Clinical Insights: September 30, 2019

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    New Drug Approval

    Jynneos (smallpox and monkeypox vaccine, live, nonreplicating) – New Vaccine Approval – September 24, 2019 – The U.S. Food and Drug Administration announced the approval of Jynneos Smallpox and Monkeypox Vaccine, Live, Non-Replicating, for the prevention of smallpox and monkeypox disease in adults 18 years of age and older determined to be at high risk for smallpox or monkeypox infection. This is the only currently FDA-approved vaccine for the prevention of monkeypox disease. <Read More>

    Rybelsus® (semaglutide) – New Drug Approval – September 20, 2019 – The U.S. Food and Drug Administration approved Rybelsus® (semaglutide) oral tablets to improve control of blood sugar in adult patients with type 2 diabetes, along with diet and exercise. Rybelsus® is the first glucagon-like peptide (GLP-1) receptor protein treatment approved for use in the United States that does not need to be injected. GLP-1 drugs are non-insulin treatments for people with type 2 diabetes. <Read More>

    New Formulation Approval

    Loperamide, Brand Name Over-The-Counter (OTC) – New Formulation Approval – September 20, 2019 – The U.S. Food and Drug Administration announced approved package size and package type limits for over-the-counter (OTC) brand-name tablet and capsule forms of loperamide, an FDA-approved drug product that helps control symptoms of diarrhea, including Travelers’ diarrhea. The changes to Imodium A-D®, Imodium® Multi-Symptom Relief and Be Health Loperamide HCl Capsules are intended to address the problem of loperamide abuse and misuse by limiting each carton to no more than 48 mg of loperamide and requiring unit-dose blister packaging. <Read More>

    New Indication Approval

    Rituxan® (rituximab) – New Indication Approval – September 27, 2019 – The U.S. Food and Drug Administration approved Rituxan® (rituximab) injection to treat granulomatosis with polyangiitis (GPA) and microscopic polyangiitis (MPA) in children 2 years of age and older in combination with glucocorticoids (steroid hormones). It is the first approved treatment for children with these rare vasculitis diseases, in which a patient’s small blood vessels become inflamed, reducing the amount of blood that can flow through them. <Read More>

    Darzalex® (daratumumab) – New Indication Approval – September 26, 2019 – The Food and Drug Administration approved daratumumab (Darzalex®, Janssen) for adult patients with multiple myeloma in combination with bortezomib, thalidomide, and dexamethasone in newly diagnosed patients who are eligible for autologous stem cell transplant (ASCT). <Read More>

    Dysport® (abobotulinumtoxinA) – New Indication Approval – September 26, 2019 Ipsen Biopharmaceuticals, announced that the United States Food and Drug Administration (FDA) has expanded the use of Dysport® (abobotulinumtoxinA) for injection to include the treatment of upper limb spasticity in children two years of age and older, excluding spasticity caused by cerebral palsy (CP). This approval makes Dysport® the first botulinum toxin approved by the FDA for both pediatric spasticity indications, following the previous approval to treat children with lower limb spasticity aged two and older received in July 2016. <Read More>

    Mavyret (glecaprevir and pibrentasvir) – New Expanded Indication Approval – September 26, 2019 The U.S. Food and Drug Administration expanded the approval of Mavyret (glecaprevir and pibrentasvir) tablets for an eight-week duration for the treatment of adults and children ages 12 years and older or weighing at least 99 pounds who have chronic hepatitis C virus (HCV) genotype 1, 2, 3, 4, 5 or 6 infection and compensated cirrhosis and have not been previously treated for HCV (treatment-naïve). Mavyretä is now the first eight-week treatment approved for all treatment-naïve adult and certain pediatric patients with HCV genotypes 1-6 both without cirrhosis and with compensated cirrhosis. <Read More>

    Delstrigo (doravirine/lamivudine/tenofovir disoproxil fumarate) – New Expanded Indication Approval – September 19, 2019 Merck that the U.S. Food and Drug Administration (FDA) approved supplemental New Drug Applications (sNDAs) for Pifeltro™ (in combination with other antiretroviral agents) and Delstrigo™ (as a complete regimen) that expand their indications to include adult patients with HIV-1 infection who are virologically suppressed (HIV-1 RNA less than 50 copies per mL) on a stable antiretroviral regimen with no history of treatment failure and no known substitutions associated with resistance to Pifeltro™ or the individual components of Delstrigo™. <Read More>

