PBAC publishes confusing Public Summary Document for tofacitinib citrate (Xeljanz)

MAESTrO Database

24 March 2021 - The purpose of a public summary document is to provide to the public, information pertaining to a PBAC recommendation, so that stakeholders are aware of the rationale for specific PBAC recommendations, and gain an improved understanding of the overall PBS listing process. The Public Summary Document for tofacitinib citrate adds confusion, not clarity.

The minor submission from Pfizer requested the PBAC review its advice that tofacitinib citrate should be treated as interchangeable on an individual patient basis with other drugs, for moderate-to-severe ulcerative colitis and severe psoriatic arthritis, under section 101(3BA) of the National Health Act 1953.

Section 4.10 of the Public Summary Document states "the PBAC noted that Pfizer’s pre-PBAC response omits a critical part of the relevant legislative provisions - which is that PBAC is only required to specify whether two or more drugs should be treated as interchangeable on an individual patient basis. The PBAC considered this plainly to mean that two drugs need not be interchangeable on an individual patient basis for it to express the view they should be treated as interchangeable on an individual patient basis. Instead, the PBAC, exercising its expertise, is simply required by the legislation to specify its view as to whether drugs should be treated as interchangeable on an individual patient basis."

What does this mean? The PBAC is talking in circles. Was this Public Summary Document written by the PBAC minutes secretary, a Department of Health lawyer or Sir Humphrey Appleby?

Read PBAC Public Summary Document for tofacitinib citrate

Michael Wonder

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Michael Wonder