Clinical Insights: April 6, 2021

    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

    Roszet™ (ezetimibe and rosuvastatin) Tablets – New Drug Approval – March 23, 2021 – Althera Pharmaceuticals, a company focused on heart health, today announced the FDA approval of Roszet™ (rosuvastatin and ezetimibe) tablets, as an adjunct to diet, for treatment of elevated low-density lipoprotein cholesterol (LDL-C) in adult patients with primary non-familial hyperlipidemia and in adults with homozygous familial hypercholesterolemia. Roszet™ contains rosuvastatin, a powerful statin for LDL-C reduction, and ezetimibe, an efficacious cholesterol absorption inhibitor. The two components work through distinct but complimentary mechanisms to give Roszet™ the power to significantly lower LDL-C. <Read More>

    New Formulation Approval

    No new update.

    New Indication/Dosage Approval

    Vyxeos® (cytarabine and daunorubicin) Injection – New Approved Indication – March 30, 2021 – Jazz Pharmaceuticals plc announced that the U.S. Food and Drug Administration (FDA) approved a revised label for Vyxeos® (daunorubicin and cytarabine) to include a new indication to treat newly-diagnosed therapy-related acute myeloid leukemia (t-AML) or AML with myelodysplasia-related changes (AML-MRC) in pediatric patients aged one year and older. The approval of Vyxeos® for this indication is supported by safety data from two single-arm trials: AAML1421, conducted by the Children’s Oncology Group (COG) and CPX-MA-1201, conducted by Cincinnati Children’s Hospital (CCH) and evidence of effectiveness from an adequate and well-controlled study in adults. <Read More>

    Myrbetriq™ (mirabegron) Extended Release Tablets and Granules – New Approved Indication and Formulation – March 25, 2021 – The U.S. Food and Drug Administration approved a new indication for Myrbetriq (mirabegron extended-release tablets) and Myrbetriqä Granules (mirabegron for extended-release oral suspension) to treat neurogenic detrusor overactivity (NDO), a bladder dysfunction related to neurological impairment, in children ages three years and older. Myrbetriq is also indicated for overactive bladder in adult patients. <Read More>

    New/Updated Drug Shortage

    April 05, 2021

    April 02, 2021

    April 01, 2021

    March 31, 2021

    March 30, 2021

    New Drug Recall and Safety Alerts

    Acetaminophen Extra Strength Tablets by A-S Medication Solutions – New Voluntary Recall – April 2, 2021 – A-S Medication Solutions, LLM (ASM) is voluntarily recalling 198,350 bottles of Acetaminophen Extra Strength 500 mg Tablets, 100 ct. bottles (NDC# 50090-5350-0) contained in Health Essentials Kits distributed by Humana to its members. See the photo below. This recall is being conducted to the consumer level. These over-the-counter (OTC) analgesic products contain an incomplete prescription drug label rather than the required OTC Drug Facts label. <Read More> 

    Guanfacine Tablets by Apotex – New Voluntary Recall  – March 31, 2021 – Apotex Corp is voluntarily recalling three (3) lots of Guanfacine Extended-Release Tablets 2mg to the consumer level due to trace amounts of Quetiapine Fumarate in one lot RX1663. Out of an abundance of caution, lots RX1662 and RX1664 are also included in the scope of this voluntary recall, as they were manufactured in the same campaign as lot RX1663. <Read More>

    New Generic/Biosimilar Approval and Launch

    No new update.

    Clinical and Pharmacy News

    Walgreens Not Following U.S. Guidance on Pfizer Vaccine Spacing – April 5, 2021 – Walgreens has inoculated hundreds of thousands of Americans against Covid-19 this year using the vaccine developed by Pfizer and Germany’s BioNTech. But the pharmacy chain has not been following guidance from federal health officials about the timing of second doses. People are supposed to get two doses, three weeks apart. Walgreens, however, separated them by four weeks because that made it faster and simpler for the company to schedule appointments. <Read More>

    New APhA Brand Highlights Value to Members, Reaffirms its Place as the Nation’s Leading Pharmacy Organization – April 5, 2021 – The American Pharmacists Association (APhA) announced the launch of a new brand identity, including a modernized website, redesigned logo, and a refined message on what the organization does and the motivation behind it: to serve, prepare, and fight for pharmacists in all practice settings. The rebrand reflects APhA’s position as the foundational pharmacy organization and the only one that supports and represents the entire pharmacy profession. As pharmacy’s leading association, APhA empowers pharmacists, elevates pharmacy, and enhances patient care by offering the gold standard in education and practice advancement tools and resources. APhA’s new website makes those assets easy and quick to access. <Read More>