    Pifeltro™ (doravirine) – New Expanded Indication Approval – September 19, 2019 Merck that the U.S. Food and Drug Administration (FDA) approved supplemental New Drug Applications (sNDAs) for Pifeltro™ (in combination with other antiretroviral agents) and Delstrigo™ (as a complete regimen) that expand their indications to include adult patients with HIV-1 infection who are virologically suppressed (HIV-1 RNA less than 50 copies per mL) on a stable antiretroviral regimen with no history of treatment failure and no known substitutions associated with resistance to Pifeltro™ or the individual components of Delstrigo™. <Read More>

    Erleada™ (apalutamide) – New Indication Approval – September 17, 2019 – The Food and Drug Administration approved apalutamide (Erleada™, Janssen Biotech, Inc) for patients with metastatic castration-sensitive prostate cancer (mCSPC). Apalutamide was initially approved in 2018 for patients with non-metastatic castration-resistant prostate cancer. <Read More>

    Keytruda® (pembrolizumab) and Lenvima® (lenvatinib) – New Indication Approval – September 17, 2019 – The Food and Drug Administration granted accelerated approval to the combination of pembrolizumab (Keytruda®, Merck) plus lenvatinib (Lenvima®, Eisai) for the treatment of patients with advanced endometrial carcinoma that is not microsatellite instability high (MSI-H) or mismatch repair deficient (dMMR) and who have disease progression following prior systemic therapy but are not candidates for curative surgery or radiation. <Read More>

    New Drug Shortage

    September 24, 2019

    September 20, 2019

    September 18, 2019

    September 17, 2019

    September 16, 2019

    New Drug Recall and Safety Alerts

    Ranitidine by Apotex Corp. – New Drug Recall – September 25, 2019 – Apotex Corp. is voluntarily, on a precautionary basis, recalling Ranitidine Tablets 75mg and 150mg (All pack sizes and Formats) to the Retail level. Apotex has learned from the U.S. Food and Drug Administration and other Global regulators that some ranitidine medicines including brand and generic formulations of ranitidine regardless of the manufacturer, contain a nitrosamine impurity called N-nitrosodimethylamine (NDMA) at low levels. To date, Apotex has not received any reports of adverse events related to use of the product. <Read More>

    Ranitidine by Sandoz, Inc. – New Drug Recall – September 23, 2019 – Sandoz Inc. is voluntarily recalling all quantities and lots within expiryof Ranitidine Hydrochloride Capsules in the US to the consumer level because of confirmed contamination with N-Nitrosodimethylamine (NDMA) above levels established by the FDA in batches of Sandoz Ranitidine Hydrochloride Capsules. To date, Sandoz has not received any reports of adverse events related to use of the product as part of this recall. <Read More>

    Losartan and Losartan /Hydrochlorothiazide by Torrent Pharma. – Expanded Drug Recall – September 19, 2019 – Torrent Pharmaceuticals Limited is expanding its recall for Losartan Potassium Tablets USP and Losartan Potassium/hydrochlorothiazide tablets, USP, to the consumer level due to the detection of trace amounts of an unexpected impurity while testing the below finished product batches manufactured utilizing active pharmaceutical ingredient (API) manufactured by Hetero Labs Limited using the old Route of Synthesis. The recall is expanded to include an additional 3 lots of Losartan Potassium Tablets USP and 2 lots of Losartan Potassium/Hydrochlorothiazide Tablets, USP. <Read More>

    Ibrance® (palbociclib), Kisqali® (ribociclib), and Verzenio® (abemaciclib) – Drug Safety Alert – September 13, 2019 – FDA is warning that Ibrance® (palbociclib), Kisqali® (ribociclib), and Verzenio® (abemaciclib) used to treat some patients with advanced breast cancers may cause rare but severe inflammation of the lungs. FDA has approved new warnings about this risk to the prescribing information and Patient Package Insert for the entire class of these cyclin-dependent kinase 4/6 (CDK 4/6) inhibitor medicines. <Read More>

