Clinical Insights: August 29, 2019

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    New Drug Approval

    Nourianz™ (istradefylline) – New Drug Approval – August 27, 2019 The U.S. Food and Drug Administration approved Nourianz™ (istradefylline) tablets as an add-on treatment to levodopa/carbidopa in adult patients with Parkinson’s disease (PD) experiencing “off” episodes. An “off” episode is a time when a patient’s medications are not working well, causing an increase in PD symptoms, such as tremor and difficulty walking. Read More>

    Xenleta™ (lefamulin) – New Drug Approval – August 19, 2019 The U.S. Food and Drug Administration approved Xenleta™ (lefamulin) to treat adults with community-acquired bacterial pneumonia. Read More>

    Rinvoq™ (upadacitinib) – New Drug Approval – August 16, 2019 AbbVie announced that the U.S. Food and Drug Administration (FDA) has approved Rinvoq™ (upadacitinib), a 15 mg, once-daily oral Janus kinase (JAK) inhibitor, for the treatment of adults with moderately to severely active rheumatoid arthritis (RA) who have had an inadequate response or intolerance to methotrexate (MTX-IR). Read More> 

    Inrebic® (fedratinib) – New Orphan Drug Approval – August 16, 2019 The Food and Drug Administration approved fedratinib (INREBIC, Impact Biomedicines, Inc.) for adults with intermediate-2 or high-risk primary or secondary (post-polycythemia vera or post-essential thrombocythemia) myelofibrosis (MF). Read More>

    Rozlytrek™ (entrectinib) – New Drug Approval – August 15, 2019 The Food and Drug Administration granted accelerated approval to entrectinib (ROZLYTREK, Genentech Inc.) for adults and pediatric patients 12 years of age and older with solid tumors that have a neurotrophic tyrosine receptor kinase (NTRK) gene fusion without a known acquired resistance mutation, are metastatic or where surgical resection is likely to result in severe morbidity, and have progressed following treatment or have no satisfactory standard therapy. Read More> 

    Wakix® (pitolisant) – New Drug Approval – August 15, 2019 Harmony Biosciences, LLC (Harmony) announced that the U.S. Food and Drug Administration (FDA) approved Wakix® (pitolisant) for the treatment of excessive daytime sleepiness (EDS) in adult patients with narcolepsy. Wakix® is the first and only treatment approved for patients with narcolepsy that is not scheduled as a controlled substance by the U.S. Drug Enforcement Administration (DEA). Read More>

    Pretomanid – New Orphan Drug Approval – August 14, 2019 The U.S. Food and Drug Administration approved Pretomanid Tablets in combination with bedaquiline and linezolid for the treatment of a specific type of highly treatment-resistant tuberculosis (TB) of the lungs. Read More> 

    Turalio™ (pexidartinib) – New Drug Approval – August 2, 2019 the U.S. Food and Drug Administration granted approval to Turalio™ (pexidartinib) capsules for the treatment of adult patients with symptomatic tenosynovial giant cell tumor (TGCT) associated with severe morbidity or functional limitations and not responsive to improvement with surgery. Read More>

    Nubeqa™ (darolutamide) – New Drug Approval – July 30, 2019 The Food and Drug Administration approved darolutamide (NUBEQA, Bayer HealthCare Pharmaceuticals Inc.) for non-metastatic castration-resistant prostate cancer. Read More>

    New Formulation Approval

    Eylea® (aflibercept) – New Formulation Approval – August 13, 2019 Regeneron Pharmaceuticals, Inc., announced that the U.S. Food and Drug Administration (FDA) has approved the Chemistry, Manufacturing and Controls (CMC) Prior-Approval Supplement (PAS) for the Eylea® (aflibercept) Injection prefilled syringe. The 2 mg, single-dose, sterilized prefilled syringe provides physicians with a new way to administer Eylea® that requires fewer preparation steps compared to vials. Read More>

    New Indication Approval

    Taltz® (ixekizumab) – New Indication Approval – August 26, 2019 Eli Lilly and Company announced that the U.S. Food and Drug Administration (FDA) has approved Taltz® (ixekizumab) injection 80 mg/mL for the treatment of adults with active ankylosing spondylitis (AS), also known as radiographic axial spondyloarthritis (r-axSpA). Read More> 

