RxStrategies Clinical Insights – April 2015 Issue 1

    Welcome to the April 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 Approvals

    Corlanor® (ivabradine)
    April 15, 2015 – The U.S. Food and Drug Administration approved Corlanor® (ivabradine) to reduce hospitalization from worsening heart failure. Corlanor® is approved for use in certain people who have long-lasting (chronic) heart failure caused by the lower-left part of their heart not contracting well. The drug is indicated for patients who have symptoms of heart failure, are stable, have a normal heartbeat (with a resting heart rate of at least 70 beats per minute) and are also taking beta blockers at the highest dose they can tolerate. Read more.


    New Drug Formulation

    Minocin® (minocycline) for Injection
    April 20, 2015 – The Medicines Company announced the U.S. Food and Drug Administration has approved a supplemental new drug application (sNDA) for a new formulation of Minocin® (minocycline) for Injection. The FDA has also granted Qualified Infectious Disease Product (QIDP) designation for the new formulation of Minocin® for Injection under the Generating Antibiotic Incentives Now Act (GAIN Act). The designation, the third granted to a product in the company’s infectious disease portfolio, would qualify Minocin® for Injection for priority review and five years of marketing exclusivity, upon an approval of the additional potential indications. Read more.

    ProAir® RespiClick (albuterol sulfate) Inhalation Powder
    April 1, 2015 – Teva Pharmaceutical Industries Ltd. announced the U.S. Food and Drug Administration has approved ProAir® RespiClick (albuterol sulfate) inhalation powder, for the treatment or prevention of bronchospasm in patients 12 years of age and older with reversible obstructive airway disease, and for the prevention of exercise-induced bronchospasm (EIB) in patients 12 years of age and older. It is expected to become commercially available to patients during the second quarter of 2015. ProAir® RespiClick is the first breath-actuated, dry-powder Short-Acting Beta-Agonist (SABA) inhaler to be approved by the FDA. Read more.

    JadenuTM (deferasirox) Tablets
    March 30, 2015 – Novartis announced the U.S. Food and Drug Administration has approved JadenuTM (deferasirox) tablets, a new oral formulation of Exjade® (deferasirox) tablets for oral suspension, for the treatment of chronic iron overload due to blood transfusions in patients 2 years of age and older, and chronic iron overload in non-transfusion-dependent thalassemia syndromes (NTDT) in patients 10 years of age and older. Jadenu is the only once-daily oral iron chelator that can be swallowed whole.
    Read more.


    New Drug Indication

    BOTOX® (OnabotulinumtoxinA)
    April 20, 2015 – Actavis plc announced the U.S. Food and Drug Administration approved an expansion of the BOTOX® (onabotulinumtoxinA) label for the treatment of adults with upper limb spasticity. The expanded label now includes the addition of two thumb muscles: flexor pollicis longus, a muscle in the forearm that flexes the thumb, and adductor pollicis, a muscle in the hand that functions to adduct the thumb. This approval increases the maximum dose from 360 to 400 units for the treatment of upper limb spasticity. The FDA also approved an increase to the maximum BOTOX® cumulative dose within three months from 360 to 400 units in adults treated for one or more indications. Read more.


    New Generic Approval

    GlatopaTM (glatiramer acetate injection)
    April 16, 2015 – Sandoz, a Novartis company, announced the U.S. approval of GlatopaTM, the first generic version of Teva’s Copaxone® (glatiramer acetate injection), a 20 mg/ml, one-time-daily, multiple sclerosis therapy. Read more.

    Norethindrone and Ethinyl Estradiol Tablets (Chewable) 0.8 mg/0.025 mg and Ferrous Fumarate Tablets, 75 mg (Chewable)
    April 7, 2015 – Mylan N.V. announced the U.S. launch of Norethindrone and Ethinyl Estradiol Tablets (Chewable), 0.8 mg/0.025 mg, and Ferrous Fumarate Tablets, 75 mg (Chewable), which is the generic version of Warner Chilcott’s Generess® Fe Tablets. Mylan’s partner, Famy Care Ltd., received final approval from the U.S. Food and Drug Administration for its Abbreviated New Drug Application (ANDA) for this product, which is indicated for the prevention of pregnancy in women who elect to use oral contraceptives as a method of contraception. Read more.


