Clinical Insights: November 7, 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

    Lorbrena® (lorlatinib) – New Drug Approval – November 2, 2018 – The Food and Drug Administration granted accelerated approval to lorlatinib (LORBRENA, Pfizer, Inc.) for patients with anaplastic lymphoma kinase (ALK)-positive metastatic non-small cell lung cancer (NSCLC) whose disease has progressed on crizotinib and at least one other ALK inhibitor for metastatic disease or whose disease has progressed on alectinib or ceritinib as the first ALK inhibitor therapy for metastatic disease. Read more.

    Udenyca™ (pegfilgrastim-cbqv) – New Biosimilar Drug Approval – November 2, 2018 – Coherus BioSciences, Inc.announced that the U.S. Food and Drug Administration (FDA) has approved Udenyca™ (pegfilgrastim-cbqv), the first pegfilgrastim biosimilar approved by both the FDA and the European Commission (EC) for patients with cancer receiving myelosuppressive chemotherapy. Udenyca™ is Coherus’ first drug to receive FDA or EC approval. Read more.

    Dsuvia™ (sufentanil) – New Drug Approval – November 2, 2018 – AcelRx Pharmaceuticals, Inc. announced the approval of Dsuvia™ by the U.S. Food and Drug Administration (FDA). Dsuvia™ is indicated for the management of acute pain in adults that is severe enough to require an opioid analgesic in certified medically supervised healthcare settings, such as hospitals, surgical centers, and emergency departments. Read more.

    Hyrimoz™ (adalimumab-adaz) – New Biosimilar Drug Approval – October 31, 2018 – Sandoz announced that the U.S. Food and Drug Administration (FDA) approved its biosimilar, Hyrimoz™ (adalimumab-adaz). The FDA granted approval for the treatment of rheumatoid arthritis (RA), juvenile idiopathic arthritis (JIA) in patients four years of age and older, psoriatic arthritis (PsA), ankylosing spondylitis (AS), adult Crohn’s disease (CD), ulcerative colitis (UC) and plaque psoriasis (Ps). Read more.

    Bijuva™ (estradiol and progesterone) – New Drug Approval – October 29, 2018 – TherapeuticsMD, Inc. announced that the United States Food and Drug Administration (FDA) has approved Bijuva™ (estradiol and progesterone) capsules, 1 mg/100 mg, the first and only FDA-approved bio-identical* hormone therapy combination of estradiol and progesterone in a single, oral capsule for the treatment of moderate to severe vasomotor symptoms (commonly known as hot flashes or flushes) due to menopause in women with a uterus. Read more.

    Xofluza™ (baloxavir marboxil) – New Drug Approval – October 24, 2018 – The U.S. Food and Drug Administration approved Xofluza™ (baloxavir marboxil) for the treatment of acute uncomplicated influenza (flu) in patients 12 years of age and older who have been symptomatic for no more than 48 hours. “This is the first new antiviral flu treatment with a novel mechanism of action approved by the FDA in nearly 20 years. Read more.

    Khapzory™ (levoleucovorin) – New Drug Approval – Oct. 23, 2018 – Spectrum Pharmaceuticals, Inc., a biotechnology company with fully integrated commercial and drug development operations with a primary focus in hematology and oncology, announced that the U.S. Food and Drug Administration (FDA) has approved Khapzory™ (levoleucovorin) for injection, a folate analog for three indications. Read more.

    Talzenna™ (talazoparib) – New Drug Approval – October 16, 2018 – The Food and Drug Administration approved talazoparib (TALZENNA, Pfizer Inc.), a poly (ADP-ribose) polymerase (PARP) inhibitor, for patients with deleterious or suspected deleterious germline BRCA-mutated (gBRCAm), HER2‑negative locally advanced or metastatic breast cancer. Patients must be selected for therapy based on an FDA-approved companion diagnostic for talazoparib. Read more.

