{"id":23781,"date":"2016-01-07T18:53:42","date_gmt":"2016-01-07T17:53:42","guid":{"rendered":"http:\/\/www.fedaiisf.it\/?p=23781"},"modified":"2016-01-07T19:44:41","modified_gmt":"2016-01-07T18:44:41","slug":"registri-aifa-lagenzia-fornisce-informazioni-sui-dati-dei-trattamenti-con-i-nuovi-farmaci-per-la-cura-dellepatite-c-n-d-r","status":"publish","type":"post","link":"https:\/\/www.fedaiisf.it\/en\/registri-aifa-lagenzia-fornisce-informazioni-sui-dati-dei-trattamenti-con-i-nuovi-farmaci-per-la-cura-dellepatite-c-n-d-r\/","title":{"rendered":"AIFA registers: the Agency provides information on treatment data with new drugs for the treatment of hepatitis CNdR"},"content":{"rendered":"

With the ultimate goal of facilitating access to new therapies for all patients with chronic hepatitis C and at the same time guaranteeing the sustainability of the NHS, it was initially necessary to identify an access strategy modulated on the basis of clinical urgency for treatment.<\/em><\/p>\n

AIFA \u2013 05\/01\/2016<\/span><\/a><\/p>\n

\"\"The Italian Medicines Agency (AIFA) intends to systematically provide, through weekly updates, public data on treatments with new second-generation direct antiviral drugs (DAAs) for the treatment of chronic hepatitis C collected from the AIFA monitoring registers.<\/p>\n

With the ultimate goal of facilitating access to new therapies for all patients with chronic hepatitis C and at the same time guaranteeing the sustainability of the NHS, it was initially necessary to identify an access strategy modulated on the basis of clinical urgency for treatment. Consequently, AIFA, through the Technical-Scientific Commission (CTS), has identified the priority reimbursement criteria for treatment with the new DAAs on the basis of the results emerging from the work of the Hepatitis C Technical Table set up at the Agency.<\/p>\n

The prioritization criteria identify the following patient groups:<\/p>\n

    \n
  1. Patients with cirrhosis in Child A or B class and\/or with HCC with complete response to surgical or loco-regional resective therapies not candidates for liver transplantation \"\"in which liver disease is critical to prognosis.<\/li>\n
  2. Recurrent HCV-RNA positive hepatitis of transplanted liver in clinically stable patient with optimal levels of immunosuppression<\/li>\n
  3. Chronic hepatitis with severe HCV-related extrahepatic manifestations (cryoglobulinaemic syndrome with end-organ damage, B-cell lymphoproliferative syndromes).<\/li>\n
  4. Chronic hepatitis with fibrosis METAVIR F3 (or corresponding Ishack)<\/li>\n
  5. On the liver transplant list with cirrhosis MELD <25 and\/or with HCC within the Milan criteria with the possibility of a waiting list of at least 2 months.<\/li>\n
  6. Chronic hepatitis after solid organ transplantation (not liver) <\/em>or marrow with METAVIR \u22652 fibrosis (or corresponding Ishack).<\/li>\n
  7. Chronic hepatitis with fibrosis METAVIR F0-F2 (or corresponding Ishack) (only for simeprevir).<\/li>\n<\/ol>\n

    In order to ensure the widest possible access to these innovative treatments, AIFA is nonetheless engaged in a continuous and timely verification of new scientific evidence and the possibility of remodulating the current eligibility criteria for treatment with DAAs.<\/p>\n

    L'update<\/a> provides the following information:<\/p>\n

      \n
    1. Cumulative trend of treatments initiated<\/li>\n
    2. Treatments initiated by criterion<\/li>\n
    3. Regional mosaic: frequency of treatments by region by criterion.<\/li>\n<\/ol>\n

      Read the summary table of Registers (DAAs)<\/a><\/em><\/p>\n

      Consult the AIFA website page: Hepatitis C update<\/a><\/em><\/p>\n

      List of centers authorized to prescribe antiviral drugs for hepatitis C - Update (30\/12\/2015)<\/h1>\n

      List of Centers authorized by the Regions and Autonomous Provinces to prescribe medicines for the treatment of hepatitis C virus infection.<\/p>\n