    Asmanex® HFA (mometasone furoate) – New Expanded Indication Approval – August 12, 2019 The FDA approved Merck’s Asmanex® HFA (mometasone furoate) inhalation solution, for the maintenance treatment of asthma as prophylactic therapy in patients 5 years of age and older. Read More>

    Dulera® (mometasone furoate/formoterol fumarate dihydrate) – New Expanded Indication Approval – August 12, 2019 The FDA approved Merck’s Dulera® (mometasone furoate/ formoterol fumarate dihydrate) inhalation aerosol, for the twice-daily treatment of asthma in patients 5 years of age and older. Read More> 

    Sirturo® (bedaquiline) – New Indication Approval – August 9, 2019 The Janssen Pharmaceutical Companies of Johnson & Johnson announced that the U.S. Food and Drug Administration (FDA) has granted approval for Sirturo® (bedaquiline) tablets as part of combination therapy in pediatric patients – those over the age of 12 and younger than 18 and weighing at least 66 pounds (30 kilograms) – with pulmonary multidrug-resistant tuberculosis (MDR-TB), when an effective treatment regimen cannot otherwise be provided. Read More> 

    Clenpiq™ (sodium picosulfate/magnesium oxide/anhydrous citric acid) – New Expanded Indication Approval – August 8, 2019 The FDA approved Ferring Pharmaceuticals’ Clenpiq™ (sodium picosulfate/magnesium oxide/anhydrous citric acid), for cleansing of the colon as a preparation for colonoscopy in adults and pediatric patients 9 years of age and older. Read More>

    Enstilar® (calcipotriene and betamethasone dipropionate) – New Expanded Indication Approval – August 1, 2019 LEO Pharma Inc., announced the U.S. Food and Drug Administration (FDA) has expanded the approved indication for Enstilar® (calcipotriene and betamethasone dipropionate) Foam, 0.005%/0.064%, for the topical treatment of plaque psoriasis to include patients age 12 and older. The FDA granted Enstilar Foam pediatric exclusivity, extending the period of U.S. market exclusivity by an additional six months to Dec. 10, 2031. Read More> 

    Taclonex® (calcipotriene and betamethasone dipropionate) – New Expanded Indication Approval – August 1, 2019 The FDA approved Taclonex® (calcipotriene and betamethasone dipropionate) Topical Suspension in the topical treatment of scalp and body plaque psoriasis in patients 12 years and older. Read More>

    Keytruda® (pembrolizumab) – New Indication Approval – June 31, 2019 Merck announced that the U.S. Food and Drug Administration (FDA) has approved Keytruda®, Merck’s anti-PD-1 therapy, as monotherapy for the treatment of patients with recurrent locally advanced or metastatic squamous cell carcinoma of the esophagus whose tumors express PD-L1 (Combined Positive Score [CPS] ≥10) as determined by an FDA-approved test, with disease progression after one or more prior lines of systemic therapy. Read More>

    New Drug Shortage

    August 21, 2019

    August 19, 2019

    August 15, 2019

    August 14, 2019

    August 13, 2019

    New Drug Recall and Safety Alerts

    Relpax® (eletriptan hydrobromide) – New Drug Recall – August 15, 2019 Pfizer Inc. is voluntarily recalling Relpax® (eletriptan hydrobromide) 40 mg tablets, lots AR5407 and CD4565, to the Patient level. Pfizer Inc. initiated this recall because these product lots may not meet Pfizer’s in-house microbiological specification for the potential presence of Genus Pseudomonas and Burkholderia. Read More>

    New Generic Approval and Launch

    Halog® (halcinonide) – New Generic Approval – August 12, 2019 Mylan launched an AB-rated generic version of Sun’s Halog® (halcinonide) 0.1% cream. Read More>

    Clinical and Pharmacy News

    Strategies for Successful IDN-based Specialty Pharmacy: The Financial Perspective – August 27, 2019 For an integrated health care system, bringing specialty pharmacy in-house is a way to align operations with a patient-centered care mission. An in-house specialty pharmacy can also provide significant financial gain for health systems by preventing revenue from being diverted to outside pharmacies. Read More>

