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  • The Role of Sentiment Analysis in Predicting Market Shifts and Driving Early Market Access Strategy

    The Role of Sentiment Analysis in Predicting Market Shifts and Driving Early Market Access Strategy

    The Role of Sentiment Analysis in Predicting Market Shifts and Driving Early Market Access Strategy

    Market access has evolved into a multidisciplinary strategy and is no longer confined to traditional pricing and reimbursement. It ensures rapid and sustained availability of therapies to the right patients at the right price.(1) As market access continues to evolve and become more dynamic with rising healthcare costs and growing stakeholder diversity, pharmaceutical companies need to look beyond conventional tools. Sentiment analysis (SA), a branch of social media listening (SML) that uses natural language processing (NLP) to classify texts based on opinion-based or emotional content, offers a compelling solution. SA enables early detection of mindset shifts in perception of treatments by mining real-time data from digital platforms.(2,3)

    SA or opinion mining works by classifying text to detect the contextual polarity of the written content as positive, neutral, or negative.(2) Apart from social media which contributes most data for SA, data is also extracted from other sources such as news articles, blogs, forums, or even clinical documents.(3) In pharmaceutical industry, SA provides early insights into how treatments or disease areas are perceived by patients, clinicians and policymakers. It captures real time emotions, doubts and hidden support which are crucial to anticipate product uptake and shaping market access decisions.(4)

    SA has various applications in early market access planning. It can enable competitive intelligence by analysing stakeholder sentiment around drug launches of competitive interventions, revealing enthusiasm or scepticism. It can help in stakeholder mapping by identifying early adopters, digital key opinion leaders (KOLs), and patient advocates, by reading their online presence. It can also detect pricing and reimbursement cues through reactions from patients and payers through policy pushback, public outrage, or unexpected support. Additionally, SA can gauge regulatory and HTA sentiment by analysing tone in consultations, policy drafts, or legislative debates, providing early advantage in navigating access challenges.(1,2)

    SA is already extensively utilized in the real-world setting in the healthcare industry. For instance, online scepticism delayed biosimilar uptake in parts of Europe despite having a regulatory approval. Feedback was captured through clinician commentary and forums.(2) SA has also been used to detect adverse drug reactions, offering earlier risk signals which may not be captured through official surveillance systems.(5,6) SA can add geographic sensitivity revealing how messaging can be pivoted or economic models can be adjusted across countries or subpopulations. This supports early stakeholder engagement in launch planning.(4)

    Despite the promising scope, SA has a few limitations including bias in source data due to overrepresentation of digitally active users, giving skewed insights.(2) Also, sentiment does not always reflect the behaviour or intent, requiring triangulation with other research methods. Ethically, SA needs to responsibly use public content ensuring transparency and privacy.(2)

    In conclusion, SA provides insight into real-world perceptions that influence access outcomes and can be used to transform market access strategies. By understanding early signs of resistance or unmet needs, SA can enable planning and better alignment with key stakeholders. In an increasingly digital healthcare environment, market access teams should embrace SA as a strategic monitoring tool to strengthen early-phase decision-making to ensure long term success.

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    References:

    1. Kumar A, Juluru K, Thimmaraju PK, Reddy J, Patil A. Pharmaceutical market access in emerging markets: concepts, components, and future. J Mark Access Health Policy. 2014 Dec 1;2.
    2. Sharma C, Whittle S, Haghighi PD, Burstein F, Keen H. Sentiment analysis of social media posts on pharmacotherapy: A scoping review. Pharmacol Res Perspect. 2020 Oct;8(5):e00640.
    3. Devika MD, Sunitha C, Ganesha A. Sentiment analysis: A comparative study on different approaches. Procedia Computer Science 2016;87:44–49.
    4. Sorayaie Azar A, Babaei Rikan S, Naemi A, Bagherzadeh Mohasefi J, Wiil UK. Predicting patients’ sentiments about medications using artificial intelligence techniques. Sci Rep. 2024 Dec 30;14(1):31928.
    5. Tricco AC, Zarin W, Lillie E, Jeblee S, Warren R, Khan PA, Robson R, Pham B, Hirst G, Straus SE. Utility of social media and crowd-intelligence data for pharmacovigilance: a scoping review. BMC Med Inform Decis Mak. 2018 Jun 14;18(1):38. 
    6. Coloma PM, Becker B, Sturkenboom MC, van Mulligen EM, Kors JA. Evaluating Social Media Networks in Medicines Safety Surveillance: Two Case Studies. Drug Saf. 2015 Oct;38(10):921-30. 

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  • Exploring Patient Registries: Managing Market Access With Real World Evidence

    Exploring Patient Registries: Managing Market Access With Real World Evidence
    Exploring Patient Registries Managing Market Access With Real World Evidence

    In the increasingly data-driven world of healthcare, patient registries have emerged as powerful tools for managing market access through the application of real-world evidence (RWE). These registries, essentially databases that collect information about patients’ demographics, clinical history, treatment outcomes, and other pertinent details, provide a treasure trove of insights that can bridge the gap between clinical trials and everyday medical practice. The use of patient registries in gathering RWE is transforming how pharmaceutical companies, healthcare providers, and policymakers evaluate and manage the accessibility and effectiveness of medical treatments and interventions.[1]

    Patient registries provide a comprehensive view of how treatments perform outside the controlled environment of clinical trials. Clinical trials, while essential for establishing the efficacy and safety of new therapies, often have limitations, such as restrictive inclusion criteria and relatively short follow-up periods. In contrast, patient registries encompass a broader patient population, including those with comorbidities and varying adherence levels, thus reflecting real-world scenarios more accurately. This inclusivity makes registries a valuable source of RWE, which is increasingly recognized by regulatory agencies and payers as critical for assessing the long-term value and impact of medical interventions. Regulators also view the use of registries as a key tool for generating RWE, supporting decision-making processes across areas such as post-market surveillance, submissions for regulatory approval, and health technology assessments (HTAs).[1]

    One of the primary benefits of utilizing patient registries is the ability to generate evidence on long-term safety and effectiveness of treatments. This ongoing evidence collection improves patient trust in the intervention, thereby increasing patient access. For instance, post-marketing surveillance through patient registries can uncover adverse effects or benefits that may not be apparent during pre-approval clinical trials. This continuous monitoring helps in ensuring that the treatments remain safe and effective once they are in widespread use, supporting regulatory decisions and guiding clinical practice. Consequently, this fosters greater confidence and willingness among patients to adopt new treatments, enhancing their accessibility and uptake in the general population.[2]

