Overdose Crisis Endures, Yet Few People Receive Existing Effective Treatment

Even before Covid-19, despite enormous unmet need, life-saving buprenorphine is vastly underprescribed

(New York, NY, August 24, 2020) –Approximately half of clinicians authorized to prescribe buprenorphine for opioid use disorder (OUD), one of three medications for OUD, are actively prescribing the medication, according to a JAMA study led by researchers at The Pew Charitable Trusts, Deerfield Management Company, and RAND Corporation.

The research letter, which appeared in the August 24th online issue of JAMA Network Open, examines national opioid use disorder buprenorphine prescribing patterns by Drug Enforcement Administration (DEA)-approved patient limits.

Buprenorphine is considered one of the most effective therapies to treat OUD. In order to become an authorized prescriber of buprenorphine to treat OUD, clinicians are required to undergo special training and licensing with the Substance Abuse and Mental Health Services Administration (SAMHSA) and DEA.

The authors of the paper point out that federal regulations currently limit these waivered clinicians to treating 30, 100, or 275 patients concurrently, with clinicians limited to treating 30 or 100 patients able to request an increased limit.

Based on a national analysis of clinician databases from the DEA and SAMHSA and clinician-level prescribing information from Symphony Health, the authors found that of 55,938 waivered clinicians, only 50.9 percent wrote at least one buprenorphine prescription during the 22-month period of April 2017 through January 2019.

Median patient monthly census calculations revealed 275-patient clinicians treated 36.9% of their patient limit, while 100-patient and 30-patient clinicians treated 23.9% and 11.3% of their patient limits, respectively.

“More than 2 million people in the United States have an opioid use disorder, yet few of them receive any type of specialty treatment, including buprenorphine,” said study co-author Alexandra Duncan, senior officer with The Pew Charitable Trusts’ substance use prevention and treatment initiative. “Removing barriers to buprenorphine prescribing can help close this treatment gap and ensure that people have access to the evidence-based addiction care they need.”

In recognition that buprenorphine is an important option for patients because it eliminates the need for the daily clinic visit required of most patients receiving methadone, NYC Health and Hospitals expanded access to the medication by integrating prescribing into primary care. Additional benefits of buprenorphine are its low potential for abuse and negligible risk for overdose.

“Our finding that about half of doctors who can prescribe buprenorphine aren’t doing so makes clear that increasing the number of patients receiving it is not just about increasing the number of clinicians who can prescribe it,” added co-author Bradley Stein, Director of RAND’s Opioid Policy Center. “We need to focus efforts on increasing reimbursement for buprenorphine’s use, educating prescribers, patients, and their families about  its effectiveness, and combatting the stigma that hampers the effective treatment of opioid use disorder.”

“Leveraging multiple large databases not only allowed us to confirm earlier evidence that clinicians are prescribing below their patient limits, but also enabled us to continue to peel back the onion on the scope of this problem, said co-author Jared Anderman, director of data analytics at the Deerfield Institute, a division of Deerfield Management Company.  “We are looking forward to continuing to work with the powerful dataset we have created and identifying additional opportunities to make an impact.”

Authors of the study, titled, “Monthly Patient Volumes of Buprenorphine-Waivered Clinicians in the U.S.,” are:  Alexandra Duncan (The Pew Charitable Trusts); Jared Anderman (Deerfield Management Company); Travis Deseran (previously Deerfield Management Company); Ian Reynolds (The Pew Charitable Trusts); and Bradley D. Stein (RAND Corporation). The work was funded by The Pew Charitable Trusts and Deerfield Management Company.

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About Deerfield Management Company

Deerfield is a healthcare investment management firm committed to advancing healthcare through investment, information and philanthropy.

Media Contacts:
Karen Heidelberger, [email protected], 212-692-7140

Warren Robak, [email protected], 310-451-6913

Deerfielders Weigh in on a Safe Return to Work Policy Amid Covid-19 Crisis

Antibody testing provides a data-driven path to getting people back into the economy

The availability of point of care antibody testing—also known as serological testing—may provide a feasible roadmap for getting people back to work safely following the COVID-19 crisis, according to an editorial published in the journal Contemporary Clinical Trials Communications.

“You can’t stop the economy forever,” asserted Governor Cuomo in a recent news conference, according to STAT. “So we have to start to think about, does everyone stay out of work? Should young people go back to work sooner? Can we test for those who had the virus, resolved, and are now immune, and can they start to go back to work?”

Regardless of whether they already have immunity to the virus, millions of Americans may try to return to work, potentially undoing all the benefits of the shutdown, suggests the editorial. 

