Clinical Insights: January 22, 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

    BalcoltraTM (levonorgestrel and ethinyl estradiol and ferrous bisglycinate) – January 19, 2018 – Avion Pharmaceuticals, LLC, received approval of its new drug application (NDA) for the oral contraceptive Balcoltra™ (levonorgestrel and ethinyl estradiol tablets and ferrous bisglycinate tablets), the company’s first internally developed NDA. Avion expects to commercially launch this new oral contraceptive to the prescribing community in Spring 2018. Read more.


    New Formulation Approval

    No new updates.


    New Indication Approval

    Trisenox® (arsenic trioxide) – New Indication Approval – January 15, 2018 – Teva Pharmaceutical Industries Ltd. announced that the U.S. Food and Drug Administration (FDA) has approved the use of Trisenox® (arsenic trioxide) injection in combination with tretinoin for the treatment of adults with newly-diagnosed low-risk acute promyelocytic leukemia (APL) whose APL is characterized by the presence of the t(15;17) translocation or PML/RAR-alpha gene expression. Read more. 

    Gilotrif® (afatinib) – New Expanded Indication Approval – January 12, 2018 – The Food and Drug Administration granted approval to afatinib (Gilotrif, Boehringer Ingelheim Pharmaceutical, Inc.) for a broadened indication in first-line treatment of patients with metastatic non-small cell lung cancer (NSCLC) whose tumors have non-resistant epidermal growth factor receptor (EGFR) mutations as detected by an FDA-approved test. Read more.


    New Drug Shortage

    January 22, 2018 

    January 18, 2018 

    January 17, 2018 


    New Drug Recall and Safety Alerts

    Levofloxacin in 5 Percent Dextrose 250mg/50mL by AuroMedics – Drug Recall Alert – January 18, 2018 – AuroMedics Pharma LLC is voluntarily recalling one lot of Levofloxacin in 5% Dextrose Injection 250mg/50mL in a Single-Use flexible container NDC 55150-243-46, Lot CLF160003, Expiry date May 2018, to the hospital level. The product has been found to contain visible particulate matter tentatively identified as mold. Read more.

    Varubi® (rolapitant) Injectable Emulsion – Drug Safety Alert – January 16, 2018 – Anaphylaxis, anaphylactic shock and other serious hypersensitivity reactions have been reported in the postmarketing setting, some requiring hospitalization. These reactions have occurred during or soon after the infusion of Varubi® (rolapitant) injectable emulsion. Read more.


    New First Time Generic

    No new updates.


    Clinical and Pharmacy News

    Medicare Could Save Billions with Additional Formulary Exclusions – January 22, 2018 – Lowering drugs costs is at the forefront of most conversations revolving around healthcare spending. To combat rising costs, pharmacy benefit managers (PBMs) implement cost-controlling tools, such as formulary exclusion lists. The Centers for Medicare and Medicaid Services (CMS) reported that between 2012 and 2015, Medicare Part D spent $397.8 billion on prescription drugs, with out-of-pocket spending for beneficiaries reaching $54.6 billion. Read more.

    Growing Evidence Shows Hepatitis C Intersects with Other Diseases – January 22, 2018 – As many as three-quarters of individuals with hepatitis C virus (HCV) experience disorders related to the virus beyond the impact on their livers, the National Viral Hepatitis Roundtable estimates. HCV-related kidney disease, depression, skin disorders, lymphoma and other conditions can seriously impact a patient, even without severe damage to the liver, studies have shown. Read more.

    Health Systems Form Drug Company to Combat Rising Costs, Shortages – January 22, 2018 – Intermountain Healthcare, Ascension, SSM Health and Trinity Health recently announced that they will create a non-profit generic drug company to reduce prescription costs and alleviate critical drug shortages. With consulting services with the VA, the four health systems, representing over 450 hospitals across the U.S., aim for the new drug company to be an FDA-approved entity that will either directly create generic drugs or sub-contract manufacturing to manufacturing organizations. Read more.

    New Clinical Practice Guideline Provides Recommendations For Use Of Anticoagulants During Heart Surgery – January 22, 2018 – The Society of Thoracic Surgeons (STS), the Society of Cardiovascular Anesthesiologists (SCA) and the American Society of ExtraCorporeal Technology (AmSECT) released a new clinical practice guideline that includes major recommendations for the use of blood thinning medication (anticoagulants) during heart surgery. The guideline was published online today in The Annals of Thoracic Surgery and in two other journals. Read more.

