The Canadian Drug Review’s CDEC Board approved simeprevir (GALEXOS) on June 18th, 2014, and has sent HepCBC a thank you letter for its simeprevir submission. Simeprevir (GALEXOS) is a new hepatitis C drug for genotype 1 infection which, at this point at least, is to be used in a triple therapy along with interferon alpha and ribavirin. This drug, developed by Janssen Pharmaceuticals and marketed in the USA as OLYSIO, is also being recommended in the US and Europe to be used in an interferon-free, ribavirin-free combination with sofosbuvir (SOVALDI). Highlights of the thank you letter included (italics are ours):

“…One of the CDEC public members presented your input at the outset of the deliberation about simeprevir to provide the whole committee with the patients’ perspectives and unmet needs, and this set the stage for the deliberation. Throughout the deliberations, CDEC members reflected on how or whether the evidence under review addressed the issues or unmet needs identified in your input…”

“The CDR reviewers and CDEC members found your submission useful, particularly with regard to the following:

  • Compelling quotations, grouped by theme, that illustrate the far-reaching consequences of the condition and the frustration and desperation of patients and caregivers.
  • Identification of fear as a major issue for those with chronic hepatitis C. Your description of their fear was read aloud to all CDEC members.”

Further links:

CDR’s Thanks (and feedback) to HepCBC for our Patient Input Submission for simeprevir (Galexos) dated July 2, 2014
http://hepcbc.ca/wp-content/uploads/2014/07/CDR_HepCBC_thanks.pdf

CDEC’s Final Recommendation for simeprevir (Galexos) for chronic hepatitis C genotype 1 infection, dated June 18, 2014
http://www.cadth.ca/media/cdr/complete/SR0347_complete_Galexos-Jun-20-14.pdf

HepCBC’s simeprevir (Galexos) submission to CADTH, dated Sept. 13, 2013
simeprevir (Galexos) – BC