Antibody testing, the authors argue, could clarify a person’s status quickly in real-time and reveal whether they have been exposed to COVID-19. Accordingly, a person who mounts an IgG positive response (suggesting the presence of immunoglobulin G antibodies) would most likely now be immune to the virus and an IgM positive result would point to the process of developing immunity in someone who more recently became infected.

“Unlike the PCR tests (a measure of virus material), the immediate results and unconstrained supply of antibody tests could fundamentally change the way we manage this epidemic,” says Robert Jackson, MD, a co-author of the paper. “And from an economic perspective, it could lead to a tractable path for people to return to work. Collecting the data and tracking individuals longitudinally, in order to confirm the hypothesis, will be necessary.”

And barring any HIPAA concerns, the authors propose that persons with positive antibody tests during periods of social distancing could get a bracelet, which indicates that they are immune-protected and can return to work. Those without a bracelet would still be asked to practice social-distancing and not yet resume their normal activities. But this approach could potentially get at least some portion of the economy back running again, suggests the authors.

According to the authors, the antibody tests are cheap, easy to administer, and could be made available at every hospital.

“Broad testing is in society’s best interest,” says Alex Karnal, a co-author of the editorial. “Until we make serological tests available in a robust way, it’s as if we are flying a plane without navigation.”

Authors of the editorial, titled, “Let’s Get Americans Back to Work Again,” are: Alex Karnal, Partner and Managing Director; Robert Jackson, MD, Partner and Chief Science Officer; and Joe Pearlberg, MD, PhD, Vice President of Scientific Affairs, all at Deerfield; and Amitabh Chandra, PhD, McCance Family Professor at Harvard Business School and Weiner Professor at the Harvard Kennedy School.

Deerfield Institute

Established in 2006, the Deerfield Institute delivers sophisticated and timely market research, which enhances the insights available to the investment team and its partners. The Institute develops and analyzes data to advance understanding of innovations and emerging products, and it also informs on trends within the healthcare market. It has published important scientific findings in peer-reviewed journals to extend learnings to the scientific community and benefit public health at large—and  ultimately patients in need. The Institute is guided by Deerfield’s core values: integrity, the pursuit of objective and unbiased research, commitment to excellence, precision and accuracy.

Deerfield Institute Capabilities: 

  • Epidemiology
  • Scientific Evaluation
  • Biostatistics
  • Clinical Trial Design, Analysis
  • Intellectual Property Evaluation
  • Commercial Market Assessment
  • Market Access (Pricing, Reimbursement, Access)
  • Territory Mapping
  • Physician Targeting Plans
  • Brand Positioning and Strategic Planning
  • Forecasting
PUBLICATIONS
We publish research data to help advance healthcare and to enable researchers to have access to recent, relevant information.
View latest publications

Confidentiality

Deerfield Institute believes that market research is a valuable resource to the growing healthcare industry. A critical component of this research is assuring respondents that their information is being used properly and within standard industry guidelines. Individual responses from any market research effort are kept confidential and are reported without individual identifying information. During our research process, we collect, aggregate, and analyze information from respondents in various healthcare-related fields. We then prepare reports based on these answers for the purposes of understanding market level dynamics.

When participating in Deerfield Institute market research, respondents may be asked to provide personally identifiable information (such as name, email, and mailing address). This information will only be used to provide respondents with services or information that they have requested. When preparing reports or analyzing the results of our market research, personally identifiable information is always removed and will not be given or sold to a third party without the respondent’s consent.

All Deerfield Institute research is conducted in compliance with the Health Insurance Portability and Accountability Act (HIPAA).

As part of our research process we seek the insight of key opinion leaders and other expert advisors in the healthcare field. Our compliance framework is designed to avoid the receipt by Deerfield Institute of confidential information and strict policies and procedures must be followed in the engagement of these advisors. All paid advisors are required to sign terms and conditions that clearly define their responsibility to not disclose information to which they have a duty of confidence.

All Deerfield participants in an advisor interaction are trained in our compliance procedures and are required to give compliance reminders to expert consultants prior to each interaction. These policies and procedures extend to all of our partners that facilitate access to our advisors.

Deerfield Institute Report – Key insights into technology transfer offices

Translation of academic innovation has matured since the passage of the Bayh-Dole Act, 28 years ago. Universities and research institutes have contributed towards this to the tune of 380,000 disclosures, 206,000 new patent applications and 84,000 issued US patents.1 The market has responded in turn, generating 11,000 startups and 10,000 products that have yielded more than $1 billion in equity for the institutions.2 Deerfield Management has joined in this effort by entering into significant collaborations with leading academic institutions. In conjunction with these investments, the Deerfield Institute, the research division of Deerfield Management, surveyed 35 university technology transfer offices to endeavor to understand current trends impacting their organizations. The survey revealed insights that can shed light on the operations of these groups, provide guidance to those seeking to collaborate with academia and serve as a guide for continuous improvement in the practice of academic commercialization.

