RxStrategies Clinical Insights — August 2015 Issue 1

    Welcome to the August 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

    Odomzo® (sonidegib)

    July 24, 2015 — The U.S. Food and Drug Administration approved Odomzo® (sonidegib) to treat patients with locally advanced basal cell carcinoma that has recurred following surgery or radiation therapy, or patients who are not candidates for surgery or radiation therapy. Skin cancer is the most common cancer and basal cell carcinoma accounts for approximately 80 percent of non-melanoma skin cancers. Read more.

    Daklinza® (daclatasvir)

    July 24, 2015 — The U.S. Food and Drug Administration approved Daklinza® (daclatasvir) for use with sofosbuvir to treat hepatitis C virus (HCV) genotype 3 infections. Daklinza is the first drug that has demonstrated safety and efficacy in treating genotype 3 HCV infections, without the need for co-administration of interferon or ribavirin—two FDA-approved drugs also used to treat HCV infection. Read more.

    Praluent® (alirocumab) Injection

    July 24, 2015 — The U.S. Food and Drug Administration approved Praluent® (alirocumab) injection, the first cholesterol-lowering treatment approved in a new class of drugs known as proprotein convertase subtilisin kexin type 9 (PCSK9) inhibitors. Praluent is approved for use in addition to diet and maximally tolerated statin therapy in adult patients with heterozygous familial hypercholesterolemia (HeFH), or for patients with clinical atherosclerotic cardiovascular disease ( heart attacks or strokes), who require additional lowering of LDL cholesterol. Read more.

    Rexulti® (brexpiprazole)

    July 10, 2015 — The U.S. Food and Drug Administration approved Rexulti® (brexpiprazole) tablets to treat adults with schizophrenia, and as an add-on treatment to an antidepressant medication to treat adults with major depressive disorder (MDD). Schizophrenia is a chronic, severe and disabling brain disorder affecting about one percent of Americans. Read more.

    Entresto™ (sacubitril and valsartan)

    July 7, 2015 — The U.S. Food and Drug Administration approved Entresto™ (sacubitril/valsartan) tablets for the treatment of heart failure. The drug has been shown to reduce the rate of cardiovascular death and hospitalization related to heart failure. Heart failure is a common condition affecting about 5.1 million people in the United States. It is a condition in which the heart can’t pump enough blood to meet the body’s needs. Read more.

    Orkambi™ (lumacaftor and ivacaftor)

    July 2, 2015 — The U.S. Food and Drug Administration approved the first drug for cystic fibrosis, directed at treating the cause of the disease in people who have two copies of a specific mutation. Orkambi™ (lumacaftor 200 mg/ivacaftor 125 mg) is now approved to treat cystic fibrosis (CF) in patients 12 years and older, who have the F508del mutation, which causes the production of an abnormal protein that disrupts how water and chloride are transported in the body. Having two copies of this mutation (one inherited from each parent) is the leading cause of CF. Read more.



    New Formulation Approval 

    Technivie™ (ombitasvir, paritaprevir and ritonavir)

    July 24, 2015 — The U.S. Food and Drug Administration approved Technivie™ (ombitasvir, paritaprevir and ritonavir) for use in combination with ribavirin for the treatment of hepatitis C virus (HCV) genotype 4 infections in patients without scarring and poor liver function (cirrhosis). Technivie, in combination with ribavirin, is the first drug that has demonstrated safety and efficacy to treat genotype 4 HCV infections without the need for co-administration of interferon, an FDA-approved drug also used to treat HCV infection. The active ingredients combination was previously approved in (ombitasvir, paritaprevir and ritonavir) in Viekira Pak™. Read more. 

    Epiduo® Forte (adapalene and benzoyl peroxide) Gel

    July 16, 2015 — Galderma Laboratories, L.P. announced the U.S. Food and Drug Administration approved antibiotic-free Epiduo® Forte (adapalene and benzoyl peroxide) Gel, 0.3%/2.5%, for the once-daily, topical treatment of acne vulgaris. Acne is the most common skin condition in the United States, affecting more than 40 to 50 million people. Epiduo Forte Gel is the first combination of these strengths of the retinoid, adapalene and benzoyl peroxide, developed for moderate to severe acne. Read more.

