FDA Postpones Opioid Approval Decision

According to an 8-K filing from Nektar Therapeutics to the U.S. Securities and Exchange Commission, the FDA has delayed a previously established drug-approval decision date for a new opioid. A letter from the FDA to Nektar Therapeutics states that the reason for postponing the decision process was not specific to the drug in question, as the FDA is currently considering a number of scientific policy issues relating to all opioids.

Nektar Therapeutics developed NKTR-181, also known as loxicodegol, an opioid for the treatment of chronic low-back pain without euphoric effects, intended to relieve pain with a reduced likelihood of addiction in patients who are new to opioid therapy. The FDA received the new drug application in May 2018 and targeted an August 29, 2019 date for finalizing their review of the application, in which they would approve or deny the drug.

However, the FDA informed Nektar Therapeutics in July that it was postponing the review process for the drug. This news came shortly after the FDA released a draft guidance document in June to describe the benefit-risk assessment framework the FDA uses when evaluating applications for opioid analgesic drugs.

The document was meant to inform drug developers of what kind of information should be included in a new drug application (NDA) for opioid medications, detailing various criteria around broader public health effects, risks and mitigation of risks related to misuse, abuse, opioid use disorder, overdose and more.

While the FDA is no longer accepting public commentary on this draft, they held a follow-up meeting on September 17th to discuss standards for future opioid analgesic approvals. The meeting was held to gather stakeholder input on the approval process for new opioids and how the FDA could best approach the matter. Along with opioid discussions, the meeting also focused on incentives for developing new, non-opioid pain medications.

For the last few years, the FDA has launched various initiatives targeting the opioid epidemic, including reassessing policies around risk evaluation and mitigation strategies (REMS) for opioid medications, tightening restrictions for transmucosal fentanyl products, proposing fixed-quantity blister packaging for certain opioids, and much more.

With these latest actions directly impacting the approval process, it is possible that significant change, though steady in delivery, could soon come.


Tags: Opioid, delay, postpone, opioid approval process, opioid policy


Robert Goldberg and Silvia Sacalis Discuss Workplace Fatigue with Risk & Insurance

Risk & Insurance, a news publication focused on risk management and commercial insurance, featured an article on how to mitigate workplace fatigue to avoid costly employee injuries.

With various factors contributing to workplace fatigue, the article addresses the need for a multilayered approach, reaching out to various industry experts, including Healthesystems’ Chief Medical Officer, Robert Goldberg, MD, FACOEM, and VP of Clinical Services, Silvia Sacalis, BS, PharmD.

Drs. Goldberg and Sacalis spoke to the need for fatigue management plans that focus on the root causes of fatigue, going over shift-work and schedule rotations, how long employees can work prior to feeling fatigue, the need for fatigue education, wellness programs, break times and locations, and more.

Read the article in full at Risk & Insurance.


Tags: Risk & Insurance, fatigue, Goldberg, Sacalis


California Publishes One-Year Report on Workers’ Comp Formulary

In late August, the Workers’ Compensation Insurance Rating Bureau of California (WCIRB) published a One-Year Checkup on the California Formulary, an early assessment of the California workers’ comp formulary’s impact on actual prescribing patterns.

Effective January 1, 2018, the formulary was intended to reduce frictional costs in workers’ comp, restrict inappropriate prescribing, and ensure that injured workers receive medically necessary medications in a timely manner. The formulary includes a list of about 300 drug ingredients that are assigned a status of exempt or non-exempt from prospective utilization review (UR). All opioids and compounded drugs are nonexempt from prospective UR.

The WCIRB’s report analyzed medical transaction data for medical services rendered between July 1, 2015 and December 31, 2018. Roughly 870,000 prescriptions were provided to California injured workers in 2018, a large decrease from 1.3 million in 2017.

Highlights of WCIRB’s findings include:

  • Prescriptions per claim decreased 29% in 2018
  • Pharmaceutical costs per claim decreased 32% in 2018
  • The utilization of drugs not subject to prospective UR increased by 41%
  • The utilization of drugs subject to prospective UR decreased 18%
  • Total drug payments for opioids decreased 33% in 2018, a stronger drop than the 14% decrease reported in 2017
  • The share of payments for physician-dispensed drugs fell from 13% in Q4 of 2017 to 6% by Q4 of 2018, after having remained steady throughout most of 2017
  • The share of payments to brand-name drugs with generic alternatives decreased from 9% in Q4 of 2017 to 6% in Q4 of 2018

These findings have led WCRIB to conclude that the California formulary has played an important role in reducing pharmaceutical costs.


Tags: California, WCIRB, formulary, report, drug cost, utilization


DEA to Improve Access to Marijuana Research

The DEA announced plans to facilitate and expand scientific and medical research for marijuana, with plans to bolster the marijuana growers program, allowing for a greater wealth of marijuana research.

New regulations to govern the marijuana growers program will soon be proposed, giving applicants and the general public an opportunity to comment on the regulations. According to the DEA’s announcement, there has already been great demand for this change, as from January 2017 to January 2019, the number of individuals registered by the DEA to conduct research with marijuana increased from 384 to 542, approximately 40%.

