On January 25, 2018 the federal CADTH Canadian Drug Expert Committee (CDEC) released its extensive reviews of two new “pan-genotypic” hepatitis C treatments: Maviret™ (AbbVie) and Vosevi™ (Gilead). In both cases, the drugs were recommended for reimbursement by provincial PharmaCares for “adult patients with chronic hepatitis C virus (HCV) genotype 1, 2, 3, 4, 5, or 6 infection with or without compensated cirrhosis.” And, for both, reimbursement would occur only if the patient is “under the care of a physician with experience in the diagnosis and management of HCV infection.”

In addition the following critical product-specific conditions were imposed:

ADDITIONAL RE-TREATMENT CRITERIA:

  • MAVIRET (glecaprevir/pibrentasvir or G/P) may be reimbursed in “patients with HCV genotype 1 infection who were previously treated with either a regimen of NS5A inhibitor or with a NS3/4A protease inhibitor but not both classes of inhibitors.”
  • VOSEVI (sofosbuvir/velpatasvir/voxilaprevir or SOF/VEL/VOX) is ONLY to be reimbursed in genotype 1, 2, 3, 4, 5, or 6 patients  who also “have previously been treated with an HCV regimen containing an NS5A inhibitor; OR genotype 1, 2, 3, or 4 infection and have been previously treated with an HCV regimen containing SOF without an NS5A inhibitor.”

ADDITIONAL COST CRITERIA:

  • MAVIRET’s drug plan cost “should not exceed the drug plan cost of treatment with the least costly direct-acting antiviral agent(s) (DAA).”
  • VOSEVI’s drug plan cost “should not exceed the drug plan cost for SOF/VEL [NOTE: EPCLUSA™, Gilead’s sofosbuvir/velpatasvir treatment].”

For full text of these recommendations, refer to:

https://www.cadth.ca/sites/default/files/cdr/complete/SR0523_Maviret_complete-Jan-25-18.pdf
and
https://www.cadth.ca/sites/default/files/cdr/complete/SR0529_Vosevi_complete_Jan-25-18.pdf

WHAT DOES THIS MEAN FOR PATIENTS and PHYSICIANS?
In BC, both these treatments are now being reviewed for reimbursement by BC PharmaCare. If Pharmacare approves these two treatments:

  • The market just became a lot more competitive, and presumably this will result in some lower costs, which could make insurance providers less nervous about the financial implications of treating almost everyone.
  • Restrictive treatment criteria requiring proof of liver damage is no longer considered at the federal level – let’s watch to see if provinces follow suit!
  • Patients and physicians would have two more pan-genotypic options in addition to Gilead’s pan-genotypic EPCLUSA (plus Merck’s ZEPATIER™ for Genotypes 1, 3, and 4).
  • Individuals who have failed DAA treatment now have two more potential ways of being successfully retreated.
  • In case of the development of resistant varieties, we now have two more chemically unique combinations to use with affected patients.
  • Maviret’s approval would mean a return to the Canadian hepatitis C market by AbbVie, who was previously unable to reach an agreement with the pan-Canadian Pharmaceutical Alliance.
  • In terms of eradicating viral hepatitis by 2030, concern revolves around the CDEC criteria that patients be “under the care of a physician with experience in the diagnosis and management of HCV infection.” This begs the question: “How are they to get such experience?” Both healthcare providers and patient groups have been advocating that treatment with the new DAAs can, in most cases, be administered by primary care physicians (and in many cases, nurse practitioners) under the direction of specialists who are available to approve initial diagnosis and prescriptions for all patients, for treatment of those with cirrhosis or serious co-morbidities, and for any patients who develop serious side-effects or treatment failure.

HepCBC welcomes both VOSEVI’s and MAVIRET’s CDEC recommendations and urges BC PharmaCare to make them available to BC’s patients with chronic hepatitis C as soon as possible. Such an action would save both lives and money, and is simply the right thing to do.

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THE ACTUAL SUMMARY TEXT (each recommendation is actually 7 full pages!):

https://www.cadth.ca/sites/default/files/cdr/complete/SR0523_Maviret_complete-Jan-25-18.pdf

GLECAPREVIR / PIBRENTASVIR (MAVIRET — ABBVIE CORPORATION)

Indication: Chronic hepatitis C virus infection

RECOMMENDATION:
The CADTH Canadian Drug Expert Committee (CDEC) recommends that glecaprevir/pibrentasvir be reimbursed for the treatment of adult patients with chronic hepatitis C virus (HCV) genotype 1, 2, 3, 4, 5, or 6 infection with or without compensated cirrhosis, including patients with HCV genotype 1 infection who were previously treated with either a regimen of NS5A inhibitor or with a NS3/4A protease inhibitor but not both classes of inhibitors, if the following conditions are met:

Conditions:

  • The patient is under the care of a physician with experience in the diagnosis and management of HCV infection.
  • Drug plan cost for glecaprevir/pibrentasvir should not exceed the drug plan cost of treatment with the least costly direct-acting antiviral agent(s) (DAA).

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https://www.cadth.ca/sites/default/files/cdr/complete/SR0529_Vosevi_complete_Jan-25-18.pdf

SOFOSBUVIR/VELPATASVIR/VOXILAPREVIR (VOSEVI — GILEAD SCIENCES CANADA, INC.)

Indication: Chronic hepatitis C virus infection

RECOMMENDATION:
The CADTH Canadian Drug Expert Committee (CDEC) recommends that sofosbuvir/velpatasvir/voxilaprevir (SOF/VEL/VOX; Vosevi) be reimbursed for the treatment of adult patients with chronic hepatitis C virus (HCV) infection, without cirrhosis or with compensated cirrhosis, who have: genotype 1, 2, 3, 4, 5, or 6 infection and have previously been treated with an HCV regimen containing an NS5A inhibitor; OR genotype 1, 2, 3, or 4 infection and have been previously treated with an HCV regimen containing SOF without an NS5A inhibitor if the following conditions are met:

Conditions:

  • The patient is under the care of a physician with experience in the diagnosis and management of HCV infection.
  • Drug plan cost for SOF/VEL/VOX should not exceed the drug plan cost for SOF/VEL.