    Zantac® (ranitidine) – Drug Safety Alert – September 13, 2019 – FDA has learned that some ranitidine medicines, including some products commonly known as the brand-name drug Zantac®, contain a nitrosamine impurity called N-nitrosodimethylamine (NDMA) at low levels. NDMA is classified as a probable human carcinogen (a substance that could cause cancer) based on results from laboratory tests. NDMA is a known environmental contaminant and found in water and foods, including meats, dairy products, and vegetables. <Read More>

    Quinacrine Dihydrochloride by Darmerica LLC – New Drug Recall – September 12, 2019 – Darmerica LLC is voluntarily recalling two lots, DR4654A and DL4654A, of Quinacrine Dihydrochloride, bulk API powder packaged in Amber HDPE Bottles to the consumer level. This product is being recalled due to a label mix-up. Product intended for further compounding use by pharmacies labeled as Quinacrine API was tested and identified as Artemisinin API. <Read More>

    Natpara® (parathyroid hormone) – New Drug Recall – September 5, 2019 – Takeda Pharmaceutical Company Limited (“Takeda”) announced that the company is issuing a US recall for all doses of Natpara® (parathyroid hormone) for Injection (25 mcg, 50 mcg, 75 mcg, and 100 mcg). This recall is being conducted after discussions with the FDA and is effective immediately due to a potential issue related to rubber particulates originating from the rubber septum of the Natpara® cartridge. <Read More>

    New Generic Approval and Launch

    No new update

    Clinical and Pharmacy News

    Winners, Losers of the Medicare Site-Neutral Payment Policy Ruling – September 26, 2019 – Hospitals rejoiced last week after a federal judge decided to toss Medicare’s most recent attempt to expand a site-neutral payment policy that would have reduced payments to hospital outpatient departments by over $1 billion over the next two years. The ruling delivered last Tuesday said that CMS overstepped its statutory authority by finalizing a policy that decreased hospital outpatient payment rates for certain services to levels similar to those used to pay physician practices for the same services. <Read More>

    Pharmacists Can Provide Optimal Migraine Treatments – September 24, 2019 – A lack of specific chemical targets related to migraine pathophysiology has led to limited efficacious treatments for migraine headaches. Therefore, the approach to migraine prophylaxis has been to investigate medications with primary indications other than migraines. Examples include beta-blockers; centrally acting alpha agonists; certain atypicals; selective serotonin reuptake inhibitors; various antidepressants, including serotonin-norepinephrine reuptake inhibitors, anticonvulsants, and tricyclic antidepressants; and others that have been used with variable efficacy. <Read More>

    The Growing Problem of Pharmacy Deserts – September 24, 2019 – Pharmacy deserts, areas with low access to prescription medications, are a challenge. There could be nearly 100 million Americans without good access to pharmacies, but pharmacists are not rushing to fill the gap. A few independent pharmacists are expanding their existing community practices with telepharmacies, either independently or in cooperation with medical clinics or retailers such as grocery and hardware stores, Federally Qualified Health Centers, hospitals, and other provider groups. That leaves pharmacy deserts as a tremendous opportunity. <Read More>

    This is What Medicare Part D Has Done To Prescription Costs – September 23, 2019 – If you’re on Medicare, you’re probably already familiar with Part D, the prescription drug benefit plan. But you may not know exactly how the optional program — which has been available to seniors since 2006 — has affected drug prices. Today, a majority of individuals who are covered by Medicare have also opted into Part D coverage. About 43 million out of 60 million people covered by Medicare have a Part D plan, according to the Henry J. Kaiser Family Foundation. <Read More>

    October is American Pharmacists Month – September 23, 2019 – Next Tuesday marks the first day of October and the start of American Pharmacists Month (APhM), a celebration in support of pharmacists around the country. While the American Pharmacists Association (APhA) has always celebrated the accomplishments of pharmacists, the Association officially launched American Pharmacists Month in 2004. Since then, APhA has used October to recognize pharmacists’ contributions to health care and all they do for their communities. <Read More>

