Welcome to May’s second 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
May 27, 2015 — Actavis plc announced Viberzi™ (eluxadoline) was approved by the Food and Drug Administration as a twice-daily, oral treatment for adults suffering from irritable bowel syndrome with diarrhea (IBS-D). Viberzi™ (eluxadoline) has mixed opioid receptor activity; it is a mu receptor agonist, a delta receptor antagonist and a kappa receptor agonist. Read more.
New Drug Formulation
Humalog® KwikPen® (insulin lispro 200 units/mL)
May 27, 2015 — The U.S. Food and Drug Administration has approved Humalog® 200 units/mL KwikPen® (insulin lispro 200 units/mL; U-200), a pre-filled pen containing a concentrated formulation of Lilly’s rapid-acting insulin Humalog® (insulin lispro 100 units/mL) to improve glycemic control in people with type 1 and type 2 diabetes, Eli Lilly and Company announced. Humalog U-200 KwikPen marks the first FDA approval of a concentrated mealtime insulin analog. Read more.
StioltoTM Respimat® (olodaterol and tiotropium)
May 26, 2015 — Boehringer Ingelheim announced the U.S. Food and Drug Administration approved once-daily StioltoTM Respimat® (tiotropium bromide and olodaterol) Inhalation Spray. It has been approved as a long-term, once-daily maintenance treatment of airflow obstruction in patients with chronic obstructive pulmonary disease (COPD), including chronic bronchitis and/or emphysema. StioltoTM Respimat® is not indicated to treat asthma or acute deterioration of COPD. Read more.
Invega Trinza™ (paliperidone palmitate) Extended-Release Injectable
May 19, 2015 — Janssen Pharmaceuticals, Inc. announced the U.S. Food and Drug Administration approved, under priority review, the New Drug Application (NDA) for the long-acting atypical antipsychotic Invega Trinza™. Invega Trinza™, a three-month injection, is an atypical antipsychotic indicated to treat schizophrenia. Before starting Invega Trinza™, patients must be adequately treated with Invega Sustenna® (one-month paliperidone palmitate) for at least four months. Priority review is a designation for drugs that, if approved, would offer significant improvement in the treatment of serious conditions. Read more.
New Indication Approval
May 27, 2015 — Valeant Pharmaceuticals International, Inc. announced its wholly owned subsidiary, Salix Pharmaceuticals, Inc., has received approval from the U.S. Food and Drug Administration for Xifaxan® 550 mg for the treatment of IBS-D in adults. The FDA approval of Xifaxan® 550 mg is based on data from three phase 3 studies, TARGET 1, TARGET 2 and TARGET 3. Xifaxan® 550 mg was studied in more than 3,000 patients, and demonstrated the efficacy and safety of repeat treatment following completion of a two-week course of treatment. A full course of Xifaxan® 550 mg for IBS-D is available in a convenient two week pack of 42 pills. Read more.
New Generic Approval
Risedronate Sodium Delayed-Release (Atelvia®)
May 19, 2015 — Teva announced the launch of Risedronate Sodium Delayed-Release Tablets, the generic version of Warner Chilcott’s Atelvia®. Atelvia® is a bisphosphonate indicated for the treatment of postmenopausal osteoporosis. Read more.
New Drug Shortage
May 22, 2015
Imipenem and Cilastatin for Injection, USP (Currently in Shortage)
May 14, 2015
Chloroquine Phosphate Tablets (Currently in Shortage)
Drug Recall Alert
Magnesium Sulfate Injection
May 19, 2015 – May 19, 2015, Hospira announceda user-level recall of one lot of magnesium sulfate injection, due to a confirmed out of specification (OOS) pH result. The likelihood of harm is expected to be low, if no change in product potency occurs. Read more.
