Divya Shankar’s research while affiliated with Boston Medical Center and other places


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Publications (5)


Process and Clinical Outcomes of a Biosimilar Adoption Program with Infliximab-Dyyb
  • Article

April 2020

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61 Reads

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24 Citations

Journal of Managed Care & Specialty Pharmacy

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Sarah Altajar

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Divya Shankar

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[...]

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Background: In 2016, the FDA approved infliximab-dyyb (IFX-dyyb) as a biosimilar to infliximab (IFX). Deemed to have comparable efficacy and safety to IFX, IFX-dyyb is 20%-30% less expensive, allowing significant cost savings for institutions and some payers. In 2018, IFX was reported to be the drug with the highest spend since 2013, costing 3.8billion;however,transitiontoIFXdyybwouldsave3.8 billion; however, transition to IFX-dyyb would save 1.1 billion. Regardless, many institutions have not transitioned to IFX-dyyb or other IFX biosimilars (e.g., IFX-abda) because of concerns about clinical outcomes, uncertainty regarding financial impact, and barriers to operationalizing biosimilar adoption. At Boston Medical Center, a decision was made in March 2018 to adopt IFX-dyyb and transition patients who have been on IFX for ≥ 6 months for all indications to IFX-dyyb. Objectives: To (a) describe a biosimilar adoption process of IFX-dyyb in patients on IFX for ≥ 6 months; (b) characterize cost savings of transitioning patients to IFX-dyyb; and (c) evaluate real-world clinical outcomes of adult patients with inflammatory bowel disease (IBD) who transitioned to IFX-dyyb. Methods: This is a retrospective cohort study of patients eligible for the IFX-dyyb switch from March 2018 to June 2019 at a large academic medical center. For process outcomes, we collected the proportion of patients who transitioned to IFX-dyyb and calculated the cost savings generated. To assess clinical outcomes of adult IBD patients who transitioned, we collected IFX and IFX-dyyb dosage, Harvey Bradshaw Index (HBI) or Simple Clinical Colitis Activity Index (SCCAI) scores, c-reactive protein (CRP) levels, and colonoscopy results. Descriptive statistics, Wilcoxon signed-rank test, and McNemar's test were used for statistical analyses. Results: Of 151 eligible patients, 146 (97%) successfully transitioned to IFX-dyyb. Based on our conversion rate to IFX-dyyb, our health system is forecasted to save approximately $500,000 annually. From March to June 2018, 63 of 75 (84%) eligible IBD patients transitioned from IFX to IFX-dyyb. In this cohort, of the 40 patients with HBI or SCCAI scores before and after transition, 36 (90%) maintained remission. For 32 patients, the mean CRP (SD) before transition was 11.2 (22) and 4.1 (4.8) after transition (P = 0.09). Since the IFX-dyyb transition, 9 patients had a colonoscopy, of which 5 (56%) were in endoscopic remission. As of October 2018, 56 (89%) patients continued with IFX-dyyb after transition. Of the 46 patients who had 12-15 months posttransition data, 38 (83%) remained on IFX-dyyb. Conclusions: Implementation of a biosimilar adoption program can be successful and result in significant cost savings without compromising clinical outcomes. A model that uses actionable strategies and embraces collaboration among stakeholders is described here, with outcomes demonstrating successful IFX-dyyb uptake and no changes in clinical outcomes of transitioned adult patients with IBD. Disclosures: No outside funding supported this study. Farraye reports advisory board fees from Janssen, Merck, and Pfizer. Shah reports speaker fees from Pfizer. The other authors have nothing to disclose.


FIG. 1. Flowchart of study.
FIG. 2. Analysis of variance for QoL classified by portal usage.
FIG. 3. Pneumococcal vaccine uptake at baseline and at 6 months after EHR intervention.
FIG. 4. Influenza vaccine uptake at baseline and at 6 months after EHR intervention.
Baseline characteristics in a clinical trial exam- ining utility of an EHR patient portal (EPIC's Mychart), for improving QoL in IBD patients
The Use of An EHR Patient Portal (Mychart-Epic) in Patients With Inflammatory Bowel Disease
  • Article
  • Full-text available

October 2019

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249 Reads

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13 Citations

Crohn s & Colitis 360

Introduction Inflammatory bowel disease (IBD) has a significant effect on patients’ overall quality of life (QoL). We hypothesized that an Electronic Health Record (EHR) patient portal (EPIC’s Mychart) can be utilized to improve QoL in IBD patients and increase vaccine uptake. Methods Patients were randomized to receive specific disease (INT) information and to a control arm (CTRL) that received periodic non-IBD related messages. Disease severity was assessed using the Harvey-Bradshaw index, and Simple Clinical Colitis Activity index. QoL was measured using the Short Inflammatory Bowel Disease Questionnaire (SIBDQ). Secondary outcome measures included overall satisfaction with the portal and influenza and pneumococcal vaccine uptake. Results One hundred twenty-seven patients were randomized: At baseline the CTRL group had a statistically significant higher QoL (Median SIBDQ 53.7) compared with the INT group (median SIBDQ 49.3), P = 0.04. At 6 months, the INT group had a trend towards a significantly greater increase in QoL (median SIBDQ 58) when compared with the CTRL group (median SIBDQ 57.5), P = 0.06. At 6 months more frequent portal use showed a significantly lower median SIBDQ (median 53) compared with patients with less frequent portal use (median 59), P = 0.038. At 6 months 88% of patients felt that the MyChart portal was useful with respect to IBD management. Patients had high rates of portal utilization with one-third of patients logging on weekly, and one-third logging on monthly. With respect to vaccine uptake, both influenza and pneumococcal pneumonia had higher rates of vaccine uptake. Conclusions Patients showed a trend towards improved QoL after receiving disease-specific information through our EHR portal. A significant increase in vaccine uptake was also seen. Frequent automated messages sent via an EHR portal can improve patient’s overall QoL. Larger studies will be needed to determine if automated portal reminders have a significant association with improved QoL, and furthermore to determine if there is any impact on disease activity.

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Citations (2)


... Fig. 1, our IBD literature search identified 5625 citations. After removal of duplicate studies, screening, and full-text review, 15 studies met the inclusion criteria for the systematic review (Table 1) [16][17][18][19][20][21][22][23][24][25][26][27][28][29][30]. The studies were published between 2013 and 2019 in the USA (n = 10), Europe (n = 4), or Australia/United Kingdom (n = 1). ...

Reference:

Interventions Increase Vaccination Rates in Inflammatory Bowel Disease and Rheumatoid Arthritis: A Systematic Review and Meta-Analysis
The Use of An EHR Patient Portal (Mychart-Epic) in Patients With Inflammatory Bowel Disease

Crohn s & Colitis 360

... Safe and effective switching between reference and biosimilar medicines, and between biosimilar medicines, is also supported by a large body of evidence accumulated from years of clinical practice [10][11][12][13]. As seen in these therapy areas, including oncology, metabolic diseases, gastroenterology, and rheumatology [14][15][16][17], the anticipated introduction of biosimilar medicines as a less costly biologic treatment option for the first time in MS is expected to increase access to biologics [18,19]. Increased access would in turn offer both clinical and economic benefits to patients with MS, healthcare systems, and payers, ultimately driving sustainability of care [6,15,18,20]. ...

Process and Clinical Outcomes of a Biosimilar Adoption Program with Infliximab-Dyyb
  • Citing Article
  • April 2020

Journal of Managed Care & Specialty Pharmacy