Clinical thought leaders in the organization who will keep pace with emerging research, clinical trial results, approvals, and expansions and create pathways and mechanisms to spread this information.
As of 2020, one in every five deaths in the United States is due to cancer.1 The prevalence of cancer in the U.S. is driving the need for new therapies to combat the disease; notable among these is theranostics. While Theranostics is not new, it has evolved significantly over the last several years, enabling radioisotope- based therapies to deliver more precise and targeted treatments with greater success rates and less toxicities.
Many healthcare organizations have the capabilities to design and provide a theranostics program; However, even those organizations with existing programs find that their services may not be well- designed for growth and optimal care delivery.
A multi-disciplinary team should define the program’s vision and goals first, and subsequently design the program elements around how best to meet them. For example, what is driving the interest in a theranostics program? Is the service substantiated by community need? What model will best suit the organization and the community now and into the future?
Whether the program is designed internally or with the support of a strategic partner, there are several program considerations that if assessed and addressed, will pave the way for successful program activation and sustainment.
Consider Program Headwinds
While the compelling Theranostics care story is encouraging healthcare leaders to develop and advance their own programs, we’ve seen organizations face significant challenges, including:
Ill-defined Vision & Strategy: Providing treatments without establishing standard operating procedures or defining program goals.
Insufficient Market Demand or Extreme Market Competition: Inadequate demand for service, or referring physicians and patients are unaware of program and treatments.
Inadequate Program Governance: Absence of a well-defined governance model and operating mechanisms resulting in poor program oversight, ineffective decision- making, and inefficient and disjointed operating practices.
Divided or Competing Leadership: Fragmented program leadership inhibiting collaboration and a smooth care pathway.
Untimely or Unreliable Radiopharmaceutical Supply Chain: Less challenging than previously, but lack of coordination can lead to delays or missed treatments
Limited Space and Location for Treatment: Limited days and hours that doesn’t allow care team to meet current and/or future demand. Location is not ideal for patient care or staff workflows.
Limited Capital for Program Investment: Insufficient financial resources necessary to acquire and maintain appropriate equipment and resources.
Untrained or Overburdened Staff: Staff “borrowed” from other areas/departments without standard processes and training resulting in safety or care gaps.
Underestimated Licensure and Regulatory Requirements: Radioactive substances are highly regulated; licensure and compliance requirements must be met to ensure patient and provider safety.
Becoming proficient in this new field requires significant dedication to education and training as well as an additional level of experience and expertise.
Program models vary based on scope and need
Establishing the appropriate program requires determining the right level of theranostics care. The table below illustrates the scope of services offered across three common program models that exist today, spanning limited outpatient services to comprehensive, multi-disciplinary oncology services.
Oncology programs
Theranostics as a service only
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Limited oncology service offerings
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Diagnostic imaging and treatment monitoring performed elsewhere
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Referrals for treatment only
Cancer care center
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Common oncology treatment options
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Shared treatment space and imaging equipment
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Multidisciplinary leadership
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Referrals for consult and treatment
Specialized theranostics care center
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Expansive and cutting-edge oncology treatment options
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Clinical trial participation
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Dedicated treatment space and imaging equipment
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Multidisciplinary leadership
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Established internal and external oncology referral patterns
Note: The above chart is only a guide. Although there are three levels listed above, many programs may fall in between levels or have varying degrees of capabilities. Each organization can adjust their individual program to community and provider needs.
Build your blueprint
Equipped with a vision and model, healthcare leaders should keep the following principles at the forefront of their program development process:
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Is the Theranostics care model patient-centric with the relationships, linkages, and transitions needed to provide a comprehensive continuity of care?
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Does the program strategy account for anticipated industry changes, community needs, and competitor dynamics?
A comprehensive assessment of current state capabilities will inform the planning and design of the program—as well as required investments—to best position the program for success. Additional program design considerations are listed below.
Defining vision and goals, as well as strengths and limitations, should inform the optimal program structure for theranostics care within your organization. Theranostics programs do not meet the “one-size-fits-all” approach, but should be tailored to meet an organization’s community, clinical, operational, and financial priorities.
Creating the optimal Theranostics program
Align
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Align the Theranostics program design with your organization's broader strategy to ensure that the program integrates seamlessly.
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Ensure that your organization's overall mission, vision, and priorities are reflected in the program design
Assess
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Assess your internal capabilities and be prepared to address any gaps.
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Establish a multidisciplinary team to govern the Theranostics program, which may include providers, staff, and leaders from Nuclear Medicine, Medical Oncology, Radiology, and/or Radiation Oncology.
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Clearly define roles and responsibilities for staff across the care pathway, realize additional staff and expertise needed, and allow for the development of defined policies and procedures.
Secure
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Secure the working relationships with radiopharmaceutical vendors, technology partners, and payers.
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Address all state and local regulatory, compliance, licensure, and safety requirements and leading practices
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Design program to best meet the needs of your patients, providers, and community.
For more information on development and expansion options, read Part 3: Why the right Theranostics strategic partner matters
REFERENCES
- https://gis.cdc.gov/Cancer/USCS/#/AtAGlance/
- The Journal of Nuclear Medicine, Vol 64, no 6, June 2023
