This is the text extract for Various Musculoskeletal System pharmaceuticals; Closing Date: Closed; Contact: Geraldine MacGibbon, browse documents here.

---

27 April 2011

Proposal involving various Musculoskeletal System pharmaceuticals

PHARMAC is seeking feedback on a proposal to make the following changes to pharmaceuticals within the “Musculoskeletal System” therapeutic group of the Pharmaceutical Schedule from 1 July 2011:  Fully fund ketoprofen long-acting capsules and tiaprofenic acid tablets through a provisional agreement with Sanofi-Aventis New Zealand Ltd; Remove the Special Authority for Manufacturer’s Price that provides for full subsidy of partly subsidised non-steroidal anti-inflammatory drugs (NSAIDs) for patients with approvals prior to 1 September 2010; and Delist hyaluronidase injection from Section B of the Pharmaceutical Schedule.





Details of the proposal can be found below and on the following pages.

Feedback sought PHARMAC welcomes feedback on this proposal. To provide feedback, please submit it in writing by Wednesday, 11 May 2011 to: Geraldine MacGibbon Therapeutic Group Manager PHARMAC Email: geraldine.macgibbon@pharmac.govt.nz Fax: 04 460 4995 Post: PO Box 10 254, Wellington 6143

All feedback received before the closing date will be considered by PHARMAC’s Board (or Chief Executive acting under delegated authority) prior to making a decision on this proposal.

Details of the proposal  The subsidy for ketoprofen and tiaprofenic acid would be increased in Section B of the Pharmaceutical Schedule from 1 July 2011 as follows (prices and subsidies expressed ex-manufacturer, excluding GST):

Chemical Ketoprofen Ketoprofen Tiaprofenic acid Presentation Cap long-acting 100 mg Cap long-acting 200 mg Tab 300 mg Brand Oruvail SR Oruvail SR Surgam Pack size 100 100 60 Current Subsidy (and Price) $6.72 ($21.56) $13.44 ($43.12) $4.03 ($19.26) Proposed Subsidy and Price $21.56 $43.12 $19.26

A417119 - T11-556

Page 1 of 3

---



Ketoprofen and tiaprofenic acid would be listed in Part II of Section H of the Pharmaceutical Schedule from 1 July 2011 as follows (prices ex-manufacturer, excluding GST):

Chemical Ketoprofen Ketoprofen Tiaprofenic acid Presentation Cap long-acting 100 mg Cap long-acting 200 mg Tab 300 mg Brand Oruvail SR Oruvail SR Surgam Pack size 100 100 60 Proposed Price $21.56 $43.12 $19.26



There would be an option to list a smaller pack size of ketoprofen 200 mg tablets in Section B and in Part II of Section H of the Pharmaceutical Schedule in the future at a price and subsidy of $12.95 per pack of 28 (ex-manufacturer, excluding GST); Oruvail SR and Surgam would have protection from delisting and subsidy reduction until 1 July 2014; The Special Authority for Manufacturers Price that currently applies to the funded NSAIDs in Section B of the Pharmaceutical Schedule would be deleted from 1 July 2011 as follows:

SA1038 Special Authority for Manufacturers Price Note: Subsidy for patients with existing approvals prior to 1 September 2010. Approvals valid without further renewal unless notified. No new approvals will be granted from 1 September 2010.







Hyaluronidase injection 1,500 iu per ml would be delisted from Section B of the Pharmceutical Schedule from 1 July 2011.

Background Increased subsidy for ketoprofen and tiaprofenic acid The recent withdrawal of the NSAIDs indomethacin and piroxicam from the market has resulted in a reduced range of fully funded NSAIDs. The Rheumatology Subcommittee of PTAC has advised that while the majority of patients can be managed adequately using the current range of fully funded NSAIDs, responses to NSAIDs are highly idiosyncratic and it is important to have as large a range of fully funded options as possible as there is a small proportion of patients who cannot be managed on the currently fully funded agents. This proposal is to increase the range of fully funded NSAIDs by fully subsidising both ketoprofen and tiaprofenic acid.

Removal of NSAID Special Authority for Manufacturers Price If the proposal to fully fund ketoprofen and tiaprofenic acid is approved we consider that the Special Authority that provides full subsidy for any partly-funded NSAID for patients with an approval prior to 1 September 2010 would no longer be needed. Fully funded options for the small number of patients who are currently accessing the remaining partly funded NSAIDs are outlined in the table on the next page:

A417119 - T11-556

Page 2 of 3

---

Pharmaceutical

Presentation

Diclofenac sodium

Tab 50 mg dispersible Tab 400 mg Tab 600 mg Cap 250 mg

Approximate number of patients currently gaining full subsidy via Special Authority 13

Alternative fully funded options*

Ibuprofen Mefenamic acid Sulindac

78 29 2

Tab 100 mg 15 Tab 200 mg 37 *The full list of fully funded options can be found in the Pharmaceutical Schedule, available at www.pharmac.govt.nz/Schedule

Diclofenac tab EC 50 mg; ibuprofen oral liquid 100 mg per 5 ml; another fully funded NSAID or analgesic Ibuprofen tab 200 mg; another fully funded NSAID or analgesic Another fully funded NSAID or analgesic Another fully funded NSAID or analgesic

Delisting of hyaluronidase Hyaluronidase injection 1,500 iu per ml is currently partly funded – the subsidy is $18.32 and the manufacturer’s price is $254.92 for a pack of 10 injections. Community usage is very low (less than 20 prescriptions per year, mostly dispensed from pharmacies associated with private hospitals). We have been advised that the most common use of hyaluronidase in New Zealand is for dispersal of local anaesthetic in cataract surgery, which we consider is not a community use of this pharmaceutical. If this proposal is approved, hyaluronidase would remain available for purchase and use in hospitals but it would no longer be partly funded in the community.

A417119 - T11-556

Page 3 of 3