Nicole Ferko
General Manager, Value and Evidence
Expertise:
Nicole directs U.S. and global projects to support multi-stakeholder medical device adoption and reimbursement. Nicole has more than 20 years of experience in health economics and research methods within academic, industry, and consulting roles. With her teams, she has successfully completed a wide range of project types including hospital value analysis briefs, market research surveys, economic sales tools, network meta-analyses, Delphi panels, and FDA clinical trial analyses. Nicole has co-authored more than 100 peer-reviewed publications including a book reflecting her area of expertise, entitled: The Science of Commerce: Succeeding in a Changed Medical Device Market. She has a broad therapeutic knowledge-base, having worked across several disease areas for biotechnology, pharmaceutical, and medical device products, including numerous medical device product types.
Nicole’s academic training includes a BSc in Biology and Pharmacology and an MSc in Health Research Methods, both from McMaster University.
Articles by Nicole Ferko
Growing EVERSANA’s Value & Evidence Global Footprint with the Additions of Monique Martin, Pamela Vo and Deepika Thakur
EVERSANA’s Value and Evidence (V&E) team grew their global Health Economics & Outcomes Research (HEOR) leadership footprint in early 2024 with the addition of Monique Martin, Pamela Vo and Deepika Thakur, showcasing EVERSANA’s growing global life sciences commercialization launch expertise. EVERSANA’s Value & Evidence team of ~150 seasoned HEOR researchers and industry experts are focused on improving healthcare outcomes. We work throughout a product’s life cycle from early-stage strategic planning, through launch, to post-launch support. We collaborate with clients to develop a Value & Evidence Platform that powers evidence development strategies, product value propositions, reimbursement submissions, payer marketing and peer-reviewed publications. Learn more. Nicole Ferko, General Manager, Value & Evidence, EVERSANA Why […]
Excel in Market Access Success: Key Considerations for Leveraging Your Evidence
Introduction The landscape of launching new medical products presents significant challenges, with a staggering 66% of launches falling short of consensus expectations. Half of these failures are attributed directly to poor market access. Recognizing this, companies are increasingly turning to early engagement with payers during the clinical development phase to glean crucial insights into payer evidence requirements. By doing so, they can tailor their evidence-generation strategies to align with payer expectations, thereby enhancing their chance of securing favorable coverage decisions. Securing regulatory approval alone is no longer sufficient for successful market access. Payers demand robust evidence that goes beyond clinical trial data, emphasizing the product’s ability to address unmet needs, […]
Single-Arm Data: Turning Limitations into Strengths with Numbers
Randomized controlled trials (RCTs) are at the top of the evidence pyramid because they are designed to be unbiased. Unfortunately, for many medical devices, these types of studies are lacking. This is either because they are not required for 510K or post-market approval (PMA), or there are challenges with implementing a randomized study design. Clinical studies without a control group, otherwise known as single-arm studies, have become “the norm” for many device categories. For example, in the oncology space, there are hundreds of uncontrolled studies evaluating thermal ablation technologies! Drug-eluting stents are another category with a wealth of non-comparative data informing the coronary disease treatment space. However, any one of […]
ISPOR 2020 PODIUM: PSM and Bayesian Hierarchical Design Methods to Integrate Single-Arm Studies into NMAs in Lung Cancer
APPLICATION OF PROPENSITY SCORE MATCHING AND BAYESIAN HIERARCHICAL DESIGN METHODS TO INTEGRATE SINGLE-ARM STUDIES INTO NETWORK META-ANALYSES (NMAS): Opportunities and Pitfalls Illustrated in a Case Study Assessing Ablation/Radiation Therapies in Lung Cancer Virtual ISPOR 2020 | TUESDAY, May 19th, 2020 | 5:45-6:00 PM ET OBJECTIVES: Network meta-analyses (NMAs) generally include direct comparative evidence from randomized controlled trials (RCTs) and/or comparative observational studies; however, comparative evidence is limited in many disease/treatment areas. The objective of this analysis was to discuss opportunities and pitfalls associated with incorporating single-arm studies into NMAs, illustrated in a case study assessing the effectiveness of ablation/radiation therapies in lung cancer. METHODS: A systematic literature review was conducted […]
ISPOR 2020 PANEL: Evidence Standards for Medical Device Adoption by U.S. Hospitals
ARE EXISTING REGULATORY EVIDENCE STANDARDS ADEQUATE FOR INFORMING DECISIONS ON MEDICAL DEVICE ADOPTION BY U.S. HEALTHCARE PROVIDERS/HOSPITALS? Virtual ISPOR 2020 | MONDAY, May 18th, 2020 | 11:00 AM ET MODERATOR: Nicole Ferko, MSC, EVERSANA ISSUE: With cost containment pressures and the need to optimize health and healthcare delivery, U.S. healthcare providers/hospitals must consider economic value, in addition to clinical evidence and feasibility of adoption, to inform medical device adoption decisions. As the majority of devices do not receive additional reimbursement by payers, providers often need to absorb the costs within operating budgets. Adoption decisions are frequently deliberated by hospital Value Analysis (VA) Committees which evaluate how a device may address a current […]