Decision to award sole supply to Fentanyl Sandoz (fentanyl transdermal patch)
PHARMAC is pleased to announce the award of Sole Subsidised Supply Status in the community, and Hospital Supply Status in DHB hospitals, to Novartis’ brand of fentanyl transdermal patch (Fentanyl Sandoz).
This was the subject of a consultation letter dated 8 July 2013. The proposal as consulted on was contingent on registration, which has now occurred.
In summary, the effect of the decision is that:
- Fentanyl Sandoz patches (a matrix-type patch) will be listed in the community and hospital sections of the Pharmaceutical Schedule from 1 February 2015.
- The currently funded brand of fentanyl patches (Mylan Fentanyl Patch) will be delisted six months after the listing of Fentanyl Sandoz, on 1 August 2015.
- Following the delisting of Mylan Fentanyl Patch, Fentanyl Sandoz patch will be the only funded brand of fentanyl patches until at least 30 June 2016.
Details of the decision
Fentanyl Sandoz patches will be listed in Section B and in Part II of Section H, of the Pharmaceutical Schedule from 1 February 2015 at the following prices and subsidies (ex-manufacturer, excluding GST):
|Chemical||Brand||Presentation||Strength||Pack size||Price and subsidy|
|Fentanyl||Fentanyl Sandoz||Patch||12.5 mcg per hour||5||$2.92|
|Fentanyl||Fentanyl Sandoz||Patch||25 mcg per hour||5||$3.66|
|Fentanyl||Fentanyl Sandoz||Patch||50 mcg per hour||5||$6.64|
|Fentanyl||Fentanyl Sandoz||Patch||75 mcg per hour||5||$9.18|
|Fentanyl||Fentanyl Sandoz||Patch||100 mcg per hour||5||$11.29|
- There will be a 6-month transition period between 1 February 2015 and 1 August 2015 where both Fentanyl Sandoz patches and Mylan Fentanyl Patches will be listed, fully funded on the Pharmaceutical Schedule.
- Fentanyl Sandoz will have Sole Subsidised Supply Status (the only funded brand of fentanyl patches in the community) and Hospital Supply Status (the only available brand of fentanyl patches in DHB hospitals, subject to a 1% Discretionary Variance (DV) limit) from 1 August 2015 until 30 June 2016.
- Mylan Fentanyl Patch will be delisted from Section B and Part II of Section H of the Pharmaceutical Schedule from 1 August 2015.
Managing the change and timelines
The brand change will occur over six months, 1 February 2015 to 1 August 2015.
The six months of dual listing is so that patients may finish therapy without having to change brands and to allow sufficient time for health professionals to transition patients if they require treatment with fentanyl patches beyond 1 August 2015. All new patients from 1 February 2015 should be started on the Fentanyl Sandoz brand, to avoid the need for these patients to switch brands.
Switching brands of fentanyl should occur under the guidance of the prescriber or the dispensing pharmacist. If patients do need to change brands we recommend that they are closely monitored and the dose of therapy is adjusted as necessary according to the patient’s clinical response. Further information on changing brands of fentanyl patches is available on the PHARMAC website.
We appreciate all of the feedback that we received and acknowledge the time people took to respond. All consultation responses received by 22 July 2013 were considered in their entirety in making a decision on the proposed changes. The table below summarises the key issues raised in relation to specific aspects of the proposal:
|Are the Fentanyl Sandoz matrix type patches, can they be cut?||Fentanyl Sandoz is a fentanyl matrix transdermal drug delivery system (patch). The manufacturer’s datasheet states that patches that are cut, divided, or damaged in any way should not be used. This advice is the same as that on the Medsafe datasheet for Mylan Fentanyl Patch and for the previously subsidised Durogesic patch.|
If you have any questions about this decision, you can email us at email@example.com or call our toll free number (9 am to 5 pm, Monday to Friday) on 0800 66 00 50.