    Envarsus® XR (tacrolimus extended-release tablets)

    July 10, 2015 — Veloxis Pharmaceuticals A/S announced U.S. Food and Drug Administration approval of Envarsus® XR (tacrolimus extended-release tablets) for the prophylaxis of rejection in kidney transplant patients, who require or desire conversion from other twice-daily tacrolimus products to once-daily Envarsus XR. Veloxis expects Envarsus XR to be available to patients in the United States and their physicians in 4Q2015. Envarsus XR is an extended release formulation of tacrolimus designed for once-daily dosing, with flatter pharmacokinetics and greater bioavailability compared to twice-daily tacrolimus. Read more.

    Tuxarin ER® (chlorpheniramine and codeine)

    July 2, 2015 — The U.S. Food and Drug Administration has granted approval for Spriaso’s new drug application (NDA) for Tuxarin ER®, a high-strength, long-acting Rx cough/cold combination product containing codeine and chlorpheniramine. Jointly developed with Nexgen Pharma, Tuxarin ER will be the first product to provide long-lasting cough suppression, with a safer opiate that is less prone to respiratory distress, while minimizing serious risk of dosing errors in patients 18 years and older. The company said Tuxarin ER, as a convenient solid unit dose form, is easy to dispense and overcomes disadvantages associated with acting liquids that are prone to spills and dosing errors. Read more.



    New Indication Approval 

    Kyprolis® (carfilzomib)

    July 24, 2015 — The U.S. Food and Drug Administration approved carfilzomib (Kyprolis®, Onyx Pharmaceuticals, Inc., an Amgen subsidiary), in combination with lenalidomide and dexamethasone, for the treatment of patients with relapsed multiple myeloma, who have received one to three prior lines of therapy. The approval was based on a demonstration of improved progression-free survival (PFS) in a multicenter, open-label trial (PX-171-009 ASPIRE). The trial enrolled 792 patients with relapsed or refractory multiple myeloma after one to three lines of prior therapies. The patients were randomized (1:1) to receive lenalidomide and dexamethasone, with or without carfilzomib, for 18 cycles. Lenalidomide and dexamethasone were continued thereafter until disease progression. Read more. 

    Iressa® (gefitinib)

    July 13, 2015 — The U. S. Food and Drug Administration approved gefitinib (Iressa®) for the treatment of patients with metastatic non-small cell lung cancer (NSCLC), whose tumors have epidermal growth factor receptor (EGFR) exon 19 deletions or exon 21 (L858R) substitution mutations, as detected by an FDA-approved test. This approval of gefitinib is being approved concurrently with a labeling expansion of the therascreen EGFR RGQ PCR Kit, a companion diagnostic test for patient selection. Read more.

    Fycompa® (perampanel hydrate)

    June 22, 2015 — Eisai Co., Ltd. announced its U.S. subsidiary Eisai Inc. has received approval from the U.S. Food and Drug Administration for an indication expansion, regarding the use of its in-house developed antiepileptic agent Fycompa® (perampanel hydrate) as an adjunctive treatment of primary generalized tonic-clonic (PGTC) seizures in patients, 12 years of age and older, with epilepsy. Read more.



    New Generic Approval

    Almotriptan malate (Axert®)

    July 8, 2015 — Teva Pharmaceutical Industries Ltd. announced the launch of generic Axert® (almotriptan malate) tablets, 6.25 mg and 12.5 mg, in the United States. Teva was the first applicant to submit an Abbreviated New Drug Application (ANDA) for almotriptan malate tablets containing a Paragraph IV patent certification. Teva is the first applicant to receive approval and will have a period of market exclusivity until the pediatric exclusivity associated with the only patent for Axert® expires on November 7, 2015. Read more.

    Aspirin/extended-release dipyridamole (Aggrenox®)
    July 1, 2015 — Teva Pharmaceutical Industries Ltd. announced the launch of generic Aggrenox® (aspirin/extended-release dipyridamole) capsules in the United States. Aspirin and extended-release dipyridamole capsules are used to lower the risk of stroke in people who have had a mini-stroke (transient ischemic attack or TIA) or stroke due to a blood clot. Read more.



