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A decision made 1 November 2010 regarding: Prescribed List - changes from 1 December 2010.

Decision Reference: MD-S-2010-0070
Decision Summary Title :	Prescribed List (Jersey) 1 December 2010		Date of Decision Summary:	27 October 2010
Decision Summary Author:	Policy Principal		Decision Summary: Public or Exempt?	Public
Type of Report: Oral or Written?	Written		Person Giving Oral Report:
Written Report Title :	Changes to be made to the Prescribed List (Jersey) as at 1 December 2010		Date of Written Report:	27 October 2010
Written Report Author:	Policy Principal		Written Report : Public or Exempt?	Public
Subject: Changes to be made to the Prescribed List (Jersey) as at 1 December 2010
Decision(s): The Minister approved the changes to the Prescribed List (Jersey) as recommended by the Pharmaceutical Benefit Advisory Committee from the meeting held on 13 October 2010. To be included from 1 December 2010: Testosterone undecanoate injection (oily) 250mg/mL (Nebido, Bayer) Aerochamber Plus spacer device (GSK) To be deleted/Generic only from 1 December 2010 Rosiglitazone tablets 4mg, 8mg; rosiglitazone/metformin tablets 2/500mg, 2/1000mg, 4/1000mg.
Reason(s) for Decision: The Pharmaceutical Benefit Advisory Committee met on 13 October 2010 and proposed the recommended changes to the Prescribed List (Jersey), effective from 1 December 2010. The changes represent best value amendments for approved medicines and ensure that General Practitioners have the choice available to them of modern, safe and effective medicines.
Resource Implications: The additions represent a cost to the fund of approximately £3,000 per annum.
Action required: Policy Principal to issue public notice listing amendments and notify all approved medical practitioners and approved contractors.
Signature:		Position: Minister
Date Signed:		Date of Decision (If different from Date Signed):

Prescribed List - changes from 1 December 2010

Recommendations of the Pharmaceutical Benefit Advisory Committee

13th October 2010

1. Summary

The Pharmaceutical Benefit Advisory Committee met on 13th October 2010 to consider the inclusion and/or deletion of certain products from the Prescribed List. The PBAC recommended the inclusion of 2 products and the deletion of one product detailed in this report. Two other decisions are recorded separately.

2. Items for inclusion

2.1 Testosterone undecanoate injection (oily) 250mg/mL (Nebido, Bayer)

Licensed for testosterone replacement therapy in adults when testosterone deficiency is confirmed by clinical features and biochemical tests.

Alternatives available on Prescribed List (approx annual cost):

Testosterone injection (Sustanon) (250mg every 3 weeks)

100mg (discontinued)

250mg £40

Testosterone implant (100mg-600mg every 4-5 months)

100mg £180 (depends on dose and frequency of use)

200mg £140 (depends on frequency of use)

Testosterone enantate injection 250mg/mL £120 – £230

Testosterone undecanoate capsules 40mg £100 – £310

The new product is given, on average, around 4-5 times per year. In comparison, the currently used product (Sustanon) has to be given around 17 times per year. There is therefore, a real reduction in associated medical costs to the patient as well as a reduction in medical benefit costs.

There will be a cost pressure of around £1,200 pa to the Health Fund for pharmaceutical costs which will be offset by a reduction in medical benefit costs. The application was unanimously accepted by the Committee.

2.2 Aerochamber Plus spacer device (GSK)

This is a medium-volume spacer device for use with pressurised (aerosol) inhalers and is available with a mask.

Adult/child/infant with mask £7.56

Standard with mouthpiece £4.53

Spacer devices have been designed to overcome poor inhaler technique and facilitate optimum drug delivery. They are particularly useful for young children and those unable to use pressurised metered-dose inhalers.

Aerochamber is more expensive than the approved Volumatic spacer device and may not be compatible with all currently used inhaler devices. However, it is smaller than the Volumatic and so may be preferred by some children and adults who find the Volumatic to be cumbersome. The estimated cost of approval is estimated to be less than £1000. The application was unanimously accepted by the Committee.

3. Items for deletion

3.1. Rosiglitazone tablets 4mg, 8mg; rosiglitazone/metformin tablets 2/500mg, 2/1000mg, 4/1000mg.

The UK Commission on Human Medicines (CHM) has concluded that there is an increased cardiovascular risk for this medicine. On 23 September 2010, the European Committee on Medicinal Products for Human Use (CHMP) recommended the suspension of the marketing authorisations of rosiglitazone across the European Union. Consequently, Rosiglitazone will cease to be available in Europe within the next few months. The suspension of European marketing authorisations will remain in place unless the marketing authorisation holder can provide convincing data to identify a group of patients in whom the benefits of the medicine outweigh the risks.

4. Recommendation

The Minister is asked to approve the changes to take effect from 1st December 2010. The total additional costs are estimated to be less than £3000.