Clinical Insights: March 23, 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

    IlumyaTM (tildrakizumab-asmn) – New Drug Approval – March 21, 2018 – Sun Pharmaceutical Industries Ltd. announced that the U.S. Food and Drug Administration (FDA) has approved IlumyaTM  (tildrakizumab-asmn) for the treatment of adults with moderate-to-severe plaque psoriasis who are candidates for systemic therapy or phototherapy. IlumyaTM  selectively binds to the p19 subunit of IL-23 and inhibits its interaction with the IL-23 receptor leading to inhibition of the release of pro-inflammatory cytokines and chemokines. Read more.

    TrogarzoTM (ibalizumab-uiyk) – New Drug Approval – March 6, 2018 – The U.S. Food and Drug Administration approved TrogarzoTM (ibalizumab-uiyk), a new type of antiretroviral medication for adult patients living with HIV who have tried multiple HIV medications in the past (heavily treatment-experienced) and whose HIV infections cannot be successfully treated with other currently available therapies (multidrug resistant HIV, or MDR HIV). Read more.

    CimduoTM (lamivudine and tenofovir disoproxil fumarate) – New Drug Approval – March 2, 2018 – Mylan N.V. announced that it will launch two new HIV treatments, Symfi LoTM  and CimduoTM , which were approved in February by the U.S. Food and Drug Administration (FDA). CimduoTM  (lamivudine and tenofovir disoproxil fumarate) 300 mg/300 mg tablets is a once-daily combination of two nucleo(t)side reverse transcriptase inhibitors and is indicated in combination with other antiretroviral agents for the treatment of human immunodeficiency virus type 1 (HIV-1) infection in adults and pediatric patients weighing at least 35 kg. Read more.

    Symfi LoTM (efavirenz, lamivudine and tenofovir disoproxil fumarate) – New Drug Approval – March 2, 2018 – Mylan N.V. announced that it will launch two new HIV treatments, Symfi LoTM  and CimduoTM , which were approved in February by the U.S. Food and Drug Administration (FDA). Symfi LoTM  (efavirenz, lamivudine and tenofovir disoproxil fumarate) 400 mg/300 mg/300 mg tablets is a once-daily, single-tablet regimen (STR) and is indicated as a complete regimen for the treatment of human immunodeficiency virus type 1 (HIV-1) infection in adult and pediatric patients weighing at least 35 kg. Read more.

    ZTlidoTM (lidocaine topical system 1.8%) – New Drug Approval – February 28, 2018 – Sorrento Therapeutics, Inc. and its majority-owned subsidiary, Scilex Pharmaceuticals Inc. (“Scilex”), received approval from the U.S. Food and Drug Administration (FDA) for ZTlidoTM  (lidocaine topical system) 1.8%. ZTlido is indicated for the relief of pain associated with post-herpetic neuralgia (PHN), also referred to as post-shingles pain. ZTlido is a major advancement in analgesics because of its proprietary adhesion technology demonstrating 12-hour wear with efficient lidocaine delivery, even during exercise. Read more.

    ApadazTM (acetaminophen and benzhydrocodone hydrochloride) – New Drug Approval – February 23, 2018 – KemPharm, Inc. announced that the U.S. Food and Drug Administration (FDA) approved its New Drug Application (NDA) for ApadazTM  for the short-term (no more than 14 days) management of acute pain severe enough to require an opioid analgesic and for which alternative treatments are inadequate. Apadaz is an immediate release (IR) combination of KemPharm’s prodrug, benzhydrocodone, and acetaminophen (APAP). Read more.

    Osmolex ERTM (amantadine hydrochloride) – New Drug Approval – February 19, 2018 – Osmotica Pharmaceutical U.S. LLC announced that the U.S. Food and Drug Administration (FDA) has approved Osmolex ERTM , an amantadine extended release tablet, for the treatment of Parkinson’s disease and for the treatment of drug-induced extrapyramidal reactions in adult patients. Extrapyramidal symptoms are known side effects of many common medications. Read more.