A hybrid approach for prediction of event times in double-blind clinical trials

In clinical trials especially those events-driven trials, it is often of great interest to predict the timing of pre-specified landmark event accurately in order to prepare for the interim or final analyses. Both parametric and non-parametric approaches have been proposed in the literature to estimate the underlying survival functions which is the key to the prediction of future event times. However, the existing approaches are neither not applicable to double-blind clinical trials or assuming smooth survival functions which might not hold in real clinical settings. In this talk, a hybrid parametric and non-parametric approach is proposed to predict event times in double-blind clinical trials with time-to-event outcomes. A greedy algorithm is first developed to detect change points in survival functions. The survival function before the last change point is estimated non-parametrically and the tail distribution beyond the last change point is estimated parametrically. Numerical results show that the proposed approach provides accurate predictions for future event times.

Predictors of laparoscopic hysterectomy for leiomyoma surgical removal in the United States

Objectives

Leiomyomas (uterine fibroids) are benign tumors that are prevalent among women of reproductive age and affect approximately 80% of premenopausal women. Hysterectomy is one of the most common surgical procedures for removal of uterine fibroids. Laparoscopic hysterectomy (LH) has increasingly been used as an alternative to the open surgical hysterectomy (OSH). The purpose of this study was to identify predictors of LH procedures among leiomyoma patients.

Methods

The National Inpatient Sample (NIS) is the largest publicly available inpatient healthcare database in the US, containing a 20% stratified systematic random sample of all US community hospital discharges. Thirteen years of available data, 2002–2014, were used for this analysis. International Classification of Diseases 9th revision (ICD-9) codes were used to identify all records of women with primary discharge diagnosis of uterine leiomyoma who had undergone either LH or OSH. Multivariate logistic regression analysis was conducted to identify significant predictors of LH. Population sampling weights were used to extrapolate results to national estimates.

Results

There were 310,150 leiomyoma LH procedures from 2002 to 2014, corresponding to 22.5% of the total number of leiomyoma hysterectomy procedures. The mean age of patients undergoing LH was significantly higher than those undergoing OSH (45.69 years vs 43.29 years; p<0.001). After adjusting for covariates, significant predictors of LH procedures included age > 50 years (OR=3.18; 95% CI=3.57-4.07), hospital location in the West (OR=1.46; 95% CI=1.38-1.86), and hospital urban non-teaching status (OR=1.20; 95% CI=1.04-1.38).

Conclusions

The study shows that despite the advances in surgical technologies, there are very few predictors of non-conventional laparoscopic approach to leiomyoma hysterectomy. Our findings suggest that there is a differential access to LH procedures among the US population which may be, in part, a result of racial and socioeconomic differences and centralization of laparoscopy services in urban areas.

Analysis of success rates for the Center for Medicare and Medicaid’s new technology add-on payment program

Objectives

To quantify the approval, denial, and withdrawal rates and identify any predictors of success or failure for all new technology add-on payment (NTAP) applications from FY 2003 to FY 2018 in the United States.

Methods

The Center for Medicare and Medicaid (CMS) releases inpatient payment methodology rulemaking annually in the Federal Register, including details of NTAP submissions. The proposed and final rulemaking documents were analyzed to quantify the approval, denial, and withdrawal rates of all applications and determine primary reasons for denial or withdrawal from FY 2003 to FY 2018. Raw data were coded to further examine any predictors of application success such as product type, therapeutic category, manufacturer type, reapplication status, and proposed rule determination.

Results

There were 95 NTAP applications submitted over the last 15 fiscal years. Approximately 30%, 25%, and 45% of applications were approved, withdrawn prior to final rule, or denied, respectively. Inability to meet the “newness criteria” developed by CMS was the primary reason for denied and withdrawn applications. Product type, therapeutic category, and reapplication status have minor to significant impact on the approval rate of an application. However, manufacturer type and proposed rule determination have little to no impact on application outcome.

Conclusions

While there are a few factors that may positively influence the outcome of a NTAP application, the approval rates for the program are low overall. Without additional reimbursement from the NTAP program, inpatient hospitals may be deterred from adopting innovative therapies because of financial burdens. CMS and manufacturers should strive to find a better consensus for a framework that adequately incentivizes the utilization of new technologies for Medicare beneficiaries.