    Consumers Still Prefer Human To Digital Pharmacists – August 26, 2019 Consumers have more digital options to shop for their prescriptions online, but many patients still like their face-to-face meeting with a pharmacist, says a new consumer study from research firm J.D. Power. Read More> 

    A New Study Reveals How The Price Of Treatments For A Devastating Disease Quadrupled Over The Past Decade – August 26, 2019 The high cost of prescription drugs is a growing problem in the US healthcare system. A new study published by the journal JAMA Neurology sheds new light on the issue, revealing how drug prices for individuals with multiple sclerosis (MS) quadrupled over a 10-year period. The average price of the treatments climbed from $18,660 in 2006 to $75,847 in 2016. Read More> 

    Study Questions Mainstay Treatment For Mild Asthma – August 26, 2019 Steroid inhalers commonly used to prevent asthma attacks may not work any better than a placebo for many people with mild asthma, according to recent research. Synthetic corticosteroids mimic the steroid hormone cortisol, reducing inflammation in the airways. But the drug targets a type of inflammation that may be found in far fewer patients than previously thought, research in a recent issue of the New England Journal of Medicine finds. Read More>

    Incorporating Pharmacists Into The ICU Team – August 24, 2019 Similar to many hospitals in the country, Robert Wood Johnson University Hospital Hamilton in Hamilton Township, N.J., had just one critical-care pharmacist working in its intensive-care unit. That changed about two years ago. Liza Andrews rounded on the 20-bed unit a few times a week and the remaining hours were filled by general pharmacists working remotely who did their best to solve routine prescription problems happening on the floor. Read More>

    COMMENTARY: Pharmacy Benefit Managers Are Squeezing Locally-Owned Drug Stores – August 24, 2019 THE U.S. Senate Finance Committee is working on reforms to bring down the cost of prescription drugs. Senators are considering a measure that would address the lack of transparency in how pharmaceuticals are priced. Read More> 

    Employers Could Reap Substantial Savings Through Biosimilars, but Not Without Targeted Effort – August 23, 3019 A new report from Matrix Global Advisors and the National Business Group on Health, sponsored by Boehringer Ingelheim, shows that employers could see substantial savings from biosimilars, but those savings won’t come without a concerted effort to encourage biosimilar use. Read More>  

    ACR Cautions Against Switching Patients with AS, axSpA to Biosimilars – August 22, 2019 Adults with active ankylosing spondylitis despite treatment with a first TNF-inhibitor, as well as those with stable disease receiving an originator TNF inhibitor, should not be switched to a biosimilar, according to updated recommendations from the American College of Rheumatology published in Arthritis Care & Research. Read More>

    Cases of Drug Diversion Increase – August 22, 2019 Regulators are seeing more complaints about drug diversions and the theft of controlled substances from pharmacies, according to a new report. The state Board of Registration in Pharmacy, which oversees the state’s prescribers, received at least 543 “drug violation” complaints stemming from “drug losses, record keeping discrepancies and drug diversions” at drug stores and pharmacies throughout the state from 2013 through 2018. Read More>

    Rheumatology and Spondylitis Organizations Release Updated Treatment Guideline for AxSpA – August 22, 2019 The American College of Rheumatology (ACR), in partnership with the Spondylitis Association of America (SAA) and the Spondyloarthritis Research and Treatment Network (SPARTAN), released the 2019 Update of the Recommendations for the Treatment of Ankylosing Spondylitis (AS) and Nonradiographic Axial Spondyloarthritis (nr-axSpA). Read More>

    Management and Treatment of Parkinson Disease: A Pharmacist’s Guide – August 22, 2019 Worldwide, there are more than 10 million people living with Parkinson Disease (PD). In the United States, there are about 60,000 individuals diagnosed yearly, foreshadowing a total of 1 million patients that will be living with PD by the year 2020. Read More>