    ErleadaTM (apalutamide) – New Drug Approval – February 14, 2018 – The U.S. Food and Drug Administration approved Erleadaä (apalutamide) for the treatment of patients with prostate cancer that has not spread (non-metastatic), but that continues to grow despite treatment with hormone therapy (castration-resistant). This is the first FDA-approved treatment for non-metastatic, castration-resistant prostate cancer. Read more.

    Glatopa® (glatiramer acetate injection) – New Biosimilar Approval – February 13, 2018 – Sandoz, a Novartis division, announced the U.S. FDA approval and launch of Glatopa® (glatiramer acetate injection) 40 mg/mL. Glatopa® (glatiramer acetate injection) 40 mg/mL is FDA-approved as a fully-substitutable, AP-rated generic version of Copaxone® (glatiramer acetate injection) 40 mg/mL three times-a-week therapy for relapsing forms of multiple sclerosis (MS). Read more.

    SymdekoTM (ivacaftor/tezacaftor tablets and ivacaftor tablets) – New Drug Approval – February 12, 2018 – The U.S. Food and Drug Administration (FDA) approved SymdekoTM  (tezacaftor/ivacaftor and ivacaftor) to treat cystic fibrosis (CF) in people ages 12 years and older who have two copies of the F508del mutation or one mutation that is responsive to SymdekoTM . Read more.

    DexycuTM (dexamethasone) – New Drug Approval – February 12, 2018 – Icon Bioscience, Inc. (IBI), a specialty biopharmaceutical company focused on utilizing its Verisome® drug-delivery platform to develop unique intraocular eye-care therapeutics, announced that the United States Food and Drug Administration (FDA) has approved IBI’s New Drug Application (NDA) for DexycuTM  (dexamethasone intraocular suspension), a dropless, long-acting therapeutic for treating inflammation associated with cataract surgery. Read more.


    New Formulation Approval

    No new updates.


    New Indication Approval

    Adcetris® (brentuximab vedotin) – New Indication Approval – March 20, 2018 – The Food and Drug Administration approved brentuximab vedotin (Adcetris, Seattle Genetics, Inc.) to treat adult patients with previously untreated stage III or IV classical Hodgkin lymphoma (cHL) in combination with chemotherapy. Read more.

    Hizentra® (immune globulin subcutaneous [human], 20%) – New Indication Approval – March 16, 2018 – CSL Behring announced that the U.S. Food and Drug Administration (FDA) approved Hizentra® (Immune Globulin Subcutaneous [Human] 20% Liquid) as the first and only subcutaneous immunoglobulin (SCIg) for the treatment of chronic inflammatory demyelinating polyneuropathy (CIDP) as maintenance therapy to prevent relapse of neuromuscular disability and impairment. RxS Clinical Insights: This is orphan drug indication approval. Read more.

    Opdivo® (nivolumab) – New Indication Approval – March 6, 2018 – Bristol-Myers Squibb Company announced the U.S. Food and Drug Administration (FDA) has approved a supplemental Biologics License Application (sBLA) updating the Opdivo® (nivolumab) dosing schedule to include 480 mg infused every four weeks (Q4W) for a majority of approved indications. This approval will provide healthcare professionals the flexibility to customize patient care with the option of using the newly approved Q4W (480 mg) flat dose in addition to the previously available option of every two weeks (Q2W) at 240 mg, now available in a new 240 mg vial. Opdivo also was approved for a shorter 30-minute infusion across all approved indications. Read more.

    Latuda® (lurasidone) – New Expanded Indication Approval – March 6, 2018 – Sunovion Pharmaceuticals Inc. (Sunovion) announced that the U.S. Food and Drug Administration (FDA) approved a supplemental New Drug Application (sNDA) that expands the use of Latuda® (lurasidone HCI) to include the treatment of major depressive episode associated with bipolar I disorder (bipolar depression) in pediatric patients (10 to 17 years of age). Read more.

