Clinical Insights: June 4, 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

    Olumiant® (baricitinib) – June 1, 2018 – Eli Lilly and Company and Incyte Corporation announced that the U.S. Food and Drug Administration (FDA) has approved the 2-mg dose of Olumiant® (baricitinib), a once-daily oral medication for the treatment of adults with moderately-to-severely active rheumatoid arthritis (RA) who have had an inadequate response to one or more tumor necrosis factor (TNF) inhibitor therapies. RxS Clinical Insight: Olumiant® was approved with “black box warning” for Serious Infections, Malignancy and Thrombosis. Read more.

    ConsensiTM (amlodipine and celecoxib) – May 31, 2018 – Kitov Pharma Ltd. announced that the U.S. Food and Drug Administration (FDA) has approved ConsensiTM (amlodipine and celecoxib) oral tablets for marketing. ConsensiTMis a patent-protected combination of celecoxib, a non-steroidal anti-inflammatory drug (NSAID), and amlodipine besylate, an antihypertensive calcium channel blocker. ConsensiTMwas approved for once daily use in three dosage forms, corresponding to the current approved dosages of amlodipine (2.5, 5, and 10 mg) for hypertension and a 200 mg dose of celecoxib for the treatment of osteoarthritis pain. Read more.

    ImvexxyTM (estradiol) Vaginal Inserts – May 30, 2018 – TherapeuticsMD, Inc., an innovative women’s healthcare company, announced that the United States Food and Drug Administration (FDA) has approved ImvexxyTM (estradiol vaginal inserts) for the treatment of moderate-to-severe dyspareunia (vaginal pain associated with sexual activity), a symptom of vulvar and vaginal atrophy (VVA), due to menopause. ImvexxyTM is the only product in its therapeutic class to offer a 4 mcg and 10 mcg dose, the 4 mcg representing the lowest approved dose of vaginal estradiol available. Read more.

    PalynziqTM (pegvaliase-pqpz) May 24, 2018 – The U.S. Food and Drug Administration approved PalynziqTM (pegvaliase-pqpz) for adults with a rare and serious genetic disease known as phenylketonuria (PKU). Patients with PKU are born with an inability to break down phenylalanine (Phe), an amino acid present in protein-containing foods and high-intensity sweeteners used in a variety of foods and beverages. Read more.

    Yonsa® (abiraterone acetate) – May 23, 2018 – Sun Pharmaceutical Industries Ltd. and Churchill Pharmaceuticals, LLC. announced that one of Sun Pharma’s wholly owned subsidiary companies has received approval from the U.S. Food and Drug Administration (FDA) for Yonsa® (abiraterone acetate), a novel formulation in combination with methylprednisolone, for the treatment of patients with metastatic castration-resistant prostate cancer (mCRPC). Read more.


    New Formulation Approval

    No new updates.


    New Indication Approval

    Xeljanz® (tofacitinib citrate) – May 30, 2018 – The U.S. Food and Drug Administration expanded the approval of Xeljanz® (tofacitinib) to include adults with moderately to severely active ulcerative colitis. Xeljanz® is the first oral medication approved for chronic use in this indication. Other FDA-approved treatments for the chronic treatment of moderately to severely active ulcerative colitis must be administered through an intravenous infusion or subcutaneous injection. Read more.

    Cimzia® (certolizumab pegol) – May 28, 2018 – UCB announced that the U.S. Food and Drug Administration (FDA) has approved extending the label for Cimzia® (certolizumab pegol) to include a new indication in adults with moderate-to-severe plaque psoriasis. Cimzia® is indicated for the treatment of adults with moderate-to-severe plaque psoriasis (PsO) who are candidates for systemic therapy or phototherapy. Read more.


    New Drug Shortage

    May 30, 2018 

    May 29, 2018 

    May 25, 2018 

    May 24, 2018 

    May 23, 2018 


    New Drug Recall and Safety Alerts

    Fluticasone Propionate Nasal Spray by Apotex Corp – New Drug Recall Alert – May 31, 2018 – The Fluticasone Propionate Nasal Spray 50 mcg per spray 120 Metered Sprays has been found to contain small glass particles. The glass particles could block the actuator and impact the functionality of the pump. The issue was discovered through a customer complaint. Read more.

    TaytullaTM (norethindrone acetate and ethinyl estradiol capsules and ferrous fumarate capsules) – New Drug Recall Alert – May 29, 2018 – Allergan recently identified, through a physician report, that four placebo capsules were placed out of order in a sample pack of TaytullaTM and the first four days of therapy had four non-hormonal placebo capsules instead of active capsules. Read more.


