Clinical Insights: October 6, 2020

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    New Drug Approval

    Alkindi® Sprinkle (hydrocortisone) Oral Granules – New Orphan Drug Approval – September 29, 2020 – Eton Pharmaceuticals, Inc, a specialty pharmaceutical company focused on developing and commercializing innovative treatments for rare pediatric diseases, announced that the U.S. Food and Drug Administration (FDA) has approved Alkindi® Sprinkle (hydrocortisone) oral granules as replacement therapy for Adrenocortical Insufficiency (AI) in children under 17 years of age. Alkindi® Sprinkle is the first and only FDA-approved granular hydrocortisone formulation for the treatment of adrenocortical insufficiency specifically designed for use in children. <Read More> 

    New Formulation Approval

    Xeljanz® (tofacitinib) – New Expanded Indication and New Formulation Approval – September 28, 2020 – Pfizer Inc. announced that the United States (U.S.) Food and Drug Administration (FDA) approved Xeljanz® (tofacitinib) for the treatment of children and adolescents 2 years and older with active polyarticular course juvenile idiopathic arthritis (pcJIA). Two formulations were approved, a tablet and an oral solution, and are dosed based upon weight. This approval makes Xeljanz® the first and only Janus kinase (JAK) inhibitor approved in the U.S. for the treatment of pcJIA. <Read More>

    New Indication/Dosage Approval

    Opdivo® (nivolumab) Injection  – New Expanded Indication Approval – October 2, 2020 – The U.S. Food and Drug Administration approved Opdivo® (nivolumab) in combination with Yervoy® (ipilimumab) for the first-line treatment of adults with malignant pleural mesothelioma that cannot be removed by surgery. This is the first drug regimen approved for mesothelioma in 16 years and the second FDA-approved systemic therapy for mesothelioma. <Read More> 

    Simponi Aria® (golimumab) Injection  – New Expanded Indication Approval – September 30, 2020 – The Janssen Pharmaceutical Companies of Johnson & Johnson announced that the U.S. Food and Drug Administration (FDA) has approved Simponi Aria® (golimumab) for patients 2 years of age and older for the treatment of active pJIA and has extended the PsA indication for this same patient population. “This latest FDA approval of Simponi Aria® for pediatric use in active pJIA and active PsA not only brings a new option to young patients living with these diseases but also adds to the growing body of evidence for this treatment,” said Mathai Mammen, M.D., Ph.D., Global Head, Janssen Research & Development, Johnson & Johnson. “For more than 20 years, we at Janssen have been committed to researching anti-TNF biologic agents for immune-mediated diseases and are encouraged to expand treatment options for these patients. <Read More> 

    Xeljanz® (tofacitinib) – New Expanded Indication and New Formulation Approval – September 28, 2020 – Pfizer Inc. announced that the United States (U.S.) Food and Drug Administration (FDA) approved Xeljanz® (tofacitinib) for the treatment of children and adolescents 2 years and older with active polyarticular course juvenile idiopathic arthritis (pcJIA). Two formulations were approved, a tablet and an oral solution, and are dosed based upon weight. This approval makes Xeljanz® the first and only Janus kinase (JAK) inhibitor approved in the U.S. for the treatment of pcJIA. <Read More> 

    Fetroja® (cefiderocol) – New Expanded Indication Approval – September 28, 2020 – Shionogi & Co., Ltd. (hereafter “Shionogi”) announced that the U.S. Food and Drug Administration (FDA) has approved a supplemental New Drug Application (sNDA) for Fetroja® (cefiderocol) for the treatment of patients 18 years of age or older with hospital-acquired bacterial pneumonia and ventilator-associated bacterial pneumonia (HABP/VABP) caused by the following susceptible Gram-negative microorganisms: Acinetobacter baumannii complex, Escherichia coli, Enterobacter cloacae complex, Klebsiella pneumoniae, Pseudomonas aeruginosa and Serratia marcescens. <Read More> 

