Clinical Insights: January 15, 2018

    Welcome to the weekly edition of RxStrategies Clinical Insights, designed to help pharmacy professionals stay up to date on the ever-changing pharmaceutical and pharmacy market place.


    New Drug Approval

    No new updates.


    New Formulation Approval

    No new updates.


    New Indication Approval

    Lynparza® (olaparib) – January 12, 2018 – The Food and Drug Administration granted regular approval to olaparib tablets (Lynparza®, AstraZeneca Pharmaceuticals LP), a poly (ADP-ribose) polymerase (PARP) inhibitor, for the treatment of patients with deleterious or suspected deleterious germline BRCA-mutated (gBRCAm), HER2-negative metastatic breast cancer who have been treated with chemotherapy either in the neoadjuvant, adjuvant, or metastatic setting. Read more.

    Xgeva® (denosumab) – January 5, 2018 – Amgen announced that the U.S. Food and Drug Administration (FDA) has approved the supplemental Biologics License Application (sBLA) for Xgeva® (denosumab) to expand the currently approved indication for the prevention of skeletal-related events in patients with bone metastases from solid tumors to include patients with multiple myeloma. Read more.

    Procysbi® (cysteamine bitartrate) – December 27, 2017 – Horizon Pharma plc announced the U.S. Food and Drug Administration (FDA) has approved an expansion to the indication for Procysbi® (cysteamine bitartrate) delayed-release capsules to include children one year of age and older living with nephropathic cystinosis. Read more.


    New Drug Shortage

    January 12, 2018 

    January 11, 2018 

    January 9, 2018 

    January 5, 2018 

    January 4, 2018 


    New Drug Recall and Safety Alerts

    Opioid Ingredients – Prescription Cough and Cold Products, Revising Labeling to Limit Pediatric Use – Drug Safety Alert – January 11, 2018 – The U.S. Food and Drug Administration announced that it is requiring safety labeling changes to limit the use of prescription opioid cough and cold medicines containing codeine or hydrocodone in children younger than 18 years old because the serious risks of these medicines outweigh their potential benefits in this population. Read more.

    Clopidogrel Tablets USP, 75 mg by International Laboratories – Drug Recall Alert – January 10, 2018 – International Laboratories, LLC is voluntarily recalling Lot# 117099A of Clopidogrel Tablets, USP 75 mg, packaged in bottles of 30 tablets, to the consumer level due to mislabeling. The product is labeled as Clopidogrel Tablets USP, 75 mg but may contain Clopidogrel 75 mg or Simvastatin Tablets USP 10 mg. Read more.

    Ampicillin and Sulbactam for Injection USP 1.5 g/vial by Auromedics – Drug Recall Alert – January 4, 2018 – AuroMedics Pharma is voluntarily recalling one lot of Ampicillin and Sulbactam for Injection USP, 1.5 g in a Single-Dose vial (equivalent to 1 g ampicillin as the sodium salt plus 0.5 g Sulbactam as the sodium salt), to the hospital level. Lot AFO l 17001-A, Expiry date Dec 2018 has been found to contain glass particles. Read more.

    Compounded Sterile Products by PharMEDium Services – Drug Recall Alert – January 2, 2018 – PharMEDium Services is voluntarily recalling certain lots of drug products to the hospital/user level due to a lack of assurance of sterility. Administration of a drug product intended to be sterile that is not sterile could result in serious infections that may be life-threatening. Read more.


    New First Time Generic

    Efavirenz (Sustiva®) – First-time Generic Launch – January 2, 2018 – ACETO Corporation announced that Rising Pharmaceuticals, its finished dosage form generics subsidiary, has launched the first generic for Efavirenz Capsules, 50mg and 200mg, an FDA-approved generic version of the reference listed drug, Sustiva® from Bristol Myers Squibb, which in combination with other drugs is indicated for the treatment of HIV-1 infection in adults and pediatric patients. Read more.


    Clinical and Pharmacy News

    Drugmakers See a Pricing Blueprint in an $850,000 Gene Therapy – January 12, 2018 – Global drugmakers are looking to a tiny biotech’s $850,000 therapy for a rare type of blindness as a model for getting paid for highly expensive – and effective – new medicines. Spark Therapeutics Inc. plans to launch its recently approved Luxturna treatment for an inherited genetic mutation that causes blindness in March. The drug is to be administered only once, by injection, and Spark plans to charge $425,000 per eye, an unprecedented price. Read more.

    CDC Study Puts Economic Burden of Asthma at More Than $80 Billion Per Year – January 12, 2018 – Asthma costs the U.S. economy more than $80 billion annually in medical expenses, days missed from work and school, and deaths, according to research published online in the Annals of the American Thoracic Society. However, actual numbers are likely to be higher, since the researchers from the CDC only counted “treated asthma,” defined as having at least one medical encounter for asthma or having a prescription for at least one asthma medicine filled during a calendar year. Read more.

