PBAC did not recommend Mounjaro for PBS :(
The outcomes from the November 2024 meeting are finally available.
Mounjaro was not recommended. However, Semaglutide in 2mg was recommended. :(
The PBAC did not recommend tirzepatide for the treatment of adult patients with inadequately controlled T2DM who (i) have comorbid severe obesity or (ii) identify as Aboriginal and Torres Strait Islander. The PBAC considered that tirzepatide 10 mg once weekly and tirzepatide 15 mg once weekly were superior in terms of effectiveness for glycaemic benefits and short term weight loss compared to semaglutide 1 mg once weekly in the target subgroup with severe obesity, but advised this claim was not supported for tirzepatide 5 mg once weekly compared to semaglutide 1 mg once weekly.
The PBAC considered the non-inferior safety claim was not adequately supported for any of the comparisons. The PBAC noted the resubmission provided a revised economic model with further amendments to the model provided in the pre PBAC response along with a price reduction. The PBAC considered the pre-PBAC response economic model did not adequately address the concerns raised by the Committee in July 2023 or the subsequent concerns raised by the Economics Sub-Committee (ESC) in this consideration. The PBAC considered that the incremental cost-effectiveness ratio was high, inadequately justified, and uncertain.
The PBAC advised that a revised economic model including a price reduction would be required for the proposed listing to be considered cost-effective. The PBAC noted the financial impact was extremely high at the prices proposed in the pre-PBAC response, although considered it likely overestimated. The PBAC considered the risk sharing arrangements proposed in the pre-PBAC response were unlikely to satisfactorily mitigate the risk to government of use outside of the proposed restriction.
The previous submission was considered in July 2023.
Comparator: semaglutide The PBAC considered that the nomination of semaglutide as the main comparator was appropriate.
Clinical claim: Tirzepatide is superior in terms of efficacy and non-inferior in terms of safety compared to semaglutide. The PBAC reaffirmed its July 2023 advice that the claim of superior comparative effectiveness was reasonable for tirzepatide 5 mg once weekly compared to semaglutide 0.5 mg once weekly and for tirzepatide 10 mg once weekly and tirzepatide 15 mg once weekly compared to semaglutide 1 mg once weekly. The PBAC considered results for 10 mg and 15 mg tirzepatide in the subgroup with BMI ≥35 kg/m2 appeared consistent with results in the whole trial population. The PBAC considered the claim of superior comparative efficacy for tirzepatide 5 mg once weekly compared to semaglutide 0.5 mg once weekly in the subgroup with BMI ≥35 kg/m2 was uncertain but likely reasonable.
The PBAC also reaffirmed its July 2023 advice that the comparison of tirzepatide 5 mg and semaglutide 1 mg remained relevant, and noted that this comparison did not support a clinically meaningful difference in either the whole trial population or the subgroup with BMI ≥35 kg/m2. The PBAC reaffirmed its July 2023 advice that the claim of noninferior comparative safety was not adequately supported by the data for any of the comparisons.
Economic claim: Cost utility analysis of tirzepatide versus semaglutide The PBAC considered the pre-PBAC response economic model did not adequately address the concerns raised by the Committee in July 2023 or the subsequent concerns raised by the ESC in this consideration.
The PBAC also reaffirmed its July 2023 advice that an ICER in the order of $25,000 to < $35,000 per QALY would be appropriate.
Sponsor’s Comment: Eli Lilly wishes to thank all of the healthcare professionals, professional societies, leadership bodies, patient organisations and consumers for their support of the tirzepatide (Mounjaro®) submission. We are disappointed by the PBAC’s decision not to recommend the PBS listing of tirzepatide for the treatment of adult patients with inadequately controlled T2D who have comorbid severe obesity or identify as Aboriginal and Torres Strait Islander. Eli Lilly remains committed to making this medicine accessible for adult patients living with T2D.