Clinical Insights: February 13, 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

    Biktarvy® (bictegravir, emtricitabine and tenofovir alafenamide) – February 7, 2018 – Gilead Sciences, Inc. announced that the U.S. Food and Drug Administration (FDA) has approved Biktarvy® (bictegravir 50mg/emtricitabine 200mg/tenofovir alafenamide 25mg, BIC/FTC/TAF), a once-daily single tablet regimen (STR) for the treatment of HIV-1 infection. Biktarvy® combines the novel, unboosted integrase strand transfer inhibitor (INSTI) bictegravir, with the demonstrated safety and efficacy profile of the Descovy® (FTC/TAF) dual nucleoside reverse transcriptase inhibitor (NRTI) backbone, and is the smallest INSTI-based triple-therapy STR available. Read more.


    New Formulation Approval

    No new updates.


    New Indication Approval

    Cosentyx® (secukinumab) – New Expanded Indication Approval February 9, 2018 – Novartis announced that the U.S. Food and Drug Administration (FDA) has approved a label update for Cosentyx® (secukinumab), the first interleukin-17A (IL-17A) antagonist approved to treat moderate to severe plaque psoriasis. The updated label includes Cosentyx data in moderate to severe scalp psoriasis – one of the difficult-to-treat forms of the disease, which affects approximately half of all psoriasis patients. Read more.

    Zytiga® (abiraterone acetate) – New Indication Approval – February 7, 2018 – The Food and Drug Administration (FDA) approved abiraterone acetate (Zytiga, Janssen Biotech Inc.) tablets in combination with prednisone for metastatic high-risk castration-sensitive prostate cancer (CSPC). Read more.

    Feraheme® (ferumoxytol injection) – New Expanded Indication Approval – February 5, 2018 – AMAG Pharmaceuticals, Inc. announced that the U.S. Food and Drug Administration (FDA) has approved its application to broaden the existing label for Feraheme® (ferumoxytol injection) beyond the current chronic kidney disease (CKD) indication to include all eligible adult Iron Deficiency Anemia (IDA) patients who have intolerance to oral iron or have had unsatisfactory response to oral iron. Read more.


    New Drug Shortage

    February 6, 2018 

    February 5, 2018 


    New Drug Recall and Safety Alerts

    No new updates.


    New Generic Launch

    Trientine hydrochloride (Syprine®) – February 12, 2018 – Teva has introduced its generic Syprine (trientine hydrochloride) capsules. The drug was included on the Food and Drug Administration’s list of off-patent, off-exclusivity branded drugs that didn’t have generics. Read more.


    Clinical and Pharmacy News

    Pharma Gets the Worst of Both Drug-Pricing Worlds – February 13, 2018 – Pharma’s pricing power just isn’t what it used to be, and it’s probably not going to recover anytime soon. Pharmacy benefit manager (PBM) Express Scripts Holding Co. last week reported a record-low 1.5 percent increase in drug spending by commercial health insurance plans in 2017. It also said per-beneficiary drug spending fell for many commercial plans and gave a discouraging forecast – for drugmakers, anyway – for the years ahead. Read more.

    White House Outlines Reforms to Lower Drug Prices – February 9, 2018 – The White House’s Council of Economic Advisers on Friday recommended easing government regulations to lower drug prices and reinforcing the Food and Drug Administration’s push to spur competition through expedited approvals. Read more.

    Rite Aid Store Transfers Pass Halfway Mark – February 9, 2018 – The Rite Aid-Walgreens transition is on track to be completed by spring. Camp Hill, Pa.-based Rite Aid has successfully transferred 1,114 stores to Walgreens Boots Alliance and has received cash proceeds of $2.424 billion, which the company continues to use to reduce debt. The drug store chain said it expects to finish the transfer by spring. Read more.

    NCPA Survey: Independents Feel Hampered by DIR Fees – February 9, 2018 – Independent pharmacists are indicated to the National Community Pharmacists Association that it should continue to make the case for reform around direct and indirect remuneration, or DIR, fees. The Alexandria, Va.-based group recently conducted a survey of its members in which 84 percent said they felt DIR fees hinder their businesses. Read more.

    Three Barriers to Biosimilar Adoption – February 9, 2018 – Biosimilar adoption in the U.S. has been slower than expected, and a new report may offer clues as to why. “The State of the US Biosimilars Market Access: Payer Perceptions of Past, Present, and Future Hurdles to Adoption,” from Trinity Partners, provides insight into U.S. payers’ perceptions of the past, present, and future state of biosimilar market access in the U.S. Read more.

