Clinical Insights: April 23, 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

    Crysvita® (burosumab-twza) – New Orphan Drug Approval – April 17, 2018 – U.S. Food and Drug Administration approved Crysvita® (burosumab-twza), the first drug approved to treat adults and children ages one year and older with x-linked hypophosphatemia (XLH), a rare, inherited form of rickets. XLH causes low levels of phosphorus in the blood. It leads to impaired bone growth and development in children and adolescents and problems with bone mineralization throughout a patient’s life. Read more.

    TavalisseTM (fostamatinib) – New Drug Approval – April 17, 2018 – The Food and Drug Administration approved fostamatinib disodium hexahydrate tablets (TavalisseTM, Rigel Pharmaceuticals, Inc.) for the treatment of thrombocytopenia in adult patients with chronic immune thrombocytopenia (ITP) who have had an insufficient response to a previous treatment. Read more.


    New Formulation Approval

    No new updates.


    New Indication Approval

    TagrissoTM (osimertinib) – New Indication Approval – April 18, 2018 – The Food and Drug Administration approved osimertinib (TagrissoTM, AstraZeneca Pharmaceuticals LP) for the first-line treatment of patients with metastatic non-small cell lung cancer (NSCLC) whose tumors have epidermal growth factor receptor (EGFR) exon 19 deletions or exon 21 L858R mutations, as detected by an FDA-approved test. Read more.

    Opdivo® (nivolumab) and Yervoy® (ipilimumab) – New Indication Approval – April 16, 2018 – The Food and Drug Administration granted approvals to nivolumab and ipilimumab (Opdivo and Yervoy, Bristol-Myers Squibb Co.) in combination for the treatment of intermediate or poor risk, previously untreated advanced renal cell carcinoma. Read more.


    New Drug Shortage

    April 20, 2018 

    April 18, 2018 

    April 17, 2018 

    April 16, 2018 


    New Drug Recall and Safety Alerts

    No new updates.


    New Generic Launch

    No new updates.


    Clinical and Pharmacy News

    FDA Rejects Pfizer’s Proposed Trastuzumab Biosimilar – April 23, 2018 – Pfizer announced that the FDA has issued a Complete Response Letter (CRL) for PF-05280014, a proposed trastuzumab biosimilar referencing Herceptin. Read more.

    Opioid Prescriptions Dropped 12 Percent in 2017 as Guidelines Change – April 23, 2018 – In 2017, the volume of opioid prescriptions saw its biggest decline in 25 years, reflecting changing guidelines and more aggressive population health management techniques, according to a new report from the IQVIA Institute for Human Data Science. Read more.

    Integrating Pharmacies into Clinical Care Improves Patient Outcomes, Fairview Studies Show – April 23, 2018 – Having an on-site pharmacist as part of a patient’s integrated care team can lead to better health outcomes, according to a series of studies from Fairview Health Services. Analyses of patient data over four years showed decreased readmission rates, more patients taking their medication correctly, and a higher rate of filled prescriptions for Fairview patients who used Fairview pharmacies. Read more.

    Five Ways Policymakers Could Lower Drug Prices – April 21, 2018 – President Donald Trump is expected to deliver a speech this week outlining policies that could help contain drug prices—a divisive issue that the administration has long discussed but has yet to tackle head on. While drug price growth has ebbed in recent months, the problem has led providers to battle unexpected price hikes for decades-old drugs and has cost consumers dearly at the pharmacy counter and in the form of rising insurance premiums. Read more.

    Opioid Prescriptions Dropped in Every State Last Year – April 19, 2018 – The number of prescriptions of opioid painkillers dropped 10.2 percent in 2017, according to the IQVIA Institute, an arm of the clinical research giant that collects data on pharmaceutical prescriptions from retail pharmacies. Read more.

    Amazon Withdraws Plans for Medication Distribution – April 19, 2018 – After months of hype, speculation and stock plummets, recent news reports have declared that Amazon is halting its interests into pharmacy at this time. This is not all surprising given some reports that have crept up in the past six months, with many commentators expecting this outcome. Read more.

    Researchers: No Outcome Differences Between Opioids and NSAIDs, Other Painkillers in Long-Term OA Study – April 19, 2018 – Nonsteroidal anti-inflammatory drugs, acetaminophen and other nonopioid medications are as effective as opioids for mitigating pain-related dysfunction in patients with chronic back pain or hip/knee osteoarthritis pain (JAMA 2018;319[9]:872-882). They are slightly more effective than opioids for relieving pain. This is the first opioid trial to report long-term outcomes. Read more.