    New Drug Shortage

    July 22, 2015

    July 13, 2015

    July 9, 2015



    Drug Recall Alert 

    Adrucil (fluorouracil injection, USP) 5 g/100 mL (50 mg/mL)

    July 27, 2015 — Teva Parenteral Medicines announced a voluntary recall of six lots of Adrucil (fluorouracil injection, USP) 5 g/100 mL (50 mg/mL), due to the potential presence of particulate matter, identified as aggregate of silicone rubber pieces from a filler diaphragm, and fluorouracil crystals. Read more.

    0.9 Percent Sodium Chloride Injection, USP, 50mL and 100mL

    July 20, 2015 — Baxter International Inc. announced it is voluntarily recalling two lots of intravenous (IV) solutions to the hospital/user level, due to the potential presence of particulate matter. The particulate matter in each case was determined to be an insect and was identified as a result of a customer complaint. Read more.



    Drug Safety Alert

    Proglycem® (diazoxide)

    July 16, 2015 — The FDA warned that a serious lung condition called pulmonary hypertension, which is high pressure in the blood vessels leading to the lungs, has been reported in infants and newborns treated with Proglycem® (diazoxide) for low blood sugar. In all cases, the pulmonary hypertension resolved or improved after Proglycemwas stopped. The FDA is continuing to investigate this safety issue and will determine whether changes are needed in the Proglycem prescribing information. Read more.

    Unapproved Prescription Ear Drop (Otic) Products

    July 1, 2015 — The FDA announced its intention to take enforcement action against companies that manufacture and/or distribute certain unapproved prescription ear drop products (known as otic products), labeled to relieve ear pain, infection and inflammation. The unapproved prescription ear drops contain active ingredients, such as benzocaine and hydrocortisone, and have not been evaluated by the FDA for safety, effectiveness and quality. The labels on these products do not disclose that they lack FDA approval, and health care professionals may not be aware of their unapproved status. Read more.



    Clinical and Pharmacy News

    Adverse Drug Event Data Is Available: Why Isn’t It Being Used?

    July 29, 2015 — The Food and Drug Administration (FDA) recently received kudos for partnering with social media and online communities to track adverse drug events reported by patients. While this sounds like good news, the fact is the FDA already tracks these events. In fact, the agency has logged more than 5 million reports (and counting) linked to more than 2,000 approved drugs. So, isn’t it good for the FDA to gather even more information directly from patients? Unfortunately, the answer is no. At least not until things change, because much of this valuable data is never used. Read more.

    Health Care Reform 2015: As Pharmacists Push For a Bigger Role in Healthcare, Doctors Flinch

    July 29, 2015 — There’s a joke in healthcare that pharmacists are the most overqualified professionals in the industry. Pharmacy students learn to do everything from counseling diabetic patients to administering high-risk anticoagulation therapy. But once they graduate, most revert to dispensing pills because a pharmacy’s revenue depends on the throughput of medicine. Read more. [RG3]

    DEA Can Improve Communications with Pharmacists, Manufacturers, Says GAO

    July 28, 2015 — A report released by the Government Accountability Office concludes the lack of effective communications between the DEA and both chain pharmacy headquarters and pharmaceutical distributors has affected legitimate access to analgesics. Both community pharmacies and distributors still request improved guidance and a greater degree of interaction with DEA, though the agency does not concur, the report noted. Read more. 

    Pharmacy Recalls Compounded Drugs Due to Sterility Concerns

    July 28, 2015 — A pharmacy in Washington is recalling unexpired human and veterinary compounded drugs due to concerns about their sterility. Moses Lake Professional Pharmacy compounded these recalled products between July 21, 2014 and July 21, 2015. The drugs were then dispensed to patients or distributed to physicians to administer to patients in Arizona, Idaho, Florida, Oregon, Texas, and Washington. Read more.

    How a Hugely Overpriced Hepatitis Drug Helped Drive Up U.S. Health Spending

    July 28, 2015 — There’s one especially eye-catching number in a new report by Medicare actuaries about U.S. health care spending: 12.6%. That’s the leap in prescription drug spending last year over the year before. How sharp an increase is it? It was five times as much as the increase of 2013 over 2012, which was a mere 2.5%. Read more.