    Yutiq™ (fluocinolone acetonide) – New Drug Approval – October 15, 2018 – EyePoint Pharmaceuticals, Inc., a specialty biopharmaceutical company committed to developing and commercializing innovative ophthalmic products, announced that the U. S. Food and Drug Administration (FDA) has approved Yutiq™ (fluocinolone acetonide intravitreal implant) for the treatment of chronic non-infectious uveitis affecting the posterior segment of the eye. Read more.


    New Formulation Approval

    No new updates.


    New Indication Approval

    Invokana® (canagliflozin) – October 30, 2018 – The Janssen Pharmaceutical Companies of Johnson & Johnson announced that the U.S. Food and Drug Administration (FDA) has approved Invokana® (canagliflozin) to reduce the risk of major adverse cardiovascular (CV) events, including heart attack, stroke or death due to a cardiovascular cause in adults with type 2 diabetes (T2D) who have established CV disease. Invokana® is the first and only oral diabetes treatment approved with this indication. Read more.

    Keytruda® (pembrolizumab) – October 30, 2018 – The Food and Drug Administration approved pembrolizumab (KEYTRUDA, Merck & Co. Inc.) in combination with carboplatin and either paclitaxel or nab-paclitaxel as first-line treatment of metastatic squamous non-small cell lung cancer (NSCLC). Read more. 

    Xyrem® (sodium oxybate) – October 29, 2018 – Jazz Pharmaceuticals plc announced that the U.S. Food and Drug Administration (FDA) approved its supplemental new drug application (sNDA) on October 26, 2018, to revise labeling for Xyrem® (sodium oxybate) oral solution, CIII, to include an indication to treat cataplexy or excessive daytime sleepiness (EDS) in patients with narcolepsy ages seven and older. Read more.

    Dupixent® (dupilumab) – October 19, 2018 – Regeneron Pharmaceuticals, Inc. and Sanofi announced the U.S. Food and Drug Administration has approved Dupixent® (dupilumab) as an add-on maintenance therapy in patients with moderate-to-severe asthma aged 12 years and older with an eosinophilic phenotype or with oral corticosteroid-dependent asthma. Read more.

    Liletta® (levonorgestrel-releasing intrauterine system)October 16, 2018 – Allergan plc, announced that the U.S. Food and Drug Administration (FDA) approved Medicines360’s Supplemental New Drug Application (sNDA) to extend the duration of use of Liletta® (levonorgestrel-releasing intrauterine system) 52 mg for the prevention of pregnancy for up to five years. Read more.

     Xarelto® (rivaroxaban) – October 11, 2018 – The Janssen Pharmaceutical Companies of Johnson & Johnson announced that the U.S. Food and Drug Administration (FDA) has approved Xarelto® (rivaroxaban) to reduce the risk of major cardiovascular (CV) events, such as CV death, myocardial infarction (MI) and stroke, in people with chronic coronary or peripheral artery disease (CAD/PAD). Read more.


    New Drug Shortage

    November 6, 2018

    October 30, 2018

    October 29, 2018

    October 25, 2018

    October 19, 2018

    October 15, 2018

    October 12, 2018


    New Drug Recall and Safety Alerts

    Ortho-Novum (Janssen) – New Drug Recall Alert – November 2, 2018 – Janssen Pharmaceuticals, Inc. has initiated a voluntary recall of one lot of Ortho-Novum® 1/35 (norethindrone/ethinyl estradiol) Tablets and two lots of Ortho-Novum® 7/7/7 (norethindrone/ethinyl estradiol) Tablets to the pharmacy level. The patient information provided inside affected packages of Ortho-Novum® does not include the appropriate instructions for the Veridate® dispenser. Read more.

    EpiPen auto-injectors – New Drug Safety Alert – November 2, 2018 – FDA is alerting patients, caregivers and healthcare professionals that the labels attached to some EpiPen 0.3mg and EpiPen Jr 0.15mg auto-injectors, and the authorized generic versions, may block access to the auto-injector and prevent the ability to easily access the product. Read more.

