RxStrategies Clinical Insights – March Issue 2

    Welcome to the March second edition of RxStrategies Clinical Insights, a concise communication to help pharmacy professionals stay up to date on the ever-changing pharmaceutical and pharmacy market place.


    New Drug Approvals

    Anthrasil™ (Anthrax Immune Globulin Intravenous – Human) – New Drug Approval
    March 25, 2015 – The U.S. Food and Drug Administration approved Anthrasil™, Anthrax Immune Globulin Intravenous (Human), to treat patients with inhalational anthrax in combination with appropriate antibacterial drugs. Inhalational anthrax is a rare disease that can occur after exposure to infected animals or contaminated animal products, or as a result of an intentional release of anthrax spores. It is caused by breathing in the spores of the bacterium Bacillus anthracis. When inhaled, the anthrax bacteria replicate in the body and produce toxins that can cause massive and irreversible tissue injury and death. Read More.

    Cholbam™ (cholic acid) – New Drug Approval
    March 17, 2015 –  the U.S. Food and Drug Administration approved Cholbam™ (cholic acid) capsules, the first FDA approved treatment for pediatric and adult patients with bile acid synthesis disorders due to single enzyme defects, and for patients with peroxisomal disorders (including Zellweger spectrum disorders). Patients with these rare, genetic, metabolic conditions exhibit manifestations of liver disease, steatorrhea (presence of fat in the stool) and complications from decreased fat-soluble vitamin absorption. Read More. 

    Unituxin™ (dinutuximab) – New Drug Approval
    March 10, 2015 – The U.S. Food and Drug Administration approved Unituxin™ (dinutuximab) as part of first-line therapy for pediatric patients with high-risk neuroblastoma, a type of cancer that most often occurs in young children. Neuroblastoma is a rare cancer that forms from immature nerve cells. It usually begins in the adrenal glands but may also develop in the abdomen, chest or in nerve tissue near the spine. Neuroblastoma typically occurs in children younger than five years of age. RxStrategies Clinical Insight: Unituxin™ has been granted an orphan drug status. Read More.

    Cresemba® (isavuconazonium) – New Drug Approval
    March 6, 2015 – The U.S. Food and Drug Administration approved Cresemba®(isavuconazonium), a new antifungal drug product used to treat adults with invasive aspergillosis and invasive mucormycosis, rare but serious infections. Aspergillosis is a fungal infection caused by Aspergillus species, and mucormycosis is caused by the Mucorales fungi. These infections occur most often in people with weakened immune systems. Cresemba® belongs to a class of drugs called azole antifungal agents, which target the cell membrane of a fungus. Cresemba® is available in oral and intravenous formulations. RxStrategies Clinical Insight: FDA also granted Cresemba® orphan drug designations for invasive aspergillosis and invasive mucormycosis. Read More. 


    New Drug Formulation

    Viibryd® (vilazodone HCl) – New Drug Formulation
    March 16, 2015 – Actavis plc announced the U.S. Food and Drug Administration approved a lower therapeutic dose of Viibryd® (vilazodone HCl) (20mg) to accompany the 40 mg daily therapeutic dose. This supplemental new drug application (sNDA) approval for Viibryd® expands dosing options available to health care providers when using Viibryd® to treat their adult patients with MDD. Read More.

    Zarxio® (filgrastim-sndz) – New Drug Formulation
    March 6, 2015 – The U.S. Food and Drug Administration approved Zarxio® (filgrastim-sndz), the first biosimilar product approved in the United States. Biological products are generally derived from a living organism. They can come from many sources, including humans, animals, microorganisms or yeast. A biosimilar product is a biological product that is approved based on a showing that it is highly similar to an already-approved biological product, known as a reference product. The biosimilar also must show it has no clinically meaningful differences in terms of safety and effectiveness from the reference product. Only minor differences in clinically inactive components are allowable in biosimilar products. Sandoz, Inc.’s Zarxio is biosimilar to Amgen Inc.’s Neupogen (filgrastim), which was originally licensed in 1991. RxStrategies Clinica Insight: Zarxio® has been approved for all the same indications as Neupogen which has been designated for 8 orphan indications and approved for 4 orphan indications. Read More.

