STATEMENT_OF_WORK_rev_with_changes_finalized.docx

May 17, 2018

STATEMENT OF WORK

Background

Hepatitis C is an infectious disease caused by a virus. Infected persons often experience mild or even no symptoms. Although the disease may resolve without treatment for some infected persons, for the overwhelming majority of infected persons it becomes chronic, often with no symptoms for many years. Often the disease leads to liver disease and cirrhosis. Possible complications of Hepatitis C include liver failure, liver cancer, or dilated blood vessels in the esophagus and stomach. It is also a leading cause for liver transplants.

Drug treatments for Hepatitis C has long been available, but prior to 2014 the likelihood of a cure with then available therapies was far from certain. Starting in 2014 new drug therapies became available that have a very high likelihood of curing the disease for infected persons to whom it is administered. The first of these drugs to come to market in 2014 bore a high price, and a course of treatment per person was in the range of $100,000. In the first year that this drug was available the Medicare program spent in excess of $4.6 billion for beneficiaries with Hepatitis C who were prescribed drug treatment. Alternatives to that drug that are also highly effective against Hepatitis C have since come into the market that are generally less costly, but still expensive. Under the sponsorship of the Centers for Disease Control (CDC), National Institutes of Health (NIH), and National Science Foundation (NSF) an ambitious research program appears to be under way to evaluate at a societal and even world level the cost-effectiveness of these new therapies.

The goal of this study is to address a much less ambitious and much more limited question: the long-term fiscal impact of these therapies on spending in the Medicare program. The need for the Hepatitis C drugs and their benefits to individual patients is not in question. The new technology does, however, present a long-term fiscal challenge for the Medicare program that the CMS Office of the Actuary desires to better understand and explore. The contractor who eventually undertakes this project will be expected to write a report that comprehensively assesses the near-term (5 to 10 year) and long-term (30 to 50 year) fiscal consequences to the Medicare program of the new technologies, including opinions as to whether and when and if so to what extent the new treatments will result in future health care costs for treated Hepatitis C patients and the Medicare program as a whole Specific issues that the contractor will be expected to address include:

1. What is the likely size of the Medicare beneficiary population with Hepatitis C (including an estimates of those with treated or untreated Hepatitis C)? Are there conditions that are associated with an increased likelihood of developing Hepatitis C relevant to forecasting future prevalence of Hepatitis C presenting in the Medicare population? How would the size of any such sub-populations be expected to vary over the next 30 to 50 years?

2. What alternative drug treatments are available for Hepatitis C patients, what are their present and likely future costs, what are their relative merits, and are there likely to be even more drugs added to the constellation of alternatives?

3. What share of beneficiaries with treated Hepatitis C have undergone drug therapy aimed at curing the disease? What was the cure rate? How have treated beneficiaries health care use and spending patterns changed following therapy?

4. What share of the beneficiaries with untreated Hepatitis C are likely to undergo drug therapy aimed at curing the disease and what are the expected costs of treatment for Hepatitis C, taking into account price variations reasonably to be expected from such things as competition among alternative pharmaceuticals, the likely marketshare of currently available treatments, and the eventual end of patent protections? Also, related to this, what the cure rate for those treated can be expected?

5. How does untreated Hepatitis C, diagnosed or undiagnosed, affect a beneficiary’s lifetime health care costs relative to beneficiaries with no Hepatitis C infection?

6. How is successful treatment for Hepatitis C likely to affect subsequent lifetime health care costs of treated beneficiaries and are certain parts of the health care sector (e.g. hospital, physician) expected to be affected disproportionately? Included here would be expected savings (or costs) from treatment avoided due to halting of the disease’s further progress such as avoiding the need for liver transplants, avoidance of liver cancer, and any other foreseeable effects on lifetime health care spending. If there are long-run savings, is there a typical length of time in which those savings are realized? In addition to the impact on lifetime health care costs, we also want to understand the net impact on Medicare annual spending over the projection period. In other words, does reduced medical spending of treated beneficiaries sufficiently offset the annual spending of beneficiaries who are not yet treated and those in treatment.

7. What factors and considerations affect the decision of a treating professional to offer a patient drug therapy for Hepatitis C?

8. What kinds of tracking mechanisms might CMS employ over time to measure realized effects on utilization related to Hepatitis C and the new drug therapies?

It bears repeating that this project is not a cost-effectiveness analysis or a comparative effectiveness analysis. Its main focus is on understanding the likely stream of fiscal consequences for the Medicare program, what might be termed a fiscal consequences analysis intended to assist the Office of the Actuary as it annually evaluates the long-term state of solvency of the Medicare program. It is expected that the research team will include or have access to medical expertise concerning prevalence, treatment, and results of treatment. This project may also provide a template for evaluating the fiscal consequences of medical technologies that arise in the future that are perceived as having the potential to have large long-term programmatic-level fiscal effects.

Purpose:

The purpose of this contract to deepen understanding of the long-term fiscal effects on the Medicare program of .newly developed effective therapies for Hepatitis C that are costly to administer.