    Irbesartan (Sciegen Pharmaceuticals) – New Drug Recall Alert – October 30, 2018 – ScieGen Pharmaceuticals, Inc. is voluntarily recalling listed lots, within expiry, of Irbesartan Tablets, USP 75 mg, 150 mg, and 300 mg dosage forms to the consumer level. These products are being recalled due to the presence of an impurity, N-nitrosodiethylamine (NDEA) contained in the API Irbesartan, USP manufactured by Aurobindo Pharma Limited. Read more.

    Irbesartan (Aurobindo Pharma) – New Drug Recall Alert – October 26, 2018 – Aurobindo Pharma Limited is voluntarily recalling 22 Batches of the drug substance Irbesartan due to the presence of an impurity, N-nitrosodiethylamine (NDEA). The impurity, which is a substance that occurs naturally in certain foods, drinking water, air pollution, and industrial processes, has been classified as a probable human carcinogen as per International Agency for Research on Cancer (IARC). Read more.

    Prednisolone and Gatifloxacin Ophthalmic Solution – New Drug Recall Alert – October 22, 2018 – Promise Pharmacy is voluntarily recalling one lot of Prednisolone and Gatifloxacin Ophthalmic Solution 1%/0.5% sterile, 3ml vials,to the patient consumer level. The product has been found to have unidentified small particulate floating in the solution. Read more.


    New Generic Launch

    Clobazam (Onfi®) – October 23, 2018 – Upsher-Smith Laboratories, LLC (Upsher-Smith) announced the launch of Clobazam Tablets, CIV, 10 and 20 mg and Clobazam Oral Suspension, CIV, 2.5 mg/mL. Upsher-Smith’s Clobazam products are AB-rated to the branded products, Onfi® (clobazam) tablets, CIV and Onfi® (clobazam) oral suspension, CIV. Read more.


    Clinical and Pharmacy News

    Survey: Pharmacists Want To Counsel Patients, Build Provider Relationships – November 2, 2018 – Patients visit their pharmacists 30 times per year, and that number is increasing as pharmacists’ roles within healthcare delivery evolve and expand, but pharmacists are only able to spend 10 percent of their time counseling patients, according to a recent survey conducted by Maru/Matchbox for AmerisourceBergen’s inaugural “Pharmacy Check-Up: Activity & Barriers to Care Analysis.” Read more.

    ‘Perverse’ Tactics in Insulin Market Drive Up Prices, Congressional Report Finds – November 2, 2018 – Several “perverse” incentives for drugmakers have led to artificially high prices for insulin, which is placing the lifesaving drug out of reach for patients, according to a bipartisan report released Nov. 1 and cited by The Hill. The report, authored by Reps. Diana DeGette, D-Colo., and Tom Reed, R-N.Y., argues that several factors drive insulin prices up, while forces that may hinder the increases have been blunted. The price of insulin has nearly tripled in the past decade. Read more.

    Pharmacies Still Blocking U.S. Teens Looking For Emergency Contraception – November 2, 2018 – Teens seeking to buy emergency contraception at pharmacies continue to face significant roadblocks, a new U.S. study suggests. Researchers checking on the accessibility of the “morning after pill” at pharmacies in four Southwestern states found that just 28 percent made it simple and straightforward for teens to purchase the emergency contraception, according to the results published in the Journal of Adolescent Health. Read more.

    The FDA Warns Against the use of Many Genetic Tests with Unapproved Claims to Predict Patient Response to Specific Medications – November 1, 2018 – The FDA is alerting patients and healthcare providers that claims for many genetic tests to predict a patient’s response to specific medications have not been reviewed by the FDA, and may not have the scientific or clinical evidence to support this use for most medications. Changing drug treatment based on the results from such a genetic test could lead to inappropriate treatment decisions and potentially serious health consequences for the patient. Read more.

