Australia's PBAC, Pharmacy Benefits Program, akin to Medicaid in USA, Rejects Sofosbuvir, here is their language
They however recommended simeprevir+peg/Rbv. In the US several medicaids have set up harsh & punitive restrictions essentially denying access to drug users who show evidence of drug use in the past 12 months & only allowing access to those with advanced liver disease, when it is very late to treat putting patients at increased risk for liver cancer. Lawsuits are being threatened in the US & there is reason to think these actions by these medicaid programs are illegal, you can read more detailed discussions about this and a link to the Social Security Act Medicaid Rebate Law where it appears that in return for receiving a 23% discount & 44% for VA the medicaid's are required to provide access, again hopefully lawsuits will be launched to challenge this, interestingly the lawsuits apparently will come from individual patients, why don't HCV advocacy organizations launch a lawsuit or at least challenge the legality of the restrictions with federal & congressional officials & political representatives. Jules Levin
HCV/Medicaid Law Suits Coming - (08/22/14)
PDF containing this language regarding their decisions on sofosbuvir:
Download the PDF here
PDF containing this language regarding their decisions on simeprevir:
Download the PDF here
Australia's TGA clears the way for Gilead's Sovaldi for hepatitis C
Australian health care regulator the Therapeutic Goods Administration (TGA) has approved the use of US anti-virals specialist Gilead Sciences' (Nasdaq: GILD) Sovaldi (sofosbuvir) for the treatment of hepatitis C in Australia.
Gilead has come up for a great deal of criticism relating to the price of this new drug - dubbed the $1,000 a day pill - but which has nevertheless demonstrated remarkable efficacy.
This is the first step in making this new treatment accessible to Australians living with chronic hepatitis C, according to consumer advocacy group Hepatitis Australia, which says it "welcomes the TGA listing of this transformative new treatment," which has very high cure rates combined with reduced side effects.
But now needs PBS listing
It adds: "We must now wait to see if the new treatment becomes available through the Pharmaceutical Benefits Scheme (PBS) to ensure its affordability to those who need it."
Hepatitis Australia's acting chief executive, Kevin Marriott, said that, "without a government subsidy financial barrier to accessing the treatment for the vast majority of people living with hepatitis C," adding: "Australia already has appallingly low treatment rates - less than 1% of people with hepatitis C receive treatment, and we are already seeing escalating rates of serious liver disease as a result.
"The Pharmaceutical Benefits Scheme is a programme of the Australian Government that provides subsidised prescription drugs to residents of Australia. According to Medicare, Australia's version of Medicaid (USA) or NICE (UK), the PBS gives all Australian residents and eligible overseas visitors access to prescription medicine in a way that is affordable, reliable and timely. Through the PBS, the Australian Government subsidises the cost of listed prescription medicine, making it more affordable for all Australians."
Media Release - For Immediate Release
Friday 22 August 2014
Hepatitis NSW Expresses Strong Disappointment at PBAC Rejection of Sofosbuvir
Hepatitis NSW has today expressed its strong disappointment at the decision by the Pharmaceutical Benefits Advisory Committee (PBAC) to reject approval for the revolutionary hepatitis C drug, sofosbuvir.
In a statement released today, the PBAC announced its decision, from its July 2014 meeting, not to support listing of sofosbuvir on the Pharmaceutical Benefits Scheme (PBS).
"230,000 Australians, including 90,000 people just in NSW, have been waiting for many years for these new, more effective, easier to take, lower side-effect and shorter duration treatments to be approved," Hepatitis NSW CEO Mr Stuart Loveday said.
"The PBAC is now telling these Australians to wait longer, potentially much longer, before they can receive these life-saving, and life-changing, new drugs."
The decision to reject approval for sofosbuvir also places Australians living with chronic hepatitis C at significant disadvantage compared to their US and European counterparts.
"Sofosbuvir has been available in the US since December last year. It now seems unlikely it will be available in Australia until mid-2015 at the earliest. Why are Australians living with chronic hepatitis C left waiting so long for their best chance at a cure?" Mr Loveday added.
