RxStrategies Clinical Insights — June/July Issue 1

    Welcome to the June/July 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

    Kengreal™ (cangrelor)

    June 22, 2015 — The U.S. Food and Drug Administration approved Kengreal™ (cangrelor), an intravenous antiplatelet drug that prevents formation of harmful blood clots in the coronary arteries, the blood vessels that supply blood to the heart. It is approved for adult patients undergoing percutaneous coronary intervention (PCI), a procedure used to open a blocked or narrowed coronary artery to improve blood flow to the heart muscle. Read more.


    New Indication Approval

    Zomig® (zolmitriptan)

    June 16, 2015 — Impax Specialty Pharma, a division of Impax Laboratories, Inc., announced the U.S. Food and Drug Administration approved Zomig® Nasal Spray for use in pediatric patients, 12 years of age and older, for the acute treatment of migraine, with or without aura. Read more.

    Promacta® (eltrombopag)

    June 12, 2015 — U.S. health regulators expanded approval of Novartis’ Promacta® to treat children with a rare blood disorder. Novartis said the U.S. Food and Drug Administration approved Promacta® (eltrombopag) for the treatment of children, six years and older, with chronic immune thrombocytopenia (ITP), who have had an insufficient response to corticosteroids, immunoglobulins or splenectomy. The drug has been approved in the U.S. for treatment of adult patients with this condition since 2008. Read more.

    Qudexy® XR (topiramate)

    June 1, 2015 — Upsher-Smith Laboratories, Inc. announced it received U.S. Food and Drug Administration approval of a supplemental new drug application (sNDA) for Qudexy® XR (topiramate) extended-release capsules for use as initial monotherapy in patients two years of age and older, who are experiencing partial-onset seizures (POS) or primary generalized tonic-clonic seizures. Read more. 

    Rapamune (sirolimus)

    May 29, 2015 — Pfizer Inc. announced U.S. health regulators approved the first drug to treat a rare, progressive lung disease. The company said the U.S. Food and Drug Administration approved its Rapamune (sirolimus) for the treatment of lymphangioleiomyomatosis (LAM), a rare, progressive disease that affects the lungs, kidneys and the lymphatic system. The disease impacts mainly women of childbearing age, and has a global incidence rate of just two to five out of every million women. Read more.


    New Generic Approval

    Guaifenesin/Pseudoephedrine – Store Brand (Mucinex® D)

    June 2, 2015 — Actavis plc and its partner Perrigo Company plc announced Actavis received U.S. Food and Drug Administration approval for its Abbreviated New Drug Application (ANDA) for guaifenesin/pseudoephedrine tablets. Perrigo will begin shipments to its retail and wholesale customers in the U.S. in time for the cough/cold season. The product will be packaged and marketed under store and proprietary brands, and will be a high quality, value alternative to Mucinex® D tablets. Read more.


    New Drug Shortage

    June 30, 2015

    Imipenem and Cilastatin for Injection, USP (Currently in Shortage)

    June 25, 2015

    Aprepitant (Emend) Capsules (Currently in Shortage)

    June 24, 2015

    Ethiodized Oil (Lipiodol) Injection (Currently in Shortage)

    June 9, 2015

    Metoprolol Tartrate Injection, USP (Lopressor) (Discontinuation)

    June 2, 2015

    Ezetimibe/Atorvastatin (LIPTRUZET) (Discontinuation)

    Nimodipine (Nymalize) Oral Solution (Currently in Shortage)


    Drug Recall Alert

    Gemcitabine for Injection and Methotrexate Injection

    June 8, 2015 — Mylan N.V. announced its U.S.-based Mylan Institutional business is expanding its voluntary nationwide recall to the hospital/user level of select lots of the following injectable products, due to the presence of visible foreign particulate matter observed during testing of retention samples. Read more.


    Drug Safety Alert

    Daytrana Patch (methylphenidate transdermal system)

    June 24, 2015 — The U.S. Food and Drug Administration is warning that permanent loss of skin color may occur with use of the Daytrana patch (methylphenidate transdermal system) for Attention Deficit Hyperactivity Disorder (ADHD). The FDA added a new warning to the drug label to describe this skin condition, which is known as chemical leukoderma. Read more. 

