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Clinical Insights: March 15, 2022

Posted on March 15, 2022 By RxStrategies, Inc. -

Welcome to RxStrategies’ Clinical Insights, designed to help pharmacy professionals stay up to date on the ever-changing pharmaceutical and pharmacy marketplace. Contact us to learn more.

New Drug Approval

Lynparza® (Olaparib) Tablets – New Drug Approval – March 11, 2022 –  The Food and Drug Administration approved olaparib (Lynparza®, AstraZeneca Pharmaceuticals, LP) for the adjuvant treatment of adult patients with deleterious or suspected deleterious germline BRCA-mutated (gBRCAm) human epidermal growth factor receptor 2 (HER2)-negative high-risk early breast cancer who have been treated with neoadjuvant or adjuvant chemotherapy. Patients must be selected for therapy based on an FDA-approved companion diagnostic for olaparib. Approval was based on OlympiA (NCT02032823), a randomized (1:1), double-blind, placebo-controlled, international study of 1836 patients with gBRCAm HER2-negative high-risk early breast cancer who completed definitive local treatment and neoadjuvant or adjuvant chemotherapy. <Read More>

New Indication/Dosage/Formulation Approval

No new update.

New/Updated Drug Shortage

March 11, 2022

March 09, 2022

New Drug Recall and Safety Alerts

Seven Compounded Products by Olympia Pharmacy – New Voluntary Recall – March 10, 2022 – Olympia Pharmacy is voluntarily recalling 11 specific lots of Trimix Formulas F-9, T-105, SB-4, Sermorelin, Sincalide, Hydroxocobalamin, and NAD, compounded injectables to the consumer level. These compounded products were found to be out-of-specification…Olympia Pharmacy has not received any reports or concerns from patients relating to the safety of the recalled sterile compounded products, and no patients have reported any adverse events attributed to any of the recalled sterile compounded products. <Read More>

New Generic/Biosimilar Approval and Launch

No new update.

Clinical and Pharmacy News

Treating Depression and Preventing Suicide: The Impact of mHealth Apps – March 14, 2022 – In a 2016 review, there were more than 165,000 mHealth apps available to patients on the market. A review published just 3 years later noted the availability of 259,000 mHealth apps worldwide. Of the rapidly evolving app market, mHealth apps are among the fastest-growing groups, with an annual estimated growth rate of 32.5%. mHealth apps focused on mental health are one of the most prominent categories. These apps can be obtained for numerous device types and through the Apple iTunes/App Store or Android Google Play App Store. There is currently no standardized review process to evaluate mHealth apps for quality or accuracy of information. There are also no centralized repositories for app reviews and ratings, and no type of standard app rating process or procedure. <Read More>

APhA Reaffirms its Support for Pharmacists and Their Ability to Serve All Patients – March 14, 2022 – The American Pharmacists Association (APhA) Board of Trustees issued the following statement in support of pharmacists and their ability to serve all patients, no matter of their race, creed, or identity:  As we prepare to travel to San Antonio, TX, for our first in-person meeting together in 3 years, we want to reaffirm our support for pharmacists and our oath which calls us to serve all patients, no matter their race, creed, or identity. The Pharmacist’s Code of Ethics has multiple statements that note “pharmacists promote the good of every patient, protect the dignity of the patient, and respect personal and cultural differences among patients.” <Read More>

NCCN Adds Newly Approved Long-acting Interferon to Its Practice Guidelines for Polycythemia Vera – March 11, 2022 – Besremi® (ropeginterferon alfa-2b-njft) is the first interferon approved specifically as a treatment for polycythemia vera. The National Comprehensive Cancer Network (NCCN) has updated its clinical practice guidelines to include the first interferon specifically approved for treating polycythemia vera, a rare disorder but one of the most common types of myeloproliferative neoplasms. The FDA approved Besremi® (ropeginterferon alfa-2b-njft), a long-acting interferon, in November 2021 as a treatment for polycythemia vera in adults. The disease results in overabundance of red blood cells and is treated therapeutic phlebotomy. But in some patients, especially those at higher risk for complications from polycythemia vera, patients, are prescribed cytoreductive agents such as hydroxyurea. The approval of Besremi® gives physicians and patients another cytoreductive therapy option. <Read More>

