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.