This is the text extract for Notification: Sirolimus (Rapamune) & etanercept (Enbrel) , browse documents here.

26 April 2007 To All Pharmaceutical Suppliers, Hospital Pharmacists, Medical Groups and Interested Parties Notification of listing of sirolimus (Rapamune) on the Pharmaceutical Schedule and amendment to listing of etanercept (Enbrel) on the Pharmaceutical Schedule. PHARMAC is pleased to advise that the PHARMAC Board has approved the proposal to list sirolimus (Rapamune) and etanercept (Enbrel) in Sections B and H of the Pharmaceutical Schedule. This means that: Etanercept: · The price and subsidy for etanercept in Section B, and the price in Part II of Section H will be amended from 1 July 2007 as follows: Table 1.

Pharmaceutical etanercept Form Injection Strength 25 mg Pack Size 4 Brand Enbrel Current Price and Subsidy $899.96 New Price and Subsidy $949.96

Note: Prices are ex-manufacturer, exclusive of GST · Community usage of etanercept will be subject to a confidential rebate. · The Special Authority for etanercept in Section B will be amended as follows from 1 July 2007 (changes in bold and strikethrough): Initial application only from a named specialist or a rheumatologist. Approvals valid for 4 months for applications meeting the following criteria: All of the following: 1 To be used as an adjunct to methotrexate therapy or monotherapy where use of methotrexate is limited by toxicity or intolerance; and 2 Patient diagnosed with Juvenile Idiopathic Arthritis (JIA) is less than 18 years of age at commencement of treatment; and 3 Patient has had severe active polyarticular course Juvenile Idiopathic Arthritis (JIA) for 6 months duration or longer; and 4 Patient has tried and not responded to at least three months of oral or parenteral methotrexate (at a dose of 10-20mg/m2 or at maximum tolerated dose) weekly in combination with oral corticosteroids (prednisone 0.25 mg/kg or at maximum tolerated dose); and 5 Patient has tried and not responded to at least three months of oral or parenteral methotrexate (at a dose of 10-15mg/m2 weekly or at maximum tolerated dose) in combination with one other disease-modifying agent; and A117897 -

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Either: 6.1.1 Patient has persistent symptoms of poorly-controlled and active disease in at least 20 active, swollen, tender joints; or 6.1.2 Patient has persistent symptoms of poorly-controlled and active disease in at least four active joints from the following: wrist, elbow, knee, ankle, shoulder, cervical spine, hip; and 6.2 Physician's global assessment indicating severe disease; and The patient or their legal guardian consents to details of their treatment being held on a central registry and has signed a consent form outlining conditions of ongoing treatment. Note: A patient declaration form http://www.pharmac.govt.nz/special_authority_forms/SA0667declaration.pdf must be signed by the legal guardian of the patient and the prescriber in the presence of a witness (over 18 years of age). Renewal only from a named specialist or a rheumatologist. Approvals valid for 6 months for applications meeting the following criteria: Both: 8 Subsidised as an adjunct to methotrexate therapy or monotherapy where use of methotrexate is limited by toxicity or intolerance; and 9 Either: 9.1 Following 4 months initial treatment, the patient has at least a 50% decrease in active joint count and an improvement in physician's global assessment from baseline; or 9.2 On subsequent reapplications, the patient demonstrates at least a continuing 30% improvement in active joint count and continued improvement in physician's global assessment from baseline.

Both: 6.1

Sirolimus · Sirolimus will be listed in Section B and Part II of Section H of the Pharmaceutical Schedule from 1 July 2007 as follows: Table 2.

Pharmaceutical sirolimus sirolimus sirolimus Form Tablet Tablet Oral liquid Strength 1 mg 2 mg 1 mg / ml Pack Size 100 100 60 ml Brand Rapamune Rapamune Rapamune Price and Subsidy $813.00 $1,626.00 $487.80

Note: Prices are ex-manufacturer, exclusive of GST · Sirolimus will be listed in the ‘Oncology Agents and Immunosuppressants – Other Immunosuppressants’ section of Section B of the Pharmaceutical Schedule. · Community and hospital usage of sirolimus would be subject to a confidential rebate. A117897 -

· Sirolimus will be subject to the following Special Authority restrictions in Section B of the Pharmaceutical Schedule: Initial application from any medical practitioner. Approvals valid without further renewal unless notified. Approvals valid for rescue therapy where patient is an organ transplant recipient. Note: Rescue therapy defined as unresponsive to calcineurin inhibitor treatment as defined by refractory rejection; or intolerant to calcineurin inhibitor treatment due to any of the following: GFR<30 ml/min; or Rapidly progressive transplant vasculopathy; or Rapidly progressive obstructive bronchiolitis; or HUS or TTP; or Leukoencepthalopathy; or Significant malignant disease We thank all those who submitted responses to consultation. Yours sincerely

Tommy Wilkinson Therapeutic Group Manager

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