    Can the U.S. Afford New Prescription Drugs Headed to the Market?

    July 28, 2015 — After enjoying a historically low rate of growth in health care spending, patients, the government and private insurers collectively are once again approaching an era of acceleration—though growth rates during the next 10 years still aren’t projected to reach the high levels that defined the period leading up to the Great Recession. Read more.

    DEA to Lead another Drug Take-Back Day

    July 28, 2015 — Expanding upon efforts to safely dispose of unused prescription drugs, the Drug Enforcement Administration (DEA) has announced plans for the 10th National Prescription Drug Take-Back Day. In a media teleconference, DEA Acting Administrator Chuck Rosenberg discussed the background of the events and explained why the administration continues to lead them. Read more.

    Teva to Acquire Allergan Generics for $40.5 Billion, Creating a Transformative Generics and Specialty Company Well Positioned to Win in Global Health Care

    July 27, 2015 — Teva Pharmaceutical Industries Ltd. announced it has signed a definitive agreement with Allergan plc to acquire Allergan Generics in a transaction valued at $40.5 billion. Upon closing, Allergan will receive $33.75 billion in cash and shares of Teva, valued at $6.75 billion, representing less than a 10% ownership stake in Teva. Read more. 

    Insurance Companies Start to Bring PBM In-House: CVS Health’s PBM Business Could Be Under Threat

    July 27, 2015 — There is abundant mergers and acquisitions in the health care sector. Be it health insurance providers, pharmacy benefit managers or drug retailers, there has been consolidation, both horizontal and vertical, in this sector. Usually, such widespread interest in consolidation is seen in rather mature industries, where growth rates are slowing down towards a (lower) long-term rate. But, the case is different with the health care sector, specifically in pharmacy benefit management. More than 30 million people are expected to come under insurance coverage, which will increase access to health care and lead to a higher number prescriptions filled. Read more. 

    FDA Approves New Cholesterol Drug—at $14,600 a Year

    July 27, 2015 — Up to 10 million Americans will soon have a new option for lowering their cholesterol—at a price of $14,600 a year. The Food and Drug Administration surprised much of the medical community by broadly approving a new cholesterol drug for a vast potential patient population. The agency approved Praluent for people with an inherited condition that causes very high levels of LDL, or bad cholesterol, as well as for the millions of Americans who have had heart attacks, strokes or other types of heart disease and whose LDL is higher than it should be. Read more.

    Prescription for Cheaper Drugs Contested

    July 26, 2015 — A battle is brewing over letting Medicare negotiate drug prices; a power some doctors say is needed to curb high drug prices, but opponents argue is unnecessary. Advocates say providing Medicare negotiating power would lead to lower prices on breakthrough treatments, which could strain federal and state budgets if prices aren’t reduced. The pharmaceutical industry and a health care transparency organization say it won’t save money because private-sector organizations already negotiate for lower prices. Read more.

    Biosimilar Substitution: A Primer for Pharmacists

    July 26, 2015 — With biosimilars set to enter the U.S. health care market, pharmacists will soon have new factors to consider when selecting and dispensing products. For those unfamiliar with biosimilars and their potential interchangeability, researchers from the University of New England College of Pharmacy recently outlined important issues and considerations in the Journal of Managed Care & Specialty Pharmacy. Read more. 

    Anthem to Buy Cigna for $54 Billion, Creating Nation’s Largest Insurer

    July 24, 2015 — Industry giant Anthem Inc. reached a $54-billion deal to buy rival Cigna Corp., creating the country’s biggest health insurer and triggering concerns about the immense power it could wield with employers and medical providers. The merger capped weeks of frenzied deal-making that could result in Anthem, along with just two other major companies, dominating the U.S. health insurance business. Read more. 

    Ruling: Washington Can Require Pharmacies to Dispense Plan B

    July 23, 2015 — The state of Washington can force pharmacies to dispense Plan B, and other emergency contraceptives, a federal appeals court said in a long-running lawsuit brought by pharmacists, who said they have religious objections to providing the drugs. The unanimous decision by the three-judge panel of the 9th U.S. Circuit Court of Appeals overturned a 2012 ruling by U.S. District Court Judge Ronald B. Leighton, who found the state’s rules violated the religious freedom of pharmacy owners. It was the second time the appeals court reversed Leighton in the case. Read more.

