Clinical Insights – December 27, 2018

    Welcome to the December 27, 2018 edition of RxStrategies Clinical Insights, designed to help pharmacy professionals stay up to date on the ever-changing pharmaceutical and pharmacy marketplace.

    New Drug Approval 

    Ultomiris™ (ravulizumab)– New Drug Approval – December 21, 2018 – The U.S. Food and Drug Administration approved Ultomiris™ (ravulizumab) injection for the treatment of adult patients with paroxysmal nocturnal hemoglobinuria (PNH), a rare and life-threatening blood disease. <Read More>

    Elzonris™ (tagraxofusp-erzs) – New Drug Approval – December 21, 2018 – The U.S. Food and Drug Administration approved Elzonris™ (tagraxofusp-erzs) infusion for the treatment of blastic plasmacytoid dendritic cell neoplasm (BPDCN) in adults and in pediatric patients, two years of age and older. <Read More> 

    Asparlas™ (calaspargase pegol-mknl) – New Drug Approval – December 20, 2018, the Food and Drug Administration approved calaspargase pegol-mknl (ASPARLAS, Servier Pharmaceuticals LLC), an asparagine specific enzyme, as a component of a multi-agent chemotherapeutic regimen for acute lymphoblastic leukemia (ALL) in pediatric and young adult patients age 1 month to 21 years. This new product provides for a longer interval between doses compared to other available pegaspargase products. <Read More>

    Motegrity™ (prucalopride)– New Drug Approval – December 17, 2018 – Shire plc announced that the U.S. Food and Drug Administration (FDA) has approved Motegrity™ (prucalopride), a once-daily, oral treatment option for adults with Chronic Idiopathic Constipation (CIC). Motegrity, a selective serotonin-4 (5-HT4) receptor agonist, provides a different class of treatment for CIC that works by enhancing colonic peristalsis to increase bowel motility. <Read More>

    Herzuma® (trastuzumab-pkrb) – New Biosimilar Approval – December 14, 2018 – The Food and Drug Administration approved Herzuma® (trastuzumab-pkrb, Celltrion Inc.) as a biosimilar to Herceptin® (trastuzumab, Genentech Inc.) for patients with HER2-overexpressing breast cancer. Herzuma® is a HER2/neu receptor antagonist indicated for the treatment of HER2-overexpressing breast cancer. <Read More>  

    Tolsura™ (itraconazole) – New Drug Approval – Mayne Pharma Group Limited announced that the US Food and Drug Administration (FDA) has approved the New Drug Application (NDA) for Tolsura™ (SUBA®-itraconazole) 65mg capsules. Tolsuraä is a new formulation of itraconazole indicated for the treatment of certain systemic fungal infections in adult patients. <Read More>

    Dextenza® (dexamethasone) – New Drug Approval – December 3, 2018 – Ocular Therapeutix™, Inc., a biopharmaceutical company focused on the formulation, development, and commercialization of innovative therapies for diseases and conditions of the eye, announced that the U.S. Food and Drug Administration (FDA) has approved Dextenza® (dexamethasone ophthalmic insert) 0.4mg for intracanalicular use for the treatment of ocular pain following ophthalmic surgery. <Read More>

    Xospata® (gilteritinib) – New Drug Approval – November 28, 2018 – The U.S. Food and Drug Administration approved Xospata® (gilteritinib) tablets for the treatment of adult patients who have relapsed or refractory acute myeloid leukemia (AML) with a FLT3 mutation as detected by an FDA-approved test. The FDA also approved an expanded indication for a companion diagnostic, to include use with Xospata®. <Read More> 

    Firdapse® (amifampridine phosphate) – New Drug Approval – November 28, 2018 – The U.S. Food and Drug Administration approved Firdapse® (amifampridine) tablets for the treatment of Lambert-Eaton myasthenic syndrome (LEMS) in adults. LEMS is a rare autoimmune disorder that affects the connection between nerves and muscles and causes weakness and other symptoms in affected patients. This is the first FDA approval of a treatment for LEMS. <Read More> 

