Prescribed List Changes: 1 September 2011

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A decision made on 29 July 2011:

Decision Reference: MD-S-2011-0059
Decision Summary Title :	Prescribed List Changes 1 September 2011		Date of Decision Summary:	29 July 2011
Decision Summary Author:	Policy Principal		Decision Summary: Public or Exempt?	Public
Type of Report: Oral or Written?	Written		Person Giving Oral Report:	N/A
Written Report Title :	WR - Prescribed List Changes 1 September 2011		Date of Written Report:	22 July 2011
Written Report Author:	Policy Principal		Written Report : Public or Exempt?	Public
Subject: Changes to be made to the Prescribed List (Jersey) as at 1 September 2011
Decision(s): The Minister approved the changes to the Prescribed List (Jersey) as recommended by the Pharmaceutical Benefit Advisory Committee on 6th July 2011. To be included from 1 September 2011 as green items (for initiation in primary or secondary care): Denosumab 60 mg/mL pre-filled syringe Dorzolamide 2%, timolol 0.5% preservative-free eye drops (Cospot) Dorzolamide 2% preservative-free eye drops (Trusopt) Levobunolol 0.5%, polyvinyl alcohol 1.4% preservative-free eye drops (Betagan) To be included as amber item (for initiation/stabilisation in secondary care before transfer to primary care) Rotigotine patches (dose in 24 hours) 1mg, 2 mg, 3 mg, 4 mg, 6 mg, 8 mg To give notice that the following items be generic only from 1 September 2011 Risedronate 35mg tablets Anastrozole 1mg tablets Pramipexole 180mcg tablets Pramipexole 700mcg tablets Pramipexole 88mcg
Reason(s) for Decision: The Pharmaceutical Benefit Advisory Committee met on 6 July 2011 and proposed the recommended changes to the Prescribed List (Jersey), effective from 1 September 2011. 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 overall impact of the changes is a reduced drug expenditure of circa £83,000 in drug costs
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: 1 September 2011

Recommendations of the Pharmaceutical Benefit Advisory Committee

6th July 2011

1. Summary

The Pharmaceutical Benefit Advisory Committee (PBAC) met on 6th July 2011 to consider the inclusion and/or deletion of certain products from the Prescribed List. The PBAC recommended the inclusion of 5 items (1 green status item, 1 amber status item and 3 additional formulations). The Committee also recommended that 5 products be listed as generic only (refer to table 3.1). The additions represent increased treatment options for existing medical conditions and will reduce unnecessary use of specialist consultant services. Moreover, establishing additional generic only criteria means that efficient and effective prescribing is promoted and cost savings are achieved without compromising quality.

2.0. Items for Inclusion

2.1. Rotigotine patches (dose in 24 hours) 1mg, 2 mg, 3 mg, 4 mg, 6 mg, 8 mg

(Amber Classification)

Indications And Licensed For:

The treatment of the signs and symptoms of early-stage Parkinson's disease as a single medicine. For later stages of the disease, it is used in combination with other appropriate medicines.

Cost Per Patient at the Recommended Dose

Rotigotine is initiated at dose of 2mg/day and increased in weekly increments of 2mg/24 hours to an effective dose, up to a maximal dose of 8mg/24 hours. The patches are changed every 24 hours.

Table 2.1.1. Dosage Cost Per Patient

Rotigotine strength	Cost per pack (28 days)	Approximate annual cost
1mg	£77.24	£1,007
2mg	£77.24	£1,007
3mg	£97.48	£1,271
4mg	£117.71	£1,534
6mg	£142.79	£1,861
8mg	£142.79	£1,861

Alternatives On The List

Ropinirole, pramipexole, cabergoline, pergolide

Table 2.1.2 Comparative costs per patient at recommended dose

Drug class	Drug	Usual dose range	Annual cost
Dopamine agonists	rotigotine	4-16mg daily	£1,530 - £3,720
	pramipexole	350mcg – 1.1mg daily	£1.390 – £4,180
	ropinirole m/r	8 -24mg daily	£549 - £1,647

This item has been used as a hospital-only product for the past two years to enable the specialist to assess its use. Subsequently, around 25 patients are established on this treatment in the island with a further 1-2 new patients per year expected. These patients have to receive repeat prescriptions from the hospital for the continuation of their medical treatment. Approval of this product under a shared care agreement (amber classification) allows the long-term prescribing for treatment to be transferred to primary care. It therefore avoids unnecessary use of specialised hospital services and the associated costs.