    Specialty Pharmacies Proliferate, Along with Questions

    July 23, 2015 — As the end of each month nears, Megan Short frets. Her 1-year-old daughter, Willow, cannot afford to miss even a single dose of a drug she takes daily to prevent her body from rejecting her transplanted heart. Because of stringent rules from her drug plan and the pharmacy she is required to use, Ms. Short cannot order a refill until her monthly supply is three-quarters gone. Yet processing a refill takes about seven days, making it touch and go whether the new shipment will arrive before the old one runs out. Read more.

    Drug Prices Soar, Prompting Calls for Justification

    July 23, 2015 — As complaints grow about exorbitant drug prices, pharmaceutical companies are coming under pressure to disclose the development costs and profits of those medicines, to rationalize what they charge. So-called pharmaceutical cost transparency bills have been introduced in at least six state legislatures in the last year, aimed at making drug companies justify their prices, which are often attributed to high research and development costs. Read more.

    Will the High Cost of Vertex’s New Cystic Fibrosis Drug Push the U.S. to European-Style Pricing?

    July 22, 2015 — Recently, Vertex received approval for a new two-drug therapy called Orkambi, designed to treat 8,500 cystic fibrosis patients, over the age of 12, who have the most common mutation for this disease. Vertex has priced this drug at $259,000 per patient annually and, not surprisingly, many are outraged. As reported by the Boston Globe’s Robert Weisman, a group of prominent cystic fibrosis physicians are battling Vertex over the price. Read more. 

    How High? The Backlash Over Rising Prescription Drug Prices Gains Steam

    July 21, 2015 — If you had any doubt that prescription drug prices are the proverbial hot potato for the pharmaceutical industry, consider some recent developments. The Laura and John Arnold Foundation plans to give a $5.2 million grant to the Institute for Clinical and Economic Review, a non-profit that examines the value of new medicines, so it can double its staff and produce more reports suggesting benchmark prices for up to 20 drugs over two years, according to The Wall Street Journal. Read more.

    What Do You Do When Your Prescription Costs $34,000 a Year?

    July 20, 2015 — As more expensive specialty drugs come on the market to treat serious chronic diseases, states are stepping in to cushion the financial pain for patients needing medicine that can cost hundreds of thousands of dollars a year. At least seven states—Delaware, Louisiana, Maine, Maryland, Montana, New York and Vermont—limit the out-of-pocket payments of patients in private health plans. Read more.

    Independent Community Pharmacists Document Underpayment for Generic Drugs by Secretive PBM Corporations

    July 20, 2015 — The National Community Pharmacists Association (NCPA) has compiled new evidence to further substantiate the need for federal sunshine legislation (H.R. 244, the MAC Transparency Act), for more insight into below-cost reimbursements from PBM (pharmacy benefit manager) corporations that do not keep pace with rising market costs for generic prescription drugs. NCPA recently asked its members for examples detailing the costs they incurred to acquire drugs, versus the reimbursement they received when they filled the prescriptions. Read more.

    Attention Pharmacists: How Are You Catching Prescription Opioid Pharmacy Shoppers?

    July 15, 2015 — Identifying patients who might be more likely than others to overdose on opioids could save lives, if pharmacies could agree on what to look for in addictive behaviors. The signs might be found in the data available to pharmacists across the country. Published in the Journal of Pain, a report revealed that nearly 50 percent of deaths attributed to prescription painkillers were Medicaid recipients. The study also concluded that abusers tend to use several pharmacies to fill their prescriptions. Read more.

    Aetna to Buy Humana for $37 Billion in Largest Insurance Industry Deal

    July 3, 2015 — Health insurer Aetna Inc said it would buy smaller rival Humana Inc for about $37 billion in cash and stock. The combination will push Aetna close to Anthem Inc’s No. 2 insurer spot by membership, and would nearly triple Aetna’s Medicare Advantage business. Read more.