    Elepsia XRTM (Levetiracetam extended-release) – New Drug Formulation
    March 04, 2015 – Sun Pharma Advanced Research Company Ltd. announced that the U.S. Food and Drug Administration approved its New Drug Application (NDA) for Elepsia XRTM (Levetiracetam extended-release tablets 1000 mg and 1500 mg). Elepsia XRTM is indicated for adjunctive therapy in the treatment of partial onset seizures in patients 12 years of age and older with epilepsy. Read More.

    Liletta™ (levonorgestrel-releasing intrauterine system) – New Drug Formulation
    Feburary 27, 2015 – Actavis plc, a leading global specialty pharmaceutical company, and Medicines360, a nonprofit women’s health pharmaceutical company, announced the approval of Liletta™ (levonorgestrel-releasing intrauterine system) by the U.S. Food and Drug Administration for use by women to prevent pregnancy for up to three years. Liletta™ is placed in the uterus by a healthcare professional and works by continuously releasing levonorgestrel, a progestin, to prevent pregnancy. Read More.

    Toujeo® (insulin glargine [rDNA origin] – New Drug Formulation
    Feburary 27, 2015 – Sanofi announced that the U.S. Food and Drug Administration approved Toujeo® (insulin glargine [rDNA origin] injection), a once-daily long-acting basal insulin, to improve glycemic control in adults living with type 1 and type 2 diabetes. Toujeo® (insulin glargine [rDNA origin] injection) is expected to be available in the U.S. at the beginning of Q2 2015. Read More.


    New Drug Indication

    Eylea® (aflibercept) – New Drug Approval
    March 25, 2015 – The U.S. Food and Drug Administration expanded the approved use for Eylea® (aflibercept) injection to treat diabetic retinopathy in patients with diabetic macular edema. Diabetic retinopathy (DR) is the most common diabetic eye disease and is a leading cause of blindness in adults in the United States. According to the Centers for Disease Control and Prevention, diabetes (type 1 and type 2) affects more than 29 million people in the United States and is the leading cause of new blindness among people ages 20 to 74 years. In 2008, 33 percent of adults with diabetes aged 40 years or older had some form of DR. Read More. 

    Kalydeco® (ivacaftor) – New Drug Indication
    March 18, 2015 – Vertex Pharmaceuticals Incorporated announced that the U.S. Food and Drug Administration  approved Kalydeco® for use in children ages 2 to 5 with cystic fibrosis (CF) who have one of 10 mutations in the cystic fibrosis transmembrane conductance regulator (CFTR) gene (G551D, G1244E, G1349D, G178R, G551S, S1251N, S1255P, S549N, S549R and R117H). Prior to this approval, Kalydeco® was approved in the United States for people ages 6 and older with these mutations. There are approximately 300 children in the United States ages 2 to 5 who have one of these 10 mutations, including 150 who have the R117H mutation and 150 who have one of the other nine mutations that result in a gating defect in the CFTR protein. A new weight-based oral granule formulation of Kalydeco®  (50 mg and 75 mg) that can be mixed in soft foods or liquids was created to meet the needs of children in this age group who may be unable to swallow a tablet. Read More.

    Saphris® (asenapine) – New Drug Indication
    March 13, 2015 – Actavis plc announced that the U.S. Food and Drug Administration has approved its supplemental new drug application (sNDA) for Saphris® (asenapine) as monotherapy for the acute treatment of manic or mixed episodes associated with bipolar I disorder in pediatric patients (ages 10 – 17). Saphris® (asenapine)  is the only atypical antipsychotic treatment option with a sublingual (under the tongue) formulation. Read More.

