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
Lumify™ (brimonidine tartrate) – New OTC Drug Approval – December 22, 2017 – Bausch + Lomb, a leading global eye health company and wholly owned subsidiary of Valeant Pharmaceuticals International, Inc., announced that the U.S. Food and Drug Administration (FDA) has approved Lumify™ (brimonidine tartrate ophthalmic solution 0.025%) as the first and only over-the-counter (OTC) eye drop developed with low-dose brimonidine tartrate for the treatment of ocular redness. Read more.
Giapreza™ (angiotensin II) Injection – New Drug Approval – December 21, 2017 – The U.S. Food and Drug Administration approved Giapreza™ (angiotensin II) injection for intravenous infusion to increase blood pressure in adults with septic or other distributive shock. Read more.
Siklos (hydroxyurea) – New Drug Approval – December 21, 2017 – The U.S. Food and Drug Administration granted regular approval to hydroxyurea (Siklos, Addmedica) to reduce the frequency of painful crises and the need for blood transfusions in pediatric patients from two years of age and older with sickle cell anemia with recurrent moderate to severe painful crises. Read more.
Macrilen™ (macimorelin) for Oral Solution – New Drug Approval – December 20, 2017 – Aeterna Zentaris Inc. announced that the U.S. Food and Drug Administration (FDA) has granted marketing approval for Macrilen™ (macimorelin), an orally available ghrelin agonist, to be used in the diagnosis of patients with adult growth hormone deficiency (AGHD). Read more.
Luxturna™ (voretigene neparvovec-rzyl) – New Drug Approval – December 19, 2017 – The U.S. Food and Drug Administration tapproved Luxturna™ (voretigene neparvovec-rzyl), a new gene therapy, to treat children and adult patients with an inherited form of vision loss that may result in blindness. Luxturna™ is the first directly administered gene therapy approved in the U.S. that targets a disease caused by mutations in a specific gene. Read more.
Steglujan™ (ertugliflozin and sitagliptin) – New Drug Approval – December 19, 2017 – Merck and Pfizer Inc. announced that the U.S. Food and Drug Administration (FDA) has approved Steglatro™ (ertugliflozin) tablets, an oral sodium-glucose cotransporter 2 (SGLT2) inhibitor, and the fixed-dose combination Steglujan™ (ertugliflozin and sitagliptin) tablets. Read more.
Steglatro® (ertugliflozin) – New Drug Approval – December 19, 2017 – Merck and Pfizer Inc. announced that the U.S. Food and Drug Administration (FDA) has approved Steglatro™ (ertugliflozin) tablets, an oral sodium-glucose cotransporter 2 (SGLT2) inhibitor, and the fixed-dose combination Steglujan™ (ertugliflozin and sitagliptin) tablets. Read more.
Prexxartan® (valsartan) Oral Solution – New Drug Approval – December 19, 2017 – Medicure Inc. announced that Carmel Biosciences, Inc. (“Carmel”) has received final approval of its New Drug Application from the U.S. Food and Drug Administration (“FDA”) for Prexxartan® (valsartan) oral solution. The FDA approval of Prexxartan® makes it the first and only approved oral liquid dosage form of the angiotensin II receptor blocker (“ARB”) valsartan in the United States. Read more.
Rhopressa® (netarsudil) Ophthalmic Solution – New Drug Approval – December 18, 2017 – Aerie Pharmaceuticals, Inc. announced that the U.S. Food and Drug Administration (FDA) has approved Rhopressa® (netarsudil ophthalmic solution) 0.02% for the lowering of elevated intraocular pressure (IOP) in patients with open-angle glaucoma or ocular hypertension. Read more.
Eskata™ (hydrogen peroxide) Topical Solution – New Drug Approval – December 14, 2017 – Aclaris Therapeutics, Inc. announced that the U.S. Food and Drug Administration (FDA) has approved Eskata™ (hydrogen peroxide) topical solution, 40% (w/w) for the treatment of raised seborrheic keratoses, or SKs. Read more.
Xepi™ (ozenoxacin) Cream – New Drug Approval – December 14, 2017 – Medimetriks Pharmaceuticals, Inc. announced that the U.S. Food and Drug Administration (FDA) approved Xepi™ (ozenoxacin) Cream, 1%, a new chemical entity for the treatment of impetigo in patients two months of age and older when applied topically twice daily for five days. Read more.
Ixifi® (infliximab-qbtx) Injection – New Biosimilar Drug Approval – December 13, 2017 – Pfizer Inc. announced that the United States (U.S.) Food and Drug Administration (FDA) has approved Ixifi™ (PF-06438179, infliximab-qbtx), a chimeric human-murine monoclonal antibody (mAb) against tumor necrosis factor, as a biosimilar to Remicade® (infliximab)* for all eligible indications of the reference product. Read more.
