Clinical Insights: December 12, 2017

    Welcome to the weekly edition of RxStrategies Clinical Insights, designed to help pharmacy professionals stay up to date on the ever-changing pharmaceutical and pharmacy market place.


    New Drug Approval

    Lonhala™ Magnair™ (glycopyrrolate) – December 5, 2017 – Sunovion Pharmaceuticals Inc. (Sunovion) announced that the U.S. Food and Drug Administration (FDA) approved the New Drug Application (NDA) for Lonhala™ Magnair™ (glycopyrrolate) Inhalation Solution (25 mcg twice daily), also known as SUN-101/eFlow®, for the long-term, maintenance treatment of airflow obstruction in people with chronic obstructive pulmonary disease (COPD), including chronic bronchitis and/or emphysema. Read more.

    Ozempic® (semaglutide) – December 5, 2017 – Novo Nordisk announced that the U.S. Food and Drug Administration (FDA) approved its New Drug Application (NDA) for Ozempic® (semaglutide) injection 0.5 mg or 1 mg, a once-weekly glucagon-like peptide (GLP-1) receptor agonist indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes.1 Ozempic® is administered once weekly, on the same day each week, and can be taken any time of the day, with or without meals. Read more. 

    Ogivri™ (trastuzumab-dkst) – December 1, 2017 – The U.S. Food and Drug Administration approved Ogivri™ (trastuzumab-dkst) as a biosimilar to Herceptin® (trastuzumab) for the treatment of patients with breast or metastatic stomach cancer (gastric or gastroesophageal junction adenocarcinoma) whose tumors overexpress the HER2 gene (HER2+). Ogivri™ is the first biosimilar approved in the U.S. for the treatment of breast cancer or stomach cancer and the second biosimilar approved in the U.S. for the treatment of cancer. Read more.

    Sublocade™ (buprenorphine) Sustained-Release – November 30, 2017 – The U.S. Food and Drug Administration approved Sublocade™, the first once-monthly injectable buprenorphine product for the treatment of moderate-to-severe opioid use disorder (OUD) in adult patients who have initiated treatment with a transmucosal (absorbed through mucus membrane) buprenorphine-containing product. Read more.

    Clenpiq™ (sodium picosulfate, magnesium oxide, and anhydrous citric acid) – November 28, 2017 – The U.S. Food and Drug Administration (FDA) has granted Ferring Pharmaceuticals Inc. approval to market Clenpiq™ (sodium picosulfate, magnesium oxide, and anhydrous citric acid) oral solution for cleansing of the colon in adults undergoing a colonoscopy. Read more.

    Impoyz™ (clobetasol propionate) – November 28, 2017 – Dr. Reddy’s Laboratories Ltd., through its wholly owned subsidiary Promius Pharma, LLC, announced its approval of Impoyz™ (clobetasol propionate) Cream, 0.025% is a high potency topical steroid approved for the treatment of moderate to severe plaque psoriasis in patients 18 years of age or older. Read more.

    Juluca® (dolutegravir and rilpivirine) – November 21, 2017 – The U.S. Food and Drug Administration approved Juluca®, the first complete treatment regimen containing only two drugs to treat certain adults with human immunodeficiency virus type 1 (HIV-1) instead of three or more drugs included in standard HIV treatment. Juluca® is a fixed-dose tablet containing two previously approved drugs (dolutegravir and rilpivirine) to treat adults with HIV-1 infections. Read more.

    Hemlibra® (emicizumab-kxwh) – New Drug Approval (Orphan) – November 16, 2017 – The U.S. Food and Drug Administration approved Hemlibra® (emicizumab-kxwh) to prevent or reduce the frequency of bleeding episodes in adult and pediatric patients with hemophilia A who have developed antibodies called Factor VIII (FVIII) inhibitors. Read more.

    Mepsevii® (vestronidase alfa) – New Drug Approval (Orphan) – November 15, 2017 – The U.S. Food and Drug Administration approved Mepsevii® (vestronidase alfa-vjbk) to treat pediatric and adult patients with an inherited metabolic condition called mucopolysaccharidosis type VII (MPS VII), also known as Sly syndrome. MPS VII is an extremely rare, progressive condition that affects most tissues and organs. Read more.

