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Expert Interview

Slingshot members are talking to an expert! The topic is:

With top-line data finally released, how does Plecanatide stack up to Linzess in IBS-C & CIC?

Ticker(s): SGYP, AGN, IRWD

Who's the expert?

Name: Dr Philip Schoenfeld - MD

Institution: Detroit VA Medical Center

Bio:

  • 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

Interview Questions
Q1.

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)

Added By: joe_mccann
Q2.

Please describe your typical treatment paradigm for CIC and IBS-C with the following agents:

  • OTC laxative use
  • Linzess (linaclotide)
  • Amitiza (lubiprostone)

Added By: joe_mccann
Q3.

Please describe your clinical experience with Linzess. What are your impression with regard to it's efficacy?

Added By: joe_mccann
Q4.

Please comment on the side effect profile of Linzess, specifically regarding the rates and severity of diarrhea:

  1. How many patients discontinue treatment due to diarrhea?
  2. How often do you need to reduce dose due to diarrhea?
  3. Do you recommend patients split capsules or skip doses due to diarrhea?

Added By: joe_mccann
Q5.

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
  • Medicare

Added By: c_admin
Q6.

 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?

Added By: c_admin
Q7.

Trulance (plecanatide) is a recently approved treatment for CIC. Have you heard of this drug and are you familiar with the data?

Added By: c_admin
Q8.

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?

Added By: c_admin
Q9.

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
Q10.

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
Q11.

Are you more likely to lower the dose in a Linzess patient with intolerable diarrhea or switch to Trulance?

Added By: c_admin
Q12.

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?

Added By: c_admin

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