25 March 2020 - Insights from the second round of public summary documents (first time rejections and deferrals).

Belimumab (Benlysta)

The PBAC considered that the economic model presented in the submission did not provide a reliable basis for estimating the cost-effectiveness of belimumab, and the financial estimates were uncertain and likely overestimated.

Real world evidence was used to inform SDI progression in the model. The PBAC considered that the structure and inputs of the model were not reasonable because the economic model’s assumption of an improvement in SDI progression with belimumab (and linear persisting benefits) based on the propensity score matched analysis was not reasonable.

Brolucizumab (Beovu)

The submission requested that the pre-statutory cut comparator price applies to brolucizumab, according to Clause 5.7 of the Strategic Agreement. The pre-subcommittee response stated that if the Minister (or Delegate) determines that Clause 5.7 applies, then ranibizumab and aflibercept have the same price [in terms of a cost minimisation price for brolucizumab]. The PBAC noted that application of the Strategic Agreement is not a matter for PBAC.

If treatment with brolucizumab is substantially more costly than any of the alternative therapies (aflibercept and ranibizumab), the PBAC could only recommend listing brolucizumab if it is satisfied that it provides, for some patients, a significant improvement in efficacy or reduction of toxicity over the alternative therapies (National Health Act 1953, Section 101(3B)). The PBAC considered that brolucizumab did not satisfy these requirements, and advised that the cost minimisation should be performed against the least costly comparator, ranibizumab, so that it is not more costly than any of the alternative therapies.

Patiromer sobitex calcium (Veltassa)

The PBAC considered the proposed population was not adequately defined and, in order to target patients with the highest clinical need, there would need to be better definition and a substantial narrowing of the eligible population.

The PBAC considered that the submission had requested listing in a broad patient population with an unclear clinical benefit across all proposed patients. The PBAC considered the population would need to be more narrowly defined to target those patients with the highest clinical need and who would most likely derive a clinically meaningly benefit from patiromer.

The PBAC noted that the key driver of the model was the reduction in the incidence of hyperkalaemia events. The PBAC considered this was inappropriate, as it did not align with the key rationale for listing patiromer, which was increasing the proportion of patients who are able to receive maximum doses of RAASi therapy.

Polatuzumab vedotin (Polivy)

The PBAC did not accept bendamustine hydrochloride in combination with rituximab, the nominated comparator, as an appropriate proxy for standard of care in relapsed/refractory diffuse large B-cell lymphoma because the combination does not reflect current clinical practice in Australia as bendamustine hydrochloride is not TGA registered or PBS listed for this indication.

The PBAC considered that the validity of the clinical effectiveness data presented was very uncertain as the results were likely confounded in favour of polatuzumab vedotin when used in combination with bendamustine hydrochloride and rituximab.

Additional insights from the November 2019 PBAC meeting will be published in future issues of MAESTrO Daily.