Anti-TNF s: Still the Best First Line Therapy for IBD Treatment?

Transcription

1 Anti-TNF s: Still the Best First Line Therapy for IBD Treatment? Pfizer Symposium - Reaching New Horizons with Biosimilars in IBD Karen I. Kroeker May 26, 2017

2 Disclosure of Commercial Support This program has received financial support from Pfizer This program has received in-kind support from N/A Potential for conflict(s) of interest: K. Kroeker has received payment from Abbvie, Janssen, Takeda, Pfizer whose product(s) are being discussed in this program.

3 Mitigating Potential Bias Sponsor representatives are not in the planning committee of the program. The planning committee carefully chooses the topics for the program in order to ensure that the principles of scientific integrity, objectivity and balance have been respected. Planning committee chair and members have individual discussions with each speaker regarding expected learning outcomes and teaching format. CME&PD Office provides information sheets and forms to each speaker, communicating the course learning objectives and requirement of scientific integrity, as well as instruction on conflict of interest disclosure and managing bias.

4 Objectives 1. Discuss the role of anti-tnf therapy as first line therapy for: Ulcerative colitis Crohn s disease 2. Discuss how other biologics factor into our discussion for first line therapy in IBD

5 Background New (non-anti-tnf) biologic therapies for the treatment of IBD are now available in Canada for treatment of IBD Crohn s: Vedolizumab UC: Vedolizumab, Ustekinumab Increasing options treatment of IBD is exciting and more challenging

6 Background Biosimilars (Second Entry Biologics) Priced 15-75% less than the reference medications Projected cost savings &?access for more patients Inflectra (biosimilar infliximab) was recently approved by Health Canada for use in CD, fistulizing CD, and UC Non-Group Blue Cross Inflectra for new starts for IBD Curr Med Chem 2017 Apr 6

7 Informed Consent "every human being of adult years and of sound mind has the right to determine what shall be done with his or her own body Voluntary Capacity Informed: adequate explanation - nature proposed investigation/treatment its anticipated outcome significant risks involved alternatives available

8 What aspects should be considered when discussing therapeutic options: Clinical efficacy risks/benefits Patient-specific factors: (Prior therapies) Demographic characteristics age, location, lifestyle Disease phenotype?extra-intestinal manifestations Co-morbidities Patient preference Cost/Insurance coverage

9 Clinical Efficacy Level 1 Evidence RCT s of clinical efficacy Network meta-analysis are being used to compare the efficacy of different biologics Need for Head-to-head studies to inform us!!!

10 Patient-Specific Factors PERSONALIZED/ PRECISION MEDICINE Demographics age; address; lifestyle Disease phenotype Fistulizing disease evidence for efficacy in different phenotypes Extra-intestinal manifestations Eg. PG anti-tnf therapy Other comorbidities: Contraindications to therapy (severe heart failure,?demyelinating ) Indications for Tx of comorbidities ( Two-for-one ) (eg. Psoriasis, AS, etc)

11 Patient Preference Preference Sensitive Decisions When there is >1 appropriate treatment choice Patients will agree on what is right for them based on how they value benefits versus harms Patients will choose a therapy based upon: Optimism of response Aversion to risk Severity of illness Tolerance of symptoms What they learn about the treatment options* Curr Opin Gastroenterol July ; 25(4):

12 Patient Preference Risk Perception 2 factors in how patients perceive risk: Dread possible consequence of a bad outcome Unknown new risk or uncertainty about risk worry Generally, rising treatment benefit leads to greater tolerance of SE Shared Decision Making How can you educate your patients to help them decide Decision aids Side to side comparison tables Curr Opin Gastroenterol July ; 25(4):

13 Cost/Insurance Coverage Biologic medications are expensive Patients need coverage to cover the costs Cost-effectiveness analysis (CEA) studies are needed Insurance companies sometimes limit the choices of therapy to save costs and protect sustainability AMA: Physician decisions drive about 70% (or more) of the costs in the system* Stewardship is one of our professional responsibilities *

14 Summary & Conclusions New therapeutic options for IBD increasing complexity when choosing treatments As part of informed consent, patients should have the options explained Head-to-head comparisons of efficacy for these options are needed to tell us which drug to choose 1st?Option of Network Meta-analyses for comparing efficacy When choosing a first-line biologic, take into consideration: Patient-specific factors Patient preference Cost/Insurance coverage Decision aids may be beneficial in helping patients choose the best biologic therapy for them

15 Questions?