    Haegarda® (C1 esterase inhibitor (human)) Subcutaneous Injection – New Expanded Indication  Approval – September 28, 2020 – CSL Behring, a global biotherapeutics leader, announced that the U.S. Food and Drug Administration (FDA) has approved an expanded indication for Haegarda® (C1 Esterase Inhibitor Subcutaneous [Human]) for routine prophylaxis to prevent hereditary angioedema (HAE) attacks in patients 6 years of age and older. A rare, genetic and potentially life-threatening condition, HAE affects about 1 in 50,000 people in the United States, causing painful, potentially debilitating and unpredictable episodes of swelling of the abdomen, larynx, face and extremities, among other areas of the body. Children have a 50% chance of inheriting HAE if one of their parents has the disease. Haegarda®, the HAE therapy that reduces attacks by a median of 95%, is now the first and only subcutaneous treatment option for prevention of hereditary angioedema (HAE) attacks in patients 6 years of age and older.  In addition to the expanded pediatric indication, the updated label now includes clinical safety data regarding Haegarda® use in pregnant women. <Read More>

    Kalydeco® (ivacaftor) – New Expanded Indication Approval – September 25, 2020 – Vertex Pharmaceuticals Incorporated announced that the U.S. Food and Drug Administration (FDA) approved Kalydeco® (ivacaftor) for use in children with cystic fibrosis (CF) ages four months to less than six months old who have at least one mutation in their cystic fibrosis transmembrane conductance regulator (CFTR) gene that is responsive to Kalydeco® based on clinical and/or in vitro assay data. Kalydeco® is already approved in the U.S. and EU for the treatment of CF in patients ages six months and older. <Read More> 

    New Drug Shortage

    October 05, 2020 

    October 02, 2020 

    September 30, 2020 

    September 29, 2020 

    New Drug Recall and Safety Alerts

    Metformin Hydrochloride Extended-Release Tablets by Marksans Pharma Limited – New Drug Recall – October 5, 2020 – Marksans Pharma Limited, India is voluntarily expanding its earlier initiated recall on June 05, 2020 to include an additional 76 unexpired lots of Metformin Hydrochloride Extended-Release Tablets, USP 500mg, & 750mg to the consumer level. Marksans performed N-Nitrosodimethylamine (NDMA) testing of unexpired identified marketed lots and observed that NDMA content in some lots is exceeding the acceptable Daily Intake Limit (ADI) of 96ng/day, therefore, out of an abundance of caution, an additional 76 lots are being recalled. <Read More> 

    New Generic/Biosimilar Approval and Launch

    No new update.

    Clinical and Pharmacy News

    Pharmacy Groups React to Landmark Supreme Court Hearing – October 6, 2020 – The National Community Pharmacists Association (NCPA) and the Arkansas Pharmacists Association (APA), alongside the American Pharmacists Association (APhA) and the National Alliance of State Pharmacy Associations (NASPA), applauded the Supreme Court for hearing Rutledge v. Pharmaceutical Care Management Association (PCMA). This historic case seeks to clarify whether states can regulate pharmacy benefit managers (PBMs), the controversial middlemen that manage prescription drug benefits for health insurers, Medicare Part D drug plans, and large employers. “Independent pharmacies serve as a vital safety net for patient care in communities across the country,” said B. Douglas Hoey, NCPA CEO. “This has never been truer than throughout the coronavirus pandemic. Yet PBMs have been dodging oversight for years while raking in record profits. For patients, that’s resulted in fewer health care choices and increased out-of-pocket costs. For community pharmacies, the lack of oversight holds them hostage to inflexible, one-sided contracts causing many of these small businesses to close their doors forever. We’re optimistic the Supreme Court will agree that PBMs do not get to act with impunity from state and federal law and will issue a ruling enabling states to protect their local businesses and their patients.” <Read More>