    Truxima™ (rituximab-abbs) – New Biosimilar Approval – November 28, 2018 – The U.S. Food and Drug Administration approved Truxima™ (rituximab-abbs) as the first biosimilar to Rituxan (rituximab) for the treatment of adult patients with CD20-positive, B-cell non-Hodgkin’s lymphoma (NHL) to be used as a single agent or in combination with chemotherapy. Truximaä is the first biosimiliar to be approved in the U.S. for the treatment of non-Hodgkin’s lymphoma. <Read More>

    Vitrakvi® (larotrectinib) – New Drug Approval – November 26, 2018 – The Food and Drug Administration granted accelerated approval to larotrectinib (VITRAKVI, Loxo Oncology Inc. and Bayer) for adult and pediatric patients with solid tumors that have a neurotrophic receptor tyrosine kinase (NTRK) gene fusion without a known acquired resistance mutation, that are either metastatic or where surgical resection is likely to result in severe morbidity, and who have no satisfactory alternative treatments or whose cancer has progressed following treatment. This is the second tissue-agnostic FDA approval for the treatment of cancer. <Read More>

    Daurismo™ (glasdegib) – New Drug Approval – November 21, 2018 – The U.S. Food and Drug Administration approved Daurismo™ (glasdegib) tablets to be used in combination with low-dose cytarabine (LDAC), a type of chemotherapy, for the treatment of newly-diagnosed acute myeloid leukemia (AML) in adults who are 75 years of age or older or who have other chronic health conditions or diseases (comorbidities) that may preclude the use of intensive chemotherapy. <Read More>

    Gamifant® (emapalumab-lzsg) – New Drug Approval – November 20, 2018 – The Food and Drug Administration approved emapalumab (GAMIFANT, Novimmune SA), a monoclonal antibody that binds and neutralizes interferon gamma, for adult and pediatric (newborn and older) patients with primary hemophagocytic lymphohistiocytosis (HLH) with refractory, recurrent or progressive disease or intolerance with conventional HLH therapy. <Read More>

    Aemcolo™ (rifamycin) – New Drug Approval – November 16, 2018 – The U.S. Food and Drug Administration approved Aemcolo™ (rifamycin), an antibacterial drug indicated for the treatment of adult patients with travelers’ diarrhea caused by noninvasive strains of Escherichia coli (E. coli), not complicated by fever or blood in the stool. <Read More>

    Yupelri™ (revefenacin) – November 9, 2018 – Theravance Biopharma, Inc. and Mylan N.V. announced that the U.S. Food and Drug Administration (FDA) has approved the  New Drug Application (NDA) for Yupelri™ (revefenacin) inhalation solution for the maintenance treatment of patients with chronic obstructive pulmonary disease (COPD). Yupelriä, a long-acting muscarinic antagonist (LAMA), is the first and only once-daily, nebulized bronchodilator approved for the treatment of COPD in the US. <Read More>

    Primatene® MIST (epinephrine) November 7, 2018 – Amphastar Pharmaceuticals, Inc., announced that the U.S. Food and Drug Administration (FDA) granted approval of its New Drug Application (NDA) for Primatene® MIST (epinephrine inhalation aerosol bronchodilator suspension), which is delivered by a metered dose inhaler (MDI) with a non-chlorofluorocarbon (CFC) propellant. Primatene® MIST is the only FDA-approved asthma inhaler available without a prescription in the United States. Primatene® MIST is indicated for the temporary relief of mild symptoms of intermittent asthma in people ages 12 and above. <Read More>

    Bryhali™ (halobetasol propionate) – November 6, 2018 – Ortho Dermatologics, announced it expects to start distribution of Bryhali™ (halobetsasol propionate) Lotion, 0.01%, to U.S. wholesale pharmaceutical distributors later this month. The company received final approval from the U.S. Food and Drug Administration (FDA) for Bryhaliä Lotion on Nov. 6, 2018. Bryhaliä Lotion, which is indicated for the topical treatment of plaque psoriasis in adult patients, is a new potent to superpotent corticosteroid in a novel vehicle lotion with safety established for dosing up to eight weeks. <Read More>

