebased care will likely improve patient outcomes but is a very challenging prospect as most healthcare systems are accustomed to the fee-for-service infrastructure.

Since most insurance companies and other payers prefer to rely on an easily billable method to easily calculate compensation, converting to value-based care from feefor-service infrastructure is a difficult transition. One method suggests running pilot model programs to ultimately determine the most effective approaches to care.1 Alternative payment models reward providers for high quality care such as helping a patient slow the progression of a disease or serving those in areas with limited healthcare access. Another effective method may consist of looping in pharmaceutical companies. As a result of fewer patients undergoing unnecessary medical interventions, suppliers have a benefit of

aligning their products and services with positive patient outcomes at a reduced cost.4 XiFin, a healthcare information technology company that acquired OmniSYS, is working to begin the process of switching to value-based care. This company works in conjunction with the pharmaceutical industry and pharmacies to help serve their patients with clinical services, medical billing, and revenue cycle management services.5 It’s evident that pharmaceutical companies are an integral part of the switch to value-based healthcare, and can offer key insights into promoting the change.

Although it will be a challenging transition, value based care is still possible by connecting the right groups and incentivizing the benefits.

Success within value-based care looks like fewer hospitalizations and illnesses.3 Patients can have ease of navigating care,

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Forget Me Not

By Ashley Huang, P1

Photo Credit: https://www.southernliving.com/forget-me-nots-care-7098903

My decision to pursue a career in pharmacy has been a deeply personal one, centered around a gallon sized ziploc bag filled to the zipper with amber vials. I would watch the bag’s owner meticulously line up the dozen or so medications for the next morning, one by one, like soldiers preparing for battle — a nightly ritual carried out with quiet determination.

In the past few years, however, what was

once a consistent routine has become disjointed and wrought with confusion. It should come as no surprise that one of the primary issues facing elderly patients is adherence to medication regimens, especially in the face of multiple morbidities.1 Since poor adherence is a major barrier in improving patient outcomes, identifying and implementing the best strategies to improve compliance is key.2 Common

strategies to improve compliance include keeping an updated medication list, reducing polypharmacy, and setting alarms or reminders.3 In my personal experience, utilizing a visual medication list with photos of the drug followed by clear dosing instructions has been incredibly helpful. This visual reference serves as the ultimate guidebook, answering questions such as when to take the medication, how much/ many to take, what it’s used for, and when it’s necessary. As healthcare professionals, and, more importantly as potential friends and family to an elderly patient, it is becoming more pertinent to recognize the unique cognitive challenges elderly patients may face when managing medications.

References 1. Barry HE, Hughes CM. An Update on Medication Use in Older Adults: a Narrative Review. Curr Epidemiol Rep. 2021;8(3):108-115. doi:10.1007/ s40471-021-00274-5 2. Christopher CM, Blebil AQ, Bhuvan KC, et al. Medication use problems and factors affecting older adults in primary healthcare. Res Social Adm Pharm. 2023;19(12):1520-1530. doi:10.1016/j.sapharm.2023.08.001 3. National Institute on Aging. Taking Medicines Safely as You Age. National Institute on Aging. Published September 22, 2022. https://www.nia.nih.gov/health/medicines-and-medication-management/taking-medicinessafely-you-age

Monopoly Medicine: The Patent Games That Kept Humira on Top

by Sakshi Shah, P1

With monoclonal antibodies (mAbs) becoming one of the most powerful classes of drugs in modern medicine, the conversation around access is more important than ever. These biologics are not luxury treatments; they are essential for patients with autoimmune conditions, cancers, and chronic inflammatory diseases. Unlike traditional small-molecule drugs, which are now relatively simple to replicate with generics, newer monoclonal antibodies are biologically complex, produced in living cells and sensitive to even the slightest change in formulation. Developing biosimilars —generic versions of biologics— is far more difficult and expensive.1 In addition to the complexity of development, intentional legal strategies have designed to keep biosimilars off the market, further limiting access to these drugs.

Adalimumab, brand name Humira, is a TNF-alpha inhibitor approved in 2002. It’s one of the most versatile and widely prescribed biologics, with FDA approvals

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across rheumatoid arthritis, Crohn’s disease, ulcerative colitis, plaque psoriasis, and other autoimmune conditions.2 More impressive than its pharmacology, however, is the way its manufacturer AbbVie managed to keep it at the top of the market for more than twenty years.