    FDA Releases Biosimilar Educational Materials for Patients – September 23, 2019 – The FDA released a new suite of resources to educate patients about biosimilars. The new materials, “Biosimilars Basics for Patients,” explain that biosimilars are safe and effective medications that “are FDA-approved biologic medications that are compared to another medication—the original biologic.” The FDA describes biosimilars are being made “from natural sources” and developed “using advanced science.” The resources explain that biosimilars can be expected to have the same benefits and risks, and that they may provide more treatment options, increase competition in the marketplace, and allow for lower costs. <Read More>

    Patient Services are Crucial to the Economics of Pharmacy – September 23, 2019 – Recent pharmacy staff layoffs at Walmart and Sam’s Club—along with Walgreens and CVS closing some stores—are shining a spotlight on the ever-increasing pharmacy jobs problem. In community settings in particular, there are simply not enough open positions for all of the pharmacy graduates as well as those changing jobs due to layoffs and other reasons. <Read More>

    Spread Pricing: From Largely Unknown To Much Scrutinized and Criticized – September 20, 2019 – If some lawmakers have their way, PBMs will no longer be able to play the spread. A small but growing number of states are scrutinizing the role that PBMs play in their Medicaid programs amid reports that these middlemen are unfairly siphoning off profits. More recently, U.S. senators have taken up what seems to be a bipartisan cause. The ranking members of the Senate Finance Com-mittee have introduced a bill that would put an end to what is known as spread pricing in Medicaid programs throughout the country. <Read More>

    Drug Manufacturers Need Digital Supply Chains – September 20, 2019 – Medication shortages come with a substantial cost to pharmaceutical companies—loss of revenue, provider loyalty, and brand reputation pose significant and detrimental threats to business. Currently, the United States Food and Drug Administration (U.S. FDA) lists over 150 drug shortages, costing the United States $216 million in labor and $200 million in substitution costs, each year. As time and resources are invested heavily in drug discovery—approximately $2.6 billion is spent to bring a drug to market—it is vital that the medication supply chain is optimal to recoup investments. <Read More>

    Walgreens And Alphabet’s Wing To Test Drone Delivery – September 19, 2019 – Calling it a retail pharmacy industry first, Walgreens is partnering with Wing to test “store to door” delivery of products via drone, the companies announced Thursday afternoon. Wing Aviation LLC, an Alphabet company, will begin deliver of “health and wellness, food and beverage and convenience items” to Walgreens customers in Christiansburg, Virginia starting next month. Financial terms of the relationship weren’t disclosed. <Read More>

    How Pharmacies Are Resisting Amazon’s Attempt to Corner Their Business – September 19, 2019 – Getting into the pharmacy business was easy for Amazon.com: It paid $753 million to buy the mail-order startup PillPack. The hard part has been prying patients away from their local drugstore. Since being acquired by the internet giant, PillPack has run into stiff opposition, from chains like CVS with thousands of stores to family-owned operations with a single shop. <Read More>

    Diagnostic and Treatment Guidelines For Severe Allergic Reactions – September 19, 2019 – Severe allergic reaction known as anaphylaxis often has no clear cause. For some it’s an allergy to food, for others it can be insect stings, medications, hormones or even physical factors like exercise. But according to the new “Idiopathic Anaphylaxis Yardstick”, there are people for whom diagnosis and treatment of anaphylaxis are difficult because the cause is unknown and therefore labeled “idiopathic.” The yardstick was published in Annals of Allergy, Asthma and Immunology, the scientific journal of the American College of Allergy, Asthma and Immunology (ACAAI). <Read More>

    Failure To Launch: Barriers To Biosimilar Market Adoption, $2.2 Billion In Lost Savings – September 18, 2019 – The report, released by the Biosimilars Council in September 2019, is the second part of a 2015 white paper that detailed how patent abuses by biologic drug makers have cost the U.S. health care system $7.6 million in savings since 2015. The new report looks specifically at the 9 biosimilar drugs now on the market and calculates an additional $2.2 billion in lost savings, not just from marketing tactics by drug makers trying to corner the market from lower cost alternatives, but inadequate incentives to expand use and insufficient information for patients. <Read More>

