LAUNCH SERVICE STRATEGY: DESIGNING AND SCALING PATIENT SERVICES FOR GLOBAL PRODUCT LAUNCHES

Reading time: 9 minuti

A successful pharmaceutical product launch depends on more than the availability of an effective therapy. As treatment pathways become increasingly complex and healthcare delivery moves beyond traditional clinical settings, patients and Healthcare Professionals (HCPs) may need support at several points along the treatment journey. Diagnostic and referral support, treatment initiation, patient education, monitoring and follow-up, and adherence support can all play a role in helping patients access and manage a new therapy.

For pharmaceutical companies, developing these Patient Services across multiple countries presents a complex set of challenges. Patient needs are not identical from one market to another, and healthcare systems differ in their infrastructure, clinical pathways, resources, reimbursement models, digital maturity, and regulatory requirements. At the same time, global teams need to avoid fragmented approaches and ensure that the services developed around a new therapy are coherent and scalable.

The literature does not describe these activities as a single, established discipline called “Launch Service Strategy”. Instead, relevant evidence is found across several fields, including patient-centred care, implementation science, human-centred design, and healthcare delivery research. Taken together, this literature highlights a number of principles that are relevant to the development of Patient Services: understanding the needs of patients and other stakeholders, involving them in service design, adapting interventions to local contexts, bringing together different areas of expertise, and considering implementation from the outset.¹¹¹

The question for pharmaceutical companies is how to bring these principles together when developing and launching Patient Services across multiple markets.

THE GROWING COMPLEXITY OF PATIENT SERVICE ECOSYSTEMS

Patient support has evolved considerably beyond traditional information and helpline-based models. Healthcare delivery is increasingly moving closer to patients, including through ambulatory and home-based models, as healthcare systems respond to ageing populations and the growing burden of chronic disease.²

These changes have broadened the role that Patient Services can play around a newly launched therapy.

Depending on the disease and treatment pathway, services may include diagnostic and referral support, treatment initiation and onboarding, patient and HCP education, monitoring and follow-up, adherence support, coordination between healthcare professionals and care settings, and digital tools that facilitate interactions throughout the patient journey.

The challenge is therefore not simply to develop a Patient Support Program (PSP). It is to understand which combination of services may be needed to support patients and HCPs at different stages of the treatment pathway, and how those services should work together.

This becomes particularly important at product launch. The introduction of a new therapy may bring changes to clinical pathways, treatment initiation, monitoring requirements, or the way patients interact with healthcare professionals. The services supporting the therapy need to be considered within this wider context.

GLOBAL SCALABILITY AND LOCAL RELEVANCE

Developing Patient Services for several countries introduces another important consideration: how to maintain a consistent global direction while responding to local healthcare realities.

Research on the adaptation of evidence-based interventions has examined the balance between maintaining the core elements of an intervention and modifying other components to fit the context in which it is implemented.˒ This distinction is particularly relevant when a service model is developed for use across different healthcare systems.

The practical differences between markets can be considerable. Healthcare infrastructure, workforce capacity, referral pathways, reimbursement mechanisms, and digital maturity may vary significantly between countries. Regulatory and data-protection requirements can also influence how patient information is collected, processed, and used, making local compliance an important consideration during service development.

For pharmaceutical companies, two approaches can create problems. A rigid global model may not fit local healthcare pathways or operational realities. At the other extreme, allowing each country to develop its own solution independently can lead to duplication, inconsistent approaches, and limited opportunities to share learning across markets.

A more balanced approach starts with collaboration between global teams and the relevant country affiliates. Local teams can contribute practical knowledge that may not be visible from a central perspective, including local compliance requirements, healthcare workflows, available infrastructure, resources, and previous experience in delivering Patient Services.

In our experience, involving countries early in the process can help identify where a common global approach is appropriate and where local adaptation will be necessary. The goal is not to make every service identical. It is to establish a clear framework that can be applied consistently where consistency matters, while allowing the elements that depend on local context to be adapted accordingly.

CO-DESIGNING PATIENT SERVICES WITH PATIENTS AND HEALTHCARE PROFESSIONALS

A service can be scalable and operationally feasible and still fail to address the needs of the people expected to use it. This is why users’ involvement is an important part of service development.