    New Formulation Approval

    No New Updates

    New Indication Approval

    Lynparza® (olaparib) – New Indication Approval – December 19, 2018 – the Food and Drug Administration approved olaparib (LYNPARZA, AstraZeneca Pharmaceuticals LP) for the maintenance treatment of adult patients with deleterious or suspected deleterious germline or somatic BRCA-mutated (gBRCAm or sBRCAm) advanced epithelial ovarian, fallopian tube or primary peritoneal cancer who are in complete or partial response to first-line platinum-based chemotherapy. <Read More>

    Keytruda® (pembrolizumab) – New Indication Approval – December 19, 2018 – the Food and Drug Administration granted accelerated approval to pembrolizumab (KEYTRUDA, Merck & Co. Inc.) for adult and pediatric patients with recurrent locally advanced or metastatic Merkel cell carcinoma (MCC). <Read More>

    Nplate® (romiplostim) – New Expanded Indication Approval – December 14, 2018 – the Food and Drug Administration approved romiplostim (NPLATE, Amgen Inc.) for pediatric patients 1 year of age and older with immune thrombocytopenia (ITP) for at least 6 months who have had an insufficient response to corticosteroids, immunoglobulins, or splenectomy. <Read More>

    Oxtellar XR® (oxcarbazepine) – New Expanded Indication Approval – December 14, 2018 – Supernus Pharmaceuticals, Inc. announced that the United States Food and Drug Administration (FDA) has approved the Company’s supplemental new drug application (sNDA) for Oxtellar XR®. The application requested FDA approval to expand the indication for Oxtellar XR® beyond the current indication of adjunctive therapy in the treatment of partial-onset seizures in adults and in children 6 to 17 years of age. <Read More>

    Tecentriq® (atezolizumab) – New Indication Approval – December 6, 2018 – the Food and Drug Administration approved atezolizumab (TECENTRIQ, Genentech, Inc.), in combination with bevacizumab, paclitaxel, and carboplatin for the first-line treatment of patients with metastatic non-squamous, non-small cell lung cancer (NSq NSCLC) with no EGFR or ALK genomic tumor aberrations. <Read More> 

    Venetoclax® (Venclexta) – New Indication Approval – November 21, 2018 – the Food and Drug Administration granted accelerated approval to venetoclax (VENCLEXTA, AbbVie Inc. and Genentech Inc.) in combination with azacitidine or decitabine or low-dose cytarabine for the treatment of newly-diagnosed acute myeloid leukemia (AML) in adults who are age 75 years or older, or who have comorbidities that preclude use of intensive induction chemotherapy. <Read More>

    Adcetris® (brentuximab vedotin) – New Indication Approval – November 16, 2018, the Food and Drug Administration approved brentuximab vedotin (ADCETRIS, Seattle Genetics Inc.) in combination with chemotherapy for previously untreated systemic anaplastic large cell lymphoma (sALCL) or other CD30-expressing peripheral T-cell lymphomas (PTCL), including angioimmunoblastic T-cell lymphoma and PTCL not otherwise specified. This is the first FDA approval for previously untreated PTCL including sALCL. <Read More>

    Promacta® (eltrombopag) – New Expanded Indication Approval – November 16, 2018 – Novartis announced that the US Food and Drug Administration (FDA) has expanded the label for Promacta® (eltrombopag) to include first-line treatment for adults and pediatric patients two years and older with SAA in combination with standard immunosuppressive therapy (IST). <Read More>

    Oralair® (Mixed Pollens Allergen Extract) – New Expanded Indication Approval – December 14, 2018 – Stallergenes Greer, a biopharmaceutical company specializing in treatments for respiratory allergies, announced that it has received approval from the U.S. Food and Drug Administration (FDA) for the extension of the indication for Oralair® (Sweet Vernal, Orchard, Perennial Rye, Timothy, and Kentucky Blue Grass Mixed Pollens Allergen Extract), an allergy immunotherapy sublingual tablet, to treat patients ages five to nine with grass pollen-induced allergic rhinitis. Oralair® is the only allergy immunotherapy tablet that contains grass pollens from five of the most common grasses in the United States and received FDA approval in patients ages ten to 65 in 2014. <Read More>