    Patient registries also play a pivotal role in market access by demonstrating the value of new treatments to payers and health technology assessment (HTA) bodies. The data derived from these registries can support health economic evaluations, such as cost-effectiveness and budget impact analyses, which are essential for reimbursement decisions. By providing robust evidence on the real-world effectiveness and safety of treatments, registries help build a compelling case for their adoption and coverage. This is particularly important in an era where healthcare budgets are constrained, and there is increasing scrutiny over the allocation of resources.[3]

    Despite their benefits, patient registries face challenges that must be acknowledged to provide a balanced perspective. Issues such as data quality inconsistencies, difficulties in patient recruitment, and regulatory hurdles can hinder their utility. For example, inconsistent data collection processes may impact the reliability of insights, and recruitment barriers can limit the diversity of patient populations within registries. Addressing these challenges requires standardizing methodologies, fostering collaboration among stakeholders, and ensuring compliance with evolving regulatory frameworks. Additionally, emerging trends such as the integration of digital health technologies and artificial intelligence (AI) are redefining the capabilities of patient registries. AI, for instance, can analyze large-scale registry data to identify patterns, predict treatment outcomes, and optimize resource allocation, enhancing the potential of RWE to inform decision-making.[4]

    Collaboration among stakeholders is critical for the success of patient registry initiatives. Engaging a diverse group of participants, including patients, healthcare providers, researchers, and industry partners, ensures that registries are comprehensive and relevant. Leveraging technologies such as electronic health records (EHRs) and mobile health applications can streamline data collection, improve accuracy, and enhance data utility. These collaborative and technological advancements position registries as powerful tools for addressing unmet medical needs, optimizing healthcare delivery, and achieving equitable access to treatments.[4,5]

    In conclusion, patient registries stand as pillars in the contemporary healthcare landscape, offering a bridge between clinical trials and real-world practice. Their role in managing market access through the application of RWE is indispensable, shaping how pharmaceuticals are evaluated, accessed, and integrated into healthcare systems. With their ability to capture the intricacies of patient experiences over time, these registries empower stakeholders to make informed decisions, driving advancements in healthcare delivery and ensuring that groundbreaking therapies reach those in need. By addressing challenges, embracing innovation, and fostering collaboration, patient registries will continue to play a transformative role in optimizing patient care and healthcare resource utilization.

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    References:

    1. Trotter JP. Patient registries: a new gold standard for “real world” research. Ochsner Journal. 2002 Sep 21;4(4):211-4.
    2. Reid CM. The role of clinical registries in monitoring drug safety and efficacy. Heart, Lung and Circulation. 2015 Nov 1;24(11):1049-52.
    3. Blommestein HM, Franken MG, Uyl-de Groot CA. A practical guide for using registry data to inform decisions about the cost effectiveness of new cancer drugs: lessons learned from the PHAROS registry. Pharmacoeconomics. 2015 Jun;33:551-60.
    4. Gliklich RE, Dreyer NA, Leavy MB. Patient registries. InRegistries for Evaluating Patient Outcomes: A User’s Guide [Internet]. 3rd edition 2014 Apr. Agency for Healthcare Research and Quality (US).
    5. Daugherty SE, Lee SB, Nowell B, Peay H, Solomon D, Valbrun TG, Velentgas P, Whicher D. The increasing focus on the patient in patient registries. In21st Century Patient Registries: Registries for Evaluating Patient Outcomes: A User’s Guide: 3rd Edition, Addendum 2018 Mar. Agency for Healthcare Research and Quality (US).

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  • Maximizing Pharmaceutical Adoption: The Role of Early Value Definition Across Stakeholders

    Maximizing Pharmaceutical Adoption: The Role of Early Value Definition Across Stakeholders
    Maximizing Pharmaceutical Adoption: The Role of Early Value Definition Across Stakeholders

    Successfully bringing a pharmaceutical product from development to market adoption requires careful planning to establish its value. The rise of emerging markets and personalized medicine has transformed the pharmaceutical landscape, introducing new considerations for defining the ‘value’ a pharmaceutical product can offer. Pharmaceutical companies must account for diverse patient populations, varying healthcare systems, and innovative treatment approaches. This shift necessitates a more nuanced understanding of value, incorporating regional market dynamics, patient-centric outcomes, and targeted therapies. Defining the value of a pharmaceutical product for different stakeholders early on and strategizing appropriate value messages to different stakeholders has a considerable influence on the success of the product.[1]

    Proactively defining value early and upfront during the development cycle allows pharmaceutical companies to center their strategies to meet the specific requirements of patients, healthcare providers, payers, and regulatory bodies. Each stakeholder group is known to interpret value differently. For instance, patients often prioritize the quality of life improvements and the cost of therapy. They look for treatments that will have real-life benefits and not have significant side effects. In contrast, healthcare providers are more interested in the safety and clinical efficacy, how well it fits into the current treatment protocols, and what impact there is on overall patient outcomes.[1] Payers, on the other hand, seek cost-effectiveness, budget impact, and the likelihood a product will contribute to a long-term reduction in healthcare costs. Each of these groups has the power to drive the overall value proposition of new pharmaceuticals. This comprehensive understanding allows pharmaceutical companies to refine their approaches to generate evidence effectively, optimizing market positioning and enhancing adoption rates.[2]

    Early value determination also expedites decision-making processes throughout the product lifecycle. It offers clarity to regulatory bodies evaluating market approval, accelerates negotiations for reimbursement with payers, and facilitates prompt engagement with healthcare providers to seamlessly integrate novel therapies into clinical practice. This proactive outlook minimizes entry delays, guaranteeing timely access to pioneering treatments for patients in critical need.[1,3]

    Defining and communicating value early is fraught with several challenges. The clinical outcomes and market dynamics during the early stages of drug development are highly uncertain. Additionally, different stakeholders are known to have different priorities and expectations, making it difficult to develop a value proposition that aligns universally. Besides, negotiating regulatory landscapes and compliance while crafting messages to different stakeholders introduces further complexity.