Trends in isolated mitral valve surgery: the changing risk profile of patients and outcomes

Abstract 00357: Open surgical repair has historically been the only corrective procedure for mitral regurgitation. There are few contemporary data examining evolving patient characteristics and surgical outcomes of mitral valve surgery. We sought to characterize trends in patient characteristics and outcomes after isolated mitral valve repair surgery over the past decade in the United States

The importance of emerging transcatheter mitral valve technologies in cost-effectiveness and post-procedure outcomes

Abstract 00165: Mitral intervention has historically been open surgical and has been limited to a small subset of patients who could tolerate surgery and where there was perceived clinical benefit. With the emergence of transcatheter mitral interventions, we sought to compare the types of patients undergoing surgical and transcatheter mitral interventions. Moreover, we sought to determine if there were any major differences in adverse events, length of stay (LOS), and cost to the healthcare system

Deerfield Continues its Commitment to Advancing Healthcare Through its Publication Activities

New York, NY – January 16, 2018 – For the third year in a row, Deerfield has fulfilled its commitment to research in healthcare through the publication of articles, reviews and abstracts, which total over 40 since 2015. In addition, Deerfield has set up strategic collaborations with renowned organizations such as Friends Of Cancer Research (FOCR) and the Peking Union School of Public Health (PUSPH). The aim of these collaborations is to jointly publish information that addresses US and China health needs.

The peer‐reviewed publications, reviews and abstracts published in 2017 are listed below:

  1. Consumer satisfaction with tertiary healthcare in China: findings from the 2015 China National patient survey. Sun J, Hu G, Ma J, Chen Y, Wu L, Liu Q, Hu J, Livoti C, Jiang Y, Liu Y. Int J Qual Heath Care, 2017; 29(2):213‐221
  2. Considerations on Bringing Warehoused HCV Patients into Active Care Following Interferon‐Free, Direct‐Acting Antiviral Drug Approval. Palak A, Livoti C, Audibert C. Postgrad Med, 2017;129(4):471‐475
  3. Investment and incentives in 21st Century pharmaceutical research in Europe: the cost of opportunity. Morgese P. The European File, March 2017.
    https://www.europeanfiles.eu/magazine/medicines‐future‐how‐to‐sustain‐pharmaceuticalinnovation‐and‐improve‐access‐and‐affordability
  4. Global perspective on colonoscopy use for colorectal cancer screening: a multi‐country survey of practicing colonoscopists. Audibert C, Perlaky A, Glass D. Contemporary Clinical Trials Communications volume 7, September 2017, pages 116‐121.
  5. Reducing waiting time and raising outpatient satisfaction in a Chinese public tertiary general hospital – an interrupted time series study. Sun J, Lin Q, Zhao P, Zhang Q, Xu K, Chen H, Hu C, Stuntz M, Li H, Liu Y. Lancet ‐ CASM conference Abstract, and BMC Public Health, 2017;17:668
  6. Trends in the molecular diagnosis of lung cancer, results from an online marker research survey. Audibert C, Shea MB, Glass DJ, Kozak ML, Cazé A, Hohman RM, Allen JD, Sigal EV, Leff JS. A Friends Of Cancer Research White Paper, July 2017.
    https://www.focr.org/sites/default/files/pdf/FINAL%202017%20Friends%20NSCLC%20White%20Paper.pdf
  7. Nationwide trends of clinical characteristics and economic burden of emergency department visits due to acute ischemic stroke. Stuntz M, Busko K, Irshad S, Paige T, Razhkova V, Coan T. Open Access Emerg Med, 2017 Sep 19;9:89‐96
  8. Is it time for the weighted log‐rank test to play a more important role in confirmatory trials? SuZ, Zhu M. Contemporary Clinical Trials Communications, September 17, 2017.
  9. Variability in the therapeutic management of advanced ovarian cancer patients: a 5‐country survey of oncologists. Audibert C, Perlaky A, Stuntz M, Glass D. Drug Des Dev Ther, 2017;.11:3471‐3479.
  10. Treatment sequencing in advanced BRAF‐mutant melanoma patients: current practice in the United States. Audibert C, Stuntz M, Glass D. Journal of Pharmacy Technology, 2017 published online December 4.
  11. Persisting disparities between sexes in outcomes of ruptured abdominal aortic aneurysm hospitalizations. Stuntz M, Audibert C, Su Z. Scientific Reports, 2017; 10.1038/s41598‐017‐18451‐2 (SREP‐17‐46111)
  12. A review of promoting access to medicines in China – problems and recommendations. Sun J, HuC, Stuntz M, Hogerzeil H, Liu Y. Accepted by BMC Health Services Research.

About Deerfield

Deerfield is an investment management firm committed to advancing healthcare through investment, information and philanthropy.

For more information, please visit www.deerfield.com.

Contacts

Deerfield Management Company
Karen Heidelberger, 212-551-1600
[email protected]