Hepatitis Australia has welcomed positive recommendations for three new antiviral therapies to be listed on the PBS, describing it as a "watershed moment" that will fundamentally change the way hepatitis C is treated in Australia.
CEO Helen Tyrrell welcomed the positive PBAC recommendations for Gilead's SOVALDI (sofosbuvir) and HARVONI (ledipasvir and sofosbuvir), and Bristol-Myers Squibb's DAKLINZA (daclatasvir dihydrochloride).
In clinical trials, the therapies have demonstrated very high cure-rates, exceeding 90 per cent, a shorter duration of treatment and a better safety profile than current treatment.
In its recommendation, the PBAC said funding the new therapies raised questions over current PBS-listed treatments.
"The PBAC advised the Minister...that the current treatment for CHC, such as peginterferon and ribavirin alone and in combination with telaprevir [Janssen's INCIVO], boceprevir [MSD's VICTRELIS] or simeprevir [Janssen's OLYSIO], are no longer cost-effective at the prices currently listed on the PBS."
INCIVO and VICTRELIS were listed in April 2013, while OLYSIO was listed last December. Their uptake has been slower than expected as clinicians and patients anticipate funding for the new antiviral therapies.
Ms Tyrrell urged the Federal Government “to accept the experts’ advice and ensure a PBS listing is not delayed”.
“The PBAC recommendations are great news for people living with hepatitis C and moves Australia a step closer to making 2015 a watershed year for hepatitis C. However, without confirmation of a PBS listing date, people with hepatitis C are still waiting for access to these medicines.
“With the approval of Cabinet, people with hepatitis C genotypes 1, 2, 3 and 4 (the main genotypes in Australia) will at last have affordable access to interferon-free therapy,” she added.
While the PBAC's outcome statement said the five-year cost of the therapies could exceed $3 billion, recent comments by Health Minister Sussan Ley inferred that it would be significantly below that amount.
Ms Ley told the recent Medicines Australia annual parliamentary dinner that recommendations from the March PBAC meeting represented $2.5 billion in new PBS spending.
Ms Tyrrell called on the Department of Health and the relevant companies to finalise negotiations so that “Cabinet can approve funding for these life-saving medicines in the next few months to help meet the nationally approved treatment targets for 2015”.
“The Government has committed to doubling hepatitis C treatment rates each year as part of the National Strategy," she said. "They now have the opportunity to make 2015 a watershed year for hepatitis C and start us on the path to eliminating hepatitis C.
She continued, “More than 50 Australians lose their lives to hepatitis C-related liver disease every month – and thousands more live with the psychological and physical burden of the illness.
“The Federal Government has an historical opportunity to make interferon-free options available for all people living with hepatitis C. Each day of delay in access to these curative medicines is agony for many of the 230,000 Australians living with the virus,” she added.