    Report Details Need for Treatment Guidelines on Comorbid Migraine, Major Depressive Disorder – October 6, 2020 – Treatment guidelines for comorbid depression and migraine are warranted to ensure optimal efficacy and avoid possible pitfalls in psychopharmacotherapy, including serotonin syndrome, according to results of a multicenter study published in the International Journal od Neuropsychopharmacology. Cross-sectional studies have found major depressive disorder (MDD) and headache disorders, such as migraine, routinely co-occur, while longitudinal studies indicate a reciprocal or bidirectional relationship between the disorders. <Read More> 

    COX-2 Inhibitors Best Traditional NSAIDS for Acute Gout – October 5, 2020 – In patients with acute gout, cyclo-oxygenase-2 (COX-2) inhibitors, especially etoricoxib (Arcoxia, Merck & Co.), may result in a greater clinical response than traditional non-steroidal anti-inflammatory drugs (NSAIDs), according to a study published in BMJ Open. “COX-2 inhibitors are comparable to traditional NSAIDs with regard to pain relief, but are preferable to traditional NSAIDs in terms of clinical symptoms and investigator’s global assessment of response,” wrote the authors, led by Xiaofeng Zeng, M.D., of Peking Union Medical College & Chinese Academy of Medical Science in Beijing, China. <Read More>

    CDC Updates “How COVID is Spread” Webpage – September 5, 2020 – The CDC issued updated guidance to its How COVID-19 Spreads website, which includes information about the potential for airborne spread of the virus that causes COVID-19. CDC continues to believe, based on current science, that people are more likely to become infected the longer and closer they are to a person with COVID-19.  This update acknowledges the existence of some published reports showing limited, uncommon circumstances where people with COVID-19 infected others who were more than 6 feet away or shortly after the COVID-19-positive person left an area.  In these instances, transmission occurred in poorly ventilated and enclosed spaces that often involved activities that caused heavier breathing, like singing or exercise.  Such environments and activities may contribute to the buildup of virus-carrying particles. CDC’s recommendations remain the same based on existing science and after a thorough technical review of the guidance. <Read More>

    New Guidelines Reduce Number of Opioid Pills Prescribed to Patients After Surgery – October 5, 2020 – The key findings of our study are that we were able to successfully reduce how many opioids we were prescribing for patients after operations using evidence-based guidelines, and that the reduction resulted in less unused opioids remaining in our community. But, importantly, that reduction also resulted in the majority of patients being overall still satisfied with their pain control after discharge and not needing more refills than if they were to get more opioids, as would have been the case in the past. <Read More> 

    Arkansas Attorney General: States Must be Able to Regulate PBMs – October 5, 2020 – Thousands of independent pharmacies could shut down if states are unable to regulate pharmacy benefit managers (PBMs), according to the National Community Pharmacists Association (NCPA). Whether states will be able to regulate PBMs will be decided by the United States Supreme Court in an upcoming ruling on Rutledge v. Pharmaceutical Care Management Association (PCMA). PBMs are intermediaries between health plans and pharmacies, providing services such as mail-order drug sales, benefit level calculations, claims processing, and making disbursements. PBMs create a maximum affordable cost list that sets reimbursement rates to pharmacies that dispense generic drugs. Because of the contracts many pharmacies agree to in order participate in a preferred network, pharmacies may choose to accept lower reimbursements for a dispensed prescription, thereby losing money on a transaction. <Read More>

    CDC Opioid Guidelines Focus on Prescribing, not Prevention – October 2, 2020 – As the opioid crisis surges on, it seems odd the Centers for Disease Control and Prevention (CDC) suggests guidelines for practitioners prescribing Schedule II acting opioids for first-time pain intervention.  Ultimately, the focus has been on educating clinicians on best practicing practices rather than viable alternatives. The federal guidelines suggest, “Primary care clinicians report having concerns about opioid pain medication misuse, find managing patients with chronic pain stressful, express concern about patient addiction, and report insufficient training in prescribing opioids.  Across specialties, physicians believe that opioid pain medication can be effective in controlling pain, that addiction is a common consequence of prolonged use, and that long-term opioid therapy often is overprescribed for patients with chronic noncancer pain.  These attitudes and beliefs, combined with increasing trends in opioid-related overdose, underscore the need for better clinician guidance on opioid prescribing. Clinical practice guidelines focused on prescribing can improve clinician knowledge, change prescribing practices and ultimately benefit patient health.” <Read More>