    Potiga (ezogabine)

    June 16, 2015 — Based on reviews of additional safety reports from patients treated with the anti-seizure drug Potiga (ezogabine), the FDA has determined the potential risks of vision loss, due to pigment changes in the retina, and of skin discoloration can be adequately managed by following the current recommendations in the Potiga labeling. To further explore any potential long-term consequences of these pigment changes, the FDA has required the Potiga manufacturer, GlaxoSmithKline, to conduct a long-term observational study. Read more.


    Clinical and Pharmacy News

    OIG Investigates Skyrocketing Gen Drug Prices

    June 25, 2015 — As soaring prices of certain widely prescribed generic drugs continue to challenge both community and hospital outpatient pharmacies, the Department of Health and Human Services’ Office of Inspector General (OIG) has begun an investigation into the impact of the increases on the Medicare rebate program. The OIG investigation was announced in a recent letter to Sen. Bernie Sanders (I-Vt.) and Rep. Elijah E. Cummings (D-Md.), who have been waging a months-long campaign to find a solution to the generic price problem. Read more.

    How to Monitor Prescription Drugs

    June 24, 2015 — Driven by a dramatic increase in prescription drug overdoses and misuse over the past decade, state prescription monitoring programs (PMPs) have gradually rolled out in 49 states. Twenty-four of those states mandate the use of PMPs by prescribers. The lone holdout is Missouri. But earlier this year, after years of opposition and delays, the state senate finally brought forth a compromise bill that would establish a PMP. Read more.

    Fraud Still Plagues Medicare’s Prescription Drug Program

    June 23, 2015 — Fraud and abuse continue to dog Medicare’s popular prescription drug program, despite a bevy of initiatives launched to prevent them, according to two new reports by the Inspector General of Health and Human Services. Their release follows the arrests of 44 pharmacy owners, doctors and others, who last week were accused of bilking the program, known as Part D. Read more.

    A Bill Would Prevent Drug Makers from Frustrating Generic Rivals

    June 23, 2015 — For the second time in less than a year, a pair of lawmakers has introduced a bill designed to end a practice that, generic drug makers complain, is used by brand-name counterparts to thwart competition. Known as the Fair Access for Safe and Timely Generics Act, the legislation follows accusations that brand-name drug makers exploit an FDA program known as Risk Evaluation and Mitigation Strategies, or REMS, which are designed to boost patient safety. Read more.

    Not Just a Pharmacy: CVS Unveils Its Digital Innovation Lab

    June 19, 2015 — Your toddler wakes you up in the middle of the night, pulling her ear. So you pull out your handy iPhone otoscope, pop it in her ear, shoot a video, and promptly send it out for diagnosis…to CVS. That’s the plan, for someday at least, as the $140 billion retail pharmacist last week unveiled its new Digital Innovation Lab near the Prudential Center in Boston. The company says the Lab will help it launch smart apps and devices to improve health care. Read more.

    First Generic for MS drug Copaxone Launches in U.S.

    June 19, 2015 — The first approved generic of the multiple sclerosis drug Copaxone launched this week, after a federal appeals court upheld a ruling Thursday that drug maker Teva Pharmaceuticals’ patent on its best-selling drug was invalid. In a 2-1 decision, the U.S. Court of Appeals for the Federal Circuit ruled against the Israeli-based pharmaceutical firm. The drug maker fought for years to delay generic competitors to its drug, which generated $4.8 billion sales worldwide in 2013. Read more.

    Preventing Readmissions with Help from Pharmacists

    June 18, 2015 — Mercy Hospital & Medical Center lowered its readmission rates using a discharge clinic staffed with a pharmacist and nurse practitioner. Ensuring that recently discharged patients recover safely and comfortably at home is one of the primary objectives of every hospital; yet, it can prove challenging. For an organization like Chicago-based Mercy Hospital & Medical Center, it was particularly so. Read more.

    CVS Buying Target’s Pharmacy Business Is Scary News For Consumers

    June 16, 2015 — CVS is buying Target’s pharmacy business for $1.9 billion. The deal means the discount retailer’s 1,660 pharmacy locations will become CVS-branded units. CVS’ acquisition could set off a series of similar deals as cost pressures hurt profits at grocery-store pharmacies, Reuters reports. Read more.

    Generic A.D.H.D. Drug, Not Equivalent to the Brand, Is in Use Anyway

    June 16, 2015 — When Dr. Louis Kraus, a chief of child psychiatry at a hospital in Chicago, writes prescriptions for patients who have attention-deficit hyperactivity disorder, he often chooses Concerta, an extended-release form of the drug Ritalin that gives patients relief from their symptoms for as long as 12 hours. He was unconcerned when, a few years ago, pharmacies began substituting lower-cost generic alternatives for brand-name Concerta. After all, generic drugs are widely seen as effective and account for the overwhelming majority of prescriptions filled nationwide. Read more.

