Clinical Insights: October 2, 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

    Verzenio™ (abemaciclib) – September 28, 2017 – The U.S. Food and Drug Administration approved Verzenio™ (abemaciclib) to treat adult patients who have hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative advanced or metastatic breast cancer that has progressed after taking therapy that alters a patient’s hormones (endocrine therapy). Verzenio™ is approved to be given in combination with an endocrine therapy, called fulvestrant, after the cancer had grown on endocrine therapy. It is also approved to be given on its own, if patients were previously treated with endocrine therapy and chemotherapy after the cancer had spread (metastasized). Read more.


    New Formulation Approval

    No new updates.


    New Indication Approval

    Keytruda® (pembrolizumab) – New indication – September 22, 2017 – Merck announced that the U.S. Food and Drug Administration (FDA) has approved Keytruda® (pembrolizumab), the company’s anti-PD-1 (programmed death receptor-1) therapy, for the treatment of patients with recurrent locally advanced or metastatic gastric or gastroesophageal junction (GEJ) adenocarcinoma whose tumors express PD-L1 [Combined Positive Score (CPS) ≥1] as determined by an FDA-approved test, with disease progression on or after two or more prior lines of therapy including fluoropyrimidine- and platinum-containing chemotherapy and if appropriate, HER2/neu-targeted therapy. This indication is approved under the FDA’s accelerated approval regulations based on tumor response rate and durability of response. Read more.

    Opdivo® (nivolumab) – New indication – September 22, 2017 – Bristol-Myers Squibb Company announced the U.S. Food and Drug Administration (FDA) has approved Opdivo® (nivolumab) injection for intravenous use for the treatment of patients with hepatocellular carcinoma (HCC) who have been previously treated with sorafenib. Approval for this indication has been granted under accelerated approval based on tumor response rate and durability of response. Read more.

    Rapivab™ (peramivir) – Expanded indication – September 21, 2017 – BioCryst Pharmaceuticals, Inc. announced that the U.S. Food and Drug Administration (FDA) has approved a supplemental New Drug Application for Rapivab™ (peramivir injection), an intravenous (i.v.) neuraminidase inhibitor, extending its availability for the treatment of acute uncomplicated influenza to pediatric patients 2 years and older who have been symptomatic for no more than two days. Read more.


    New Drug Shortage

    September 29, 2017

    September 28, 2017

    September 27, 2017

    September 25, 2017


    New Drug Recall and Safety Alerts

    No new updates.


    New First Time Generic

    No new updates.


    Clinical and Pharmacy News

    Do Pharma’s Claims On Drug Prices Pass The Smell Test? We Found 5 Stinkers. – October 2, 2017 – Drug companies launched an ad and publicity extravaganza this year right after President-elect Donald Trump said they “are getting away with murder” on sky-high pill prices. More than it has in years, the pharmaceutical industry fears major legislation that would curb prices and shrink profits. TV spots lauding drug companies, quoting poet Dylan Thomas and showing heroic scientists have been hard to escape. Read more.

    Effects of Breast Cancer Can Be Eased By Some Non-Drug Therapies – October 2, 2017 – Breast cancer and its treatments can increase the likelihood of anxiety, depression, fatigue, insomnia, pain, stress and more. To subdue these negative effects, up to 86 percent of people with breast cancer turn to complementary therapies such as acupuncture, dietary supplements, meditation and yoga, according to a study published in Breast Cancer Research and Treatment. Read more.

    Study: Ending DIR Fees Could Save Medicare Billions – September 29, 2017 – Pharmacists from around the country have raised concerns over the effect of direct and indirect remuneration (DIR) fees. Pharmacy advocacy organizations, such as the National Association of Specialty Pharmacy (NASP) and the National Community Pharmacy Association (NCPA), have made it their job to educate legislators and the general public about the harms of DIR fees for both patients and pharmacies. Read more.

    An Easy Way to Cut Drug Costs – September 28, 2017 – In the absence of national action to control the high price of prescription drugs, California is considering a small state rule that could make a big difference. It targets a game that pharmaceutical companies play to keep people spending more than they need to on medicines. The rule, contained in legislation now on the governor’s desk, would bar the use of coupons to help consumers cover the cost of co-payments for any brand-name drugs for which there is a generic alternative that works as well. Read more.