    Various approaches can be undertaken to face these challenges head-on. For instance, early and frequent stakeholder involvement in the process of drug development can help understand evolving needs, thereby providing valuable inputs to adjust value propositions accordingly. Adopting a patient-centric approach empowers the patient’s voice at the heart of the value discussions, thereby instilling trust and acceptance by all stakeholders. Familiarizing with the principles of health economics and outcomes research (HEOR) can be invaluable to plan for generating robust data; this can support value claims and facilitate payers and providers to make more informed decisions. Realizing the importance of real-world evidence (RWE) to complement the clinical trial data is essential to strategize conduct of real-world studies.[5]

    Communication of the value message to diverse stakeholders is also highly essential and requires tailored marketing strategies. For instance, patient-centric approaches by highlighting real-life benefits and patient testimonials often resonates effectively with patients. Healthcare providers can be engaged through clinical trials, peer-to-peer discussions, and medical education programs, emphasizing clinical effectiveness and protocol integration. Payers can be persuaded through comprehensive economic evaluations, budget impact analyses, and outcomes-based pricing models, demonstrating cost-effectiveness and long-term value. Regulatory clarity can be ensured through transparent and timely communication of clinical data, safety profiles, and quality assurances. By adopting such diverse strategies, pharmaceutical companies can navigate the complexities of value definition, communication, and adoption, ultimately enhancing market success and improving patient outcomes.[6]

    The voyage from pharmaceutical inception to widespread adoption pivots on the early determination of contextual value definitions. By proactively addressing the diverse needs and expectations of various stakeholders and fortifying strategies, pharmaceutical entities can elevate their market stature and optimize the adoption of groundbreaking therapies. This compelling approach to value communication not only enhances adoption rates but also builds lasting relationships with key stakeholders, fostering a collaborative environment conducive to ongoing innovation and improvement in healthcare.

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    References:

    1. Champagne D, Davidson A, Pérez L, and Saunders D. Creating value from next-generation real world evidence. McKinsey & Company Whitepaper. 2020. Creating value from next-generation real-world evidence (mckinsey.com) Accessed on 15 July, 2024.
    2. Bilinski A, Neumann P, Cohen J, Thorat T, McDaniel K, Salomon JA. When cost-effective interventions are unaffordable: Integrating cost-effectiveness and budget impact in priority setting for global health programs. PLoS Medicine. 2017 Oct 2;14(10):e1002397.
    3. Burns L, Le Roux N, Kalesnik-Orszulak R, Christian J, Hukkelhoven M, Rockhold F, O’Donnell J. Real-world evidence for regulatory decision-making: guidance from around the world. Clinical Therapeutics. 2022 Mar 1;44(3):420-37.
    4. Davies J, Martinec M, Martina R, Delmar P, Coudert M, Bordogna W, Golding S, Crane G. Retrospective indirect comparison of alectinib phase II data vs ceritinib real-world data in ALK+ NSCLC after progression on crizotinib. Annals of Oncology. 2017 Apr 1;28:ii36.
    5. Dagenais S, Russo L, Madsen A, Webster J, Becnel L. Use of real‐world evidence to drive drug development strategy and inform clinical trial design. Clinical Pharmacology & Therapeutics. 2022 Jan;111(1):77-89.
    6. Brogan AP, Hogue SL, Vekaria RM, Reynolds I, Coukell A. Understanding payer perspectives on value in the use of pharmaceuticals in the United States. Journal of Managed Care & Specialty Pharmacy. 2019 Dec;25(12):1319-27.

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  • When is the Ideal Moment to Start HEOR Activities Within Product Development?

    When is the Ideal Moment to Start HEOR Activities Within Product Development?
    When is the Ideal Moment to Start HEOR Activities Within Product Development?

    Health Economics and Outcomes Research (HEOR) has grown into a vital domain in the health and care industry. It plays a key role by offering vital insights into how drugs in the market affect both health and finances. With the means of data driven and evidence-based insights, it plays a critical role in the development and dissemination of new healthcare products by providing important findings regarding clinical development strategies, informing regulatory decisions, and supporting market access. Medical affairs teams in pharmaceutical companies are often concerned about the ideal time for beginning HEOR activities within the product development cycle. The simple answer to this question is: the earlier, the better.[1]

    One can consider engaging in HEOR activities as early as the preclinical or discovery phases of product development. This way, HEOR insights can contribute significantly to the foundational understanding of the economic and clinical landscape. It has been observed that early HEOR involvement can result in more informed decision-making, and influence stakeholder engagement and investment decisions. HEOR helps identify and address potential market access barriers. By understanding the economic landscape and the outcomes that matter most to payers and patients, developers can tailor their products to meet these needs.[2]

    HEOR activities can further strengthen evidence generation in Phase I and II clinical trials. This period is considered critical for gathering preliminary data on safety, efficacy, and health-related quality of life (HRQoL) outcomes. Complementing this data with observations from HEOR studies can help refine economic models and identify the most relevant clinical endpoints. Additionally, HEOR data in early phases can be very useful to inform trial design in Phase III studies, ensuring that all necessary economic and QOL endpoints are captured, to support future health technology assessments (HTAs).[3]

    Advancing to Phase III clinical trials marks a very important milestone in the development of a new pharmaceutical product. At this stage, HEOR has a critical role of providing comprehensive data and evidence needed to confirm the product’s value proposition in the market. This is the phase where the most extensive and rigorous data on efficacy, safety, and outcomes are collected. HEOR activities in Phase III should define clinical endpoints, finalize economic models, undertake full cost-effectiveness analyses, and prepare dossiers required for regulatory submission and reimbursement applications. Embedding HEOR insights into Phase III activities can help predict and prevent potential concerns from regulatory agencies and payers. It showcases the value of the product not only through its clinical efficacy but also through the economic and patient-centered outcomes.[4,5]

    Following Phase III and the acquisition of marketing authorization, the product is launched in the market and becomes available for prescription to patients in the real-world setting. Throughout this stage, the accumulating real-world evidence (RWE) further helps in refining the value of the product by evaluating the efficacy and performance of the product in the diverse patient population. This evidence further substantiates the ongoing research by providing invaluable and robust insights into long-term outcomes, adherence patterns, and overall economic impact of the product. Continuous HEOR efforts post-launch help to support ongoing market access, reimbursement renewals, and potential label expansions. They also provide feedback that can be used to optimize the product’s use and improve patient outcomes over time.[5]

    In summary, HEOR is one continuous process that evolves over the whole cycle of product development. Early initiation of HEOR activities during the development process embeds economic and patient outcome considerations within the strategy of the product from the very beginning. This method not only increases the chances of a drug receiving the appropriate regulatory and reimbursement approval but also guarantees that new therapies are beneficial to both the patient and the medical system. Such proactive HEOR strategy, will put the pharmaceutical companies in a position to better navigate the complexities associated with market access, and to ensure that innovative therapies reach the patients who deserve them most.