Integrating Pharmacists Into Care Teams Is Crucial – March 11, 2022 – Tapping their specific skill sets and training can help serve patients more effectively, although challenges exist. Pharmacists receive training in general health, medication use, patient and provider education, pharmacotherapy, preventive care, and wellness. However, it was not until the early 1960s that the health care model adapted to allow pharmacists a more clinical role. Historically, a pharmacist’s core role was dispensing medications and ensuring their safe use. In the 1960s, government health care programs began enlisting pharmacists to aid in disease management and primary care. By the 1970s, a core responsibility of pharmacists became drug regimen reviews, particularly in long-term care facilities—this practice has extended into all other settings in which pharmacists are employed. By the early 2000s, collaborative drug agreements were on the rise in government health care facilities, further expanding the scope of practice for pharmacists within direct patient care. The role of pharmacists and their impact on patient care is still evolving and adapting to gaps in the health care system. Within integrated care teams, a pharmacist’s primary responsibility is to optimize patient medication therapies through continuous coordinated medication management and review. <Read More>

Most Physicians Unable to Estimate Patients’ Out-Of-Pocket Costs: How Pharmacists Can Help – March 11, 2022 – An estimated one in three Americans struggles to afford their medical bills. Who do they go to for help finding solutions to this common problem? “My physician” is the typical answer. But according to a recent study published in JAMA, few are equipped to help…Only one in five physicians accurately estimated the hypothetical patient’s out-of-pocket costs. The vast majority of the doctors, the study suggested, cannot tell patients what to expect when they pick up their prescriptions. As many patients may not know the price of their medications with certainty until they reach the pharmacy counter, pharmacists—rather than physicians—may need to step in to help them find more affordable options when needed. <Read More>

Four Tips for Navigating Pharmacy Compliance Audits in 2022 – March 11, 2022 – In recent years, the auditing process has evolved into a full-blown investigation, often requiring pharmacies to submit hundreds of pages of documentation. Compliance audits launched by pharmacy benefit managers (PBMs) have long been a cause of frustration for pharmacies, especially independent community pharmacies with limited manpower and resources compared to large chains. This challenge has only magnified since the onset of the COVID-19 pandemic in early 2020. PBMs have adapted their practices by switching to virtual audits, leaving them with the ability to review more claims than ever before. As a result, pharmacies that are juggling the chaos of audit documentation, vaccine distribution, prescription refills, and a plethora of other responsibilities stand to lose. It’s no wonder that the average audit in 2020 cost pharmacies $23,978, which is 35% more than the annual average over the previous 5 years, according to the pharmacy audit assistance service, PAAS National. <Read More>

2021: Pharmacists Are Moderately Satisfied With Salary, Job Satisfaction, Survey Shows (Part 3) – March 11, 2022 – In the third part of the series, we further explore the factors that contribute to overall happiness in a position. Part 1 of our analysis of the Pharmacy Times® Salary and Job Satisfaction Survey provided an overview of results. These showed that when pharmacists were asked to rate their overall job satisfaction on a scale of 1 to 7 (with 1 being “not at all” and 7 being “extremely”), the average response among the 151 respondents was 4.41. Part 2 highlighted pharmacists’ satisfaction with their total compensation, with the average response again being 4.41. In Part 3 of the series, we further explore pharmacists’ job satisfaction and the factors that contribute to their overall happiness in a position. <Read More>

Three Facts and Three Predictions for Prior Authorization – March 10, 2022 – Evidence-based prior authorization automation is on the rise as physicians and payers look for better ways to do business with one another. Recent physician surveys show that nearly 80% of physicians have experienced an increase in payer prior authorization (PA) requirements, with more than a third of delays resulting in adverse patient outcomes. These were among the results from a MGMA poll and an American Medical Association (AMA) survey. Countering this, evidence-based PA automation is on the rise as physicians and payers look for better ways to do business with one another while Congress reintroduces related mandates. <Read More>