    340B in the News

    Transparency: The Best Medicine for 340B Drug-Pricing Program

    July 27, 2015 — If ever a well-intentioned government program was trusted too much and verified too little, it’s the 340B Drug Pricing plan, created by Congress in 1992 to help indigent and uninsured patients acquire costly prescription medicines. The policy forces manufacturers to sell those drugs to participating hospitals at reduced rates; some price at more than 50 percent below retail. However, a lack of proper oversight combined with passage of the Affordable Care Act has resulted in collusion between big hospitals, big pharmacies and big government, causing an explosion in the size of 340B. Read more.

    GAO Report Concludes Prescribing Incentives Exist at 340B Hospitals

    July 27, 2015 — According to a report released July 6, 2015 by the Government Accountability Office, hospitals that qualify to participate in the 340B Drug Pricing Program, by serving a disproportionate share of low-income patients (340B DSH hospitals), had higher rates of per‑beneficiary Medicare Part B drug spending than non‑340B hospitals in 2008 and 2012. Read more. 

    Time to End Abuse of Drug Discount Program

    July 24, 2015 — If there’s one universal truth in Washington D.C. politics, it’s that policymakers don’t want the public to know about well-intended government programs that have run amok. In March, the health subcommittee of the Energy and Commerce Committee in the U.S. House sought to change that by holding the first hearing on the 340B Drug Pricing Program in nearly a decade. Read more.  

    Letter: Don’t Eliminate 340B Drug Pricing Program

    July, 19, 2015 — Too often in our nation’s capital the slogan is “Fix it ‘till it’s broke.” Missourians know this all too well. As folks in cities and towns around our state—and across the country—grapple with serious challenges to patient access, there’s an effort afoot in Washington D.C. that could undermine a program that doesn’t need fixing. Read more.

    Don’t Cut Program that Cuts Cost of Prescription Drugs

    July 17, 2015 — Even with the Affordable Care Act, health care options for many Americans must take a backseat to other daily expenses, due to the struggle to pay for the soaring cost of prescription drugs. Unfortunately, while prescription drugs costs are rising faster than ever, a critical federal program that helps to discount drugs for those receiving care through qualifying hospitals is at risk. The Public Health Service 340B Drug Pricing Program helped provide about $3.8 billion in drug discounts in 2013—around 2 percent of the $325 billion in total U.S. spending on prescription drugs. Read more. 

    Apexus Launches New Online Education Program Aimed to Improve 340B Compliance

    July 13, 2015 — Apexus, the nation’s leading source of information about the 340B Drug Pricing Program, has released a new online educational resource for the growing number of health care professionals working in the 340B field. The program’s content has been reviewed and certified by the U.S. Health Resources and Services Administration (HRSA), as consistent with its interpretation of federal 340B policy. Read more.

    Acquisitions by 340B Hospitals Drive up Health Care Costs

    July 10, 2015 — As the 340B Drug Pricing Program has ballooned in size over the last several years, some hospitals are getting creative about how to make the program work for their own financial gain. Of course, this comes at the expense of the uninsured or vulnerable patients the program was created to help. One of the latest trends is an increase in acquisitions of independent physician practices by 340B-participating hospitals. According to a new report from Avalere Health, 340B hospitals make up a disproportionate fraction of U.S. hospitals. Read more. 

    Hospitals Slam GAO Finding that 340B Drug Discounts Fuel Prescribing

    July 7, 2015 — Hospitals say the U.S. Government Accountability Office used faulty methodology when it determined hospitals that serve large numbers of low-income patients abuse a federal drug discount by overprescribing medications. The GAO report found that in both 2008 and 2012, per-beneficiary Medicare Part B drug spending, including oncology drug spending, was substantially higher at hospitals utilizing the 340B discount than at other hospitals. Read more.

    GAO Wants Financial Incentives Removed From 340B Drug Program, Cites Abuse

    July 7, 2015 — The Government Accountability Office believes Congress should slash the financial incentives the government pays hospitals in the 340B Drug Pricing Program, it said in a new report detailing concerns that participating hospitals are disproportionately prescribing more than other facilities. The 340B program currently gives incentives for health care providers to prescribe more drugs and more expensive drugs to treat Medicare Part B beneficiaries, according to the report. Read more.