Clinical Insights: August 25, 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

    Gocovri™ (amantadine) – August 24, 2017 – Adamas Pharmaceuticals, Inc., announced that the U.S. Food and Drug Administration (FDA) has approved Gocovri™ (amantadine) extended release capsules (previously ADS-5102) for treatment of dyskinesia in patients with Parkinson’s disease receiving levodopa-based therapy, with or without concomitant dopaminergic medications. Gocovri™, previously granted orphan drug status by the FDA, is the first and only medicine approved by the FDA for this indication. Read more.

    Duzallo® (allopurinol and lesinurad) – Aug. 21, 2017 – Ironwood Pharmaceuticals, Inc., announced Duzallo® was approved by the U.S. Food and Drug Administration (FDA) as a once-daily oral treatment for hyperuricemia associated with gout in patients who have not achieved target serum uric acid (sUA) levels with a medically appropriate daily dose of allopurinol alone. Read more.


    New Formulation Approval

    No new updates.


    New Indication Approval

    Besponsa® (inotuzumab ozogamicin) – August 17, 2017 – Pfizer Inc., announced that the U.S. Food and Drug Administration (FDA) has approved Besponsa® (inotuzumab ozogamicin) for the treatment of adults with relapsed or refractory B-cell precursor acute lymphoblastic leukemia (ALL). Besponsa® was reviewed and approved under the FDA’s Breakthrough Therapy designation and Priority Review programs. Read more.

    Lynparza® (olaparib) – August 17, 2017 – AstraZeneca and Merck & Co., Inc., announced that the U.S. Food and Drug Administration (FDA) has granted approval for the PARP inhibitor, Lynparza® (olaparib), for maintenance treatment of adult patients with ovarian cancer, fallopian tube cancer, or primary peritoneal cancer, when the cancer has come back. Read more.


    New Drug Shortage

    August 22, 2017

    August 18, 2017


    New Drug Recall and Safety Alerts

    Ninjacof and Ninjacof A – August 23, 2017 – Centurion Labs is voluntarily recalling 1 lot of Ninjacof (Lot# 200N1601) and 1 lot of Ninjacof A (Lot# 201NA1601) manufactured by Vilvet and distributed by Centurion Labs to the retail level due to potential contamination with Burkholderia cepacia. Read more.


    New First Time Generic

    No new updates.


    Clinical and Pharmacy News

    You May Be Paying More for Prescription Drugs If You Use Your Health Insurance – August 24, 2017 – Consumer lawsuits have been filed against CVS and Walgreens for so-called ‘clawbacks’ that raise prices for people who buy drugs through their insurance. Read more.

    Study: Reference Pricing Can Help Insurers, Employers Cut Prescription Drug Costs – August 24, 2017 – Insurers and employers take note: A new study has found that reference pricing is associated with “significant” changes in drug selection and spending for patients covered by employer-based insurance. Read more. 

    Anthem Health Plans Reduce Opioid Prescriptions Filled at Pharmacy by 30 Percent – August 24, 2017 – Health plans affiliated with Anthem, Inc., have reached the company’s collective goal of reducing opioid prescriptions members filled at pharmacies by 30 percent during the past five years. The Anthem health plans were among the first to limit coverage for short-acting opioid coverage to seven days for all individual, employer-sponsored, and Medicaid members beginning new opioid prescriptions. Read more.

    States Take on Drug Price Transparency, Gouging – August 23, 2017 – As the U.S. Congress continues to highlight specific drug price increases rather than adopt wide-reaching legislation to curb such practices, states are taking the matter into their own hands. Read more.

    Top 5 Highest Grossing Specialty Drugs of the Year – August 23, 2017 – Prescription drug spending has skyrocketed over the past few years, with many Americans struggling to access proper treatment. Lawmakers have attempted to address this issue, but it is likely that the trend of escalating drug spending will continue as costly specialty drugs dominate the market. Read more.

    How to Tell If the Price Is Right on Your Next Prescription – August 23, 2017 – Filling a prescription is no longer the simple errand you run after a doctor visit. With drug prices rising and insurance coverage shrinking, it pays to ask questions and do a little research before handing over your insurance card at the pharmacy counter. Having coverage offers no guarantee that you’re getting the best price for your medicine. Read more.

    More PBMs Tackling Opioids at The First Fill as State Comp Laws Evolve – August 23, 2017 – Pharmacy benefits management firms are aligning their business with state laws on how much opioids an injured worker can be prescribed on the first fill of their prescriptions despite backlash from doctors, experts say. Read more.

    The Dems Are Wrong on Prescription Drug Prices – August 22, 2017 – Congressional Democrats recently released “A Better Deal,” their new economic platform. It calls for many reforms, such as expanding vocational programs and strictly enforcing anti-trust laws, that would benefit working-class Americans. But one of the proposals – letting the government “negotiate” Medicare prescription drug prices – would be disastrous. If it were implemented, 40 million Americans with Medicare drug coverage could lose access to vital prescriptions. Read more.