    Five Factors Driving Up the Cost of Oncology Drug – January 22, 2018 – One of the key factors that leads to higher costs with all drugs—not just those for cancer treatment—is the way the cost of these drugs is reimbursed, says Anna Kaltenboeck, program director and senior health economist at Memorial Sloan Kettering’s Center for Health Policy and Outcomes. Read more.

    Pharma, Payers Clash Over CMS Part D Drug Rebate Plan – January 18, 2018 – The proposal would change how drugmaker rebates are passed onto consumers buying medicine under Part D by requiring sponsors to pass on a minimum percent of a cost-weighted average of rebates to consumers. CMS issued a request for information (RFI) to gather comments on the idea as part of a larger proposed rule in November, noting the widening disparity between gross Part D drug costs and costs net of direct or indirect remuneration (DIR). Read more.

    New DIR Proposal Supported by Chains, Pharmacy Organizations – January 17, 2018 – Medicare Part D direct and indirect (DIR) fee reform is gaining momentum in Congress this year, as more than 115 organizations and a bipartisan group of 80 U.S. Representatives endorsed a proposal changing how the fees are charged. Read more.

    FDA Aims to Improve Access to Clinical Trial Info for New Drugs – January 17, 2018 – To better enhance transparency around FDA drug approval decisions, the agency is launching a pilot program aimed at improving provider access to key information related to new drugs, according to a statement. After approvals of new drug applications (NDAs), the FDA releases certain information used during the reviewing process of the NDA, including summaries written by medical reviewers, proposed labeling or other requirements, and other relevant data on the product’s safety and efficacy. Read more.

    Clear Benefit for Hormones to Prevent Postmenopausal Chronic Conditions – January 17, 2018 – There’s no question that prevalence and incidence of most chronic and other health conditions—coronary heart disease, dementia, stroke, fractures and breast cancer, for example—increase with age. With menopause occurring at an average age of 51.3 years, the role of declining hormones in promoting those diseases has long been debated. Read more.

    Walmart is Giving Away Free Opioid Disposal Kits – January 17, 2018 – Walmart is trying to help curb America’s opioid crisis. The retail chain said Wednesday that its pharmacies will offer a free kit that allows patients to safely throw out unused opioid prescription pills at home. The packet, called DisposeRx, dissolves pills into a biodegradable gel. Walmart says it’s the first national pharmacy to offer the solution. Read more.

    Medicare Part D Misses $3.4B In Savings from Excluded Generic Coverage – January 17, 2018 – The CMS and Medicare beneficiaries could have saved more than $3 billion over four years if the Medicare Part D program covered more generic prescriptions, a new study found. The study, published in JAMA on Tuesday, found a potential $3.4 billion in Medicare Part D savings between 2012 and 2015 if the CMS required generic substitutes for 62 brand-name drugs that weren’t covered by the two largest pharmacy benefit managers, CVS or Express Scripts. Read more.

    Prescription Drug Rates Continue to Challenge Cancer Centers – January 17, 2018 – Prescription drug rates and the costs of new treatment modalities continued to challenge cancer centers, according to the most recent Trending Now in Cancer Care survey from the Association of Community Cancer Centers (ACCC). Read more.

    FDA Commissioner Scott Gottlieb, M.D. Responding to Report from GAO and Updating on FDA’s Ongoing Efforts to Increase Access to Complex Generic Drugs – January 16, 2018 – The U.S. Government Accountability Office (GAO) published a report titled “Generic Drugs: FDA Should Make Public Its Plans to Issue and Revise Guidance on Nonbiological Complex Drugs.” In preparing the report, GAO studied a number of issues related to the FDA’s review and approval of “nonbiological complex drugs.” The report contained a single recommendation for the FDA – that the agency publicly announce its plans to issue or revise guidance for these drug products. Read more.

    FDA Commissioner Scott Gottlieb, M.D., Updates on Some Ongoing Shortages Related to IV Fluids – January 16, 2018 – Earlier this month, we updated on the FDA’s efforts to mitigate ongoing IV saline shortages that resulted from, or were worsened by, the devastating impact of Hurricane Maria in Puerto Rico. We also provided some additional updates related to our continued efforts to help the island fully recover from this disaster. Read more.