Specific Tasks

Under this contract, the contractor shall perform the following tasks:

Task 1. Project Management

1. a. Kick-off Conference Call

After the award of the contract there shall be a conference call to introduce personnel who will work on the contract and to discuss the plan of research to be executed including initiation of steps needed to obtain access to any needed CMS data under a Datua Use Agreement which complies with CMS requirements.

1. b. Ongoing Communication (via telephone)

As deemed necessary by the Project Officer, but at least monthly, the contractor will meet via telephone with the project officer and/or other OACT long-run modeling staff to discuss progress on tasks, as well as to highlight any major developments, identify roadblocks, or seek or provide clarification on any component of the required tasks.

1.c. Quarterly Progress Reports

The contractor shall submit quarterly written administrative progress reports outlining all work accomplished during the previous quarter.

Task 2: Meetings

The contractor will travel to Baltimore to present the major findings and recommendations of the final report to the Project Officer and other OACT long-run modeling staff.

Task 3. Research Plan

The contractor will present a research plan for approval by CMS OACT. The plan shall identify specific research questions to be investigated, describe the methods to be employed in the investigation, identify the data sources to be examined and the plan for acquiring needed data, and specify the methods of analysis that will be implemented to answer the questions in the research plan.

Task 4: Execution of Research Plan

The contractor shall execute the final research plan upon approval of the plan by the Project Officer. To the degree reasonably feasible, all modeling work shall be performed with SAS software.

Task 5. Reports:

5.a. Draft of Final Report

Upon completion of Task 4 the contractor shall prepare and submit a comprehensive written report that delineates the major findings of the project. The Final Report shall include results of all modeling work completed and recommendations for future work. Complete computer code for all models estimated by the contractor will be included in an appendix to the Final Report. Data sets and estimating programs in electronic form for all models estimated by the contractor shall be delivered with the Final Report.

5.b. Final Report

The contractor shall prepare and submit a Final Report revised in light of feedback from the Project Officer and the OACT Long Term Modeling Team.

References

Centers for Disease Control. Viral Hepatitis. https://www.cdc.gov/hepatitis/hcv/index.htm

Jagpreet Chhatwal, PhD; Fasiha Kanwal, MD, MSHS; Mark S. Roberts, MD, MPP; and Michael A. Dunn, MD, “Cost-Effectiveness and Budget Impact of Hepatitis C Virus Treatment With Sofosbuvir and Ledipasvir in the United States.” Annals of Internal Medicine 62(6):397-406.(2015)

Jagpreet Chhatwal, Xiaojie Wang, Turgay Ayer et.al, “Hepatitis C Disease Burden in the United States in the Era of Oral Direct-Acting Antivirals,” Hepatology Volume 64(5):1442-1450 (2016).

Jagpreet Chhatwal, Qiushi Chen, Turgay Ayer et. al., “Updated Prevalence of Hepatitis C in the United States: Results from a Simulation Model Including the Non-NHANES Population,” Poster at the 2017 AASLD Liver Meeting.

J. Chhatwal1, Q. Chen1, T. Ayer et. al., “Hepatitis C virus re-treatment in the era of direct-acting antivirals: projections in the USA,” Aliment Pharmacol Ther. 47:1023–1031 (2018).

Dienstag JL Chronic viral hepatitis. In GL Mandell et al., eds., Mandell, Douglas, and Bennett's Principles and Practice of Infectious Diseases, 7th ed., vol. 1, pp. 1593-1670. Philadelphia: Churchill Livingstone Elsevier (2010).

Flamm SL (2003). Chronic hepatitis C virus infection. JAMA, 289(18): 2413-2417.

Mina Kabiri, MS; Alison B. Jazwinski, MD; Mark S. Roberts, MD; Andrew J. Schaefer, PhD; and Jagpreet Chhatwal, PhD, “The Changing Burden of Hepatitis C Virus Infection in the United States: Model-Based Predictions,” Annals of Internal Medicine 161(3):170-80 (2014).

Section 508 Compliance for Communications The Contractor’s Final Report concerning this Task Order shall comply with the standards, policies, and procedures below. In the event of conflicts between the referenced documents and this Statement of Work, the Statement of Work shall take precedence.

Rehabilitation Act, Section 508 Accessibility Standards

1. 29 U.S.C. 794d (Rehabilitation Act as amended)

1. 36 CFR 1194 (508 Standards)

1. www.access-board.gov/sec508/508standards.htm (508 standards)

1. FAR 39.2 (Section 508)

1. CMS/HHS Standards, policies and procedures (Section 508) In addition, all contract deliverables are subject to these 508 standards as applicable.

Regardless of format, all Web content or communications materials produced, including text, audio or video - must conform to applicable Section 508 standards to allow federal employees and members of the public with disabilities to access information that is comparable to information provided to persons without disabilities. All contractors (including subcontractors) or consultants responsible for preparing or posting content must comply with applicable Section 508 accessibility standards, and where applicable, those set forth in the referenced policy or standards documents above and below. Remediation of any materials that do not comply with the applicable provisions of 36 CFR Part 1194 as set forth in the Statement of Work, shall be the responsibility of the contractor or consultant.

The following Section 508 provisions apply to the content or communications material identified in this Statement of Work:

36 CFR Part 1194.22 a – j, l – p 36 CFR Part 1194.41 a – c