AbbVie built a patent thicket around Humira — deliberately dense web of patents

designed to delay or block biosimilar entry.3 While the primary patent for Humira expired in 2016, AbbVie filed over 250 secondary patent applications, the majority of which came after the drug was on the market. These secondary patents covered surface changes to formulations, injection devices, dosing schedules, and manufacturing processes. In total, more than 130 patents were granted, many of which extended exclusivity into the 2030s.4 Due to these patents, there was no biosimilar competition in the U.S. until 2023, although biosimilars launched in Europe back in 2018.5 During that five-year delay, AbbVie continued to raise Humira’s price while maintaining a monopoly that generated billions in revenue annually.6 There are now more than 120 FDA-approved monoclonal antibodies, and that number continues to grow.7 If the Humira strategy taught the industry anything, it’s

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Understanding 505(b)(2) Drugs and Reimbursement

by Maria Ghaly, P1 At the 2025 Hematology/Oncology Pharmacy Association (HOPA) Annual Conference, experts shed light on the evolving role of the FDA’s 505(b)(2) approval pathway and impact on drug reimbursement practices, especially in oncology. The 505(b)(2) pathway allows pharmaceutical companies to modify existing drugs by changing dosage forms, combining medications, or altering the route of administration while relying partially on previously established safety and efficacy data.1 This route helps reduce development costs and accelerates the time to bring medications to market. Between 2003 and 2023, over 940 drugs were approved via this method.1 While this pathway was originally designed to foster innovation, recent changes by the Centers for Medicare & Medicaid Services (CMS) are transforming how these drugs are reimbursed. Previously, drugs under this category shared a common J-code for billing purposes. However, as of January 2023, CMS has begun issu-

by Anisha Desai, P2

Photo Credit: https://www.evotec.com/therapeutic-areas/oncologyimmuno-oncology

ing unique J-codes to 505(b)(2) drugs that are not considered therapeutically equivalent to their reference drugs.2 This policy shift has significant implications for infusion centers and hospital pharmacies. According to Dr. Scott Soefje, Director of Pharmacy Cancer Care at Mayo

Clinic, “Now the 505(b)(2) manufacturers may request the FDA to give them therapeutic equivalents, but FDA does not automatically do it.”1 As a result, many of these drugs are being treated as sole-source products, giving them unique J-codes and changing how they are reimbursed by CMS and other payers. For pharmacists, especially those working in oncology or institutional settings, understanding the distinction between therapeutic equivalence and regulatory classification is essential. The 505(b)(2) pathway offers flexibility and exclusivity, but it also adds new layers of complexity in operational and billing practices that pharmacists must navigate to ensure optimal patient care and institutional compliance.

References 1. Soefje SA, Irvine CA. 505(b)(2) Drugs:New Chaos for Infusion Centers.

Presented at: Hematology/Oncology Pharmacy Association (HOPA) 2025 Annual Conference; Portland, Oregon; April 9-12, 2025.

2. Alana Hippensteele, Lead Editor. “Hopa 2025: Understanding the Recent Changes for 505(b)(2) Drugs and Reimbursement.” Pharmacy Times, Pharmacy Times, 12 Apr. 2025, www.pharmacytimes.com/view/hopa-2025-understanding-the-recent-changes-for-505-b-2-drugs-and-reimbursement.

Role of Pharmacists in Oncology

The majority of oncology patients in the US are treated at community oncology centers with the priority of patient centered care and lower costs. A unique feature of many of these centers is an integrated dispensing pharmacy where interdisciplinary teams are focused on coordinated care. Literature has shown that oncology pharmacists contribute to positive outcomes for patients by identifying drug interactions, facilitating patient understanding, managing side effects, and maintaining adherence.

In a single center study at Florida Cancer Specialists & Research Institute, a descriptive analysis assessed pharmacist-led clinical interventions for patients receiving oral oncolytic therapy.1 Intervention data was categorized by the following types: strength and dosing, clarification of prescription directions for use, drug-drug interactions, treatment discontinuation or hold, treatment cycle, or lab abnormalities.

The study primarily aimed to measure the number of interventions and secondarily the intervention acceptance rates.