    New Generic Launch

    No new updates.


    Clinical and Pharmacy News

    FDA Wants to Shorten New Drug Monopolies to Cut Costs – June 3, 2018 – In an effort to increase competition and bring down prescription drug prices, FDA Commissioner Dr. Scott Gottlieb wants to speed approval times for rivals to promising new first-to-market medicines. Read more.

    Prescription Drug Monitoring Program Use Continues to Rise – June 1, 2018 – Physician use of state-run prescription drug monitoring programs is dramatically increasing while doctors have decreased opioid prescribing nationwide for the fifth consecutive year. That’s among the findings of a new report released on Thursday by the American Medical Association, which the organization says shows progress toward reversing the U.S. opioid epidemic. Read more.

    Generic Prescription Drug Prices, Patient Cost-Sharing Increase – June 1, 2018 – Medicare Part D beneficiaries are paying more for generic prescription drugs, despite the fact that the market price for those drugs has remained unchanged, according to an analysis from Avalere. This trend is likely due to the tier these drugs are placed on in prescription drug formularies, the analysts explained. Read more.

    How Pharmacists are Slashing Readmission Rates at a Philadelphia Hospital – June 1, 2018 – Pharmacist interventions at Philadelphia-based Einstein Medical Center cut the hospital’s 30-day readmission rate by more than half for traditional Medicare patients, according to a study published in the American Journal of Health-System Pharmacy. Read more.

    Use of Prescription Drugs Declines for Most Children, Adolescents – May 31, 2018 – With some notable exceptions for specific medication classes and age groups, use of prescription drugs generally dropped for children and adolescents in the United States from 1999 to 2014. That’s according to an article in the Journal of the American Medical Association. Read more.

    Medicare Part D Drug Coverage Gap Closing at Faster Clip – May 31, 2018 – Headlines earlier this year announced the “doughnut hole” in Medicare’s Part D prescription-drug coverage is closing ahead of schedule. That’s welcome news for the beneficiaries who fall into the coverage gap, many of whom should see savings next year. But as is often the case, the devil is in the details. Read more.

    Statement from FDA Commissioner Scott Gottlieb, M.D., on FDA’s Work to Mitigate Shortages of Intravenous Drugs, Shorten Supply Disruptions And Better Predict Vulnerabilities – May 31, 2018 – Without question, one of the most frustrating challenges that healthcare providers and patients must contend with is when a drug that’s medically necessary and critical to patient care is unavailable due to a shortage. We know that the uncertainty over how long a drug will be in shortage, how to ration supplies in the meantime, or worse, how to prepare for a sudden event that might place unforeseen demands on a product that’s in short supply, adds burdens and stress on providers and patients. Read more.

    Statement from FDA Commissioner Scott Gottlieb, M.D., on New Policies to Reduce the Ability of Brand Drug Makers to Use REMS Programs as a Way to Block Timely Generic Drug Entry, Helping Promote Competition and Access – May 31, 2018 – Our system for developing new drugs is based on a careful equilibrium enshrined in legislation by Congress that seeks to balance access with innovation. That system enables market-based rewards for novel innovation as a way to create incentives for the time, risk and capital required to develop new medical advances. At the same time, the law allows for brisk competition from safe and effective generic medicines once the period of patent protection or exclusivity has lapsed on a new medicine. Read more.

    Conflicting Guidance on Opioid Prescribing can Jeopardize Pain Management for Patients with Cancer – May 30, 2018 – Persistent pain and recurrent episodes of pain are common for those who are living with cancer, or for those undergoing cancer treatment. When used properly, prescription opioids have long been known to help combat pain experienced by people with cancer. Read more.

    Benefit Change could Raise Costs for Patients Getting Drug Copay Assistance – May 29, 2018 – Since Kristen Catton started taking the drug Gilenya two years ago, she’s had only one minor relapse of her multiple sclerosis, following a bout of the flu. She can walk comfortably, see clearly and work part-time as a nurse case manager at a hospital near her home in Columbus, Ohio. This is a big step forward; two drugs she previously tried failed to control her physical symptoms or prevent repeated flare-ups. Read more.

    Hepatitis C Virus Guideline Updated for Unique Populations – May 29, 2018 – The hepatitis C virus (HCV) guidelines for unique populations have recently been updated. These guidelines provide new testing and management recommendations for pregnant women, individuals who inject drugs, men who have sex with men (MSM), and individuals who are incarcerated. Pharmacists can play an important role in managing these unique populations as part of the healthcare team. Read more.