    Could a Text Messaging System Be the Answer to Adherence Issues? – August 22, 2017 – Diabetes is a serious condition that is characterized by high blood sugar, excessive urination, increased appetite, and extreme thirst. Diabetes is often accompanied by a wide variety of comorbidities such as high blood pressure, abnormal cholesterol, and others. Read more.

    How RFID Technology Can Help Drug Safety – August 22, 2017 – Nearly 40 percent of ambulatory care providers surveyed in the first half of 2016 failed compliance inspections for safe storage of medications, according to a report by the Joint Commission. Improper drug storage ranked third in the top five most challenging requirements affecting ambulatory care. Read more.

    American Society of Clinical Oncology Updates Guidelines for Treatment of Advanced Non-Small Cell Lung Cancer – August 21, 2017 – The American Society of Clinical Oncology (ASCO) recently updated its clinical guidelines for advanced non-small cell lung cancer (NSCLC) so that oncologists can select the most appropriate treatment for patients. Read more.

    AAP Issues New Pediatric Hypertension Clinical Practice Guideline – August 21, 2017 – New blood pressure tables and streamlined recommendations are among the changes in new pediatric hypertension guidelines that can help pediatricians identify and address this generally asymptomatic and often-unrecognized chronic disease. Read more.

    Multiple Sclerosis Drug Costs Called into Question – August 21, 2017 – Multiple sclerosis (MS) drug manufacturers are on the hot seat, as U.S. House Democrats are launching an investigation into the high costs of treatments for the disease, according to Reuters. High drug costs have been an ongoing topic, and regulators and lawmakers have begun pushing back. Read more.

    Collaboration Between Community, Hospital Pharmacists Central to Reducing Hospital Readmission Rates – August 20, 2017 – Community pharmacists play an integral role in reducing hospital readmissions when they partner with area hospitals to assist with transitions in care, according to a presentation at the National Association of Chain Drug Stores (NACDS) Total Store Expo held in San Diego this week. Read more.

    Pharmacy Becomes Go-To for Flu Shots – August 18, 2017 – Vaccinations represent an emerging category within retail pharmacy for one simple reason: The majority of Americans prefer visiting their local pharmacy to get their inoculations, as opposed to visiting the doctor’s office, according to the PrescribeWellness 2017 Vaccination and Preventive Care Survey. Read more.


    340B in the News

    340B Update: HRSA Delays Final Rule on 340B Pricing and Manufacturer CMPs Yet Again – August 24, 2017 – On August 21, 2017, the Health Resources and Services Administration (“HRSA”) published a Notice of Proposed Rulemaking to further delay the effective date of final rules on drug pricing calculations and civil monetary penalties (“CMPs”) for manufacturers that knowingly and intentionally overcharge covered entities under the 340B Drug Pricing Program (“340B Program”) until July 1, 2018. Read more.

    Influential Advisory Panel Asks CMS to Reject $1.65 Billion in Cuts to 340B – August 21, 2017 – A panel that advises HHS on outpatient hospital payments wants the CMS to drop a draft rule that could cut up to $1.65 billion out of the 340B discount drug program. Read more.

    Don’t Gut Important Drug Discount Program – August 19, 2017 – Getting diagnosed with cancer is devastating. Being unable to afford expensive medications to fight it is worse. Drug prices have been increasing on average of 10 percent over the past three years, and new drugs are being introduced at astronomical prices. Cancer drugs cost $11,325 per month in 2014, compared to $1,869 per month in 2010. Read more.

    COMMENTARY: Rural and Inner-City Hospitals Threatened by Big Pharma Effort – August 18, 2017 – Unless you work in health care, you are probably unaware of the 340B program. But the population served by your rural or inner-city hospital depends on it. More than 25 years ago, a deal was made between the pharmaceutical drug companies and the federal government. Pharma won access to a guaranteed market for their drugs through Medicaid in return for agreeing to provide cheaper medications to hospitals serving poorer populations, primarily rural and inner-city hospitals where a disproportionately high percentage of low-income patients are treated. Read more.

    Another Potential Delay for Drugmaker Penalty Rule – August 18, 2017 – Drugmakers are set to get more relief from a final rule imposing penalties on them for overcharging safety-net hospitals and other providers. The Department of Health and Human Services is proposing to delay the rule’s effective date until July 1, 2018, the agency said in a notice to be published Aug. 21 in the Federal Register. The effective date has already been delayed several times, and most recently the rule was set to take effect Oct. 1. The HHS is seeking comments on the additional delay for the rule, which was issued under the 340B drug pricing program. Comments are due Sept. 20. Read more.