Results showed a total of 3528 clinical interventions identified, with the greatest percentage being strengths and dosing, followed by treatment discontinuation or

Photo Credit: https://www.onlymyhealth.com/trends-to-look-out-for-in-radiation-oncology-1688465917

hold.1 The medications with the most frequent interventions were chemotherapies administered in cycles or drugs that significantly affect blood counts.

Capecitabine was the most frequently intervened on drug.1 A total of 2910 interventions were accepted, corresponding to an 82% acceptance rate.1 The 618 interventions not accepted were most likely due to discussions with the provider that determined the best route of treatment was to continue with careful observation. Factors that must also

be considered in oncological care include off-label indications and palliative care measures, all of which may impact dosing and scheduling strategies.

The results highlighted the importance of pharmacists in oncology to provide highquality coordinated care. Pharmacists have the ability to provide clinically relevant interventions in settings where they have access to patient’s medical issues.

References 1. Kaufman Natalie, Bentivegna Nicole, Orr Roger. Outcomes of PharmacistDriven Clinical Interventions in a Medically Integrated Oncology Speciality Pharmacy Practice. Pharmacy Times 2025; Volume 7: 13-17.

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The Other Pill: YCT-529 as a Prospective Male Contraceptive

by Sam Jacob, P1

Photo Credit:https://femtechinsider.com/yourchoice-therapeutics-advances-hormone-free-male-birth-control-pill-to-second-human-study/

In today’s market, the only options for male contraceptives are condoms – with an 87% success rate with average use— and vasectomies— which are used as a permanent option. Compared to the multitude of options that women have for birth control, ranging from the pill, ring, injections, and implants, medication development continues to make the argument that the burden of controlling reproduction falls on women. Developing an option that gives men the opportunity to use pharmaceutical contraceptives not only shifts this imbalance but also gives men the autonomy in controlling if and when they want to become fathers on their own terms. Pharmaceutical companies are aware of how beneficial a male birth control option could be and have dedicated research towards developing such a drug. Unfortunately, past efforts have encountered a series of complications that have made the endeavor unfavorable.

Under development is a highly selective non-hormonal retinoic acid receptor antagonist, YCT-529, which targets RARα.

Retinoic acid, a metabolite of vitamin A, is vital for spermatogenesis, secreted by Sertoli cells to prompt spermatogonia to differentiate and enter meiosis.1 When silencing the genes that encode the retinoic acid receptors, RARα, RARβ, and RARγ, effects on male fertility in mice most closely resemble vitamin A deficiency in the absence of specifically the retinoic acid receptor α.2 By selectively inhibiting this receptor, YCT-529 was proven to be 99% effective at preventing pregnancies in preclinical trials done on mice and on primates.2 Full fertility was also regained after ending the treatment within 10-15 weeks.

This was not the first time that retinoic acid signaling inhibition was investigated for its effect on male germ cell development.

WIN-18446 was an experimental medica-

tion that was researched in the late 1950s.

It altered retinoid metabolism and irreversibly inhibited ALDH1A2, which blocks the production of retinoic acid, and its effects on fertility were completely reversible when drug administration stopped.3 However, due to an additional side effect on ALDH2, an enzyme responsible for alcohol metabolism, drug development for WIN-18446 was stopped. Patients who drank alcohol while taking this medication built up acetaldehyde and would experience an assortment of symptoms, such as vomiting, nausea, headache, and facial flushing.3 Since the medication disrupted both forms of this enzyme, it could no longer be investigated as a potential contraceptive.

Adverse effects like these have halted a multitude of prospective contraceptives meant to be marketed to men. Female birth control often gets away with its laundry list of side effects because it prevents the many serious complications of pregnancy.4 For women, a drug that has an increased risk of blood clots is still an acceptable risk since the risk of blood clots is even higher in pregnancy; in men, there is no such comparison.4 In this context, for the FDA to approve a male contraceptive, it would have to be without any of the risks that come with the female alternatives currently on the market. This is the reason that there are no testosterone or testosterone derivatives on the market. Although researched, hormonal contraceptives impact many pathological systems, so that development in such a drug for men with concerning risks was unfavorable to invest in.