Drug Safety Alert
Zerbaxa™ (ceftolozane and tazobactam)
May 20, 2015 — The U.S. Food and Drug Administration is warning health care professionals about the risk for dosing errors with the antibacterial drug Zerbaxa™ (ceftolozane and tazobactam), due to confusion about the drug strength displayed on the vial and carton labeling. Zerbaxa’s™ vial label was initially approved with a strength that reflects each individual active ingredient (e.g. 1 g/0.5 g); however, the product is dosed based on the sum of these ingredients (e.g. 1.5 g). To prevent future medication errors, the strength on the drug labeling has been revised to reflect the sum of the two active ingredients. Thus, one vial of Zerbaxa™ will now list the strength as 1.5 grams equivalent to ceftolozane 1 gram and tazobactam 0.5 gram. Read more.
SGLT2 Inhibitors Ketoacidosis Risk
May 15, 2015 — The U.S. Food and Drug Administration (FDA) is warning the type 2 diabetes medicines canagliflozin, dapagliflozin and empagliflozin may lead to ketoacidosis, a serious condition where the body produces high levels of blood acids called ketones that may require hospitalization. The FDA is continuing to investigate this safety issue and will determine whether changes are needed in the prescribing information for this class of drugs, called sodium-glucose cotransporter-2 (SGLT2) inhibitors. Read more.
Clinical and Pharmacy News
Generic Drug Prices Dropping More Slowly According to AARP Report
May 28, 2015 — The new Rx Price Watch Report released today by AARP Public Policy Institute (PPI) shows a number of popular generic drugs had substantial price increases, with some prices going up as much as 1,000%. Overall, retail prices for generic prescription drugs widely used by older Americans fell an average of 4% in 2013. Read more.
Will Scrutiny Press Insurers Into Covering High-Cost Drugs?
May 27, 2015 — The subject of high-cost drug accessibility is in the spotlight following two recent lawsuits brought against Anthem for allegedly withholding hepatitis C treatments. On top of that, California’s insurance exchange has added fuel to the fire by becoming the first to implement caps for monthly prescription costs, and the state legislature is considering a bill to do the same for employer-based plans. Read more.
Lawmakers Seek to Curb Skyrocketing Generic Drug Prices
May 27, 2015 — Two prominent lawmakers are following through on a promise to do something about recent rises in generic drug prices, with identical House and Senate bills that would force generic drug makers to pay state Medicaid rebates when prices rise faster than inflation. The Medicaid Generic Drug Price Fairness Act of 2015, introduced Monday by Sen. Bernie Sanders (I-Vt.) and Rep. Elijah Cummings (D-Md.), follows concerns over generic drug price hikes outlined in February letters to HHS Inspector General Daniel Levinson. Read more.
If You Think You Are Being Screwed by the Drug Companies, You Are Correct
May 27, 2015 — The greed of pharmaceutical companies is coming under increasing scrutiny in the news, if not by the FDA, FTC, DOJ and Medicare. Brian Overstreet of MedPage Today released an article on May 26, 2015 titled “Shadow Pricing, Highway Robbery, and the Price of Drugs.” The article looks at three different areas of drug pricing and the strategies of the drug companies in getting higher prices for drugs, while reducing competition. The common claim of pharmaceutical companies is that drugs are expensive because it takes so long to develop and test the safety of new drugs. Read more.
H.I.V. Treatment Should Start at Diagnosis, U.S. Health Officials Say
May 27, 2015 — People with H.I.V. should be put on antiretroviral drugs as soon as they learn they are infected, federal health officials said Wednesday, in an announcement about halting the largest ever clinical trial of early treatment because its benefits were already so clear. The study was stopped more than a year early because preliminary data already showed that those who got treatment immediately were 53 percent less likely to die during the trial or develop AIDS or a serious illness, than those who waited. Read more.
New Push Ties Cost of Drugs to How Well They Work
May 27, 2015 — Express Scripts Holding Co., a large manager of prescription-drug benefits for U.S. employers and insurers, is seeking deals with pharmaceutical companies that would set pricing for some cancer drugs based on how well they work. The effort is part of a growing push for so-called pay-for-performance deals, amid complaints about the rising price of medications, some of which cost more than $100,000 per patient a year. Read more.
