Clinical Insights: December 22, 2020

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

    New Drug Approval

    OrgovyxTM (relugolix) Tablets – New Drug Approval – December 18, 2020 – Myovant Sciences, a healthcare company focused on redefining care for women and for men, announced that the U.S. Food and Drug Administration (FDA) has approved Orgovyx™ (relugolix) for the treatment of adult patients with advanced prostate cancer. Orgovyx™, which was granted Priority Review by the FDA, is the first and only oral gonadotropin-releasing hormone (GnRH) receptor antagonist for men with advanced prostate cancer. The approval is based on efficacy and safety data from the Phase 3 HERO study of Orgovyx™  in men with advanced prostate cancer. Orgovyx™  is expected to be available in January 2021. <Read More>

    MargenzaTM (margetuximab-cmkb) Injection – New Drug Approval – December 16, 2020 – The Food and Drug Administration approved margetuximab-cmkb (MargenzaTM, MacroGenics) in combination with chemotherapy, for the treatment of adult patients with metastatic HER2-positive breast cancer who have received two or more prior anti-HER2 regimens, at least one of which was for metastatic disease. Efficacy was evaluated in SOPHIA (NCT02492711), a randomized, multicenter, open-label trial of 536 patients with IHC 3+ or ISH-amplified HER2+ metastatic breast cancer who had received prior treatment with other anti-HER2 therapies. <Read More>

    Klisyri® (tirbanibulin) Ointment – New Drug Approval – December 14, 2020 – Athenex, Inc., a global biopharmaceutical company dedicated to the discovery, development, and commercialization of novel therapies for the treatment of cancer and related conditions, announced that the U.S. Food and Drug Administration (FDA) has approved Klisyri® (tirbanibulin) for the topical treatment of actinic keratosis (AK) on the face or scalp. Klisyri® is the first FDA approved branded proprietary product for Athenex and will be launched in partnership with Almirall in the U.S. during the first quarter of 2021. Klisyri® will be manufactured by Athenex, highlighting the vertically integrated capabilities of the company ranging from a preclinical lead to a developed product for market launch. <Read More>

    New Formulation Approval

    No new update.

    New Indication/Dosage Approval

    Xpovio® (selinexor) Tablets – New Approved Indication – December 18, 2020 – Karyopharm Therapeutics Inc., a commercial-stage pharmaceutical company pioneering novel cancer therapies, announced that the U.S. Food and Drug Administration (FDA) has approved Xpovio® (selinexor), the Company’s first-in-class, oral Selective Inhibitor of Nuclear Export (SINE) medicine, in combination with bortezomib and dexamethasone for the treatment of adult patients with multiple myeloma who have received at least one prior therapy. Xpovio® was previously approved under the FDA’s Accelerated Approval Program for the treatment of adult patients with relapsed or refractory multiple myeloma who have received at least four prior therapies and whose disease is refractory to at least two proteasome inhibitors, at least two immunomodulatory agents, and an anti-CD38 monoclonal antibody. <Read More>

    Ocrevus® (ocrelizumab) Injection – New Approved Indication – December 14, 2020 – Genentech, a member of the Roche Group, announced that the U.S. Food and Drug Administration (FDA) has approved a shorter two-hour infusion time for Ocrevus® (ocrelizumab), dosed twice-yearly for those living with relapsing or primary progressive multiple sclerosis (MS) who have not experienced any prior serious infusion reactions (IRs). The approval was based on data from the randomized, double-blind ENSEMBLE PLUS study. <Read More>


    New/Updated Drug Shortage

    December 21, 2020

    December 18, 2020

    December 17, 2020

    December 16, 2020

    December 15, 2020

    New Drug Recall and Safety Alerts

    No new update.

    New Generic/Biosimilar Approval and Launch

    RiabniTM (rituximab-arrx) Injection – New Biosimilar Drug Approval – December 17, 2020 – Amgen announced that the U.S. Food and Drug Administration (FDA) has approved Riabni™ (rituximab-arrx), a biosimilar to Rituxan® (rituximab), for the treatment of adult patients with Non-Hodgkin’s Lymphoma (NHL), Chronic Lymphocytic Leukemia (CLL), Granulomatosis with Polyangiitis (GPA) (Wegener’s Granulomatosis), and Microscopic Polyangiitis (MPA). RiabniTM will be made available in the U.S. in January 2021. <Read More> 

