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2011;96(8):E1303-1307

Quan J, et al

and/or Imported or manufactured in Australia as therapeutic goods, or for use in therapeutic goods, for supply, in accordance with the Therapeutic Goods ct 1989

Some are, including GLP-1 receptor agonists (semaglutide, tirzepatide), insulin, and a range of hormone-based therapeutics

When that exclusion is present, no amount of clinical documentation changes the answer, because the denial is a benefit-design decision rather than a medical-necessity determination