Evidence on patient engagement suggests that meaningful involvement requires appropriate preparation, continued involvement throughout the process, and clear evidence that stakeholder contributions have influenced the outcome.¹

Human-centred design offers one way of putting these principles into practice. A recent study involving a Patient Advisory Group described the value of involving patients throughout the process, from defining the problem to contributing to the development and validation of engagement tools. The authors also highlighted the importance of establishing realistic expectations about the role of patients from the beginning.

In the context of a pharmaceutical launch, co-design can bring together several perspectives.

Patients and Patient Advisory Groups can help identify unmet needs and assess whether proposed services address meaningful barriers. HCPs can provide insight into clinical workflows, referral pathways, and the practical integration of a service into routine care. Where appropriate, physicians who have experience with the relevant therapy, including those who participated in clinical trials, may also contribute valuable insight into how the treatment is likely to be used in clinical practice.

Bringing these perspectives together early can help uncover practical issues before a service is implemented and increase the likelihood that the final model is relevant to those who will deliver and use it.

THE NEED FOR MULTIDISCIPLINARY EXPERTISE

The range of perspectives involved in Patient Service development also creates a need for different areas of expertise.

A service may need to be clinically appropriate, operationally feasible, compliant with applicable requirements, supported by suitable technology, and easy for patients and HCPs to use. These questions cannot always be answered from a single professional perspective.

Human-centred design and design-thinking approaches have been applied in different healthcare settings, with research reporting generally positive effects on usability and stakeholder satisfaction, although the comparative evidence base remains limited.

In practice, medical and nursing expertise can help assess clinical pathways and patient needs. Operations specialists can consider how a service will work within real healthcare environments. Digital expertise can help evaluate technology and interoperability. Service design can bring these perspectives together around the experience of patients and HCPs.

This combination becomes particularly important when a service is intended for implementation across several countries. A model that is clinically appropriate may prove difficult to deliver within a particular healthcare system. A digital solution may be technically attractive but unsuitable for the infrastructure available locally. A service that appears intuitive from a corporate perspective may not address the barriers patients actually experience.

A multidisciplinary approach can help bring these questions into the design process rather than identifying them only once implementation is already underway.

A MODULAR APPROACH TO PATIENT SERVICE DEVELOPMENT

The same need for flexibility also supports a modular approach to Patient Services.

Research on intervention adaptation suggests that scaling an intervention across different settings requires a balance between preserving essential elements and modifying others according to local circumstances.˒ The same logic can be applied when considering how a Patient Service ecosystem might be structured across multiple markets.

Rather than treating a service as one fixed intervention, pharmaceutical companies can consider a set of components that can be combined and adapted according to the needs of a particular patient population and healthcare system.

Depending on the therapy and the market, these components might include diagnostic and referral support, treatment initiation, patient education, monitoring and follow-up, adherence support, or digital interactions.

Not every country will require every component, and the way a component is delivered may also differ. A modular approach can therefore provide a degree of consistency without requiring every market to implement exactly the same model.

This does not mean that modularity itself has been established as a distinct evidence-based methodology for pharmaceutical Patient Services. Rather, it is a practical application of the broader principle of adapting interventions to context while preserving their essential elements.˒

FROM INDIVIDUAL PRINCIPLES TO A LAUNCH SERVICE STRATEGY

The evidence discussed above comes from different areas of healthcare research, but several themes recur.

Patient engagement research highlights the importance of understanding and involving patients.¹ Research on intervention adaptation points to the need to balance consistency with local relevance.˒ Human-centred design supports structured involvement of patients and other stakeholders in developing solutions.˒ Digital health research recognises the differences in infrastructure and digital maturity that can affect implementation.¹⁰ Implementation science highlights the importance of considering the context in which an intervention is introduced and sustained.¹¹

These areas of evidence are not usually brought together under a single methodology for pharmaceutical launches. Yet, for companies developing Patient Services across multiple markets, they address different parts of the same practical problem.

This is where the concept of a Launch Service Strategy can provide value.

Rather than representing a new discipline in its own right, a Launch Service Strategy can be viewed as an integrated way of bringing these established principles together around the launch of a therapy. It connects patient and stakeholder insights with local adaptation, co-design, multidisciplinary expertise, modular service development, digital enablement, and implementation.

BRIDGING THE GAP BETWEEN STRATEGY AND EXECUTION

Developing a service framework is only the beginning. The way that framework is implemented can ultimately determine whether it delivers the intended value.