    Saphris® (asenapine) – First-time Generic and Authorized Brand Alternative – December 11, 2020 – Breckenridge Pharmaceutical, Inc. announced that the U.S. Food and Drug Administration has granted final approval of its Abbreviated New Drug Application for Asenapine Sublingual Tablets in 2.5mg and 10mg strengths (generic for Saphris®).  Breckenridge plans to launch these strengths immediately.  Additionally, the U.S. Food and Drug Administration granted tentative approval for the 5mg strength. This product was developed in collaboration with MSN Laboratories Private Limited. According to industry sales data, Saphris® generated annual sales of $239 million during the twelve months ending September 2020. <Read More>

    Clinical and Pharmacy News

    AHA/ACC Urge Shared Decisions in Hypertrophic Cardiomyopathy – December 21, 2020 – Updated clinical practice guidelines from the American Heart Association/American College of Cardiology, published online Nov. 20 in Circulation, emphasize shared decision-making in the management of hypertrophic cardiomyopathy (HCM). Steve R. Ommen, M.D., from the Mayo Clinic in Rochester, Minnesota, and colleagues have developed guidelines for the diagnosis and treatment of patients with HCM to update the previous version issued in 2011. <Read More>

    Attitudes, Barriers, and Perceptions Influence Naloxone Prescribing by Pharmacists – December 21, 2020 – In 2017, an estimated 17% of the US population filled at least 1 opioid prescription, an average of 3.4 opioid prescriptions per patient, resulting in more than 47,000 opioid-related deaths. In 2018, the US surgeon general released an advisory statement encouraging increased education regarding naloxone use and patient access to naloxone. In 2017, Idaho had 266 drug-induced deaths,3 accounting for 14.4 deaths per 100,000 individuals.4 The average number of opioid prescriptions remains higher than the national average at 70.3 compared with 58.7 per 100 individuals, respectively… Pharmacists are medication experts, receiving extensive training in pathophysiology, pharmacology, medication therapy management, and therapeutics.13 More than 90% of the US population lives within 5 miles of a community pharmacy.14 Pharmacists’ involvement with drug therapy initiatives, such as immunization and tobacco cessation management, have resulted in increased access to cost-effective and safe medication therapy.15 In 2015, Idaho passed legislation allowing pharmacists to prescribe naloxone. However, anecdotal evidence suggests that community pharmacists in Idaho do not actively use their prescriptive authority. <Read More>

    CDC Updates Treatment Guidelines for Gonococcal Infection – December 18, 2020 – Neisseria gonorrhoeae, a bacterium that infects the urethra, rectum or throat of both male and females, is an important cause of sexually transmitted infections (STIs) that can have severe reproductive health consequences. N. gonorrhoeae is able to rapidly develop resistance to antibiotic therapies. The CDC has recently updated their treatment guidelines for the infection, adding a recommendation of an intramuscular dosage of 500 mg ceftriaxone for uncomplicated gonorrhea. Also added was a recommended treatment if a coinfection with Chlamydia trachomatis occurs. The recommended treatment for coinfection is an oral dose of 100 mg doxycycline twice daily for 7 days. However, the treatment should only be administered when chlamydial infection has not been excluded. <Read More>

    Pharmacy as a Destination for Receiving Vaccines During the COVID-19 Pandemic – December 18, 2020 – The novel severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) has sparked much fear and anxiety during the coronavirus disease 2019 (COVID-19) pandemic. As a result, many individuals have decided to cancel scheduled physician visits, including visits to get vaccinated, over concerns of SARS-CoV-2 infection. In addition, many physician offices had reduced hours or temporary closings due to stay-at-home orders, limiting access. This decline in vaccinations has put many patients, especially pediatric patients, and communities at risk from otherwise vaccine-preventable diseases. However, as stay-at-home orders lift and communities start returning to a new sense of normal, pharmacists and pharmacies are well positioned to help individuals catch up on missed and overdue vaccines. The need for pharmacist immunization services is even more apparent. At the directive of the US Department of Health & Human Services (HHS), pharmacists can now play a larger role in increasing vaccination rates. Therefore, this article includes highlights of how pharmacies can continue to be safe and convenient settings in which patients can receive vaccines, and it explores the pharmacy’s role in COVID-19 vaccine administration, when such a vaccine becomes available. <Read More>