    New Drug Shortage

    April 10, 2015
    Calcium Gluconate Injection (Currently in Shortage)


    Drug Safety Alerts

    Flurbiprofen-Containing Topical Pain Medications
    April 17, 2015 – The FDA is alerting pet owners, veterinarians, health care providers and pharmacists that pets are at risk of illness and death when exposed to topical pain medications containing the nonsteroidal, anti-inflammatory drug, (NSAID) flurbiprofen. People using these medications should use care when applying them in a household with pets, as even very small amounts could be dangerous to animals. The FDA received reports of cats in two households that became ill or died after their owners used topical medications containing flurbiprofen on themselves to treat muscle, joint or other pain. Read more.

    Feraheme® (ferumoxytol)
    March 31, 2015 – The FDA is strengthening an existing warning that serious, potentially fatal, allergic reactions can occur with the anemia drug Feraheme® (ferumoxytol). The FDA changed the prescribing instructions and approved a boxed warning, FDA’s strongest type of warning, regarding these serious risks. Also added is a new contraindication, a strong recommendation against use of Feraheme® in patients who had an allergic reaction to any intravenous (IV) iron replacement product. Read more.


    Drug Recall Alert

    Intravenous (IV) Solutions (Select Lots) by Baxter
    April 10, 2015 – Baxter International Inc. is voluntarily recalling select lots of intravenous (IV) solutions to the hospital/user level, due to the potential presence of particulate matter. Intravenous administration of a solution containing sterile particulate matter may lead to adverse health consequences. The extent and severity of harm depends on the size, number and composition of the foreign material, and a patient’s underlying medical condition. In the absence of in-line filtration, these particles may cause: local vein irritation, inflammatory reaction, aggravation of preexisting infections, allergic reactions and systemic embolization. In high-risk patients, this may lead to serious adverse health consequences. Read more.  


    Clinical and Pharmacy News

    Prescription Drug Abuse is Lower, but Heroin Use Up: Study
    April 20, 2015 – Recent changes in the prescription drug market may have helped curb abuse of a class of prescription drugs known as opioids, but it may have also fueled a comparable rise in heroin use. Researchers examining insurance data over the course of about a decade found the introduction of a special form of the branded opioid OxyContin that’s harder to abuse, and the withdrawal from the market of another widely abused opioid in the same year. Both occurances coincided with drops in the amount of opium-containing drugs prescribed and the number of overdoses suffered by abusers.
    Read more.

    Double-Digit Cost Hike Predicted for Pharmacy Drugs
    April 20, 2015 – Driven by the developmental and retail costs of specialty drugs, and a less-than-robust generic drug market, pharmaceutical price increases will move into the double-digit range by 2016, via an analysis of cost factors by Aon Hewitt forecasts. The results emerged from an actuarial analysis of medical trend cost information from client experience, government sources and carriers to third-party sources. Read more.

    Implementation Strategy to Bring Medication Therapy Management into High-Volume Community Pharmacies
    April 20, 2015 – For more than a decade, the formal term medication therapy management (MTM) has been used to describe the crucial suite of services pharmacists can provide that make them indispensable in the health care field. Before the advent and recognition of MTM, pharmacists tended to be seen as mere medication dispensers and as sources for quick health care consultations or advice. As MTM opportunities increased, however, pharmacists moved closer to being accepted as sophisticated health care practitioners and to being recognized for their unmatched ability to provide crucial, individualized medication recommendations that help to optimize patient care.
    Read more. 

    Why Walgreens Won’t Buy a PBM Anytime Soon
    April 18, 2015 – While Walgreens Boots Alliance (WBA) appears open to deal-making, even while merging two giant drugstore chains and shedding $1.5 billion in costs over the next three years, its biggest individual shareholder and current CEO doesn’t appear ready to buy a pharmacy benefit management firm. Read more.

    How Pharmacy Graduates Can Get Rid of $100k of Student Loans
    April 18, 2015 – Graduates of pharmacy school have more student debt than almost any other profession. In 2012, graduates entering the workforce had an average student loan debt of $123,063. Luckily, pharmacists who enter the private sector will likely make a salary that allows them to responsibly pay the large amount back. Read more.  

    Hurdles Remain for Biosimilars—Including Savings
    April 16, 2015 – Is the March FDA approval of Zarxio, Sandoz’s filgrastim biosimilar: a) the dawning of a new age of access to low-cost, complex biologic agents in the United States, or b) the first step on a long road to convincing stakeholders of the drugs’ savings potential, safety and efficacy? Experts speaking at a recent symposium on biosimilars tended toward the latter camp. Read more.