    Otiprio® (ciprofloxacin otic suspension) – New Indication Approval – March 2, 2018 – Otonomy, Inc. announced that the U.S. Food and Drug Administration (FDA) has approved Otiprio® (ciprofloxacin otic suspension) 6% for the treatment of acute otitis externa (AOE) in patients 6 months of age and older due to Pseudomonas aeruginosa and Staphylococcus aureus. Otiprioâ is the first single-dose antibacterial approved by the FDA for treating AOE. Read more.

    VerzenioTM (abemaciclib) – New Expanded Indication Approval – February 26, 2018 – The Food and Drug Administration approved abemaciclib (VerzenioTM , Eli Lilly and Company) in combination with an aromatase inhibitor as initial endocrine-based therapy for postmenopausal women with hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative advanced or metastatic breast cancer. Read more.

    Luzu® (luliconazole) – New Expanded Indication Approval – February 20, 2018 – Ortho Dermatologics, a division of Valeant Pharmaceuticals North America, LLC, announced that the U.S. Food and Drug Administration (FDA) approved the supplemental New Drug Application (sNDA) to expand the use of Luzu® (luliconazole) cream, 1% for the topical treatment of patients 12 and older with athlete’s foot (interdigital tinea pedis) and jock itch (tinea cruris) and patients two and older with ringworm (tinea corporis), caused by the organisms Trichophyton rubrum and Epidermophyton floccosum. Read more.

    ImfinziTM (durvalumab) – New Indication Approval – February 16, 2018 – The U.S. Food and Drug Administration approved ImfinziTM  (durvalumab) for the treatment of patients with stage III non-small cell lung cancer (NSCLC) whose tumors are not able to be surgically removed (unresectable) and whose cancer has not progressed after treatment with chemotherapy and radiation (chemoradiation). Read more.


    New Drug Shortage

    March 23, 2018 

    March 20, 2018 

    March 16, 2018 

    March 6, 2018 

    March 1, 2018 

    February 28, 2018 


    New Drug Recall and Safety Alerts

    Alka-Seltzer Plus Products – New Drug Recall Alert – March 16, 2018 – Bayer is voluntarily recalling Alka-Seltzer Plus packages that were sold only in the U.S. at Walmart, CVS, Walgreens and Kroger (including Dillons Food Stores, Fred Meyer, Fry’s Food Stores, Ralphs, King Soopers and Smith’s Food and Drug) after February 9, 2018. Read more.

    Methylprednisolone Sodium Succinate for Injection – New Drug Recall Alert – March 6, 2018 – Sagent Pharmaceuticals, Inc. announced the voluntary nationwide recall of ten lots of Methylprednisolone Sodium Succinate for Injection, USP, 40mg, 125mg and 1g. A detailed listing of products and lots is listed in the recall notice. Read more.

    Hydromorphone HCL Injection USP by Hospira – New Drug Recall Alert – March 5, 2018 – Hospira is voluntarily recalling three lots of Hydromorphone HCl Injection, USP CII 10 mg/mL, 1 mL in 2 mL Single Dose Vials lot numbers 71330DD (NDC 0409-2634-01), and 691853F and 700753F (NDC 0703-0110-01 – Teva lots) to the hospital/institution level. Read more.

    Zinbryta® (daclizumab) – New Drug Product Withdrawal – March 2, 2018 – Biogen and AbbVie announced the voluntary worldwide withdrawal of Zinbryta® for relapsing multiple sclerosis. The companies believe that characterizing the complex and evolving benefit/risk profile of Zinbryta® will not be possible going forward given the limited number of patients being treated. Read more.

    SumavelTM  DoseProTM  (sumatriptan injection) – New Drug Product Withdrawal – February 27, 2018 – Endo Pharmaceuticals has informed the Food and Drug Administration (FDA) of the discontinuation of SumavelTM DoseProTM  (sumatriptan injection), in the 4mg/0.5mL formulation. However, the 6mg/0.5mL dose of Sumavel DosePro will remain available. Read more.

    Labetalol Hydrochloride Injection by Hospira – New Drug Recall Alert – February 23, 2018 – Hospira is voluntarily recalling 3 lots of Labetalol Hydrochloride Injection, USP, 100 mg/20 mL Vial (NDC 0409-2267-20), and one lot of Labetalol Hydrochloride Injection, USP, Novaplus (NDC 0409-2267-25) to the hospital/institution level. Read more.