    Overdose Deaths Accelerating During COVID-19 – December 17, 2020 – Over 81,000 drug overdose deaths occurred in the United States in the 12 months ending in May 2020, the highest number of overdose deaths ever recorded in a 12-month period, according to recent provisional data from the Centers for Disease Control and Prevention (CDC). While overdose deaths were already increasing in the months preceding the 2019 novel coronavirus disease (COVID-19) pandemic, the latest numbers suggest an acceleration of overdose deaths during the pandemic. “The disruption to daily life due to the COVID-19 pandemic has hit those with substance use disorder hard,” said CDC Director Robert Redfield, M.D. “As we continue the fight to end this pandemic, it’s important to not lose sight of different groups being affected in other ways. We need to take care of people suffering from unintended consequences.” <Read More>

    Tobacco Product Use Down Among Youths in 2020 – December 17, 2020 – A report out from the Centers for Disease Control and Prevention (CDC), in collaboration with the Food and Drug Administration (FDA), found that current tobacco product use declined among U.S. middle and high school students from 2019 to 2020—driven by decreases in e-cigarette, cigar, and smokeless tobacco use. However, the National Youth Tobacco Survey (NYTS) data analysis also found that about 1 in 6 (nearly 4.5 million) students were current users of some type of tobacco product in 2020. <Read More>

    Lonoke Pharmacy Sues PBMs – December 17, 2020 – Lonoke pharmacy has filed suit in circuit court against pharmacy benefit managers, claiming they are violating Arkansas law by withholding information to pharmacies and reimbursing their own pharmacies more than they reimburse independent ones. The suit says Lackie Drug Store has been forced to routinely sell prescriptions to consumers at a loss and alleges that the plaintiff is entitled to its actual financial losses and reasonable attorneys’ fees. It seeks a “disgorgement,” or a return to itself of profits gained from wrongful activities. It also seeks civil penalties of $10,000 per violation, along with injunctions to end actions in violation of Arkansas law. <Read More>

    The American College of Gastroenterology Issues Its First Clinical Guideline on Management of Irritable Bowel Syndrome – December 15, 2020 – The American College of Gastroenterology (ACG) is pleased to announce the publication of its first-ever ACG Clinical Guideline on the Management of Irritable Bowel Syndrome (IBS), which was published online ahead-of-print in The American Journal of Gastroenterology. The guideline provides clinical recommendations for both diagnostic testing and therapeutic treatments for IBS. IBS is a disorder of bowel function and sensation in which patients have changes in bowel habits such as constipation or diarrhea and abdominal pain, along with other symptoms including abdominal bloating, and rectal urgency with diarrhea. The guideline authors write that IBS is estimated to affect 4.4%-4.8% of the population, according to Rome IV diagnostic criteria, and more commonly affects women than men. <Read More>

    In Drug Pricing, PBMs Called the “Arsonist and the Firefighter in One” – December 15, 2020 – Pharmacy benefit managers (PBMs), once just administrators created to ease claims processing, have grown to a position of power that comes with conflicts of interest aplenty. Today, pharmacies and consumers alike encounter pitfalls, such as spread pricing, the use of rebate aggregators, and threats of drugs being removed from formularies. All this makes dealing with PBMs an unfortunate reality for drug manufacturers and pharmacies, and for patients who depend on the drugs that PBMs control, said a panel of experts at Patient-Centered Oncology Care® 2020. <Read More>

    340B in the News

    AHF to HRSA: Reject Kalderos’ Plan to Hurt 340B Drug Discount Program – December 21, 2020 – AIDS Healthcare Foundation ( AHF ) sounded the alarm at reports that drug companies – through their vendor Kalderos – are moving forward with plans to undermine the 340B drug program – to the harm of safety net providers, who are already struggling to maintain services to their populations in the midst of a pandemic ( 340B Report 12/17/20 ). “The ‘Kalderos’ plan would convert the 340B Drug Price Program from a discount to a rebate program and would set Kalderos up as the arbiter of who will get the rebate and when, putting the fox in charge of the henhouse,” said Tom Myers, AHF chief of public affairs and general counsel. <Read More>

    340B and the Biden Administration – December 18, 2020 – It’s been a busy week in health care policy, as congressional leaders inch toward a COVID-19 relief package and key lawmakers announced a deal to end surprise medical bills (read my analysis of that agreement here). Less noticed this week, California Attorney General—and President-elect Biden’s nominee to lead the Department of Health and Human Services (HHS)—Xavier Becerra led a letter to HHS calling on Secretary Azar to enforce provisions of the 340B Drug Pricing Program he maintains pharmaceutical companies are violating. The letter is significant because it signals that the man who could take over HHS in a few months is gearing up to expand the bloated and abused 340B program. <Read More>