    Itraconazole Drug Shows Potential in Cancer TreatmentItraconazole drug shows potential in cancer treatment
    April 16, 2015 – An anti-fungal drug shows promise as a potential new cancer treatment. A common anti-fungal treatment has joined the ranks of drugs that may be suitable for use in treating cancer, according to research from the Repurposing Drugs in Oncology (ReDO) project published in ecancermedicalscience. The ReDO project is an international collaboration of anticancer researchers dedicated to promoting the cause of common medicines, which may represent an untapped source of novel therapies for cancer.
    Read more.

    $373.9 Billion Spent on Drugs in 2014
    April 15, 2015 – Drug spending in the United States last year was one for the record books. Pharmacists filled a record 4.3 billion prescriptions in 2014 that cost nearly $374 billion, according to a new report issued by the IMS Institute for Healthcare Informatics. Read more.

    Endo Guidelines Keep Cholesterol Targets in T2D
    April 15, 2015 – Cholesterol targets stay, according to new, more comprehensive American Association of Clinical Endocrinologists (AACE) guidelines for Type 2 diabetes management that address both glycemic control and risk factors. The group did not endorse the American Heart Association/American College of Cardiology (AHA/ACC)’s lipid and obesity guidelines in 2013, which controversially eliminated LDL goals and called for its members to use AACE guidelines instead. Read more.

    Adherence to Blood Thinner Best with Pharmacist Management, Researcher Says
    April 15, 2015 – Researchers found that adherence to a new-generation anticoagulant, used to prevent stroke in heart disease patients, is best at sites with pharmacist-led management. Patients are more likely to take a new type of blood thinner correctly, and without missing doses, when they are managed by pharmacists, rather than only by doctors or nurses, according to a study co-authored by a researcher at the Stanford University School of Medicine. Read more.

    Feds to Probe Impact of Generic Drug Price Increases on Medicaid
    April 14, 2015 – Following prodding from Congressional lawmakers, the Office of the Inspector General of the U.S. Department of Health & Human Services says it will conduct a new review of generic drug price increases on the Medicaid drug rebate program. The agency plans to review price increases between 2005 and 2014, in order to determine the extent to which generic drug prices exceeded the inflation rate, according to a letter the OIG sent to U.S. Sen. Bernie Sanders (I-Vt.) and U.S. Rep. Elijah Cummings (D-Md.). Read more.

    Specialty Drugs Are Driving Up the U.S. Medication Spend – Indeed a Prime Revenue Opp
    April 14, 2015 – Need proof that orphan indication’s the way to go? The demand for specialty medications—and their premium pricing—is driving up the total American spend on medication, a new study says. A revenue darling for most budding biotechs, specialty drugs accounted for $124.1 billion of medication dollars spent, out of a total of $373.9 billion overall, according to a new study from the IMS Institute for Healthcare Informatics. Cancer, hepatitis C and autoimmune disease are the main drivers, with orphan indications filling in the gaps of the specialty medicine super-spend. Read more.

    The High Cost of Inventing New Drugs—And of Not Inventing Them
    April 11, 2015 – There is a financial cost to developing new drugs—and it’s a big one. There is also a big cost to not developing new drugs, and that cost can be both financial and human. People may be able to live with the pain that an undiscovered drug might have alleviated, but they may not be able to do all the things they would have. A cancer patient might still have a few productive years after a diagnosis, but how much would it be worth to the patient—and to society (think Steve Jobs)—if a new drug meant that extended life could be indefinite? Read more.

    Walgreens to Close 200 Stores, Boost Cost Cutting
    April 9, 2015 – Drugstore chain Walgreens Boots Alliance announced, as part of its first earnings report since it merged with European drug retailer Alliance Boots last year, plans to close about 200 U.S. stores. Walgreens, the largest U.S. drugstore chain, said it will close the stores amid plans to boost its previously announced cost-cutting initiative by $500 million. Read more.

    PBMs Just Say No to Some Drugs—But Not to Others
    April 8, 2015 – Formulary exclusions give added clout to drug companies in this day and age of high-priced medications for conditions that really aren’t so rare. As PBMs honed their tactics to manage costs and therapy, formulary design evolved from a simple arrangement of a single tier to a complex arrangement with as many as five tiers. Now, finally, the ultimate tier has been firmly established. Exclusion—tossing drugs out of a pharmacy plan—is the logical next step. Read more.

