11Assessment of dosage of pharmaceutical benefit

11 Assessment of dosage of pharmaceutical benefit

(1) The dose of a pharmaceutical benefit that has a drug mentioned in column 1 of an item in the following table and that is prescribed by an authorised prescriber for a person’s condition mentioned in column 2 of that item must: (a) be appropriate for treatment of the person under this Special Arrangement; and (b) subject to subsections (2) and (3), not exceed the dose calculated in accordance with column 3 of that item.

<table cellspacing="0" cellpadding="0" style="margin-left:0.25pt; border-collapse:collapse"><thead><tr><td colspan="4" style="width:404.85pt; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top"><p class="TableHeading"><span>Dose of pharmaceutical benefit</span></p></td></tr><tr><td style="width:24.9pt; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top"><p class="TableHeading"><span>Item</span></p></td><td style="width:59.6pt; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top"><p class="TableHeading"><span>Column 1</span></p><p class="TableHeading"><span>Drug</span></p></td><td style="width:187.65pt; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top"><p class="TableHeading"><span>Column 2</span></p><p class="TableHeading"><span>Condition</span></p></td><td style="width:100.3pt; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top"><p class="TableHeading"><span>Column 3</span></p><p class="TableHeading"><span>Maximum dose</span></p></td></tr></thead><tbody><tr><td style="width:24.9pt; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top"><p class="Tabletext"><span>1</span></p></td><td style="width:59.6pt; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top"><p class="Tabletext"><span>Somatropin</span></p></td><td style="width:187.65pt; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top"><p class="Tabletext"><span>In the category of:</span></p><p class="Tablea"><span>(a) short stature and slow growth; or</span></p><p class="Tablea"><span>(b) short stature associated with biochemical growth hormone deficiency; or</span></p><p class="Tablea"><span>(c) growth retardation secondary to an intracranial lesion or cranial irradiation; or</span></p><p class="Tablea"><span>(d) risk of hypoglycaemia secondary to biochemical growth hormone deficiency in neonates/infants; or</span></p><p class="Tablea"><span>(e) biochemical growth hormone deficiency and precocious puberty; or</span></p><p class="Tablea"><span>(f) hypothalamic</span><span>‑</span><span>pituitary disease secondary to a structural lesion, with hypothalamic obesity driven growth</span></p></td><td style="width:100.3pt; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top"><p class="Tablea"><span>7.5 mg/m</span><span style="font-size:6.67pt; vertical-align:super">2</span><span>/week</span></p></td></tr><tr><td style="width:24.9pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top"><p class="Tabletext"><span>2</span></p></td><td style="width:59.6pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top"><p class="Tabletext"><span>Somatropin</span></p></td><td style="width:187.65pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top"><p class="Tabletext"><span>In the category of:</span></p><p class="Tablea"><span>(a) short stature associated with Turner Syndrome; or</span></p><p class="Tablea"><span>(b) short stature due to short stature homeobox (SHOX) gene disorders; or</span></p><p class="Tablea"><span>(c) short stature associated with chronic renal insufficiency</span></p></td><td style="width:100.3pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top"><p class="Tabletext"><span>9.5 mg/m</span><span style="font-size:6.67pt; vertical-align:super">2</span><span>/week</span></p></td></tr><tr><td style="width:24.9pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top"><p class="Tabletext"><span>3</span></p></td><td style="width:59.6pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top"><p class="Tabletext"><span>Somatropin</span></p></td><td style="width:187.65pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top"><p class="Tabletext"><span>In the category of short stature and poor body composition due to Prader</span><span>‑</span><span>Willi Syndrome, where the person has a non</span><span>‑</span><span>mature skeleton</span></p></td><td style="width:100.3pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top"><p class="Tablea"><span>7.5 mg/m</span><span style="font-size:6.67pt; vertical-align:super">2</span><span>/week</span></p></td></tr><tr><td style="width:24.9pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top"><p class="Tabletext"><span>4</span></p></td><td style="width:59.6pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top"><p class="Tabletext"><span>Somatropin</span></p></td><td style="width:187.65pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top"><p class="Tabletext"><span>In the category of short stature and poor body composition due to Prader</span><span>‑</span><span>Willi Syndrome, where the person has a mature skeleton</span></p></td><td style="width:100.3pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top"><p class="Tablea"><span>0.04 mg/kg/week</span></p></td></tr><tr><td style="width:24.9pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top"><p class="Tabletext"><span>5</span></p></td><td style="width:59.6pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top"><p class="Tabletext"><span>Mecasermin</span></p></td><td style="width:187.65pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top"><p class="Tabletext"><span>In the category of severe primary insulin</span><span>‑</span><span>like growth factor 1 deficiency (Primary IGFD)</span></p></td><td style="width:100.3pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top"><p class="Tabletext"><span>0.12 mg/kg twice daily</span></p></td></tr><tr><td style="width:24.9pt; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top"><p class="Tabletext"><span>6</span></p></td><td style="width:59.6pt; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top"><p class="Tabletext"><span>Somatrogon</span></p></td><td style="width:187.65pt; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top"><p class="Tabletext"><span>In the category of:</span></p><p class="Tablea"><span>(a) short stature associated with biochemical growth hormone deficiency; or</span></p><p class="Tablea"><span>(b) short stature and slow growth</span></p></td><td style="width:100.3pt; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top"><p class="Tabletext"><span>0.66 mg/kg/week</span></p></td></tr></tbody></table>