Nintedanib
Idiopathic Pulmonary Fibrosis (IPF) and Chronic Fibrosing Interstitial Lung Disease with a progressive phenotype (PF-ILD).
Decisions on record
- Meeting Nov 2024 Not recommended Idiopathic pulmonary fibrosis; progressive fibrosing interstitial lung disease
- Meeting Sep 2021 Recommended Progressive fibrosing interstitial lung disease (PF-ILD) no PSD
- Meeting Mar 2021 Not recommended Progressive fibrosing interstitial lung disease
- Meeting Nov 2016 Recommended Idiopathic pulmonary fibrosis (IPF)
- Meeting Mar 2016 Not recommended in combination with docetaxel for the treatment of patients with locally advanced, metastatic or recurrent non- small cell lung cancer (NSCLC) of adenocarcinoma tumour histology after failure of first line chemotherapy
- Meeting Nov 2015 Deferred Idiopathic pulmonary fibrosis
- Meeting Mar 2015 Not recommended Idiopathic pulmonary fibrosis (IPF)
- Meeting Mar 2015 Not recommended Non-small cell lung cancer (NSCLC)
Access path
- Mar 2015Not recommended
Comparator changed: weighted comparator (87% pemetrexed and 13% docetaxel monotherapy) →…
- Mar 2015Not recommended
Comparator changed: weighted comparator (87% pemetrexed and 13% docetaxel monotherapy) →…
- Nov 2015Deferred
- Mar 2016Not recommended
Did not demonstrate non-inferior effectiveness compared with pemetrexed; economic analysis was inconsistent with the…
- ↻ resubmittedNov 2016Recommended
Comparator changed: pemetrexed → best supportive care
- Mar 2021Not recommended
uncertain magnitude of overall survival benefit, uncertain and likely underestimated ICER, price reduction required to…
- ↻ resubmittedSep 2021Recommended · restricted
- Nov 2024Not recommended
Comparator changed: placebo + best supportive care (BSC) → pirfenidone
From the public summary
5.1 The PBAC did not recommend that the risk sharing arrangement (RSA) subsidisation caps for nintedanib for IPF and PF-ILD be combined. The PBAC advised that the evidence provided by the submission did not sufficiently justify the requested combination of the subsidisation caps and considered that the proposed arrangements would not adequately manage the risks originally identified in relation to the nintedanib listings.PSD · Nov 2024
5.2 The PBAC noted that the submission did not present estimates of use, and that the estimated additional PBS/RPBS expenditure associated with the revised RSA versus the existing RSA was estimated by the Department to be $ million over 4 years. The PBAC considered that there should not be a cost to Government associated with establishing a new RSA or lapsing of the current subsidisation caps.PSD · Nov 2024
The submission presented a stepped economic evaluation based on a direct randomised trial (INBUILD) and implemented a modelled economic evaluation using microsimulation. Table 9 summarises the key components of the economic evaluation.PSD · Mar 2021
Overall survival was modelled separately from acute ILD exacerbations and FVC.PSD · Mar 2021
The submission described nintedanib as superior in terms of effectiveness compared to placebo + BSC. The claim of superior comparative effectiveness was based on a statistically significant slower decline in FVC (p<0.0001), and a statistically significantly lower risk of progression (≥10% absolute decline in FVC%Pred) (p=0.0005) for nintedanib over 52 weeks when compared to placebo + BSC.PSD · Mar 2021
The submission did not formally consider the requirements outlined in the PBAC guidelines for linking proposed surrogate measures to target clinical outcomes. The ACM considered that a decrease in FVC correlates to an increase in mortality rates and that this is an appropriate marker for surrogate endpoints.PSD · Mar 2021
4.2 The PBAC noted and welcomed the input from organisations (1) via the Consumer Comments facility on the PBS website. The comments described a range of benefits of treatment with nintedanib from patients receiving it through the PBS, including fewer 5PSD · Nov 2024
4.3 The submission’s request was based on the arguments that the current subsidisation caps for IPF are based on underestimated nintedanib uptake rates and maximum uptake has not yet been reached, and that nintedanib uptake under the IPF PBS item code has increased at a faster rate than under the PF-ILD PBS item code, due to: a) Patients who are first prescribed nintedanib under the IPF PBS item code are restricted from transitioning to the PF-ILD PBS …PSD · Nov 2024
Cost-effectiveness
Category 3 submission (administrative revision of risk sharing arrangement caps); no economic evaluation undertaken. ICER values are not applicable as this is a subsidisation cap negotiation, not a clinical/economic assessment.
As a Category 3 submission, no evaluation of the clinical evidence was undertaken. PBAC · 2024
Decision context
PopulationAdults with Idiopathic Pulmonary Fibrosis (IPF) or Chronic Fibrosing Interstitial Lung Disease with a progressive phenotype (PF-ILD).
Risk sharingRisk Sharing Arrangement (RSA) with subsidisation caps. Current IPF and PF-ILD listings have separate Deeds with separate caps. Submission proposes combining the subsidisation caps for IPF and PF-ILD for the remaining duration of the PF-ILD deed. A 100% rebate applies to Government expenditure beyond the financial cap.
Submission history
| Decided | Outcome | Comparator | ICER | Evidence |
|---|---|---|---|---|
| Nov 2024 | Not recommended | pirfenidone | — | Other |
| Sep 2021 | Recommended · restricted | placebo + best supportive care (BSC) | — | RCT · PFS |
| Mar 2021 | Not recommended | placebo + best supportive care (BSC) | — | RCT · FVC |
| Nov 2016 | Recommended | best supportive care | $75k–105k | RCT · PFS |
| Mar 2016 | Not recommended | pemetrexed | — | RCT · PFS |
| Nov 2015 | Deferred | best supportive care | $105k–200k | RCT · PFS |
| Mar 2015 | Not recommended | weighted comparator (87% pemetrexed and 13% docetaxel monotherapy) | — | RCT · OS |
| Mar 2015 | Not recommended | best supportive care | — | RCT · PFS |
Consumer voice
One organisation provided consumer input via the PBS website describing benefits of nintedanib treatment, including fewer side effects compared to pirfenidone and noting financial difficulties patients would face without PBS listing.
The comments described a range of benefits of treatment with nintedanib from patients receiving it through the PBS, including fewer side effects such as nausea and vomiting compared to treatment with pirfenidone and financial difficulties patients would experience if it was not PBS listed. Consumer comments · PSD