    Opdivo® (nivolumab) – New Drug Indication
    March 4, 2015 – the U. S. Food and Drug Administration granted approval to nivolumab (Opdivo®, Bristol-Myers Squibb Company) for the treatment of patients with metastatic squamous non-small cell lung cancer (NSCLC) with progression on or after platinum-based chemotherapy. Nivolumab was previously approved in December, 2014 for the treatment of previously treated unresectable or metastatic melanoma.  Nivolumab is a monoclonal antibody that binds to the PD-1 receptor and blocks its interaction with PD-L1 and PD-L2, thereby releasing PD-1 pathway-mediated inhibition of the immune response, including anti-tumor immune response. Read More.


    New Drug Shortage

    March 18, 2015

    March 13, 2015


    Drug Safety Alerts

    Sofosbuvir in Combination With Another Direct Acting Antiviral Drug: Drug Safety Alert
    March 24, 2015 – FDA is warning that serious slowing of the heart rate can occur when the antiarrhythmic drug amiodarone is taken together with either the hepatitis C drug Harvoni® (ledipasvir/sofosbuvir) or with Sovaldi® (sofosbuvir) taken in combination with another direct acting antiviral for the treatment of hepatitis C infection. FDA is adding information about serious slowing of the heart rate, known as symptomatic bradycardia, to the Harvoni® and Sovaldi® labels. FDA is recommending that health care professionals should not prescribe either Harvoni® or Sovaldi® combined with another direct acting antiviral, such as the investigational drug daclatasvir or Olysio® (simeprevir), with amiodarone. Read More.

    Zyprexa® Relprevv (olanzapine pamoate): Drug Safety Communication
    March 23, 2015 – FDA has concluded a review of a study undertaken to determine the cause of elevated levels of the injectable schizophrenia drug Zyprexa® Relprevv (olanzapine pamoate) in two patients who died. The study results were inconclusive. FDA is unable to exclude the possibility that the deaths were caused by rapid, but delayed, entry of the drug into the bloodstream following intramuscular injection. The study suggested that much of the drug level increase could have occurred after death, a finding that could explain the extremely high blood levels found in the two patients who died 3 to 4 days after receiving injections of appropriate doses of Zyprexa® Relprevv. Read More. 

    Over-the-Counter Asthma Products Labeled as Homeopathic: Drug Safety Alert
    March 19, 2015 – FDA is warning consumers not to rely on asthma products labeled as homeopathic that are sold over-the-counter (OTC). These products have not been evaluated by the FDA for safety and effectiveness. Asthma is a serious, chronic lung condition. If asthma is not appropriately treated and managed, patients may have wheezing, shortness of breath, and coughing, and could be at risk for life-threatening asthma attacks that may require emergency care or hospitalization. Although there is no cure for asthma, there are many prescription asthma treatments approved by FDA as safe and effective, as well as some products that are marketed OTC in accordance with an FDA monograph. Read More.

    Chantix (varenicline): Drug Safety Communication
    March 9, 2015 – FDA is warning that the prescription smoking cessation medicine Chantix (varenicline) can change the way people react to alcohol. Interactions between alcohol and Chantix have resulted in some patients experiencing increased intoxicating effects of alcohol, sometimes associated with aggressive behavior and/or amnesia. In addition, rare accounts of seizures in patients treated with Chantix have been reported. FDA has approved changes to the Chantix label to warn about these risks. Read More.


    Drug Recall Alerts

    Lactated Ringer’s Irrigation, 3000mL by Hospira: Drug Recall Alert
    March 12, 2015 – Hospira initiated a voluntary recall of one lot of Lactated Ringer’s Irrigation, 3000mL (NDC 0409-7828-08, Lot 40-008-JT; Expiry 1APR2016) to the user level (both human and veterinary) due to a confirmed customer report of several dark, fibrous particulates floating within the solution of the primary container. The particulate was confirmed as a common non-toxic, non-invasive mold, Aspergillus kanagawaensis. Read More.

