Simeprevir (trade name GALEXOS™, produced by Janssen, Inc.) was recently approved for use in Canada to treat hepatitis C, but BC PharmaCare doesn’t cover it yet. Like similar drugs telaprevir/INCIVEK™ and boceprevir/VICTRELIS™, simeprevir is generally given to genotype 1 patients for several weeks in combination with two other medications (hence the name, “Triple Therapy”). In Triple Therapy with simeprevir, the drug is taken once a day (one pill) along with interferon (injected once per week) and ribavirin (taken orally twice per day). BC Pharmacare is now considering coverage for simeprevir, and is asking for input from patient groups and individuals (patients and caregivers). HepCBC needs your help to make a good group submission! For information about simeprevir, scroll down to “WHY HepCBC WANTS BC PHARMACARE TO COVER SIMEPREVIR” below.

HOW YOU CAN HELP, part 1: HepCBC is filling out the “PATIENT GROUP Questionnaire” but we’d love to get input from as many HCV+ people and caregivers as possible. We will use the best patient (or caregiver) quotes in our general submission about why HepCBC thinks BC PharmaCare should cover GALEXOS™.  To help us out, please answer the five questions below (Note: For caregiver input, describe your experience caring for a patient or patients). Skip any questions you wish.

  1. OPTIONAL: What is your genotype (or that of the person you care for)?
  2. Describe how hepatitis C affects your day-to-day life.
  3. If you (or someone you care for) have tried simeprevir/GALEXOS™, please tell us about the effects you/they experienced.
  4. Besides simeprevir/GALEXOS™, what other drugs or treatments have you/they used, or are currently using, for hepatitis C? Please list all of the drugs and tell us about your/their experience with each treatment. In particular we would be interested in hearing about experiences with current “Triple Therapy” [interferon + ribavirin + EITHER boceprevir/VICTRELIS™ OR telaprevir/INCIVEK™]. Generally “Triple Therapy” is given to genotype 1 patients only, but as you can read below, some doctors may wish to combine simeprevir with other drugs (such as sofosbuvir/SOVALDI™) to create an interferon-free treatment for other genotypes.
  5. Please tell us why you believe simeprevir/GALEXOS™ should be included in the BC PharmaCare program.

Please send us your answers by email to info@hepcbc.ca. In order to have time to add them in, HepCBC’s deadline for patient/caregiver comments is midnight Tuesday, May 28th, 2014. To read more about why HepCBC is advocating that BC Pharmacare cover simeprevir/GALEXOS™,  read WHY HepCBC WANTS BC PHARMACARE TO COVER SIMEPREVIR below.

HOW YOU CAN HELP, part 2: If you have LOTS of time…we also encourage you to send in your own personal input as well at http://www.health.gov.bc.ca/pharmacare/yourvoice/#druglist. (Scroll down to the chart. Find “simeprevir [GALEXOS™]” and select either “PATIENT Questionnaire” or “CAREGIVER Questionnaire”.) Deadline (for INDIVIDUAL SUBMISSIONS ONLY!) is midnight Tuesday, May 30th, 2014. (Note deadline for input into HepCBC’s Patient Group submission is May 28th.)

WHY HepCBC WANTS BC PHARMACARE TO COVER SIMEPREVIR

  1. Fewer side-effects than boceprevir/VICTRELIS™ or telaprevir/INCIVEK™.
  2. Lower pill burden than boceprevir or telaprevir (simeprevir is given once a day).
  3. Fewer dietary requirements than telaprevir, though patients still must take simeprevir with food.
  4. Even after stronger, more expensive, drugs such as sofosbuvir/SOVALDI™ are approved (we assume this will happen sometime this year), they may not be the first choice. BC Pharmacare has said they “may cover a drug only for people who have the illness or condition and have not responded to other drugs used to treat that illness or condition.” For genotype 1 patients, this could possibly mean they’d have to go through Triple Therapy first, and fail it before BC PharmaCare would cover the more effective but costlier drugs. In this case, the addition of simeprevir to the PharmaCare formulary looks particularly attractive, providing all patients – not just the wealthy or those with third-party insurance accessing simeprevir now – with a less harsh alternative to boceprevir and telaprevir.
  5. Simeprevir is already being prescribed off-label, in combination with other drugs such as sofosbuvir, with or without ribavirin, particularly for hard-to-treat patients such as those with advanced liver damage, prior null response to treatment, and genotype 1 and 4 patients who cannot take interferon. This combination is currently undergoing trials with all genotypes. Once both simeprevir and sofosbuvir are covered by PharmaCare, it is likely that combining them will be another excellent option for patients who do not respond to standard of care.
  6. There is one problem with simeprevir, but Janssen seems to be dealing with it proactively. If a patient has the genotype 1a form of the virus, they must take a blood test to find out if their virus has a “Q80K” mutation (see May, 2014 hepc.bull for more information). If it does, the patient should not take simeprevir as it is not effective in the presence of Q80K. Janssen covers the cost of the Q80K test.

Those are HepCBC’s reasons for urging PharmaCare to approve simeprevir. What are YOURS? Let us know in an email to info@hepcbc.ca before midnight on May 19, 2014. T H A N K S !!!