MRx Trend Alert

Our MRx Trend Alert keeps you up-to-date on the latest pharmacy and medical benefits trends and payer impacts. In addition, we feature a Medical Pharmacy Corner where we dive into the unique dynamics impacting the medical benefit drug ecosystem. Topics in this quarterly publication span from clinical to regulatory to legislative affairs with possible significance for clients, as well as impending pipeline agents and their potential market impact.

February 2018
Volume 5, Issue 1

Did You Know? States Take on Rising Drug Prices
Rising drug costs have received a great deal of attention recently. For anticancer drugs in particular, recent data has demonstrated that both the initial launch price point and the subsequent rate of price increases after launch have accelerated over the last decade. [more...]

FDA Approvals: A Year in Review
In January, the Food and Drug Administration’s (FDA) Center for Drug Evaluation and Research (CDER) published Advancing Health through Innovation: 2017 New Drug Therapy Approvals. [more...]

Keep on Your Radar: The 4th Industrial Revolution – Digital Therapeutics
The 4th Industrial Revolution has arrived and is fundamentally transforming how we live, work, and connect. Fueled with a digital engine, robotics, artificial intelligence, voice-enabled devices, wearables, and autonomous cars are accelerating at an unprecedented rate and disrupting almost every industry. The medical field is no exception. [more...]

Medical Pharmacy Corner: Biosimilars – A Slow Start Out of the Gate?
Biologic drugs are large, complex molecules manufactured in living organisms and are an important treatment modality for a wide range of diseases. Biologic drugs are more complicated and difficult to manufacture than traditional, small molecule drugs, and constitute some of the most costly drugs on the market. [more...]

Pipeline Report: 1st and 2nd Quarter 2018

November 2017
Volume 4, Issue 4

Amazon Prime Pharmacy
Over the past few years, Amazon, Netflix, and Hulu have disrupted the television world with ondemand programming, much to the astonishment of network television. Prime programming is only a small part of Amazon’s offerings. [more...]

Keep on Your Radar: Mother Nature and Drug Shortages
Harvey, Irma, Jose, and Maria. Sound familiar? Unfortunately, 2017 has been 1 of the busiest tropical storm seasons on record, dealing catastrophic devastation to human life, homes, infrastructure, and survival basics. In September, Hurricane Maria, a Category 4 storm, blew in with 150 mph winds causing a major humanitarian crisis in the U.S. Territory of Puerto Rico (PR). [more...]

Did You Know? FDA Initiatives - Orphan Drugs, Abuse-Deterrent Opioids, and Generic Competition
In May 2017, Scott Gottlieb, M.D., was announced as the new Commissioner of the FDA. Under new leadership, the FDA has unveiled several new initiatives. One of their initiatives is a plan aimed to reduce the backlog of Orphan drug designation requests, known as the Orphan Drug Modernization Plan. [more...]

Medical Pharmacy Corner
Chimeric Antigen Receptor-T Cells (CAR-T): A Unique Revenue Cycle for a Unique Therapy
There are now 2 FDA-approved CAR-T therapies, tisagenlecleucel (Kymriah™) and axicabtagene ciloleucel (Yescarta™). As described in a prior edition of the MRx Trend Alert, these products are live cell therapies, different from traditional drugs and biologics. [more...]

Pipeline Report: 4th Quarter 2017/1st Quarter 2018

August 2017
Volume 4, Issue 3

The Path to Prescision Medicine: A New Milestone
In the world of chemotherapy, individual drugs are frequently utilized in more than 1 type of cancer. For example, the drug cisplatin was originally approved by the Food and Drug Administration (FDA) in 1978 for use in testicular and ovarian cancers. [more...]

Did You Know? SCOTUS Biosimilar Crescendo
The Supreme Court of the United States (SCOTUS) recently quickened the tempo by issuing a ruling on 2 specific provisions impacting biosimilars. [more...]

Keep on Your Radar: The False Claims Act versus the First Amendment
For more than 50 years, the FDA has strictly regulated prescription drug advertising in order to protect the public health. In the last decade, the FDA has successfully brought suit under the False Claims Act against several pharmaceutical companies for off-label promotion of their drug products. [more...]

Medical Pharmacy Corner - A New Clinical Frontier: CAR-T Therapies
The era of immuno-oncology (IO) began nearly 3 decades ago with the approval of interferon alfa-2b and interleukin-2 (aldesleukin) to treat cancer. [more...]

