NIH/NCI 384 - Digital Healthcare Platform to Reduce Financial Hardship for Cancer Patients

Fast-Track proposals will be accepted.

Number of Anticipated Awards: 2-3

Budget (total costs, per award):

Phase I: up to $300,000 for up to 9 months

Phase II: up to $2,000,000 for up to 2 years

PROPOSALS THAT EXCEED THE BUDGET OR PROJECT DURATION LISTED ABOVE MAY NOT BE FUNDED.

Summary

The cost of cancer care has risen exponentially over the last 20 years, with new cancer drugs routinely priced over $120K per year. Concurrently, commercial insurers have been shifting healthcare costs to patients though higher co-pays and deductibles. On average, cancer patients pay about $5K/year in out-of-pocket costs, however, prices higher than $10K a month for individual drugs and biologic agents are common. A growing number of patients experience financial hardship during cancer treatment, which negatively affects their quality of life. When compared to individuals without a cancer history, cancer survivors report higher out-of-pocket costs, lasting years after diagnosis. Further, cancer and its treatment can limit survivors’ ability to work, which further exacerbates the financial burden of cancer. There is growing concern that the exorbitant cost of cancer therapies will limit patients’ access to their potential benefits, leading to poorer treatment response and worse prognosis.

The National Academy of Medicine has cited patient-physician communication as a key strategy for helping patients understand and anticipate the costs of their cancer treatment. However, conversations about cost rarely occur. An important barrier to discussing costs as part of treatment decision making is that oncologists, nurses and other members of the healthcare team seldom know how much patients will have to pay for their care. Estimating a patient’s costs for a course of treatment is time consuming and expensive. It requires someone within the healthcare system to aggregate information about pricing, patient’s insurance coverage, available rebates, and other related information, all of which are stored in different places. Although some systems have dedicated financial counselors or financial navigators who can collate this information and help patients minimize financial burden, even practices willing to devote substantial resources to financial navigation are not equipped to do this for everyone. As a result, many patients begin a course of treatment, only to be blind-sided by expensive medical bills.

Project Goals

The goal of this contract solicitation is to develop an IT-based platform to streamline the calculation of patient’s out-ofpocket costs for cancer treatment. Depending upon clinic workflow, information about costs could be provided by the oncologist or nurse during the clinical encounter or soon after the clinical encounter by a financial navigator. When cost information is readily available, providers can inform patients about the expense of different treatment options; patients can make more informed treatment decisions; and providers, financial navigators or other staff can proactively explore strategies to minimize patients’ financial hardship.

Offerors are required to incorporate a cost calculation function into their proposed platform, which will be used by healthcare providers to estimate a patient’s out-of-pocket costs for cancer therapy. Out-of-pocket cost calculations can be based on the treatment plan for primary and adjuvant therapy, patient’s insurance coverage, or negotiated health system and pharmacy pricing. Additional modules that could also be included as part of the platform are tools to facilitate prescription and other financial assistance and visualization tools to support side-by-side comparisons of alternative treatment options. To be considered responsive, applicants should partner with at least one provider system (hospital, clinic), or insurer. The platforms should be developed for medical oncology providers who treat adult cancer patients. Offerors should design approaches that can be scaled up for the treatment of several cancers, although the platform can initially be developed in the context of a single cancer.

Activities not responsive to this announcement: Development of applications that are only patient-facing will not be considered responsive.

Phase I Activities and Deliverables

• Establish a project team with expertise in the areas of software development, computer programming, user-centered design, health communication, oncology, oncology nursing, health services research, and cyber security, as appropriate for the proposed project. Provide a report outlining team member credentials, specific project roles, and timelines for performance.
• Conduct an environmental scan of currently available technological platforms for financial hardship to identify gaps, existing capabilities and resources.
• Identify a partner hospital, clinic or insurer and conduct key informant interviews with anticipated end-users to understand user needs and clinical workflows.
• Provide a report including detailed description and/or technical documentation of the proposed system capabilities and specifications, including:
  • specific data systems that will support each module of the platform;
  • how the platform will interoperate with these systems to extract the necessary data;
  • how data will be visualized for the end-users; and
  • protections to ensure the confidentiality of patient information.
• Develop a prototype that includes:
  • the database structure for the proposed platform, user-interfaces, and metadata requirements;
  • data and security standards for collection, transport, and storage of data inputs that ensure patient privacy following standard NIH policies;
  • data visualization, data query functions, feedback and reporting systems for clinical monitoring and research applications; and
  • data adaptation for mobile application(s) if applicable.
• Conduct a pilot usability testing.
• Present Phase I findings and demonstrate prototype to an NCI evaluation Panel.

Phase II Activities and Deliverables

Phase II deliverables will focus on specifying technical requirements, testing usability of the prototype and evaluate its implementation in a cancer delivery system.

• Evaluate specific IT customization requirements to support hardware, software, or communications system integration of the technology into the target software environment in preparation for validation. Provide a report documenting the specific IT customization requirements and timelines for implementation.
• Evaluate (and enhance as necessary) and document that the technology and communications systems maintain compliance with HIPAA, data security, privacy, and consent management protocols as required for the proposed project.
• Enhance systems interoperability for deployment in diverse software environments and provider networks. Provide a report detailing communication systems architecture and capability for data reporting to healthcare providers, researchers, electronic health records, and health surveillance systems as appropriate for the proposed project.
• Refine prototype and conduct usability testing
• Test the integration of the technology in the information system of the cancer delivery system. Provide a report documenting the results of system testing and timelines for trouble-shooting.
• Design and conduct a validation study, including:
  • specify study aims, participant characteristics, recruiting plans, inclusion and exclusion criteria, measures, primary and secondary endpoints, design and comparison conditions (if appropriate), power analyses and sample size, and data analysis plan;
  • develop appropriate human subjects protection / IRB submission packages and documentation of approval for the research plan; and
  • provide study progress reports quarterly, documenting recruitment and enrollment, retention, data quality assurance and control measures, and relevant study specific milestones. 
• Prepare a tutorial session for presentation at NCI and/or via webinars describing and illustrating the technology, its intended use and results from the validation study.
• In the first year of the contract, provide the program and contract officers with a letter(s) of commercial interest.
• Provide the program and contract officers with a letter(s) of commercial commitment.

Closing date: October 22, 2018, 5:00 PM Eastern Daylight Time

Apply for this topic on the Contract Proposal Submission (eCPS) website.

For full FY19 Contract Solicitation, CLICK HERE.