Clinical Insights: October 16, 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

    No new updates.


    New Formulation Approval

    Lyrica® CR (pregabalin) – October 12, 2017 – Pfizer Inc. announced that the United States Food and Drug Administration (FDA) has approved Lyrica® CR (pregabalin) extended-release tablets CV as once-daily therapy for the management of neuropathic pain associated with diabetic peripheral neuropathy (pDPN) and the management of postherpetic neuralgia (PHN). Lyrica® CR did not receive approval for the management of fibromyalgia. Read more.


    New Indication Approval

    No new updates.


    New Drug Shortage

    October 13, 2017

    October 12, 2017

    October 11, 2017

    October 10, 2017


    New Drug Recall and Safety Alerts

    No new updates.


    New First Time Generic

    No new updates.


    Clinical and Pharmacy News

    The Cost of Developing Drugs Is Insane. That Paper That Says Otherwise Is Insanely Bad – October 16, 2017 – For years, the pharmaceutical industry has relied on estimates from the Tufts Center for the Study of Drug Development, the most recent of which that puts the cost of bringing a medicine from invention to pharmacy shelves at $2.7 billion. Last month, two cancer researchers grabbed headlines by asserting that estimate is way off. Their number, published in JAMA Internal Medicine: $648 million. In an editorial that ran alongside the new study, journalist Merrill Goozner wrote: “Policymakers can safely take steps to rein in drug prices without fear of jeopardizing innovation.” Read more.

    We may soon have our first $1 million drug. Who will pay for it? And how? – October 15, 2017 – Gene therapy has the potential to be a one-shot treatment that could reverse blindness, restore blood-clotting function to hemophiliacs, or even cure rare diseases outright. But what kind of price tag comes with that promise — and who will pay for it? The question is no longer academic: On Thursday, Spark Therapeutics won unanimous support from a Food and Drug Administration advisory panel for its gene therapy drug, Luxturna. Read more. 

    Diabetes Treatment Failure May Actually Be Nonadherence – October 14, 2017 – Second-line treatment is often initiated without evidence of recommended use of first-line treatment. Metformin is the first-line agent for treating type 2 diabetes as recommended by American Diabetes Association and European Association for the Study of Diabetes. It is relatively safe and has great Medication Adherence evidence of efficacy lowering glucose levels in addition to microvascular and macrovascular benefits. Read more.

    Managing the Cost of Diabetes – October 13, 2017 – Diabetes is one of the most common and costly chronic diseases, affecting more than 30 million Americans, with a total annual cost of $245 billion. Prevalence continues to increase as obesity rises, with the highest rates of diabetes found in minorities and older Americans. Consequences of diabetes include hypertension, coronary heart disease, stroke, chronic kidney disease and blindness. Despite significant medical advancement in treatment, diabetes remains the seventh leading cause of death in the United States. Read more.

    Medicare Part D: A First Look at Prescription Drug Plans in 2018 – October 13, 2017 – During the Medicare open enrollment period from October 15 to December 7 each year, beneficiaries can enroll in a plan that provides Part D drug coverage, either a stand-alone prescription drug plan (PDP) as a supplement to traditional Medicare, or a Medicare Advantage prescription drug plan (MA-PD), which provides all Medicare-covered benefits including drugs. Part D plans vary in numerous ways that can have a significant effect on an enrollee’s out-of-pocket spending, including premiums, deductibles, cost sharing, tier placement, the list of covered drugs and preferred pharmacies. Read more.

    Pharmacy’s Changing Role as Cancer Care Transitions from Infused to Oral Therapies – October 13, 2017 – An increasing number of cancer drugs are now delivered in oral formulations, with an estimated 25 percent to 35 percent in the research pipeline being orals. Increasingly, patients prefer to receive their oral cancer drugs and ancillary oral therapies in a safe, reliable, accessible and affordable environment, tightly integrated with their overall cancer care. Depending on state pharmacy laws, community cancer clinics have established facilities to dispense oral drugs operating either under the physician’s license or as in-practice closed-door pharmacies. Read more.

    New Campaign Launched for Low Cost Generics – October 13, 2017 – Patients for Affordable Drugs is launching a new campaign to pass a bill aimed at easing hurdles to bringing lower cost generic drugs to the market. The group wants the CREATES Act passed, viewing it as a measure for decreasing the costs of prescription drugs. Read more.

