Con l’obiettivo finale di favorire l’accesso alle nuove terapie per tutti i pazienti affetti da epatite C cronica e garantire al tempo stesso la sostenibilità del SSN, si è reso  inizialmente necessario individuare una strategia di accesso modulata sulla base dell’urgenza clinica al trattamento.

AIFA – 05/01/2016

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.

Con l’obiettivo finale di favorire l’accesso alle nuove terapie per tutti i pazienti affetti da epatite C cronica e garantire al tempo stesso la sostenibilità del SSN, si è reso  inizialmente necessario individuare una strategia di accesso modulata sulla base dell’urgenza clinica al trattamento. Di conseguenza, l’AIFA, tramite la Commissione Tecnico Scientifica (CTS), ha individuato i criteri di  rimborsabilità prioritaria al trattamento con i nuovi DAAs sulla base dei risultati emersi dai lavori del  Tavolo tecnico epatite C istituito presso l’Agenzia.

The prioritization criteria identify the following patient groups:

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.
2. Recurrent HCV-RNA positive hepatitis of transplanted liver in clinically stable patient with optimal levels of immunosuppression
3. Epatite cronica con gravi manifestazioni extra-epatiche HCV-correlate (sindrome crioglobulinemica con danno d’organo, sindromi linfoproliferative a cellule B).
4. Chronic hepatitis with fibrosis METAVIR F3 (or corresponding Ishack)
5. In lista per trapianto di fegato con cirrosi MELD <25 e/o con HCC all’interno dei criteri di Milano con la possibilità di una attesa in lista di almeno 2 mesi.
6. Chronic hepatitis after solid organ transplantation (not liver) or marrow with METAVIR ≥2 fibrosis (or corresponding Ishack).
7. Chronic hepatitis with fibrosis METAVIR F0-F2 (or corresponding Ishack) (only for simeprevir).

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.

L'update provides the following information:

1. Cumulative trend of treatments initiated
2. Treatments initiated by criterion
3. Regional mosaic: frequency of treatments by region by criterion.

Read the summary table of Registers (DAAs)

Consult the AIFA website page: Hepatitis C update

Lista Centri autorizzati alla prescrizione dei farmaci antivirali per l’epatite C – Aggiornamento (30/12/2015)

List of Centers authorized by the Regions and Autonomous Provinces to prescribe medicines for the treatment of hepatitis C virus infection.

• Victrelis
  • Form (see List of new Registers)
  • List (Update 12/30/2015)
• Sovaldi
  • Form (see List of new Registers)
  • List (Update 12/30/2015)
• Olisio
  • Form (see List of new Registers)
  • List (Update 12/30/2015)
• Daklinza
  • Form (see List of new Registers)
  • List (Update 12/30/2015)
• Harvoni
  • Form (see List of new Registers)
  • List (Update 12/30/2015)
• Viekirax_Exviera
  • Form (see List of new Registers)
  • List (Update 12/30/2015)

Ed: Gilead, the maker of Sovaldi, has signed several voluntary licensing agreements with generic drug makers in India, but these agreements impose restrictions, including which countries have access to the medicines produced in "low-cost" versions, which patients and which medical facilities.
However, since India has not recognized the patentability of the drug, today several Indian manufacturers are able to sell the generic therapy.

Gilead has also reached agreements with other developing countries, such as Egypt, where hepatitis C infection is present in about 20% of the population, to grant Sovaldi at a reduced "political" cost. To avoid exporting from Egypt, Gilead has mandated that the drug be sold only by government-controlled pharmacies and the patient must open the package and take the first pill in front of the pharmacist's eyes.

Given the high costs, some states, namely Argentina, Brazil, China, Ukraine and Russia, are filing legal actions against Gliead.

The pre-established association of the drug sofosbuvir with ledipasvir (Hervoni) in patients with genotype 1 infection of the virus allows a cure without interferon, currently limited to the rarer genotypes 2 and 3.

In Italy, the drugs for hepatitis C have been approved by AIFA which has ordered free administration to the most serious patients (30,000, for now), then the therapy should also be available for other cases.
In Toscana una delibera della giunta regionale ha stabilito che il farmaco per l’epatite C verrà dato gratuitamente a tutti i pazienti (toscani) che ne hanno bisogno. Si stima che siano 26.224 (pari allo 0,7% della popolazione toscana).

Hervoni is distributed free of charge by centers authorized by AIFA for the prescription of antiviral drugs for hepatitis C, as indicated above.

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Hepatitis C, free treatment in Egypt. That's how. In Bangladesh and India generics.

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