    Trump Aims to Reduce Drug Costs Under Medicare – February 9, 2018 – President Donald Trump will propose lowering prescription drug costs for Medicare beneficiaries by allowing them to share in rebates that drug companies pay to insurers and middlemen, an administration official said Thursday. A senior administration official outlined the plan on condition of anonymity ahead of the release of Trump’s 2019 budget plan next week. Read more.

    Updated: Mixed Bag for Biosimilars in Short-Term Continuing Resolution – February 8, 2018 – The U.S. House of Representatives on Tuesday passed another short-term continuing resolution to keep the government open through March 23, though buried in the bill are two provisions that would impact the biosimilars industry. However, a Senate draft bill unveiled Thursday only contained the one provision that would be positive for the biosimilars industry. Read more.

    6 Ways to Mitigate Specialty Drug Costs – February 8, 2018 – At an average monthly outlay of $3,000, specialty drugs cost 10 times the average non-specialty drug, according to Strategic Benefit Advisors. And it’s only expected to get worse. CVS Caremark estimates that specialty drugs could account for about half of the total pharmacy spend in 2018, which is up from one-third two years earlier. Read more.

    Insulin Quality Questions Have Diabetes Experts Scrambling – February 7, 2018 – Preliminary research suggesting that some diabetes patients may be injecting medicine that has partially disintegrated is causing concern even as serious questions are raised about the research itself. The study author, a pharmacist, bought vials of insulin at a number of pharmacies and found that on average the vials had less than half of what was listed on the label and none met a minimum standard. Read more.

    2017 Was Another Record-Setting Year for Generic Drugs – February 7, 2018 – In 2017, FDA’s Center for Drug Evaluation and Research’s generic drug program marked several major accomplishments on behalf of the American people. Our Office of Generic Drugs (OGD) marked another record-setting year for generic approvals at FDA with 1,027 new generic drugs, 214 more than our previous record of 813 set in 2016. Of those, 843 were full approvals and 184 were “tentative” approvals, that is, applications that are ready for approval from a scientific perspective, but cannot be fully approved due to patents or exclusivities on the brand-name drug. Read more.

    Top 3 Legislative Priorities for Pharmacists – February 7, 2018 – The National Community Pharmacists Association (NCPA) recently asked its independent pharmacy members to rank the most significant legislative and regulatory priorities for 2017, according to a press release. Read more.

    Drug Combinations Improve First-Stroke Risk Reduction – February 7, 2018 – Two or more drugs are better than one when it comes to reducing first-time strokes. That’s according to a presentation at the recent American Stroke Association’s International Stroke Conference 2018 in Los Angeles. Researchers report that a combination of an antihypertensive with a cholesterol-reducing agent reduced first-time strokes by 44 percent. Read more.

    DIR Fees Tops List of Legislative Concerns Among Independents – February 6, 2018 – DIR fees remains the top legislative or regulatory thorn in the side of community pharmacists, according to the fourth annual survey of National Community Pharmacists Association members. Read more.

    House Subcommittee Meeting Points to Compounding Turf War – February 6, 2018 – All drugs should be compounded under suitable quality standards, but who should be ensuring those standards among traditional compounders and outsourcing facilities was debated at the House Energy and Commerce Subcommittee on Health. Read more.

    Impact of a Pharmacy-Led Medication Reconciliation Program – February 5, 2018 – Obtaining accurate medication histories and performing medication reconciliation are keys to three main transitions of care in the hospital setting: hospital admission, transitions between hospital units and hospital discharge. Medication reconciliation at hospital admission, the first step in the process, can affect hospital admission orders and medication reconciliation at future transitions of care. Admission medication reconciliation is the process of comparing a patient’s inpatient medication orders with the medications in use prior to admission and intervening to ensure that the correct medications are ordered. Read more.

    New Anticoagulant Guidelines for Cardiac Surgery Released – February 5, 2018 – The guidelines were developed by The Society of Thoracic Surgeons (STS), the Society of Cardiovascular Anesthesiologists (SCA), and the American Society of ExtraCorporeal Technology and were published simultaneously in The Annals of Thoracic Surgery, Anesthesia & Analgesia and the Journal of ExtraCorporeal Technology, The new evidence-based recommendations include optimal heparin dosing for initiation and maintenance of cardiopulmonary bypass (CPB), identification of contraindications to the use of heparin, options for alternatives to heparin and ideal methods for reversal of anticoagulation after CPB. Read more.