    Clarithromycin (Biaxin) – New Drug Safety Communication – February 22, 2018 – FDA is advising caution before prescribing the antibiotic clarithromycin (Biaxin) to patients with heart disease because of a potential increased risk of heart problems or death that can occur years later. FDAs recommendation is based on a review of the results of a 10-year follow-up study of patients with coronary heart disease from a large clinical trial that first observed this safety issue. Read more.

    Acyclovir 400mg Tablets by Apace – New Drug Recall Alert – February 13, 2018 – Apace Packaging LLC is voluntarily recalling one lot of Acyclovir Tablet, USP, 400mg, 50ct Unit Dose, NDC# 50268-061-15, Lot Number 19900, to the retail level. These products have been recalled due to a product mix-up. A small number of blister cards containing Acyclovir Tablets, 400mg, UD Blister Cards may potentially also include Torsemide, 20mg Tablets. Read more.


    New Generic Launch

    ritonavir (Norvir®) – March 20, 2018 – Hikma Pharmaceuticals PLC announced that its wholly owned U.S. subsidiary West-Ward Pharmaceuticals Corp. (West-Ward), has launched Ritonavir Tablets USP, 100 mg, the first AB-rated generic to Norvir® tablets. According to the FDA product approval letter, West-Ward is eligible for 180 days of generic drug exclusivity. Read more.

    memantine (Namenda XR®) – February 21, 2018 – Amneal Pharmaceuticals has launched memantine hydrochloride extended-release capsules, the company’s AB-rated equivalent for Namenda XR®, in 7 mg, 14 mg, 21 mg and 28 mg strengths. Read more.


    Clinical and Pharmacy News

    Study Proposes Five Diabetes Types – March 22, 2018 – A new study published in The Lancet clusters individuals with adult-onset diabetes and describes novel subgroups and outcomes associated with these data. Research led by Professor Leif Groop of the Lund University Diabetes Centre in Sweden and the Institute for Molecular Medicine Finland in Helsinki and colleagues groups individuals with adult-onset diabetes and describes associated novel subgroups and outcomes. Read more.

    Drug Copayments Often Cost More Than Prescription Drugs – March 22, 2018 – HealthDay News — Drug copayments frequently exceed prescription drug costs, with overpayments affecting 23 percent of all prescriptions, according to a research letter published in the Journal of the American Medical Association. Read more.

    NCCN’s New Guidelines Promote Better Cancer Care for People With HIV – March 22, 2018 – At the 23rd National Comprehensive Cancer Network (NCCN) Annual Conference, held March 22-24 in Orlando, Florida, Gita Suneja, MD, Duke Cancer Institute, presented NCCN’s new guidelines on treating cancer in people living with HIV. “The story of HIV in America began in June of 1981,” said Suneja, with the CDC’s Morbidity and Mortality Weekly Report that described five young men with biopsy-confirmed Pneumocystis carinii pneumonia. Read more.

    Cardiovascular Drugs May Lower Heart Disease Risk from Breast Cancer Chemotherapy – March 20, 2018 – Some breast cancer drugs have been linked to serious adverse events among patients. The American Heart Association recently issued a scientific statement that warns the cardiovascular risks associated with breast cancer drugs may outweigh the benefits. Certain patients may be more likely to die from heart disease related to treatment rather than cancer itself, according to the statement. Read more.

    New Hepatitis C Virus Subtype Resistant to Antivirals – March 20, 2018 – A newly discovered hepatitis C virus (HCV) genotype 1 subtype harbors multiple resistance-associated mutations that combine to block therapeutic effect of NS5A inhibitor direct-acting antivirals (DAAs). Read more.

    Testosterone Therapy Guidelines Updated – March 20, 2018 – Updates to the Endocrine Society’s 2010 clinical practice guidelines for testosterone therapy in men with hypogonadism discourage screening and treating all healthy men older than 65 years with low testosterone. Read more.

