Clinical Insights: October 24, 2017

    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

    Shingrix (Zoster Vaccine Recombinant, Adjuvanted) – New Vaccine Approval – October 20, 2017 – GlaxoSmithKline plc announced that the U.S. Food and Drug Administration (FDA) has approved Shingrix (Zoster Vaccine Recombinant, Adjuvanted) for the prevention of shingles (herpes zoster) in adults aged 50 years and older. Shingrix is a non-live, recombinant subunit vaccine given intramuscularly in two doses. Read more.

    Yescarta™ (axicabtagene ciloleucel) – New Drug Approval – October 18, 2017 – The U.S. Food and Drug Administration approved Yescarta™ (axicabtagene ciloleucel), a cell-based gene therapy, to treat adult patients with certain types of large B-cell lymphoma who have not responded to or who have relapsed after at least two other kinds of treatment. Yescarta™, a chimeric antigen receptor (CAR) T cell therapy, is the second gene therapy approved by the FDA and the first for certain types of non-Hodgkin lymphoma (NHL). Read more.


    New Formulation Approval

    Bydureon BCise (exenatide extended-release) – October 23, 2017 – AstraZeneca announced that the U.S. Food and Drug Administration (FDA) has approved Bydureon BCise (exenatide extended-release) injectable suspension, a new formulation of Bydureon in an improved once-weekly, single-dose autoinjector device for adults with type-2 diabetes whose blood sugar remains uncontrolled on one or more oral medicines in addition to diet and exercise, to improve glycaemic control. Read more.


    New Indication Approval

    Soliris® (eculizumab) – New Indication Approval – October 23, 2017 – Alexion Pharmaceuticals, Inc. announced that the U.S. Food and Drug Administration (FDA) has approved Soliris® (eculizumab) as a treatment for adult patients with generalized myasthenia gravis (gMG) who are anti-acetylcholine receptor (AchR) antibody-positive. Read more. 

    Simponi Aria® (golimumab) – New Expanded Approval – October 20, 2017 – Janssen Biotech, Inc. announced that the U.S. Food and Drug Administration (FDA) has approved Simponi Aria® (golimumab), the only fully-human anti-tumor necrosis factor (TNF)-alpha therapy administered via a 30-minute infusion, for the treatment of adults with active psoriatic arthritis (PsA) or active ankylosing spondylitis (AS). Read more.

    Stelara® (ustekinumab) – New Expanded Indication Approval – October 13, 2017 – Janssen Biotech, Inc. announced that the U.S. Food and Drug Administration (FDA) has approved an expanded indication for Stelara® (ustekinumab) for the treatment of adolescents (12 years of age or older) with moderate to severe plaque psoriasis who are candidates for phototherapy or systemic therapy. Read more.


    New Drug Shortage

    October 24, 2017

    October 23, 2017

    October 19, 2017

    October 17, 2017

    October 16, 2017


    New Drug Recall and Safety Alerts

    Injectable Products by SCA Pharmaceuticals – New Drug Recall Alert – October 21, 2017 – SCA Pharmaceuticals LLC (“SCA Pharmaceuticals”) is voluntarily recalling various lots of injectable products to the hospital level. The is a potential for the products to contain microbial contamination. See the recall notice for a full list of products. Read more.

    Octagam® [Immune Globulin Intravenous (human)] 10% liquid preparation] – New Drug Recall Alert – October 16, 2017 – Octapharma USA Inc., is initiating a voluntary market withdrawal of one lot of Octagam® [Immune Globulin Intravenous (human)] 10% Liquid Preparation], in the interest of public safety. This market withdrawal is being performed as a result of an increased number of reports of hypersensitivity events. All cases resolved without serious injury. Read more.


    New First Time Generic

    No new updates.


    Clinical and Pharmacy News

    Patients with Rheumatic Diseases Bail on Biosimilars – October 24, 2017 – Almost one-quarter (24 percent) of patients with rheumatoid arthritis, psoriatic arthritis or ankylosing spondylitis who switched from infliximab (Remicade) to its biosimilar CT-P13 discontinued the biosimilar by six months, primarily for subjective reasons, Dutch researchers found. Read more.

    Independent Pharmacies Adding Patient Care Services, Products – October 23, 2017 – Independent pharmacies are expanding the scope of services they offer, partly to absorb lower reimbursements for dispensing prescription medications, according to the 2017 National Community Pharmacists Association (NCPA) Digest. Read more.

