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Simeprevir 6 years 11 months ago #857

  • Johnboy
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In Australia, the PBS has listed Simeprevir. This means it can be supplied here (for use as a combination).

Question for the good doctor......

Could you prescribe it for Australians? I suppose they would stop you as soon as you started? I do know someone who is taking it and he got his locally and used it in tandem with Indian Sofosbuvir.
G1 58yo F1 54,000 viral load Relapser 2003/4 Sof/Dac started 21/9/2015

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Last edit: by Johnboy.

Simeprevir 6 years 11 months ago #1052

No I could not prescribe it (on the PBS). I could prescribe it privately but it costs $14,000

The PBS listing is here: www.pbs.gov.au/medicine/item/10197q-10200w

It's an authority item. Click on the red "Authority Required" and you will see the requirements to qualify for it are:

Chronic genotype 1 hepatitis C infection

Clinical criteria:

Patient must have compensated liver disease,

AND

Patient must not have received prior interferon alfa or peginterferon alfa treatment for hepatitis C,

AND

The treatment must be in combination with peginterferon alfa and ribavirin,

AND

The treatment must be limited to a maximum duration of 12 weeks,

AND

The treatment must cease if the results of an HCV RNA quantitative assay at week 4 show that the plasma HCV RNA is 25 IU/mL or greater.

Population criteria:

Patient must be aged 18 years or older,

AND

Patient must not be pregnant or breastfeeding. Female partners of male patients must not be pregnant. Patients and their partners must each be using an effective form of contraception if of child-bearing age.

Treatment criteria:

Must be treated in an accredited treatment centre.

Evidence of chronic genotype 1 hepatitis C infection (repeatedly anti-HCV positive and HCV RNA positive) must be documented in the patient's medical records.

Patients who have received prior treatment with an NS3/4A protease inhibitor are not eligible to receive PBS-subsidised simeprevir, except where the patient has developed an intolerance to the other NS3/4A protease inhibitor of a severity necessitating permanent treatment withdrawal. Details of the intolerance must be documented in the patient's medical records.

Authority Required
Chronic genotype 1 hepatitis C infection

Clinical criteria:

Patient must have compensated liver disease,

AND

Patient must have received prior treatment with interferon alfa or peginterferon alfa for hepatitis C,

AND

The treatment must be in combination with peginterferon alfa and ribavirin,

AND

The treatment must be limited to a maximum duration of 12 weeks,

AND

The treatment must cease if the results of an HCV RNA quantitative assay at week 4 show that the plasma HCV RNA is 25 IU/mL or greater.

Population criteria:

Patient must be 18 years or older,

AND

Patient must not be pregnant or breastfeeding. Female partners of male patients must not be pregnant. Patients and their partners must each be using an effective form of contraception if of child-bearing age.

Treatment criteria:

Must be treated in an accredited treatment centre.

Evidence of chronic genotype 1 hepatitis C infection (repeatedly anti-HCV positive and HCV RNA positive) must be documented in the patient's medical records.

Patients who have received prior treatment with an NS3/4A protease inhibitor are not eligible to receive PBS-subsidised simeprevir, except where the patient has developed an intolerance to the other NS3/4A protease inhibitor of a severity necessitating permanent treatment withdrawal. Details of the intolerance must be documented in the patient's medical records.


So it you wanted to have Interferon and Riba as well, and you were being treated in an accredited treatment centre (read Liver Clinic) it can be prescribed.
YMMV

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Last edit: by DrJames.
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