Shivani Shah
Senior Consultant, NAVLIN Market Access & HTA Consulting
Expertise:
Shivani Shah is Senior Consultant at EVERSANA and has around 6 years of experience working as consultant in pharmaceutical and life-science industry.
Prior to joining EVERSANA, she has worked at one of the top ten Indian pharmaceutical companies such as Macleods Pharmaceuticals and Fortune 500 corporations like IQVIA.
Shivani specializes in the development and implementation of solutions that support critical commercial decision-making; specifically, in the areas of drug pricing & reimbursement strategy, health technology assessment and market access strategy primarily in Europe and Asia-Pacific. She has been involved in developing HTA and market access strategy, PRO strategy for products in clinical development phase, primarily in therapeutic areas including oncology, rare diseases, and cell and gene therapies.
Her academic training includes Bachelor of Pharmacy from Bombay College of Pharmacy, Mumbai, and Master of Sciences of Pharmacy, (MPharm) in Drug Development and Regulatory Sciences from Narsee Monjee Institute of Management Studies (NMIMS), Mumbai.
Articles by Shivani Shah
Predicting PICOs for EU HTA: The Validated PICO Planner Approach Based on Retrospective Analysis
The EU Health Technology Assessment Regulation (EU HTAR) and Joint Clinical Assessment (JCA) aim to harmonize clinical evaluations across Europe while preserving national HTA decisions. To navigate this complexity, early and strategic PICO (Population, Intervention, Comparator, Outcome) planning is essential for effective evidence generation strategies. This study, presented at ISPOR Europe 2025, demonstrates how NAVLIN […]
Strategic PICO Planning: Navigating Oncology Markets with NAVLIN by EVERSANA
Strategic PICO Planning in Oncology Markets In today’s dynamic healthcare environment, early and strategic PICO (Population, Intervention, Comparator, Outcome) planning is critical to successful evidence generation. With evolving regulatory frameworks—like the European Joint Clinical Assessment (JCA)—now leveraging PICOs to guide therapy evaluations, NAVLIN by EVERSANA® enables clients to anticipate HTA requirements, align internal stakeholders, and […]
Strategic PICO Planning: Enhancing Early-Phase Development for Market Access
Future-Proofing Early Development with Strategic PICO Planning A global pharmaceutical company with a diverse pipeline needed to align early clinical planning with future market access requirements—before Phase II. With Target Product Profiles (TPPs) still in development, the team turned to NAVLIN by EVERSANA® to anticipate EU Joint Clinical Assessment (JCA) expectations and build a strategic […]
Evaluation of HTA Frameworks for In Vivo Diagnostics: Assessing Methodological Gaps and Implications for Market Access
Health technology assessments (HTAs) are crucial for market access and reimbursement of diagnostic innovations, yet current frameworks often fail to reflect the true value of in vivo diagnostics—such as molecular imaging (MI) tracers and contrast media (CM). These technologies are frequently assessed using methodologies designed for pharmaceuticals, resulting in inconsistent evaluations and delayed patient access […]
Preparing for Joint Clinical Assessments: How Early PICO Planning Ensures Smoother Submissions
Because the EU Health Technology Assessment (HTA) regulation will take effect in January 2025, pharmaceutical and medical device companies must prepare for a new era in health technology evaluations. The Joint Clinical Assessment (JCA), a core feature of the regulation (EU 2021/2282), promises a more streamlined, harmonized assessment process across Europe, particularly benefiting companies aiming […]
Utilization of Indirect Treatment Comparison (ITC), External Control Arms (ECA) and Patient-Reported Outcome Measures (PROMs)
Health Technology Assessment (HTA) is crucial to assessing the effectiveness, safety and cost-effectiveness of healthcare interventions. Indirect Treatment Comparison (ITC) is one trend that has gained traction in the HTA space as a way to evaluate interventions and enable researchers to compare the effectiveness of two treatments indirectly. Additionally, utilizing External Control Arms (ECAs) uses […]