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.

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.

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.

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. Chronic hepatitis with severe HCV-related extrahepatic manifestations (cryoglobulinaemic syndrome with end-organ damage, B-cell lymphoproliferative syndromes).
4. Chronic hepatitis with fibrosis METAVIR F3 (or corresponding Ishack)
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.
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

List of centers authorized to prescribe antiviral drugs for hepatitis C - Update (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 Tuscany, a resolution of the regional council has established that the drug for hepatitis C will be given free of charge to all (Tuscan) patients who need it. It is estimated that there are 26,224 (equal to 0.7% of the Tuscan population).

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

Related news: Hepatitis C: 41 million euro reimbursement to the regions in implementation of the pay-back mechanism for the Sovaldi and Harvoni drugs

AIFA declaration on Sovaldi. Guariniello: "culpable injuries and omission of treatment". Codacons warns ministry and regions

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

“Hepatitis C super drug too expensive”. Five countries sue the manufacturer

Hepatitis C. The big dilemma: we have the drugs to stop it but not the money to buy them for everyone.

Who will get the anti-hepatitis C super drug

Medicines: in San Marino or from India, rush to buy anti-hepatitis C (2014)