    Here’s How Drug Companies Game the Patent System – October 23, 2017 – The Senate Health Committee held a hearing Oct. 17 about why prescription drugs cost so much and what might be done to make them more affordable. According to the committee’s website, the witnesses included a lobbyist for the pharmaceutical industry, a lobbyist for the pharmacy industry and a lobbyist for the pharmacy benefits-management industry. Read more.

    Many Factors Driving Up Medicare Drug Premiums in 2018 – October 23, 2017 – Medicare drug premiums will rise next year due to many factors, including higher prices for specialty drugs, fewer drugs coming off patent, and the shifting of cost sharing to premiums, policy experts say. Average monthly Part D prescription drug plan premiums are expected to increase for the third year in a row, rising nine percent for 2018 to $43.48. Read more.

    U.S. Hospitals Wrestle With Shortages of Drug Supplies Made in Puerto Rico – October 23, 2017 – One of the workhorses of Clarke County Hospital, a 25-bed facility in rural Osceola, Iowa, is an unassuming product known as a Mini-Bag. It is a small, fluid-filled bag used by nurses to dilute drugs, like antibiotics, so that they can be dripped slowly into patients’ veins. The bag’s ease of use has made it popular in small facilities like Clarke County, where the pharmacy is closed on nights and weekends, as well as at nationally known hospitals like the Cleveland Clinic, which uses 34,000 of the bags every month. Read more.

    Report: Medicare Biosimilar Changes Could Save Billions – October 23, 2017 – If the U.S. government revised its current reimbursement policy for biosimilar drugs, it could save $11.4 billion over the next 10 years, according to a new report. This finding is from “The Fiscal Implications of Discrete Codes for Biosimilars” analysis, conducted by The Moran Company for the Association for Accessible Medicines (AAM) and its Biosimilars Council. Read more.

    FDA Taking New Steps to Better Inform Physicians about Biosimilars Through Education about these Potentially Cost-Saving Options – October 23, 2017 – The cost of prescription drugs is an ongoing concern, however, a growing market for potentially lower-cost biological products called biosimilars can offer more competition and options for patients. Biosimilars can potentially reduce costs for consumers by creating price competition for products that previously faced few market competitors. Read more.

    Despite Price Dip, Specialty Rx Still Huge Cost Driver – October 23, 2017 – Although prescription drug benefit cost trends are expected to dip slightly next year, the 2018 Segal Health Plan Cost Trend Survey cautions that they remain in the double-digits and are much higher than medical trend. For example, specialty drugs and biologics are projected to decline to 17.7 percent from 18.7 percent in 2017, while outpatient Rx coverage for actives and retirees under age 65 will fall to 10.3 percent from 11.6 percent. Read more.

    Recommendations for Systemic Therapy in Eczema – October 23, 2017 – New recommendations from the International Eczema Council aim to address a question that has gone largely unanswered: When should dermatologists and others prescribe systemic therapy to treat atopic dermatitis? “We are entering a revolution in systemic therapy of atopic dermatitis,” says article author Lawrence F. Eichenfield, M.D., chief of pediatric and adolescent dermatology, Rady Children’s Hospital, San Diego. Read more.

    Poor Adherence to Guidelines for Preventing Chemotherapy-Induced Nausea, Vomiting – October 21, 2017 – Adherence to antiemetic regimens for patients undergoing emetogenic cancer chemotherapy is poor, according to an online survey of oncology nurses in the United States. That poor adherence has diverse causes and might be contributing to chemotherapy regimen modifications and emergency room visits, survey results suggested. Results of the survey were published in Supportive Care in Cancer. Read more.

    Payers Struggle to Keep Up with High Rate of FDA Drug Approvals – October 20, 2017 – FDA incentives to encourage development of rare disease therapies have paid dividends, with an unprecedented number of novel treatments in the orphan drugs pipeline. But expedited regulatory review has also raised concerns about a lowered evidentiary bar when it comes to drug efficacy, cautioned speakers at an October 19 session of the Academy of Managed Care Pharmacy (AMCP) 2017 Nexus in Dallas. Read more.

    Evolving Your Pharmacy Practice in an Era of Great Change – October 19, 2017 – The face of health care is rapidly changing as the entire industry evolves to a value-based care model that pays for quality and performance. What does that mean for pharmacists? It means that pharmacists can finally move ‘beyond the script’ and get paid for more than dispensing medications through opportunities to get paid for providing total care and support for the patient. All of this necessitates a change in how you operate as a pharmacy and pharmacist. Read more.

