RxStrategies Clinical Insights – November 2014, Issue 2

    Welcome to the second November 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

    Lemtrada™ (alemtuzumab)

    November 14, 2014—The U.S. Food and Drug Administration has approved Lemtrada™ (alemtuzumab) as a disease-modifying therapy for people with relapsing forms of Multiple Sclerosis (MS). Lemtrada™ is given as intravenous infusions – for five consecutive days initially and for three consecutive days one year later. Because of its safety profile, the prescribing information indicates use of Lemtrada™ should generally be reserved for people who have had an inadequate response to two or more MS therapies. Read more.


    New Drug Formulation

    Vasostrict™ (vasopressin injection)

    November 12, 2014—Par Pharmaceutical Companies, Inc. announced it has received approval for its New Drug Application (NDA) for Vasostrict (vasopressin injection, USP) 20 units/mL from the U.S. Food and Drug Administration pursuant to section 505(b)(2) of the Federal Food, Drug, and Cosmetic Act. Par’s Vasostrict is the first and only vasopressin injection, USP, product with an NDA approved by the FDA. Vasostrict is indicated to increase blood pressure in adults with vasodilatory shock (e.g., post-cardiotomy or sepsis), who remain hypotensive despite fluids and catecholamines. Read more.


    Xigduo XR™ (dapagliflozin and metformin hydrochloride)

    October 30, 2014—AstraZeneca announced the U.S. Food and Drug Administration has approved once-daily Xigduo™ XR (dapagliflozin and metformin hydrochloride extended-release) for the treatment of adults with type 2 diabetes. Xigduo™ XR combines two anti-hyperglycemic agents with complementary mechanisms of action, dapagliflozin (trade name in the U.S. FARXIGA™), an inhibitor of sodium-glucose cotransporter 2 (SGLT2), and metformin hydrochloride (HCl) extended-release, a biguanide, in a once-daily oral tablet. Xigduo™ XR is the first U.S. approval for a once-daily tablet combining SGLT2 inhibitor and metformin HCl extended-release. Read more.


    New Drug Indication

    Avastin® (bevacizumab)

    November 17, 2014—The U. S. Food and Drug Administration approved Avastin® (bevacizumab) solution for intravenous infusion in combination with paclitaxel, pegylated liposomal doxorubicin, or topotecan, for the treatment of patients with platinum-resistant, recurrent epithelial ovarian, fallopian tube or primary peritoneal cancer. Read more.


    Invega® Sustenna® (paliperidone palmitate extended-release)

    November 13, 2014—The U.S. Food and Drug Administration has approved the supplemental New Drug Applications (sNDAs) from U.S. health care giant Johnson & Johnson’s subsidiary, Janssen, for Invega® Sustenna® (paliperidone palmitate) for monotherapy or adjunctive therapy in schizoaffective disorder. Read more.


    Cyramza® (ramucirumab) in combination with paclitaxel

    November 5, 2014—The U.S. Food and Drug Administration approved Cyramza® (ramucirumab) for use in combination with paclitaxel for the treatment of patients with advanced gastric or gastroesophageal junction (GEJ) adenocarcinoma. Cyramza® (ramucirumab) was approved in April 2014 as a single agent for the treatment of patients with advanced gastric or GEJ adenocarcinoma refractory to follow or progress first-line therapy with platinum or fluoropyrimidine chemotherapy. Read more.


    Olysio® (simeprevir)

    November 5, 2014—The U.S. Food and Drug Administration has given the green light to a combination of Johnson & Johnson’s Olysio® and Gilead Sciences’ Sovaldi® for patients with hepatitis C genotype 1. This means Olysio® (simeprevir) now has an additional approval as a once-daily, all-oral interferon- and ribavirin-free treatment option. It is the second all-oral therapy that does not require interferon or ribavirin to get the FDA’s thumbs-up. Harvoni®, which combines Gilead’s ledipasvir with Sovaldi® (sofosbuvir), was approved by the agency last month. Read more.


