Clinical Insights: January 31, 2019

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    New Drug Approval

    Tosymra™ (sumatriptan) – New Drug Approval – January 28, 2019 – Dr. Reddy’s Laboratories Ltd. and its subsidiary, Promius Pharma, LLC announced the approval of Tosymra™ (previously known as DFN-02) by the U.S. Food and Drug Administration (FDA). Tosymra™ is indicated for the acute treatment of a migraine with or without aura in adults. Tosymra™ is the latest product to join the Promius Pharma acute migraine treatment portfolio. Read More>

    Ontruzant® (trastuzumab-dttb) New Biosimilar Approval – January 21, 2019 – Samsung Bioepis Co., Ltd. announced that the U.S. Food and Drug Administration (FDA) has approved Ontruzant® (trastuzumab-dttb), a biosimilar referencing Herceptin® (trastuzumab), across all eligible indications, namely adjuvant treatment of HER2-overexpressing breast cancer, metastatic breast cancer and metastatic gastric cancer or gastroesophageal junction adenocarcinoma in patients who have not received prior treatment for metastatic disease. Read More>

    New Formulation Approval

    No New Updates

    New Indication Approval

    Imbruvica® (ibrutinib) – New Expanded Indication – January 28, 2019 – The Janssen Pharmaceutical Companies of Johnson & Johnson announced the U.S. Food and Drug Administration (FDA) approval of Imbruvica® (ibrutinib) in combination with obinutuzumab in treatment-naïve patients with chronic lymphocytic leukemia/small lymphocytic lymphoma (CLL/SLL), the most common form of leukemia in adults. This is the first approval for a non-chemotherapy combination regimen for treatment-naïve patients with CLL/SLL, and marks the tenth FDA approval for Imbruvica® since its U.S. launch in November 2013. Read More>

    Cabometyx™ (cabozantinib) – January 14, 2019 – The Food and Drug Administration approved cabozantinib (CABOMETYX, Exelixis, Inc.) for patients with hepatocellular carcinoma (HCC) who have been previously treated with sorafenib. Read More>

    Sprycel® (dasatinib) – January 2, 2019 – Bristol-Myers Squibb Company announced the U.S. Food and Drug Administration (FDA) has expanded the indication for Sprycel® (dasatinib) tablets to include the treatment of pediatric patients one year of age and older with newly diagnosed Philadelphia chromosome-positive (Ph+) acute lymphoblastic leukemia (ALL) in combination with chemotherapy. Sprycel is the only second-generation tyrosine kinase inhibitor approved for this patient population. Read More>

    Ravicti® (glycerol phenylbutyrate) – December 27, 2018 – Horizon Pharma plc announced the U.S. Food and Drug Administration (FDA) has approved a supplemental new drug application (sNDA) to expand the age range for Ravicti® (glycerol phenylbutyrate) Oral Liquid to include infants younger than two months of age living with a urea cycle disorder (UCD). Read More>

    New Drug Shortage

    January 29, 2019

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    January 25, 2019

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    January 11, 2019

    January 08, 2019

    New Drug Recall and Safety Alerts

    Losartan and Losartan and Hydrochlorothiazide – New Drug Recall Alert – January 22, 2019 – Torrent Pharmaceuticals Limited is expanding its voluntary recall from 10 lots of Losartan potassium tablets USP to include six lots of Losartan potassium and hydrochlorothiazide 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. Read More>

    Irbesartan and Irbesartan and Hydrochlorothiazide – New Drug Recall Alert – January 18, 2019 – Prinston Pharmaceutical Inc., dba Solco Healthcare LLC., has initiated a voluntary recall of one (1) lot of Irbesartan and seven (7) lots of Irbesartan HCTZ Tablets to the consumer level due to the detection of trace amount of an unexpected impurity found in an active pharmaceutical ingredient (API) manufactured by Zhejiang Huahai Pharmaceuticals. Read More>

    Vecuronium Bromide for Injection – New Drug Recall Alert – January 8, 2019 – Sun Pharmaceutical Industries, Inc. (SPII), a wholly owned subsidiary of Sun Pharmaceutical Industries, Ltd. is voluntarily recalling three lots of Vecuronium Bromide for Injection, 10 mg (lyophilized powder), and one lot of Vecuronium Bromide for Injection, 20 mg (lyophilized powder) to the hospital level. The Vecuronium Bromide for Injection has been found to contain particulate matter identified as glass. Read More>