    Emergency Department Opioid Prescriptions Align with CDC Guideline – October 12, 2017 – Opioid prescriptions to opioid-naive patients in the emergency department (ED) setting were shown to be more in line with the Centers for Disease Control and Prevention (CDC) recommendations and less likely to lead to long-term opioid use compared with non-ED prescriptions, according to the results of a recent study published in the Annals of Emergency Medicine. Read more.

    Congress Urges Elimination of DIR Fees – October 12, 2017 – More than 50 members of Congress recently sent a letter to the Department of Health and Human Services (HHS) and the Centers for Medicare and Medicaid Services (CMS) calling on the agencies to eliminate direct and indirect remuneration (DIR) fees. This action would ensure that rebates and discounts are passed along to Medicare Part D beneficiaries to lower out-of-pocket costs. Read more.

    Driving Patient Adherence (and Outcomes) Through Appointment-Based Refill Programs – October 12, 2017 – One of the biggest struggles facing patients today is ensuring they have the proper medications on hand and that they are taking their medications correctly. Often, patients are given new prescriptions and asked to manage multiple, complex therapies on their own. This can result in delays in starting therapy, duplicate therapies being taken, and gaps in care because of numerous issues. For most patients, it can be incredibly confusing to navigate the world of health care, pharmacy, prior authorizations and drug interactions. Studies have shown retail adherence averaging 30 percent to 50 percent when patients are asked to manage their therapy on their own, and up to half of all new medications may never get filled. Read more.

    California Becomes the Latest State to Enact Drug Pricing Legislation – October 11, 2017 – On Monday, Democratic California Governor Jerry Brown signed into law SB 17, a law that seeks to generate greater transparency concerning drug pricing. Sponsored by State Senator Ed Hernandez, a Democrat, the law requires health plans to provide cost information related to prescription drugs to the Department of Managed Healthcare and the Department of Insurance. The two departments will be required to publish the aggregated information online by the first of each year. Additionally, drug makers who market prescription drugs that cost $40 or more for a 30-day supply will be required to provide to purchasers with 60-day advanced notices when they increase prices by a margin greater than 16 percent. These notices must include the rationale for the company’s decision to increase a drug’s price. Read more.

    New Cancer Drugs May Not Improve Survival – October 11, 2017 – The efficacy of newly approved cancer drugs has been called into question due to limited or no gains in survival and quality of life for patients, according to a new study published by The BMJ. The authors found that many novel cancer drugs received approval based on indirect measures, which may not be able to predict whether patients will live longer or have a better quality of life. These findings may result in questions about new drug approval standards, according to the study. Read more.

    Antibiotics Before Low-Risk Operations Do Not Seem to Breed Postop Antibiotic Resistance – October 10, 2017 – Surgical patients who receive antibiotics before certain types of low-risk operations are not at an increased risk for antibiotic-resistant infections immediately after their procedures, according to results from a large-scale study conducted by researchers from Columbia University Medical Center, New York City. These findings may reassure surgeons who refrain from ordering a short-course of antibiotics prior to patients’ surgical procedures because of concerns about breeding antibiotic resistance. Read more.

    Breaking Down Barriers to Antimicrobial Stewardship in Small Hospitals – October 10, 2017 – Owing to their success in promoting patient safety at larger institutions, various national regulatory and accreditation agencies have mandated that all hospitals, regardless of size, implement antimicrobial stewardship programs (ASPs). In 2015, 73 percent of U.S. hospitals had fewer than 200 beds, and 10 percent had fewer than 25 beds, many of which hold critical access hospital (CAH) designation, according to a recent study in Clinical Infectious Diseases. Read more.


    340B in the News

    Guest Commentary: Leave 340B Drug Pricing Program Alone – October 15, 2017 – For 25 years, the 340B Drug Pricing Program has made a difference in the lives of millions of Americans. The relatively-unknown program, started in 1992, reduces the cost of drugs for many “safety-net” hospitals and providers who serve low-income, underinsured, or uninsured patients. Read more.