Consumers Sue Anthem for Denying Coverage for a Gilead Hepatitis C Drug
May 26, 2015 — The controversy over the new crop of hepatitis C treatments has taken yet another turn as consumers are starting to file lawsuits against insurers that deny them access to the medicines. Over the past two weeks, two different women alleged that Anthem Blue Cross refused to pay for the Harvoni treatment sold by Gilead Sciences GILD +2.39%, because it was not deemed “medically necessary.” Read more.
FDA Policies Are Needlessly Driving Up Costs of Generic Drugs
May 25, 2015 — Consumers increasingly report sticker shock as generic drugs sold for decades have suddenly become scarce and expensive. Sometimes generic drug prices skyrocket due to aging equipment. Old drugs are often made on aging production lines, which are sometimes shut down for maintenance or stopped after the manufacturer is warned by the U.S. Food and Drug Administration (FDA) that the facility is out of compliance with current good manufacturing practices. Read more.
Specialty Drug Costs: Hard Pills to Swallow
May 24, 2014 — When Stella Armstrong’s doctor told her that she needed to begin treatment for hepatitis C in October 2013 she refused interferon therapy, the only treatment available to her at that time. To Armstrong, the side effects of the anti-viral drug sounded just as bad as the disease— fever, fatigue, depression, hair loss—and the cure rate was low. So when her doctor told her that new and better medicines were on the horizon, she decided to wait. Read more.
Cancer Doctors Sound Alarm Over Crushing Costs of New Drugs
May 22, 2105 — The year’s biggest cancer research conference kicks off May 29 in Chicago, and physicians will learn about the latest advances in treatment. The gathering of the American Society of Clinical Oncology also will address another big issue in cancer care: affordability. “One of things we are seeing is clear price inflation for new cancer drugs that are the backbone of treatment for many patients with selected cancers,” said Rena Conti, a health economist at the University of Chicago. Read more.
CVS’s Deal for Omnicare May Signal a Slowdown in Pharmacy Mergers
May 21, 2015 — CVS Health’s $12.7 billion deal for Omnicare portends lower merger activity in the pharmacy sector. The drugstore company’s purchase gives it entrance to nursing homes and expands specialty medicine distribution. But the increasingly concentrated industry is bumping up against antitrust concerns and may have to live with fewer transactions. Read more.
The Changing Role of Pharmacy
May 20, 2015 — As health systems seek new sources of revenue and means for improving performance under value-based payment, some are turning to an unlikely source: their own pharmacies. Typically seen by chief financial officers (CFOs) as a cost center on the balance sheet—and unseen by almost everyone else—pharmacy is now regarded as a hidden asset by many forward-looking organizations. Read more.
New Bill Aims to Cut Federal Workers’ Prescription Drug Costs
May 19, 2015 — Congressman Stephen F. Lynch (D-MA) has introduced the FEHBP Prescription Drug Oversight and Cost Savings Act (H.R. 2175), legislation aimed at improving federal oversight of the prescription drug benefits available to federal workers, retirees and their families through the Federal Employees Health Benefits Program (FEHBP). The bill would also better ensure that program enrollees and the American taxpayer are receiving the best prescription drug benefit for their dollar. Read more.
Keeping a Closer Eye on Post-Discharge Planning
May 19, 2015 — Regulatory and financial pressures are forcing hospitals to ramp up their post-discharge strategy initiatives. Some of the pressure is coming from the Affordable Care Act (ACA); Section 2717 requires that hospitals report the results of their efforts to prevent hospital readmissions. Whether it’s patient education and counseling, comprehensive discharge planning or post-discharge reinforcement by an appropriate health care professional, federal officials want to know what hospitals are doing to keep patients out of the hospital—and how many health care dollars are being saved in the process, experts noted. Read more.