Pipeline Report: 3rd/4th Quarter 2017

May 2017
Volume 4, Issue 2

The 21st Century Cures Act: Research Focus and Information – Part 2
Previously, this publication reviewed the “Development” subsection of the 21st Century Cures Act of 2016 (“Cures Act”). While not reviewed here, the legislation also included another division regarding mental health care and components of Medicare, much of which was met with overwhelming support. [more...]

Genetic Tests: A Voyage of Human Discovery
The genetic voyage begins in the 19th century with the father of genetics, Gregor Mendel. It transitions to the 20th century with the discovery of the deoxyribonucleic acid (DNA) double helix and arrives in the 21st century at the ambitious Human Genome Project (HGP), which mapped the human genetic blueprint. [more...]

Keep on Your Radar: Clearing out America’s Medicine Cabinets
Ensuring safe disposal of unused prescription medications has been an ongoing challenge. The problem of leftover, undisposed opioid prescription medications is an especially troubling problem. [more...]

Did You Know? FDA Advisory Committees
The FDA relies on advisory committees to provide independent advice from external experts. It has over 15 separate drug advisory committees grouped primarily by disease area or product type and also has advisory committees for blood, vaccines, biologics, medical devices, and other non-drug products. [more...]

Pipeline Report: 2nd/3rd Quarter 2017


February 2017
Volume 4, Issue 1

The 21st Century Cures Act: Drug Development – Part 1
On December 13, 2016, the 21st Century Cures Act was signed into law. Largely bipartisan, it was met with broad support and one congressman likened it to a holiday gift for the American people. [more...]

FDA Approvals: A Year in Review
Every year the FDA’s Center for Drug Evaluation and Research (CDER) publishes a synopsis of the previous year’s drug approvals. This report, titled “Novel Drugs Summary,” provides a benchmark for approvals and highlights the game-changers approved in the past year. [more...]

Keep on Your Radar: Biosimilars – A Rose by any Other Name
The highly-anticipated biosimilar naming guidance, titled “Nonproprietary Naming of Biologic Products,” was recently published by the FDA. The agency specifies that these products should bear the same nonproprietary name as the originator drug followed by a distinguishable 4-letter suffix attached by a hyphen. [more...]

Did You Know? Liquid Biopsies: A Promising Step Toward Less Invasive Tumor Biopsies
A fundamental principle regarding cancer treatment is the need to establish a tissue diagnosis prior to initiating therapy. Obtaining the tissue necessary for diagnostic evaluation has historically involved a tumor biopsy, which is often invasive and may require surgery. [more...]

Pipeline Report: 1st/2nd Quarter 2017


November 2016
Volume 3, Issue 4

Keep on Your Radar: Medical Device Cybersecurity – The New Reality
Ransomware, malware, distributed denial of service attacks, Mirai – bad actors in a scary sci-fi thriller targeting your personal computer (PC), tablet, or gaming device? Cyber attacks look for vulnerabilities in any system, not just your PC. [more...]

Did You Know: Precision Medicine – Just How Precise?
The “5 Rights” of medication administration is an axiom historically taught to nursing students. The right patient, right drug, right time, right dose, and right route, have long have been promoted as a technique to reduce medication administration errors. Advances in molecular genomics takes this old axiom to a new level. [more...]

Abuse-Deterrent Opioids – One Year Later
In a previous issue, we discussed the role of abuse-deterrent opioids. One year later, ongoing initiatives have been developed and implemented to confront opioid abuse, including the introduction of additional new abuse-deterrent opioid formulations. [more...]

Telehealth: The Wave of the Future? – Part 2, Telepharmacy
In our last edition, we looked at the current role of telemedicine in the delivery of healthcare. Telepharmacy, a component of telehealth, is built on a similar principle. The National Association of Boards of Pharmacy has developed a definition for the practice of telepharmacy; practically speaking, it is the provision of pharmacy services via telecommunication. Telepharmacy, though not new, has expanded as technology has grown. [more...]

Pipeline Report: 4th Quarter 2016 / 1st Quarter 2017

August 2016
Volume 3, Issue 3

Enhanced Steps to Combat the Opioid Epidemic
While the opioid epidemic has received attention for the past handful of years, significant steps have occurred in 2016 to combat this public health concern. In March 2016, the Centers for Disease Control and Prevention (CDC) published guidelines on the use of opioids for the treatment of noncancer chronic pain. [more...]