    Keytruda® (pembrolizumab) – New Indication Approval – November 9, 2018 – the Food and Drug Administration granted accelerated approval to pembrolizumab (KEYTRUDA, Merck & Co., Inc.) for patients with hepatocellular carcinoma (HCC) who have been previously treated with sorafenib. <Read More>


    New Drug Shortage

    December 20, 2018

    December 19, 2018

    December 18, 2018

    December 17, 2018

    December 13, 2018

    New Drug Recall and Safety Alerts

    Fluoroquinolone Antibiotics – New Safety Alert – December 20, 2018 – FDA review found that fluoroquinolone antibiotics can increase the occurrence of rare but serious events of ruptures or tears in the main artery of the body, called the aorta.  These tears, called aortic dissections, or ruptures of an aortic aneurysm can lead to dangerous bleeding or even death.  They can occur with fluoroquinolones for systemic use given by mouth or through an injection. <Read More>

    Losartan (Torrent Pharmaceuticals) – New Drug Recall Alert – December 20, 2018 – Torrent Pharmaceuticals Limited is voluntarily recalling 2 lots of Losartan potassium tablets, USP to the consumer level due to the detection of trace amounts of an unexpected impurity found in an active pharmaceutical ingredient (API) manufactured by Hetero Labs Limited. The impurity detected in the API is N-nitrosodiethylamine (NDEA). <Read More>

    Dyural-40 and Dyural-80 – New Drug Recall Alert – December 17, 2018 – Torrance, CA, Asclemed USA Inc is voluntarily recalling 20 lots of Dyural-40 and 61 lots of Dyural-80, to the user level. The products include recalled Sodium Chloride, USP, 0.9% manufactured by Fresenius Kabi, which has been recalled due to product labeling incorrectly stating stoppers do not contain latex. <Read More>

    Promise Pharmacy Products – New Drug Safety Alert – December 7, 2018 – The U.S. Food and Drug Administration is alerting health care professionals and patients not to use drug products intended to be sterile that were produced in an inadequately designed processing room and distributed by Promise Pharmacy, Palm Harbor, Florida, due to lack of sterility assurance. <Read More>

    Infants’ Ibuprofen Concentrated Oral Suspension (Tris Pharma) – New Drug Recall Alert – December 5, 2018 – Tris Pharma, Inc. has voluntarily recalled three (3) lots of Infants’ Ibuprofen Concentrated Oral Suspension, USP (NSAID) 50 mg per 1.25 mL, to the retail level. The recalled lots of the product have been found to potentially have higher concentrations of ibuprofen. <Read More>

    Amlodipine and Valsartan and Valsartan and Hydrochlorothiazide – New Drug Recall Alert – December 4, 2018 – Mylan N.V. announced that its U.S. based Mylan Pharmaceuticals business is expanding its consumer-level voluntary nationwide recall to include all lots of Valsartan-containing products within expiry. <Read More>

    Idhifa® (enasidenib) -New Drug Safety Aert – November 29, 2018 – The U.S. Food and Drug Administration (FDA) is warning that signs and symptoms of a life-threatening side effect called differentiation syndrome are not being recognized in patients receiving the acute myeloid leukemia medicine Idhifa (enasidenib). The Idhifa prescribing information and patient Medication Guide already contain a warning about differentiation syndrome. <Read More>

    Lemtrada® (alemtuzumab) – New Drug Safety Alert – November 29, 2018 – The U.S. Food and Drug Administration (FDA) is warning that rare but serious cases of stroke and tears in the lining of arteries in the head and neck have occurred in patients with multiple sclerosis (MS) shortly after they received Lemtrada® (alemtuzumab). These problems can lead to permanent disability and even death. As a result, we have added a new warning about these risks to the prescribing information in the drug label and to the patient Medication Guide. <Read More>

    Amlodipine/Valsartan & Amlodipine/Valsartan/Hydrochlorothiazide – New Drug Recall Alert – November 27, 2018 – Teva Pharmaceuticals has initiated a voluntary recall in the United States, to the patient level, of all lots of Amlodipine / Valsartan combination tablets and Amlodipine / Valsartan / Hydrochlorothiazide combination tablets (see table below) due to an impurity detected above specification limits in an active pharmaceutical ingredient (API) manufactured by Mylan India. <Read More>