    Generic Drug Companies Call for Fixes to GDUFA, Citing Few Returns on Investment

    June 15, 2015 — Several of the generic drug industry’s most prominent groups are calling on the U.S. Food and Drug Administration to make major changes to the program supporting one of its marquee funding sources, the Generic Drug User Fee Act (GDUFA). GDUFA is modeled off several other conceptually similar user fee programs, including the Prescription Drug User Fee Act and the Medical Device User Fee Act. Read more. 

    CVS to Buy Target’s Pharmacy Business for $1.9 Billion

    June 15, 2015 — CVS Health Corp.is paying $1.9 billion to buy and run Target Corp.’s pharmacies and clinics, creating an unusual partnership that reflects the tough economics of the prescription-drug business. CVS, already the country’s dominant provider of prescription drugs, will grow even larger under the deal. The 1,660 drugstores inside Target locations will be rebranded as CVS/pharmacy, while Target’s nearly 80 medical clinics will be changed over to CVS’s MinuteClinic banner. The companies said they would co-develop smaller format TargetExpress stores. Read more. 

    Hospital Readmissions: A Health Care Transformation

    June 11, 2015 — Various pharmacy segments have recently been focusing their attention on what they can do to reduce avoidable readmissions of patients to hospitals, including improving the discharge process. Preventable hospital readmissions currently cost the U.S. health system an estimated $25 billion annually. This is a significant avoidable cost. Because of changes in the reimbursement system, reductions in readmissions can have a positive impact on a health system’s bottom line. Read more.

    Pharmacy Delivery Startup PillPack Locks In $50 Million to Take On Walgreens

    June 3, 2015 — Pharmaceutical delivery startup PillPack raised $50 million in a growth round of Series C financing to start building retail pharmacies, and take on other retail drugstores like RiteAid and Walgreens. The startup launched in 2014 as a way to ship medications on a regular basis straight to someone’s door, instead of making them go to the pharmacy every time. Read more. 

    Here’s How Much We Spent on Prescription Drugs Last Year

    June 2, 2015 — We remain a prescription nation. Nearly 70% of Americans are taking at least one prescription drug, and more than half take two, according to researchers at the Mayo Clinic and Olmsted Medical Center. What’s more, about 20% of Americans use at least five prescription medications. That same research shows that prescription drug use has been increasing steadily in the U.S. for the past decade. Read more.


    340B in the News

    Drug Discount Supporters to Strategize on 340B Program

    June 27, 2015 — Safety net providers and clinics that participate in the 340B Drug Pricing Program will meet next month to address criticism that some 340B participants are abusing the discount program. Drugmakers and some lawmakers have called for tougher oversight, because some hospitals are receiving discounted drug benefits, despite serving a small number of low-income patients. Read more.

    340B Supporters Cope with Mounting Criticism of Expanded Program

    June 26, 2015 — Safety net providers and clinics that participate in the 340B Drug Pricing Program will meet next month to address backlash from critics who feel the rising number of participants is a way to game the system. Drug makers and some lawmakers have called for greater oversight of the program in light of complaints that some hospitals are receiving discounted drug benefits despite serving a small number of low-income patients. Read more.

    340B Program Likely To Face Significant Changes in Coming Years

    June 25, 2015 — The 340B Drug Pricing Program for safety-net hospitals will likely undergo significant changes in the coming months, as the result of new “mega-guidance” soon to-be-published by HSRA, which oversees the program. The contents of the guidance remained a little bit of a mystery, according to officials with 340B Health, the program’s primary lobbying group, who spoke at this week’s Healthcare Financial Management Association’s annual national institute in Orlando, Florida. Read more. 

    HRSA Proposes Penalties for Drug Manufacturers that Overcharge Covered Entities

    June 24, 2015 – On June 16, 2015, the U.S. Department of Health and Human Services (“HHS”) and the Health Resources and Services Administration (“HRSA”) released proposed rules on civil monetary penalties and drug ceiling prices under the 340B Drug Pricing Program (the “340B Program”). Comments on the proposed rule are due August 17, 2015. The proposed rules, which Congress required as part of the Patient Protection and Affordable Care Act (“ACA”), are the latest in a series of events that have put a spotlight on the 340B Program, including the recent litigation surrounding HRSA’s orphan drug rules, the upcoming release of HRSA’s omnibus 340B Program guidance (which is expected to cover topics like contract pharmacy arrangements and the definition of a 340B “patient”), and congressional interest in reforming the program. Read more.