    Trump Says He is Working to Lower Prescription Drug Prices – March 19, 2018 – President Donald Trump promised to bring down prescription drug prices on Monday, saying U.S. citizens pay far more than people in other countries do for the same product and that his administration would announce new measures in about a month. Read more.

    Collaborating with Prescribers to Treat Chronic Pain – March 19, 2018 – Pain is an emotional condition, and a big part of addressing chronic pain is addressing its emotional component. “Having a team approach to that is fundamental,” said Noah Nesin, MD, FAAFP, vice president of medical affairs at Penobscot Community Health Care (PCHC), a federally qualified health center in Maine. Prescribers are open to having another partner on the team, he added. Read more.

    Pharmacists’ Role in Managing Contraceptive Care Continues to Evolve – March 18, 2018 – Attendees of the American Pharmacists Association’s Annual Meeting & Exposition (APhA2018) in Nashville, Tennessee, learned about the evolving role of community pharmacists in managing women’s contraceptive care at a continuing-education session. Read more.

    Hospitals are Confronting a New Opioid Crisis: An Alarming Shortage of Pain Meds – March 17, 2018 – The incident command system kicked in at Brigham and Women’s Hospital about a week ago. A large team of doctors, pharmacists and nurses began assembling every morning to confront an emerging crisis with the potential to severely undermine care for patients. Read more.

    Lawmakers Seek to Remove “Gag Clauses” That Keep Pharmacists from Revealing Lower Prescription Drug Prices – March 16, 2018 – A group of bipartisan senators introduced two pieces of prescription drug legislation, including a ban on “gag clauses” that can lead to consumers paying higher prices at the pharmacy. The group — led by Susan Collins, R-Maine, Claire McCaskill, D-Mo., and Debbie Stabenow, D-Mich. — revealed the Patient Right to Know Drug Prices Act and the Know the Lowest Price Act March 15, according to a joint news release from senators. Read more.

    Adherence Levels Similar Between Branded, Generic HIV Drug – March 16, 2018 – Among patients with HIV, adherence to antiretroviral therapy (ART) is key to viral suppression, while nonadherence has been linked to both drug resistance and disease progression. With the introduction of single-tablet regimens (STRs) for ART, treatment regimens have been simplified, thereby increasing adherence compared with multi-tablet regimens (MTRs). Read more.

    New Insulin Products and Best Practices – March 16, 2018 – More than 90 years ago, the first patient was treated with insulin, putting an end to the standard treatment of a severe calorie-restricted diet for patients with diabetes. This revolutionary treatment allowed patients with diabetes to live longer than ever. Since then, scientific innovation has made the disease more manageable through the creation of glucose monitors, insulin pens, and oral diabetes medications. An estimated 23.1 million individuals (7.2 percent of the U.S. population) have been diagnosed with diabetes. Read more.

    Drug Costs May Not Solely Drive Increasing U.S. Healthcare Spending – March 15, 2018 – Countless studies have established that Americans spend much more on healthcare than Europeans. It is believed that higher costs for prescription drugs in the United States may be the main reason for this discrepancy. Although drug costs are a major contributor, excessive use of imaging and surgical procedures are also significant factors in American overspending on healthcare compared with Europe, according to an editorial published by JAMA. Read more.

    Specialty Pharmacy Now Runs the Healthcare Gamut – March 14, 2018 – Specialty pharmacy is no longer simply set apart by the medication it dispenses. As a result of the patients it serves — whose conditions span disease states from oncology and rare diseases to cystic fibrosis and others that require high-cost, specialized medication — specialty pharmacy has expanded the scope of its services to patients, as well as payers, prescribers and manufacturers. Read more.

    Checklist Designed to Help Manage Drug Shortages – March 14, 2018 – Drug shortages continue to affect hospitals and health systems, and certainly make safe management of drugs a challenge. There are so many considerations: operational, information technology (IT), clinical, financial and, of course, the ever-difficult decisions about the use of alternative sources. Read more.

