Health Economic Research Study Presented at ISPOR, and Published in the Journal Value in Health, Demonstrates Reduction in Total Cost of Care with Increased Use of New Medicines for Treatment of Patients with Pancreatic Cancer

Health technology assessment programs are increasingly using real-world, longitudinal patient data to assess the effect of new medicines on total cost of care. This study analyzed such data to measure the impact of new pancreatic cancer therapies on other, non-drug medical expenditures.

“Our study looked at treatment inflation-adjusted expenses per patient for pancreatic cancer care between 2009 and 2016 and found that for every additional $1 spent on medicines for pancreatic cancer in 2016, there was a reduction in non-drug spending of $8 – $9,” said Robert Goldberg, Ph.D., Vice President and Co-Founder of the Center for Medicine in the Public Interest. “The value of advancing and accessing next-generation novel therapies is apparent from our total cost of care analysis looking at both medical and pharmacotherapy costs.”

The study showed that between 2009 and 2016, average inflation-adjusted per patient spending on pancreatic cancer care declined from $37,000 to $10,000. Prescription drug spending increased during the same time period from $2,200 to $6,100 per person (inflation adjusted). In effect, for every additional dollar spent on disease-altering therapies for pancreatic cancer between 2009 and 2016, there was a reduction in non-drug spending of $8 – $9.

Furthermore, there was a decline in the length of stay in hospital settings and a decrease in hospital deaths for this cohort of patients with pancreatic cancer. From 2009 to 2016, the mean length of stay decreased by 1 day. The proportion of deaths in hospitals during that time period also decreased by 2.8%.

The analyses also evaluated hemorrhage complicating a procedure, including Whipple surgeries. Hemorrhages are estimated to occur in 7.2 to 8.5% of those patients who have undergone a pancreatectomy and are associated with longer and more expensive hospital stays. Patients who were discharged from inpatient settings after being diagnosed with a complicating hemorrhage appeared to be routed to less intensive settings of care. In particular, the proportion of those discharged into home health care, as opposed to short term hospital care or another institution, increased by 1.2% between 2009 and 2016.

The study analyzed longitudinal patient-level data from the Medical Expenditure Panel Survey (MEPS, 1996 – 2017). The study evaluated 80 patients who had a diagnosis of pancreatic cancer and available prescription data. Individual age and employment status were accounted for as covariates. Notably, the data revealed that while prescription medicine expenses have increased as part of the total cost of treating patients with pancreatic cancer over the last ten years, the overall healthcare cost of treating pancreatic cancer patients has gone down.

All analyses were performed using R version 3.6.1 on Ubuntu 19.04. Means and standard deviations were computed for the raw and inflation-adjusted total health care costs excluding drug spending. Study averages were computed for the total health care costs, including prescription medicine costs for the period between 2009-2016 which included approval and/or use of novel treatment approaches such as Abraxane® (nab-paclitaxel), FOLFIRINOX and erlotinib. The prescription medicines expenses, and proportion of healthcare spending were also plotted along with a LOESS curve using the same parameters. All expenditures are adjusted for inflation using 2012 U.S. Dollars.

As a result of this health economic outcomes study, further analysis of a larger, longitudinal set of patient-level data is needed to more fully explore the relationship between spending on medical innovation, and reduction in total cost of patient care, as well as improvements in quality of life.

Details of this study are being presented at the ISPOR Virtual Meeting held from May 18 to May 20. For more information on ISPOR’s virtual program please visit the conference website at: https://www.ispor.org/conferences-education/conferences/upcoming-conferences/ispor-2020.

The health economic outcomes poster on pancreatic cancer presented at the ISPOR virtual conference is as follows:

Title: Using longitudinal patient level data to assess the value of new pancreatic cancer treatments on total health spending.

Authors: Robert Goldberg¹, Michele Korfin², Giuseppe Del Priore², Semmie Kim², Vincent J. Picozzi³, M Mandelson³, Victoria G. Manax⁴

Institutions: Center for Medicine in the Public Interest, NY, NY¹, Tyme Technologies, Inc., NY, NY², Virginia Mason Medical Center, Seattle, WA³, Pancreatic Cancer Action Network, Manhattan Beach, CA⁴

Virtual ISPOR 2020/Abstract Information:
https://www.ispor.org/conferences-education/conferences/upcoming-conferences/ispor-2020/abstract-Information

Abstract Number: PCN259

About Advanced Pancreatic Cancer
Advanced pancreatic cancer is a difficult-to-treat cancer with the lowest survival rates among all cancer types. Across all patients with pancreatic cancer, relative 5-year survival is 8% and is less than 3% for those with advanced disease.¹ The median survival for patients in end-stage of the disease is approximately 3 months. There are two main types of pancreatic cancer - adenocarcinomas, which accounts for approximately 90% of all pancreatic cancer, and neuroendocrine tumors. Pancreatic cancer is relatively uncommon with new cases accounting for only 2.1% of all newly diagnosed cancers. However, pancreatic cancer is the fourth most common cause of cancer death for men and women in the United States.