Retail Healthcare: Growing Trend for Healthcare Service Delivery
May 18, 2015 — Although more Americans than ever have private insurance or Medicaid coverage due to the Patient Protection & Affordable Care Act (PPACA), access to care continues to worsen as the number of primary care physicians has not kept pace with the clinical demands of an aging population and newly covered patients. The need for additional care settings, along with recent increases in patient out-of-pocket costs, has prompted the growth of non-traditional health care delivery settings, such as retail clinics and urgent care centers. Read more.
Drug Costs Top $50K a Year for Half Million Americans
May 13, 2015 — With the drug industry launching more expensive targeted therapies, the number of Americans with annual medication costs of more than $50,000 has jumped more than 60 percent to nearly 600,000, a new analysis shows. The latest drug spending trend report from pharmacy benefit manager Express Scripts shows 576,000 Americans with annual medication costs of $50,000 or more. That’s a 63 percent increase in 2014 from 2013, when 352,000 Americans had such high costs. Read more.
Is Your Pharmacy Ready for Drug Supply Chain Integrity?
May 13, 2015 — Beginning July 1, 2015, most pharmacies in the U.S. will be required to have systems in place to receive transaction information regarding the prescription drugs they purchase from suppliers. The requirement stems from a 2013 federal law called the Drug Supply Chain Security Act (DSCSA), enacted as one component of the Drug Quality and Security Act. In addition to accepting the so-called “3T” information (Transaction History, Transaction Statement, and Transaction Information) for each prescription drug it purchases on or after July 1, covered pharmacies also must have systems in place to segregate and investigate suspect products. Read more.
340B in the News
Congress Waking Up to 340B Corporate Slush Fund
May 26, 2015 — By the time it got to the president’s desk, the final page tally of the Affordable Care Act came in at 2,700 pages. As Rep. Nancy Pelosi (D-Calif.) so famously said, we had to “pass it to know what’s in it,” so it’s little wonder that unpleasant surprises have awaited us around every corner. For proof, consider the rapid expansion of the federal 340B drug program—the latest in a long string of provisions buried in those thousands of pages that are finally seeing the light of day. Read more.
House Subcommittee Circulates Proposed Legislation Providing Insight on the Future of the 340B Drug Pricing Program
May 26, 2015 — The 340B Federal Drug Pricing Program (the 340B Program) requires pharmaceutical manufacturers to offer drugs at discounted prices to eligible hospitals, clinics and other entities for use in the outpatient setting. The 340B Program was created by the Veterans Health Care Act of 1992 (codified at Section 340B of the Public Health Services Act) and is administered by the Department of Health and Human Services (HHS), Health Resources and Services Administration (HRSA), Office of Pharmacy Affairs (OPA). Read more.
Hospitals Ask Congress to Protect 340B Pricing Program
May 22, 2015 — More than 500 CEOs of hospitals and health systems urged Congress to protect the 340B Drug Pricing Program, which helps fund free and low-cost medication access and clinics for the underserved. And they were successful. The House Energy & Commerce Committee, which had been weighing whether to add language about 340B to the 21st Century Cures bill, decided not to and the nonpartisan 21st Century Cures Act was unanimously approved on May 21 without a mention of the 340B program. Read more.
340B Drug Pricing Debate Pits Hospitals against Doctors against Big Pharma
May 21, 2015 — As the Obama Administration mulls changes to the federal 340B drug discount program, hospital systems are looking to preserve the current model, while independent doctors and drug companies lobby for reforms. This June, the Health Resources and Services Administration will issue guidance on the 23-year-old, $7.2 billion 340B Drug Discount Program for hospitals and outpatient centers. Read more.
Hospitals Urge Congress to Protect 340B Program
May 20, 2015 — The 340B Drug Pricing Program is “a lifesaver for low-income patients” and critical to maintaining the nation’s health care safety net, hospital leaders stressed today, and, in a letter to Congress, called any legislation that might change the program “premature.” “For more than 20 years, the 340B drug discount program has played a critical role in enabling public and nonprofit hospitals that care for a high number of low-income Medicare and Medicaid patients to service our communities,” stated the letter signed by leaders of 524 hospitals and health systems across the country. Read more.