    Magnesium Sulfate in 5 Percent Dextrose Injection by Hospira: Drug Recall Alert
    March 6, 2015 – Hospira announced a voluntary recall of one lot of Magnesium Sulfate in 5% Dextrose, Inj., USP, 10 mg/mL (NDC: 0409-6727-23, Lot 42-120-JT, Expiry 1DEC2015) to the user level due to confirmed customer reports of an incorrect barcode on the primary bag labeling. The barcode on the overwrap is correct; however, there is potential for the primary container barcode to be mislabeled with the barcode for Heparin Sodium 2000 USP units/1000 mL in 0.9% Sodium Chloride Inj. The product is labeled with the correct printed name on the primary container and overwrap. Read More.

    0.9 Percent Sodium Chloride Injection, USP, 250 mL Container by Hospira: Drug Recall Alert
    March 6, 2015 – Hospira announced a voluntary nationwide recall of one lot of 0.9% Sodium Chloride Injection, USP, 250 mL VisIV flex container (NDC 0409-7983-25, Lot 45-110-C6, Expiry 1MAR2016) to the user level due to one confirmed customer report of particulate in a single unit. The foreign particle was confirmed by Hospira as human hair free-floating within the solution. To date, Hospira has not received reports of any adverse events associated with this issue for this lot. Read More.


    Clinical and Pharmacy News

    The Drugs That Cost 743 Percent More In 2014 Than 2013
    March 28, 2015 – A new drug-trends report shows a 743 percent increase in the amount spent on hepatitis C drugs in the United States in 2014 compared with 2013. In what’s being called a seismic change, overall spending on prescription medications also spiked — rising 13 percent — the largest increase in the past 10 years. Costs were up for drugs covered by all types of insurance, including Medicare and Medicaid. Read More.

    Men Are New Target for Osteoporosis Treatment
    March 23, 2015 – Bone-health experts are making a new push to reduce rates of osteoporosis, with a particular focus on controlling the bone-wasting disease in men. An important goal is to get greater numbers of men to be tested for osteoporosis when they come to a hospital or clinic with a fracture to the wrist, vertebrae or other bones that wasn’t from a major accident or trauma. Read More.

    New NCCN Guidelines for Smoking Cessation Published
    March 16, 2015 – Tobacco-related diseases are the most preventable cause of death worldwide; smoking cessation leads to improvement in cancer treatment outcomes, as well as decreased recurrence. According to the American Cancer Society, in 2015, nearly 171,000 of the estimated 589,430 cancer deaths in the United States–more than 25 percent–will be caused by tobacco smoking. Read More.

    Insurers, Drugmakers Tussle Over Drug Copay Caps
    March 13, 2015 – The battle over soaring U.S. drug prices is heading for the states. With the price of some treatments topping $100,000, patient groups are pushing for state laws to make sure insurers cover most of the costs. Their campaign is backed by an important ally: the drug industry. Read More.

    The Five Essential Truths about Prescription Drug Spending
    March 13, 2015 – Every day patients around the world are living healthier, more productive lives thanks to innovative medicines developed by biopharmaceutical companies.  Retail prescription medicines have consistently accounted for just 10 percent of United States health care spending and federal actuaries project this share will remain stable through the next decade. At the same time, these medicines have helped to curb downstream health care system costs by reducing spending on expensive hospitalizations and long-term care. Read more 

    How Expensive Medications Are Increasingly Out Of Reach
    March 13, 2015 – The biggest battle in health care these days — besides the ongoing fight over Obamacare — is over the price of expensive life-saving medications. Specialty drug spending fueled a 13 percent increase in prescription drug spending last year, the largest annual increase in the past decade, according to a report this week from pharmacy benefits manager Express Scripts. These drugs represent just 1 percent of all U.S. prescriptions, yet they made up nearly 32 percent of all drug spending in 2014, up from 28 percent in 2013. Read more. 

    By The Numbers: How Community Pharmacists Measure Up
    March 13, 2015 – How do the nation’s pharmacists rate with Americans? According to Gallup, the answer is very, very high year after year. Each year, Gallup researchers conduct a national poll to gauge Americans’ level of trust in the people engaged in a wide variety of professions, from doctors and police officers to business leaders and educators. And community pharmacists consistently rank at or near the top of the most trusted professionals. Read More.