    Become A Certified HEOR Professional – Enrol yourself here!

    References:

    1. Holtorf AP, Brixner D, Bellows B, Keskinaslan A, Dye J, Oderda G. Current and future use of HEOR data in healthcare decision-making in the United States and in emerging markets. American health & drug benefits. 2012 Nov;5(7):428.
    2. Van Nooten F, Holmstrom S, Green J, Wiklund I, Odeyemi IA, Wilcox TK. Health economics and outcomes research within drug development: challenges and opportunities for reimbursement and market access within biopharma research. Drug discovery today. 2012 Jun 1;17(11-12):615-22.
    3. Zou KH, Baker CL, Cappelleri JC, Chambers RB. Data Sources for Health Economics and Outcomes Research. InStatistical Topics in Health Economics and Outcomes Research 2017 Nov 22 (pp. 1-13). Chapman and Hall/CRC.
    4. Garrison Jr LP, Neumann PJ, Erickson P, Marshall D, Mullins CD. Using real‐world data for coverage and payment decisions: the ISPOR real‐world data task force report. Value in health. 2007 Sep;10(5):326-35.
    5. Chou JW, Portelli A, Cournoyer A. De-risking Market Launch: Leveraging HEOR Evidence Planning to Support Informed Payer Decisions. J Clin Pathways. 2022;8(8):63-65.

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  • Market Access for Digital Health Assets: Creating Frameworks for Digital Health Technologies

    Market Access for Digital Health Assets: Creating Frameworks for Digital Health Technologies
    Market Access for Digital Health Assets: Creating Frameworks for Digital Health Technologies

    Digital health technologies are rapidly innovating the healthcare model in wearables, telehealth platforms, AI-driven diagnostics, and digital therapeutics. Properly harnessed, such digital assets hold immense potential to greatly change patient care, and improve outcomes, with considerable opportunities to effectively reduce cost of treatment. Nevertheless, the journey from the conceptualization of these technologies to their real-world application is not that easy and is generally found littered with challenges. A crucial factor in the successful adoption of these innovations is the development of robust market access frameworks that clearly illustrate the advantages these technologies can bring to patient care. These technologies offer immense benefits to the end users, helping the process of adoption, and also ensuring that the correct treatment is delivered to the patients in need, at the right time and cost. By establishing these frameworks, it is possible to seamlessly integrate digital health assets into mainstream healthcare, and transform the industry forever.[1,2]

    Billions of dollars are invested worldwide in medical product development, including digital health assets, increasing the pressure to maximize the revenues of these investments. A market access decision clearly assumes a thorough understanding of decision-making in various health systems. The market access for digital health technologies implies overcoming regulatory requirements, securing reimbursement, and attaining widespread acceptance among healthcare providers and patients.[3,4]

    Regulatory authorities such as the FDA in the United States and the EMA in Europe are essential in safeguarding the safety, effectiveness, and dependability of digital health products. For example, the FDA’s Digital Health Innovation Action Plan outlines a comprehensive roadmap for developers, highlighting the importance of substantial clinical evidence and ongoing post-market surveillance. Understanding and complying with these regulations not only facilitates quicker market access but also fosters confidence among healthcare providers and patients.[5]

    Reimbursement models are essential for maintaining the financial sustainability of digital health technologies. They determine the payment mechanisms for these services and products, which may include insurance coverage, government initiatives, or direct payments from patients. Generally, government bodies and regulatory agencies have a big influence in the formation of key healthcare policies and in shaping of pricing and reimbursement structures in many countries.[6] For instance, they may introduce financing assistance initiatives, such as the Medical Devices program that provides regulatory and financial support to companies, or the breakthrough devices program aimed at improving access to medical devices for treating life-threatening or debilitating conditions. Additionally, insurance companies also have a significant role, albeit with limitations that can pose financial barriers for patients with insurance covers.[7]

    In light of these challenges, it is paramount to develop open and sustainable concepts of reimbursement to allow for broad acceptance of digital health technologies. Their integration into existing insurance models could provide a powerful incentive for healthcare providers to implement these innovations and enhance patient care.[7]

    A market entry strategy for digital health technologies needs to engage key stakeholders at the healthcare provider, patient, payer, and policymaker levels. This engagement allows for the resolution of concerns and gathering of valuable feedback. Engaging clinicians, for instance, could ensure that the technology is developed in a way that meets their requirements and is fully integrated into their workflows. When patients are engaged the tool would further enhance usability and acceptance of digital health, ensuring they are user-friendly and addressing real patient needs.[8]

    A 2021 study corroborates this approach by showing that all stakeholder groups, including venture capitalists, digital health companies, payers, and providers – firmly believed that the engagement of frontline providers and patients was one of the main driving forces for the widespread diffusion of patient-facing digital tools. Here, one can see just how the power of collaborative efforts and deliverance of engagement work together in surmounting barriers to adoption and hence in creating an enabling environment for digital health innovations.[9]

    The future of market access for digital health assets depends on the adoption of innovations while continuing to be flexible in regulatory and reimbursement frameworks. In keeping with constant evolution in digital health technologies, the frameworks have to morph and adapt with new developments that come up. It may involve creation of agile regulatory procedures that provide fast-track access to low-risk digital health products or innovative reimbursement models that represent the unique value propositions of digital health solutions. Moreover, strong data privacy and security will be important in maintaining the information of patients for building user confidence, hence facilitating the broader diffusion of these technologies. The full potential of digital health assets can only be potentially unlocked if regulatory agility and data protection are addressed, therefore taking a step to further improve healthcare outcomes.[10]

