RibavirinIbavyr
Chronic hepatitis C infection (CHC) in adults, for use in combination therapy with other oral agents. The submission specifically concerned listing of an additional 200 mg tablet strength.
Decisions on record
- Meeting Jul 2016 Recommended Chronic hepatitis C virus infection
- Meeting Jul 2016 Recommended Chronic hepatitis C
- Meeting Nov 2015 Recommended Hepatitis C
- Meeting Jul 2015 Deferred Hepatitis C
- Meeting Mar 2015 Not recommended Chronic hepatitis C (CHC).
Access path
- TGA registered · Ibavyr
TGA label equal than the PBS population
- Jul 2008Recommended
vs usual standard care
- Mar 2015Not recommended
Submission had not justified the incremental cost effectiveness of ribavirin compared to the currently listed ribavirin…
- Jul 2015Deferred
Evidence: Other → Cost-minimisation
- Nov 2015Recommended · restricted
Comparator changed: no treatment → ribavirin component in co-packaged Pegasys RBV® and…
- Jul 2016Recommended · restricted
Comparator changed: ribavirin component in co-packaged Pegasys RBV® and Pegatron® →…
- Jul 2016Recommended
Comparator changed: ribavirin component in co-packaged Pegasys RBV® and Pegatron® →…
- PBS listing · Restricted
From the public summary
6.1 The PBAC recommended the listing of ribavirin in combination with daclatasvir and sofosbuvir as a 12 week treatment course for the treatment of Genotype 3 CHC in treatment naïve and treatment experienced cirrhotic patients.PSD · Jul 2016
6.2 The PBAC noted that the sponsor and some clinicians had informally stated they had requested ribavirin from the sponsor on compassionate grounds to treat CHC patients with decompensated liver disease outside current PBS listings.PSD · Jul 2016
3.7 As a minor submission, there was no economic comparison presented.PSD · Jul 2016
5.3 The duration of treatment proposed was 24 weeks, in combination with daclatasvir and sofosbuvir. Patients weighing less than 75 kg would receive 1,000 mg/ day, while patients over 75 kg will receive 1,200 mg/ day. The cost per course was averaged between a 50/50 split of patients above and below the dose/weight threshold.PSD · Jul 2016
Cost-effectiveness
Not modelled — minor submission (additional strength) with no new economic comparison
The PBAC accepted the listing of the additional strength is not expected to result in an additional cost to the PBS as the proposed price is at the same AEMP as the currently listed strengths. PBAC · 2016
Decision context
PopulationAdult patients with chronic hepatitis C infection requiring combination therapy with other oral agents, including those requiring dose reduction (up to 10% of patients)
Submission history
| Decided | Outcome | Comparator | ICER | Evidence |
|---|---|---|---|---|
| Jul 2016 | Recommended · restricted | daclatasvir and sofosbuvir without ribavirin (24 weeks) | — | Single-arm · Surrogate |
| Jul 2016 | Recommended | — | — | Cost-minimisation · Cost-minimisation |
| Nov 2015 | Recommended · restricted | ribavirin component in co-packaged Pegasys RBV® and Pegatron® | — | Cost-minimisation · Cost-minimisation |
| Jul 2015 | Deferred | no treatment | — | Cost-minimisation · Cost-minimisation |
| Mar 2015 | Not recommended | no treatment | — | Other |
| Jul 2008 | Recommended | usual standard care | $15k | RCT | Single-arm · SVR |
Consumer voice
Consumer input highlighted the benefit of highly effective interferon-free treatments for all infected individuals, emphasizing improved quality of life and avoidance of side effects associated with current treatments. Representatives from hepatitis and drug user advocacy organizations engaged in discussions with PBAC.
the benefit of the availability of a highly effective treatment that should be made available for all infected individuals Consumer comments · PSD
Similar precedents
Regulatory · TGA
Label equal than PBS population — Both specify CHC in adults requiring combination therapy with other oral agents; PBAC adds operational detail about dose reduction but no population restriction.