    Pharmacy-based adherence efforts: The value of face-to-face interventions
    March 13, 2015 – Drugs don’t work in patients who don’t take them.” That obvious but overlooked truism, uttered by the late former U.S. surgeon general C. Everett Koop, sums up the nagging and very expensive problem of medication non-adherence. The failure of many patients to take their medicines as prescribed, abandoning prescription therapy in the course of treatment or failing altogether to even fill a written prescription, is one of health care’s most challenging choke points. It compromises successful health outcomes and costs an estimated $300 billion a year in unnecessary hospitalizations, physician interventions and other costs. Read More.

    WHO Issues its First Hepatitis B Treatment Guidelines
    March 12, 2015 – WHO today issued its first-ever guidance for the treatment of chronic hepatitis B, a viral infection which is spread through blood and body fluids, attacking the liver and resulting in an estimated 650 000 deaths each year – most of them in low- and middle-income countries. Read More.

    Lifesavers or kickbacks? Critics say patient-assistance programs help keep drug prices high
    March 7, 2015 – He says it was a choice between covering his mortgage and paying for his cancer drug. That was the predicament facing Andre Rucker, a Baltimore heavy equipment mechanic, when he was diagnosed with multiple myeloma, a blood cancer, nearly six years ago. Rucker’s union health plan covered most of the cost of his medication, Revlimid, a maintenance therapy drug manufactured by Summit, N.J.-based Celgene with an average cost of $142,000 a year. But he still had to shell out nearly $500 a month out-of-pocket for the drug. Read More.

    FDA Launches Drug Shortages Mobile App
    March 4, 2015 – the U.S. Food and Drug Administration launched the agency’s first mobile application (app) specifically designed to speed public access to valuable information about drug shortages.

    The app identifies current drug shortages, resolved shortages and discontinuations of drug products. Read More.

    CVS Might Have Tougher Times Ahead As Competition in the PBM Market Heats Up
    March 2, 2015- The United States has the most expensive healthcare system in the world. Government spending on heath care forms about 18% of the country’s GDP currently and the share is only expected to go up with time. If the historical growth rate of health care costs continues, projections place the share by 2040 at a whopping 34% (over a third of the GDP!). Read More.


    340B in the News

    Generic Drugs Complicating Hospital Pharmaceutical Spending
    March 27, 2015 – Spending on healthcare providers’ drug supply is becoming more complicated as generics flood the market, a trend that makes it more important for finance and purchasing execs to understand the changes. In 2014, 78 percent of the prescription drugs dispensed in the U.S. were generic – up from 69 percent in 2009, according to the National Community Pharmacists Association. The NCPA attributed the spike to blockbuster generic drugs “falling off the patent cliff,” allowing generic alternatives to be marketed. Read More.

    Bill Could End Health Center’s Tax Exemption
    March 27, 2015 – Sen. Chas Vincent of Libby has proposed a bill in the Montana Legislature that could lead to the revocation of Northwest Community Health Center’s tax-exempt status.

    The bill, SB407, would revoke the tax-exempt status and impose a fine in lieu of taxes for non-profit pharmacies operating commercial enterprises under a federal drug discount program. Read More.

    Federal Watchdogs Seek Better Oversight of 340B Drug Discounts
    March 24, 2015 – Federal officials told lawmakers Tuesday that the 340B drug discount program needs greater transparency and more clarity about which providers and patients should be eligible. Such changes will improve oversight of a program that has seen a stark rise in its participation over the past decade, they said. Read More.

    Welcomed Movement on 340B Reform
    March 24, 2015 – After a decade since the last Congressional review of the 340B program, the Energy and Commerce Subcommittee on Health rescheduled a much-needed hearing for on the subject. The 340B program was created in 1992 to improve access to prescription medications for underserved patients, but in many ways has fallen off the rails after years of accelerated growth coupled with a lack of transparency and accountability among program beneficiaries.  The examination of this program comes not a moment too soon. Read More.

