Sacubitril With ValsartanARX-SACUBITRIL/VALSARTAN
Treatment of chronic heart failure (NYHA Class II-IV) with reduced left ventricular ejection fraction in adult patients. This submission specifically requested amendment to allow nurse practitioners to initiate treatment.
Decision on record
- Meeting Nov 2024 Recommended Chronic heart failure
Access path
- TGA registered · ARX-SACUBITRIL/VALSARTAN
TGA label narrower than the PBS population
- Mar 2016Not recommended
uncertain cost-effectiveness in the context of high predicted financial impact, dose of enalapril used in trial was…
- Jul 2016Deferred
Listing: Authority Required → Restricted
- Nov 2024Recommended
Evidence: RCT → Cost-minimisation
- PBS listing · Authority Required
From the public summary
5.1 The PBAC recommended the amendment to the PBS listings of Entresto to allow nurse practitioners (NPs) to initiate sacubitril + valsartan (Entresto) for the treatment of chronic heart failure (HF).PSD · Nov 2024
5.2 The PBAC noted the TGA Product Information (PI) stated Entresto should be initiated, and up-titration conducted, by a physician experienced with the treatment of HF. The PBAC also noted the pre-PBAC response stated that this is in line with the PI as NPs currently prescribe Entresto for the treatment of chronic HF as continuing therapy only (CTO) within a shared care model.PSD · Nov 2024
6.8 In the previous major submission considered by PBAC in March 2016, the submission presented a cost-effectiveness analysis comparing sacubitril/valsartan with enalapril. The PBAC considered that the submission’s model failed to reflect the progression of patients though heart failure, and the incremental cost effectiveness ratio (ICER) generated was not reliable and therefore the cost-effectiveness of sacubitril/valsartan was unknown.PSD · Jul 2016
6.9 The minor re-submission does not alter the economic model structure from the submission considered in March 2016 but, as noted above under ‘Background’, seeks to re-specify the best estimate of the base case ICER by: Introducing a flat-pricing structure in line with the PBAC Public Summary Document March 2016 (7.5) and based on a selected price/day.PSD · Jul 2016
6.6 The clinical claim remains unchanged from the original submission. At the March 2016 meeting, the PBAC considered that the clinical claim of superior comparative effectiveness compared to enalapril was reasonable, but the size of the benefit was uncertain due to the issues with study design and early stopping of the PARADIGM- HF trial.PSD · Jul 2016
The minor submission attempted to address the PBAC’s concern by including a criterion in the proposed restriction that patients must have previous or current use of an ACE-I or ATRA at recommended doses, unless contraindicated or not tolerated.PSD · Jul 2016
4.2 The PBAC noted and welcomed the input from five health care professionals and one organisation via the Consumer Comments facility on the PBS website. The comments from health care professionals stated that allowing NPs to initiate treatment with Entresto is within NP’s scope of practice, promotes the use of guideline directed medical therapy and would be advantageous to patients.PSD · Nov 2024
4.3 The submission stated the proposed amendment to the listing of Entresto would streamline the patient’s journey with HF, resulting in more timely access to treatment and minimising the risk of delays in HF management.PSD · Nov 2024
Cost-effectiveness
not-modelled — this is a Category 4 minor submission for a prescriber-type amendment (nurse practitioner initiation rights) with no new economic evaluation
The PBAC therefore considered the change was likely to result in a nil financial impact to the PBS and RPBS. PBAC · 2024
Decision context
PopulationAdults with chronic heart failure (NYHA Class II-IV) and documented left ventricular ejection fraction ≤40% who are symptomatic and receiving concomitant optimal standard heart failure treatment
Submission history
| Decided | Outcome | Comparator | ICER | Evidence |
|---|---|---|---|---|
| Nov 2024 | Recommended | — | — | Cost-minimisation |
| Jul 2016 | Deferred | enalapril | — | RCT · Other |
| Mar 2016 | Not recommended | enalapril | — | RCT · Composite of cardiovascular death or first heart failure hospitalisation |
Consumer voice
Five healthcare professionals and the hearts4heart organisation provided input supporting nurse practitioner (NP) initiation of Entresto treatment. They stated that allowing NPs to initiate treatment is within their scope of practice, promotes guideline-directed medical therapy, provides more efficient care, and helps reduce burden on doctors.
allowing NPs to initiate treatment with Entresto is within NP's scope of practice, promotes the use of guideline directed medical therapy and would be advantageous to patients Consumer comments · PSD
Similar precedents
Regulatory · TGA
Label narrower than PBS population — PBAC requires documented LVEF ≤40% and optimal standard heart failure treatment; TGA label does not specify these quantitative or treatment thresholds.