2.2. Denosumab 60 mg/mL pre-filled syringe (Green classification)

Indications and Licensed for:

The treatment of osteoporosis in postmenopausal women at increased risk of fractures.

NB. This product is recommended for addition to the Prescribed List only for use in accordance with NICE Technology Appraisal TA 204 published in October 2010.

Cost Per Patient at The Recommended Dose

The recommended dose is 60mg by subcutaneous injection every 6 months and the patient must be adequately supplemented with calcium and vitamin D.

Cost per 60mg injection £183

Approximate annual cost £366 per patient

Alternatives on The List

Oral therapies - alendronate, risedronate, ibandronate, strontium, raloxifene.

Table 2.2.1: Comparative Costs At Recommended Doses

Denosumab is marketed as an alternative to oral medicine and intravenous therapies. It is used for patients who have not responded adequately or tolerated standard oral therapies. Approval of this product which is administered by 6 monthly injection, allows patients currently treated by 3 monthly intravenous injection therapy in the hospital to be treated in the community.

Compared with other community treatments available, denosumab is cost-neutral and transfer of treatment from hospital to the community will incur additional expenditure for the Health Fund. Nevertheless, it will reduce the cost of providing specialist Hospital services.

2.3. Dorzolamide 2%, timolol 0.5% preservative-free eye drops (Cospot) (Green classification)

2.4. Dorzolamide 2% preservative-free eye drops (Trusopt) (Green classification)

2.5. Levobunolol 0.5%, polyvinyl alcohol 1.4% preservative-free eye drops (Betagan) (Green classification)

Items 2.3.to 2.5 are indicated and licensed for the treatment of a raised pressure inside a patient’s eyeball. If such a condition is left untreated, it will lead to permanent eye disease including the loss of vision. Approval of the formulations listed 2.3 to 2.5, although more expensive than the standard formulation, provide an alternative treatment option for patients with an established sensitivity to other available medicines.

3. Items to be listed as Generic Only

A generic drug is a drug product that is comparable to brand/reference listed drug product in dosage form, strength, route of administration, quality and performance characteristics, and intended use. The use of generic medicines is one of the simplest ways of reducing the cost of medicines to the Health Insurance Fund. Table 3.1. details the cost of generic prices compared to the branded price.

Table 3.1: Generic Price Of Medicines Compared To Branded Priced Medicines

	Generic price	Brand price
Risedronate 35mg tablets	£2.20 / 4 tabs	£19.12 / 4 tabs
Anastrozole 1mg tablets	£7.86 / 28 tabs	£68.56 / 28 tabs
Pramipexole 180mcg tablets	£5.37 / 30 tabs £17.97 / 100 tabs	£19.10 / 30 tabs £63.67 / 100 tabs
Pramipexole 700mcg tablets	£19.01 / 30 tabs £71.82 / 100 tabs	£76.40 / 30 tabs £254.9 / 100 tabs
Pramipexole 88mcg	£3.74 / 30 tabs	£9.55 / 30 tabs

4. Summary of Recommendations

The additions, as detailed in table 4.1 will result in an increased drug cost of approximately £73,000. The approval of generic only items as detailed in table 4.2. will result in a cost saving of approximately £156,000. Therefore the overall impact to the fund is a saving of approximately £83,000.

Table 4.1: New Products And Formulations To Be Added

Item	Net effect on annual expenditure
Rotigotine patches 1mg, 2 mg, 3 mg, 4 mg, 6 mg, 8 mg	£60,000
Denosumab 60 mg/mL pre-filled syringe	£10,000
Dorzolamide 2%, timolol 0.5% preservative-free eye drops (Cosopt)	<£1,000
Dorzolamide 2% preservative-free eye drops (Trusopt)	<£1,000
Levobunolol 0.5%, polyvinyl alcohol 1.4% preservative-free eye drops (Betagan)	<£1,000
Total	- £73,000

Table 4.2.: Items to Be Listed Generic Only

	Estimated annual savings
Risedronate 35mg tablets	£3,000
Anastrozole 1mg tablets	£115,000
Pramipexole 180mcg tablets	£38,000
Pramipexole 700mcg tablets
Pramipexole 88mcg
Total	£156,000

5. Recommendation

The Minister is asked to approve the changes to take effect from 1st September 2011. Despite the additions, the overall impact of the changes is a reduced expenditure of circa £83,000 in drug costs.