    In summary, gaining market access to digital health assets requires a multifaceted strategy that necessitates the establishment of comprehensive frameworks. These frameworks must encompass regulatory compliance, reimbursement structures, stakeholder engagement, and the capacity for innovation and flexibility. The development of such frameworks shall aid in fully tapping into the potentials of these digital assets for transforming the healthcare landscape towards better health outcomes for all. Collaboration between stakeholders and a commitment to adapt to new advancements will be key to successfully traversing this evolving field.potential

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    References

    1. Fraser AG, Nelissen RG, Kjærsgaard-Andersen P, Szymański P, Melvin T, Piscoi P. Improved clinical investigation and evaluation of high-risk medical devices: the rationale and objectives of CORE–MD (Coordinating Research and Evidence for Medical Devices). EFORT open reviews. 2021 Oct 19;6(10):839-49.
    2. Farah L, Borget I, Martelli N. International Market Access Strategies for Artificial Intelligence–Based Medical Devices: Can We Standardize the Process to Faster Patient Access?. Mayo Clinic Proceedings: Digital Health. 2023 Sep 1;1(3):406-12.
    3. Dorsey ER, De Roulet J, Thompson JP, Reminick JI, Thai A, W et al. Funding of US biomedical research, 2003-2008. Jama. 2010 Jan 13;303(2):137-43.
    4. Ijzerman MJ, Steuten LM. Early assessment of medical technologies to inform product development and market access: a review of methods and applications. Applied health economics and health policy. 2011 Sep;9:331-47.
    5. FDA. Digital Health Innovation Action Plan. Retrieved from https://www.fda.gov/media/106331/download
    6. Chinyio E, Olomolaiye P, editors. Construction stakeholder management. John Wiley & Sons; 2009 Oct 22.
    7. Woo JH, Kim EC, Kim SM. The current status of breakthrough devices designation in the United States and innovative medical devices designation in Korea for digital health software. Expert Review of Medical Devices. 2022 Mar 4;19(3):213-28.
    8. Vat LE, Finlay T, Robinson P, Barbareschi G, Boudes M, et al. Evaluation of patient engagement in medicine development: A multi‐stakeholder framework with metrics. Health Expectations. 2021 Apr;24(2):491-506.
    9. Lyles CR, Adler-Milstein J, Thao C, Lisker S, Nouri S, Sarkar U. Alignment of key stakeholders’ priorities for patient-facing tools in digital health: mixed methods study. Journal of Medical Internet Research. 2021 Aug 26;23(8):e24890.
    10. Rockwern B, Johnson D, Snyder Sulmasy L, Medical Informatics Committee and Ethics, Professionalism and Human Rights Committee of the American College of Physicians. Health information privacy, protection, and use in the expanding digital health ecosystem: a position paper of the American College of Physicians. Annals of Internal Medicine. 2021 Jul;174(7):994-8.

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  • Impact of Patient Advocacy Organizations on Market Access: Best Practices and Challenges

    Impact of Patient Advocacy Organizations on Market Access: Best Practices and Challenges
    Impact of Patient Advocacy Organizations on Market Access: Best Practices and Challenges

    In order to make sure that the patients who need their cutting-edge treatments the most receive them, pharmaceutical companies frequently face enormous challenges. Regulatory clearances, pricing negotiations, and reimbursement rules typically play a complex role in enabling market access to all advances.  Patient advocacy organizations (PAOs) are essential in negotiating these complications since they advocate for patient’s needs and offer valuable insights that can impact drug research, shape healthcare legislation, and ease market access.[1]

    It is normally necessary to follow specific best practices while interacting with PAOs in order to guarantee efficient cooperation and patient needs alignment.  Maintaining alignment with patient objectives throughout the product lifecycle is made possible by early and ongoing interaction with PAOs, which guarantees the integration of patient viewpoints from the beginning of the medication development process. For example, clinical trial designs and post-market support programs were influenced by Roche’s early discussions with PAOs on its treatment for hemophilia. Additionally, open communication is essential because it fosters trust with PAOs by providing information on safety data, clinical trials, and potential risks and benefits. An example of this emphasis on openness may be seen in Gilead’s collaboration with PAOs in the development of HIV medications, which eventually aided in winning over patient confidence and advocacy support.[1,2]

    Through PAOs, patient insights can be integrated into clinical trial designs, patient support programs, and market entry tactics, improving the acceptance and relevance of health innovations. Companies and PAOs working together to advocate for novel medicines can have a significant impact on policy and reimbursement decisions by communicating the benefits of these therapies in a way that legislators and payers understand. One instance is the partnership between Novartis and PAOs on therapies for spinal muscular atrophy, which aided in promoting more accessibility and advantageous reimbursement guidelines.[3]

    Interacting with PAOs may present a number of difficulties as well. First of all, the goals and objectives of PAOs are frequently varied and may not always coincide with those of pharmaceutical corporations. Interacting with PAOs may present a number of difficulties as well. Balancing these conflicting goals calls for sensitivity and negotiation abilities. Furthermore, a lot of PAOs have limited funding, which can limit their capacity to interact completely with pharmaceutical corporations. Concerns about compliance and regulations also come up a lot in these encounters. Maintaining ethical standards and avoiding conflicts of interest need interactions to be compliant with regulatory frameworks. Maintaining ethical standards and avoiding conflicts of interest need interactions to be compliant with regulatory frameworks.[4,5]

    Pharmaceutical businesses can take numerous innovative steps to improve their market access strategy by interacting with PAOs. Building successful ties with PAOs involves doing research, selecting groups pertinent to the therapy area or illness state, and giving priority to those that have a proven track record of patient participation and advocacy efforts. Early engagement of PAOs in the medication development process guarantees the integration of patient viewpoints from the outset of product lifecycles, hence augmenting the pertinence and acceptability of novel medicines. By working together, patient education and support programs can better meet the needs and preferences of patients by using the resources and expertise of PAOs in the creation of materials and activities. By partnering with PAOs, businesses may gain vital access to patient communities and customize their market access tactics according to a better understanding of patient preferences and needs. Ultimately, showcasing a business’s actual commitment to meeting patient requirements and enhancing healthcare outcomes is demonstrated by forming solid partnerships with PAOs and exhibiting a commitment to patient-centered care.[6]

    Market access strategies that are successful must interact with PAOs.  Early and ongoing involvement, open communication, and using patient perspectives are examples of best practices. Pharmaceutical businesses may provide patient requirements at the forefront of healthcare developments and improve market access by using novel strategies and establishing meaningful collaborations.