    ER Docs Report Drug Shortages, Lack of Disaster Prep – May 27, 2018 – The vast majority of emergency medicine physicians face shortages of key medications, and doubt whether their organizations are “fully prepared” for a disaster, polling data showed. The poll’s findings were released by the American College of Emergency Physicians (ACEP) in Washington. The survey was conducted from April 30 to May 7, 2018, and had 247 respondents. Read more.

    Building Trust through Technology for Medication Adherence – May 26, 2018 – The directions are usually pretty basic: Take one tablet once a day with water. Simple, right? For eons, providers, payers and pharmacists have resorted to good old-fashioned trust and assumed that the patient was following those simple instructions. Medication nonadherence (or noncompliance) is a big problem. Read more.

    Lawmaker Eyes Drug Discounts in Bid to Reduce Rx Pricing – May 25, 2018 – A House health panel this summer will turn its attention to drug rebates and how the discounts negotiated by pharmaceutical industry middlemen and others affect what Americans pay at the pharmacy, the panel’s chairman told Bloomberg Law. Read more.

    Declining Number of Rural Pharmacies ‘A Worrisome Trend’ – May 25, 2018 – Small-town pharmacists dispense medication, of course. But they might also provide clinical services like immunizations and blood pressure screenings; consult on health issues; or even act as a de facto benefits or case manager for customers. Pharmacies clearly are important to healthcare in rural communities. Yet nearly 500 rural communities in Washington lost their only retail pharmacy between 2003 and 2013. Read more.

    Pharmacists Group Urges Congress to Take Action on Opioid Drug Shortage Problem – May 25, 2018 – American Society of Health-System Pharmacists (ASHP) is urging policymakers to take swift action to address the shortages of medications in hospitals and health systems. In a survey of 343 pharmacists, ASHP, which represents pharmacists who serve in acute and ambulatory care settings, found that nearly all (98.4 percent) said the hospital had been affected by shortages of the injectable opioids morphine, hydromorphone and fentanyl. About 70 percent called the shortages “severe.” Read more.

    Proposed Drug Price Changes to Increase Patient Out-of-Pocket Costs – May 24, 2018 – Proposed amendments to drug price coverage could adversely impact patient out-of-pocket costs, causing some patients to pay more for their treatments than they had before, according to a recent analysis from Avalere. Earlier this month, the Trump Administration published a blueprint for overhauling drug pricing in Medicare and Medicaid. Among the many provisions listed in the blueprint was a proposal to shift certain Medicare Part B drugs to Medicare Part D. Read more.

    Health System-Led Drug Company Garners Strong Provider Support – May 24, 2018 – Providers are optimistic that a health system-led generic-drug company can lower drug costs and mitigate shortages, and the vast majority say they will buy drugs from the venture, according to a new survey. Intermountain Healthcare, Ascension, SSM Health and Trinity Health are working with the U.S. Veterans Affairs Department to pool their capital and fight back against drug companies that unexpectedly hike the prices of decades-old off-patent generic drugs. Read more.

    Unnecessary Antibiotic Use for Asthma Exacerbations Linked to Increased Hospital Stays, Costs – May 23, 2018 – Administering antibiotics to adults hospitalized with an asthma exacerbation without any documented indication of lung infection appears to lengthen hospital stay, increase cost and result in increased risk for antibiotic-related diarrhea, according to new research presented at the ATS 2018 International Conference. Read more.

    Hepatitis C Infections Resulting from Medical Treatment Occur Despite Clear Guidelines – May 23, 2018 – In a 10 year span, more than 130,000 patients were notified of medical errors that may have exposed them to blood-borne illness, including Hepatitis C. However, the majority of these notification events were discovered only after patients became acutely ill rather than through proactive reporting of violations of health safety protocols, according to a review in The Journal of the American Osteopathic Association. Read more.

    Drug Makers Called Out For Delaying Generics Have Cost Medicare And Medicaid Billions – May 23, 2018 – Makers of brand-name drugs called out by the Trump administration for potentially stalling generic competition have hiked their prices by double-digit percentages since 2012 and cost Medicare and Medicaid nearly $12 billion in 2016, a Kaiser Health News analysis found. Read more.

    The U.S. is Running Out of Commonly Used Drugs Including Ones Used in Epidurals, and it’s Put Us on ‘The Brink of a Public Health Emergency – May 23, 2018 – The U.S. has had a long-standing problem with drug shortages, but now, the situation is reaching a tipping point. In the past year, the healthcare industry dealt with the aftermath of Hurricane Maria, which shut down many facilities that manufactured commonly used healthcare products such as saline and other intravenous (IV) fluids. Read more.