Implementation science has long recognised the difficulty of maintaining the benefits of an intervention when moving from controlled or highly supported environments into routine practice. The Dynamic Sustainability Framework, for example, emphasises the interaction between interventions and the changing contexts in which they are implemented over time.¹¹

For global Patient Services, this means that a successful launch requires more than a well-designed blueprint. Clear ownership, appropriate resources, local engagement, and the ability to learn and adapt over time all need to be considered.

This is where the different elements described throughout this article come together. Patient insights inform the service. Co-design helps ensure that it reflects the perspectives of those who will use and deliver it. Multidisciplinary expertise brings together clinical, operational, digital, and service design considerations. A modular structure allows relevant components to be adapted to local circumstances. Collaboration between global and country teams helps connect strategic consistency with local feasibility.

In our experience, pharmaceutical organisations often have access to valuable patient insights and internal expertise. The difficulty is bringing these capabilities together and translating them into a coherent approach that can be implemented across multiple countries.

SELECTING THE RIGHT STRATEGIC PARTNER

Addressing these challenges requires more than a global blueprint; it demands practical expertise across the key disciplines that determine whether a Patient Service can move successfully from strategy to implementation.

A partner capable of driving this process needs to bring together medical, nursing, operational, digital, and service design capabilities centred around the real-world needs of patients and HCPs. This multidisciplinary combination enables end-to-end support throughout the lifecycle, from unearthing deep stakeholder insights, to designing a cohesive service model, to guiding its practical execution across local markets.

 

CONCLUSION

The successful launch of a new therapy depends not only on the medicine itself, but also on the systems and services that support patients and HCPs around it.

Patient Services can play an important role across the treatment journey, but designing and implementing them at global scale is complex. Healthcare systems differ, patient and HCPs needs vary, and the regulatory, operational, and technological conditions required for implementation are not the same in every market.

Research across patient engagement, intervention adaptation, human-centred design, digital health, and implementation science points to a number of principles that can help address these challenges.¹¹¹

A Launch Service Strategy provides a way to do this. It brings together insights and needs exploration, local co-design, multidisciplinary expertise, adaptable service components, digital solutions, and implementation considerations around the launch of a therapy.

In our experience, the value of this approach lies in connecting global strategy with local reality. The objective is to help pharmaceutical companies develop Patient Service ecosystems that are sufficiently coherent to scale across markets, while remaining relevant and feasible within the healthcare environments in which they are delivered.

This means moving beyond the idea of a Patient Support Program as an isolated initiative and towards a broader approach to Patient Services—one that considers the needs of patients and HCPs throughout the treatment journey and gives the service ecosystem the same strategic attention as the therapy it is designed to support.

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REFERENCES

  1. Bombard Y, Baker GR, Orlando E, Fancott C, Bhatia P, Casalino S, Onate K, Denis JL, Pomey MP. Engaging patients to improve quality of care: a systematic review. Implement Sci. 2018;13(1):98.
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  4. Escoffery C, Lebow-Skelley E, Udelson H, Böing EA, Wood R, Fernandez ME, Mullen PD. A scoping study of frameworks for adapting public health evidence-based interventions. Transl Behav Med. 2019;9(1):1-10.
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  6. OECD/European Union. Health at a Glance: Europe 2022: State of Health in the EU Cycle. Paris: OECD Publishing; 2022.
  7. Regulation (EU) 2016/679 of the European Parliament and of the Council of 27 April 2016 (General Data Protection Regulation). Official Journal of the European Union. 2016;L119:1-88.
  8. Knaub M, Leon S, Pokharel S, Kiryanova V, Giroux K, Khanna P, Rychtera A, Duquette D, Mathura P, Verdin N, Ambasta A. Using Human-Centred Design to Codesign Patient Engagement Tools With a Patient Advisory Council: Successes and Challenges. Health Expectations. 2025;28(2):e70230.
  9. Altman M, Huang TTK, Breland JY. Design thinking in health care. Prev Chronic Dis. 2018;15:E117.
  10. World Health Organization. Global Strategy on Digital Health 2020-2025. Geneva: WHO; 2021.
  11. Chambers DA, Glasgow RE, Stange KC. The dynamic sustainability framework: addressing the paradox of sustainment amid ongoing change. Implement Sci. 2013;8:117.