    Top 4 Trends for Hospital Pharmacists in 2018 – January 11, 2018 – Pharmacy leaders leaving their positions earlier than expected and pharmacists’ increasing role in combatting the opioid crisis are two of the top issues that will affect hospital pharmacists over the next five years, according to ASHP. Read more.

    New Drug Approvals for 2018: Strong Specialty Pipeline – January 11, 2018 – By 2020, about half of the money spent on the pharmacy benefit will be on specialty drugs, and these medications will be prescribed for fewer than two percent of patients, according to Aimee Tharaldson, PharmD, a senior clinical consultant in emerging therapeutics at Express Scripts. Read more.

    Pharmacy Technology: Disruption or Improvement? – January 11, 2018 – The disruption that new technology gives the pharmacy industry also gives pharmacists more responsibility. Although many pharmacies and prescribers have mastered electronic prescribing and share important patient information via electronic health records (EHRs), there is room for more digital disruption in pharmacy. According to the ONC, physician use of e-Rx using an EHR jumped from seven percent in December 2008 to 70 percent in April 2014. Read more.

    FDA Could Rethink Orphan Drug Incentives – January 11, 2018 – FDA Commissioner Scott Gottlieb, MD, has said that he is open to rethinking aspects of a 35-year-old law that create incentives for drug companies to develop orphan drugs for rare diseases affecting fewer than 200,000 people, because the market has changed since the law was passed. Read more.

    Antibiotic Use in Hospitals May Be Associated with Increased Susceptibility – January 10, 2018 – Hospital antibiotic usage was associated with increased antibiotic susceptibility, rather than decreased susceptibility, for many organisms, according to a recent Canadian study. Read more.

    HHS Nominee Azar Signals New Line of Attack on Drug Prices – January 9, 2018 – Alex Azar, Trump’s pick to lead the Health and Human Services Department, doubled down on his commitment to bringing down prescription drug prices Tuesday – and even added a new target for future policymaking: drug makers’ list prices. Read more.

    Automation Drives New Role for Hospital Pharmacists – January 8, 2018 – Pharmacists at Summa Health System-Barberton Campus in Barberton, OH are engaging in more patient-focused care thanks to the deployment of an automated central pharmacy system. In October 2017, the 113-bed community hospital transitioned from a manual medication inventory management system to the Omnicell XR2. Read more.

    Pharmacists Hesitant to Dispense Lifesaving Overdose Drug Naloxone – January 6, 2018 – Gale Dunham, a pharmacist in Calistoga, Calif., knows the devastation the opioid epidemic has wrought, and she is glad the anti-overdose drug naloxone is becoming more accessible. But so far, Dunham said, she has not taken advantage of a California law that allows pharmacists to dispense the medication without a doctor’s prescription. Read more.

    Will Biosimilars Deliver on Expectations? – January 6, 2018 – The biosimilars market began to pick up in 2017 as federal agencies offered more clarity about the emerging regulatory landscape and the FDA issued draft guidance on naming and interchangeability. Those regulatory clarifications will help bring the United States into the biosimilars era – if their manufacturers can seize sufficient market share, according to experts. Read more.

    Statement from FDA Commissioner Scott Gottlieb, M.D. on New Steps to Facilitate Efficient Generic Drug Review to Enhance Competition, Promote Access and Lower Drug Prices – January 3, 2018 – The FDA announced additional steps to encourage generic competition as part of our continued implementation of the Drug Competition Action Plan. This plan has three main components: reducing gaming by branded companies that can delay generic drug entry; resolving scientific and regulatory obstacles that can make it difficult to win approval of generic versions of certain complex drugs; and improving the efficiency and predictability of the FDA’s generic review process to reduce the time it takes to get a new generic drug approved and lessen the number of review cycles undergone by generic applications before they can be approved. Read more.

    Telepharmacy at Rural Hospitals Provides Big Savings, Quality Improvements – January 3, 2018 – As technology vendors increasingly specialize on telepharmacy, rural providers are deploying the tools to offer patients 24/7 pharmacy services. Read more.

    Why Pharmaceutical Companies, Under Attack for Drug Prices, Started an Industry War – January 3, 2018 – It’s not easy to get Americans mad at a behind-the-scenes industry they’ve barely even heard of, but pharmaceutical companies have spent most of last year trying. “Who decides what you pay for your medicines?” Read more.

    3 Ways to Optimize Pharmacy Revenue Capture and Boost The Bottom Line – January 2, 2018 – Health care executives need look no further than the pharmacy department to drive new revenue. The pharmacy department historically is one of a hospital’s greatest cost centers. Most improvement efforts focus on reducing cost. However, pharmacy can also be a major contributor to revenue – with little upfront investment. Consider that pharmacy can provide support services to decrease length of stay, manage medication through collaborative practices, and facilitate appropriate medication reimbursement. Read more.


    340B in the News

    AHA, Health Systems Appeal 340B Decision – January 11, 2018 – The organizations and health systems filed the lawsuit in November after the CMS’ final rule that lowered payments for 340B, a program that requires drug companies to provide outpatient drugs to certain providers at a reduced cost. Read more.