    Fasenra™ (benralizumab) – November 14, 2017 – AstraZeneca announced that the U.S. Food and Drug Administration (FDA) has approved Fasenra™ (benralizumab) for the add-on maintenance treatment of patients with severe asthma aged 12 years and older, and with an eosinophilic phenotype. Read more.

    Abilify MyCite® (aripiprazole) – November 13, 2017 – The U.S. Food and Drug Administration approved the first drug in the U.S. with a digital ingestion tracking system. Abilify MyCite® (aripiprazole tablets with sensor) has an ingestible sensor embedded in the pill that records that the medication was taken. The product is approved for the treatment of schizophrenia, acute treatment of manic and mixed episodes associated with bipolar I disorder and for use as an add-on treatment for depression in adults. Read more.


    New Formulation Approval

    Tekturna® (aliskiren) – New Formulation and Indication Approval – November 14, 2017 – Noden Pharma DAC, announced the approval by the U.S. Food and Drug Administration of Tekturna® (aliskiren) Oral Pellets for the treatment of hypertension in adults and children six years of age and older. Read more.


    New Indication Approval

    Avastin® (bevacizumab) – December 5, 2017 – Genentech, a member of the Roche Group announced that the U.S. Food and Drug Administration (FDA) has granted full approval for Avastin® (bevacizumab) for the treatment of adults with glioblastoma that progressed following prior therapy (referred to as recurrent disease). Avastin was previously granted provisional approval in this setting under the FDA’s accelerated approval program. Read more.

    Repatha® (evolocumab) – December 1, 2017 – Amgen announced that following priority review of its supplemental Biologics License Application, the U.S. Food and Drug Administration (FDA) approved Repatha® (evolocumab) as the first PCSK9 inhibitor to prevent heart attacks, strokes and coronary revascularizations in adults with established cardiovascular disease. Read more.

    Taltz® (ixekizumab) – December 1, 2017 – Eli Lilly and Company, announced that the U.S. Food and Drug Administration (FDA) has approved Taltz® (ixekizumab) injection 80 mg/mL for the treatment of adults with active psoriatic arthritis (PsA). Taltz was first approved by the FDA in March 2016 for the treatment of adult patients with moderate-to-severe plaque psoriasis who are candidates for systemic therapy or phototherapy. Read more.

    Isentress® (raltegravir) – November 29, 2017 – Merck announced that the U.S. Food and Drug Administration (FDA) has approved Isentress® (raltegravir), the company’s integrase inhibitor, for use in combination with other antiretroviral agents, for the treatment of HIV-1 in neonates – newborn patients from birth to four weeks of age – weighing at least 2 kg. Read more.

    AUVI-Q® (Epinephrine Injection) – New Expanded Indication Approval – November 20, 2017 – Kaléo, announced that the U.S. Food and Drug Administration (FDA) has approved its supplemental New Drug Application (sNDA) for AUVI-Q® (epinephrine injection, USP) 0.1 mg, the first and only epinephrine auto-injector (EAI) specifically designed for the treatment of life-threatening allergic reactions, including anaphylaxis, in infants and small children weighing 16.5 to 33 pounds (7.5 to 15 kilograms) who are at risk for or have a history of serious allergic reactions. Read more.

    Sutent® (sunitinib malate) – November 16, 2017 – The U.S. Food and Drug Administration approved Sutent® (sunitinib malate) for the adjuvant treatment of adult patients who are at a high risk of kidney cancer (renal cell carcinoma) returning after a kidney has been removed (nephrectomy). Read more.

    Gazyva® (obinutuzumab) – November 16, 2017 – Genentech, a member of the Roche Group, announced that the U.S. Food and Drug Administration (FDA) approved Gazyva® (obinutuzumab) in combination with chemotherapy, followed by Gazyva alone in those who responded, for people with previously untreated advanced follicular lymphoma (stage II bulky, III or IV). Read more.