    Why MyHealthEData Could Change the Pharmacy Field – March 14, 2018 – I did not attend the Healthcare Information and Management Systems Society annual meeting this year, but I heard about many exciting developments that came out of the conference. One that stands out is a speech given by Centers for Medicare and Medicaid Services (CMS) Administrator Seema Verma. She spoke about how CMS is rethinking data management and patient care. Read more.

    Four Ways Pharmacists Are Fighting Opioid Abuse – March 14, 2018 – Efforts to address the opioid epidemic are as complex as the problem, with involvement ranging from government agencies to state pharmacy boards to addiction specialists to medical professionals. Pharmacists may be the first to suspect opioid abuse and misuse, and many have altered the way they interact with patients who take opioids. Studies have found that pharmacists say the epidemic has changed the way they counsel patients about pain management and potential problems. Read more.

    Patients Overpay for Prescriptions 23 Percent of the Time, Analysis Shows – March 13, 2018 – As a health economist, Karen Van Nuys had heard that it’s sometimes cheaper to pay cash at the pharmacy counter than to put down your insurance card and pay a copay. So one day, she asked her pharmacist how much her prescription would cost if she didn’t use her health coverage and paid cash. Read more.

    Drugmakers Try a Rare Tactic to Boost Sales: Cutting the Price – March 12, 2018 – Drugmakers tried just about every move under the sun to nurture sales of its products ­– pharmacy coupons for patients, exclusive deals with insurers, even selling a medicine’s patent to a Native American tribe to shield it from a legal challenge. What’s far rarer is the step two drugmakers announced Saturday: a price cut. Read more.

    What the $52-billion Cigna Purchase of Express Scripts Means For Consumers – March 12, 2018 – The healthcare industry is consolidating in a series of head-snapping deals. But like many of the recent multibillion-dollar combinations, it’s not clear whether the just-announced $52-billion merger of Cigna Corp. and Express Scripts Holding Co. will deliver lower premiums or cheaper drugs for consumers. Read more.


    340B in the News

    340B Health CEO Ted Slafsky Departs Suddenly – March 22, 2018 – The board of directors for 340B Health announced Thursday that Ted Slafsky would step down Thursday from his role as CEO of the association, leaving the organization without a CEO for the rest of March. Read more.

    The Uncertain State of the 340B Program: Where are We Now? – March 22, 2018 – In January 2018, in the wake of the publication of the House Energy and Commerce Committee’s Review of the 340B Drug Discount Program, I wrote that it was too soon to know whether 2018 will be a game-changing year for the 340B Program. In sum, there were just too many moving parts to discern whether there was a path forward for legislative change. Read more.

    340B is a Well-Intentioned Drug Discount Program Gone Awry – March 22, 2018 – Hospitals and clinics serving high-risk, high-need patient populations, including low-income and uninsured individuals, have long benefitted from a federal program that allows them to buy medicines from drug makers at a steep discount. Read more.

    Reforming Medicaid’s Drug Discount Program Would Be A Real Congressional Achievement – March 22, 2018 – The Senate HELP Committee hearing last week examining the 340B Drug Discount Program, another example of a well-intentioned government scheme gone awry, shows that Washington is finally getting serious about passing much-needed modernization and reform. Read more.

    Flashpoint: Hoosiers Should Not Support Changes to the 340B Drug Pricing Program – March 21, 2018 – Two things are true now, more than ever before: healthcare is expensive and prescription drug prices are sky-high. Indiana residents — especially those in rural areas, who have to travel long distances for a doctor — are struggling to seek treatment and afford medication. Read more.

    HHS Makes Case Against Hospitals’ 340B Suit in New Filing – March 21, 2018 – HHS argued that its double-digit payment reductions in the 340B Drug Pricing Program “were justified by developments in the market” due to the program’s overexpansion, according to a brief filed this week as part of the ongoing lawsuit from hospitals seeking to reverse the cuts. Read more.