    Ceftriaxone for Injection – New Drug Recall Alert – January 5, 2019 – Lupin Pharmaceuticals, Inc. is voluntarily recalling five lots of Ceftriaxone for Injection, USP, 250mg, 10 lots of Ceftriaxone for Injection, USP, 500mg, 24 lots of Ceftriaxone for Injection, USP, one gram and three lots of Ceftriaxone for Injection, USP two grams, to the hospital/physician level. The products have been found to contain visual grey particulate matter in reconstituted vials. Read More>

    Losartan – New Drug Recall Alert – January 3, 2019 – Torrent Pharmaceuticals Limited is expanding its voluntary recall from two lots of Losartan potassium tablets USP to a total of 10 lots, 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. Torrent is only recalling lots of losartan-containing products that contain N-nitrosodiethylamine (NDEA) above the acceptable daily intake levels released by the FDA. Read More>

    Amlodipine and Valsartan, Valsartan and HCTZ and Valsartan – New Drug Recall Alert – December 31, 2018 – Aurobindo Pharma USA, Inc. is conducting a voluntary recall of 80 lots of Amlodipine Valsartan Tablets USP, Valsartan HCTZ Tablets, USP and Valsartan Tablets USP to the consumer level due to the detection of trace amounts of an unexpected impurity found in the finished drug product. Read More>

    New Generic Approval and Launch

    Fluticasone and Salmeterol Inhalation (Advair Diskus®) – New Generic Drug Approval – January 30, 2019 – The U.S. Food and Drug Administration approved the first generic of Advair Diskus (fluticasone propionate and salmeterol inhalation powder) for the twice-daily treatment of asthma in patients aged four years and older and maintenance treatment of airflow obstruction and reducing exacerbations in patients with chronic obstructive pulmonary disease (COPD). Mylan obtained approval to market its generic inhaler in three strengths: fluticasone propionate 100 mcg/ salmeterol 50 mcg, fluticasone propionate 250 mcg/ salmeterol 50 mcg and fluticasone propionate 500 mcg/ salmeterol 50 mcg. Read More>

    Vigabatrin (Sabril® ) – New Generic Drug Approval – January 16, 2019 – The U.S. Food and Drug Administration approved the first generic version of Sabril (vigabatrin) 500 mg tablets for treating complex partial seizures, also called focal seizures, as an adjunctive therapy (given with another primary treatment) in patients 10 years and older who have responded inadequately to several alternative (refractory) treatments. Read More>

    Albuterol sulfate (Ventolin® HFA) New Authorized Generic – January 15, 2019 – GSK announced the availability of an authorized generic (AG) of Ventolin HFA (albuterol sulfate) inhalation aerosol. The AG will be manufactured by GSK and distributed by Prasco LLC. Read More>

    Sofosbuvir/Velpatasvir (Epclusa® and Ledipasvir/Sofosbuvir (Harvoni® ) – New Authorized Generic – January 1, 2019  Asegua Therapeutics LLC, a subsidiary of Gilead Sciences, Inc., has launched an authorized generic of Epclusa® (sofosbuvir/velpatasvir) and an authorized generic of Harvoni® (ledipasvir/sofosbuvir). Read More>

    Clinical and Pharmacy News

    How Pharmacists Can Help Ensure That Patients Take Their Medicines – January 31, 2019 What if there was a way to significantly improve health outcomes, reduce hospital and nursing home admissions, and save $105 billion in health spending? There is one such compelling opportunity: a greater systemic focus on medication adherence. When healthcare professionals use the term “medication adherence,” what we’re really referencing is whether or not patients take their medicines as prescribed. Shockingly, about half the time, they don’t. And the consequences of non-adherence are great. Read More>

    The Art of Evidence-Based Medicine – January 30, 2019 Evidence-based medicine now routinely defines the standard of care for many conditions. This approach mandates that new information gleaned from randomized controlled trials and consolidated into clinical practice guidelines, can and must be used to improve the quality of care that patients receive. Read More>

    National Association of Specialty Pharmacy (NASP) Calls for DIR Reform in Response to CMS Medicare Part D Rule – January 29, 2019 – The National Association of Specialty Pharmacy (NASP) submitted extensive comments to the Centers for Medicare and Medicaid Services (CMS) supporting Medicare Part D reforms that will lower out-of-pocket costs for beneficiaries, improve the transparency of fees, and improve the competitive market balance under the Medicare Part D program. Read More>

    More Research Finds Low Awareness of Biosimilars Among Oncology Providers – January 29, 2019 – The need for improved biosimilar education among providers has been demonstrated, and with even more anticancer biosimilars gaining FDA approval, oncologists’ education on these products is a growing area of concern. A newly published study sought to investigate oncology providers’ understanding of biosimilars and the information and data that they feel are important to assess before prescribing these products. The researchers found that understanding of biosimilars remains low among oncologists, pharmacists, and advanced practice providers. Read More>

