The strategic importance of theranostics in personalized medicine Insights Brief: 9 steps on how to establish a theranostics program

A thorough understanding of the workflow is essential for integrating theranostics into clinical practice. This involves mapping out the entire process from patient selection, diagnostic imaging, radiopharmaceutical preparation, to the administration of therapy and subsequent monitoring. Attention must be paid to staffing, scheduling, and resource allocation to ensure smooth and efficient operation. A dedicated team comprised of trained technologists, radiopharmacists, nurses, and specialists in nuclear medicine is crucial for the effective execution of the theranostics process. State-of-the-art imaging technologies, such as PET/CT and SPECT/CT, along with the latest advancements in radiopharmaceuticals, are essential for maximizing the precision and effectiveness of treatments.

Depending on the existing infrastructure and the presence of a nuclear medicine or radiation oncology department, implementing theranostics usually requires investments in technology and infrastructure. Providers need to equip their facilities – also mentioned before –with advanced imaging and therapeutic equipment, which are critical for the application of radionuclides and radiopharmaceuticals.

Comprehensive financial planning and cost-benefit analysis is necessary for the successful and sustainable implementation of theranostics. This includes developing a robust financial model with detailed projections for costs, revenues, and potential savings from more efficient treatment pathways. Initial investments in technology and infrastructure upgrades must be balanced with long-term financial sustainability. A thorough analysis should encompass not only the upfront investments but also the ongoing costs of technology maintenance, operations, staff training, and waste management.

Theranostics faces unique reimbursement challenges requiring simultaneous approval for both components but offers additional revenue opportunities as reimbursement extends to therapeutic aspects. Various jurisdictions handle these issues differently, making effective management essential for hospitals. In the U.S., reimbursement involves both Medicare and private insurers, with intricate processes for concurrent approvals. Insurance claims can be denied if incorrect criteria are applied.

Optimistically, reimbursement frameworks are expected to evolve, supporting early-stage cancer diagnosis and treatment. This evolution addresses ethical considerations in socially funded health insurance systems, ensuring fair resource allocation. In Europe, for example, broader applications and early-stage interventions are expected to lead to more accessible pricing and clearer reimbursement pathways. Australia’s smoother reimbursement processes, facilitated by private insurers, showcase a model where theranostics thrives without significant financial barriers.

Effective training, development, and recruitment programs are essential for the successful implementation of theranostics. Existing staff may require ongoing training programs and new specialists may need to be recruited, as needed. Training programs should cover all aspects of theranostics, from patient selection and diagnostic imaging to the preparation and administration of radiopharmaceuticals.

With the right team in place, patient outcomes can be enhanced and hospitals can ensure that they remain at the forefront of innovative cancer care.

Ensuring regulatory and ethical compliance is critical for implementing theranostics. This involves adhering to the specific regulations on handling and disposing of radioactive materials and meeting local, national, and international standards. A dedicated compliance team may be necessary to monitor and adapt to ongoing regulatory changes. Robust internal regulatory and ethical processes are also important for hospitals to mitigate risks, enhance patient trust, and deliver safe, effective theranostic treatments.

Ethical considerations include obtaining informed consent, ensuring patient privacy, and addressing dilemmas that arise during treatment. Patients must fully understand the nature, risks, benefits, and outcomes of theranostics to make informed decisions.

Hospitals should also balance the focus on early-stage versus late-stage cancers to ensure fair resource allocation. Equitable access is essential, as theranostics can be expensive and resource-intensive. Ensuring all patients, regardless of socio-economic status, have access to these treatments should be a priority, particularly in publicly funded systems.

Entering into strategic partnerships and collaborations to cover gaps can be essential for driving theranostic applications. Partnerships with biotech firms, pharmaceutical companies, and academic institutions can provide hospitals with the latest advancements in theranostic technologies and treatments. Collaborating with industry leaders and engaging in joint research projects and clinical trials can also be of value. Such collaborations can facilitate the exchange of knowledge and best practices, enhancing the overall quality of care provided to patients. By fostering a collaborative ecosystem, hospitals can accelerate the development and implementation of theranostic solutions.

Implementing a system for ongoing evaluation of clinical outcomes, patient satisfaction, and financial performance allows hospitals to monitor the success of their theranostic treatments, while data analytics can provide valuable insights into the effectiveness of different treatment protocols and identify areas for improvement. This iterative process of evaluation and adaptation supports the continuous improvement of theranostic services, leading to better patient outcomes and operational efficiencies.