    Faslodex® (fulvestrant) – November 15, 2017 – AstraZeneca announced that the U.S. Food and Drug Administration (FDA) has approved a new indication for Faslodex® (fulvestrant), expanding the indication to include use with abemaciclib, a CDK4/6 inhibitor, for the treatment of hormone receptor-positive (HR+), human epidermal growth factor receptor 2 negative (HER2-) advanced or metastatic breast cancer (MBC) in women with disease progression after endocrine therapy. Read more.

    Vraylar™ (cariprazine) – November 13, 2017 – Allergan plc, announced that the U.S. Food and Drug Administration (FDA) has approved the supplemental New Drug Application (sNDA) for Vraylar™ (cariprazine) for the maintenance treatment of adults with schizophrenia. Vraylar™ is also approved in the U.S. in adults for the acute treatment of schizophrenia and acute treatment of manic or mixed episodes of bipolar I disorder. Read more.


    New Drug Shortage

    December 11, 2017 

    December 1, 2017 

    November 30, 2017 

    November 28, 2017 

    November 21, 2017 


    New Drug Recall and Safety Alerts

    Pharmacist Choice Alcohol Prep Pads by Simple Diagnostics – New Recall Alert – December 5, 2017 – Simple Diagnostics voluntarily recalled three lots of Pharmacist Choice Alcohol Prep Pads (UPC # 898302001050, NDC # 98302-0001-05). Read more.

    Riomet (Metformin Hydrochloride Oral Solution) – New Drug Recall Alert – November 27, 2017 – Sun Pharmaceutical Industries is recalling two lots of Riomet (Metformin Hydrochloride Oral Solution), which were found to be contaminated with Scopulariopsis brevicaulis. Use of the affected Riomet potentially could result in a risk of infection, especially in the immunocompromised patient. Read more.

    Diphenoxylate Hydrochloride and Atropine Sulfate – New Drug Recall Alert – November 17, 2017 – Greenstone, a wholly owned subsidiary of Pfizer Inc., is voluntarily recalling multiple lots of diphenoxylate hydrochloride and atropine sulfate tablets, USP to the consumer level. Greenstone initiated this recall because product from these lots has the potential to be super potent or sub potent. Read more.

    Febuxostat (Brand Name Uloric) – New Drug Safety Alert – November 15, 2017 – FDA is alerting the public that preliminary results from a safety clinical trial show an increased risk of heart-related death with febuxostat (Uloric) compared to another gout medicine called allopurinol. Read more.

    Nexterone (amiodarone HCl) 150 mg/100 mL Premixed Injection – New Drug Recall Alert – November 15, 2017 – Baxter International announced it is voluntarily recalling one lot of Nexterone (amiodarone HCl) 150 mg/100 mL Premixed Injection – distributed between 8/23/2017 and 10/2/2017 in the United States to wholesalers/distributors and healthcare facilities – due to the potential presence of particulate matter. Read more.


    New First Time Generic

    Sildenafil (Viagra®) – New First Time Generic Launch – December 11, 2017 – Teva Pharmaceutical Industries Ltd., announced the exclusive launch of its generic Viagra®1 (sildenafil citrate) tablets in the U.S. Sildenafil tablets are a phosphodiesterase-5 (PDE5) inhibitor indicated for the treatment of erectile dysfunction (ED). Read more.


    Clinical and Pharmacy News

    Pharmacy Is Dead – December 11, 2017 – After months of speculation, CVS Health formally announced its decision to acquire Aetna on December 3. The deal will merge the largest pharmacy, the third largest PBM, and the third largest insurer. Perhaps most significantly, the deal represents a shift in pharmacy and in its value to health care. The deal is still subject to antitrust scrutiny, but many analysts believe the deal will go through without a hitch. Read more.

    The Other Big Drug Problem: Older People Taking Too Many Pills – December 9, 2017 – Consider it America’s other prescription drug epidemic. For decades, experts have warned that older Americans are taking too many unnecessary drugs, often prescribed by multiple doctors, for dubious or unknown reasons. Researchers estimate that 25 percent of people ages 65 to 69 take at least five prescription drugs to treat chronic conditions, a figure that jumps to nearly 46 percent for those between 70 and 79. Read more.

