The strategic importance of theranostics in personalized medicine

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

Article authors: Isabel Heim and Lady Tatiana Sawoszczyk | Reading time: 10 minutes


Theranostics has revolutionized the way we think about personalized medicine, especially cancer treatment. In the last 10 years, theranostics has emerged as an innovative approach to tailored disease management. Discover the strategic importance of theranostics and learn how it can be deployed in healthcare systems today.

Implementing a theranostics program into an existing practice requires a comprehensive set of considerations including technology investments, staff training, regulatory compliance, strategic partnerships, and financial planning.

1. Evaluate potential patient base

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.

2. Understand the workflow and technology

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.

3. Conduct financial planning and cost-benefit analysis

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.

4. Explore reimbursement possibilities

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.

5. Implement training and development programs

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.

6. Ensure regulatory and ethical compliance

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.

7. Explore opportunities for strategic partnerships and collaboration

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.

8. Develop effective marketing strategies
Theranostics offers advanced, personalized treatment options that can attract patients seeking innovative cancer care. To effectively communicate the benefits of these relatively new and complex services, institutions should develop targeted marketing campaigns that highlight the personalized nature and clinical efficacy of theranostic treatments. Utilizing patient success stories and data-driven results can illustrate the tangible benefits of theranostics, building trust and interest among potential patients and other healthcare providers.
9. Ensure continuous evaluation and adaptation

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.


What is theranostics?


Theranostics is an advanced, integrative approach to healthcare that combines diagnostics and therapeutics to enhance personalized and precise medical care.

Theranostics has transformed the way we provide medical care and has revolutionized the way we think about personalized medicine, especially cancer treatment. In the last 10 years, theranostics has emerged as an innovative, new approach to tailored disease management. Since 2014, more than 20,000 articles on theranostics have beenpublished.1 But, what exactly is theranostics? How is it being used today? And what issues must be addressed to unlock its full potential in the years ahead?

This paper evaluates the strategic importance of theranostics and discusses how it can be deployed in healthcare systems today. It also assesses its potential in terms of improving patient outcomes, operational efficiency, and patient care standards. In order to make effective use of theranostics, healthcare leaders can gain a competitive advantage by having a clear understanding of how to integrate it into their services. This paper provides a 9-step guide that enables establishing a theranostics program.

Strategic relevance

Theranostics, a combination of “therapy” and “diagnostics”, is an approach within personalized medicine that uses radioactive drugs both to diagnose and treat specific cancer types. This method pairs diagnostic and therapeutic biomarkers to different radiotracers targeting the same tumor. Both the diagnostic and therapeutic radiotracers attach to the same specific biological markers.

This integration allows for highly targeted treatments based on precise diagnostic data, improving treatment efficacy and reducing side effects.2

Theranostics leverages molecular imaging to tailor treatments to the individual patient. By using techniques such as PET (Positron Emission Tomography)/CT and SPECT (Single Photon Emission Computed Tomography)/CT, theranostics can accurately locate tumors and assess their characteristics, enabling personalized dosimetry and treatment planning. This approach ensures that treatments are specific to the patient’s unique tumorprofile.3

The current impact of theranostics is greatest in oncology, where it already plays a key role in the management of prostate cancer, neuroendocrine tumors, thyroid cancer, and metastatic liver cancer. 

Currently, many healthcare institutions and outpatient clinics are establishing theranostics programs to meet the demand of the increasing patient volume. Increasing the number of theranostics facilities can contribute to reducing long waiting lists and enable timely treatment for patients. 

In the coming years, the growth of theranostics is projected to be significant. The global theranostics market is currently valued at more than US$2 billion, and some projections anticipate a compound annual growth rate of more than 13% between now and 2032.4

Identifying and selecting suitable patients, often involving genetic testing or imaging studies to identify targets that theranostic agents can address, is essential. Other criteria used to identify patients include the type of cancer, the presence of certain biomarkers, and a patient’s previous treatment history.

Once suitable patients have been identified, advanced pre-therapy diagnostic imaging is required to plan the therapeutic strategy. This usually involves advanced imaging technologies like PET and SPECT, enhanced by AI-driven algorithms, to facilitate detailed, non-invasive tumor assessments. A radiolabeled diagnostic agent is administered to the patient. This agent is designed to bind specifically to cancer cells or other disease markers. After allowing time for the agent to circulate and bind to target cells, imaging is performed using techniques like PET or SPECT. These images provide detailed information about the location and extent of disease, and more importantly, confirm the presence of the target biomarker. At this point, patients undergo further evaluation and preparation which includes clinical assessment and baseline imaging to confirm the suitability for theranostic procedures.

Once this patient assessment and preparation has been completed, the next step involves radiopharmaceutical production and delivery. Radiopharmaceuticals (compounds labeled with radioisotopes) are prepared in a dedicated radiopharmacy. This includes calibration and dose preparation tailored to individual patient needs based on the pre-therapy imaging results. Prepared doses must then be rigorously checked for quality and safety. Theranostic treatment consists of radiopharmaceutical administration supported by a further imaging. Patients receive the radiopharmaceuticals intravenously in specialized injection rooms, followed by a period of waiting while the compound localizes in the target tissues. Imaging sessions are conducted, again using high-resolution PET/CT or SPECT/ CT systems, to confirm the distribution and uptake of therapeutic agents.
Post-therapy imaging and assessment is then used to assess the efficacy of the therapeutic intervention, providing vital information on how the disease has responded to treatment. Based on these results, additional rounds of therapy may be adjusted or optimized, continuing the cycle of assessment and treatment as needed. All imaging data is then analyzed using advanced software that provides quantitative assessments of radiotracer uptake. This data is critical for determining therapeutic impact and planning future treatment cycles. Detailed reports are generated for each patient, documenting the treatment course and outcomes, which are then reviewed in multidisciplinary team meetings.
Patients are continuously monitored through scheduled follow-ups involving imaging and clinical assessments to manage any long-term treatment effects and to ensure optimal care.

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