Simeprevir
Recommended HepatologyAuthority Required 💬 consumer voice
Treatment of chronic hepatitis C infection in treatment naïve and treatment-experienced patients.
4
Submissions
3 resub
2014–16
On the record
—
ICER range
Not modelled
Cost basis
Decisions on record
- Meeting Mar 2016 Recommended Chronic hepatitis C (CHC) infection
- Meeting Nov 2015 Recommended Hepatitis C
- Meeting Jul 2015 Deferred Hepatitis C
- Meeting Jul 2014 Recommended Olysio® Janssen-Cilag Pty Ltd New Listing (Major submission) 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 c
Access path
- Jul 2014Recommended · restricted
vs telaprevir and boceprevir
- Jul 2015Recommended · restricted
Comparator changed: telaprevir and boceprevir → no treatment; supplementary comparators…
- Nov 2015Recommended · restricted
Comparator changed: no treatment; supplementary comparators included…
- Mar 2016Recommended · restricted
Evidence: RCT → Other
- PBS listing · Authority Required
RecommendedDeferredNot recommended
From the public summary
PBAC outcome
4.1 The PBAC recommended to the Minister (delegate) to change the current Section 100 Highly Specialised Drug Programme public hospital listings for simeprevir (treatment naïve and treatment experience patients) to Authority required (telephone).PSD · Mar 2016
4.2 The Committee noted that at the November 2015 meeting the PBAC recommended simeprevir for use in combination with sofosbuvir, but that the listing conditions have not yet been agreed between the Department and the sponsor.PSD · Mar 2016
Economic analysis
6.26 The submission presented a modelled cost-utility analysis of SMV+SOF compared with a mixture of no treatment ('''''''''''%) and SMV+PR (''''''''''%). The submission presented an incremental cost-effectiveness ratio (ICER) weighted by the comparator treatment and by patients’ disease severity at baseline.PSD · Jul 2015
6.27 The Pre-Sub-Committee Response (PSCR, p1) requested that IFN-free SIM+SOF be considered on a cost-minimisation basis with the LDV/SOF and DAC+SOF, recommended at the March 2015 PBAC meeting. Given the clinical outcomes, the ESC considered that it was appropriate to consider that the price of a course of treatment should be the same as the price of a course of treatment with other high efficacy/ low toxicity IFN-free treatments.PSD · Jul 2015
Clinical claim
6.21 The submission described SMV+SOF as superior in terms of efficacy and inferior in terms of safety compared with no treatment. Based on the evidence provided in the submission, the PBAC considered this claim was reasonable.PSD · Jul 2015
6.22 The submission described SMV+SOF as similar in terms of efficacy and safety to other interferon-free treatment regimens. The SVR12 rates in both treatment-naïve and treatment-experienced patients without cirrhosis were consistently high and reasonably similar for each of the alternative interferon-free treatment regimens.PSD · Jul 2015
Consumer comments
6.2 The PBAC noted and welcomed the input from individuals (78), health care professionals (16) and organisations (17) via the Consumer Comments facility on the PBS website. The large number of comments and discussion reiterate the comments received during previous considerations of the IFN-free treatments, namely the benefit of the availability of a highly effective treatment that should be made available for all infected individuals, the improved …PSD · Jul 2015
Financial management – risk sharing
6.43 The sponsor indicated they would be willing to work with the Department of Health to negotiate a Deed of Agreement to address the uncertainty regarding the number of patients who would be treated with all-oral, interferon-free HCV regimens if they are listed on the PBS.PSD · Jul 2015
Cost-effectiveness
This is an administrative/listing change application with no new economic evaluation. The PBAC's March 2015 advice noted the drug was no longer cost-effective at its listed price compared to newer interferon-free treatments.
The PBAC reiterated its previous advice that at its current list price, simeprevir would not be considered a cost-effective treatment for Hepatitis C, following the recent listing of interferon-free oral treatment. PBAC · 2016
ICER / price too highCost-effectiveness accepted
Decision context
PopulationTreatment naïve and treatment-experienced patients with chronic hepatitis C infection.
Submission history
| Decided | Outcome | Comparator | ICER | Evidence |
|---|---|---|---|---|
| Mar 2016 | Recommended · restricted | — | — | Other |
| Nov 2015 | Recommended · restricted | ledipasvir/sofosbuvir, daclatasvir in combination with sofosbuvir, paritaprevir/ritonavir/ombitasvir + dasabuvir ± ribav | — | RCT · Surrogate |
| Jul 2015 | Recommended · restricted | no treatment; supplementary comparators included ledipasvir/sofosbuvir, daclatasvir + sofosbuvir, and paritaprevir/riton | — | RCT · SVR |
| Jul 2014 | Recommended · restricted | telaprevir and boceprevir | — | RCT · SVR |
Consumer voice
The PBAC noted a large number of comments and presentations from patients, healthcare professionals, and organisations highlighting the benefits of new hepatitis C treatments, particularly interferon-free regimens.
The PBAC noted the large number of comments and presentations from patients, health care professionals and organisations that have previously been received, highlighting the benefits of the availability of new treatments, particularly IFN-free regimens. Consumer comments · PSD
treatment accessunmet needquality of life
Similar precedents
Regulatory · TGA
Label narrower than PBS population — PBAC restricts to genotype 1 with compensated liver disease and specified combination therapy, excluding genotype 4.