Pharmacist-Led Program Cuts ED Visits for OUD – March 10, 2022 – An opioid use disorder (OUD) initiative led by emergency department (ED) pharmacists contributed to a decrease in OUD-related ED visits at Boston Medical Center (BMC) over three years, even as such visits were on the rise nationwide, according to a study presented at the ASHP 2021 Midyear Clinical Meeting and Exhibition, held virtually. The initiative focused on improving access to medications for OUD (MOUD)—as well as the opioid overdose reversal agent naloxone—and developing ED-specific guidelines for OUD treatment, the study showed. After implementation, monthly ED visits related to OUD declined from more than 200 in September 2017 to between 150 and 175 visits per month by September 2021, according to the researchers. <Read More>

Total Pharmacy Solutions Summit to Provide Actionable Insights in Independent Pharmacy – March 10, 2022 – This can’t-miss event is being held April 30, 2022. The second Total Pharmacy Solutions Summit is coming to a computer near you. On April 30, join community pharmacy thought leaders online for a day of education, conversation, and insights on actionable business solutions for today’s pharmacists. The upcoming Total Pharmacy Solutions Summit will feature sessions on best practices in leveraging technology, improved staffing and retention, effective Point-of-Care models, as well as pharmacy finance, legal and regulatory updates and insights. Speakers will include thought leaders like Paige Clark, RPh, vice president of pharmacy programs and policy at Prescryptive Health, Inc., who will be leading a conversation on point of care testing and in-store services. Attendees can earn 1.75 live CE credits via 2 accredited sessions, presented by faculty from the Massachusetts College of Pharmacy and Health Sciences and WellDyne, a leading pharmacy benefit management company. <Read More>

Can CAR T-Cell Rx be Moved Outside Hospital? – March 10, 2022 – Although most people who are prescribed chimeric antigen receptor (CAR) T-cell therapy receive it entirely as inpatients, there is growing interest in delivering at least part of the revolutionary treatment in the outpatient setting. One major factor is reimbursement. As the revenue cycle team knows, payment terms often are more favorable when medications are administered outside the hospital. But it’s not just about money, according to Mary McGann, PharmD, BCOP, a clinical pharmacy specialist in blood and marrow transplantation and cellular therapy at the Hollings Cancer Center, Medical University of South Carolina (MUSC), in Charleston. <Read More>

NACDS, AMA Spar Over Biden’s Test to Treat Initiative – March 10, 2022 – NACDS CEO responds to comments by AMA president. The National Association of Chain Drug Stores (NACDS) is blasting back at the American Medical Association (AMA) after the physician’s organization criticized President Joe Biden’s inclusion of pharmacies in the administration’s COVID-19 Test to Treat initiative…NACDS President and CEO Steven C. Anderson called the AMA’s criticism of the role of pharmacy-based clinics “extremely unfortunate, but also extremely predictable.” “The effectiveness of COVID-19 antivirals depends on patients’receiving them shortly after the onset of symptoms. When it comes to the patient journey for these medications, access and equity are critically important, and pharmacy-based clinics, pharmacies and pharmacists have essential roles to play,” Anderson said. <Read More>

NCPA President Discusses 3 Ways to Ride the Pharmacy Surge Wave – March 10, 2022 – Implement technology solutions, initiate clinical services, and shift to a proactive mindset, Michele Belcher says. It is no secret that the COVID-19 pandemic has presented many challenges for pharmacists. In addition to an overwhelming list of daily responsibilities, pharmacists have been facing the clamor for COVID-19 vaccinations, treatment, and testing, especially in response to the Omicron variant. For example, the number of fully vaccinated Americans has steadily increased since summer 2021, with 65% of the population fully vaccinated. As of March 4, 2022, 49.9% of booster-eligible individuals in the United States had not received their booster doses. The continued testing and vaccination demand, coupled with never-ending to-do lists, staffing shortages, and technology gaps, a exacerbates spikes in patient volume and workload for pharmacy professionals. <Read More>

How Data Can Help Demonstrate the Value of the Health-System Specialty Pharmacy – March 10, 2022 – Insurers, accountable care organizations, and manufacturers increasingly look for demonstrable clinical outcomes as proof for reimbursement or access to limited distribution networks. You know the old riddle, “If a tree falls in a forest and no one is around to hear it, does it still make a sound?” That also can be applied to specialty pharmacies today, especially those based in hospitals and health systems. We all know that these pharmacies do a great job caring for patients and getting them quick access to needed, sometimes life-saving medications. They also score high in patient satisfaction. But if they can’t quantify the impact of their efforts through clinical outcomes data, can they truly demonstrate their differentiation in the market? <Read More>