There is still potential for the success of YCT-529 as a non-hormonal drug. Preclinical studies produced no significant changes in testosterone, inhibin B or FSH, and trials proceeded with little to no side effects.5 As a result of its success in these pre-clinical trials, the drug was able to complete phase I clinical trials. While the

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Continued from page 1 training or other educational resources, access to options, and opportunities to participate in disease prevention programs.1 Although implementing value-based care may be challenging at first, it is evident that it is a key change necessary to promote the

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health and well being of patients.

References 1. Centers for Medicare & Medicaid Services. Value-Based Care. www.cms. gov. Published August 14, 2023. https://www.cms.gov/priorities/innovation/ key-concepts/value-based-care 2. Ahmed, Tufayel. “Fee-For-Service vs Value-Based Care: Understanding the Key Differences (2023) - Streamline Health.” Streamline Health Solutions, 31 Aug. 2023, streamlinehealth.net/fee-for-service-vs-value-basedcare/. Accessed 15 Oct. 2024.

3. Ang, Adam. “Key to Implementing Value-Based Care at National Scale.”

Healthcare IT News, HIMSS Media, 14 Oct. 2024, www.healthcareitnews. com/news/asia/key-implementing-value-based-care-national-scale 4. NEJM Catalyst. What Is Value-Based Healthcare? NEJM, ed. The New England Journal of Medicine. Published online January 1, 2017 5. Nowosielski B. Q&A: How Pharmacists Stand in the Gap for Value-Based Care. Drug Topics. Published October 15, 2024. https://www.drugtopics. com/view/how-pharmacists-stand-in-the-gap-for-value-based-care

Behavioral Addictions

by Vinayak Shende, P1 Among many researchers and clinicians, “addiction” has come to refer to a disorder in which an individual becomes intensely preoccupied with a behavior that at first provides a desired or appetitive effect.

Behavioral addiction is a mental health issue in which an individual becomes obsessed with a behavior that they think is rewarding and/or relaxing. This differs from traditional substance addiction because a behavioral addiction does not need to involve a specific legal or illegal substance. While behavioral addictions do not cause their users direct physical harm, they can still have a severe impact on their mental health and quality of life. The most widely recognized behavioral addiction is Pathological Gambling, which is a diagnosable disorder by the DSM-5 and ICD10.1 Other behavioral disorders, such as social media addiction and compulsive shopping, are not formally diagnosable due to a lack of criteria and data.

In the past, pharmaceutical therapies have helped patients improve their quality of life. Imipramine and Isoniazid, medications discovered in the 1950s, helped healthcare professionals recognize and treat depression. The further development of medication for treating neurological disorders created psychopharmacology and the viewpoint that mental health disorders may be treated in a biological manner. In the 1990s, Fluoxetine and other SSRIs further advanced the treatment of depression with a milder side effect profile than older drugs.2 While drugs have become an important part of mental health treatment, patients still require other forms of treatment to truly get better.

Photo Credit: https://devtechnosys.com/insights/build-an-app-for-de-addiction/

Behavioral addictions have become increasingly prevalent in the past couple of years, due to several reasons. During the COVID-19 pandemic, the isolation of quarantine and the lack of social options lead people to use technological devices and social media more frequently. Studies conducted during the pandemic found a correlation between excessive social media and gaming use with an increase in depression, anxiety, and other mental health problems.1 Additionally, the 2018 Supreme Court decision to reverse the ban on sports gambling has led to 38 states legalizing sports betting, the prevalence of which is reflected in commercials from multibillion dollar entities such as the NBA. These factors have led to an increased need for diagnostic criteria and treatment options for behavioral addictions.

Currently, most data has been collected on pathological gambling disorders. While there are no formal indications for gambling treatment yet, opioid antagonists such as Naltrexone have produced results.

However, more data is needed before opi-

oid antagonists can be considered a clinical treatment option. Other medication classes, such as SSRIs and Glutamate agents, have also been tested.3,4 However, they have produced less sure results, and more data is needed before they can be considered clinical treatment options. For other behavioral addictions, such as social media and online shopping, it is difficult to obtain data as there is no formal diagnostic criteria.