    Gilenya (fingolimod) – New Drug Safety Alert – November 20, 2018 – FDA is warning that when multiple sclerosis (MS) medicine Gilenya (fingolimod) is stopped, the disease can become much worse than before the medicine was started or while it was being taken. This MS worsening is rare but can result in permanent disability. <Read More>

    Valsartan, Amlodipine & Valsartan, Valsartan & Hydrochlorothiazide – New Drug Recall Alert – November 20, 2018 – Mylan N.V. announced that its U.S. based Mylan Pharmaceuticals business is conducting a voluntary nationwide recall to the consumer level of select lots of Valsartan-containing products, including six lots of Amlodipine and Valsartan Tablets. These products are being recalled due to detected trace amounts of an impurity, N-nitrosodiethylamine (NDEA) contained in the API Valsartan, USP, manufactured by Mylan Laboratories Limited. <Read More> 

    Sodium Chloride Injection, USP, 0.9% (Fresenius Kabi USA) – New Drug Recall Alert – November 20, 2018 – Fresenius Kabi USA is voluntarily recalling 164 lots of Sodium Chloride Injection, USP, 0.9%, 10 mL fill in a 10 mL vial and Sodium Chloride Injection, USP, 0.9%, 20 mL fill in a 20 mL vial to the user level. The product insert states that stoppers for both the 10mL and the 20mL vials do not contain natural rubber latex; the tray label for the two vial sizes and the vial label for the 20mL vial also state that the stoppers do not contain latex. <Read More>

    Sterile Drug Products From Pharm D Solutions – New Drug Recall Alert- November 19, 2018 – The U.S. Food and Drug Administration is alerting health care professionals and patients not to use drug products intended to be sterile that are produced and distributed by Pharm D Solutions LLC, Houston, Texas, due to lack of sterility assurance. Administration of a non-sterile drug product intended to be sterile may result in serious and potentially life-threatening infections or death. <Read More>  

    Losartan and Hydrochlorothiazide (Sandoz, Inc) – New Drug Recall Alert – November 8, 2018 – Sandoz Inc. is voluntarily recalling one lot of Losartan Potassium Hydrochlorothiazide Tablets, USP 100mg/25mg to the consumer level. This product is being recalled due to the trace amount of an impurity, N-nitrosodiethylamine (NDEA) contained in the API Losartan, USP manufactured by Zhejiang Huahai Pharmaceutical Co. Ltd. Sandoz Inc. <Read More>

    New Generic Approval and Launch

    Dalfampridine extended-release (Ampyra®) – New Generic Drug Launch – December 19, 2018 – Hikma Pharmaceuticals has launched dalfampridine extended-release tablets in a 10-mg dosage strength. The product, which is the generic of Acorda Therapeutics’ Ampyra®, is indicated to help improve walking in adult patients with multiple sclerosis as demonstrated by an increase in walking speed. <Read More> 

    Mesalamine (Canasa®) – New Generic Drug Launch – December 17, 2018 – Global pharmaceutical company Mylan N.V. announced the U.S. launch of Mesalamine Rectal Suppository, 1000 mg, the first generic version of Allergan’s Canasa® Rectal Suppository, 1000 mg. Mylan Pharmaceuticals received final approval from the U.S. Food and Drug Administration (FDA) for its Abbreviated New Drug Application (ANDA) for this product, which is for the treatment of mildly to moderately active ulcerative proctitis. <Read More> 

    Silodosin (Rapaflo®) – New Generic Drug Launch – December 4, 2018 – Pharma major Lupin announced the launch of Nystatin and Triamcinolone Acetonide Cream USP 100,000 units/gm; 0.1 %, having received approval from the United States Food and Drug Administration (FDA) earlier. <Read More>

    Ganirelix Acetate (Ganirelix Acetate®) – New First Time Generic – December 3, 2018 – Sun Pharmaceutical Industries has received final approval from US FDA for its Abbreviated New Drug Application (ANDA) for a generic version of Ganirelix Acetate Injection, 250 mcg/0.5 mL. The generic version is therapeutic equivalent to Organon’s Ganirelix Acetate Injection, 250 mcg/0.5 mL. <Read More>