    NCCN Updates Clear Cell RCC Guidelines – April 3, 2021 – The National Comprehensive Cancer Network (NCCN) has updated its Clinical Practice Guidelines to include tivozanib (Fotivda) as a recommended regimen for subsequent therapy in patients with clear cell renal cell carcinoma (RCC), according to an announcement from AVEO Oncology. The current NCCN guidelines for RCC categorically make treatment recommendations for frontline or subsequent options of patients with the disease. Specifically, the network now recommends tivozanib as a subsequent treatment for patients with clear cell RCC who have previously received 2 or more systemic therapies (category 2a). <Read More>

    The Role of Specialty Pharmacy in Managing Rheumatoid Arthritis – April 2, 2021 – Although rheumatoid arthritis (RA) was once characterized by debilitating deformation, advancing treatment options have improved the outlook for RA patients, shifting the goals of therapy to low disease activity or even remission. Early, aggressive treatment can greatly improve outcomes, but managing this chronic condition can be a challenge for providers and patients. Barriers to controlling RA include nonadherence to therapy and the presence of comorbidities. <Read More>

    Expert: Community Pharmacists Are a ‘Part of the Solution in the Vaccination Endeavor Globally’ – April 2, 2021 – Pharmacist-led services are not only important during COVID-19 immunization efforts in the United States, but are additionally critical in vaccination endeavors globally, according to Catherine Duggan, FRPhamS, CEO of the International Pharmaceutical Federation (FIP) during a webinar hosted by United States Pharmacopeia, World Health Organization (WHO), and the Sabin Vaccine Institute. “Pharmacists are part of the solution in this vaccination endeavor that we have globally,” Duggan said during the webinar. “The world has changed since previous vaccination campaigns were in place. We have to pick what worked then.” <Read More>

    COVID-19 has Devastating Effects for Patients Suffering From COPD – April 2, 2021 – While the prevalence of COVID-19 in patients with COPD is relatively low, those who are infected with the virus experience more severe symptoms than those without COPD. The COVID-19 pandemic has dramatically impacted lives across the world. Many are now working from home, avoiding gatherings, adhering to social distancing rules, and are not leaving the house without a mask. Heightened awareness and concern to slow the spread of this deadly disease is particularly important to protect those with underlying respiratory ailments, such as chronic obstructive pulmonary disease (COPD). Proper management of COPD and strategies to prevent contraction of the virus are imperative to maintain the health of this vulnerable population during such a challenging time. <Read More>

    CDC Issues Updated Guidance on Travel for Fully Vaccinated People – April 2, 2021 – The Centers for Disease Control and Prevention (CDC) updated its travel guidance for fully vaccinated people to reflect the latest evidence and science. Given recent studies evaluating the real-world effects of vaccination, CDC recommends that fully vaccinated people can travel at low risk to themselves. A person is considered fully vaccinated two weeks after receiving the last recommended dose of vaccine. Fully vaccinated people can travel within the United States and do not need COVID-19 testing or post-travel self-quarantine as long as they continue to take COVID-19 precautions while traveling – wearing a mask, avoiding crowds, socially distancing, and washing hands frequently. <Read More>

    Psychiatric Pharmacy Involves Advanced Clinical Training – April 2, 2021 – Psychiatric pharmacists specialize in caring for patients with mental health disorders and illnesses through medication therapy management and can also play an important role in opioid and substance use disorders treatment. This is especially important now because the COVID-19 pandemic has taken a huge toll on mental health and wellness. According to results of a recent survey, 4 in 10 adults in the United States reported symptoms of anxiety or depressive disorder during the pandemic. The behavioral health workforce projections indicate a shortage of psychiatrists by 2030, further emphasizing the need for more psychiatric pharmacists. This career path opens the door to a variety of opportunities for pharmacists to provide comprehensive medication management and improve health outcomes for patients with neurologic and psychiatric disorders as part of an interdisciplinary team. <Read More>

    Coronavirus (COVID-19) Update: FDA Makes Two Revisions to Moderna COVID-19 Vaccine Emergency Use Authorization to Help Increase the Number of Vaccine Doses Available –April 1, 2021 – The U.S. Food and Drug Administration announced two revisions regarding the number of doses per vial available for the Moderna COVID-19 Vaccine. The first revision clarifies the number of doses per vial for the vials that are currently available, in that the maximum number of extractable doses is 11, with a range of 10-11 doses. The second revision authorizes the availability of an additional multi-dose vial in which each vial contains a maximum of 15 doses, with a range of 13-15 doses that can potentially be extracted. <Read More> 