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    References:

    1. Roche position on working with patient groups [Internet]. Available from: https://assets.roche.com/f/176343/x/d9f667b276/roche_position_on_working_with_patient_groups.pdf.
    2. Gilead partners with CHAI and Penta to improve treatment and adherence rates among children with HIV in low- and middle-income countries [Internet]. Available from: https://www.gilead.com/news-and-press/press-room/press-releases/2023/7/gilead-partners-with-chai-and-penta-to-improve-treatment-and-adherence-rates-among-children-with-hiv-in-low-and-middle-income-countries.
    3. Newborn screening for spinal muscular atrophy (SMA) [Internet]. Available from: https://www.novartis.com/diseases/spinal-muscular-atrophy-sma/newborn-screening-spinal-muscular-atrophy-sma.
    4. National Academies of Sciences, Engineering, and Medicine; Health and Medicine Division; Board on Population Health and Public Health Practice; Committee on Addressing Sickle Cell Disease: A Strategic Plan and Blueprint for Action; Martinez RM, Osei-Anto HA, McCormick M, editors. Addressing sickle cell disease: a strategic plan and blueprint for action. Washington (DC): National Academies Press (US); 2020 Sep 10. Community engagement and patient advocacy. Available from: https://www.ncbi.nlm.nih.gov/books/NBK566476/.
    5. Kanter GP. Extending the Sunshine Act from physicians to patient advocacy organizations. Am J Public Health. 2018;108(8):978-979. doi:10.2105/AJPH.2018.304520.
    6. Rach C, Lukas J, Müller R, Sendler M, Simon P, Salloch S. Involving patient groups in drug research: a systematic review of reasons. Patient Prefer Adherence. 2020;14:587-597. doi:10.2147/PPA.S232499.

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  • Challenges and Opportunities in Market Access for Advanced Diagnostics and Comprehensive Genomic Profiling

    Challenges and Opportunities in Market Access for Advanced Diagnostics and Comprehensive Genomic Profiling
    Challenges and Opportunities in Market Access for Advanced Diagnostics and Comprehensive Genomic Profiling

    Precision medicine is becoming increasingly integrated into healthcare, which is causing a revolutionary change in the industry. Comprehensive genomic profiling (CGP) and sophisticated diagnostics are two cutting-edge discoveries that have the potential to completely transform patient care by providing highly individualized treatment plans. Though these innovative technologies have great potential, getting market access is extremely difficult for them.[1]

    Advanced diagnostics refers to a wide range of technologies designed to identify conditions early on, forecast the course of diseases, and accurately track the effectiveness of treatment. CGP typically includes all major classes of genomic variants (single nucleotide variants, indels, copy number variants, fusions, and splice variants) and is capable of detecting biomarkers at nucleotide-level precision. Furthermore, CGP maximizes the potential to identify clinically actionable mutations by detecting genomic signals such as TMB and MSI (tumor mutational burden and microsatellite instability, respectively). Across a variety of tumor types, numerous studies have shown that CGP can detect genetic abnormalities that may be clinically significant.[1,2]

    Since the number of targeted medicines is expanding quickly, molecular profiling could be very beneficial to many patients.  These include the development of innovative medicines for less common gene changes, such as NTRK fusions, which account for less than 1% of all cancer cases.  When combined, these technologies can enable precision medicine, which could lead to a major improvement in patient outcomes, especially in oncology. To assist reduce tissue use and potential waste, for example, CGP can identify specific genetic abnormalities driving tumor growth in cancer treatment, enabling clinicians to choose tailored medicines that are more likely to be beneficial.[3,4]

    The market access challenges that advanced diagnostics and CGP encounter are manifold and can be largely classified into three categories: practical, economic, and regulatory. Gaining regulatory approval is a significant challenge that calls for a thorough assessment to prove clinical validity, usefulness, and safety. Though regulatory organizations are increasingly realising the need for adaptive frameworks to keep pace with technical breakthroughs, the quickly evolving nature of genomic technologies often outpaces regulatory rules, producing a lag between invention and clearance.[5]

    One major financial barrier is the high cost of CGP and sophisticated diagnostics. The cost of testing is increased by these technologies since they sometimes require specialized chemicals, pricey equipment, and knowledgeable staff.  The cost-benefit ratio must be taken into account by healthcare providers and payers, who must weigh the significant long-term advantages of precision medicine against its exorbitant upfront costs. Reimbursement policies are critical, necessitating persuading payers of the benefits of these technologies, such as insurance companies and government health programs. In order to obtain favorable payment terms, it is imperative to demonstrate cost-effectiveness through comprehensive health economic studies. Failure to do so may result in healthcare providers being unwilling to implement these technologies, hence restricting patient access. [6]

    The incorporation of CGP and advanced diagnostics into clinical practice requires substantial modifications to current procedures.  Healthcare facilities must make investments in the equipment required, such as genomic sequencing labs and bioinformatics platforms, and provide their clinicians with the appropriate training to analyze complicated genomic data and apply these insights to treatment decisions. Furthermore, patient education is essential because patients must comprehend the possible advantages and restrictions of genetic testing in addition to the consequences of the findings. To guarantee that decisions are well-informed, physicians and patients must communicate effectively. [6]

    Advanced diagnostics and CGP can enter the market more easily through a number of techniques. Firstly, it is imperative to involve important parties early on in the commercialization process, including administrators, payers, lawmakers, regulators, and healthcare providers. Firstly, it is imperative to involve important parties early on in the commercialization process, including administrators, payers, lawmakers, regulators, and healthcare providers. Firstly, it is imperative to involve important parties early on in the commercialization process, including administrators, payers, lawmakers, regulators, and healthcare providers. Thirdly, successful commercialization requires the involvement of the entire organization; all key departments need to be aware of what is needed to launch and scale an advanced diagnostic. Innovators should start small, with a dedicated staff leading market growth with early adopters, then grow when coding, coverage, and payment structures are established. Preparing for the long term is another key strategy, as the commercialization process for advanced diagnostics is lengthy. It is recommended that innovators invest substantial resources across ten years or more, while also maintaining flexibility to adjust to the needs of the diagnostic test. Finally, given the sizeable total addressable markets and promising biomarkers for numerous tests in development, investors should assess possible investments based on the clinical value of the diagnostic test and its route to reimbursement and access.[4-6]

    Precision medicine has the potential to transform patient care through the use of advanced diagnostics and CGP.  Stakeholders can help integrate these innovations into mainstream healthcare by adopting cooperative regulatory frameworks, proving economic benefits, developing clinical capability, and improving patient participation. Although there are several obstacles in this process of general adoption, the potential benefits for better patient outcomes make the effort worthwhile.