    Guideline-Directed Care in Heart Failure Must Target Optimal Dosing – August 21, 2019 Robert J. DiDomenico, PharmD, FCCP, FHFSA, FACC, who is Associate Professor, Cardiovascular Clinical Pharmacist at the University of Illinois at Chicago College of Pharmacy, brought the 2019 Directions in Pharmacy conference to a close. He discussed improving transitions of care for patients who have heart failure, with an emphasis on the pharmacist’s role. This topic is timely because 6.2 million adults in the United States are currently diagnosed with heart failure. Read More>

    Pharmacists Must Be Part Of The Opioids Solution – August 21, 2019 As a clinical pharmacy specialist in palliative care at Johns Hopkins Hospital in Baltimore and president of the American College of Clinical Pharmacy, I have followed The Post’s series on the opioid epidemic. To achieve a health-care system that adequately addresses this crisis, it is vital to establish a team-based, patient-centered approach that focuses on the patient’s medical condition and integrates the appropriate use of medications for opioid-use disorder. Read More> 

    Specialty Drugs Account For 40% Of Employers’ Drug Costs – August 20, 2019 New data released Tuesday by Willis Towers Watson (WTW) indicates employers are spending a sizable amount on a small subset of prescription drugs.In analyzing data from the WTW Rx Collaborative, the coalition found that about 40% of its total drug costs were the result of specialty drugs that account for less than 1% of prescriptions. Read More> 

    Pharmacy Automation Market Revenue is Projected to Touch Over US$ 20.0 Bn by 2025 – QY Research, Inc – August 20, 2019 QY Research’s experienced market analysts have come up with a highly detailed and accurate report on the global pharmacy automation market. Titled “Global Pharmacy Automation Industry Research Report, Growth Trends and Competitive Analysis 2018-2025,” the report offers a brilliant study of the global market, taking into consideration critical factors impacting its growth. Read More> 

    Survey: Customer Satisfaction With Pharmacists Remain High – August 20, 2019 Despite e-commerce disruptions to the industry, a recent study found that the United States pharmacy industry continues to maintain high levels of customer satisfaction in both the brick-and-mortar and mail order segments. Read More> 

    Women and Elderly At Higher Risk Of Dangerous Drug Interactions – August 20, 2019 A new study led by researchers at Indiana University has found that women and older adults who use multiple prescription drugs are significantly more likely to be prescribed pills whose combination produces dangerous side effects. Read More> 

    Brand-name Drug Prices Rising At Slower Pace, Lower Amounts – August 19, 2019 Drug companies are still raising prices for brand-name prescription medicines, just not as often or by as much as they used to, according to an Associated Press analysis. After years of frequent list price hikes, many drugmakers are showing some restraint, according to the analysis of drug prices provided by health information firm Elsevier. Read More>

    ACP Calls For ‘Stricter’ Conflicts Standard For Clinical Guidelines – August 19, 2019 Clinical guidelines have come under increased scrutiny over the years, thanks in part to many organizations relying on expert opinions rather than just the evidence to develop the standards, according to American College of Physicians President Dr. Robert McLean. Read More>

    High Demand for Infusion Clinics Presents Business Opportunities – August 15, 2019 Demand for infusion clinics outside of the pricey hospital setting is climbing, with dozens of noncancer IV drugs facing possible approval over the coming years and payors struggling to contain costs for these drugs. Although the situation presents an opportunity for entrepreneurial pharmacists, starting a clinic in the wrong way can be disastrous. Read More>

    Doctors Can Change Opioid Prescribing Habits, But Progress Comes In Small Doses – August 15, 2019 When they started practicing medicine, most surgeons say, there was little or no information about just how many pain pills patients needed after specific procedures.As a result, patients often were sent home with the equivalent of handfuls of powerful and addictive medications. Read More> 

    Guidelines for Treatment Of Migraine In Children And Teens – August 14, 2019  For children and teens with migraine, the pain and symptoms that accompany migraine attacks can be debilitating, resulting in missed school days, absence from social or sporting events, and affected home activities. Now the American Academy of Neurology (AAN) and the American Headache Society have developed two guidelines that include recommendations for preventing and treating migraine in children and teens. Read More>

    Medicare Part D Pharmacy Benefit Managers Get 0.4% of Rebates – August 14, 2019 After facing over $100 billion in Medicare Part D expenditures in 2016, Congress called on the Government Accountability Office to discern the pharmacy benefits manager’s (PBM’s) role in the healthcare industry and evaluate utilization management’s effects on expenditures. Read More>

