Clinical Insights: December 1, 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

    Imcivree®  (setmelanotide) Injection – New Drug Approval – November 27, 2020 – The U.S. Food and Drug Administration approved Imcivree®  (setmelanotide) for chronic weight management (weight loss and weight maintenance for at least one year) in patients six years and older with obesity due to three rare genetic conditions: pro-opiomelanocortin (POMC) deficiency, proprotein subtilisin/kexin type 1 (PCSK1) deficiency, and leptin receptor (LEPR) deficiency confirmed by genetic testing demonstrating variants in POMC, PCSK1, or LEPR genes considered pathogenic (causing disease), likely pathogenic, or of uncertain significance. Imcivree is the first FDA-approved treatment for these genetic conditions. <Read More>

    Danyelza®  (naxitamab-gqgk) Injection – New Drug Approval – November 25, 2020 – Y-mAbs Therapeutics, Inc., a commercial-stage biopharmaceutical company focused on the development and commercialization of novel, antibody-based therapeutic products for the treatment of cancer, announced that the U.S. Food and Drug Administration (“FDA”) has approved Danyelza®  (naxitamab-gqgk) 40mg/10ml. Danyelza® is indicated, in combination with granulocyte-macrophage colony-stimulating factor (“GM-CSF”), for the treatment of pediatric patients 1 year of age and older and adult patients with relapsed or refractory high-risk neuroblastoma in the bone or bone marrow who have demonstrated a partial response, minor response, or stable disease to prior therapy. This indication is approved under accelerated approval regulation based on overall response rate and duration of response. Continued approval for this indication may be contingent upon verification and description of clinical benefits in a confirmatory trial. Danyelza® is a humanized, monoclonal antibody that targets the ganglioside GD2, which is highly expressed in various neuroectoderm-derived tumors and sarcomas. Danyelza® is administered to patients three times in a week in an outpatient setting and the treatment is repeated every four weeks. The product has received Priority Review, Orphan Drug, Breakthrough Therapy, and Rare Pediatric Disease designations from the FDA. <Read More>

    Oxlumo® (lumasiran) Injection – New Drug Approval – November 23, 2020 – The U.S. Food and Drug Administration approved Oxlumo® (lumasiran) as the first treatment for primary hyperoxaluria type 1 (PH1), a rare genetic disorder. This approval is a cumulation of the work of experts and community members coordinated by the Oxalosis & Hyperoxaluria Foundation and the Kidney Health Initiative. “The approval of Oxlumo® represents a great triumph of community involvement to address a rare disease. It is a result of input from patients, treating physicians, experts and sponsors at a patient-focused drug development meeting and through other collaborative efforts,” said Norman Stockbridge, M.D., Ph.D., director of the Division of Cardiology and Nephrology in the FDA’s Center for Drug Evaluation and Research. <Read More>

    New Formulation Approval

    No new update.

    New Indication/Dosage Approval

    Xofluza®  (baloxavir marboxil) Tablets and Granules for Oral Suspension – New Approved Indication – November 24, 2020 – Roche announced that the U.S. Food and Drug Administration (FDA) has approved a supplemental New Drug Application (sNDA) for Xofluza® (baloxavir marboxil) as a treatment to prevent influenza in people 12 years of age and older following contact with someone with influenza (known as post-exposure prophylaxis). Xofluza®  is the first single-dose influenza medicine approved for post-exposure prophylaxis. “With this approval, Xofluza is now available as the first single-dose, post-exposure preventive treatment for influenza,” said Levi Garraway, M.D., Ph.D., Roche’s Chief Medical Officer and Head of Global Product Development. “We’re hopeful that reducing the burden of influenza may help to mitigate the strain on our healthcare system amid the COVID-19 pandemic.” <Read More>

    New/Updated Drug Shortage

    November 30, 2020

    November 23, 2020

    New Drug Recall and Safety Alerts

    No new update.

    New Generic/Biosimilar Approval and Launch

    No new update.