    New Drug Shortage

    November 17, 2014

    Ticarcillin disodium and clavulanate potassium (Timentin) Sterile Powder for Injection & Sterile Injection (Discontinuation)


    November 14, 2014

    Cefazolin Injection (Currently in Shortage)


    November 13, 2014

    Mesna Injection (Discontinuation)


    November 12, 2014

    Imipenem and Cilastatin for Injection (Primaxin I.V. ADD-Vantage) (Discontinuation)


    November 07, 2014

    Vancomycin Hydrochloride for Injection, USP (Currently in Shortage)


    New Drug Recall

    Venlafaxine hydrochloride

    November 18, 2014—A U.S. subsidiary of Indian drug major recalls 68,194 bottles of anti-depressant venlafaxine hydrochloride, a third recall for the drug since March. Sun Pharma Global Inc, a unit of Sun Pharmaceutical Industries, has initiated recall of 68,194 bottles of anti-depressant venlafaxine hydrochloride in the U.S. and Puerto Rico after the drug failed to dissolve properly. Read more.


    Drug Safety Alerts

    Drug Safety Labeling Changes

    November 17, 2014—The MedWatch October 2014 Safety Labeling Changesposting includes 37 products with safety labeling changes to the following sections: BOXED WARNINGS, CONTRAINDICATIONS, WARNINGS, PRECAUTIONS, ADVERSE REACTIONS and PATIENT PACKAGE INSERT. Read more.


    Long-term Antiplatelet Therapy: Safety Announcement – Preliminary Trial Data Shows Benefits, but a Higher Risk of Non-Cardiovascular Death

    November 16, 2014—The FDA is evaluating preliminary data from a clinical trial showing treatment for 30 months with dual antiplatelet blood-thinning therapy decreased the risk of heart attacks and clot formation in stents, but there was an increased overall risk of death compared to 12 months of treatment. The clinical trial compared 30 months versus 12 months of treatment with dual antiplatelet therapy, consisting of aspirin plus either clopidogrel (Plavix) or prasugrel (Effient), following implantation of drug-eluting coronary stents. Read more.


    Clinical and Pharmacy News

    Prescription Drug System Broken

    November 17, 2014—Our prescription drug system is broken and needs fixing. Prescription drugs, including even generic, are soaring in prices. Pharmaceutical companies argue that development costs of new drugs are expensive, but obviously mushrooming costs of generic drugs are inexcusable. Richard Anderson, in a study titled “Pharmaceutical industry gets high on fat profits,” Nov. 6, 2014 in BBC News, reported “drug companies spend more on marketing drugs—in some cases twice as much—than developing them,” and that last year, “five pharmaceutical companies made a profit margin of 20 percent or more,” and Pfizer, the largest, made a 42 percent margin. Read more.


    Hospitals and Pharmacies Grapple with Rising Drug Prices

    November 16, 2014—Fed up with the rising price of drugs, Ascension Health last month did something unusual. It publicly banned a drug company’s sales reps. The reason: The company had reclassified three cancer drugs, causing prices to spike. In a memo to employees, Dr. Roy Guharoy and Michael Gray, two top executives with the Edmundson-based hospital chain, explained: “Already scarce resources will need to be stretched with potential serious impact on the range and breadth of health services we currently provide to our patients and our communities.” Read more.


    Second Generic Version of ADHD Drug Concerta Found to Have Problems

    November 14, 2014—U.S. regulatory officials say they have identified not one, but two, supposed generic copies of the attention deficit hyperactive disorder (ADHD) treatment drug Concerta that have failed to demonstrate required levels of equivalency. Read more.


    New Prescription Drug Abuse Trend: Students Report Pressure from Friends to Sell ADHD Meds

    November 14, 2014—One in five college students who participated in a new online survey reported abusing prescription stimulants at least once in their lives. But the real surprise came when students who have been legally prescribed drugs to treat their ADHD answered some questions. More than half reported being pressured by their friends into sharing or selling their drugs. Read more.


    Federal Investigation into Painkillers Targets N.F.L. Teams’ Medical Staffs

    November 16, 2014—Federal drug enforcement agents questioned medical-staff members from the San Francisco 49ers and several other teams on Sunday as part of a continuing investigation into the distribution of painkillers in the N.F.L. The unannounced visits by the Drug Enforcement Administration were spurred, in part, by reports of widespread abuse of painkillers that were included in a class-action lawsuit against the N.F.L. Read more.