Amazon Pharmacy Partners With Health Plans for Discount Drugs – March 10, 2022 – Amazon Pharmacy is offering a prescription drug discount card to Blue Cross Blue Shield insurance customers in five states, Nworah Ayogu, chief medical officer for Amazon Pharmacy, said in an interview at a health technology conference this week. So far, the program includes partnerships with Blue Plans in New Jersey, Nebraska, Alabama, Florida, and Kansas. The partnership lets plan customers get discounts through a MedsYourWay card when they use Amazon Pharmacy to buy their medications — and the cost of those drugs still counts towards their insurance deductibles. <Read More>

ACR Updates Guidance on Juvenile Idiopathic Arthritis Treatment – March 9, 2022 – The American College of Rheumatology (ACR) has released updated guidelines on pharmacologic and nonpharmacologic treatments for juvenile idiopathic arthritis. The American College of Rheumatology (ACR) has released 2 updated guideline papers in the 2021 American College of Rheumatology Guideline for the Treatment of Juvenile Idiopathic Arthritis (JIA). As stated in an ACR press release, one guideline provides updates on the pharmacologic management of JIA and focuses on therapeutic approaches for oligoarthritis, temporomandibular arthritis, and systemic JIA (sJIA) with and without macrophage activation syndrome. The other guideline focuses on recommendations for nonpharmacologic therapies, medication monitoring, immunizations, and imaging, regardless of JIA phenotype. <Read More>

NCPA to CMS: Implement Changes We Suggested in Part D Rule – March 9, 2022 – The National Community Pharmacists Association said it has strong concerns about CMS’s proposed Medicare Part D rule, which outlines the latest efforts by the agency to lower out-of-pocket drug costs for patients and address pharmacy direct and indirect remuneration fees. In comments submitted on the rule, NCPA CEO B. Douglas Hoey said that without incorporating changes suggested by the association, the proposed rule “will fail to achieve its intended goals.” Some of those changes: ensure transparency of pharmacy reimbursement at the point of sale; close the coverage gap loophole; address the effects on pharmacy cash flow; and enforce existing network adequacy and contract provision requirements. <Read More>

Prior Authorization Panel Yields Insights Into Role of PBMs in Biosimilar Uptake – March 9, 2022 – A discussion at a recent community oncology conference yielded insights into recent dynamics between pharmacy benefit managers (PBMs) and practices over uptake of biosimilars—along with concerns that without reform, the savings gained from biosimilars could be lost. Thursday’s session, “Prior Authorization: How the Sausage Is Made,” drew a large crowd during the Association of Community Cancer Centers’ 2022 Annual Meeting & Cancer Center Business Summit, held in Washington, DC. Most of the discussion focused on how prior authorization has increased administrative burdens on oncology practices. However, panelists suggested that the quest for rebates by PBMs prevents uptake of some biosimilars—and could soon bleed over into biosimilar formulary placement. <Read More>

The ‘OG’ Women of Specialty Pharmacy – March 9, 2022 – How a cadre of visionary female leaders broke through the market’s glass ceiling. Competing in the specialty pharmacy space is no easy task, given its intensive data reporting requirements, cold chain logistics and closed-door payor contracts, to name just a few challenges. But if you were a female pharmacy leader eyeing market entry in the early days, there was yet another roadblock to overcome: a traditionally male-dominated business that didn’t always embrace the idea that women belonged in the specialty space. <Read More>

Pharmacists’ Role in the Management of Chronic Graft-Versus-Host Disease – March 9, 2022 – Graft-versus-host disease (GVHD), an immunologic disorder affecting multiple organ systems, is caused by donor T cells responding to foreign recipient antigens, which can injure the host organs. GVHD is a leading cause of morbidity and non-relapse mortality after allogeneic hematopoietic cell transplantation (HCT), with a significant impact on quality of life. This immunologic disorder can be either acute or chronic, based on timing and clinical presentation. Given the complexity of cGVHD, a multidisciplinary approach to patient care is critical…Pharmacists can play a key role in optimizing patient care through various interventions, including medication management, therapeutic drug monitoring (TDM), adverse effect monitoring, education, and counseling. <Read More>