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    References

    1. Wheler JJ, Janku F, Naing A, et al. Cancer therapy directed by comprehensive genomic profiling: a single center study. Cancer Res. 2016 Jul 1;76(13):3690-701.
    2. Hirshfield KM, Tolkunov D, Zhong H. Clinical actionability of comprehensive genomic profiling for management of rare or refractory cancers. Oncologist. 2016 Nov;21(11):1315-1325.
    3. Fabrizio, et al. Clinical and analytic validation of FoundationOne CDx for NTRK fusion-positive solid tumors in patients treated with entrectinib. In: Proceedings of the AACR-NCI-EORTC International Conference on Molecular Targets and Cancer Therapeutics; 2019. AACR; Mol Cancer Ther. 2019; Abstract A028.
    4. Foundation Medicine. Why comprehensive genomic profiling? Available from: https://www.foundationmedicine.com/resource/why-comprehensive-genomic-profiling.
    5. Svoboda M, Lohajova Behulova R, Slamka T, Sebest L, Repiska V. Comprehensive genomic profiling in predictive testing of cancer. Physiol Res. 2023;72(S3)–S275.
    6. Snow S, Brezden-Masley C, Carter MD, Dhani N, Macaulay C, Ramjeesingh R, Raphael MJ, Slovinec D’Angelo M, Servidio-Italiano F. Barriers and unequal access to timely molecular testing results: addressing the inequities in cancer care delays across Canada. Curr Oncol. 2024;31(3):1359–75.

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  • Transforming Pharma Market Access: The Rise of Artificial Intelligence

    Transforming Pharma Market Access: The Rise of Artificial Intelligence
    Transforming Pharma Market Access: The Rise of Artificial Intelligence

    The pharmaceutical industry is amidst a profound transformation, driven by the rapid adoption of Artificial Intelligence (AI). Among its many applications, AI holds immense promise in optimizing market access, a critical stage in delivering new drugs to patients efficiently.

    One of the primary advantages AI brings to market access is its capability to enhance data analysis and insights. Traditionally reliant on human expertise, market access now benefits from AI algorithms’ automation. By automating data collection and leveraging machine learning, AI can uncover intricate patterns within vast datasets, providing deeper insights into payer behavior, treatment costs, and potential market barriers. Moreover, AI’s predictive capabilities can enable companies to simulate various market scenarios, aiding in the development of effective pricing, launch strategies, and value propositions tailored to specific markets and patient demographics.[1]

    Furthermore, AI can streamline regulatory navigation, a pivotal aspect of market access. By automating repetitive tasks and analyzing regulatory data, AI can expedite document preparation for submissions and identify potential regulatory hurdles. This empowers companies to proactively address regulatory requirements, accelerating the approval process. Additionally, AI can assist in risk assessment, enabling companies to prioritize resources and develop mitigation strategies for potential regulatory obstacles.[2]

    Pricing and reimbursement strategies also benefit from AI integration. AI can facilitate the development of value-based pricing models by analyzing real-world data to determine a drug’s true value proposition based on clinical and economic outcomes. Segmenting payers based on preferences and budget constraints allows companies to tailor pricing strategies, increasing negotiation success rates. Moreover, AI potentially predicts reimbursement likelihood from different payers, aiding in targeted market prioritization and strategy development.[3]

    Personalized patient targeting and engagement are critical for successful market access, and AI plays a pivotal role in this realm. Through data analysis, AI can identify patient populations most likely to benefit from new therapies, enabling targeted outreach and education campaigns. Real-world data analysis demonstrates a drug’s effectiveness, bolstering its value proposition to healthcare providers and patients. Additionally, AI-driven patient support programs can improve adherence and thereby improve health outcomes.[4]

    Enhanced risk management and compliance are paramount in market access, where AI offers significant assistance. By analyzing healthcare claims data, AI can detect potentially fraudulent activities and can monitor compliance with regulations, enabling timely corrective actions. Furthermore, AI can expedite adverse event identification, allowing companies to address safety concerns promptly and effectively.[5]

    Despite its immense potential, AI adoption in pharmaceutical market access faces multifaceted challenges. Ensuring data accuracy and transparency emerges as a critical hurdle, necessitating the implementation of robust data governance processes. Given the sensitivity of healthcare data, maintaining data integrity becomes paramount to mitigate risks associated with erroneous insights or decision-making. Additionally, transparency in AI algorithms becomes imperative to build trust and accountability, demanding measures to ensure algorithm explainability and fairness. Moreover, the complexity of healthcare data further complicates the challenge, requiring sophisticated data management solutions to handle diverse data sources and formats effectively.[1, 6]

    Integration with existing IT infrastructure poses another significant challenge in AI adoption. The seamless integration of AI solutions with legacy systems becomes essential to leverage the full potential of AI-driven insights. However, disparate data sources and incompatible formats often hinder this integration process, necessitating investments in data integration solutions and interoperability standards. Furthermore, the scalability and performance of AI solutions within existing infrastructure frameworks must be carefully evaluated to ensure optimal performance without disrupting existing workflows. Addressing these integration challenges effectively is crucial to harnessing AI’s transformative power in pharmaceutical market access.[1,6]

    In conclusion, AI presents a monumental opportunity to revolutionize pharmaceutical market access. By enhancing data analysis, decision-making, and overall efficiency, AI enables companies to deliver new drugs to patients faster, more effectively, and at a lower cost. Addressing challenges related to data quality, algorithm transparency, and system integration is imperative to realizing AI’s full potential in market access. Through strategic navigation of these challenges, the pharmaceutical industry can unlock AI’s transformative power, ensuring that life-saving medications reach those in need efficiently and expeditiously.