Telemedicine: The Wave of the Future? Part 1
Telemedicine or telehealth, terms often used interchangeably, involves the use of technology to deliver healthcare to a remote location. Think of it as a virtual house call. With the advanced technology of today including e-mail, mobile applications, and text messaging, there are many opportunities for telemedicine. [more...]

The Hope for Personalized Medicine in Behavioral Health
Pharmacogenomics aims to improve efficacy and safety of medications by tailoring them to an individual patient’s genetics. While its role has been touted as the future of drug therapy for some time, the clinical application of pharmacogenomics to personalize drug therapy is still limited. [more...]

Keep on Your Radar: The High Cost of Convenience — Pharmaceutical Kits
Many people are willing to pay more for convenience; grocery stores who sell pre-diced vegetables figured that out long ago. Recently, pharmaceutical manufacturers seem to be capitalizing on this trend of “convenience.” [more...]

Pipeline Report: 3rd/4th Quarter 2016


June 2016
Volume 3, Issue 2

Keep On Your Radar: Medicare Part B Drug Pricing – The Next Frontier?
The most recent battleground over drug pricing is taking place in doctors’ offices and outpatient clinics rather than retail pharmacies. [more...]

The Cost of Waste: Impact of Vial Size on Cancer Drug Spending
A recent study found that Medicare and private health insurers lose nearly $3 billion annually related to disposed waste resulting from excessive vial size of the top 20 selling cancer drugs. [more...]

What is Calcarea Phosphorica 6X HPUS and Why Didn’t I Learn Latin?
Labels of ingredients for homeopathic products, listed in Latin, can be daunting; however, there are similarities between these and allopathic (traditional) medicines. For example, Calcarea phosphorica is simply calcium phosphate. [more...]

Did You Know? Over-the-Counter (OTC) Medications: Past, Present, and Future
Forty years ago, several antihistamines and decongestants became the first products to make the shift from prescription-only (Rx) to OTC availability. [more...]

Pipeline Report: 2nd/3rd Quarter 2016

February 2016
Volume 3, Issue 1

Keep on Your Radar: Value-Based Pricing of Drugs
One of the major tenets of healthcare reform in the U.S. has been the shift from volume-based reimbursement towards value-based reimbursement; however, the same has not been true for pharmaceuticals. [more...]

Meet the Watchdog: Institute for Clinical and Economic Review (ICER)
ICER, a Boston-based non-profit organization consisting of over 20 experts in clinical and business fields, evaluates evidence on prescription drugs, tests, and delivery systems to improve the efficacy, efficiency, and impartiality of the healthcare system. [more...]

Struck by a Macaw? Bitten by a Sea Lion? There’s a Code for That!
In the unfortunate event you have either been struck by a macaw or bitten by a sea lion, rest assured the information will now be adequately captured, thanks to the implementation of the International Classification of Disease Systems, 10th Revision, Clinical Modification (ICD-10-CM). [more...]

A Step in the Right Direction: Empowering Patients, Improving End of Life Care
Effective January 1, 2016, healthcare providers are eligible to be reimbursed for counseling their patients regarding advance care planning and end of life preferences. [more...]

Did You Know? Off-Label Drug Use and Freedom of Speech
One mission of the Office of Prescription Drug Promotion (OPDP), a division within the FDA, is to protect the public through surveillance, enforcement, education, and improvement of labeling and promotional materials. [more...]

Pipeline Report: 1st/2nd Quarter 2016


November 2015
Volume 2, Issue 4

In the Headlines: Older Drugs, Newer Price Tags
While the price of new hepatitis C drugs still dominates the news, current headlines concerning price increases of older, well-established medications are also in the headlines. [more...]

Did You Know? Drug Shortages
The number of reported drug shortages nearly tripled between 2005 and 2010 and has risen almost 75% over the last five years. [more...]

Abuse-Deterrent Pain Medications: Promises and Pitfalls
Opioids are a class of medications for the treatment of severe pain. Prescription opioid abuse has been a growing problem in the U.S. over the last two decades. [more...]

Keep on Your Radar: Utilizing Technology to Improve Medication Adherence
As the world makes rapid advances in technology, the tech boom may benefit patient outcomes. [more...]

Pipeline Report: 4th Quarter 2015 / 1st Quarter 2016

Bonus Pipeline Report: Duchenne Muscular Dystrophy (DMD)


August 2015
Volume 2, Issue 3

Risk-Sharing: A Glimpse at Value Driven Healthcare
It was recently announced that Novartis’ new heart failure medication, sacubitril/valsartan (Entresto™), may be tied to a risk-sharing agreement. [more...]