    Congress Needs to Tackle The Real Driver of Healthcare Costs
    March 23, 2015 – Unless you’ve bought a prescription drug recently, you may not be aware just how much they’ve gone up. And it’s not just brand-name medicines. Some generics are up 2800 percent. These massive increases in drug prices are no accident. Neither is the pharmaceutical industry’s assault on a much-needed drug discount program that helps health care providers treat the needy across the country.  The House Energy and Commerce committee is holding a hearing on Tuesday on that program, called 340B, and it’s essential that some basic facts be understood about how the pharmaceutical industry operates. Read More.

    Medicare Panel Focuses on Discount Drug Program
    March 6, 2015 – Thursday’s snowstorm delayed a House hearing on the government’s 340B discount drug program, but Congress’ advisers on Medicare soldiered on with a separate discussion about the issue. The Medicare Payment Advisory Commission plans to include a discussion of the 340B program in its regular June report to Congress, although the drug discount offerings fall somewhat outside of its jurisdiction. “We are not yet close to the point of making recommendations,” said Glenn M. Hackbarth, MedPAC’s chairman, beginning a discussion about the program and Medicare’s drug purchase through its Part B benefit. “If we as a group elect to pursue recommendations, that would happen next cycle,” meaning that publication would not happen before 2016. Read More.

    Mother Nature Axes 340B Hearing, But Written Testimony Survives
    March 6, 2015 – Mother Nature claimed another victim this week.  The U.S. House of Representatives Energy and Commerce Subcommittee on Health was scheduled to hold a hearing on March 5, 2015 – Examining the 340B Drug Pricing Program.   But with another winter storm aimed at Washington, the hearing was cancelled.  The cancellation came after witnesses had submitted their written testimony to subcommittee staff. Read More.

    House Energy and Commerce Subcommittee on Health Hearing
    March 6, 2015 – Chairman Pitts, Ranking Member Green, and Members of the Subcommittee: I am pleased to be here today as you examine the 340B Drug Pricing Program (340B Program), including issues concerning its oversight. The program, created in 1992 and named for the statutory provision authorizing it in the Public Health Service Act (PHSA), n1 requires drug manufacturers to sell outpatient drugs at discounted prices to eligible clinics, hospitals, and other entities–commonly referred to as covered entities–in order to have their drugs covered by Medicaid. Read More.

    First, do no Harm
    March 5, 2015 – The Health Subcommittee of the House Energy and Commerce Committee postponed a hearing slated for today on the 340B drug discount program. We welcome congressional interest in this vital mechanism that helps hospitals and other providers better care for the poorest in our communities. We also ask that lawmakers let the regulatory process work so that hospitals that serve our most vulnerable citizens can continue this mission. Read More.

    HRSA renews 340B Prime Vendor contract with Apexus
    March 1, 2015 – When it comes to the 340B Drug Pricing Program, compliance is the responsibility of the covered entity, which is why it is essential to have a well-designed, well-managed program that is compliant with the Health Resources and Services Administration’s (HRSA) policies and rules. As the organization that manages HRSA’s 340B Prime Vendor Program, Apexus stands ready to help entities stay compliant so they can receive critical discounts on medications. Read More.

    Keep 340B Savings Where They Belong—With Patients And Communities
    February 28, 2015 – Few government programs produce as much good for so many people with as little cost to taxpayers as the 340B drug pricing program. The concept is simple: Pharmaceutical manufacturers sell outpatient drugs at a discount to hospitals and other providers that serve large numbers of low-income patients. Hospitals use the money they save on drug purchases to support not only affordable medications for indigent patients, but also to provide a broad variety of services to the vulnerable: community-based primary care, cancer clinics and chronic disease management, for example. Savings from 340B free up resources for vulnerable patients that a hospital might otherwise spend to buy medications. Read More.

    ‘340B’ Program Must Survive
    February 25, 2015 – It’s our mission to take care of whomever walks through our doors. Whether critically ill, poor or in decent health, it doesn’t matter: at Heart of America Medical Center in Rugby, we help all of our patients get the care and medicine they need to get better and remain healthy. Read More.