    Emphasize Medication Adherence to Patients – September 18, 2019 – Former US Surgeon General C. Everett Koop, MD, once stated something that is still powerful and relevant today: “Drugs don’t work in patients who don’t take them.” In the United States, the consumption and spend on prescription drugs continue to increase, with 2018 data showing 5.8 billion prescriptions dispensed at a cost of $344 billion. Of those prescriptions, two-thirds were intended for chronic diseases. With targeted medication therapy accounting for up to 80% of chronic disease management, the incredible missed return on those prescriptions is a sobering event, given that an estimated 30% to 50% of medications are not taken as prescribed. <Read More>

    Alternative Payment Models Rein in State Prescription Drug Spending – September 18, 2019 – As Medicaid programs look to provide costly gene therapies, specialty drugs, and other potentially life-saving medications to beneficiaries, states are getting creative by implementing alternative payment models, explained a recent study from Duke’s Margolis Center for Health Policy. With drug prices rocketing higher each year, it is no surprise that states struggle to control high prescription drug spending. Although Medicaid programs’ prescription drug spending began to go down in 2017 and 2018, following a 24 percent increase in spending in 2014, gene therapies and other expensive treatments bolster the upward spending trajectory. <Read More>

    How McKesson is Working for Real DIR Fee Reform – September 17, 2019 – Ask independent pharmacists to name their biggest struggle today, and without skipping a beat, they’ll say direct and indirect remuneration, or DIR, fees. Pharmacies increasingly are being reimbursed differently by pharmacy benefit managers based on either their individual pharmacy or pharmacy services administration organizations’ performance. In fact, the Centers for Medicare and Medicaid Services estimates that DIR fees have increased by more than 45,000% since 2010. <Read More>

    Medicaid Pharmacy Cost Trend Increases Despite Drop In Utilization – September 17, 2019 – The net cost per claim for specialty and traditional prescription drugs increased last year despite a decline in utilization, according to Magellan Health’s annual Medicaid pharmacy trend report released Tuesday morning.Net claims for specialty drugs increased by $27.02 per claim, while traditional drugs rose $2.30 per claim. <Read More>

     Walmart Debuts First Stand-Alone Health-And-Wellness Center – September 17, 2019 – Walmart is debuting the first Walmart Health center in Dallas, Ga. The stand-alone health clinic will include primary care services, as well as lab, x-ray, EKG, counseling, dental, optical, hearing and such community health services as nutritional and fitness services in partnership with local providers. <Read More>

    Hospitals Retain 91% of Profit from Physician-Administered Drugs – September 17, 2019 – Physician practices and hospital outpatient clinics treat a similar number of commercially insured patients needing physician-administered drugs, but hospitals receive a larger share of the gross profits, according to a recent analysis by the Partnership for Health Analytic Research, LLC (PHAR). The analysis revealed that hospitals collected 91 percent of the gross profit margin while serving just 53 percent of patients receiving physician-administered medications. In contrast, physician offices treated 47 percent of patients in the commercial market and retained just nine percent of the gross margin. <Read More>

    Older Patients Don’t See Diabetes Recommendations Same Way Doctors Do – September 16, 2019 – Doctors’ advice for starting or stopping diabetes medicines often doesn’t resonate with older patients, a new study suggests. When deciding how much medicine patients should take and how low their blood sugar needs to be, doctors use medical guidelines to balance the benefits against the side effects and burdens of the treatment, said Dr. Nancy Schoenborn, lead author of the study and a gerontology researcher at Johns Hopkins University School of Medicine in Baltimore. <Read More>

    HHS Recommendations to Reduce Fraud, Waste and Abuse Take Aim at CMS and Increased Oversight of Compounded Drugs – September 15, 2019 – The Health and Human Services Office of Inspector General (“OIG”) released its annual report entitled Solutions to Reduce Fraud, Waste, and Abuse in HHS Programs: OIG’s Top Recommendations. The report specifically contains the top 25 unimplemented recommendations that would “most positively” affect cost savings, program effectiveness and efficiency, and public health and safety. The report notes that the recommendations were compiled from audit and evaluation reports. Perhaps unsurprisingly, 18 of the 25 recommendations are directed to Centers for Medicare and Medicaid Services (“CMS”) programs. <Read More>