    Lawmakers Support 340B Drug Discount Program, But Want More Transparency – October 13, 2017 – While Rep. Morgan Griffith (R-Va.) and other lawmakers Oct. 11 said they generally support the federal 340B drug discount program, they said they want more accountability and transparency in the program. The 340B program helps hospitals and other eligible entities stretch their resources so they can provide more care for uninsured and underinsured patients, Griffith said at a hearing of the House Energy and Commerce Oversight and Investigations Subcommittee. Read more.

    Lawmakers Continue Drug Pricing Program Review – October 13, 2017 – Legislators are continuing their review of the 340B drug pricing program as a means of improving patient care, boosting services, and helping to reduce the cost of prescription drugs. The Subcommittee on Oversight and Investigations recently conducted a hearing on the 340B initiative in the wake of Health Resources and Services Administration (HRSA) officials previously testifying they did not have the authority to track how a participating entity might manage their savings in order to improve patient care. Data on program use is largely unavailable as a result. Read more.

    Is Trump Administration Working with Big Business to Keep Drug Prices High? – October 13, 2017 – As President Donald Trump wields his executive power to roll back portions of Obamacare, a new lawsuit seeks to force his administration to detail why it delayed penalizing drug makers for overcharging for certain prescriptions. The suit, filed Friday by the nonprofit watchdog group Democracy Forward and shared first with Newsweek, pushes the Office of Management and Budget for details about any role an ex-pharmaceutical lobbyist has played in blocking the anti-price gouging regulation. Read more.

    House Republicans Urge Greater Transparency for 340B Hospitals – October 12, 2017 – A program that helps lower the costs of prescription drugs for safety net hospitals and clinics has come under scrutiny from the House Energy and Commerce’s Oversight and Investigations Subcommittee. At a Wednesday hearing, subcommittee chairman Rep. Morgan Griffith (R-Va.) lauded some of the so-called 340B program’s achievements while also highlighting some concerns. Read more.

    Hospitals Defend 340B Drug Program Amid Scrutiny – October 11, 2017 – Lawmakers looking to root out misspent government funds have recently turned their attention to the drug program, citing a 2014 report from the Office of Inspector General that found some covered entities “do not offer the discounted 340B price to uninsured patients in their contract pharmacy arrangements.” Read more.

    Lawmakers Worry Providers Are Abusing The 340B Program – October 11, 2017 – Federal lawmakers said Wednesday that the 340B program that allows hospitals to purchase drugs at discounted rates does not have enough oversight, leaving it susceptible to misuse. Approximately 45 percent of all acute-care hospitals participate in the 340B program, which has grown significantly. The Medicare Payment Advisory Commission estimates that 2,140 hospitals participated in the program in 2014, up from 583 in 2005. Read more.

    GOP Lawmaker Calls for Transparency in Drug Discount Program – October 11, 2017 – Congress must ensure accountability and transparency in the federal 340B drug discount program, Rep. Morgan Griffith (R-Va.) said Oct. 11. While the 340B program helps hospitals and other eligible entities stretch their resources to help care for uninsured and underinsured patients, the dramatic growth of the program and the lack of information about how it is used have led to questions about whether it has grown beyond Congress’s original intent, Griffith said at a hearing of the House Energy and Commerce Oversight and Investigations Subcommittee. Read more.

    Reforming the 340B Program Will Lower the Price of Prescription Drugs – October 10, 2017 – The U.S. health care system needs systemic reforms that comprehensively address the problems of declining quality and rising costs. Alas, beneficial systemic reforms will not be implemented any time soon. There are still opportunities for Congress to implement tailored reforms that can help address these problems in the near term. One such opportunity is reforming the out-of-control 340B drug pricing program (the federal drug discount program created under the Veterans Health Care Act of 1992). Read more.

    Oversight and Reform of the 340B Program – October 10, 2017 – Tomorrow the House Energy and Commerce Committee will hold a hearing before the Oversight and Investigations Subcommittee entitled “Examining How Covered Entities Utilize the 340B Drug Pricing Program.” It is worth taking a close look. Read more.

    The 340B Program: Mandatory Reporting, Alternative Eligibility Criteria Should Be Top Priorities for Congress – October 10, 2017 – Policymakers have renewed their focus on how the 340B drug discount program functions among “safety net” hospitals, particularly Disproportionate Share Hospitals (DSH), which qualify for the 340B program because they provide a sufficient amount of inpatient care to Medicaid and low-income Medicare beneficiaries. Read more.