    Drug Makers Are Pulling Back From a Program to Help the Needy – December 15, 2020 – Some of the nation’s top pharmaceutical companies have stopped giving federally mandated drug discounts to hospitals and clinics that care for the poorest Americans, a move that is prompting bipartisan calls for the health secretary, Alex M. Azar II, to demand reinstatement of the price breaks or punish the firms. The companies — including two that are partnering with the Trump administration on coronavirus vaccines — began scaling back their participation in the federal drug pricing program over the summer, saying that some hospitals and clinics were exploiting it to pad their own bottom lines. They say individual patients are not being hurt. But hospitals, clinics and pharmacies that serve the poor say the change violates federal law and has been devastating — both to patients and to their own budgets — in the middle of an economic downturn spurred by the worst pandemic in 100 years. They say that the cutbacks are illegal and that now is not the time to reduce discounts that help them better serve the poor. <Read More>

    New HHS Board Will Hear 340B Drug Pricing Disputes – December 15, 2020 – On December 14, 2020, HRSA established a long overdue Administrative Dispute Resolution (ADR) process that allows covered entities and drug manufacturers to bring claims against each other related to the 340B Drug Pricing Program (340B Program). The ADR process will allow covered entities and drug manufacturers to formally request agency review of alleged 340B violations. The ADR process will begin amid contentious disputes about the scope and future of the 340B Program. In recent months, multiple drug manufacturers have taken unilateral action to curtail the availability of 340B pricing dispensed through a covered entity’s contracted pharmacies. HRSA, the agency responsible for overseeing the 340B Program, has not yet issued a final opinion on those actions. Members of Congress have urged HRSA to take enforcement action against the manufacturers for violations of the Public Health Services Act. Covered entities and their trade associations have sued HRSA to compel the agency to take action. (See Ryan White Clinics for 340B Access et al v. Azar et al, 1:20cv2906 (U.S. District Court for the District of Columbia); National Association of Community Health Centers v. Azar et al, 1:20cv3032 (U.S. District Court for the District of Columbia).) The courts hearing these suits will now need to decide how the finalization of the ADR process impacts the litigation. <Read More>

    AHA Asks Biden to Extend Public Health Emergency and to be Allowed to Retain Relief Funds – December 15, 2020 – The American Hospital Association has asked President-elect Joe Biden to extend the public health emergency, which is currently set to expire on January 20, 2021, in a letter sent on Friday. The AHA requested that providers be allowed to retain Provider Relief Fund dollars by allowing for any reasonable method of calculating COVID-19-related lost revenue, movement of targeted distributions within a system and use of funds for increased staffing costs. The letter also urged the new administration to protect the 340B drug savings program and require that private plans eliminate administrative and financial barriers to coverage for COVID- 19 testing and treatment. <Read More>

    HRSA Releases Final Rule Establishing Dispute Resolution Process for the 340B Program – December 15, 2020 – On December 10, 2020, the Health Resources and Services Administration (HRSA) released a Final Rule to establish an administrative dispute resolution (ADR) process and ADR panels to resolve certain 340B Program disputes between drug manufacturers and 340B covered entities. The establishment of a 340B ADR process was mandated by the Affordable Care Act (ACA) more than 10 years ago. Nevertheless, the timing of the release has raised concerns regarding the effectiveness of the Final Rule in light of recent efforts by drug manufacturers to limit access to 340B drugs for dispensing under contracted pharmacy arrangements. Questions also remain as to when ADR panels will be established and begin hearing claims. <Read More>

    Twenty-seven States and D.C. Call for HHS to Rein in Drugmakers Over 340B Moves After Hospital Group Lawsuit – December 14, 2020 – A collection of 27 states and the District of Columbia wrote to the Department of Health and Human Services (HHS) imploring the agency to rein in drugmakers they say are restricting access to 340B discounted drugs. The letter, released Monday, is the latest salvo in an escalating feud between 340B covered entities and drug companies who have restricted sales to contract pharmacies, which are third-party entities that dispense 340B-discounted products. The letter comes after a collection of hospital groups sued HHS Friday to spur the agency into action. “Discounts afforded under the 340B Drug Pricing Program are more critical now than ever,” said California Attorney General Xavier Becerra in a statement. “We call on HHS to hold these non-compliant drug manufacturers accountable and provide immediate relief for healthcare centers and the Americans they serve.” <Read More>