    Aetna Fined $1M after Thousands Complain about Erroneous Pharmacy Network
    April 7, 2015 – Aetna has been penalized $1 million by federal Medicare officials after thousands of people complained about the nearly 6,900 pharmacies the insurer listed as in-network, when they were really out of network. The 6,887 pharmacies were listed as in-network for 2015 on the company’s website and by its call-center customer-service representatives, according to an April 2 notice to Aetna from the federal Centers for Medicare & Medicaid Services, or CMS. Read more.

    New Guidelines Would Greatly Boost Number of Young People on Statins
    April 6, 2015 – If all doctors followed new cholesterol guidelines aimed at children, almost half a million Americans aged 17 to 21 would be prescribed a cholesterol-lowering statin drug, a new study predicts. In 2011, the U.S. National Heart, Lung, and Blood Institute (NHLBI) issued new guidelines on reducing heart disease in adolescents and young adults. Those guidelines recommended that all people aged 17 to 21 get their blood cholesterol levels checked and initiate statin treatment above a certain level.
    Read more.

    ADHD Treatment: Too Much Medication, Too Little Therapy
    April 4, 2015 – All children have those days when they’re bouncing off the walls, but kids with ADHD may need more help than average to manage their behavior. And the kind of help they get may make a big difference in their health. In a first-ever national study on the topic, the Centers for Disease Control and Prevention (CDC) reported on current treatment trends for children with ADHD. Behavioral therapy was recommended as the first choice, especially for younger children, because it was the safest option. Read more.

    FDA Issues Final Guidance on the Evaluation and Labeling of Abuse-Deterrent Opioids
    April 1, 2015 – The U.S. Food and Drug Administration today issued final guidance to assist in developing opioid drug products with potentially abuse-deterrent properties. Opioid drugs provide significant benefit for patients when used properly; however, opioids also carry a risk of misuse, abuse and death. To combat opioid misuse and abuse, the FDA is encouraging manufacturers to develop abuse-deterrent drugs that work correctly when taken as prescribed, but may be formulated in such a way that deters misuse and abuse. For example, making it difficult to snort or inject the drug for a more intense high. Read more. 

    Opposition Continues Against Proposed FDA Generic Label Rule
    March 31, 2015 – Major pharmaceutical companies continue to actively oppose a yet-to-be-finalized proposed rule that would require generic drug companies to update labels on products if they receive new safety information. Generic makers currently do not have to make such changes, unless the company that developed the original version of the product does so first. The U.S. Food and Drug Administration says the rule will make it easier for generic drug companies to pass on safety information. Read more.

    New Hepatitis C Drugs Are Costing Medicare billions
    March 29, 2015 – Medicare spent $4.5 billion last year on new, pricey medications that cure the liver disease hepatitis C—more than 15 times what it spent the year before on older treatments for the disease, previously undisclosed federal data shows. The extraordinary outlays for these breakthrough drugs, which can cost $1,000 a day or more, will be borne largely by federal taxpayers, who pay for most of Medicare’s prescription drug program. But the expenditures will also mean higher deductibles and maximum out-of-pocket costs for many of the program’s 39 million seniors and disabled enrollees, who pay a smaller share of its cost, experts and federal officials said. Read more.


    340B in the News

    Save Discount Medicine Program
    April 18, 2015 – Genesis Health System is a medium-sized, not-for-profit health system that includes several critical-access hospitals in rural Iowa and Illinois. Our hospitals treat all sick people, regardless of their ability to pay. Almost 70 percent of our patients are on Medicaid or Medicare, or lack health insurance altogether. The 340B drug discount program helps us care for our neediest patients. The program requires drug companies to sell discounted medications to health-care providers that serve high numbers of low-income Medicare and Medicaid patients or those in remote, rural areas. These hospitals pass the discounts on to needy outpatients and primary care clinics that help the under-served to treat cancer, HIV/AIDS and diabetes. Read more.

    Congress Needs to be Flexible in Approach to 340B Program
    April 18, 2015 – Thanks for bringing the 340B drug discount program to the forefront with the article “Federal watchdogs seek better oversight of 340B drug discounts” (ModernHealthcare.com, March 24). Given that the recent 340B hearing was the first congressional review of the program in 10 years, it was interesting to listen to parties on both sides of the aisle agree regarding the vital importance of 340B. Read more. 

    PhRMA Presses Case For Dumping 340B Orphan Drug Rule
    April 14, 2015, – Pharmaceutical Research and Manufacturers of America is once again pushing a D.C. federal court to nix a U.S. Department of Health and Human Services interpretative rule on discounts for orphan drugs under the 340B program, arguing that the rule has legally binding consequences that are ripe for judicial review. PhRMA said in a brief that HHS has already threatened some noncompliant drug makers with administrative action that could lead to monetary penalties and the exclusion from the 340B program, or even from Medicaid entirely, placing the interpretative rule on par with a final agency action. Read more. 