    Vardenafil (Staxyn® Orally Disintegrating Tablets) – New First Time Generic – November 20, 2018 – Alembic Pharmaceuticals Limited announced that the company has received approval from the US Food & Drug·Administration (USFDA) for its Abbreviated New Drug Application (ANDA) Vardenafil Hydrochloride Orally Disintegrating Tablets, 10 mg (base). The approved ANDA is therapeutically equivalent to the reference listed drug product (RLD), Staxyn® Orally Disintegrating Tablets, 10 mg, of Bayer Healthcare Pharmaceuticals, Inc. Vardenafil Hydrochloride Orally Disintegrating Tablets are indicated for the treatment of erectile dysfunction. <Read More>


    Clinical and Pharmacy News

    Prescription Drug Prices Rise Again After Brief Pause – December 20, 2018 – Several dozen pharmaceutical companies are planning to raise their prices again in 2019 after temporarily holding off on increases as a result of federal pressure. Reuters reports that nearly thirty drug makers, including Novartis, Bayer, and GlaxoSmithKline have filed notifications with the state of California that prescription drug prices will increase. <Read More>

    What’s New in the U.S. HIV Clinical Guidelines – December 20, 2018 – HIV/AIDS medical practice guidelines are updated at various intervals to reflect the recommendations directed at clinical providers serving persons living with HIV. These federal guidelines, issued by the U.S. Department of Health and Human Services (HHS), are available on AIDSinfo. Each set of guidelines is vetted by committees of subject matter experts. <Read More>

    Providers, Insurers Call For Strong Enforcement Of Drug Price Transparency – December 19, 2018 – Providers and insurers want the CMS to put some real teeth—including financial penalties—into any plan requiring greater price transparency from drugmakers. In comments on a proposed rule to require drugmakers to list a drug’s wholesale price in TV ads, several provider and insurers groups told the agency that a stick is needed to ensure pharmaceutical companies follow through. <Read More>

    With the Future of the ACA in Question, Are US Biosimilars at Risk? – December 19, 2018 – Federal Judge Reed O’Connor, in the Federal District Court in Fort Worth, Texas, has ruled in Texas v Azar that the Affordable Care Act (ACA)’s individual coverage mandate is unconstitutional. According to his ruling, in the absence of the individual mandate, the rest of the ACA cannot stand. While many stakeholders are concerned most immediately about how the ruling could affect US patients’ healthcare options and coverage for pre-existing conditions, the biosimilars industry is also concerned about the future of one key feature of the ACA that keenly impacts the biosimilars landscape. <Read More>

    Hospitalwide Innovation Through Medication Management: 4 Ways Hospitals Are Accomplishing It – December 18, 2018  – Hospital performance can be a moving target for hospital administrators due to changing regulatory pressures, reimbursement challenges and the transition from inpatient to ambulatory care. <Read More>

    Hypertension Treatment Guidelines Update – December 14, 2018 – Health care providers often encounter patients with high blood pressure (BP), especially systolic, who come and go without proper treatment and eventually end up in the hospital with a heart attack, kidney failure, or a stroke. Below is a summary of the most recent national guidelines for evaluating these patients. <Read More>

    Study: Insulin Shortage Looming – December 14, 2018 – Newly published research recognizes that the amount of insulin needed worldwide to treat type 2 diabetes (T2DM) in the future is unknown, and that the impact of alternative treatment alogrithms on insulin use and adverse outcomes, given the limited access to insulin in numerous areas, is unclear. The research goal was to examine projected global insulin use under different treatment algorithms and varying access to insulin. <Read More>

    Reconciling Medication for Diabetic Patients – December 13, 2018 – New research published in Diabetes Care highlights the importance of conducting medication reconciliation, especially in patients diagnosed with diabetes. The researchers emphasized the importance of reconciling all medications; however, they found improvements even when just some of the medications were reconciled. <Read More>

