This is the text extract for Approval of agreements with Apotex (for risperidone and topiramate) and Mylan (for risperidone, quetiapine and lithium carbonate), browse documents here.

---

21 August 2009

Approval of agreements with Apotex (for risperidone and topiramate) and Mylan (for risperidone, quetiapine and lithium carbonate)

PHARMAC is pleased to announce the approval of an agreement with Apotex NZ Ltd to fund a new brand of risperidone tablets and oral liquid (Apo-Risperidone) and topiramate tablets (Apo-Topiramate), and an agreement with Mylan NZ Ltd to fund a new brand of risperidone oral liquid (Risperon) and to amend the terms of listing of the Lithicarb brand of lithium carbonate and the Quetapel brand of quetiapine. Details of the decision Apo-Risperidone, Risperon and Apo-Topiramate will be listed in Section B and in Part II of Section H of the Pharmaceutical Schedule at the following prices and subsidies (exmanufacturer, excluding GST) and on the following dates: Pharmaceutical

Risperidone Risperidone Risperidone Risperidone Risperidone Risperidone Risperidone Risperidone Topiramate Topiramate Topiramate Topiramate

Brand

Apo-Risperidone Apo-Risperidone Apo-Risperidone Apo-Risperidone Apo-Risperidone Apo-Risperidone Apo-Risperidone Risperon Apo-Topiramate Apo-Topiramate Apo-Topiramate Apo-Topiramate

Form and Strength

Tab 0.5 mg Tab 1 mg Tab 2 mg Tab 3 mg Tab 4 mg Oral liquid 1 mg per ml Oral liquid 1 mg per ml Oral liquid 1 mg per ml Tab 25 mg Tab 50 mg Tab 100 mg Tab 200 mg

Pack Size

60 60 60 60 60 100 ml 30 ml 30 ml 60 60 60 60

Price and subsidy

$7.80 $15.39 $30.77 $46.16 $61.53 $61.16 $18.35 $18.35 $13.02 $22.13 $37.63 $64.93

Listing Date

1 Dec 09 1 Dec 09 1 Dec 09 1 Dec 09 1 Dec 09 1 Dec 09 Following registration 1 Oct 09 1 Dec 09 1 Dec 09 1 Dec 09 1 Dec 09

In the event that Apo-Risperidone oral liquid 1 mg per ml in a 30 ml pack size receives Medsafe registration prior to 1 December 2009, the listing of Apo-Risperidone oral liquid 1 mg per ml in a 100 ml pack size may not proceed. We will update you on this via the Pharmaceutical Schedule update.

A301419

Page 1 of 2

---

Apo-Risperidone, Apo-Topiramate and Risperon will have protection from delisting and subsidy reduction until 1 July 2012. From 1 December 2009, the price and subsidy for Quetapel (quetiapine) tablets will reduce in Section B and in Part II of Section H of the Pharmaceutical Schedule as outlined in the following table (prices and subsidies expressed ex-manufacturer, excluding GST). Quetapel will have protection from delisting and subsidy reduction until 1 July 2012. Form and Strength

Tab 25 mg Tab 100 mg Tab 200 mg Tab 300 mg

Pharmaceutical

Brand

Pack Size

Current price and subsidy

$20.62 $41.25 $70.88 $119.25

New price and subsidy

$16.78 $32.59 $56.70 $95.40

Quetiapine Quetiapine Quetiapine Quetiapine

Quetapel Quetapel Quetapel Quetapel

90 90 90 90

The agreement with Mylan also included an increase in the price and subsidy for Lithicarb (lithium carbonate) tablets which was implemented on 1 August 2009. Lithicarb will have protection from delisting and subsidy reduction until 1 July 2012.

Feedback received We appreciate all of the feedback that we received and acknowledge the time people took to respond. Most responses were supportive of the proposals; however some responders raised concerns about a brand switch in patients with epilepsy stabilised on the currently funded brand of topiramate (Topamax). We note that this decision to fund an additional brand of topiramate (Apo-Topiramate) will not require patients to change brands of topiramate as Topamax will remain fully funded. This is similar to the current situation with lamotrigine, where there are multiple brands fully funded. However, if clinicians have concerns about a particular patient they can ensure that the patient continues on their previous brand by specifying this on the prescription. We note that Apo-Topiramate has met the standards required by Medsafe to gain registration in New Zealand, including the requirement to demonstrate bioequivalence versus Topamax. Because of this, we expect that people will experience the same clinical benefit from either brand of topiramate.

More information If you have any questions about this decision, you can call our toll free number (9 am to 5 pm, Monday to Friday) on 0800 66 00 50.

A301419

Page 2 of 2