"It makes no sense to delay access to these treatments, placing at risk the health of people who are ready, and waiting, to go onto treatment now."
The recently released Hepatitis Report Card showed that, without significant intervention, the number of deaths per year attributable to hepatitis C, which already stands at 530 per year, will increase by a massive 230% by 2030.
Currently, only approximately 1% of people living with hepatitis C in Australia are treated each year. It had been hoped approval of the new drug sofosbuvir would help lead to a treatment 'revolution', which is vital to avert the worst long-term consequences of Australia's hepatitis C epidemic.
"The PBAC's rejection of sofosbuvir is deeply disappointing for Hepatitis NSW, its members and the affected community," Mr Loveday said.
In positive news, the PBAC has recommended that another new treatment, simeprevir, be approved for people living with chronic hepatitis C genotype 1, in combination with interferon and ribavirin.
Simeprevir offers improvement on existing treatments, particularly lower side-effects, but is not effective for people with hepatitis C genotypes 2, 3 or 4.
It is now up to the Government to agree to list simeprevir on the PBS. Hepatitis NSW strongly encourages the Commonwealth Government to do so as quickly as possible.
"The recommendation to approve simeprevir is a small step forward for some Australians living with hepatitis C. But most people have been left waiting for the great leap." Mr Loveday said.
For further information please contact Stuart Loveday at Hepatitis NSW on 0410 488 144
To access the Hepatitis Report Card visit www.liverdangerzone.com.au
Watching the world get better
July 15th, 2014
In Australia, waiting rooms in liver clinics are crowded with people waiting for hepatitis C treatment. They're not just waiting for the old treatment, they're waiting for the new treatment. Doctors cannot answer when the so-called miracle drug sofosbuvir will be available, even though it is currently in the pipeline of being approved for medical use. Sadly, it's not as simple as that in Australia. And so anxiety increases and anticipation ebbs and flows, as those living with the hepatitis C virus (HCV) in Australia continue to wait patiently for more certainty.
So, what does it mean when you are told by a doctor that a drug such as sofosbuvir is awaiting approval by the Pharmaceutical Benefits Scheme (or PBS) in Australia? The Pharmaceutical Benefits Scheme is a programme of the Australian Government that provides subsidised prescription drugs to residents of Australia. According to Medicare, Australia's version of Medicaid (USA) or NICE (UK), the PBS gives all Australian residents and eligible overseas visitors access to prescription medicine in a way that is affordable, reliable and timely. Through the PBS, the Australian Government subsidises the cost of listed prescription medicine, making it more affordable for all Australians. This all sounds very promising, especially when most members of the hepatitis C community are more than likely aware of the huge $84k price tag attached to sofosbuvir. Does that mean Australians are going to get sofosbuvir for free when it gets approved by the Australian Government's PBS programme? Perhaps, but doctors and HCV community groups are hesitant to make promises. This is because there are no clear indications of whether such new and expensive drugs will be fully subsidised, to which end the prescribing of sofosbuvir might well be controlled by strict eligibility criteria.
If you live with hepatitis C, then you might already be familiar with what it feels like to have your liver health measured. Sometimes, it might feel that this measure extends further than the treatment setting, as our liver health has an effect on our everyday life. Health care is something we all expect when we visit our GP or hospital. We don't expect to be turned away. But if you are living with hep C in Australia, then you might very well feel like you are being turned away. Whilst there are no answers about when new drugs for the treatment of HCV will be available, it can be a very exhausting experience to join the masses in the queues forming in liver clinics across Australia. Our goal as a community is clearly to live in a world free from viral hepatitis, but are we living in a country where the possibility of getting treated doesn't mean having to undergo the harsh regime of pegylated interferon and ribavirin?
Watching the world get better is at times a bittersweet pill to taste. On the one hand, it is exciting to see the news headlines of so many overseas HCV related support groups with promising results of people who are already undergoing new treatment. On the other, it is sometimes a despondent experience to read such headlines knowing that so much uncertainty still exists. However, no matter where we are in the world, we can each take comfort in the recent advances made for the treatment of hepatitis C and rest assured that there will be something better available sooner than later.