    FDA Issues Draft Guidance On Decision Support Software – December 8, 2017 – The Food and Drug Administration has issued draft guidance on clinical decision support software for health care providers to clarify what types of systems will no longer be defined as medical devices and therefore will not be regulated by the agency, based on provisions of the 21st Century Cures Act. Read more.

    Retail Drug Prices Increase More Than 50X Faster Than Inflation Rate – December 7, 2017 – Retail prices for 768 prescription drugs commonly used by older adults increased by an average of 6.4 percent in 2015, outpacing the general inflation rate of 0.1 percent. This is at least the 12th straight year of substantial retail price increases for prescription drugs, according to the latest in a series of AARP Public Policy Institute reports that began tracking drug prices in 2004. Read more. 

    How 2 Hospitals Use Remote Pharmacy Services To Execute Their Strategic Initiatives – December 7, 2017 – Hospital pharmacists are taking on a greater role in organizations’ strategic initiatives in recent years, with pharmacists leading medication reconciliation and patient discharge programs. However, deploying pharmacists to drive these clinical initiatives creates a shortage in the workforce needed to perform more routine tasks, such as medication order entry and review. Read more.

    Pharmacies Trafficking Opioids Targeted by DEA – December 7, 2017 – The Drug Enforcement Administration recently identified 26 pharmacies in California, Hawaii, and Nevada that may be illegally trafficking opioids. The investigation is part of the agency’s Operation Faux Pharmacy, which has resulted in the seizure of nearly 600,000 dosage units of scheduled drugs nationwide. Read more.

    Prescription Drug Spending Cuts Require Payer Policy Changes – December 6, 2017 – The U.S.’s current prescription drug policies require updates that cut prescription drug spending while increasing competition in the market, a new report from the National Academies of Sciences, Engineering, and Medicine (NASEM) found. Read more.

    Weight Management Program Can Put Type 2 Diabetes Into Remission – December 5, 2017 – Type 2 diabetes can be reversed following an intensive weight management program, according a randomized trial in adults who have had the condition for up to six years. Almost half of participants achieved and maintained diabetes remission at one year without antidiabetic medications. Read more.

    Real-time Interaction With Patient Data To Enable Robust Pharmacy-Patient Coherence – December 4, 2017 – Over 12.5 million people misused prescription opioids in 2015. Pharmacists have a great responsibility to track and manage the use of controlled substances and other drugs of interest not only for the betterment of the industry but for the good of humanity. Non-adherence also remains a huge burden of the healthcare system. Half of all patients with chronic diseases don’t take their medications as prescribed. Read more. 

    Medication Errors For Admitted Patients Drop When Pharmacy Staff Take Drug Histories in ER – December 4, 2017 – When pharmacy professionals – rather than doctors or nurses – take medication histories of patients in emergency departments, mistakes in drug orders can be reduced by more than 80 percent, according to a study led by Cedars-Sinai. Read more.

    If CVS Buys Aetna, America’s Pharmacy Choices Narrow – December 3, 2017 – If the pharmacy giant CVS Health is successful buying health insurer Aetna, it will further narrow U.S. choices of where they pick up their prescriptions and receive their healthcare services. Even before reports surfaced more than a month ago that CVS would purchase Aetna, the trend to narrow health plan networks was on the rise. Read more.

    Hospitals Take Lead Role In Newest Gene Cancer Rx – December 2, 2017 – Two revolutionary new cancer therapies that use genetic engineering to treat acute lymphoblastic leukemia (ALL) and certain types of lymphoma are going to rely on the expertise of oncology departments at health systems, with pharmacies playing key roles in providing ongoing supportive patient care, according to experts. Read more.

    Telepharmacy Market Analysis, Size, Share, Growth, Trends and Forecast 2016 – 2024 – December 1, 2017 – “The Report Telepharmacy Market – Global Industry Analysis, Size, Share, Growth, Trends and Forecast 2016 – 2024 provides information on pricing, market analysis, shares, forecast and company profiles for key industry participants. Read more.