Historically, research institutions have faced much difficulty completing the intensive, time-consuming application process to study marijuana that required cooperation with the DEA, the National Institute on Drug Abuse (NIDA) and the FDA.

Changing these rules could allow for a significant increase in medical marijuana research, and the clinical findings could greatly impact marijuana utilization in healthcare as well as public policy.

Furthermore, changes to the manufacturing of marijuana for medical research could allow for more dynamic types of research to be conducted. The Washington Post reported in 2017 that government research-grade marijuana differs significantly from the various marijuana products available to the public.

According to interviews with marijuana researchers working in cooperation with the federal government, at times government-issued marijuana contained stems and leaves, parts of the plant that are not regularly consumed, and at other times carried levels of mold and yeast far exceeding standards for states such as Colorado and Washington.

Allowing for broader, more diverse research into marijuana could potentially clear up the debates dominating healthcare headlines in the not-too-distant future.


Tags: DEA, National, Federal, marijuana, grower, grow, research


Johnson & Johnson to Pay $572 Million in Opioid Trial

An Oklahoma judge has ruled that drug manufacturer Johnson & Johnson created a public nuisance in their deceptive marketing of opioid pain medications, helping to cause the state’s opioid crisis, ordering the manufacturer to pay $572 million to the state.

Originally seeking $17.5 billion, the ruling acknowledged that the cost of repairing the damage caused by the opioid epidemic will require more resources. It is estimated that the $572 million payment may only fund Oklahoma’s recovery plan for one year.

However, this ruling has created much excitement, as there are an unprecedented number of other lawsuits being waged against opioid manufacturers. Healthesystems previously reported on the high volume of lawsuits launched against opioid manufacturers from various state and city governments, with over 41 state Attorney Generals banding together to investigate drug makers and distributors, while federal courts oversee more than 200 lawsuits from cities and counties.

These lawsuits seek monetary damage, claiming drug makers misled doctors and patients regarding the safety of opioid products, resulting in the harm of the opioid epidemic.

This Oklahoma ruling is the first trial where a drug maker has been held responsible for the opioid epidemic. And with nearly 2,000 other cases being managed in the National Prescription Opiate Litigation, a federal proceeding, it is possible other cases could result in more significant monetary rulings.

Earlier this year, other drug makers being sued by Oklahoma reached settlements instead of going to trial. Purdue Pharma paid Oklahoma state $270 million, while Teva Pharmaceutical Industries paid $85 million. Johnson & Johnson plans to appeal the judgment.


Tags: Opioid, trial, payment, lawsuit, drug maker, manufacturer, opioid epidemic, Johnson & Johnson, Teva, Purdue, Attorney General


Three Insights from WOHC 2019

The Western Occupational & Environmental Medical Association (WOEMA) recently held the 2019 Western Occupational Health Conference (WOHC) in San Diego, an event that promotes and protects the health of people at work and in their environment through preventive service, clinical care, research and evaluation.

The conference offers various educational sessions, which included a presentation from Healthesystems’ Chief Medical Officer, Robert Goldberg, MD, FACOEM, titled The Future of Healthcare: What Trends Will Shape Occupational Medicine and Workers’ Comp?

Dr. Goldberg’s presentation covered various health trends across patient engagement, value-based care, population health, non-pharmaceutical approaches, big data and advanced analytics, and smart technology.

Insight 1 –Engaging Patients for Healthier Lifestyles

On the patient engagement front, several trends radiate around employee wellness. With comp claims experiencing a near tripling of comorbidities in the last decade, promoting self-care and healthier living is crucial for managing patients more holistically.

However, ensuring that workplace environments support employee health is also important. Approximately 27% of workers have unintentionally fallen asleep on the job due to fatigue, while 28% of employees have likely had an anxiety or panic attack on the job due to high workplace stress.

Insight 2 – The Workforce is Diversifying

The workforce is facing diversification like never before, and with such diverse populations come diverse concerns.

The Bureau of Labor Statistics reports that in the next decade, one in four workers will be 55 or older. With older workers come unique medication concerns, especially as the Centers for Disease Control and Prevention (CDC) report that three in four workers over 55 have at least one chronic health condition.

Meanwhile, the U.S. Census Bureau estimates that by 2024, 43% of workers will be minority workers. This is noteworthy as members of different ethnic or cultural groups may face specific health concerns. For example, according to the CDC, Black populations are 50% more likely to have high blood pressure, while Latino populations are 50% more likely to have diabetes.

Insight 3 – Exploring Non-Pharma Alternatives for Pain

With healthcare professionals recoiling from the opioid epidemic, institutions like the Centers for Disease Control and Prevention (CDC), the American College of Physicians, and the National Academies of Sciences, Engineering and Medicine are advocating shifts to nonpharmacological approaches for the treatment of pain.

While this has led healthcare professionals to diversify care in a variety of ways, one key point is that this has led to greater interest in alternative therapies. Around the U.S., 50 reputable institutions have recently established alternative or complementary medicine programs, including Harvard, Stanford, Duke University and the Mayo Clinic. Evidence-based guidelines like ACOEM and ODG support the selective use of alternative therapies, and 25% of millennials use alternative therapies more than conventional options.


Tags: WOHC, Goldberg, conference, population health, minorities, older workers, alternative therapy, patient engagement