Admelog® (insulin lispro) Injection – New Drug Approval – December 11, 2017 – The U.S. Food and Drug Administration approved Admelog® (insulin lispro injection), a short-acting insulin indicated to improve control in blood sugar levels in adults and pediatric patients aged three years and older with type 1 diabetes mellitus and adults with type 2 diabetes mellitus. Admelog® is the first short-acting insulin approved as a “follow-on” product (submitted through the agency’s 505(b)(2) pathway). Read more.
Sinuva™ (mometasone furoate) Sinus Implant – New Drug Approval – December 8, 2017 – Intersect ENT, Inc., a company dedicated to transforming care for patients with ear, nose and throat conditions, announced that it has received approval from the U.S. Food and Drug Administration (FDA) for the Sinuva™ (mometasone furoate) Sinus Implant, a new targeted approach to treating recurrent nasal polyp disease in patients who have had previous ethmoid sinus surgery. Read more.
New Formulation Approval
No new updates.
New Indication Approval
Perjeta® (pertuzumab) – New Indication Approval – December 20, 2017 – The U.S. Food and Drug Administration granted regular approval to pertuzumab (PERJETA, Genentech, Inc.) for use in combination with trastuzumab and chemotherapy as adjuvant treatment of patients with HER2-positive early breast cancer at high risk of recurrence. Read more.
Opdivo® (nivolumab) – New Indication Approval – December 20, 2017 – The U.S. Food and Drug Administration granted regular approval to the anti-PD1 monoclonal antibody, nivolumab (OPDIVO, Bristol-Myers Squibb Company) for the adjuvant treatment of patients with melanoma with involvement of lymph nodes or in patients with metastatic disease who have undergone complete resection. Nivolumab was previously approved for the treatment of patients with unresectable or metastatic melanoma. Read more.
Bosulif® (bosutinib) – New Indication Approval – December 19, 2017 – The U.S. Food and Drug Administration granted accelerated approval to bosutinib (BOSULIF, Pfizer Inc.) for treatment of patients with newly-diagnosed chronic phase (CP) Philadelphia chromosome positive (Ph+) chronic myelogenous leukemia (CML). Read more.
Cabometyx® (cabozantinib) – New Indication Approval – December 19, 2017 – The U.S. Food and Drug Administration granted regular approval to cabozantinib (Cabometyx, Exelixis, Inc.) for treatment of patients with advanced renal cell carcinoma (RCC). Read more.
Xeljanz®/Xeljanz® XR (tofacitinib) – New Indication Approval – December 14, 2017 – Pfizer Inc. announced that the United States Food and Drug Administration (FDA) has approved Xeljanz® 5 mg twice daily (BID) and Xeljanz® XR (tofacitinib) extended release 11 mg once daily (QD) for the treatment of adult patients with active psoriatic arthritis (PsA) who have had an inadequate response or intolerance to methotrexate or other disease-modifying antirheumatic drugs (DMARDs). Read more.
Nucala® (mepolizumab) – New Expanded Indication Approval – December 12, 2017 – The U.S. Food and Drug Administration expanded the approved use of Nucala® (mepolizumab) to treat adult patients with eosinophilic granulomatosis with polyangiitis (EGPA), a rare autoimmune disease that causes vasculitis, an inflammation in the wall of blood vessels of the body. This new indication provides the first FDA-approved therapy specifically to treat EGPA. Read more.
Omidria® (phenylephrine/ketorolac) – New Expanded Indication Approval – December 12, 2017 – Omeros Corporation announced that the U.S. Food and Drug Administration (FDA) approved Omeros’ supplemental new drug application (sNDA) following review of efficacy and safety data from a pediatric clinical trial, expanding the indication for Omidria® (phenylephrine and ketorolac intraocular solution) 1% / 0.3% to include use in pediatric patients (ages birth through 17 years old). Read more.
New Drug Shortage
December 21, 2017
- Albiglutide (Tanzeum) Injection (Discontinuation)
- Progesterone Injection, USP(Currently in Shortage)
December 20, 2017
- Acetazolamide (Diamox Sequels) Extended Release Capsules (Discontinuation)
December 19, 2017
December 14, 2017
- Memantine Hydrochloride (NAMENDA) Oral Solution (Discontinuation)
December 13, 2017
- Bumetanide Injection, USP (Currently in Shortage)
New Drug Recall and Safety Alerts
AuroMedics Pharma LLC, Linezolid Injection – Drug Recall Alert – December 22, 2017 – AuroMedics Pharma LLC is voluntarily recalling one lot of Linezolid Injection 600mg/300mL flexible bags, NDC 55150 -242 -51 batch CLZ160007 expiration August 2018 to the hospital level. This batch was distributed May 15 through August 14, 2017. Read more.