    Top 8 Specialty Drug Categories Driving Spending in 2018 – February 5, 2018 – It is well-known that specialty products are a major driver of prescription drug spending, a trend that is projected to continue well into the future. The new Vizient Drug Price Forecast suggests that although drug costs are projected to increase by 7.35 percent, specialty pharmacies can help bring spending down even further. Read more.


    340B in the News

    More Oversight For 340B Needed, White House Council Says – February 12, 2018 – In its report, the CEA offered ways that the CMS can lower domestic drug prices while the federal government reforms the FDA to “encourage more robust price competition.” The CEA said the federal government also needs to look into how its policies inflate drug prices and temper price competition. Read more.

    Trump Administration Drug Pricing Policy Hurts the Most Vulnerable – February 12, 2018 – Here in Southern West Virginia, we are on the front lines of taking care of all patients regardless of their ability to pay. While we are fortunate to live in a beautiful state, West Virginia has much higher rates of cancer, opioid addiction and heart disease than the national average. Our patients – many of whom are low-income, elderly and either uninsured or underinsured – depend on us to provide them with high-quality, low-cost specialized services and care. Read more.

    Report Slams 340B Drug Discount Program – February 12, 2018 – The 340B Drug Discount program, designed to give discounted prescription drugs to poor Americans, has not been effective in serving its targeted population, according to a new report. The report, “Addressing the Problems of Abuse in the 340B Drug Pricing Program,” by the Pacific Research Institute, found that the 340B program is now an overpriced and inefficient way to provide important medications to low-income Americans, and it’s in desperate need of reform. Read more.

    Some Hospitals Feel Impact of Federal Drug-Discount Cutbacks – February 11, 2018 – Three dozen hospitals in Michigan are adjusting to a new federal rule that slashed Medicare reimbursement rates on certain drugs from six percent above the sales price from pharmaceutical companies to 22.5 percent under the sales price, a move that is estimated to save drug companies $1.6 billion annually. Read more.

    Rural Hospitals, Clinics Under Attack – February 9, 2018 – Right now, policy developments in Washington, D.C. are placing our rural North Dakota hospitals and other healthcare providers at significant risk of shutting down, choking off healthcare access for thousands of patients in rural communities who have few other options. Read more.

    5 Proposals in Alex Azar’s Drug Price Plan – February 9, 2018 – The President and his new HHS secretary concur that drug prices in the United States are too high, and in a press briefing yesterday, Azar said that he has been “working a great deal on these issues already,” according to a Bloomberg report. Read more.

    Hospital and Pharma Jockeying Over 340B Puts Lawmakers into A Tight Spot – February 8, 2018 – A late-December protest of U.S. Rep. Scott Peters’ district office in San Diego by AIDS groups morphed into an ongoing advertising campaign against the California Democratic congressman in what has become the most public battle in the intense lobbying war over 340B. Read more.

    Is Federal Policy Really to Blame for The High Cost of Cancer Care? – February 8, 2018 – U.S. healthcare costs have been high for decades, outpacing other developed countries since at least the 1980s. But costs continue to rise, and that is causing many experts to ask why. Some people blame federal policies. As an example, they point to reimbursement policies that create incentives for healthcare providers to consolidate. When hospitals merge with each other, or when hospitals buy out physician practices, healthcare providers gain negotiating leverage over insurers, which enables them to negotiate higher prices. Read more.

    COA: Analysis Shows Texas Hospitals Benefit from Recent Changes in Medicare Payment – February 8, 2018 – Hospitals in Texas, especially those in rural areas, will benefit from recent changes to Medicare prescription drug payments, including changes to a federal program known as the 340B Drug Discount Program. On average, Texas hospitals will see a 3.6 percent increase—among the largest statewide increases in the United States—in Medicare payments related to the changes. Read more.

    Hatch Asks Azar to Shift 340B Oversight to CMS – February 6, 2016 – Senate Finance Committee Chair Orrin Hatch has released a letter in which he asked HHS Secretary Alex Azar to shift the 340B program to his committee’s jurisdiction. With this letter, the Utah Republican joined the mounting effort in Congress to scale back the program and redefine how hospitals should use the drug manufacturer discounts they receive through the program. Read more.

    Court Grants Hospital Groups’ Request for Expedited Brief In 340B Case Appeal – February 5, 2018 – A federal appeals court has agreed to a request from several hospital groups for an expedited brief schedule in their case against the Department of Health and Human Services over cuts to the 340B drug discount program. Read more.