    FDA Improves Access To Reports Of Adverse Drug Reactions – September 28, 2017 – The U.S. Food and Drug Administration launched a new user-friendly search tool that improves access to data on adverse events associated with drug and biologic products through the FDA’s Adverse Event Reporting System (FAERS). The tool is designed to make it easier for consumers, providers and researchers to access this information. Read more.

    CDC Issues Guidelines to Halt Surgical Site Infections – September 28, 2017 – The CDC has issued long-awaited recommendations for the prevention of surgical site infections. Replacing a guideline from 1999, this is the first SSI guideline from the CDC to use current evidence-based guideline methods rather than expert opinion. The document covers 14 areas of surgical care and offers 12 “strong” recommendations. Of these, eight are considered category 1A recommendations, supported by high- to moderate-quality evidence suggesting net clinical benefits or harms. Read more.

    Hospital Formulary Management – September 28, 2017 – Money makes the world go round, right? Perhaps to a degree, but a common misconception about formulary management is that money is the driving force behind the entire operation. Although economic considerations play a role in the decision-making process, we would argue that formulary management is more than medication cost. The creation and continuous evaluation of a hospital’s formulary facilitates superior patient care, achieves therapeutic goals, and improves patient safety while curtailing expenses. Read more.

    Biosimilars and Follow-on Biologics – September 28, 2017 – Pharmacists need to be experts on follow-on biologics (FOBs), including biosimilars, so they can provide education to health professionals about safe prescribing and use, which ultimately affects patient care. Seamless interchangeability among biosimilars and FOBs may not be permissible under the law, or as appropriate, as it is with brand and generic chemically derived drugs. Read more.

    Study Finds High Rate Of Prescriptions Not Filled For New Cholesterol Lowering Drugs – September 27, 2017 – In the first year of availability of the cholesterol lowering medications PCSK9 inhibitors, fewer than 1 in 3 adults initially prescribed one of these inhibitors actually received it, owing to a combination of out-of-pocket costs and lack of insurance approval, according to a study published by JAMA Cardiology. Read more.

    Biosimilars: A Similar Frontier – September 27, 2017 – Biologics, drug products made from living organisms, have revolutionized the treatment of life-threatening illnesses and chronic diseases, including cancer, rheumatoid arthritis, diabetes, and autoimmune disorders. The market for biologics continues to increase and is expected to reach $390 billion by 2020 and represent 28 percent of the value of the world’s pharmaceutical products. In 2014, 10 of the top 25 drugs in the United States were biologics. Read more.

    Opioid Prescription Study Challenges Government Guidelines For 7-Day Limit – September 27, 2017 – A medical study is challenging the federal government’s one-size-fits-all solution to stop the overprescribing of painkillers. The study says that for certain procedures, opioids can be prescribed safely for five days to as long as two weeks; federal guidelines say opioid prescriptions should not exceed seven days. “The overprescription of pain medications has been implicated as a driver of the burgeoning opioid epidemic; however, few guidelines exist regarding the appropriateness of opioid pain medication prescriptions after surgery,” says the study, whose findings were published Wednesday in the Journal of the American Medical Association. Read more.

    Beta Blockers Not Needed For Heart Attack Survivors Taking These Drugs – September 27, 2017 – Beta blockers are not needed after a heart attack if heart attack survivors are taking ACE inhibitors and statins, according to a new study. The study, published in the Journal of the American College of Cardiology, is the first to challenge the current clinical guideline that heart attack survivors should take all three drugs: beta blockers, ACE inhibitors and statins—for the rest of their lives. Read more.

    FDA Approves First Continuous Glucose Monitoring System For Adults Not Requiring Blood Sample Calibration – September 27, 2017 – The U.S. Food and Drug Administration approved the FreeStyle Libre Flash Glucose Monitoring System, the first continuous glucose monitoring system that can be used by adult patients to make diabetes treatment decisions without calibration using a blood sample from the fingertip (often referred to as a “fingerstick”). Read more.