Pharmacist Groups Call on Biden Administration to Remove Limits on Prescribing COVID Treatments – March 9, 2022 – Fourteen pharmacy organizations urged the Biden administration to remove barriers preventing pharmacists from ordering oral antivirals and expand patient access to the “Test to Treat” initiative announced last week during the State of the Union. In a letter sent to President Biden, the groups called for the removal of a limitation placed on the emergency use authorization (EUA) of COVID-19 antivirals by the Food and Drug Administration (FDA). The limitation prevents pharmacists from ordering the medications. The groups stressed that limitations in the EUAs for COVID-19 oral antivirals mean that patients in rural and underserved communities will be less likely to benefit from the test to treat approach. <Read More>

‘Test-to-Treat’ Launches at Several Hundred Pharmacies – March 9, 2022 – The White House’s “test-to-treat” initiative launched this week, allowing high-risk patients with COVID-19 symptoms to get tested at pharmacies and receive free antiviral pills on the spot, according to NPR. HHS’ Office of the Assistant Secretary for Preparedness and Response started distributing Merck’s and Pfizer’s antiviral pills to participating pharmacy-based clinics March 7. The agency said it also plans to launch a program for long-term care pharmacies to directly order antivirals for eligible residents at an increased risk of developing severe COVID-19. The program is launching at several hundred sites and will expand from there, Natalie Quillian, deputy coordinator for the White House COVID-19 response, told NPR. The initial roll-out will focus on large retail chains that offer on-site healthcare services, such as CVS Minute Clinics. <Read More>

340B in the News

Drug Pricing Program Needs Protection – March 12, 2022 – President Biden’s call during his State of the Union address for Congress to pass legislation to control drug prices provides a good opportunity to note a law that already is on the books that helps curb drugmakers’ price hikes. As lawmakers prepare to debate the proposals, it is a law worth protecting. Congress created the 340B drug pricing program in 1992 through bipartisan legislation that offered a simple tradeoff…The facts are clear. 340B hospitals provide 60% of all uncompensated and unreimbursed care in the nation and 75% of all hospital care for Americans with Medicaid. Because it relies on drug company discounts, 340B doesn’t cost taxpayers a single dime. And it saves the health care system money by helping keep drug price increases in check. It is long past time for these drug company actions to stop and for the restoration of 340B’s full potential in supporting our nation’s health care safety net. <Read More>

Association of 340B Contract Pharmacy Growth With County-Level Characteristics – March 10, 2022 – The growth of 340B contract pharmacies since 2010 is unprecedented. This study’s findings suggest that patterns of growth differ between safety-net clinics and hospitals. Results: We find that growth of contracts with 340B hospitals was uncorrelated with uninsured rates, poverty rates, or areas of medical underservice. By contrast, we find that growth of contracts with 340B safety-net clinics was positively correlated with poverty rates and metropolitan statistical status. These findings suggest different patterns of access for patients. Conclusions: Our results add systematic evidence of a difference in how the 2 main types of 340B participants—hospitals and safety-net clinics—use the 340B program. Policy proposals to reform 340B should consider reforms for safety-net clinics and hospitals separately. <Read More>

House Appropriations Committee Unveils Omnibus Spending Package with Health Provisions – March 9, 2022 – Package funds government through Sept. 30 and includes helpful provisions protecting 340B hospitals, extending telehealth flexibilities and improving maternal health, among others. The legislation would protect certain 340B hospitals that lost their 340B eligibility due to a drop in their disproportionate share hospitals (DSH) adjustment percentage below the required threshold for 340B eligibility to gain limited access to the program. Access to the 340B drug discounts would be available only from the date of the bill’s enactment through the end of 2022 and not retrospectively. This exception would apply only to 340B hospitals actively participating in the 340B program from the day prior to the start of the COVID-19 public health emergency (Jan. 31, 2020) and who subsequently lost eligibility during the cost reporting periods of 2020, 2021, and ending Dec. 31, 2022. Hospitals qualifying for the exception would be required to attest to the HHS Secretary that the reason for their loss of 340B eligibility was the result of “any actions taken by or other impact on such hospital in response to or as a result of the COVID-19 public health emergency that may have impacted the ability to meet the applicable requirement for the disproportionate share adjustment percentage.” <Read More>