Long-Acting Beta agonists (LABAs) and Inhaled Corticosteroids (ICS) – Drug Safety Alert – December 20, 2017 – FDA’s most prominent warning, the Boxed Warning, about asthma-related death has been removed from the drug labels of medicines that contain both an ICS and LABA. A FDA review of four large clinical safety trials shows that treating asthma with long-acting beta agonists (LABAs) in combination with inhaled corticosteroids (ICS) does not result in significantly more serious asthma-related side effects than treatment with ICS alone. Read more.
AuroMedics Pharma LLC., Pantoprazole Sodium – Drug Recall Alert – December 19, 2017 – East Windsor, New Jersey, AuroMedics Pharma LLC is voluntarily recalling one lot of Pantoprazole Sodium for Injection 40 mg per vial, to the hospital level. The product was found to contain glass particles in the vial. Read more.
Gadolinium-based contrast agents (GBCAs) are retained in the body – Drug Safety Alert – December 19, 2017 – The U.S. Food and Drug Administration (FDA) is requiring a new class warning and other safety measures for all gadolinium-based contrast agents (GBCAs) for magnetic resonance imaging (MRI) concerning gadolinium remaining in patients’ bodies, including the brain, for months to years after receiving these drugs. Read more.
New First Time Generic
Viread® (tenofovir disoproxil fumarate) – First-time Generic Launch – December 15, 2017 – Teva Pharmaceutical Industries Ltd. announced the exclusive launch of a generic version of Viread® (tenofovir disoproxil fumarate) tablets 300 mg in the U.S. Read more.
Clinical and Pharmacy News
3 Ways to Optimize Pharmacy Revenue Capture and Boost the Bottom Line – January 2, 2018 – Healthcare executives need look no further than the pharmacy department to drive new revenue. The pharmacy department historically is one of a hospital’s greatest cost centers. Most improvement efforts focus on reducing cost. However, pharmacy can also be a major contributor to revenue — with little upfront investment. Consider that pharmacy can provide support services to decrease length of stay, manage medication through collaborative practices, and facilitate appropriate medication reimbursement. Read more.
Pharma, Under Attack for Drug Prices, Started an Industry War – January 2, 2018 – It’s not easy to get Americans mad at a behind-the-scenes industry they’ve barely even heard of, but pharmaceutical companies have spent most of this year trying. “Who decides what you pay for your medicines? Not who you might think,” a concerned woman’s voice says in a radio spot airing in the District last month. “More than one-third of the list price of a medicine is rebated back to middlemen, like insurers and pharmacy benefit managers.” Read more.
Prescription Drug Prices Kept Rising In 2017, But Greater Scrutiny Contained Them a Bit – January 1, 2018 – We are still losing the battle to contain fast-rising drug prices in Michigan and across the country, but increased scrutiny of pricey pharmaceuticals led to some minor victories in 2017 for more affordable health care, according to several of Michigan’s larger insurers. Read more.
Four PBM Programs Poised to Rein in The Opioid Epidemic – January 1, 2018 – Pharmacy benefit managers (PBMs) are well suited to address the opioid epidemic—and, it’s imperative that they do so, according to industry experts. “PBMs are uniquely positioned to connect and partner with physicians, pharmacists, patients, pharmaceutical manufacturers, health systems and other components of the industry, and therefore are better able to drive improvements in education surrounding the dangers of opioid therapy, as well as the various tools available for constituents to positively change the course of this epidemic,” says Managed Healthcare Executive Editorial Advisor David Calabrese RPh, MHP, OptumRx’s chief pharmacy officer. Read more.
Guidelines in the Management of Febrile Neutropenia for Clinical Practice – December 29, 2017 – Febrile neutropenia (FN) is a serious complication of cancer chemotherapy that can lead to delays in treatment and necessary dose reductions of chemotherapy, which compromise treatment efficacy. Approximately one percent of patients with cancer receiving chemotherapy develop FN, which contributes to morbidity and mortality, and imposes substantial burdens on healthcare resource use for management of this affected population. Read more.
Flu Widespread In 36 States, CDC Reports – December 29, 2017 – Outbreaks of influenza are getting an early start this year in part because of cold weather gripping much of the U.S.A. and low efficacy associated with this year’s flu vaccine. It’s still too early to say whether this winter will be a bad season for the flu, but epidemiologists in 36 states already have reported widespread influenza activity to the federal Centers for Disease Control and Prevention in data released Friday. Read more.