Patient Support Programs and Home Treatment: Clinical and Organizational Requirements for Home Infusion

Reading time: 4 minuti

In recent years, Patient Support Programs (PSPs) have taken on an increasingly central role in care models, responding to the growing complexity of chronic diseases and the need to ensure the sustainability of healthcare systems. In this context, patient support programs represent a strategic tool to improve therapeutic adherence, continuity of treatment, and home-based care1,2.

Home Treatment PSPs represent one of the most advanced models in patient support services, enabling the administration of drug therapy directly at home. In particular, home infusion programs make it possible to transfer the hospital setting to the patient’s home, ensuring therapeutic continuity, clinical safety, and quality of care3.

The value of a Patient Support Program is not limited to therapy administration; it lies in the ability to design a structured organizational model capable of generating concrete benefits for patients, clinicians, the healthcare system, and pharmaceutical companies.

 

THE VALUE OF HOME TREATMENT PATIENT SUPPORT PROGRAMS FOR PATIENTS, CLINICIANS, AND PHARMACEUTICAL COMPANIES

A well-designed Home Treatment model represents a strategic tool. For patients and caregivers, home infusion reduces hospital visits and travel, with positive impacts on quality of life and daily disease management. Scientific evidence shows that PSPs improve compliance, clinical outcomes, and patient experience, while also contributing to a more efficient use of healthcare resources1,2.

For the specialist physician, this program supports clinical management and patient monitoring; for the healthcare system, it promotes greater organizational efficiency and reduces the burden on hospital care. For pharmaceutical companies, Patient Support Programs help strengthen reputation and positioning, promoting continuity of treatment and the quality of the care pathway1.

 

CRITICAL SUCCESS FACTORS OF A HOME INFUSION PATIENT SUPPORT PROGRAM

The effectiveness of a Home Treatment PSP depends on the integration of design, clinical and managerial skills, and technological infrastructure. Let’s look at the main factors that determine the program’s solidity and effectiveness.

 

NEEDS ANALYSIS AND PROGRAM DESIGN

An effective Patient Support Program stems from a structured analysis of the clinical and organizational needs of patients and clinicians. Advisory boards and focus groups gather useful information to design PSP services that align with the patient journey, focusing on therapeutic continuity and home-based care.

 

DISCIPLINARY TEAM AND PROGRAM QUALITY

The presence of a multidisciplinary team represents a key element. Alongside the Design Manager and Program Manager, who are responsible for design and operational coordination, specialist figures operate to guarantee clinical quality, regulatory compliance, and the overall value of the program.

The Medical Department defines and updates care protocols, ensuring clinical appropriateness and high quality standards, while pharmacovigilance and compliance specialists oversee the regulatory aspects required by pharmaceutical companies. In parallel, technological support helps optimize the patient experience and the overall effectiveness of the project.

 

MEDICAL DEPARTMENT AND CLINICAL SAFETY IN HOME INFUSION

The Medical Department represents a pillar of home infusion PSP programs, playing a central role in defining care protocols and training nursing staff. Operator training includes not only the technical execution of the infusion, but also the clinical management of the patient and knowledge of the disease and drug.

During service delivery, the Medical Department maintains an active role, authorizing therapy administration based on the clinical parameters detected and supporting the management of any critical issues in coordination with the specialist physician. Real-world evidence indicates that home infusion can maintain a favorable safety profile, improve therapeutic compliance, and increase patient satisfaction³,.

 

TECHNOLOGY AND DIGITALIZATION OF THE PSP

Technology represents a strategic element in Patient Support Programs, as digitalization enables structured and secure clinical data collection, real-time sharing with the Medical Department and the specialist physician, and more timely patient management. In home treatment models, the technological infrastructure also allows for the monitoring of performance indicators (KPIs) and service levels (SLAs), ensuring traceability and continuous control of the program.

The integration of clinical expertise and digital tools helps improve safety, therapeutic adherence, and continuity of care, supporting the development of care models increasingly focused on home-based care and the personalization of the patient journey5.

 

CONCLUSIONS

An effective Home Treatment Patient Support Program is not limited to the administration of home therapy; it is founded on a structured organizational model capable of guaranteeing clinical quality and safety1.

In a healthcare context increasingly focused on home-based care, Patient Support Programs represent a key tool for developing home care models with high clinical and organizational value1.