    Assessing Telemedicine Impact on Medication Management – December 13, 2018 – A new study published in Annals of Internal Medicine reports findings by researchers who examined the potential association between the rate of antibiotic prescribing by physicians using telemedicine compared with not prescribing antibiotics for outpatients with respiratory tract infections. <Read More> 

    Virginia Naloxone Maker To Launch Generic Version, Drop List Price by $3,922 – December 12, 2018 – A month after Kaleo came under fire for raising the price of its opioid antidote 600 percent to $4,100, the Virginia drugmaker announced it will launch a generic version at a fraction of the cost, according to a STAT news report. <Read More>

    FDA Outlines New Plans for Biosimilars in 4 Guidance Documents and Proposed Rule – December 12, 2018 – On Tuesday, the FDA took significant steps toward a long-awaited transition of insulins and other products that have historically been regulated as drugs and follow-ons to regulation as biologics and biosimilars. <Read More>

    Specialty Spending Among Top 5 Health-System Pharmacy Trends to Watch – December 11, 2018 – Health-system pharmacies could see more opportunities for revenue recovery in 2019, as well as increased transparency and access to care for patients. At the 2018 American Society of Health-System Pharmacists (ASHP) Midyear Clinical Meeting in Anaheim, CA, a group of advisors from McKesson RxO shared 5 trends they believe will help shape the industry in 2019. <Read More>

    Investigation of Generic ‘Cartel’ Expands to 300 Drugs – December 9, 2018 – Executives at more than a dozen generic-drug companies had a form of shorthand to describe how they conducted business, insider lingo worked out over steak dinners, cocktail receptions and rounds of golf. The “sandbox,” according to investigators, was the market for generic prescription drugs, where everyone was expected to play nice. <Read More>

    Patent Abuse Is Driving Up Drug Prices. Just Look At Lantus – December 7, 2018 – A rare point of consensus following the midterm elections is that Americans are adamant about lowering drug prices. Bipartisan pledges to seek common ground on this vexing issue suggest we might finally see action to make medicines more affordable. <Read More>

    Consumers Still Prefer Independent Pharmacies, CR’s Ratings Show – December 7, 2018 – When it comes to filling prescriptions, consumers still prize the friendliness, courtesy, and expertise of the local drugstore. That’s according to Consumer Reports’ most recent ratings of walk-in pharmacies based on survey responses from more than 78,000 CR members. Independent pharmacies earned high scores on such measures as courtesy, helpfulness, and speed of checkout and filling prescriptions, as well as pharmacists’ knowledge and accuracy. <Read More>

    CMS Proposes Changes to Lower Drug Prices – December 7, 2018 – On November 30, 2018, the Centers for Medicare & Medicaid Services (CMS) published 83 Fed. Reg. 62152, which proposes changes to Medicare Part D (prescription drug benefit) and drug plans offered by Medicare Advantage (managed care) in an effort to reduce out-of-pocket costs for beneficiaries. <Read More>

    Partially Filled Vials and Syringes in Sharps Containers Are a Key Source of Drug Diversion – December 6, 2018 – A 36-year-old hospital care aide (nursing assistant) who had been diverting discarded drugs died after self-administering what she may have thought was an opioid but was actually a neuromuscular blocking agent. Kerry O’Keefe had found an unlabeled syringe containing a clear solution in a biohazard box, injected the solution, and suffered immediate paralysis, respiratory arrest, and then death. <Read More>

    3 Ways Your Hospital Can Contain Escalating Drug Prices And Shortages – December 5, 2018 – The one-two punch of exorbitant prices and sketchy access to inpatient drugs have left hospitals across the nation reeling. The shortages are often accompanied by dramatic price hikes. Sometimes the supply is readily available, but the price is prohibitively high, as is often the case when sole suppliers leverage their monopolies. <Read More>

    Pharmacists and Burnout: The First Step Is to Acknowledge the Data about Providers – December 5, 2018 – We know that burnout continues to plague health care professionals. A study recently published in the Journal of the American Medical Association described physician burnout as an epidemic that affects health care delivery and patient safety. <Read More>