Drug Prices Rise as Pharma Profit Soars – December 28, 2017 – The amount of money people spend on prescription drugs has nearly doubled over the past three decades as pharmaceutical sales and profit margins have ballooned, according to a government report. Retail prescription drug expenses accounted for about 12 percent of total U.S. healthcare spending in 2015, up from about seven percent through the 1990s. Read more.
Hard to Swallow? New Digital Pill Raises Personal Privacy Concerns – December 27, 2017 – The U.S. Food and Drug Administration recently approved a new digital pill capable of monitoring whether individuals are taking a prescribed medication. People not taking their medications – especially those with chronic conditions – is a major national health problem that costs about $300 billion a year in additional treatments and hospitalizations. The high-tech digital pill will be available in a limited number of health plans starting next year. But it is already raising concerns about healthcare providers and insurance companies gaining greater access into patients’ personal lives. Read more.
The Role of Direct Oral Anticoagulants in the Management of Venous Thromboembolism – December 27, 2017 – Appropriate treatment of venous thromboembolism (VTE) is critical to minimizing long-term morbidity and mortality. The emergence of direct oral anticoagulants (DOACs) has provided clinicians with expanded therapeutic options for patients with VTE, and as a result, updated practice guidelines released by the American College of Chest Physicians favor DOACs over traditional anticoagulants, such as warfarin. Read more.
Kmart to Pay $32.3M to Settle False Claims Act Allegations – December 27, 2017 – Federal prosecutors say the retailer offered discounted generic drug prices to cash-paying customers but knowingly failed to disclose those prices when reporting to federal health programs. Kmart Corp. will pay the federal government $32.3 million to settle allegations that its pharmacies failed to report discounted prescription drug prices to Medicare Part D, Medicaid and TRICARE, the Justice Department announced. Read more.
The Impact of Telemedicine on Pharmacists and Implications for Controlled Substance – December 25, 2017 – One-quarter of Americans live in rural areas and are unable to easily reach medical services. To better accommodate this significant portion of the population, a new form of healthcare has broken through to redefine the nature of medicinal services: telehealth. This new branch—which includes telemedicine, telepharmacy, telepsychiatry and more—has allowed primary care providers, as well as previously unavailable specialists, to reach remote patients. Read more.
340B in the News
Letter: 340B Program Is Working as Intended – December 29, 2017 – Rena Conti’s Dec. 18 column “340B effort is in need of reforms” mischaracterizes the 340B Drug Discount Program and undervalues how essential it is to hospitals like ours and the patients we serve. The 340B program was created by Congress in 1992 and requires drug companies to sell medications at a discount to hospitals that serve large numbers of low-income and rural patients. Read more.
Judge Tosses AHA Challenge To 340B Cuts – December 29, 2017 – A federal judge on Friday allowed the CMS to move forward with its planned $1.6 billion cut to a federal drug discount program. U.S. District Judge Rudolph Contreras ruled that the American Hospital Association, Association of American Medical Colleges, America’s Essential Hospitals and three hospitals prematurely sued the CMS, since the proposed 340B program cuts have not gone into effect yet. Read more.
Mixed Reactions to CMS Policy to Cut Back on Spending in 340B Program – December 28, 2017 – A new Centers for Medicare & Medicaid Services (CMS) policy to redistribute savings under the 340B Drug Discount Program has been greeted by a mixture of praise and criticism from supporters and critics of the program. Read more.
340B Guidance from CMS Further Inflames Worries Over Reimbursement Cuts – December 19, 2017 – Guidance meant to provide more clarity on forthcoming changes to the 340B program has only added anxiety and uncertainty for hospital executives. Although legislators are considering trying to stop the changes, as the rules stand now payment for drugs in the program are soon going to drop sharply. Read more.
Report: 340B Drug Program Rife with Abuse, Profiteering – December 19, 2017 – A program designed to help poor people afford prescription drugs is being used by hospitals to generate easy profits, according to a Pacific Research Institute report. Read more.
340B Update for Hospitals: CMS Publishes FAQs Clarifying Use of Modifiers in Connection with 340B Program Reimbursement Cut on Part B Drugs – December 18, 2017 – On December 13, 2017, the Centers for Medicare & Medicaid Services (“CMS”) published subregulatory guidance to answer questions about billing for drugs acquired through the 340B Drug Pricing Program (“340B Program”) (hereinafter the “FAQ”). Read more.