Overall, behavioral addictions have been getting more attention in the past decade, due to changes in the law and worldwide events. These patterns of behavior have been shown to impact patient health negatively and while medications such as Naltrexone have shown promise in research trials, they are not clinical treatments at this point in time.

stage of development, the oral contraceptive was a higher dose and had a higher likelihood of adverse effects than that of the modern pill due. During the study in Puerto Rico, the dosage of norethynodrel was 5mg but resulted in severe side effects, causing a 66-fold reduction of dose of norethynodrel to 75mcg.7 Within one year of the contraceptive’s approval, six fatal cases and twenty non-fatal cases of thrombosis were reported to the FDA. Since then, the dosage has been progressively lowered over time.6 The nature of drug trials and the process for accepting medica-

tions have evolved since, but the stained history of female contraceptives still contribute to the current lack of balance concerning the burden of taking birth control.

Resources 1. Alimoradi, Z., Broström, A., Potenza, M.N. et al. Associations Between Behavioral Addictions and Mental Health Concerns During the COVID-19 Pandemic: A Systematic Review and Meta-analysis. Curr Addict Rep 11, 565–587 (2024). https://doi.org/10.1007/s40429-02400555-1 2. Braslow JT, Marder SR. History of Psychopharmacology. Annu Rev Clin Psychol. 2019 May 7;15:25-50. doi: 10.1146/annurev-clinpsy-050718-095514. Epub 2019 Feb 20. PMID: 30786241.

3. Brand, M., Antons, S., Bőthe, B., Demetrovics, Z., Fineberg, N. A., Jimenez-Murcia, S., …

Potenza, M. N. (2025). Current Advances in Behavioral Addictions: From Fundamental Research to Clinical Practice. American Journal of Psychiatry, 182(2), 155–163. https://doi.org/10.1176/appi.ajp.20240092 4. Grant, J.E., Chamberlain, S.R. Pharmacotherapy for Behavioral Addictions. Curr Behav Neurosci Rep 3, 67–72 (2016). https://doi.org/10.1007/s40473-016-0065-6

Continued from page 4 results of these trials are not known to the public, the results were sufficient for YCT529 to enter phase II as of September 2024.

The importance of such a birth control option is underscored when considering the origins of the female contraceptive. The original oral tablet was a medication that was initially indicated for menstrual disorders, only recognized by the FDA as a contraceptive years after it was on the market.6 The decision was based on a trial done on impoverished Puerto Rican women who were not fully informed of the risks and reported a slew of side effects.7 At that

References 1. Zhao, Yue, et al. “The role of retinoic acid in spermatogenesis and its application in male reproduction.” Cells, vol. 13, no. 13, 24 June 2024, p. 1092, https://doi.org/10.3390/ cells13131092.

2. Mannowetz, Nadja, et al. “Targeting the retinoid signaling pathway with YCT-529 for effective and reversible oral contraception in mice and primates.” Communications Medicine, vol. 5, no. 1, 13 Mar. 2025, https://doi.org/10.1038/s43856-025-00752-7.

3. Paik, Jisun, et al. “Inhibition of Retinoic Acid Biosynthesis by the Bisdichloroacetyldiamine Win 18,446 Markedly Suppresses Spermatogenesis and Alters Retinoid Metabolism in Mice.”

The Journal of Biological Chemistry, U.S. National Library of Medicine, 23 May 2014, www. ncbi.nlm.nih.gov/pmc/articles/PMC4031560/.

4. Anthes, Emily. “Why We Can’t Have the Male Pill.” Bloomberg, Bloomberg, 3 Aug. 2017, www.bloomberg.com/news/features/2017-08-03/why-we-can-t-have-the-male-pill.

5. First Hormone-Free Male Birth Control Pill Clears Another Milestone, University of Minnesota, 26 Mar. 2025, twin-cities.umn.edu/news-events/first-hormone-free-male-birth-controlpill-clears-another-milestone.

6. Kao, Audiey. “History of oral contraception.” AMA Journal of Ethics, vol. 2, no. 6, 1 June 2000, https://doi.org/10.1001/virtualmentor.2000.2.6.dykn1-0006.

7. Christin-Maitre, Sophie. “History of oral contraceptive drugs and their use worldwide.” Best Practice & Research Clinical Endocrinology & Metabolism, vol. 27, no. 1, Feb. 2013, pp. 3–12, https://doi.org/10.1016/j.beem.2012.11.004.

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