    Cardinal Health Launches Online Tool to Help Retail Pharmacies Make It Easier for Patients to Compare Medicare Part D Plans

    November 13, 2014—With the window for Medicare enrollment open from mid-October through Dec. 7, Cardinal Health recently launched a new online tool, developed by eHealth, Inc., so their retail pharmacy customers can help their patients compare Medicare Part D prescription drug plans. Read more.


    Leadership and Growth Opportunities for Clinical Pharmacists

    November 13, 2014—For almost a decade, the pharmacy profession has been discussing and planning for a potential shortage in leadership. In 2005, the American Journal of Health-System Pharmacy published a survey summary assessing the current and future supply of candidates for leadership roles in pharmacy, defined as pharmacy directors and middle managers. Of the survey population, only 30 percent of current practitioners were interested in pursuing a leadership position in the future. The concerns regarding future leadership were raised in light of a projected vacancy of more than 70 percent of current leadership roles. Read more.


    The Upside of High Drug Costs

    November 11, 2014—There has been much consternation over the past few years about the rising costs of medications. Examples include the exorbitant costs of newly approved medications for niche disease states, the high prices of biologics that are used by many patients for common disease states, the increased product costs due to supply chain restrictions imposed by manufacturers, and the recently recognized growth in the cost of single-source generics. It is not uncommon to find a treatment course of oral or intravenous therapy to be greater than $100,000 per year. Read more.


    AGA Releases Irritable Bowel Syndrome Drug Treatment Guideline

    November 11, 2014—The American Gastroenterological Association (AGA) has released a new guideline that includes recommendations on drugs for the treatment of irritable bowel syndrome (IBS). The document, which was recently published in the Gastroenterology journal, aims to help patients, as well as physicians, decide the best treatments for the disease’s symptoms, and the association believes it provides an evidence-based tool to improve patients’ health. Read more.


    Retail Pharmacies Expanding Services to Compete with Specialty Pharmacies

    November 10, 2014—Specialty pharmacies will be under increasing threat from the retail sector, as large chains anticipate continued growth in adding services once considered to be the sole domain of the specialty pharmacy, according to new research from HRA – Healthcare Research & Analytics. In the company’s most recent study, “Healthcare Reform: The Changing Role of Retail and Specialty Pharmacy,” research shows that retail pharmacies, under increasing pressure to offset reimbursement shortfalls, are looking for new business models and have specialty pharmacy squarely in the crosshairs.

    According to input from 128 retail pharmacies across the United States, 45 percent of those organizations are already filling specialty prescriptions, with another 10 percent planning to add that service within the next 12 months. Large chains are leading the charge in this area, with 56 percent currently filling and 12 percent planning to add specialty prescriptions in the next year. Read more.


    Novel Opioid Addiction Treatment Option Reaches Retail Pharmacies

    November 5, 2014—The first buccal film formulation of buprenorphine and naloxone (Bunavail) is anticipated to reach retail pharmacies by the end of this week, offering a new treatment option to the more than 2.5 million opioid-dependent patients in the United States. The FDA originally approved Bunavail in June 2014 for the maintenance treatment of opioid addiction, as part of a complete treatment plan that includes counseling and psychosocial support. Read more.


    Raising Co-Pays at Cigarette Sellers Boosts CVS Bottom Line

    October 29, 2014—When drugstore giant CVS Health decided to discontinue the sale of cigarettes across its pharmacies, many folks in the health care community applauded the company’s noble move. In spite of the loss of millions of dollars in sales, CVS pulled the plug on this line of income in an effort to simply position its stores as “healthier” places to shop. As it turns out, there appears to have been an ulterior motive that would effectively recoup the sales losses on the cancer-causing tobacco products by coordinating a strategy with the pharmacy benefit manager (PBM) branch of the corporation, CVS Caremark. In a move that seems suspiciously self-serving, CVS will begin to offer plans that raise co-pays for patients who shop at stores that still sell cigarettes. Read more.