    New Blood Pressure Guidelines Highlight Need for Greater Awareness and Proactive Treatment – December 1, 2017 – According to new guidelines issued in November by the American Heart Association and the American College of Cardiology, 46 percent of U.S. adults—about 103-million Americans—are now considered to be in the high blood pressure range. Under the previous guidelines, which had not been updated in over a decade, only 32 percent of U.S. adults (or 72 million Americans) were considered to be living with high blood pressure. Read more.


    340B in the News

    Commentary: Drug Discount Program Helps Utah Hospitals – December 11, 2017 – Holly Richardson’s November 30 op-ed contains misinformation and sorely mischaracterizes the 340B drug discount program, particularly as it applies to Utah hospitals. The 340B program, created in 1992, was not initiated to address high cost drugs like HIV medications. The program was actually created in response to Federal legislation that inadvertently raised drug prices for safety-net providers. Congress’ intent of 340B is to help safety-net hospitals “stretch scarce Federal resources as far as possible.” Read more.

    Trending News Today: Senators Try to Block Cuts to 340B Program – December 8, 2017 – Six senators—half of whom are Republicans—are seeking to stop cuts to the 340B program, which gives discounts to hospitals and clinics that serve low-income and uninsured patients, according to The Hill. The Centers for Medicare & Medicaid Services recently proposed $1.6 billion in cuts to the program starting on January 1, 2018. Read more. 

    Program Helping Patients In Dire Need At Risk Of Cutbacks – December 7, 2017 – We all know health care costs are steep and continue to rise – at unaffordable rates for many. People with diabetes, in particular, are confronted with that reality regularly as they have to pay for life-saving insulin. St. Luke’s Health System gets help from a federal program that makes the drug – and other medications – more affordable for a lot of patients who are in dire need. But that’s now put at risk by some cutbacks that are expected to go into effect the first of the year. Read more.

    CMS to Reduce 340B Drug Payments to Hospitals by $1.6 Billion – December 6, 2017 – On November 13, CMS published the final rule revising the Medicare hospital Outpatient Prospective Payment System for 2018. Among a number of changes, the final rule dramatically reduces Medicare Part B payments to hospitals for separately payable drugs purchased through the 340B Program. Currently, Medicare pays hospitals the Average Sales Price (ASP) plus 6 percent for these drugs regardless of whether the hospital purchased the drug at a discount through the 340B Program. Read more.

    Groups Sue CMS Over $1.6B Cut To 340B Payment – December 2, 2017 – Three major hospital groups sued the Centers for Medicare & Medicaid Services (CMS) over a new rule released Nov. 2 that dramatically cuts outpatient drug payments under the federal 340B Drug Pricing Program. Read more.

    CMS’ Cuts to the 340B Drug Payment Program Cause Hospital Uproar – December 1, 2017 – The 340B program requires drug or pharmaceutical manufacturers to provide outpatient drugs to eligible health care organizations at significantly reduced prices. Hospitals falling within the following categories are eligible to participate in the program: disproportionate share hospitals, children’s hospitals and cancer hospitals exempt from the Medicare prospective payment system, rural sole community hospitals and critical access hospitals. Read more. 

    340B is Vital For Iowa’s Critical Access Hospitals – December 1, 2017 – The 340B drug discount program was created in 1992 and requires drug companies to sell medications at a discount to hospitals that serve large numbers of low-income and rural patients. In Iowa and across America, 340B is part of the solution to high prescription drug prices. Read more.

    Hill Lawmakers Race To Block HHS Medicare Cuts To 340B Hospitals – December 1, 2017 – A fierce battle over HHS’ new Medicare cuts to 340B hospitals has ratcheted up as lawmakers negotiate their year-end spending deal, pitting hospitals, Congress and the Trump administration against each other before the rule is finalized. 340B hospitals face $1.6 billion in annual Medicare cuts through the CMS’ finalized hospital outpatient hospital prospective payment rule if Congress doesn’t block or delay its implementation before Jan. 1, according to the American Hospital Association and Association of American Medical Colleges. Read more.