Clamoroso: l’Australia rifiuta di approvare Sofosbuvir e approva Simeprevir
Con una incredibile e discutibilissima decisione le autorità sanitarie Austaliane hanno rifiutato l’approvazione di Sofosbuvir per la cura dell’epatite cronica C. Le motivazioni pubblicate si concentrano sull’elevato impatto economico e la costo-efficacia definita “incerta”.
Allo stesso tempo le Autorità Sanitarie hanno approvato l’utilizzo di Simeprevir (Olysio)
Documenti integrali possono essere scaricati qui
July 2014 PBAC OUTCOMES - "1st time" decisions not to recommend
Drug Name, form(s), strength(s), Sponsor, Type of Submission | Drug Type and Use
| Listing requested by Sponsor / Purpose of Submission | PBAC Recommendation |
SOFOSBUVIR. tablet, 400 mg, Sovaldi® | Hepatitis C | Section 100 (Highly Specialised Drugs Program) Public and Private Hospital Authority Required (Streamlined) listing for the treatment of genotypes 1, 2, 3, 4, 5, and 6 hepatitis C viral infection in patients 18 years or older who have compensated liver disease. | The PBAC rejected the submission for Section 100 (Highly Specialised Drugs Program) Authority Required (STREAMLINED) listing for sofosbuvir for the treatment of chronic hepatitis C on the basis of unacceptably high and likely underestimated cost-effectiveness and the high and likely underestimated budgetary impact on the PBS. The PBAC noted that HCV Genotype 1 or Genotype 3 account for 88-92% of infections in Australia. The PBAC considered that the ICER/QALYs were high and uncertain in IFN-free regimes for treatment for genotype 1 and genotype 3 compared to no treatment, which the PBAC considered to be the most informative treatment groups for decision making in the broader context of HCV treatment. The financial estimates presented in the submission estimated that listing sofosbuvir would have a high financial impact on the health budget. The PBAC considered that the estimates were likely underestimated due to increasing number of patients seeking treatment regimens which are of shorter duration, less adverse effects and are interferon-free. The PBAC considered, as the clinical management of individuals with HCV is moving so rapidly, that a broader Government and community approach is needed to maximise clinical outcomes and patient access to treatment. As well as subsidising new treatment on the PBS, other factors that increase the capacity to treat patients need to be explored. Independent of the submission, the Transplantation Society of Australia and New Zealand (TSANZ) and the Australian Liver Association (ALA) corresponded with the PBAC, highlighting patients with a high clinical need for treatment, namely patients with HCV infection who are awaiting a liver transplant or have cirrhosis complicated by severe portal hypertension. Through clinical evidence is emerging of the benefit to these patient populations with treatment with interferon-free regimens, the comparative clinical benefit had not been presented to the committee and cost-effectiveness had not been established. The PBAC considered that establishing cost-effectiveness in this high need population may be an early step towards a broader access for a treatment for Australians with HCV infection. |
Sponsor Comment: | The sponsor needs to clarify the decision with the PBAC. |
SIMEPREVIR, capsule, 150 mg Olysio® Janssen-Cilag Pty Ltd New Listing |
Hepatitis C | Section 100 (Highly Specialised Drug Program) Private Hospital Authority required and Public Hospital Authority required (Streamlined) listing for the treatment of chronic genotype 1 hepatitis C infection in patients who meet certain criteria | The PBAC recommended the Section 100 (Highly Specialised Drugs Program) listing of simeprevir, in combination with PR, to treat hepatitis C virus (HCV) genotype 1 infection in treatment naïve and treatment experienced patients who meet certain criteria with a maximum quantity of 6 packs with 0 repeats. Listing was recommended at the price proposed in the submission. The trial-based equi-effective doses are simeprevir 150mg once daily and telaprevir 750mg three times per day. The PBAC considered that the submission supported the claim that simeprevir is non-inferior in terms of comparative effectiveness (in achieving an SVR) and superior in terms of safety when compared with boceprevir and telaprevir. The PBAC considered that a cost-minimisation analysis was the appropriate approach for valuing simeprevir at the present time. The PBAC noted that on the basis of indirect evidence presented by the submission, for every 100 treatment naïve patients treated with SMV12+PR24/48 in comparison to TVR12+PR24/48 or BOC24+PR28/48:
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