    Pharma Giants in Antitrust Pricing Lawsuit over Biosimilars – September 26, 2017 – Pfizer sued Johnson & Johnson (J&J) in federal court in Pennsylvania last week, alleging anticompetitive discounts and other actions to prevent competition with J&J’s biologic Remicade. The complaint illustrates the hurdles to successfully bringing a biosimilar to market, despite the Biologics Price Competition and Innovation Act (BPCIA). The case also will provide another opportunity for courts to evaluate the antitrust implications of loyalty discounts and bundling. Read more.

    Study: Emergency Physicians Prescribe Opioids At Lower Rates Than Other Doctors – September 26, 2017 – Opioid prescriptions written by emergency department clinicians tend to have lower doses and a shorter supply duration than when such medications are prescribed in other medical settings, according to a new study. An analysis of more than 5.2 million opioid prescriptions written between 2009 and 2015 comparing prescribing characteristics between ED and non-ED clinicians found those written by emergency physicians were more likely to follow guidelines issued by the Centers for Disease Control and Prevention last year. Read more.

    FDA Conducts Major Global Operation To Protect Consumers From Potentially Dangerous Prescription Drugs Sold Online – September 25, 2017 – The U.S. Food and Drug Administration, in partnership with international regulatory and law enforcement agencies, recently took action against more than 500 websites that illegally sell potentially dangerous, unapproved versions of prescription medicines, including opioids, antibiotics and injectable epinephrine products to American consumers. Read more.


    340B in the News

    More Clouds Form Over 340B Program – September 29, 2017 – Drug manufacturers, and to a lesser extent hospitals, have complained for years about the shortcomings of the 340B Drug Pricing Program, which allows nearly 3,000 hospitals and approximately 10,000 health clinics around the country to buy pharmaceuticals at a deep discount as a means of generating revenue, ostensibly to help lower-income patients and their communities. Complaints from both parties have been validated by the Government Accountability Office (GAO) and the Office of Inspector General (OIG) of the Department of Health and Human Services (HHS) and discussed at congressional hearings, where the program’s opaque guidelines and barely visible program integrity efforts have been thoroughly aired. Read more.

    Congress Must Fix the Broken 340B Drug Pricing Program That Benefits Hospitals, Starves the Poor – September 28, 2017 – Too often government programs start with a noble goal but are soon denigrated by special interests groups who use well intentioned programs for their own gain. Unfortunately, this has happened with the 340B drug discount program. Due to limited oversight, bad actors have been able to profit from this federal program, abusing the system and hurting the exact people the program was intended to help. Created by Congress in 1992, the 340B drug discount program requires drug manufacturers to provide outpatient drugs to eligible entities that serve vulnerable or uninsured populations at steep discounts averaging 30 to 50 percent. Today, the 340B program has deteriorated into a huge profit center for hospitals in well-off communities and is not always helping the underserved as intended. Read more.

    Penalties Delayed Again for Drugmakers That Charge Too Much – September 28, 2017 – A final rule from the Obama administration imposing penalties on drug companies for overcharging safety-net hospitals and other providers is being held off another nine months, at least. July 1, 2018, is the new effective date for the Department of Health and Human Services rule, the agency said in a notice to be published Sept. 29 in the Federal Register. Read more.

    Moody’s Sees Drug Price Increases Slowing – September 27, 2017 – Despite the slowing rate, rising drug costs and potential changes to Medicare 340B payments for outpatient drugs would further reduce hospitals’ margins. Inpatient drug costs will continue to rise for not-for-profit hospitals, but the pace will slow under growing scrutiny of drug makers’ pricing practices, Moody’s Investors Service said in a new report. Read more.

    Moody’s: Proposed Cuts To Medicare 340B Payments Would Hurt Nonprofit Hospital Margins – September 27, 2017 – CMS’ proposed changes to 340B Drug Pricing Program payments would harm nonprofit hospital margins, according to Moody’s Investors Service. In July, CMS released its 2018 Medicare Outpatient Prospective Payment System proposed rule. CMS proposed paying hospitals 22.5 percent less than the average sales price for drugs purchased through the 340B program. Read more.

    Drug Discount Programs Have Become Wasteful — They Don’t Help Patients – September 25, 2017 – Drug discount programs have become wasteful — they don’t help patients There are many reasons why the cost of health care is rising, including massive and unchecked federal programs that have proliferated throughout the entire health-care system. The 340B drug discount program is among those that must be examined and reined in. Read more.