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With top-line data finally released, how does Plecanatide stack up to Linzess in IBS-C & CIC?Ticker(s): SGYP, AGN, IRWD
Name: Dr Philip Schoenfeld - MD
Institution: Detroit VA Medical Center
- Chief of Gastroenterology at the Detroit VA medical center and previous Director of Gastrointestinal Epidemiology and Professor of Medicine at University of Michigan
- Co-authored the American College of Gastroenterology’s Guideline on Colon Cancer Screening and the American College of Gastroenterology/American Society for Gastrointestinal Endoscopy Position Statement on Quality Indicators in Colonoscopy
- Has published more than 100 original research studies in peer-reviewed journals and past Associate Editor (Colon) for American Journal of Gastroenterology; has served on the editorial boards of Alimentary Pharmacology and Therapeutics and Journal of Clinical Gastroenterology
Please describe your clinical practice (academic/community). How many patients a month do you see for the following indications?
- Chronic idiopathic constipation (CIC)
- Irritable bowel syndrome – constipation (IBS-C)
Please describe your typical treatment paradigm for CIC and IBS-C with the following agents:
- OTC laxative use
- Linzess (linaclotide)
- Amitiza (lubiprostone)
Please describe your clinical experience with Linzess. What are your impression with regard to it's efficacy?Added By: joe_mccann
Please comment on the side effect profile of Linzess, specifically regarding the rates and severity of diarrhea:
- How many patients discontinue treatment due to diarrhea?
- How often do you need to reduce dose due to diarrhea?
- Do you recommend patients split capsules or skip doses due to diarrhea?
Is cost or insurance coverage a typical barrier to usage for Linzess? How broadly are these products covered for CIC and IBS-C, and are certain payors more difficult in terms of pre-authorizations or out-of-pocket costs to patients?
- Private insurance
Linzess recently received approval for a lower dose (72 mcg).i. How do you anticipate employing this new dosing flexibility?
- Do you plan to start patients on the lowest dose and titrate up or start at the mid- or high dose and titrate down?
- Do you view dosing flexibility as a meaningful attribute?
- Given the clinical data and cost of therapy, will patients be incentivized to use Linzess 145 mcg every other day, rather than 72 mcg daily?
Trulance (plecanatide) is a recently approved treatment for CIC. Have you heard of this drug and are you familiar with the data?
Per clinical trials and the FDA label Trulance appears to have comparable (or slightly lower) efficacy (responder rates of 8-11% Trulance vs. 15-20% Linzess) but a significantly lower rate of diarrhea (5% Trulance vs. 16-22% Linzess). How do you plan to prescribe Trulance, if at all?
- How important will insurance coverage impact your possible prescribing?
- Do you view co-pay assistance as necessary for patient compliance?
- How would your prescribing be impacted by the cost of Trulance, if priced below or above Linzess?
Do you view Trulance as meaningfully differentiated from Linzess? Trulance only has one approved dosage vs. 3 for Linzess. How does that impact your potential Trulance usage?Added By: c_admin
In your opinion will your use of Trulance come at the expense of Linzess or are you likely to use the two products interchangeably in patients who find OTC laxatives as insufficient?Added By: c_admin
Are you more likely to lower the dose in a Linzess patient with intolerable diarrhea or switch to Trulance?
Trulance also successfully conducted two randomized trials in IBS-C and anticipates a possible label expansion for this indication by YE17
- How will your prescribing habits change if and when Trulance is also approved for the treatment of IBS-C?
- Would you prescribe Trulance to a IBS-C patient ahead of the label expansion?
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