Life Science Compliance Update

May 24, 2017

Drug Prices Are Growing at Slowest Rate in Years


You’d think, from listening to politicians and news anchors, that the cost of prescription drugs is the highest it has ever been, and continuing to rise out of control. However, in reality, growth in drug prices this year was half of last year and the average out-of-pocket cost to consumers has decreased. This information comes from a new report from The QuintilesIMS Institute.

According to the report, growth in spending on prescription medications in the United States fell in 2016, as competition increased among manufacturers, and payers focused on efforts to limit price increases. According to the report,

Drug spending grew at a 4.8 percent pace in 2016 to $323 billion, less than half the rate of the previous two years, after adjusting for off-invoice discounts and rebates. The surge of innovative medicine introductions paused in 2016, with fewer than half as many new drugs launched than in 2014 and 2015. While the total use of medicines continued to climb—with total prescriptions dispensed reaching 6.1 billion, up 3.3 percent over 2015 levels—the spike in new patients being treated for hepatitis C ebbed, which contributed to the decline in spend. Net price increases—reflecting rebates and other price breaks from manufacturers—averaged 3.5 percent last year, up from 2.5 percent in 2015.

New medicines that have been introduced in the past two years are where most of the total spending growth comes from, representing at least half of total spending growth. These treatments treat common conditions, such as cancer, autoimmune diseases, HIV, multiple sclerosis, and diabetes. The prospects for continued innovation over the next five years are fueled by a robust late-phase pipeline of more than 2,300 novel products that include over 600 treatments for cancer alone.  

Out-of-pocket costs to patients are down $1.18 to prescription, to $8.47, since 2013. But on branded medicines, out-of-pocket costs have increased $111.61, or 48%, to $341.59. On average, medicines are cheaper. But in exceptional cases, patients are paying much more.

However, even with prices on a slower rise, it doesn’t feel that way to consumers, who are more frequently being asked to pay more on branded drugs, while their insurers and employers pocket discounts. New drugs for conditions like cancer and hepatitis C, known as specialty medicines, tend to be very expensive. And some companies have attempted to capitalize on high prices by jacking up prices dramatically, as occurred with Valeant Pharmaceuticals and Martin Shkreli, and have been publicly vilified for it.

Patients tend to not get the discounted rates negotiated by their insurers or by  pharmacy benefit managers, except in the form of lowered insurance premiums. If a patient is asked to pay a share of the drug price, it’s usually off the list price.

List prices on existing drugs increased 9.2% last year, compared to 12% in 2015, QuintilesIMS says. But net prices grew at just 3.5%. Essentially, where market forces are keeping prices down, consumers are being left out of the competition, forced to pay full price when their employers and insurance companies are pocketing a sale.

To recap, the highlights of this report included the following:

  • After accounting for discounts and rebates, spending on medicines grew just 4.8 percent in 2016. 
  • Prices for brand-name medicines increased just 3.5 percent after accounting for negotiated discounts and rebates.
  • Prices for brand-name medicines after accounting for negotiated discounts and rebates is projected to grow between 2 percent and 5 percent through 2021. This lower spending follows the loss of patent protection projected to total $103 billion through 2021, which excludes biologics that will face competition from biosimilars entering the market.
  • More than half (52 percent) of commercial patients’ out-of-pocket spending for brand medicines were filled in the deductible or with coinsurance, meaning patients paid the full list price for their medicines, even if their insurer receives a discount.

Improving Outcomes – Analyzing a Compliance Training Curriculum to Reduce Risk


Life sciences compliance departments are under constant pressure to roll out updated and comprehensive training that addresses a growing milieu of subject matter, from off-label promotion, HIPAA, and data security, to antibribery laws around the globe. The rush to cover all the topics across all the potential audiences can lead to a convoluted curriculum, with gaps or redundancies in terms of which audiences receive what training. Building a curriculum that appropriately addresses the company’s unique risks is an important first step, but a regularly-scheduled analysis of all content, and audiences and delivery methods, is critical to ensure on-going effectiveness against risk.

In response to regulatory changes, compliance departments continually push out training focused on changing rules, regulations, and policies. Redundancies, misalignments, and occasionally, even gaps, emerge. This threatens the effectiveness of the curriculum. Regular, comprehensive analysis, with subsequent reconfiguration and realignment, is necessary to ensure that targeted training is being deployed to the appropriate audiences, at a frequency that maximizes engagement.

An effective, three-phase process begins with a comprehensive documentation of existing training content and components.

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May 23, 2017

FDA Public Meeting on Training Health Care Providers on Pain Management and Safe Use of Opioid Analgesics


In 2012, FDA instituted a risk evaluation and mitigation strategy (REMS) for extended-release and long-acting (ER/LA) opioids that required companies marketing ER/LA opioids to provide a medication guide and make training available to prescribers.

Under the REMS, the training must be provided by accredited providers and cover all elements of the agency's Blueprint for Prescriber Education for Extended-Release and Long-Acting Opioid Analgesics. However, while the agency set goals for prescriber participation, prescribers were not required under the REMS to go through with the training.

On May 9th and 10th, 2017, the Food and Drug Administration held a public meeting, discussing how to train health care providers on pain management and the safe use of opioid analgesics. This meeting follows a May 2016 joint meeting of the Drug Safety and Risk Management Advisory Committee and the Anesthetic and Analgesic Drug Products Advisory Committee to discuss whether the risk evaluation and mitigation strategy (REMS) for ER and LA opioids would reach intended goals.