    HRSA Takes Its First Steps on 340B Rules

    June 22, 2015 — The 340B Drug Pricing Program has operated for more than 20 years with just a few governing regulations codified in 42 CFR Part 10. Through the Affordable Care Act, Congress adopted several amendments to the 340B program. One of those amendments required the Department of Health and Human Services to impose a maximum $5,000 civil monetary penalty on participating manufacturers for each instance in which the manufacturer knowingly and intentionally charged a participating 340B entity a purchase price for a 340B drug that exceeds the statutory ceiling price. Read more.

    HRSA Proposes Price Ceilings for 340B Program

    June 20, 2015 — The Health Resources and Services Administration has proposed a new rule that would place a cap on how much drug manufacturers could charge safety-net hospitals participating in the 340B program for drugs intended for outpatient treatment. Under the 340B program, any drug manufacturer that participates in the Medicaid program must provide drugs discounted up to 50 percent to safety-net hospitals. Read more.

    Proposed Rule Sets Fines for Drug Companies that Overcharge 340B Hospitals

    June 19, 2015 — The Obama administration issued draft regulations that would impose fines on drug companies that overcharge hospitals and clinics for medication purchased under the government’s 340B Drug Pricing Program. The penalties are part of a proposed rule the Health Resources and Services Administration released Wednesday that establishes a system for calculating “ceiling prices” for covered outpatient drugs. Read more.

    Who Benefits from the 340B Drug Discount Program?

    June 10, 2015 — The 340B program was created by Congress in 1992 to help vulnerable or uninsured patients gain access to needed prescription medicines, by requiring pharmaceutical manufacturers to provide steep discounts to certain types of clinics and hospitals as a condition of their drugs being covered by Medicaid. Read more.

    With Better Oversight, 340B Drug Discounts Can Still Do Some Serious Good

    June 8, 2015 — The best of intentions sometimes go awry, and that is what has happened with a federal drug discount program aimed at helping the most vulnerable Americans get the medications they need and manage their health effectively. In 1992, Congress created a program called 340B, so-named for the section where it resides in the Public Health Service Act. The program requires drug manufacturers to provide steep discounts—20 to 50 percent—to health care providers serving large populations of low-income or uninsured patients in exchange for their drugs being covered under Medicaid. Read more.

    340B Hospitals Are More Likely to Acquire Physician Practices, New Study Suggests

    June 8, 2015 — A new analysis released by Avalere Health and funded by the Alliance for Integrity and Reform of 340B (AIR 340B) found hospitals participating in the 340B Drug Pricing Program were more likely to acquire independent physician practices than non-340B hospitals. Researchers examined 4,865 hospitals and patterns in patient volume to identify potential acquisitions. Read more.

    Safety-net Hospitals Indeed Treat the Underserved

    June 5, 2015 — There’s been a policy battle raging lately about the little-known federal 340B drug pricing program. It allows hospitals and other providers that serve the poor in large numbers to buy prescription drugs at a discount. Hospitals use the savings to stretch resources and reach more patients. Central to this fight has been the drug industry’s contention that many hospitals in the program somehow don’t treat the poor of this country. Nothing could be further from the truth – and new research from the firm Dobson DaVanzo and Associates shows why. Read more.

    340B Hospitals Provide Far More Care to Low-Income Patients

    June 4, 2015 — A new survey by an advocacy group for the 340B Drug Pricing Program indicates that participants provide far more care to low-income patients than those hospitals that are not involved in the program. Data was compiled by Dobson DaVanzo & Associates, a D.C-area health care consulting firm, using 2012 Medicare cost reports and 2013 American Hospital Association facility surveys. Read more.

    Drug Program Protects Patients

    June 3, 2015 — The Congress Blog post by Ellen Weaver and Lindsay Boyd, “Congress waking up to 340B corporate slush fund” (May 26), falsely claims hospitals are exploiting the 340B Drug Pricing Program. The truth is that hospitals eligible for this necessary program stretch their scarce federal resources to do more for patients. For example, they expand care, provide services to more patients and reduce the price of pharmaceuticals. In addition, increasing patients’ access to drugs helps to improve health outcomes and reduce future health care spending. Read more.