    Six New Clinical Services for Pharmacists – August 13, 2019 When I was a pharmacy student two decades ago, I met an acquaintance who asked what I was studying. As I described the pharmacy school curriculum, her response was incredulous: “You need to know all that to put pills in a bottle?” These days, community pharmacists are far beyond putting pills in a bottle and have many opportunities to use their drug knowledge to provide services for patients. Read More> 

    15% of Pharmacies Bought Nearly Half of Opioids – August 13, 2019 In a federal database tracking every pain pill sold in the U.S. at the height of the opioid crisis, one Albany, Ky., pharmacy has come into sharp focus: Shearer Drug. The family-run pharmacy in Clinton County purchased nearly 6.8 million pills that contained hydrocodone and oxycodone from 2006 through 2012, enough to give 96 pills each year to every person in the county of roughly 10,000 residents, the Washington Post reports. Read More>

    Preventing Errors with High-Risk Medications – August 12, 2019 Medication errors present a global challenge that threatens the quality of care and patient safety and contributes to continually escalating healthcare spending. Medication errors result in 2% to 5% of all hospital admissions worldwide—the majority of which experts believe are preventable, according to the Agency for Healthcare Research and Quality. Read More> 

    340B in the News

    340B Specialists Help Maintain Program Integrity – August 23, 2019 Pharmacy technician 340b specialists act as liaisons between pharmacies and other departments to help maintain program integrity. They develop and uphold policies and procedures related to 340B program auditing and compliance. Tech 340B specialists also work with contract pharmacies, other 340B advocacy groups, split-billing vendors, and wholesalers to optimize the program, as well as maintain compliance and uphold procedures. They are considered experts on 340B and are responsible for competency, education, and training for staff and steering committee members. Read More> 

    Does HHS Have Zero Negotiating Power In Drug Pricing? – August 22, 2019 Through the 340B program, the government is able to negotiate drug pricing for patients seeking care in certain covered entities and the savings from this program should be passed on to consumers. Read More>

    CMS Takes Another Swing at 340B Reimbursement Cuts. Will It Be Strike Three? – August 13, 2019 The proposed 2020 Outpatient Prospective Payment (OPPS) rule was published on August 9, 2019. Buried in the 819 pages of proposed changes and justifications, CMS took another swing at cutting Medicare Part B reimbursement rates for 340B drugs.   CMS opened its discussion of 340B provisions in the 2020 OPPS proposed rule by first stating it was keeping in effect the 340B reimbursement cut first implemented though the 2018 OPPS rule. Read More>

    340B Update: CMS Addresses Ongoing Litigation and Reimbursement Changes for 340B Drugs in CY 2020 OPPS Proposed Rule – August 7, 2019 On July 29, 2019, the Centers for Medicare & Medicaid Services (“CMS”) released its annual proposed rule announcing potential changes to the Medicare Outpatient Prospective Payment System (“OPPS”) for upcoming Calendar Year (“CY”) 2020 (“Proposed Rule”). [1] In addition to proposing certain payment rates for the upcoming year, CMS used the Proposed Rule to comment on the ongoing litigation relating to the reimbursement cuts under the OPPS in CY 2018 and CY 2019 for drugs purchased under the 340B Drug Discount Program (“340B Program” or “340B”). Read More>

    There’s a Program To Address High Drug Prices – And It Is Working, Says Major Hospital Company – August 6, 2019 Each day, Alabamians and Americans across the country see the impact of rising drug prices. More than a quarter of Americans admit to not taking their medicines as prescribed at some point in the past year, primarily citing the cost. For many, these high prices lead to difficult decisions between adherence to medication or paying for other necessities, like food or housing. Read More>

    Opinion: Time for Greater Transparency in Critical 340B Federal Drug Pricing Program – August 3, 2019 The 340B Drug Pricing Program was created by Congress in 1992 to allow nonprofit healthcare providers with limited resources to ensure access to medicines for uninsured patients with acute and chronic health conditions and disorders. Since its inception 26 years ago, the program has grown dramatically, and many now question whether it is due for an overhaul. Read More>