    Biosimilars Can Play a Key Role in Value-Based Care, Review SaysNovember 1, 2018 – Given the high burden of cancer in the senior population, and given the increasingly high cost of cancer care, there is a growing interest in value-based oncology care payment models, particularly within CMS. A recent review, authored by The Center for Biosimilars® advisory board member Kashyap Patel, MD, and colleagues, provides an overview of value-based care models and discusses the role of biosimilars in meeting these models’ objectives. Read more.

    New Melanoma Guidelines Identify Recommended Treatments, Weigh in on Genetic Testing – November 1, 2018 – New guidelines released by the American Academy of Dermatology (AAD) will help physicians provide the best treatment for more than 1 million Americans living with melanoma, the deadliest form of skin cancer. The guidelines were published Thursday, November 1, in Journal of the American Academy of Dermatology. Read more.

    Patient-Centered Care: The Case for Site Expansion to Include Health System Specialty Pharmacy – October 31, 2018 – Caring for patients with complex diseases is inherently challenging. When specialty medications are prescribed, informing and educating the patient about their disease state and treatment plan is only part of the puzzle. Behind the scenes, you need a team that works with the patient and other stakeholders to ensure drug coverage, secure financial assistance, and monitor the patient’s medication adherence and tolerance. Read more.

    Nearly Half of Consumers Abandoned a Prescription at the Pharmacy because it was Too Expensive – October 30, 2018 – Nearly half of consumers have abandoned a medication prescribed by their physician because it was too expensive, according to a survey released by DrFirst. At a time when the federal government is pushing a variety of measures to make prescription drug prices more transparent to consumers, the national survey revealed that 73 percent of consumers would change pharmacies if they knew that doing so would save them money on a prescription. Read more.

    Survey: Medication Reconciliation Improves Patient Safety – October 30, 2018 – According to a 2018 survey of physician leaders, including chief medical information officers (CMIOs), the system-wide use of enhanced medication reconciliation has improved patient safety, and issues common just a few years ago are less likely to occur today because of these checks and balances. However, the same survey revealed that more work is needed to ensure that continued gaps are completely addressed. Read more.

    The Unintended Consequences of the CDC Opioid Guideline According to Pain Management Specialists – October 30, 2018 – The guideline formulated by the Centers for Disease Control and Prevention (CDC) in an effort to curb opioid overdose-related deaths included a recommendation for steep reductions in opioid doses for patients taking high doses of the drug for chronic pain — including individuals with no evidence of drug addiction or misuse. This guideline has had dire consequences for patients and the physicians who treat them, according to critics. Read more.

    Many Doctors Writing Clinical Practice Guidelines Receive Undisclosed Industry Payments, Study Finds – October 29, 2018 – Last month, controversy stemming from undisclosed financial relationships with the drug industry led to the resignation of one the top breast cancer doctors in the country. But two new studies have found that the issue of financial conflicts of interest in medicine goes beyond just one doctor. Both studies were published Monday in the Journal of the American Medical Association, based on the assumption that financial conflicts of interests may affect the objectivity of clinical practice guidelines. Read more.

    Trump Administration Proposes New Medicare Drug Payment Model to Reduce Costs – October 25, 2018 – President Trump on Thursday proposed to reduce prescription drug costs in a move projected to save taxpayers and patients $17.2 billion over five years. America’s Health Insurance Plans commends the proposed payment model, while the American Medical Association voiced more caution. Under the proposed International Pricing Index model, Medicare’s payments for select physician-administered drugs would shift to a level more closely aligned with prices in other countries. Read more.

    Trump Signs New Opioid Bills, Introduces Rule to Lower Drug PricesOctober 25, 2018 – A package of opioid bills was signed into law Wednesday by President Trump in a broad effort to wrangle the opioid abuse epidemic, which claimed 72,000 lives in overdose-related deaths last year. The president also proposed making major changes to Medicare drug pricing on Thursday. The legislation, Support for Patients and Communities Act, was approved by Congress in early October with wide bipartisan support. Read more.