    ‘Unreviewable’: HHS Asks D.C. Circuit to Curb Hospitals’ 340B Suit – March 21, 2018 – The judiciary has no authority to second-guess the OPPS rates HHS sets each year, according to the latest court filings in a suit that aims to halt planned cuts to the 340B Drug Pricing Program. The federal government argued in a court filing this week that an appellate judge should dismiss a lawsuit brought by a long list of hospital organizations challenging a reduction in payments under the 340B Drug Pricing Program. Read more.

    Pharmaceutical, Hospital Industries Go to War Over Drug Discount Program – March 20, 2018 – The pharmaceutical and hospital lobbies are dueling to sway lawmakers pondering changes to a drug discount program for some hospitals. The stakes are high for what is called the 340B Drug Discount Program. Lawmakers are considering changes to the program that in 2016 gave the hospitals $8 billion in drug discounts, representing about 1.3 percent of total drug spending. Read more.

    Opinion: Successful 340B Outpatient Drug Program a Bargain for Taxpayers – March 19, 2018 – For 25 years, a highly effective but little-known program created by Congress—the 340B Drug Pricing Program—has allowed healthcare providers at safety-net hospitals such as ours, UC San Diego Health, to enhance and strengthen the care we provide to our communities and especially to vulnerable patients—all at no cost to taxpayers. Read more.

    340B Vendor Selection – March 19, 2018 – Among the most important members of the 340B team of a covered entity (CE) are the software vendors. Their primary function involves providing software that, based on the CE’s data elements for its internal and contract pharmacy relationships, drives 340B operations, including reporting capabilities to maintain auditable records for compliance and financial review. Software vendors also maintain support staff to troubleshoot problems and operational issues. Read more.

    Trending News Today: Senators Now Looking into 340B Program – March 16, 2018 – The FDA said yesterday it plans to significantly reduce the nicotine content in cigarettes in an effort to help individuals quit smoking and prevent others from starting, according to NPR. Although there have been major efforts to reduce the harms of tobacco, cigarette smoking still kills nearly 500,000 Americans each year. The FDA has yet to determine how much nicotine it will cut, but it cited research that supported reducing levels to 0.3 to 0.5 milligrams per cigarette, according to the article. Read more.

    Senate Lays Groundwork For 340B Reporting Legislation – March 15, 2018 – Senators on Thursday signaled their chamber will join the U.S. House of Representatives to push hospitals to report where they direct their 340B drug discounts, wading into the fierce lobbying battle between Big Pharma and hospitals that has been waging for months. Read more.

    Dems, Republicans Split on 340B Drug Pricing Program in Senate Hearing – March 15, 2018 – The dividing line between Senate Democrats and Republicans on the 340B drug pricing program was set on Thursday, with Democrats siding with the hospitals, saying the savings from the program is desperately needed for the poorest populations, while Republicans took the side of drugmakers, saying the program is being abused and needs to be reformed. Read more.

    Grassley’s Senate Proposal Could Inject Drug Discount with The Transparency It Needs – March 14, 2018 – One day in business school, we did a strategy exercise on hospitals: was it better to be nonprofit or a for-profit? The instructor took us through a (very simplified) cash flow for different procedures at our imaginary hospital, then calculated the bottom line. If the hospital couldn’t make enough of a margin on its portfolio of procedures, we learned it would be better to adjust prices for some patients, or accept a certain number of charity cases, to ensure we didn’t make a profit — because then we wouldn’t have to pay taxes. Read more.

    Analysis Finds Higher Outpatient Drug Spending At 340B Hospitals – March 14, 2018 – A new analysis finds hospitals participating in the 340B Drug Discount Program have higher per patient outpatient pharmacy costs than their non-340B counterparts – meaning patients at 340B hospitals are prescribed more medicines and/or more expensive medicines. Read more.

    340B Hospitals Delivered $26B in Unreimbursed, Uncompensated Care – March 14, 2018 – Hospitals and health systems that participate in the 340B Drug Pricing Program play a crucial role in serving uninsured, Medicaid, Medicare, low-income and other indigent patients, according to a new study. The study was prepared by health policy research firm L&M Policy Research and commissioned by 340B Health, a lobby group representing 340B healthcare organizations. Read more.