    Rising Insulin Costs Addressed at Senate Hearing on Drug Prices – January 29, 2019 – In a congressional hearing held on Capitol Hill, the damaging impact of rising insulin prices was the centerpiece of a larger discussion on rising drug costs in the United States. The Senate Finance Committee hearing, held by Chairman Senator Charles Grassley, R-Iowa, was the first of a series of hearings that will focus on drug pricing. Read More>

    AHA Updates Guidelines for Anticoagulants in AFib – January 28, 2019 – Non-vitamin K oral anticoagulants (NOACs) are now the preferred alternative to warfarin for reducing the risk for stroke in atrial fibrillation (AFib), according to updated guidelines from the American Heart Association, American College of Cardiology, and Heart Rhythm Society. Read More>

    Antibiotics Linked To Increased Hospital Stay for Exacerbated Asthmatics – January 28, 2019 – More evidence indicates that antibiotic therapy may actually be counterintuitive to the care of hospitalized asthmatics suffering from exacerbations. In a new study from investigators at the Institute for Healthcare Delivery and Population Science, University of Massachusetts Medical School, antibiotic treatment was found to have an association with greater lengths of hospital stay—and therefore costs—in patients hospitalized for an asthma exacerbation previously treated with systemic corticosteroids. Read More>

    Judge Okays $52M Sale of Shopko Pharmacy Assets To Chains Led By Walgreens – January 28, 2019 – A U.S. Bankruptcy Court Judge Monday approved the sale of bankrupt retailer Shopko’s prescription files and related pharmacy assets to more than 20 drugstore and grocery chains led by Walgreens Boots Alliance, CVS Health and Albertsons. Shopko is exiting the pharmacy business as part of a financial restructuring announced earlier this month by the bankrupt Green Bay, Wis.-based retailer. Read More>

    Why Your Health System Needs a Chief Pharmacy Officer – January 28, 2019 – Chief pharmacy officers play a leadership role in key areas for health systems such as standardization, says the new CPO at West Virginia University Health System.Pharmacy is a critical component of an integrated health system, with significant financial and clinical considerations. Financially, medication costs are rising, and precision medicine is likely to extend that burden. Read More>

    Pharmacists Face Challenges When Dispensing Medications To Elderly Patients – January 26, 2019 – Brown bag consults can be essential educational and safety tools to measure and ensure quality care. By asking patients to bring in all their current medications, including OTC, mail-order, specialty, and herbal products, pharmacists can guarantee appropriate and up-to-date care. Read More>

    NACDS Weighs in on DIR Fee Reform in Comments to CMS – January 25, 2019 – The National Association of Chain Drug Stores has formally weighed in on what needs to change about direct and indirect remuneration, or DIR, fees. The organization on Friday said it submitted comments based on insight from its members to the Centers for Medicare and Medicaid services in response to the agency’s proposed reform to the fees as part of an effort to reduce out-of-pocket costs for patients. Read More>

    Pursuing Specialty Pharmacy Accreditation – January 25, 2019 – In 2017, specialty medications accounted for 46.5 percent ($210 billion) of the total $453 billion drug spend in the United States. To put this in perspective, a total of 5.8 billion prescriptions were dispensed in 2017, but only 1.9 percent (110 million) of those were attributed to specialty medications. Although patients are utilizing savings programs for 42 percent of their specialty medications, employers and payers are extremely interested in containing costs and ensuring high-quality results for services. Read More>

    Pharmacy-Benefit Managers Charge Hefty Markups on Generic Drugs: Pharmacists’ Report – January 25, 2019  Pharmacy-benefit managers are taking increasingly large markups on generic drugs in New York, according to an analysis of Medicaid prescriptions at independent pharmacies in the state. In Medicaid, private insurers are paid by the state to cover low-income citizens. The insurers in turn usually contract with pharmacy-benefit managers, or PBMs, paying them to provide drug coverage. Read More>

    Why Biosimilars Can Never Be Identical To Originators–and Why They Don’t Need to Be – January 25, 2019  The acceptance of biosimilars has always been clouded by two words: “highly” and “similar.” The FDA’s approval criteria require a biosimilar to be highly similar to its original biologic and show “no clinically meaningful differences.” But mere similarity is not close enough for many clinicians and some patients; it makes biosimilars seem riskier than the original biologics. Patients and clinicians would be much more comfortable if biosimilars were described as “identical” in the way that the active ingredients of generic small-molecule drugs are identical to their branded counterparts. Read More>