    Drugmaker Amgen Just Cut the Price of its $14,000-a-Year Medication by 60 Percent – October 24, 2018 – Amgen Inc, looking to boost use of its potent cholesterol drug Repatha, has cut the medication’s U.S. list price by 60 percent to $5,850, the U.S. biotechnology company said on Wednesday. Repatha and rival drug Praluent from partners Regeneron Pharmaceuticals Inc and Sanofi SA were launched in 2015 at list prices of more than $14,000 a year. Read more.

    Drug Cost Concerns Feed into Docs’ Aversion to Risk in Pay Models- October 24, 2018 – Physicians are pushing back against federal and private pay models that force them to take on more downside risk, worrying that they will be responsible for costs they can’t control, according to a new study. The American Medical Association and RAND Corp. found that doctors don’t want to be penalized for increased patient spending stemming from new, high-priced drugs. Read more.

    FDA Approving Generic Drugs at Record Pace, Report Finds – October 23, 2018 – The FDA is continuing to set records for the number and speed of its generic drug approvals. In fiscal year 2018, the agency approved 781 generics, up 90 percent from 2014, the first year the Generic Drug User Fee Act was in full effect, according to a new report from multinational professional services firm PwC. Read more.

    Study Supports Pharmacies’ Dispensing of Vaccine During Flu Epidemics – October 22, 2018 – Adding pharmacies to the mix, along with physicians’ offices and hospitals, and extending their hours could streamline administering vaccinations in the event of a flu epidemic caused by a novel virus, a new study led by researchers at the Johns Hopkins Bloomberg School of Public Health found. This strategy could save thousands of lives and billions of dollars, the authors concluded. Read more.


    340B in the News

    Would the IPI Model Reduce Medicare Reimbursement for Providers? – November 5, 2018 – Physicians and hospitals would not see Medicare reimbursement drop under the proposed International Pricing Index (IPI) model, the former Senior Advisor to the Secretary for Drug Pricing Reform recently assured providers. “The model will increase the add-on compensation available for provider costs associated with drugs covered by the IPI model, by undoing a cut to compensation that was imposed by budget sequestration (from 6 percent of ASP [average sales price] to 4.3 percent),” Dan Best wrote in a new Q&A blog post on the HHS website. Read more.

    Patients Feel the Pinch from 340B Program Cuts – November 1, 2018 – The battle over the 340B drug discount program centers around patients—are they getting the medications and care the program was intended to provide, or are funds being used to fill hospital coffers? Conversely, are cuts actually hurting vulnerable patients? The debate is playing out in the courts, Congress, and communities across the nation. Read more.

    HHS to Move Forward with Long-Delayed 340B Ceiling Price Rule – October 31, 2018 – HHS wants to cancel its plans to postpone imposing new ceiling prices for the 340B drug discount program. The agency issued a proposed rulemaking on Wednesday that suggested the long-delayed rule will now be effective Jan. 1, instead of July 1, 2019, as originally announced earlier this year. Read more.

    340B Drug Program Was Created to Help Patients, Not Boost Hospital Profits – October 28, 2018 – Enacted more than 25 years ago with bipartisan support, the 340B program was designed to help healthcare safety net providers deliver more affordable outpatient prescription drugs to vulnerable or uninsured patients.These safety net providers include certain hospitals, such as disproportionate share hospitals, or DSH hospitals, and children’s hospitals, as well as federal grantees, such as federally qualified health centers and Ryan White HIV/AIDS clinics. Read more.

    Six Initiatives States May Pursue to Curb Drug Prices and the 340B Factor – October 23, 2018 – For much of the past 18 months, the Trump Administration, and in particular CMS, have talked a good game regarding reducing pharmaceutical prices. On October 16, 2018, a key component of the Administration’s strategy was revealed in the form of CMS’ Proposed Rule requiring manufacturers to include the “list price” for prescription drugs reimbursable by Medicaid or Medicare in television advertisements. Read more.