    Drugmakers Testify on Pricing Strategy, PBM Contracting in Congress – October 2, 2020 – Democrats on the House Oversight Committee pressed executives from Amgen, Novartis and Mallinckrodt to explain price hikes on their drugs in a series of hearings Oct. 1 following the committee’s 18-month investigation into the drug industry’s pricing practices, STAT reported. The Oct. 1 hearings largely focused on pharmacy benefit managers after the House panel’s investigation found both Novartis and Teva Pharmaceuticals contracted with insurers and their affiliated PBMs to block cheaper generic drugs from competing in the market. Teva testified Sept. 30, along with Celgene and Bristol Myers Squibb. Internal documents from Novartis showed that executives openly discussed certain PBM and insurance plans’ willingness to help organize a strategy to block generics from entering the market, STAT reported. The executives also allegedly discussed how to work around states that had passed laws banning this practice. <Read More>

    A Windfall in Savings From Biosimilars – October 2, 2020 – Transitioning patients taking infliximab to a biosimilar product and improving adherence to imatinib are among the strategies specialty pharmacists at Boston Medical Center Health System (BMC) used to help the system better use health care resources, according to a session at the 2020 NASP Annual Meeting & Expo Virtual Experience. The shift from originator infliximab to an infliximab biosimilar is forecasted to yield approximately $500,000 in annual savings, without compromising clinical outcomes, reported Alexander Pham, PharmD, BMC’s director of pharmacy strategy and business development. <Read More>

    Flip the Pharmacy – October 1, 2020 – For many years, grantors, grantees, like-minded schools of pharmacy, and other supporters have focused resources to innovate in community-based pharmacy practice. A famous example is the Asheville Project, launched in 1997 in North Carolina, which provided education and personal oversight for city employees with chronic health problems, such as asthma, diabetes, high cholesterol, and hypertension. The project demonstrated better adherence and clinical measures, increased worker productivity, and lowered overall cost of care…Enter Flip the Pharmacy (FtP), a new pharmacy-practice transformation effort focused on identifying and adopting best practices for workflows that enable enhanced delivery of community pharmacy health care services. The program is founded and funded by the CPF. An FtP team comprises a team lead and coaches who are assigned to participating pharmacies. FtP team members meet regularly with the pharmacy’s staff throughout the process, following a set of materials and aides, guided by the FtP transformation leads, Cody Clifton, PharmD, and Randy McDonough, PharmD, MS. <Read More> 

    Clinical Practice Guidelines on Pharmacologic Glycemic Treatment in Type 2 Diabetes (ADA, 2020) – September 30, 2020 – In September 2020, the American Diabetes Association (ADA) published clinical practice guidelines on pharmacologic glycemic treatment in patients with type 2 diabetes mellitus, as an update to the ADA’s Standards of Medical Care in Diabetes. It is preferred that metformin be employed as the initial pharmacologic agent for type 2 diabetes treatment. To lengthen the time to treatment failure, consideration in some patients can be given to early combination therapy at initiation of treatment. <Read More>

    ESMO Updates Guidelines on Cancer Adrenal Gland – September 30, 2020 – European Society for Medical Oncology (ESMO) has released its updated Clinical Practice Guidelines on cancer adrenal gland. Two different primary malignancies can arise from the adrenal gland: adrenocortical carcinoma (ACC) from the adrenal cortex and malignant phaeochromocytoma from the adrenal medulla. Both malignancies are rare. The new guidelines providing recommendations on the management of adrenal cancer, including levels of evidence and grades of recommendation and have been published in Annals of Oncology. <Read More>