    Cholesterol Guideline Updated With Newer Medications, More Personalized Risk Calculation – January 24, 2019  New recommendations from the American Heart Association, American College of Cardiology, American Diabetes Association and nine other societies advise a stepped approach to cholesterol management, including use of statins, ezetimibe and PCSK9 inhibitors for patients with prior cardiovascular disease at very high risk for another event. Read More>

    Major Health Systems Create New Company to Tackle Drug Shortages – January 24, 2019  Drug shortages are preventing hospitals from providing even the most basic care to patients. In a recent study by the National Opinion Research Center (NORC) at the University of Chicago, approximately 80 percent of hospitals found it challenging to obtain common drugs, like opioid injectables for pain management, saline for intravenous therapy, rehydrating patients, and wound cleaning and irrigation, and sodium bicarbonate, which is used as an alkalinizing agent for oral or parenteral therapy. Read More>

    Walgreens-Microsoft Alliance Puts More Pressure on Hospitals – January 24, 2019  News that Walgreens Boots Alliance has formed a strategic partnership with Microsoft is more bad news for hospitals that a drugstore chain with more than 9,500 U.S. locations is looking for even more ways to keep the patient inside the drugstore.Certainly, hospitals and health systems have their own information systems and partners like Cerner and Epic helping them with interoperability and communicating with other providers to make sure the care is being given in the right place, in the right amount, and at the right time. Read More>

    Combining Technology, Perceptions to Detect Prescription Nonadherence – January 23, 2019  If pharmacists and other healthcare providers could better identify patients likely to be nonadherent to their prescription medications, they might be more effective in combating the problem. That’s the assumption behind a study published online by Pediatric Nephrology. It looked at the predictive value of combining technology with the perceptions of healthcare providers. Read More>

    Existing Drugs, Not Just New, Play Large Role in Price Increases – January 23, 2019  The high costs of research, development, and marketing is often blamed for exorbitant drug prices. A new study questions that explanation, however. The report in Health Affairs points out that bringing new drugs to market plays a role in driving up costs but that the price of older drugs is also being steadily increased. Read More>

    Guidelines Developed for Managing Severe Atopic Dermatitis – January 22, 2019  Guidelines have been developed for the management of severe atopic dermatitis (AD); the recommendations have been published as a clinical management review in the January issue of The Journal of Allergy and Clinical Immunology: In Practice. Read More>

    World’s First Smart Inhaler is Arriving – January 22, 2019  The world’s first smart inhaler was recently approved by the FDA. Teva’s ProAir Digihaler (albuterol sulfate) is being introduced to the United States market through a sNDA application, and it will join Proteus Digital Health as being a potential game changer for digital medicines. The ProAir Digihaler is built on the RespiClick inhaler formulation. It has a sensor that tracks when it is used in real-time and syncs this data to a mobile app. Read More>

    MedPAC Recommends Congress Target Rebate Traps, Biosimilars to Bring Down Drug Prices – January 18, 2019  Congress should focus its efforts to reduce drug costs around making changes to Medicare Parts B and D, reducing reinsurance rates and improving biosimilar availability, the Medicare Payment Advisory Commission (MedPAC) said during its meeting on Friday. Read More>

    Drug Company Payments To Doctors May Influence Opioid Overdose Deaths, Study Finds – January 18, 2019  It’s long been known that drug company payments to doctors influence how many opioid prescriptions they write. But a study released Friday offers the first suggestion they also may be linked to overdose tolls in their communities. Aggressive marketing of prescription narcotics over the past 20 years has been widely blamed for the staggering death toll of the opioid epidemic. Read More>

    Medicare Part B Drug Plan Could Raise Out-of-Pocket Patient Costs – January 17, 2019  An HHS proposal to shift some Medicare Part B drugs to Medicare Part D may decrease overall drug spending, but it could increase out-of-pocket patient costs, data suggests. The HHS proposal would shift Part B drugs to Part D prescription drug plans. The proposal, announced in May 2018 as a part of the Trump Administration’s drug pricing blueprint, would create drug price negotiation flexibilities for healthcare payers, ideally lowering the overall cost of medications. In turn, cost savings should be passed onto patients, HHS reasoned. Read More>

    Mail Order Pharmacies Can Lessen Generic Usage, Study Finds – January 17, 2019  Although nearly 90 percent of all drugs dispensed in the U.S. are now generic drugs, a new study published in Therapeutic Innovation & Regulatory Science explores the determinants of generic substitution across therapeutic classes and found that in five of eight studied classes, patients using a mail order pharmacy had significantly less generic substitution than patients filling at retail pharmacies. Read More>