    340B in the News

    HHS Delays 340B Drug Ceiling Prices and Penalties for The Fifth Time – June 1, 2018 – The Trump administration is once again delaying regulations that would set price ceilings under the 340B Drug Discount Program despite repeated pleas from hospital groups to implement new rules. The Department of Health and Human Services (HHS) announced on Friday it will delay until July 2019 regulations that would set a ceiling price and impose civil penalties on drug companies that knowingly charge 340B hospitals above that limit. Read more.

    Where the 340B Program Currently Stands – May 31, 2018 – Critics and advocates are debating several policies to improve the effectiveness of the federal discount drug pricing program. May has been an eventful month for the 340B Drug Pricing Program, as numerous policy proposals and decisions affecting the federal program have been debated by both critics and advocates. Read more.

    Hospital Groups Urge HRSA to Institute 340B Final Rule – May 31, 2018 – The Health Resources and Services Administration is considering another delay of a final rule that would set price ceilings in the 340B Drug Discount Program, but hospital organizations are urging the agency to finalize the price caps now. HRSA issued a proposed rule (PDF) earlier this month that would delay to July 2019 regulations that would set the ceiling price and impose civil penalties on drug companies that knowingly charge 340B hospitals above that price cap. Read more.

    Drug Discount Program Needs Modernization: Letter to the Editor – May 31, 2018 – Despite congressional partisanship and gridlock in Washington, D.C., our elected officials need to focus on solving problems that impact needy patients in America. The 340B Drug Discount Program helps vulnerable patients. For more than two decades, the 340B program has helped uninsured, low-income patients get prescription medicine and access healthcare by providing eligible hospitals and community clinics with discounted medicine. Read more.

    S&P: 340B Cuts will Weaken Nonprofit Hospitals – May 30, 2018 – The $1.6 billion in cuts to Medicare payments made under the 340B Drug Discount Programs could add to the financial stress of smaller not-for-profit hospitals and health systems, leading to cuts in patient care and eventually leading more patients to rely on emergency departments, according to Standard & Poor’s (S&P) Global Ratings. The cuts to 340B went into effect Jan. 1, 2018, from a provision in this year’s Medicare outpatient payment rule. Read more.

    In a Time of Rising Drug Prices, Preserve the 340B Program – May 29, 2018 – In a recent blog post, Congressman Bradley Byrne highlighted that Alabama hospitals receive the lowest Medicare reimbursement rate in the country. Because Medicare is the largest payor in most hospitals, this issue impacts the fiscal sustainability of hospitals across the state. We gratefully acknowledge and applaud Congressman Byrne’s leadership in calling attention to the impact it has on Alabama’s hospitals. Read more.

    Early 340B Hospital Participants Provided More Low-Profit Services than Nonparticipants, Study Finds – May 29, 2018 – Early participants in the 340B Drug Pricing Program spent more on uncompensated care and were more likely to provide low-profit services compared with nonparticipants, according to a study published May 21 in JAMA Internal Medicine. The study examined how nonprofit and public hospital 340B participants differed from nonparticipants in 2015 in terms of financial stability, uncompensated care and low-profit services. Read more.

    Commentary: Attacks on 340B Program Distract from Source of Drug-Pricing Problem – May 26, 2018 – Given all the good things hospitals accomplish thanks to 340B Drug Pricing Program savings—from affordable medications to comprehensive services for the poor—it might seem odd the program has taken so much heat lately. But if you consider the larger context of the attacks—the national debate on runaway drug prices—you’ll understand why drugmakers have worked so hard to shift attention to this critical source of safety-net support. Read more.

    HHS 340B Rule Delay would Put Hospitals at Risk for High Drug Prices – May 24, 2018 – Safety-net hospitals urged HHS not to postpone a rule setting new ceiling prices for the 340B Drug Discount Program, saying the delay would leave them defenseless against rising costs. Although HHS was supposed to set ceiling prices starting July 1, the agency wants to hold off on the rule for a year. Read more.

    340B Hospitals Provide More Low-Profit Services – May 23, 2018 – Hospitals that participate in the 340B program offer more low-profit service lines than nonparticipants, according to research published in JAMA Internal Medicine. “Effective January 2018, [CMS] reduced Medicare reimbursement to physicians administering discounted drugs acquired by most 340B hospital participants,” Sayeh Nikpay, PhD, MPH, from Vanderbilt University School of Medicine, and colleagues wrote. “Opponents of reform contend that 340B revenues finance safety-net services, whereas supporters contend that most participants do not direct revenue back to safety-net care.” Read more.