This is the text extract for Listing of new presentations of omeprazole and introduction of a sole supply brand, browse documents here.

---

7 April 2008

Notification of Pharmaceutical Schedule Changes

Listing of New Presentations of Omeprazole and Introduction of a Sole Supply Brand

Outline of the changes Capsules We are making some changes to the reimbursement of the heartburn and gastric ulcer treatment omeprazole that will result in Dr Reddy’s Omeprazole brand being the only fully subsidised brand of omeprazole 10 mg, 20 mg and 40 mg capsules from 1 January 2009. All other existing brands of omeprazole (Losec and Omezol) will remain subsidised and listed on the Pharmaceutical Schedule until 31 December 2008. Injection & Infusion Listing of Dr Reddy’s Omeprazole injection and infusion will occur as soon as possible following necessary regulatory approvals being obtained. Once registered there will be a transition period during which existing brands of injection and infusion remain available, followed by delisting of all brands other than Dr Reddy’s Omeprazole. It is anticipated that sole supply will commence from 1 January 2009.

What the changes mean for patients In order to continue to receive a medicine that is fully subsidised, all patients who are prescribed omeprazole from 1 January 2009 will need to receive the Dr Reddy’s Omeprazole brand. Other brands of omeprazole may continue to be available after 1 January 2009, however, these will not be subsidised. What the changes mean for prescribers and pharmacists Dr Reddy’s Omeprazole will have the same “dispensed all at once” restriction. Most prescriptions should be dispensed all-at-once however any repeats for omeprazole that are for a brand name will need to be amended by the prescriber after 1 January 2009. We continue to recommend that prescriptions for most medicines are written using the generic name. This will enable pharmacies to choose which brand to dispense without referring back to the prescriber. Why the changes are happening Omeprazole expenditure is one of the highest costs to the Community Pharmaceutical Budget annually; this change is the result of a competitive bidding process which will provide

A187452 - T07-130

1

---

significant savings to that budget, savings which can then be reinvested in other pharmaceuticals for additional health gain. Details of the changes Dr Reddy’s Omeprazole The subsidy details and listing changes for Dr Reddy’s Omeprazole are summarised in the table below.

Form and Strength 10 mg capsule 20 mg capsule 40 mg capsule 40 mg injection 40 mg infusion Pack Size 28 30 28 30 28 30 1 1 Brand Name Current price and subsidy $2.99 $4.27 $5.01 New price and subsidy $2.00 $2.14 $2.85 $3.05 $3.35 $3.59 $8.22 $7.73 Following regulatory approval Following regulatory approval 1 May 2008 1 May 2008 Date of change

Dr Reddy’s Omeprazole Dr Reddy’s Omeprazole Dr Reddy’s Omeprazole Dr Reddy’s Omeprazole

1 May 2008

Dr Reddy’s Omeprazole All prices are expressed ex-manufacturer, excluding GST.

Other brands of omeprazole The Omezol (Pacific Pharmaceuticals Limited) brand of omeprazole will be reference priced (current subsidies reduced to Dr Reddy’s Omeprazole subsidies) in Section B of the Pharmaceutical Schedule from 1 July 2008 as follows:

Form and Strength 10 mg capsule 20 mg capsule 40 mg capsule Pack Size 30 30 30 Current price and subsidy $6.28 $6.28 $9.50 New price and subsidy $2.14 $3.05 $3.59

The Losec (AstraZeneca Limited) brand of omeprazole, which is subject to a rebate, will remain fully subsidised in Section B of the Pharmaceutical Schedule until 31 December 2008.

Form and Strength 10 mg capsule 20 mg capsule 40 mg capsule 40 mg injection Pack Size 30 30 30 1 Current price and subsidy $17.37 $24.81 $29.05 $12.50

Delisting Both the Omezol and Losec brands will be delisted from Section B and Part II of Section H of the Pharmaceutical Schedule from 1 January 2009.

A187452 - T07-130

2

---

Hospital Supply Status The following brands will have a 1% DV limit Hospital Supply Status from 1 January 2009 until 30 June 2011 as follows:

Form and Strength 10 mg capsule 20 mg capsule 40 mg capsule 40 mg injection 40 mg infusion DV Limit 1% 1% 1% 1% 1% DV Pharmaceuticals Brand name (Supplier) Losec (AstraZeneca) Omezol (Pacific) Losec (AstraZeneca) Omezol (Pacific) Probitor (Novartis) DP-Omeprazole (Douglas) Losec (AstraZeneca) Omezol (Pacific) Losec (AstraZeneca) Losec (AstraZeneca) DV Limit applies from 1 January 2009 1 January 2009 1 January 2009 1 January 2009* 1 January 2009*

*Subject to registration being obtained prior to implementation of Hospital Supply Status. Feedback received during consultation We appreciate the feedback we received as a result of our 5 February 2008 consultation letter and acknowledge the time people took to respond. We considered all the responses and presented them to the PHARMAC Board before it made this decision. Some of the key themes raised during the consultation that we are able to discuss are summarised below.

Theme There was concern that the removal of the Losec rebate would threaten the viability of wholesalers and the distribution of pharmaceuticals. Response While we accept there will be a significant impact for wholesalers from this change, it is not PHARMAC’s role to use subsidies to manage payments to wholesale businesses. We have highlighted this issue to DHBs who manage the pharmacy contract which contains provision for wholesaler payments. The Dr Reddy’s Omeprazole brand dissolves easily with sodium bicarbonate, and we identified no issues with compounding. Dr Reddy’s Omeprazole was registered by Medsafe using Losec as the reference product and therefore foresee no issues with stability. There was concern about the stability of the Dr Reddy’s Omeprazole infusion. We believe these issues will be resolved following regulatory approval. Any changes in stability will be communicated to users.

There was concern about making an omeprazole suspension from Dr Reddy’s Omeprazole capsules.

More information If you have any further questions about these changes, you can call our toll-free number on 0800 66 00 50 (9am to 5pm, Monday to Friday). Resources for patients about the changes will be sent to prescribers and pharmacists closer to the time of implementation.

A187452 - T07-130

3