In addition to the joint Advisory Committee advice on prescriber education, a Request for Information (RFI) was posted by the Department of Health and Human Services (HHS) Assistant Secretary of Planning and Education on July 8, 2016, seeking comments on the most promising approaches in prescriber education/training programs and effective ways to leverage HHS programs to implement/expand them.

The FDA Education Blueprint for Health Care Providers Involved in the Management or Support of Patients with Pain (May 2017) lists draft revisions to the FDA Blueprint for Prescriber Education for Extended-Release and Long-Acting Opioids. The proposed Blueprint broadens the current Blueprint to include information on pain management, including the principles of acute and chronic pain management; non-pharmacologic treatments for pain; and pharmacologic treatments for pain (both non-opioid analgesic and opioid analgesic). The draft also provided context for discussions at the public meeting.

Electronic or written comments to the Blueprint may be submitted by July 10, 2017.

The 2017 public workshop on May 9 and 10 attempted to build on one of the requests outlined in that RFI: the request for suggestions of additional activities HHS and its federal partners can implement to support universal prescriber education on appropriate pain management and opioid analgesic prescribing.

The workshop had three main goals. First, participants discussed the role that health care provider training plays – within the broader context of ongoing activities – to improve pain management and the safe use of opioids. Second, participants commented the best way to provide health care providers who prescribe or are directly involved in the management or support of patients with pain appropriate training in pain management and the safe use of opioids. Finally, participants discussed various issues and challenges that are associated with possible changes to federal efforts to educate health care providers on pain management and the safe use of opioids.

Opening Session

During the opening session, Dr. Janet Woodcock, Director of the FDA’s Center for Drug Evaluation and Research (CDER), discussed the extent of opioid prescribing and considerations in addressing prescriber training. She said that there are 200 million prescriptions for opioids dispensed annually, contributing to a “surge in opioid-related substance abuse disorders.”

Dr. Woodcock said that historically, “the liabilities of prescribing opioids were minimized” for an “entire generation of prescribers.” She cited alternative modalities, such as physical therapy and cognitive and behavioral therapy, and said the selection of a pain treatment modality should be a “sophisticated decision that weighs costs and benefits.” She noted that although opioids will remain a “mainstay in many situations,” including acute trauma, there should be a “renewed understanding that any opioid prescription confers risk.”

Dr. Doug Throckmorton, CDER’s Deputy Director for Regulatory Programs, said the meeting would focus on improving prescriber education while continuing access to appropriate treatment. He said healthcare worker education is a part of the FDA’s Opioid Action Plan. He pointed to a variety of inter-agency efforts, such as the Department of Health and Human Services’ multi-pronged opioid plan, the Surgeon General’s efforts, National Institutes of Health Centers of Excellence in Pain Education, and Centers for Disease Control and Prevention (CDC) opioid prescribing guidelines.

Veterans Affairs Experience

Dr. Bernie Good, Chair of the Medical Advisory Panel for Pharmacy Benefits Management at the VA, provided an overview of the VA’s efforts to ensure appropriate prescribing of opioids and combat opioid abuse. He said that in 2000, the VA mandated pain as fifth vital sign, encouraging veterans’ feedback on their pain severity. Approximately 30,000 VA prescribers had written at least one opioid prescription and the thought was that if veterans have to provide regular feedback on their pain severity, perhaps less prescriptions would be written.

In 2014, the VA started an academic detailing programs on opioid medications involving one-on-one meetings between a clinical pharmacist and prescriber. The VA has 285 academic detailers, and 10,436 clinical staff have been detailed. Dr. Good said that there has been a 58 percent reduction in high-dose opioid prescribing among those receiving detailing compared with 34% reduction among those without detailing.

Dr. Good noted that VA providers have mandatory training on opioids and that as part of the VA’s Opioid Safety Initiative, the VA distributes individualized prescriber and regional reports and identifies high-risk patients.

Risk Evaluation and Mitigation Strategies (REMS) Options and Considerations

Doris Auth, Acting Director of the FDA’s Office of Medication Error Prevention and Risk Management, discussed options and considerations for using FDA REMS authority under Federal Food, Drug, and Cosmetics Act (FFD&CA) to assure prescriber training on opioid medications. She noted that REMS can have elements to assure safe use and can be restrictive or non-restrictive.

She provided examples of how prescriber education could be required under REMS. For instance, the acne drug isotretinoin has a REMS known as the iPLEDGE program to prevent fetal exposure and reduce the risk of birth defects. It requires informing providers and patients about the risk of fetal exposure, initial documentation of a negative pregnancy test, pharmacy authorization from the REMS program, a medication guide with each prescription, a voice or web-based authentication prior to dispensing, patient enrollment and informed consent, an ongoing monthly negative pregnancy test for female patients, and other dimensions.

Ms. Auth reviewed a potential structure for an opioid REMS involving training. She said there could be:

  • No patient enrollment or patient-specific requirements; and
  • Required prescriber training prior to dispensing.

She believes that such a program would be quite a bit larger than any existing REMS and at least double the size of the current extended-release/long-acting opioid REMS. If pursued, it would involve ninety manufacturers, some of which would have multiple products.

Andrew Rosenberg, JD with the CME Coalition, Thomas Sullivan of Rockpointe and others gave comments at the meeting to reinforce that education is a valuable tool in fighting the opioid epidemic.  To encourage clinician's to participate in the Opioid REMS the CME Coalition recommended that FDA work with CMS to include Opioid REMS CME as an improvement activity in the Quality Payment Program.

Overall the value of continuing education in the REMS program is perhaps the most valuable tool that the government and others can engage to help reduce opioid deaths.


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