    Clinical and Pharmacy News

    Stiff Penalties Common When Physicians Found Guilty of Opioid-Related Crimes – December 1, 2020 – Physicians from a variety of clinical specialties are increasingly being prosecuted for opioid-related offenses, according to a study submitted to the canceled 2020 annual meeting of the International Anesthesia Research Society (IARS). Principal investigator Guohua Li, DrPH, a professor of anesthesiology at Columbia University Vagelos College of Physicians and Surgeons, in New York City, and Julia Berman, an undergraduate research intern from Dartmouth College in Hanover, N.H, were inspired to undertake the study because of the numerous class action lawsuits against pharmaceutical companies and distributors filed by state and local governments. <Read More>

    The U.S. Must Support Access to Care and Incentives for the Innovation that Transforms It – December 1, 2020 – The deadly spread of Covid-19 around the world has highlighted the importance of innovation and cooperation between the various actors in the U.S. health care system. It has shown what can be achieved in an environment that rewards innovation and promotes scientific advances. But it has also exposed that the system does not work for everyone. Now is the time to focus on how to preserve and grow what makes the U.S. research, innovation, and health care system strong, and how to address the shortfalls. <Read More>

    Secure, Safe, and Equitable Vaccine Distribution – November 30, 2020 – As several COVID-19 vaccines near regulatory approval in the U.S., the E.U., Japan, and other countries, governments around the world must establish systems to ensure effective and equitable distribution within their countries. At Microsoft, we have been working with public and private sector organizations around the world to help support this monumental task. In some ways, the challenges related to the distribution and administration of the COVID-19 vaccine are similar to other vaccines. There are logistical challenges of supply procurement and demand forecasting, distribution, adverse reaction tracking and reporting, and integration with immunization records. But there are unique challenges as well: fair allocation, prioritization and phased eligibility, registration, tracking, as needed cold-chain storage supply, and the need to vaccinate a critical mass of the world’s population of over seven billion people in short order during a global pandemic. <Read More>

    Lyme Disease Guidelines Released: Prevention, Diagnosis, and Treatment – November 30, 2020 – New evidence-based clinical practice guidelines for the prevention, diagnosis, and treatment of Lyme disease have been developed by a multidisciplinary panel led by the Infectious Diseases Society of America, the American Academy of Neurology, and the American College of Rheumatology. Representatives from an additional 12 medical specialties and patients also served on the panel. The guidelines provide practical recommendations for clinicians treating patients with Lyme disease, including, but not limited to, primary care physicians, infectious diseases specialists, emergency physicians, internists, pediatricians, family physicians, neurologists, rheumatologists, cardiologists, and dermatologists. <Read More>

    Coronavirus (COVID-19) Update: FDA Announces Advisory Committee Meeting to Discuss Second COVID-19 Vaccine Candidate – November 30, 2020 – The U.S. Food and Drug Administration has scheduled a meeting of its Vaccines and Related Biological Products Advisory Committee (VRBPAC) on Dec. 17 to discuss the request for emergency use authorization (EUA) for a COVID-19 vaccine from Moderna Inc. “In keeping with the FDA’s commitment to ensuring full transparency, dialogue and efficiency, the Vaccines and Related Biological Products Advisory Committee, made up of outside scientific and public health experts from around the country, will meet to discuss the totality of the safety and effectiveness data provided by Moderna for their EUA submission,” said FDA Commissioner Stephen M. Hahn, M.D. “The FDA understands there is tremendous public interest regarding vaccines for COVID-19. We remain committed to keeping the public informed about the evaluation of the data of a potential COVID-19 vaccine, so that once available, the public and the medical community can have trust and confidence in receiving the vaccine for our families and ourselves.” <Read More>

    Study of 2 Treatments for PAH Finds 1 Reduces Risk of Hospitalization – November 25, 2020 – A real-world comparison of the 2 FDA-approved treatments for pulmonary arterial hypertension (PAH) is offering insight into related hospitalizations for patients taking either treatment. The study, relying on administrative claims from over 200 patients receiving either treprostinil (Orenitram) or selexipag (Uptravi) between January 2015 and September 2017, showed that selexipag is associated with a lower risk of hospitalization for patients with PAH. “These results provide real-world evidence suggesting the two available oral agents targeting the prostacyclin pathway may yield different clinical outcomes, specifically all-cause and PH-related hospitalizations,” wrote the researchers. <Read More>

    ASCO Systemic Therapy Guideline Developed for Advanced HCC – November 25, 2020 – Evidence-based clinical practice guidelines to identify the preferred treatment options for first-line and subsequent systemic therapy for advanced hepatocellular carcinoma (HCC) were developed and presented in a recent study published in the Journal of Clinical Oncology (2020. doi:10.1200/JCO.20.02672). “This guideline incorporates the evidence for systemic therapy options for patients with advanced HCC to provide recommendations to clinicians who are treating patients within the target population,” explained John Gordan, MD, PhD, University of California, San Francisco, (San Francisco, CA) and colleagues. <Read More>

