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FDA Approval of Sarepta’s Drug Shows Disregard to Legal Standards

Despite many disagreements within the agency, the FDA recently approved the first drug for Duchenne muscular dystrophy. This decision was largely based on a single study of Sarepta Therapeutics Inc.’s drug, Eteplirsen, featuring 12 patients with this crippling disease. This small study as well as the strong, emotional responses from parents of children with muscular dystrophy, swayed the opinions of those on the FDA advisory panel.

Although, with still a great lack of data and information, many FDA experts argued that Eteplirsen was not fit for approval. Against their judgment, a powerful figure in the FDA, Dr. Woodcock, decided to push the accelerated approval causing a greater uproar.

In an article, “FDA Approves Sarepta’s Muscular Dystrophy Drug”, Thomas M. Burton quotes the director of Public Citizen Health Research Group, Michael A Carome:

“The decision by Dr. Woodcock to approve eteplirsen, against the strong objections of FDA experts who reviewed the drug and the advice of its advisory committee, represents a disturbing disregard for the agency’s legal standards for approving new drugs. In particular, such action eviscerates the FDA’s longstanding requirement that there be substantial evidence of effectiveness for new drugs—even drugs for serious rare diseases—before they are marketed.”

This accelerated approval of Eteplirsen showcases the broken drug pipeline. The FDA advisory panel’s job is to look at the bigger picture of the drug’s effectiveness, as well as the unintended consequences, to determine if a drug is fit for approval. In this case, many members on the board were easily swayed by emotion and the power of a controversial figure going outside of the given requirements.

Read the full article, FDA Approves Sarepta’s Muscular Dystrophy Drug, from the Wall Street Journal for more information about this unique situation.

Companies Should Worry About Abuse in the Health Care System

The health care industry is complex and difficult to understand with many intricacies that most consumers and employers are not educated on. A complete lack of transparency has led to many areas of hidden fraud, waste, and abuse. Combined, these three areas lead to an estimated 1% of prescription drug costs. Although it does not sound like much, this amounts to hundreds of millions of dollars for health care payers like yourself.

Many larger companies and nonprofits hire a Pharmacy Benefits Manager (PBM) to negotiate discounts with pharmacies and drug makers for their employee’s prescriptions. These PBMs determine where patients fill their prescriptions, what drugs are available, and how much pharmacists are reimbursed for dispensing them.

However, many traditional PBMs lack transparency leaving pharmacists and companies frustrated with hidden abusive practices. These practices allow for PBMs to make huge profits from filled prescriptions by not actually lowering the cost, but instead controlling the cost so it appears to remain steady over time. This abuse of power, not only harms pharmacies, but also many companies as it impacts their bottom line and puts pressure on the benefits managers who work hand-in-hand with the PBM.

Although this is just one area of abuse within the system, there are many others that affect today’s consumers. It is nearly impossible for you to discover what care and coverage is best for your company and your employees without seeing all the options available.

Give us a call today at 888-633-5850 to talk with a BCR specialist on how we can help to navigate this maze of madness.

Mylan’s Top Executives Receive a Generous Payday

Mylan remains under fire after significantly raising prices for the allergy reversing drug, EpiPen. As more questions are thrown their way, people are beginning to focus on the large payday top executives are receiving. As one of the smaller companies in the drug industry, with EpiPen being the only big-selling brand product they supply, Mylan holds some of the top paid executives, even compared to larger companies with little to no explanation.

In the article, “EpiPen Maker Dispenses Outsize Pay”, Mark Maremont writes:

“Mylan’s combined total of $292.1 million in pay for its top five executives over the five years ended last December outpaced that at industry rivals several times its size, according to the analysis, including Johnson & Johnson, Pfizer Inc., Bristol-Myers SquibbCo. and Eli Lilly & Co.

Of the 22 companies Mylan named in its 2016 proxy as its preferred peer group for pay purposes—some of them much larger than itself—none paid their top managers more than Mylan over the same five years, the analysis showed.”

There is speculation that the EpiPen price increase was in fact, due to the incentives agreed upon by the company’s board, which included a rewards plan for executives when they hit high growth targets.

This raises the question if there is an ethical responsibility for companies to provide reasonable priced, life saving drugs, as consumers shouldn’t pay a large amount simply to improve the salary of top executives.

Read the full article, EpiPen Maker Dispenses Outsize Pay, from the Wall Street Journal for more information.

Consumers Begin to Question the Increase in Drug Prices

This past week, several news stories shared different viewpoints on the trending topic of inflated drug prices. One medication drug in particular being the well known, allergy reversing EpiPen. Mylan, the maker of the EpiPen, is under great pressure as prices raised from $94 to $608 in less than 10 years time.

Consumers are beginning to challenge the drug and health care industry questioning, “Why are these prices so high?”

In an article written by Frederick Daso, he inquires about the justification of the dramatic increase proposing two questions:

“One, do pharmaceutical companies have an inherent social responsibility to produce affordable medicinal products and services? Two, should the federal government step in to prevent price gouging of medical products within the pharmaceutical industry to protect consumers and ensure access to life-enhancing care?”

These questions spark an interesting conversation that needs to be discussed by today’s consumers. Why are these prices so high and is there anything that could bring them back to an even playing field? Others may believe in a Laissez-faire approach, waiting for the market to naturally run its course without interference.

Read the full article by Daso, America’s Allergic Reaction to Mylan CEO Heather Bresch’s Insatiable Greed, for a unique perspective on this controversial topic.

Insurers Offer Limited Health Care Options to Fight Rising Costs

Insurers are looking to cut costs as they try to adapt under the pressure of the Affordable Care Act. Many are moving toward health care plans that narrow the choices in hospitals and doctors in order to fight rising health care costs. Instead of offering Preferred Provider Organizations (PPO) that offer a larger selection in health care options and out-of-network coverage, insurers are offering Exclusive Provider Organizations (EPO) that significantly limit the selection available.

In a recent article discussing this situation, Anna Wilde Mathews writes:

“Since the ACA’s first year, insurers have offered narrow-network plans on the exchanges to keep premiums down, but the trend appears set to jump. The HMO-style plans represented 64% of the exchange offerings in the McKinsey sampling of states in 2016, and 55% in 2015.”

Although this trend may seem like a good idea to help businesses fight costs, it takes away the employees’ right to choose the care and coverage of their liking. If you want to discover all the health care possibilities available for your company to help mitigate the costs while still providing employees with all the options for doctors and facilities, give BCR a call today.

Read the full article, Insurers Move to Limit Options in Health-Care Exchange Plans, from the Wall Street Journal for more information.