    Hospital Prescription Drug Spending Increased 18.5% Per Admission – January 16, 2019  Average total hospital prescription drug spending per admission rose by 18.5 percent between the 2015 and 2018 fiscal years, according to a new study conducted by NORC at the University of Chicago. Hospitals spent an average of $555.40 per adjusted admission during the three-year period, which resulted in $1.8 million in new prescription drug spending for the average hospital. Read More>

    Rising Drug Prices Said to Strain Hospitals, Force Budget Cuts – January 15, 2019  Rising costs of prescription drugs have strained hospital budgets and operations, forcing health systems to cut costs by reducing staff, a new study found. Hospital drug spending increased by 18.5 percent between 2015 and 2017, a rate far exceeding medical inflation for the period, according to a report prepared for three health associations by the research group NORC at the University of Chicago. Read More>

    No-Haggle Policy On Drug Pricing Cost Medicare At Least $14.4B, Study Finds – January 15, 2019  Medicare Part D could have saved $14.4 billion on the top 50 medications covered in 2016 if the program had been able to pay the same prices as the Department of Veterans Affairs, which often negotiates discounts, according to new analysis published in JAMA Internal Medicine cited by STAT. Read More>

    Fragile Pharmaceutical Supply Chain Increases Costs, Compromises Care – January 15, 2019  The increasing frequency of drug shortages has injected some complexity into how Ochsner Health Systems manages supply scarcities. It has pharmacy experts across the system that are constantly calling wholesalers and suppliers to get a hint of what drug may soon be in short supply. Ochsner has a phone call twice a week with its pharmacy, supply chain, chief nursing and chief operating officers to identify the next problem, said Dr. Robert Hart, executive vice president and chief medical officer for Ochsner Health System. Read More>

    Infusion Pump Errors: an Unseen Peril at the Bedside – January 14, 2019 – There’s a healthcare crisis plaguing today’s hospitals and patients, yet few seem willing to address it. Hiding in plain sight at the bedside of nearly 90 percent of patients within hospitals are IV pumps, and these critical devices are responsible for numerous medication errors reported to the FDA each year. Some of these errors have been deadly, and many could have been prevented. Read More>

    340B in the News

    California’s Drug-Pricing Plan Could Pare Down 340B Program – January 23, 2019 – The controversial 340B drug discount program could be looking at a serious trim in California, home to the biggest Medicaid population in the country. Health clinics and hospitals are monitoring a potentially huge money shift away from hospitals in the program in the wake of Democratic Gov. Gavin Newsom’s sweeping executive order on drug pricing. Read More>

    340B Hospitals Breathing Easier Under Dem-Controlled House – January 12, 2019 – A year after the 340B drug discount program faced the prospect of major changes designed to curb what Republicans argued was a program that had grown way too large given its purpose, hospitals receiving the pharmacy benefit now face an easier path with Democrats controlling the House. Read More>

    Ruling on 340B Drug Price Cuts a Credit Positive for Nonprofit Hospitals, Says Moody’s – January 7, 2019 – A federal judge’s ruling that blocked a Trump administration reduction in payments to hospitals under the 340B drug discount program is a credit positive for nonprofit hospitals, according to Moody’s Investors Service. In December, Judge Rudolph Contreras, a district judge in Washington, D.C, blocked cutting the drug payments, ruling that the federal government overstepped its authority to address high prescription medication costs. Read More>

    340B Hospitals Saw Greater Per-Patient Drug Spend Than Counterparts, Study Finds – January 4, 2019 – Hospitals that recently enrolled in the 340B drug pricing program saw greater increases in per-patient drug spend compared to non-340B hospitals, according to a Berkeley Research Group study funded by the Pharmaceutical Research and Manufacturers of America, a drug lobby. Using Medicare fee-for-service hospital outpatient claims and U.S. Health Resources and Services Administration Office of Pharmacy Affairs data, researchers examined 379 disproportionate share hospitals enrolling in the 340B program between January 2009 and January 2016. Read More>

    HHS Overstepped Authority with 340B Reimbursement Cuts, Judge Rules – January 2, 2019 – A federal judge in Washington DC recently struck down a nearly 30 percent reduction in 340B reimbursement cuts. U.S. District Judge Rudolph Contreras ruled that HHS Secretary Alex Azar exceeded his statutory authority by issuing a policy that would alter the hospital reimbursement formula for certain covered outpatient drugs paid under the 340B Drug Pricing Program. The policy from the final 2018 Hospital Outpatient Prospective Payment System (OPPS) rule changed the formula for certain covered outpatient drugs from the average sales price (ASP) of the drug plus six percent to the ASP minus 22.5 percent starting on Jan. 1, 2018. Read More>