    Most U.S. Adults Who Vape Want to Quit: Study – April 1, 2021 – More than 60% of American adults who vape say they want to stop, a new study reports. Some use electronic cigarettes to try to quit smoking traditional cigarettes, then end up vaping and smoking, the researchers found. “While e-cigarettes may work for some people, they’re hindering quit attempts for other people,” said study first author Amanda Palmer, a postdoctoral fellow at the Medical University of South Carolina (MUSC), in Charleston. The new study included data on more than 30,000 adults across the United States. The findings showed that ex-cigarette smokers were most interested in giving up vaping, too. <Read More>

    NCCN Guidelines Urge Patients With Cancer to Get a COVID-19 Vaccine, Whichever is Available – March 31, 2021 – With a limited number of COVID-19 vaccines available, the most important takeaway from the updated NCCN guidelines is that patients with cancer get a COVID-19 vaccine — no matter which one it is — according to an expert from the Seattle Cancer Care Alliance and Fred Hutchinson Cancer Research Center. Earlier this month, the National Comprehensive Cancer Network (NCCN) released an updated set of guidelines offering treatment advice and COVID-19 vaccine guidance in patients with cancer. In an interview with CURE®, Dr. Steven Pergam, medical director of infection prevention at Seattle Cancer Care Alliance and associate professor in the Vaccine and Infectious Disease Division and Clinical Research Division at Fred Hutchinson Cancer Research Center, discussed the most important aspects of the guidelines and what patients could expect in the future regarding vaccines. <Read More>

    WHO Advises That Ivermectin Only be Used to Treat COVID-19 Within Clinical Trials – March 31, 2021 – The current evidence on the use of ivermectin to treat COVID-19 patients is inconclusive. Until more data is available, WHO recommends that the drug only be used within clinical trials. This recommendation, which applies to patients with COVID-19 of any disease severity, is now part of WHO’s guidelines on COVID-19 treatments. Ivermectin is a broad spectrum anti-parasitic agent, included in WHO essential medicines list for several parasitic diseases. It is used in the treatment of onchocerciasis (river blindness), strongyloidiasis and other diseases caused by soil transmitted helminthiasis. It is also used to treat scabies. <Read More>

    Outsourcing SP Expertise? Warnings to Heed – March 31, 2021 – As more health systems enter the specialty pharmacy space, many are using an outside third-party entity to manage their on-site specialty pharmacies. Although the arrangements offer many benefits, stakeholders need to be ready for state and federal scrutiny surrounding anti-kickback statutes, reimbursement and other compliance issues that could derail these arrangements if they are not managed proactively. <Read More> 

    CVS Health Inks Larger PBM Contract with Federal Employee Program, Adds Specialty Pharmacy Care – March 31, 2021 – CVS Caremark, the Pharmacy Benefit Manager (PBM) of CVS Health announced a larger PBM contract with the Government-wide Service Benefit Plan (also known as the Federal Employee Program), which has provided benefits to the federal workforce for 60 years and covers 5.5 million employees, retirees and their families. CVS Health has been the pharmacy benefit manager for the Service Benefit Plan since 1993 and has partnered with them to provide and evolve the pharmacy services their members need over the many years. <Read More> 

    Pharmacists Have a Role to Play in Dismantling Systemic Racism – March 31, 2021 – To begin understanding systemic racism and its impact on social determinants of health, researchers said pharmacists must first look inward and examine their own biases and socializations. With an evolving understanding of systemic racism as a public health issue, leaders in the pharmacy field have begun exploring ways in which pharmacists can impact these issues in their communities. To begin having this wider impact, experts say pharmacists must first recognize racism and its links to social determinants of health. <Read More>

    It is Time to Address the Bully in Florida’s Prescription Drug Program | Opinion – March 31, 2021 – Florida is home to over 1,400 unique independent pharmacies, many that provide exceptional care and lead to lifelong relationships between patients and their pharmacy. As the relationship between providers, insurance companies and drug manufacturers has become more complex, the pharmacy benefit manager role was created to help manage claims. As pharmacy claims increased and became more complicated, the power of pharmacy benefit managers (PBMs) increased. PBMs, however, have little accountability, which allows them to engage in anti-competitive practices. They have developed formulary lists driven by rebates from manufacturers; encouraged vertical integration of the pharmacy market, thereby reducing competition and dictating costs; and reduced access to care by squeezing independent pharmacies out of business. These numerous, anti-competitive practices are pushing pharmacies that have served communities for generations to the curb. <Read More>