 

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REFERENCES

  1. Sacristán JA, Artime E, Díaz-Cerezo S, Comellas M, Pérez-Carbonell L, Lizán L. The Impact of Patient Support Programs in Europe: A Systematic Literature Review. Patient. 2022 Nov;15(6):641-654.
  2. Ganguli A, Clewell J, Shillington AC. The impact of patient support programs on adherence, clinical, humanistic, and economic patient outcomes: a targeted systematic review. Patient Prefer Adherence. 2016 Apr 28;10:711-25.
  3. Toscano A, Musumeci O, Sacchini M, Ravaglia S, et al. Safety outcomes and patients’ preferences for home-based intravenous enzyme replacement therapy (ERT) in pompe disease and mucopolysaccharidosis type I (MPS I) disorder: COVID-19 and beyond. Orphanet J Rare Dis. 2023 Oct 27;18(1):338.
  4. Ceravolo F, Mascaro I, Sestito S, Pascale E, Lauricella A, Dizione E, Concolino D. Home treatment in paediatric patients with Hunter syndrome: the first Italian experience. Ital J Pediatr. 2013 Sep 9;39:53.
  5. Alotaibi YK, Federico F. The impact of health information technology on patient safety. Saudi Med J. 2017 Dec;38(12):1173-1180.

PSPS AND SUPRANATIONAL DESIGN

Reading time: 3 minuti

The growing number of publications and observational studies regarding PSPs in Europe over the last 10 years demonstrates the significance of their impact on healthcare. However, as demonstrated by the literature in this field, achieving their full potential requires developing guidelines and recommendations to harmonize the definition of PSPs at the European level, standardizing their methods, systematically measuring their impact, and developing digital technologies and care models capable of integrating with each nation’s individual healthcare offering.

The challenges of glocalization

Each PSP presents unique challenges and requires a design targeted at specific objectives, target audiences, and countries. There is no plug-and-play method that can be replicated across different territories, although it is possible to define a set-up of standardized components with the flexibility for last-mile adaptations differentiated by country. In the pharma-provider relationship, it therefore becomes crucial to create value for all PSP stakeholders, monitor and analyze the services and products delivered through a data-driven approach, and optimize the application of regulations and GDPR regarding personal data processing and privacy.

The financial return

Today, healthcare companies are called upon to develop treatments and services that support people suffering from rare, chronic, or degenerative diseases (and their caregivers) throughout their entire stay in therapy. The PSP represents the model capable of satisfying this therapy-service combination, ensuring patient safety and pharmacovigilance by monitoring all potentially serious side effects; better disease management, especially in chronic conditions and long-term monitoring; and greater treatment efficacy.

In a 2018 briefing paper prepared by the NHS Confederation, which supports and speaks for the healthcare system in England, Wales, and Northern Ireland, it was estimated that there are over 15 million patients with long-term conditions in the UK, whose care accounts for the largest consumption of NHS resources, averaging 55% of GP appointments, 68% of outpatient and emergency department appointments, and 77% of inpatient bed days. Improving care for chronic patients is therefore the objective for better managing healthcare budgets. The design of effective PSPs aimed at patient-centered care and digital management represents the solution to this challenge.

Digital support e home therapy

A study conducted by Rock Health Advisory, a digital health innovation accelerator, regarding the growth of investments and digital health startups has shown how investor interest in remotely managed digital health, through mHealth platforms, generated a turnover of 6 billion dollars in 2017 alone. Digital technologies certainly require attention both from the perspective of the structure of the service provided—to ensure that there are appropriate features to guarantee compliance with obligations such as Pharmacovigilance —and from the perspective of personal data protection, but they open up new scenarios for PSP customization and the streamlining of multi-country procedures. Indeed, through technological innovations and software solutions, it is possible to dematerialize the patient journey and make the entire care process, as well as the activities of the figures involved—from patients and doctors to healthcare professionals—more efficient. In the case, however, of applying care-based support, such as home therapy, it is necessary to possess a knowledge and setup that, in addition to integrating with each national reality’s individual offering, complies with the procedures and regulations set forth by the responsible supranational bodies, such as the European Medicines Agency (EMA), the Committee for Advanced Therapies (CAT), the Committee for Medicinal Products for Human Use (CHMP).