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    References

    1. Lee D, Yoon SN. Application of artificial intelligence-based technologies in the healthcare industry: Opportunities and challenges. International journal of environmental research and public health. 2021 Jan;18(1):271.
    2. Kumar P. Artificial Intelligence: Reshaping Life and Business. BPB Publications; 2019 Sep 19.
    3. Paul D, Sanap G, Shenoy S, et al. Artificial intelligence in drug discovery and development. Drug discovery today. 2021 Jan;26(1):80.
    4. Godman B, Fadare J, Kwon HY, et al. Evidence-based public policy making for medicines across countries: findings and implications for the future. Journal of comparative effectiveness research. 2021 May;10(12):1019-52.
    5. Al Kuwaiti A, Nazer K, Al-Reedy A, Al-Shehri S, Al-Muhanna A, Subbarayalu AV, Al Muhanna D, Al-Muhanna FA. A Review of the Role of Artificial Intelligence in Healthcare. J Pers Med. 2023 Jun 5;13(6):951.
    6. Askin S, Burkhalter D, Calado G, El Dakrouni S. Artificial intelligence applied to clinical trials: opportunities and challenges. Health and Technology. 2023 Mar;13(2):203-13.

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  • How to Improve Transparency with Real World Data to Support Market Access?

    How to Improve Transparency with Real World Data to Support Market Access?

    The USFDA defines real-world data (RWD) as ‘the data relating to patient health status and/or the healthcare delivery that is routinely collected from a variety of sources’, and real-world evidence (RWE) as ‘the clinical evidence regarding the usage and potential risks/benefits of a medical product obtained from analysis of RWD.’[1] RWD includes data from electronic health records (EHRs), administrative and medical claim databases, pharmacy data; data from product, patient, and disease registries, patient-generated data (including in-home use settings, social media data, patient forums, etc), and data gathered from other sources that can inform on health status.[1]

    RWD has been extensively used for pharmacovigilance in the form of phase 4 post-marketing surveillance studies. Lately, it is being realised that RWE and RWD can play additional role in the drug approval cycle. For example, the approval of Avelumab for the treatment of metastatic Merkel cell carcinoma (MCC) in March 2017 utilised electronic health record (EHR) data as historical control data for efficacy. Likewise, the approval of Lutetium Lu 177 dotatate for the treatment of certain neuroendocrine tumors in 2018 by the USFDA made extensive use of safety and efficacy data from the ERASMUS study, which was an expanded access study.[2]

    RWD has also been used for market access and to make reimbursement decisions in several countries. For example, in France, RWD collected during temporary authorization for use of a drug can be used to assess the price and level of reimbursement through health technology assessment (HTA). In the UK, RWD collected during early access to medicine scheme can be used as dossier of market access. In fact, the UK NHS has performed cost-effectiveness studies based on RWE and established a scheme to collect RWD for pharmacovigilance purposes. RWD are also used for pay-for-performance schemes in the USA.[3]

    Despite the raising importance of RWD in improving market access, a constant critique of RWD is that, since RWD is collected from routine healthcare, there is no set objective for RWD collection, unlike randomized controlled trials (RCTs) which generally have an objective and hypothesis. In other words, since RWE studies are secondary analysis of existing data that are collected unplanned (i.e., without a specific objective), they are susceptible to bias; this is not that prominent an issue for pre-planned studies of prospectively collected data (such as RCTs). Thus, there are high chances that RWE studies are more susceptible to results-driven design modifications than RCTs, thus bringing a question about transparency of RWD and the resulting RWE.[4]

    Data transparency improves the ability of decision-makers to assess the quality and validity of an RWE study by giving a deeper understanding of why and how the research was conducted and whether the results reflect pre-established questions and methods. It also facilitates the replication of results and an understanding of why findings of apparently similar studies differ. In line with these concepts, attempts are being made to improve RWD transparency, with an intention to strengthen the confidence that different stakeholders have on RWD, thereby further boost its usage for different aspects, including enhancing market access of drugs.[4]

    One such method for improving data transparency is by promoting registries for RWE studies. Though existing registries register and ClinicalTrials.gov) collect many features that are required for improving data transparency, they focus on primary data, and are not specific for RWD.[4] In 2017, International society for Pharmacoeconomics and Outcomes Research (ISPOR) and International Society for Pharmacoepidemiology (ISPE) formed a joint task force to identify good practices for addressing the concerns and to enhance confidence in evidence derived from RWE studies. The ISPOR-ISPE Special Task force recommends the researchers should declare the hypothesis to be tested, post study protocols and analysis publicly; and during publication attestation of any conformation or deviation from the initial study protocol.[4] In lines with the same, the ISPOR RWE registry was formally launched in October 2021, and represents a fit-for-purpose platform for registering RWE study designs prior to data collection, with an intention to facilitate RWD transparency and to elevate the trust in the study results; the RWE registry can be accessed at https://osf.io/registries/rwe/discover.

    Another method to improve RWD transparency is the concept of tokenization of healthcare data, by which different sources of patient-level RWD (for example; claims, EHR, registries, molecular biomarkers, and laboratories) can be linked to provide a complete, non-duplicate, and comprehensive understanding of the patient’s health. By providing an option to cross-check same patient data from different sources, tokenization can help improve the confidence in RWD from different sources.[5]

    RWD play enormous role in research and development process, they also help in estimating the risks and benefits of any treatment in real world scenarios. Enhancing RWD with transparency can go a long way in increasing its usage for market access.

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    References

    1. Framework for FDA’s real-world evidence program. Dec 2018. Available from: https://www.fda.gov/media/120060/download
    2. Feinberg BA, Gajra A, Zettler ME, et al. Use of real-world evidence to support FDA approval of oncology drugs. Value Health. 2020 Oct;23(10):1358-1365. 
    3. Pulini AA, Caetano GM, Clautiaux H, et al. Impact of real-world data on market authorization, reimbursement decision & price negotiation. Ther Innov Regul Sci. 2021;55(1):228-238.
    4. Orsini LS, Berger M, Crown W, et al. Improving transparency to build trust in real-world secondary data studies for hypothesis testing-why, what, and how: recommendations and a road map from the real-world evidence transparency initiative. Value Health. 2020 Sep;23(9):1128-1136. 
    5. Dagenais S, Russo L, Madsen A, et al. Use of real-world evidence to drive drug development strategy and inform clinical trial design. Clin Pharmacol Ther. 2022;111(1):77-89.

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