    Key Questions Surround Biosimilars, Generics in Specialty Pharmacy – January 15, 2018 – Every pharmacist throughout their career will inevitably have a conversation with a patient about generic medications. The conversation will most often progress with the pharmacist touting the advantages of generic medications, explaining that the drug within the medication is identical to the brand. Read more.


    340B in the News

    Reduced 340B Reimbursements? Nonprofit Institutions Act May Provide New Possibilities – January 22, 2018 – A recent Centers for Medicare & Medicaid Services (CMS) final rule reduces some Medicare reimbursements to hospitals in 2018, paying 28 percent less for certain “specified covered outpatient drugs” (SCODs) purchased at a discount through the 340B Drug Pricing Program (340B). Although hospitals recently lost a challenge to the lower CMS rates in American Hospital Association v. Hargan, they may be able to offset a portion of the losses from a countervailing development in antitrust law. Read more.

    Hospitals Should Accept the Cuts To 340B Drug Payments – January 22, 2018 – The Centers for Medicare and Medicaid Services rang in the new year by cutting what Medicare pays hospitals for certain drugs by nearly 30 percent. Hospitals are naturally opposed to this decision and have sued to block the change, arguing that patients and hospitals alike will suffer. But don’t be fooled. A review of the program shows this cut is smart policy that will benefit both patients and taxpayers. Read more.

    WV Hospitals Could Lose $15M For Low-Income Care – January 20, 2018 – West Virginia’s hospitals stand to lose as much as $15 million toward treating low-income patients if federal cuts to the Medicaid’s Disproportionate Share Hospital program remain in place, warned Joe Letnaunchyn, president and CEO of the West Virginia Hospital Association. Read more.

    Viewpoint: N.D. Hospitals at Risk Of Shutting Down – January 20, 2018 – Right now, policy developments in Washington, D.C., are placing our rural North Dakota hospitals and other healthcare providers at significant risk of shutting down, choking off healthcare access for thousands of patients in rural communities who have few other options. Read more.

    Protesters Oppose Bucshon Drug Bill – January 18, 2018 – A group of about 50 protesters picketed in front of U.S. Rep. Larry Bucshon’s Terre Haute district office Thursday morning to denounce his recent introduction of legislation they say could harm drug discounts and limit safety net providers. Read more.

    Fight Over Federal Drug Discount Program Continues in 2018 (Updated) – January 18, 2018 – The battle over the fate of a 25-year-old federal drug discount program could heat up on Capitol Hill this year. At issue is the 340B discount program, which safety-net providers such as hospitals use to obtain often steep discounts on medications from pharmaceutical companies. Covered hospitals and clinics saved approximately $6 billion on their outpatient drugs on approximately $12 billion in discounted purchases during calendar 2015 through the program, according to a recent congressional report. Read more.

    340B Drug Program Sees Massive Changes on the Horizon – January 18, 2018 – A proposal in the Senate aims to create savings for health providers while a new report details how to maximize the program’s pharmacy benefits. The 340B Drug Pricing Program represents ample healthcare and business opportunities to some, while others see it as a federal program in need of significant reforms to address outstanding cost concerns. Read more.

    This Year May be a Game Changer for 340B Drug Discount Program, Take Two – January 18, 2018 – I previously said that the year 2014 may be a game-changer for the 340B Drug Discount Program. Increasing HRSA audits, a lawsuit over the 340B Orphan Drug Rule, and HRSA’s promise to issue a 340B mega-regulation, all pointed to major changes in how the 340B Program operates. Read more.

    Proposed Bill to Protect 340B Program, Patient Access to Treatment – January 18, 2018 – Louisiana Senator Bill Cassidy (R-LA), MD, has introduced legislation that would close hospital loopholes in the 340B Program, which helps low-income and uninsured patients access treatment and medications with fewer financial barriers. Read more.

    House to Consider Bills That Would Define 340B-Eligible Patients – January 17, 2018 – The odds in Congress’ big-money fight over 340B drug discounts are shifting against hospitals with a soon-to-be-introduced package of bills that would limit the patients qualifying for the discount and expand reporting requirements for how hospitals use the dollars. Read more.

    Community Oncology Alliance Strongly Supports 340B HELP ACT – January 17, 2018 – The Community Oncology Alliance (COA) applauds Senator Bill Cassidy (R-LA) on his leadership to improve transparency and accountability in the 340B Drug Discount Program with the introduction of the Helping Ensure Low-income Patients have Access to Care and Treatment (HELP ACT). Read more.