Australia against Sovaldi price
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25.08.2014

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(Source: Pharmaceutical Benefits Advisory Committee, the committee that makes recommendations to the Australian Minister for Health and Ageing regarding drugs which should be made available as pharmaceutical benefits |  http://www.pbs.gov.au/industry/listing/elements/pbac-meetings/pbac-outcomes/2014-07/first-time-decisions-not-recommend.docx )
The PBAC rejected the submission for Section 100 (Highly Specialised Drugs Program) Authority Required (STREAMLINED) listing for sofosbuvir for the treatment of chronic hepatitis C on the basis of unacceptably high and likely underestimated cost-effectiveness and the high and likely underestimated budgetary impact on the PBS.
The PBAC recognised that treatment of hepatitis C virus (HCV) can be curative, compared to other viral infections such as human immunodeficiency virus (HIV) and hepatitis B virus, and that sofosbuvir is the first oral direct acting antiviral agent (DAA) which can be used to treat HCV genotypes 1-6 and to provide patients with the first interferon-free treatment option. The PBAC considered that consideration of new treatment options for HCV should be framed in the evolving treatment landscape where patients are most likely waiting for the availability of interferon-free regiments.
The PBAC noted that HCV Genotype 1 or Genotype 3 account for 88-92% of infections in Australia. The PBAC considered that the ICER/QALYs were high and uncertain in IFN-free regimes for treatment for genotype 1 and genotype 3 compared to no treatment, which the PBAC considered to be the most informative treatment groups for decision making in the broader context of HCV treatment.
The financial estimates presented in the submission estimated that listing sofosbuvir would have a high financial impact on the health budget. The PBAC considered that the estimates were likely underestimated due to increasing number of patients seeking treatment regimens which are of shorter duration, less adverse effects and are interferon-free.
The PBAC considered, as the clinical management of individuals with HCV is moving so rapidly, that a broader Government and community approach is needed to maximise clinical outcomes and patient access to treatment. As well as subsidising new treatment on the PBS, other factors that increase the capacity to treat patients need to be explored.
Independent of the submission, the Transplantation Society of Australia and New Zealand (TSANZ) and the Australian Liver Association (ALA) corresponded with the PBAC, highlighting patients with a high clinical need for treatment, namely patients with HCV infection who are awaiting a liver transplant or have cirrhosis complicated by severe portal hypertension. Through clinical evidence is emerging of the benefit to these patient populations with treatment with interferon-free regimens, the comparative clinical benefit had not been presented to the committee and cost-effectiveness had not been established. The PBAC considered that establishing cost-effectiveness in this high need population may be an early step towards a broader access for a treatment for Australians with HCV infection.