    Trump Administration Revives Rebate Safe Harbor Rule in Late Effort to Reform Drug Pricing – November 25, 2020 – On November 20, 2020, the U.S. Department of Health and Human Services (HHS) Office of Inspector General (OIG) finalized its previously abandoned 2019 proposal to exclude certain rebates paid by drug manufacturers from the discount safe harbor to the federal anti-kickback statute (AKS). The final rule, entitled “Fraud And Abuse; Removal of Safe Harbor Protection for Rebates Involving Prescription Pharmaceuticals And Creation of New Safe Harbor Protection for Certain Point-of-Sale Reductions in Price on Prescription Pharmaceuticals and Certain Pharmacy Benefit Manager Service Fees” [hereinafter “OIG Rebate Rule”], is the first update to the AKS discount safe harbor since the establishment of the Medicare Part D program. <Read More>

    Prescriber Alleges Defamation Against Pharmacy Chain – November 24, 2020 – When the employees of a chain community pharmacy refuse to honor prescriptions issued by a local physician, will the lawsuit for defamation filed by that practitioner succeed? A physician, board certified in anesthesiology, was operating a pain management practice in a southern state. He was alerted by patients that staff members at a particular pharmacy chain were refusing to honor his prescriptions for opiate products. The physician alleged that those patients who presented prescriptions from him for dispensing were told things such as, “This doctor is under investigation” or “We are no longer allowed to fill his prescriptions.” The practitioner filed a lawsuit in state court against the pharmacy chain advancing 3 legal claims for recovery of monetary damages. <Read More>

    Track-and-Trace Requirements go Into Effect on Friday – November 24, 2020 – Starting Friday, November 27, 2020, pharmacies must buy and sell only products with a required “product identifier” on their packages. This requirement is part of the phased-in implementation of the Drug Supply Chain Security Act of 2013 (DSCSA), also known as the “track-and-trace” law. By Friday, dispensers should be familiar with this requirement and know what to do if a product identifier is not on the package when they receive products that require it. The product identifier is on most drug packages in both human-readable format and on a machine-readable 2D data matrix barcode. <Read More>

    Three Pharmacy Industry Groups Sue to Stop New US Drug Import Rule – November 24, 2020 – Three pharma industry groups are suing HHS and the FDA to block a rule that would allow the importation of certain prescription drugs from Canada. The groups filing the suit are Pharmaceutical Research and Manufacturers of America, Partnership for Safe Medicines and the Council for Affordable Health Coverage. President Donald Trump signed an executive order in July to allow states, wholesalers and pharmacies to import FDA-approved drugs from Canada and other countries where drug prices are significantly lower. The groups argue that the final rule disregards key protections under the federal Food, Drug, and Cosmetic Act that ensure patient safety. The groups also say that there is no indication that the final rule would reduce costs to patients. <Read More>

    Pharmacy Groups Say New Rebate Rule Does Not Do Enough to Support Patients – November 24, 2020 – The country’s leading pharmacy groups issued the following statement on the Trump administration’s new final rule on prescription drug rebates. While we want our patients to pay less for their prescription drugs, this rule does not accomplish that. It will likely increase their insurance premiums and out-of-pocket costs, and may limit patients’ access to care by forcing more pharmacies to close. The HHS drug rebate rule will increase insurance premiums and out-of- pocket costs and limit patients’ access to care We have repeatedly provided evidence that any action on prescription rebates must also address pharmacy direct and indirect remuneration fees. Pharmacy DIR fees are causing patient prescription drug costs to soar and limiting patient access to care as more pharmacies are forced to close. <Read More>

    Opioid Overdoses are Spiking Amid the Pandemic – PBMs Can Help Combat Opioid Abuse and Misuse – November 24, 2020 – The opioid epidemic in the United States is a crippling crisis with devastating impacts on public health and economic welfare. According to the Centers for Disease Control and Prevention, in 2018, more than one in five people filled an opioid prescription, and 40 people died daily after taking prescription opioids. Since the start of the pandemic, data shows a concerning spike in opioid mortality rates across the country, with 40 states reporting increases. With the heightened uncertainty brought on by a pandemic, patients are facing new emotional, financial and social stressors that contribute to a spike in opioid overdoses. The increased reports of opioid abuse and misuse can also be attributed to pandemic-related barriers to health care, such as limited access to treatment facilities, lack of coverage and high cost for non-opioid pain treatments, insufficient access to telehealth, and prolonged opioid dependency with postponed elective surgeries. <Read More>