    Are Orphan Drug Biosimilars Too Costly and Difficult to Produce – March 30, 2021 – Potential developers of orphan drug biosimilars face daunting challenges to get these drugs approved and onto market, said a panel of experts. It is tough enough to get manufacturers to take the plunge and develop biosimilars for even-lucrative drugs that address major diseases, so what are the chances of seeing biosimilars developed for orphan drugs? Very slim, said a panel of experts who spoke at the Festival of Biologics USA conference. Orphan drugs address conditions that affect relatively small patient populations, and it is difficult to recruit patient populations large enough for clinical trials needed to prove that experimental drugs are going to be efficacious. The expense of development and the small patient base for these agents translate into very high prices, which it is why it is desirable to have lower-cost biosimilar versions. <Read More>

    A Call for More SPs on Rare Disease Teams – March 30, 2021 – Specialty pharmacists are key stakeholders in the distribution network for rare disease drugs, and they should be considered part of the pharmaceutical manufacturer team in getting patients access to needed therapies, a panel of experts said during Informa’s Hub and SPP Model Optimization 2021 virtual event. Training and education for specialty pharmacies and their pharmacists around drug products must be ongoing and continual, said Dave MacLeod, the head of patient services and specialty pharmacy operations for Amylyx Pharmaceuticals. <Read More>

    APhA Applauds Expansion of Activated Pharmacies in National COVID-19 Vaccination Strategy – March 30, 2021 – The Biden administration has moved to activate 40,000 local pharmacies within the Federal Retail Pharmacy Program, which is a part of the administration’s national COVID-19 vaccination strategy. This action will allow Americans to have access to COVID-19 vaccines in these additional pharmacy locations by April 19. The American Pharmacists Association (APhA) released a statement applauding this decision, noting that the activation is a huge step toward achieving the Biden administration’s new goal of 200 million shots in arms within Biden’s first 100 days in office. <Read More>

    340B in the News

    Hospital Outpatient Payment Would Suffer if 340B Cuts Reversed – April 2, 2021 – Outpatient payments would decrease for the majority of hospitals if HHS reversed a controversial policy reducing 340B drug reimbursement, according to a new Avalere analysis. The analysis examined complete fee-for-service claims for hospital outpatient departments at 3,454 facilities paid under Medicare’s Outpatient Prospective Payment System (OPPS). The data showed that 82 percent of all OPPS hospitals would see net total payment decreases in 2021 as a result of policy reversal. The impact of the policy’s reversal would also be greater for rural OPPS hospitals, of which 90 percent would see a net payment decrease. <Read More>

    AHA Wants HHS to Issue Waivers to 340B Hospitals – April 1, 2021 – The American Hospital Association is asking Health and Human Services Secretary Xavier Becerra to ensure that hospitals participating in the 340B drug pricing program continue to have access to the program despite changes in their payer mix as a result of COVID-19. The AHA specifically requests a Section 1135 waiver of the Social Security Act for certain 340B program eligibility criteria for 340B hospitals enrolled during the public health emergency that may have experienced a temporary change in payer mix due to the COVID-19 pandemic. <Read More>

    The Year Ahead for Rx Pricing: A Waiting Game – April 1, 2021 – Political divisiveness on Capitol Hill and the ongoing push for financial relief for the COVID-19 pandemic so far have caused a slowdown in the Biden administration’s ability to make sweeping changes affecting health care, a policy expert said during Informa’s Hub and SPP Model Optimization 2021 virtual event…Significant debates abound in the legal community regarding 340B drug pricing. One contentious issue is the use of third-party contract pharmacies by institutions that qualify for 340B drug pricing but do not have in-house pharmacies. The use of contract pharmacies can yield significant cost savings for these hospitals, but the practice has drawn the ire of drug manufacturers, many of which have sought to block these arrangements over the past year. The conflict has resulted in an administrative ruling by the Department of Health and Human Services to uphold the rights of contract pharmacies to access 340B prices. <Read More>

    Shifting Payer Mix Puts 340B Hospitals at Risk of Losing Eligibility – April 1, 2021 – Hospitals enrolled in the 340B drug discount program may no longer be eligible after the pandemic shifted their payer mix, according to a Wednesday letter the American Hospital Association sent to HHS Secretary Xavier Becerra. Depleted patient volumes and canceled elective surgeries lowered the proportion of hospital patients who are Medicaid and Medicare SSI patients in 2020, according to AHA. When hospitals file their Medicare cost reports reflecting those changes, they may no longer meet the criteria for the program and lose access. <Read More>