    The Winners and Losers of 340B Changes – January 11, 2018 – On January 1, a ruling from the Centers for Medicare and Medicaid Services went into effect that reduces reimbursement rates on 340B qualified drugs from six percent above the sales price to 22.5 percent less than the sales price. According to Kenneth Maxik, BS, MBA, Director of Patient Safety and Compliance for CompleteRx, the cuts—estimated to be $1.6 billion—will only impact certain hospitals. Read more.

    AHF on New 340B Report: ‘Bought and Paid for by Big Drug Companies!’ – January 11, 2018 – 340B Drug Pricing Program advocates from the AIDS Healthcare Foundation (AHF) stepped up their criticism of Congressional leaders following the release yesterday of a hit-piece from the House Energy and Commerce Committee masquerading as a so-called investigation. “This biased report was bought and paid for by big drug companies whose only interest is further increasing their profits at the expense of safety net providers who care for countless patients across the country,” said Michael Weinstein, President of the AIDS Healthcare Foundation. Read more.

    House E&C Offers Recommendations to Improve 340B Drug Pricing Program – January 10, 2018 – The House Energy & Commerce (E&C) Committee on Wednesday released an 80-page report outlining issues and recommendations to improve the 340B Drug Pricing Program, which helps reduce the prices of certain drugs for participating hospitals, health centers and other entities that provide care for vulnerable patients. Read more.

    Drug Discount Program Is Broken, GOP Says, Promising Fixes – January 10, 2018 – A federal drug discount program for hospitals has major problems, and a legislative solution is on the way, House Republicans said. At issue is the 340B discount program, which pharmaceutical companies and congressional Republicans say has grown beyond its original intent of helping indigent patients with their drug costs. Congress didn’t clearly identify the intent of the program when it was created in 1992, Rep. Greg Walden (R-Ore.) said Jan. 9 during a call with reporters. Read more.

    Lawmakers Look to Step Up Oversight on Discount Drug Program – January 10, 2018 – House Republicans are demanding more oversight and transparency for a discount drug program they say has grown out of control in recent years. The 340B drug program, created to help rural and charity hospitals and clinics, has become the subject of intense scrutiny in recent years, with more than 12,000 entities now participating in the multibillion-dollar program, far more than when the program was created in 1992. Read more.

    Hospital Groups to Appeal Lawsuit Dismissal That Permits $1.6B In Medicare Payment Cuts – January 9, 2018 – The American Hospital Association, Association of American Medical Colleges and America’s Essential Hospitals formally notified the court Tuesday of their intent to appeal a federal judge’s dismissal of the groups’ lawsuit that sought to halt a $1.6 billion reduction to Medicare payments made under the 340B Drug Pricing Program. Read more.

    Pushing “PAUSE” on the 340B Program: The New Bi-Partisan Bill that Could Reshape the 340B Program – January 8, 2018 – In late December 2017, Republican Rep. Larry Bucshon (with bi-partisan support) introduced the “340B Protecting Access for the Underserved and Safety-net Entities Act” (340B PAUSE Act), legislation that would implement a two-year moratorium on most new 340B hospital participants, including both hospitals new to 340B and new locations of existing hospital participants. This is the first significant 340B legislative activity since the provisions that were eventually passed and implemented as part of the Affordable Care Act in 2010. Read more.

    Editorial: All Harm, no Help in 340B Cuts – January 6, 2018 – Now that a U.S. District Court has postponed the hospital industry’s legal challenge to cutbacks in the 340B Drug Discount Program, it falls to Congress to reverse the Trump administration’s egregious new rules. Believe it or not, there’s hope, since the new rules benefit no one—quite literally. Legislation reversing them has even gained bipartisan backing in Congress. Read more.

    Opinion: CMS 340B Reimbursement Cuts Cause Big Pharma Profits While Underserved Patients Lose – January 3, 2018 – As you and your readers may now be aware, the 340B Drug Pricing Program has been under siege for the past couple months. The program requires drug manufacturers to provide outpatient drugs to eligible health care organizations at significantly reduced prices, so that those savings can be passed on to the patients and the community at large. Henry Ford Health System is one of the largest, if not the single largest 340B entity in the nation and serves thousands of disadvantaged patients in the metropolitan Detroit and Jackson areas in Michigan every year. Read more.

    House Gears Up For 340B Oversight Push – January 2, 2018 – Pressure over the status of a federal drug discount program has intensified on Capitol Hill as Medicare reimbursement cuts for 340B hospitals have officially gone into effect. On Friday, a federal court dismissed several hospital associations’ suit that sought to block the cuts and lawmakers geared up for a legislative battle that has grown increasingly convoluted now that financial cuts have become conflated with a push for program transparency. Read more.

    Federal Judge Denies American Hospital Association’s 340B Injunction Request – January 2, 2018 – Federal District Court Judge Rudolph Contreras ruled to deny the American Hospital Association and other health care groups a preliminary injunction halting the implementation of the Medicare Part B payment reduction to 340B hospitals. Contreras said Friday that his reason was due to the plaintiffs failing to present a claim to the Health and Human Services secretary for a final decision. Read more.