    IDSA Releases New Guidelines for COVID-19 Treatment – November 24, 2020 – The Infectious Diseases Society of America has recently updated their list of COVID-19 guidelines for the treatment and management of the disease. The list, which describes different ways to treat and manage COVID-19, includes revisions in the information on lopinavir/ritonavir, tocilizumab, remdesivir and bamlanivimab. Led by Adarsh Bhimraj, MD., associate staff physician in the Department of Infectious Disease at the Cleveland Clinic in Ohio, the panel of experts in the field of infectious disease agreed upon the new guidelines to aid in the information available on the treatment and management of COVID-19. <Read More>

    340B in the News

    State HIV Task Force Says Cuts to Rebate Program Can Hurt Its Efforts – November 30, 2020 – The task force, also called ETE, had the ambitious goal of ending the epidemic in the state by 2020. Part of the way they planned to do that was by using funds from a federal rebate program called 340B, which went toward giving patients discounts on prescriptions or funding agencies that provide care to HIV patients. Dr. Bill Valenti is a physician with Trillium Health. He says Trillium has been able to help people access care as a direct result of the 340B program. Now, members of the ETE say the state Legislature wants to make changes to that rebate program, but it’s not clear why. <Read More>

    Anticipating The Biden Administration’s Health Care Agenda – November 30, 2020 – As Washington looks toward 2021, the incoming Biden administration and the 117th Congress, a number of federal health care policy issues lie on the agenda for both branches of government. A narrowly divided Washington, D.C. — notably a Senate that will be either controlled by Republicans with at-most two votes to spare or be tied 50-50 with Vice President-elect Kamala Harris breaking ties — will have a significant impact on this agenda over the coming two years… A number of Trump administration policies promulgated through the annual payment regulations — such as requiring disclosure of rates hospitals negotiate with insurers — are under legal challenge. Some of these contentious issues could be reversed by the Biden administration, such as cuts to 340B hospitals. However, in making changes to existing final rules, the administration could invite new lawsuits. <Read More>

    NY State Plans to Withhold 20% From Crucial HIV Programs – November 30, 2020 – On the eve of World AIDS Day, HIV leaders across New York state demanded that Governor Andrew Cuomo not abandon his commitment to the Ending the Epidemic Blueprint. Specifically, they urge the state not to implement a 20% across-the-board withholding of funding for HIV programs and not to cut nearly $60 million from 340B safety net funds and pharmacy rebates… King noted that Cuomo, who endorsed much of the Ending the HIV/AIDS Epidemic plan in 2015, has been an ally in fighting HIV. In recent years, his administration’s efforts have led to many improvements. In fact, in October 2019, Cuomo announced that the Empire State was on track to end AIDS by 2020, meaning that there would be 750 or fewer new HIV infections per year, thanks to fewer (and earlier) HIV diagnoses, better linkage to care, and more people taking PrEP (pre-exposure prophylaxis to prevent HIV). <Read More>

    MVHC Joins Fight to Preserve Pharmacy Program – November 29, 2020 – Muskingum Valley Health Centers is a Federally Qualified Health Center located in southeast Ohio serving the residents of Coshocton, Guernsey, Morgan and Muskingum counties. MVHC is a critical primary care resource to the region that serves numerous vulnerable populations that would otherwise not have access to on-going primary care. As an FQHC, MVHC relies on the 340B Drug Pricing Program to provide patients with affordable medications. The savings the 340B program creates is used to support key patient programs at MVHC. Recently, pharmaceutical manufacturers have launched broadside attacks that will dismantle the program and force patients to pay higher costs and reduce access to prescriptions and valuable patient programs. Unfortunately, this attack comes at a time when health centers are serving on the front line in the fight against the COVID-19 pandemic. <Read More>

    Katko Urges Against HHS Changing Drug Pricing Program – November 23, 2020 – U.S. Rep. John Katko (R-NY) joined a bipartisan contingent of lawmakers in requesting that the U.S. Department of Health and Human Services (HHS) resist changing the 340B Drug Pricing Program from a discount model to a rebate model. Such a change would cause a significant increase in the cost of prescription medications just as many residents are experiencing increased economic strain due to the COVID-19 pandemic, according to the congressman. “With lawmakers from both sides of the aisle, I’m urging HHS to prevent pharmaceutical companies from implementing changes that would damage the 340B program,” Rep. Katko said. “Especially during this pandemic, we must be resolute in our defense of the 340B program to ensure underserved communities have access to the medications they need, at affordable prices.” Rep. Katko reiterated that stance in a recent letter sent to HHS Secretary Alex Azar. U.S. Rep. Abigail Spanberger (D-VA) was among the 215 other lawmakers who signed the letter. <Read More>