    Why Drug Makers Should Worry About Anthem’s New PBM – October 19, 2017 – News that Anthem will launch its own new pharmacy benefit manager in 2020 in partnership with CVS Health should worry the pharmaceutical industry. Insurers are closing ranks around a model that brings the PBM closer to the health plan in hopes of creating a savvier buyer of prescription medicines while seeking more transparency. UnitedHealth Group already owns OptumRx, a fast-growing PBM, and other insurers are looking at new relationships with PBMs. Read more.

    Anthem’s New PBM To Spark Change Throughout the Industry – October 18, 2017 – Anthem’s creation of its own pharmacy benefit management company could drive change throughout the industry as health plans and PBMs aim to maintain their competitive edge, experts said. The national health insurer is teaming up with CVS Health to form IngenioRx, which will take shape in 2020 after Anthem’s long-disputed contract with Express Scripts ends. IngenioRx will offer the PBM’s services to customers of Anthem-affiliated health plans and members outside of the brand. Read more.

    Cancer Drug Prices Rising Far Faster Than Inflation – October 18, 2017 – The prices of injectable cancer drugs – even older medicines around since the 1990s – are increasing at a rate far higher than inflation, researchers report in the Journal of Clinical Oncology. The study, led by Dr. Daniel Goldstein of Emory University in Atlanta, looked at 24 injectable cancer drugs approved since 1996 and found the average increase was 25 percent over eight years. After inflation, the average increase was 18 percent. Read more.

    Senators Growing Impatient with Talk on High Drug Prices – October 17, 2017 – Senators from both sides of the aisle appear to be growing weary of the pharmaceutical industry’s responses to the problem of high prescription drug costs, judging by a Tuesday morning Health, Education, Labor, & Pensions (HELP) Committee hearing on the subject. Read more.


    340B in the News

    PhRMA Lobbies for Drug Discount Program to Be Constrained – October 23, 2017 – The leading U.S. trade group for the pharmaceuticals industry is lobbying for the federal 340B drug discount program to be constrained. Created in 1992, the program requires drug manufacturers in the U.S.A. to discount outpatient drugs for certain public or nonprofit health care providers, such as children’s hospitals and rural referral centers. Read more.

    Insulin Costs Burdening Patients – October 21, 2017 – Ever-increasing costs for lifesaving insulin are starting to fuel desperation among at least a portion of those with Type-1 diabetes. Earlier this year, drugmakers Eli Lilly and Novo Nordisk boosted their insulin list prices by almost eight percent. The American Diabetes Association said the average price of insulin nearly tripled between 2002 and 2013. Read more.

    Michael D. Shaw: Protect WV Rural Hospitals from Ruinous Policies – October 20, 2017 – Hospitals are an indispensable resource for the people they serve. That fact has particular relevance for West Virginia’s rural hospitals, which have scarce resources, problems retaining staff, difficulties hiring works, and low Medicare and Medicaid reimbursement rates. These hospitals need Rep. David McKinley’s support, since he is a member of the House Energy and Commerce Committee, which can prevent these hospitals from closing. Read more.

    Hospitals Caring for Low-Income, Rural Patients Urge CMS To Withdraw Proposal to Slash Payments for Outpatient Drugs – October 19, 2017 – A group of more than 1,300 hospitals serving low-income and rural communities is urging the Centers for Medicare & Medicaid Services (CMS) to withdraw its proposal to cut Medicare reimbursement for outpatient prescription drugs. Earlier this year, CMS issued a proposed rule that would cut Medicare Part B drug payments to hospitals participating in the 340B drug discount program. Since that proposal, a bipartisan majority of House and Senate members have raised significant concerns. A decision is expected in the near future. Read more.

    Letter: Drug Prices the Real Culprit – October 19, 2017 – Drug prices the real culprit. This summer, the Centers for Medicare and Medicaid Services put out a proposal that would cut funding for prescription drugs obtained through Medicare’s 340B program by nearly 30 percent. While this may seem like a bit of obscure medical policy, it is anything but to the safety-net hospitals — particularly in rural areas of Indiana and other states — that depend on the discounts they get from this program to be able to provide the care their patients need in a financially sustainable way. Read more. 

    Letter: Reform Program to Save Local Cancer Care – October 19, 2017 – A government program that gives drug discounts to hospitals that care for poor and vulnerable patients sounds like the right thing to do. But as often happens, doing the right thing falls prey to politics. The well-intentioned 340B Drug Discount program was created 25 years ago to extend drug discounts to health care institutions that serve high numbers of uninsured or poor patients, including facilities that provide a great deal of charity care. Over the years, the program has unfortunately been monopolized and abused by some large corporate hospitals, including here in Ohio. Read more.