    This Revenue Stream is Working Wonders for Community Health, But Some States Want to Take it Away – March 31, 2021 – If you’re a patient of Callen-Lorde Community Health Center — a primary-care center that serves the LGBTQ community with its main clinic in midtown Manhattan — and you’re experiencing an unexpected medical issue, you can call the center and speak with a registered nurse who can help figure out whether you need the emergency room or a quick trip to a drugstore. It’s called nurse triage. Callen-Lorde has been providing this service for 15 years, and it had 30,000 nurse triage interactions in 2020 — a 20 percent increase over 2019…But now, states including New York have been looking to take away community health centers’ access to 340B revenue streams. If the New York State legislature doesn’t repeal or delay changes passed in last year’s state budget — intended to help close an $8 billion budget gap — Callen-Lorde and more than 70 other community health centers across New York State will lose 340B revenue streams overnight on May 1 of this year. At Callen-Lorde, 340B revenues represent $12 million a year, or 14 percent of the organization’s annual budget. <Read More>

    340B in 2021: What Covered Entities and Their Partners Need to Know Now Recap – March 31, 2021 – Since March 2010, increased growth in the 340B Program has been accompanied by increased scrutiny from state and federal governments and conflicts between various 340B Program stakeholders. A transition in U.S. Department of Health & Human Services (HHS) and Health Resources & Services Administration (HRSA) leadership may lead to changes in 340B Program policy, but the ongoing conflicts, particularly around contract pharmacies, will not likely be resolved quickly. In this webinar, we discussed the current issues affecting 340B Program stakeholders, the tools (and their limitations) that may be employed by stakeholders and government agencies to resolve those issues, and what covered entities can expect in future developments affecting the 340B Program. <Read More>

    Pitts: Fixing Drug Program Can Make Big Difference for Struggling Patients – March 30, 2021 – The COVID-19 pandemic has made the issue of health care access more urgent than ever. Yet, at a time of deep divisions in Washington, chances for major reform are slim. But the Biden administration doesn’t need an ambitious package of reforms to make health care more affordable. Federal officials could instead focus on fixing dysfunctional programs already on the books. A drug discount program known as 340B should be high on their list. Its original goal was to make brand-name drugs more affordable for uninsured and low-income populations. Instead, in recent years, pharmacies and hospitals have abused 340B discounts to boost their own profit margins. Cleaning up this well-meaning program would go a long way towards improving health care access. <Read More>

    340B Update: Federal Court Halts 340B Administrative Dispute Resolution Rule – March 29, 2021 – Safety net providers participating in the 340B Drug Pricing Program (340B Program) continue to grapple with drug manufacturers imposing restrictions on 340B contract pharmacy arrangements. In response to these actions, the U.S. Department of Health and Human Services (HHS) issued an Advisory Opinion in support of these arrangements. HHS also finalized the long-awaited 340B Administrative Dispute Resolution (ADR) rule setting up a process for challenging the restrictions. Manufacturers sued HHS in multiple federal district courts challenging the Advisory Opinion as well as the 340B ADR rule. In this regard, the U.S. District Court for the Southern District of Indiana recently granted one of these manufacturers a preliminary injunction stopping HHS from implementing the 340B ADR rule. At this point, it is unclear whether HHS will want to appeal this injunction or, instead, reissue the 340B ADR rule. Moreover, given the other pending lawsuits, the scope of the court’s decision and status of the rule remain unclear. This client alert provides an overview of these developments and what to expect next. <Read More>

    Another Voice: Medicaid Carve Out Would Harm Vulnerable Populations – March 29, 2021 – Community-based health providers and Western New York’s most vulnerable patients have a lot to lose if a 340B carve out is not reversed or delayed in the 2021 New York State budget. There are six federally qualified health centers, or FQHCs, in Western New York: The Chautauqua Center, Community Health Center of Buffalo, Evergreen Health, Jericho Road, Neighborhood Health Center and Universal Primary Care. All of us provide lifesaving health services at our practices in Bradford, Buffalo, Blasdell, Cheektowaga, Cuba, Dunkirk, Hamburg, Houghton, Jamestown, Lockport, Niagara Falls, Olean and Salamanca. Our thousands of patients span all of Western New York and include some of the region’s most vulnerable and traditionally marginalized populations, including communities of color, individuals living with HIV, refugees and the LGTBQ+ community. <Read More>