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Epclusa™, a Direct-Acting-Antiviral combo for ALL GENOTYPES of Chronic Hepatitis C, received approval from CADTH on October 28, 2016.
This combo of (generics) sofosbuvir and velpatasvir, from Gilead Sciences, was recommended by CADTH’s Canadian Drug Expert Committtee (CDEC) for reimbursement by provincial and territorial PharmaCares…
“if the following CRITERION and CONDITION are met:
(1) CONDITION: “Reduce the price.” CDEC noted that the cost of treatment with Epclusa™ under PharmaCare should not exceed that of treatment with the least costly alternative interferon-free option.
(2) CRITERION: “Treatment should be initiated by physicians experienced in the management of patients with chronic hepatitis C.” HepCBC would prefer that more physician-treaters become available, which implies some sort of physician training such as online CME courses. CADTH’s criterion does not consider the value of such potential training or any benefits of widening the pool of physician-treaters.
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HOW DOES A PAN-GENOTYPIC (all genotypes 1 through 6) TREATMENT WORK?
For one, pre-treatment genotype testing eventually will not be needed, though some genotypes and cirrhotics still require special considerations including addition of ribavirin and/or longer treatment time.
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FURTHER RESEARCH NEEDED:
(1) Trial results are needed on patients who are actively using drugs, or co-infected with HIV or hepatitis B.
(2) More research is needed into resistance-associated variants, which could adversely affect both individuals’ treatment results and the public health, as well as having possible implications for future pharmacare budgets.
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WHEN WILL EPCLUSA™ BE COVERED BY PHARMACARE?
We hope satisfactory pricing can be arranged (presumably through a grand bargain in which the provinces get rid of their current “F2+” treatment criteria in return for Gilead granting significantly reduced pricing) and that this new treatment will be fast-tracked through the various PharmaCares late 2016 or early 2017. We look forward to making our Epclusa™ submission to BC PharmaCare in the coming weeks.
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Read CADTH’s full (8 page) recommendation at:
https://www.cadth.ca/sites/default/files/cdr/complete/SR0486_complete_Epclusa-Oct-28-16.pdf