Keep on Your Radar: Assessing the Value of Chemotherapy
The value associated with cancer treatments, particularly chemotherapy drugs, has been a hot topic this summer, and oncologists have been leading the dialogue. [more...]

Expedited Drug Approval Pathways: Balancing Speed with Safety
The FDA, responding to criticisms of delaying access to promising new therapies, has established four possible routes to an expedited new medication review. [more...]

Did You Know? Revamping Drug Take-Back Programs
DEA Chief Chuck Rosenberg announced the need to revitalize the drug take-back initiatives in the U.S. [more...]

Pipeline Report: 3rd and 4th Quarter, 2015


May 2015
Volume 2, Issue 2

Biosimilars – What’s in a Name?
The Food and Drug Administration (FDA) made history on March 6, 2015 with the approval of the first biosimilar. [more...]

Variations in Prescription Drug Monitoring Programs
Many states established prescription drug monitoring programs (PDMPs) to address the prescription drug abuse problem. [more...]

This Summer’s Pharmaceutical Blockbuster?
This summer, the Proprotein Convertase Subtilisin/Kexin Type 9 (PSCK9) inhibitors may turn out to be the pharmaceutical equivalent of a summer blockbuster. [more...]

Did You Know? The Raw Truth of Opioid Drug Shortages
Shortages of opioids (narcotic painkillers like morphine and codeine) cause frequent obstacles for patients, prescribers, dispensers, federal regulators, and health care facilities. [more...]

Keep on Your Radar: Electronic Prior Authorization (ePA)
Prior authorization is a tool used by pharmacy benefit managers (PBMs) to ensure safe and cost efficient use of medications; however, the list of drugs requiring prior authorization (PA) and the criteria associated with those
PAs differ among plans. [more...]

Pipeline Report: 2nd and 3rd Quarter, 2015

February 2015
Volume 2, Issue 1

Why are Some Generic Drugs Skyrocketing in Price?
This was the title of a November 2014 Senate subcommittee hearing where pharmacists and physicians testified about the impact of soaring generic drug prices. [more...]

Did You Know?
There are now more than 100 medications on the market containing “personalized medicine” information in their labeling. [more...]

Keep on Your Radar: Community Management of Opioid Overdose
The crisis of abuse and addiction to opioid analgesics has emerged in the past decades and has worsened over the last few years. [more...]

“Right-to-Try” Laws
Right-to-Try laws are intended to provide terminally ill patients access to investigational drugs and circumvent the established FDA expanded access or “compassionate use” pathways. [more...]

The Changing Landscape of Newly Approved FDA Drugs
A near record number of new drugs, a total of 41, were approved by the FDA in 2014. [more...]

Pipeline Report: 2nd and 3rd Quarter, 2014

November 2014
Volume 1, Issue 2

Safety and Efficacy of Compounded Medications: Paying More for Less?
An issue receiving increased attention from the media, the FDA, and especially pharmacy payers involves compounded prescriptions. [more...]

Regulation of the Prescription Drug Benefit
Recently proposed legislation in several states has the potential to impact health plans and the prescription drug benefits they provide. [more...]

Avoiding the Cliff: Product Hopping, Forced Switches, and Other Patent Extension Tactics
The term “patent cliff” refers to the imminent period when a branded medication faces the end of its patent life and the field opens for generic competition. [more...]

The End of Warehousing is in Sight
Hepatitis C and new therapies available for treatment continue to be a hot topic in healthcare. [more...]

Keep on Your Radar: Biosimilars
Recent data show generic drugs saved Americans and their insurers $239 billion in 2013 by substituting generic alternatives for older brand name drugs whose patents have expired. [more...]

Did You Know?
As healthcare costs and related outcomes have come under increasing scrutiny in the last decade, evidence based medicine has become a cornerstone of formulating treatment options. [more...]

Pipeline Report: Late 2014/Early 2015


July 2014
Volume 1, Issue 1

Hepatitis C: The Hot Topic in Health Care
Hepatitis C (HCV) is a health crisis in both the United States and worldwide. [more...]

Medication Synchronization: Coming Soon to a Legislative Session Near You?
Legislation supporting the implementation of medication synchronization programs has been filed in at least 10 states during recent legislative sessions. [more...]

What happened to generic Nexium®?
Esomeprazole magnesium (Nexium®) is a widely prescribed medication used to treat the symptoms of heartburn which resulted in sales of well over $5 billion last year. [more...]

Pipeline Report: 2nd and 3rd Quarter, 2014