    Could retroactive DIR fees become a thing of the past? – December 4, 2018 – APhA and other pharmacy groups hailed a CMS proposed rule that, if finalized, would pass drug price concessions directly to Medicare Advantage (MA) and Part D beneficiaries at the pharmacy counter. The proposed rule would account for pharmacy price concessions, also known as direct and indirect remuneration (DIR) fees, at the point of sale (POS). CMS projects this policy would reduce beneficiary out-of-pocket costs and improve price transparency and market competition under the Part D program. <Read More>

    Not-for-Profit Hospital Expenses Will Continue To Outpace Revenue in 2019 – December 3, 2018 – Moody’s Investors Service expects not-for-profit hospitals will continue on their course in 2019 with expenses continuing to outpace revenue, according to its new report. Moody’s maintained its negative outlook on the sector as weak volume trends, reimbursement compression, more Medicare patients and growing bad debt loads will limit revenue growth, analysts projected in its 2019 outlook released Monday. <Read More>

    Diabetic Patients Report Skimping on Tx Because of High Costs – December 3, 2018 – One in four patients at an urban diabetes center reported underuse of prescribed insulin because of insulin costs, researchers reported. In a survey of nearly 200 individuals with type 1 or type 2 diabetes prescribed insulin, over a quarter reported using less insulin than was prescribed by their provider, citing cost as the reason, according to Kasia Lipska, MD, MHS, of Yale School of Medicine in New Haven, Connecticut, and colleagues. <Read More>


    340B in the News

    340B Hospital Drug Spending Higher Than At Non-340B Facilities, Report Says – December 21, 2018 – Patients at 340B hospitals had an average total drug spending increase of 32.4% in the year following enrollment, according to a Berkeley Research Group study funded by the drugmaker lobby PhRMA. The control group in non-340B hospitals’ drug spend per patient increased by only 13.4% — about one-third less. <Read More>

    No More Waiting: 340B Drug Pricing Program Pharma Oversight and Enforcement Rule To Be Effective January 1, 2019 – December 18, 2018 – The U.S. Department of Health and Human Services (“HHS”) recently published a final rule on the 340B Drug Pricing Program (“340B Program”), moving the effective date for changes to the program up to January 1, 2019.  Making the rule effective next month is welcome news for eligible hospitals, clinics, and health centers that serve vulnerable populations (“Covered Entities”) because it establishes the methodologies for pharmaceutical manufacturers’ 340B ceiling prices as well as establishes civil monetary penalties (“CMPs”) for manufacturers that knowingly and intentionally charge Covered Entities more than the designated ceiling price. <Read More>

    HRSA to Enforce 340B Program Oversight of Drug Manufacturers Next Year and Share 340B Ceiling Prices with Covered Entities – December 13, 2018 – Two recent announcements by the Health Resources and Services Administration (HRSA) highlight the agency’s plans for increased oversight in the next year of drug manufacturers under the 340B drug pricing program and transparency into 340B ceiling prices for health care providers participating in the program, referred to as covered entities. <Read More>

    Ahead of Udenyca Launch, Coherus Signs 340B Contract Agreement With Apexus – December 9, 2018 – Coherus Biosciences, which recently gained its first biosimilar approval for Udenyca, a pegfilgrastim biosimilar referencing Neulasta, has announced that it has signed a 340B prime vendor program contract with Apexus LLC. <Read More>

    CEO Power Panel: Despite Expected Gridlock, Divided Government May Still Be Boon To Hospitals – December 8, 2018 – The Democrats’ 40-seat majority sweep of the U.S. House of Representatives brightened hospital prospects for looming money battles with the Trump administration, Congress and Big Pharma. But by a roughly 60%-to-40% margin, healthcare executives think the expected political gridlock will hinder needed progress in a way that hurts their organizations, according to Modern Healthcare’s most recent Power Panel, a survey of 75 healthcare CEOs. <Read More>

    HHS to Implement 340B Drug Price Ceiling, Penalties in Jan 2019 – December 03, 2018 – After several delays, HHS will implement drug price ceilings and civil monetary penalties for manufacturers under the 340B Drug Pricing Program in 2019, according to a final rule from the HHS agency, Health Resources and Services Administration (HRSA). <Read More>