    340B News

    HHS Withdraws 340B ‘Mega Rule’

    November 17, 2014—The HHS Health Resources and Services Administration has withdrawn sweeping regulations for the 340B drug pricing program and instead intends to issue proposed guidance addressing key policy issues beginning in 2015. Read more.


    Department of Health and Human Services OIG Releases 2015 Work Plan

    November 17, 2014—The United States Department of Health and Human Services (HHS) Office of Inspector General (OIG) released its Fiscal Year 2015 Work Plan (2015 Plan) on Oct. 31, 2014. OIG releases a work plan annually to identify the new and ongoing investigative, enforcement and compliance activities that it will undertake during that fiscal year (FY). Read more.


    Protect Health Program that Helps the Poor

    November 16, 2014—Everyone deserves a shot at good health. As the CEO of the Regional Medical Center in Orangeburg, I know our team does everything we can to help our patients get the medicine they need to get better. As a “safety-net” hospital, we treat everyone, including our state’s most vulnerable patients—the men, women and children who would otherwise not be able to afford health care when they need it most. Roughly 80 percent of the patients we see are covered by Medicare, Medicaid or are uninsured. And while we and other safety-net hospitals are only a third of all U.S. hospitals, together we provide 62 percent of uncompensated hospital care delivered across the country, according to the American Hospital Association. Read more.


    Election Results May Have Caused HHS to Withdraw Controversial Drug Discount Rule, Attorney Says

    November 14, 2014—The Department of Health and Human Services has pulled a controversial proposed rule on drug discounts for safety-net providers, such as hospitals, which was under review at the White House, according to Bloomberg BNA’s Bronwyn Mixter. Martin Kramer, director of communications at the HHS Health Resources and Services Administration, said the agency in 2015 “plans to issue a proposed guidance for notice and comment that will address key policy issues raised by various stakeholders committed to the integrity of the 340B program.” Read more.


    HHS Drug Discount Program Holds Off on ‘Mega-Reg’

    November 14, 2014—HHS has scrapped plans to issue sweeping regulations clarifying the federal 340B Drug Pricing Program in light of a court ruling against another 340B rule challenged by the pharmaceutical industry. Drug manufacturers, hospitals and pharmacies that participate in the 340B program have been waiting since last spring for what they call a “mega-reg,” a regulation that may narrow the reach of the drug discount program. Read more.


    Let’s Put People Ahead of Big Pharma and Protect 340B

    November 11, 2014—The midterm election results are great news for Republicans and the country. We now have the opportunity to demonstrate how we can govern. Let’s start by putting people first in addressing the skyrocketing cost of prescription medicines. And while we are at it, let’s block the drug industry’s effort to gut an important drug discount program. Read more.


    Hospitals Manipulate Drug Program for Poor

    November 11, 2014—Health insurance costs are set to jump dramatically. A new report from the Centers for Medicare and Medicaid Services found average premiums will rise nearly 7 percent in 2014—and then continue to increase by at least 5 percent annually over the next decade. The rising cost of insurance is putting a squeeze on American families. And this problem could get even worse if lawmakers don’t fix a little-known federal drug program called “340B.” Read more.


    Separating Fact from Fiction in the Latest 340B Data

    November 5, 2014—Recent growth is certainly not the direct result of profits derived from drug savings realized through 340B participation. Unexpected windfall or fragile safety net? Affluent communities or vulnerable poor? Welfare check or supplemental provider program? Making sense of the latest 340B program study published by the journal Health Affairs depends on your perspective—and how you dice the data. As emphasized by Healthcare Finance News, the 340B discount drug program is a financial lifeline to help eligible health care organizations offset the losses incurred when treating underinsured and uninsured patients. Read more.


    How a Noble Prescription Drug Program Turned into Corporate Welfare

    November 5, 2014—Each year, one in four Americans avoids the doctor when sick or skips filling a prescription drug because of cost concerns. This is a huge problem. When patients forego needed medications, their health deteriorates, often to the point of requiring expensive and invasive in-hospital care. The problem of drug access is particularly pronounced in rural areas. The per-capita annual income of people living outside of cities is $7,400 less than that of their urban counterparts. Rural residents are much more likely to be unable to afford needed medications. Read more.