    Blood Pressure Control Not Well-Met Among Diverse Heart Failure Population – September 14, 2019 – The most recent major clinical guidelines for systolic blood pressure (BP) targets for the prevention of heart failure (HF) may not be well-achieved among patients with HF, and even more so for race/ethnicity groups at a distinguished risk for HF and cardiovascular events. In a study presented at the Heart Failure Society of America (HFSA) 2019 Scientific Sessions in Philadelphia, PA, a team of investigators from Northwestern University Feinberg School of Medicine reported findings no significant associations between BP control and cardiovascular mortality in treated and untreated patients with HF. <Read More>

    HHS OIG: Medicare Part D Drug Rebates ‘Substantially’ Reduced Spending Growth – September 13, 2019 – Between 2011 and 2015, rebates for brand-name prescription drugs still increased $2 billion.Total rebates for brand-name prescription drugs in Medicare Part D nearly doubled between 2011 and 2015, according to a Department of Health and Human Services (HHS) Office of Inspector General (OIG) report released Friday. <Read More>

    Americans Take Aspirin For CVD Prevention Despite Recommendations Against It – September 13, 2019 – Health care practitioners have their work cut out for them in discussing appropriate aspirin use with patients. New study findings published on July 22 in Annals of Internal Medicine found that aspirin is widely used for cardiovascular disease (CVD) prevention—despite recent changes in guidelines—and is not always taken with a physician’s recommendation. <Read More>

    340B in the News

    Hospitals Demand CMS Drop 340B, Site-Neutral Cuts In OPPS Due To Court Rulings – September 27, 2019 – Hospital groups sought to give the Trump administration a legal lesson by saying that cuts in the latest hospital payment rule were deemed unlawful in recent rulings. Major groups targeted cuts to the 340B drug discount program and the continued phase-in of site-neutrality cuts in comments to the hospital outpatient payment system (OPPS) rule. Comments on the Centers for Medicare & Medicaid Services (CMS) rule ended Friday. <Read More>

    CMS to Collect 340B Drug Cost Information – September 26, 2019 – The CMS on Thursday issued a notice that it will collect information from hospitals participating in the 340B drug discount program about the prices they pay for eligible drugs. Although a federal judge tossed the CMS’ planned 340B reimbursement cuts in December, the agency hopes that it will win an appeal and move forward with the changes. If that happens, the CMS will need information on the actual prices that hospitals pay for drugs under the 340B program to calculate average sales prices and make the cuts. <Read More>

    New PBM State Laws Indicate a Shifting Battlefront over 340B Program Drug Pricing – September 18, 2019 – While much attention has been paid to the ongoing litigation related to the ongoing 340B Medicare Part B payment reduction litigation (which is now pending before the US Court of Appeals for the DC Circuit), new legislation at the state level may also have a significant impact on covered entity reimbursement for 340B drugs. Specifically, state legislatures have been getting involved in 340B Program reimbursement rate regulation between covered entities and pharmacy benefit managers (PBMs) regarding 340B drugs. <Read More>

    Court Win May Not Solve Hospitals’ Site-Neutral Pay Problem – September 18, 2019 – While hospital groups have welcomed a federal judge’s ruling against the CMS’ expansion of site-neutral payments for basic doctor’s visits, some analysts see it as a short-term solution that can’t survive as a long-term strategy. U.S. District Judge Rosemary Collyer’s ruling Tuesday sealed the divide between the Trump administration and hospitals in the push to lower costs. But policymakers and regulators will continue to push for deep payment reforms despite the recent loss. <Read More>

    CMS OPPS Proposed Rule Seeks Comments on Potential Remedies for 340B Program Cuts – September 16, 2019 – The Centers for Medicare and Medicaid Services (“CMS”) published its annual proposed rule detailing changes to the Medicare Outpatient Prospective Payment System (“OPPS”) for the 2020 calendar year. The rule contains the usual proposed payment rates for the upcoming year, but also addresses the ongoing litigation relating to the 2018 and 2019 reimbursement cuts for the 340B Drug Discount Program. <Read More>