    CVS/Aetna, Cigna/Express Scripts Megamergers Could Lower Long-term Medical Costs – April 19, 2018 – The proposed acquisition of Aetna by CVS Health and Cigna Corp. acquisition of Express Scripts will be a short-term ding on their credit outlooks but could lower medical costs in the long run, Moody’s Investors Service says. Read more.

    Pharmacists Can Make a Difference as Certified Diabetes Educators – April 19, 2018 – Certified Diabetes Educators (CDEs) can make a tremendous difference in the lives of people who have diabetes. Many pharmacists are unaware that pharmacists comprise a significant proportion of CDEs, with their numbers exceeded only by nurses and dietitians. Increasingly, pharmacists are seeking certification in this field to differentiate themselves from other pharmacists, develop niche level expertise, and provide better care to patients who have diabetes. Read more.

    Survey: Many Americans Unaware of Cancer Drug Shortages – April 18, 2018 – In a nationally representative U.S. survey, many individuals reported that they were unaware of oncology drug shortages that may cause patients to receive less effective or more toxic treatments, according to a study published in Cancer. Read more.

    Clinicians May Be Overtreating Older Patients with Diabetes – April 18, 2018 – Despite guidelines, clinicians may treating older patients with diabetes too aggressively, according to a study published in Journal of the American Board of Family Medicine. Read more.

    Healthcare Megadeals May Have Major Long-Term Impact, Moody’s Says – April 18, 2018 – Moody’s said hospitals may feel the impact of UnitedHealth’s Optum buying DaVita Medical and Humana investing in Kindred Healthcare. However, Cigna’s purchase of Express Scripts won’t have much of an effect on hospitals. Read more.

    Medicare Biosimilar Reimbursement: Hopes for Cost Savings, A Dream Deferred – April 18, 2018 – Recent updates to the Medicare reimbursement policies, the passage of the president’s Bipartisan Budget Act of 2018, and analyses of these changes from various consultants have unveiled the chaos that is biosimilar reimbursement. Read more.

    DIR Fees: Just One of Many Reimbursement Battles – April 17, 2018 – Everyone is talking about DIR fees these days. And rightly so. They are an embarrassment to our profession and arguably the most unethical “legal” reimbursement tactic going on in healthcare today. According to a recent survey by NCPA, eliminating DIR fees should be the #1 priority of the organization in 2018. This is because the proliferation of these fees is likely to deliver a fatal blow to many pharmacy businesses. Read more.

    Bundled Payments That Include Drug Costs Would Penalize Practices Based on Patient Mix – April 17, 2018 – Including cancer drug costs in bundled payments in Medicare could destabilize the cancer care delivery environment, according to an analysis of a hypothetical bundled payment published in Journal of Oncology Practice (JOP) from the American Society of Clinical Oncology (ASCO). Read more.

    Meta-Analysis: ‘Floor’ for Lipid-Lowering Mortality Benefits May Be Real – April 17, 2018 – The mortality benefit of cholesterol treatment is greater for more intensive treatment started at higher baseline low-density lipoprotein (LDL) levels, with 100 mg/dL being a key threshold – as in the ODYSSEY Outcome trial – a meta-analysis affirmed. Read more.

    When Drugs Are Wrong: The Cost of Non-Optimized Medications – April 17, 2018 – Rising drug prices have gotten a lot of attention lately, but the actual cost of prescription medications is more than just the dollars and cents on the bill. Researchers at Skaggs School of Pharmacy and Pharmaceutical Sciences at University of California San Diego estimate that illness and death resulting from non-optimized medication therapy costs $528.4 billion annually, equivalent to 16 percent of total U.S. health care expenditures in 2016. Read more.


    340B in the News

    340B Payment Reduction Litigation: Are There Limitations to the HHS Secretary’s Rate-Setting Authority? – April 20, 2018 – Commencing Jan. 1 this year, non-exempt 340B covered entities reimbursed under the Medicare Outpatient Prospective Payment System (“OPPS”) started receiving nearly 30 percent less in reimbursements for prescription medication purchased through the 340B discount drug program. Read more.

    Don’t Stop Discount Prescriptions – April 20, 2018 – Community health centers such as First Choice Health Centers in East Hartford, Manchester and Vernon provide consistent, preventive care that keeps people healthy and productive, regardless of ability to pay. Read more.

    Opinion | Congress Created a Prescription Drug Program in 1992. Now it is Out of Control. – April 19, 2018 – We strive in Tennessee to keep government programs small, targeted and effective. That is why I am alarmed when I see a federal government program growing exponentially, while questions are being raised about whether it is helping the people for whom it was intended. Read more.