    Has the 340B Program Lost Its Way?
    April 14, 2015 – When it started more than 20 years ago, the 340B prescription drug discount program sought to ensure that safety net hospitals could dispense brand name drugs to low-income patients. Today, critics accuse some participating hospitals of using the program to boost profits—perhaps at the expense of health plans and pharmacy benefit managers. What began as a well-intended program has become a textbook example of unintended consequences. Some hospitals, clinic, and health systems are buying drugs at a deep discount through a network of contract pharmacies—sometimes collecting manufacturers’ rebates on top of the discounts—dispensing them to Medicare beneficiaries and privately insured patients, and then billing at the full price. Read more.

    Pharmaceutical Company Operates with the Heart of a Nonprofit, Soul of Social Enterprise
    April 13, 2015 – A San Francisco-based pharmaceutical company is bringing a new contraceptive to the U.S. market. The product is Liletta, an intrauterine device (IUD), which, like any other IUD, is long lasting and highly effective at preventing pregnancy when inserted properly. However, the story here is not the product—it’s the company’s model as an all-in-one nonprofit, social enterprise and pharmaceutical company. “We’re showing the pharmaceutical industry that there’s another model,” Pamela Weir, chief operating officer of Medicines360, told MintPress News. That model is an affordable, accessible, 340B Drug Discount Pricing Program model, sustained not by donations, but by sales. Liletta is sold in the private sector through a distribution partner, Actavis, and Medicines360 receives a portion of the profits. Those profits directly support the company’s mission of expanding contraceptive access to women in the public sector. Read more.

    The 340B Drug Pricing Program: Keeping Up with Changes
    April 12, 2015 – Staying abreast of changes to the 340B Drug Pricing Program is critical for maintaining program compliance, especially given the increased attention to oversight in the 340B industry. The intent of the 340B Drug Pricing Program is to permit covered entities “to stretch scarce federal resources as far as possible, reaching more eligible patients and providing more comprehensive services.” The guiding principles for maintaining program integrity are to maximize oversight reach and manage compliance risk, and the strategies for meeting these are initial certification, annual recertification, program audits and site visits. Read more. 

    Congress Holds Hearing on 340B Program
    April 3, 2015 – The U.S. House of Representatives Committee on Energy and Commerce and Subcommittee on Health held a hearing on March 24, 2015 to review the functionality of the 340B Drug Pricing Program, to understand how it impacts patients, providers, manufacturers and other stakeholders. At the hearing, entitled “Examining the 340B Drug Pricing Program,” committee members heard from key witnesses from the Health Resources and Services Administration (HRSA), the Government Accountability Office (GAO) and the HHS Office of Inspector General (OIG). Read more.

    Congressional Scrutiny Over 340B Program Continues to Grow
    March 30, 2015 – A little more than a year ago, I warned about the growing abuse of the 340B Drug Pricing Program, noting that chain drug stores like Walgreens, Rite Aide and CVS Caremark could see profits fall if Congress restored sanity to a program originally designed to help the poor and uninsured. Originally the program assisted that cohort in getting the drugs they need, at a cost they could afford. It now seems a day of reckoning could be finally approaching. Congress recently held its first hearing on the 340B program since 2005, with a consensus view that the program needs some reform and transparency. Read more.

    OIG Testimonies Examine 340B Savings and Medicare Fraud
    March 25, 2015 – The Office of the Inspector General (OIG) recently posted written testimonial on 340B savings and Medicare fraud, as submitted to the House of Representatives from Ann Maxwell, Assistant Inspector General of the OIG Office of Evaluation and Inspections, and Gary Cantrell, Deputy Inspector General for Investigations in the OIG Office of Investigations. Read more.

    Cancer Drug Costs Soared in Two Decades
    March 25, 2015 – Cancer drug prices have increased 10 percent each year since 1995, even after adjusting for inflation and incremental health benefits. In 1995, 58 leading cancer drugs cost approximately $54,100 for each year of life they were expected to add. The same drugs cost approximately $207,00 for each additional year of life in 2013—an increase of about 120%, in aggregate, a new study from the Massachusetts Institute of Technology (MIT) revealed. The rising drug prices may reflect more social tolerance for significant health care costs, despite criticism by physicians and other health care groups, the authors said. Read more.