    Most Erectile Dysfunction is Treatable – September 30, 2020 – Erectile dysfunction (ED), the inability to develop or keep an erection, is men’s most common sexual problem, and it affects about 30 million Americans. ED often occurs when blood flow to the penis is limited or nerves are damaged, often by consistent hyperglycemia in diabetes. ED can signal serious illness, such as atherosclerosis, diabetes, heart disease, and hypertension. Other risk factors include alcohol or tobacco use, an enlarged prostate, psychological factors, sleep disorders, and stress. Other sexual problems are often mistaken for ED, which is not a decreased interest in sex, occasional trouble having an erection, or structural problems that affect ejaculation. Age alone does not cause ED, but the condition is most common in middle-aged and older men. <Read More> 

    Reasons for Primary Medication Nonadherence in Oncology Specialty Pharmacy – September 30, 2020 – The algorithm by which primary medication nonadherence is traditionally defined overestimates the true rate of primary medication nonadherence, according to a study presented at the virtual 2020 National Association for Specialty Pharmacy (NASP) Annual Meeting & Expo. “Primary medication nonadherence is the rate at which a prescription is written, but not obtained by a patient within a specified time period,” explained Autumn Zuckerman, MD, PharmD, BCPS, AAHIVP, CSP, Vanderbilt Specialty Pharmacy, Nashville, Tennessee, during her presentation. <Read More>

    Pharmacy Groups Blast US Importation of Drugs From Canada – September 29, 2020 – APhA is warning about potential fallout from a new FDA rule, published September 25, that sanctions the import of prescription medicines from Canada. The Trump administration asserts that Americans will save money on their medications, but APhA fears the rule will compromise patient safety. Relying on outside sourcing will create weakness in the supply chain that could make it easier for counterfeit or unsafe drugs to slip through the cracks, the group argues. It cites limited patient access to drugs, insurance issues, and problems with pharmacy reimbursement as additional concerns. <Read More>

    340B in the News

    Assessing the Administration’s Proposal for Reducing Insulin and Epinephrine Costs – October 2, 2020 – Millions of Americans depend on insulin and epinephrine, and yet both of these medicines are unaffordable for many. In order to improve affordable access to these medications, the Trump Administration recently proposed requiring certain health centers to make these medicines available to specific individuals at the heavily discounted price offered under the 340B Drug Pricing Program—a program that allows health clinics to generate savings. While the proposal may offer significant savings to those who do benefit, the scope is limited, and any reduction in revenue to the health centers that may result from this policy change will reduce clinics’ ability to pass those savings on to other patients. <Read More>

    A Year of Living Dangerously: 2020 and Maneuvers on the 340B Drug Pricing Program Battlefield – September 30, 2020 – In a December 12, 2017 Advisory Board article, “The 340B drug pricing controversy, explained,” Scott Orwig wrote, “the 340B Drug Pricing Program is one of the most contentious issues in health care: Its critics say it ‘hurts patients’ and is being ‘abused’ by hospitals. Its defenders say it’s ‘vital’ to the health of low-income patients and essential to helping safety net hospitals care for their communities.” Mr. Orwig’s words from 2017 can easily be recycled today as an apt description of what’s currently going on in the world of the 340B Drug Pricing Program (“340B Program”).  Critics are still saying that 340B Program-participating hospitals and other providers (“Covered Entities”) are enriching themselves on discounts that were meant to bring expensive prescription drug therapy to the vulnerable populations routinely treated by the country’s safety-net hospitals.  In reply, 340B Program-participating hospitals are saying that pharmaceutical manufacturers are enriching themselves at the expense of safety-net hospitals and the populations they serve. <Read More>

    HRSA Issues Proposed Rule Requiring Community Health Center Grant Recipients to Provide Certain Drugs to Low-Income Patients at 340B Prices – September 29, 2020 – On September 24, 2020, the Health Resources and Services Administration (HRSA) released a proposed rule that, if finalized, would require 340B-participating recipients of federal grants under Section 330(e) of the Public Health Service Act (known as community health centers (CHCs)) to provide insulin and injectable epinephrine to low-income patients at 340B acquisition prices. HRSA will accept public comments on the proposed rule until October 28, 2020. <Read More>