About SM-88
SM-88 is an oral investigational modified proprietary tyrosine derivative that is believed to interrupt the metabolic processes of cancer cells by breaking down the cells’ key defenses and leading to cell death through oxidative stress and exposure to the body’s natural immune system. Clinical trial data have shown that SM-88 has demonstrated encouraging tumor responses across 15 different cancers, including pancreatic, lung, breast, prostate and sarcoma cancers with minimal serious grade 3 or higher adverse events.

About Tyme Technologies
Tyme Technologies, Inc., is an emerging biotechnology company developing cancer therapeutics that are intended to be broadly effective across tumor types and have low toxicity profiles. Unlike targeted therapies that attempt to regulate specific mutations within cancer, the Company’s therapeutic approach is designed to take advantage of a cancer cell’s innate metabolic weaknesses to compromise its defenses, leading to cancer cell death through oxidative stress and exposure to the body’s natural immune system. For more information, visit www.tymeinc.com. Follow us on social media: @tyme_Inc, LinkedIn, Instagram, Facebook and YouTube.

Forward-Looking Statements/Disclosure Notice
In addition to historical information, this press release contains forward-looking statements under the Private Securities Litigation Reform Act that involve substantial risks and uncertainties. Such forward-looking statements within this press release include, without limitation, statements regarding our drug candidates including SM-88 and TYME- 18 and their clinical potential and non-toxic safety profiles, our drug development plans and strategies, ongoing and planned clinical trials, preliminary data results and the therapeutic design and mechanisms of our drug candidates; and readers can identify forward-looking statements by sentences or passages involving the use of terms such as “believes,” “expects,” “hopes,” “may,” “will,” “plan,” “intends,” “estimates,” “could,” “should,” “would,” “continue,” “seeks,” or “anticipates,” and similar words including their use in the negative or by discussions of future matters such as the cost of development and potential commercialization of our lead drug candidate and of other new products, expected releases of interim or final data from our clinical trials, possible collaborations, the timing, scope and objectives of our ongoing and planned clinical trials and other statements that are not historical. The forward-looking statements contained in this press release are based on management’s current expectations, which are subject to uncertainty, risks and changes in circumstances that are difficult to predict and many of which are outside of TYME’s control. These statements involve known and unknown risks, uncertainties and other factors which may cause the Company’s actual results, performance or achievements to be materially different from any historical results and future results, performances or achievements expressed or implied by the forward-looking statements. These risks and uncertainties include, but are not limited to, that the information is of a preliminary nature and may be subject to change; uncertainties inherent in the cost and outcomes of research and development, including the cost and availability of acceptable-quality clinical supply and the ability to achieve adequate clinical study design and start and completion dates; the possibility of unfavorable study results, including unfavorable new clinical data and additional analyses of existing data; risks associated with early, initial data, including the risk that the final data from any clinical trials may differ from prior or preliminary study data; final results of additional clinical trials that may be different from the preliminary data analysis and may not support further clinical development; that past reported data are not necessarily predictive of future patient or clinical data outcomes; whether and when any applications or other submissions for SM-88 may be filed with regulatory authorities; whether and when regulatory authorities may approve any applications or submissions; decisions by regulatory authorities regarding labeling and other matters that could affect commercial availability of SM-88; the ability of TYME and its collaborators to develop and realize collaborative synergies; competitive developments; and the factors described in the section captioned “Risk Factors” of TYME’s Annual Report on Form 10-K filed with the U.S. Securities and Exchange Commission on June 12, 2019, as well as subsequent reports we file from time to time with the U.S. Securities and Exchange Commission available at www.sec.gov.

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¹2018 American Cancer Society patient statistics; Metastatic Pancreatic Cancer: ASCO Clinical Practice Guidelines; Abrams et al 2017; Bachet et al 2009

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