Recommendations of the Pharmaceutical benefit Advisory Committee
22 October 2009
1. SUMMARY
The Pharmaceutical Benefit Advisory Committee met on 22nd October 2009 to consider the inclusion and/or deletion of certain products from the Prescribed List. The PBAC recommended the inclusion of 15 products, the deletion of one product and two items to be listed as generic only as detailed in this report. A further three items were recommended for inclusion subject to ratified guidelines.
- BACKGROUND
Items for inclusion
2.1. Strontium ranelate (Protelos, Servier) granules 2g/sachet (open order).
Licensed indication is for the treatment of postmenopausal osteoporosis to reduce the risk of vertebral and hip fractures. The annual cost is approximately £334. Strontium is added to the Prescribed List for initiation in primary or secondary care (GREEN drug) in line with NICE guidance.
2.2. Tripotassium dicitratobismuthate (De-Noltab, Astellas) tablets 120mg (open order).
This is licensed for the treatment of gastric and duodenal ulcers. Application to PBAC relates specifically to use in the treatment of H.pylori infection. The approximate cost of Tripotassium dicitratobismuthate 120mg four times daily for 2 weeks is £3.64. ). It is recommended for the treatment of patients with H.pylori infection who have failed other therapies. There are no alternatives available on the Prescribed List. (Green drug)
2.3. Betamethasone dipropionate 0.05%, calcipotriol 50 micrograms/g (Xamiol, Leo) scalp gel (open order). Group (BNF): 13.5.2 Treatments for psoriasis
Licensed indication is the treatment of scalp psoriasis and requires 1-4 g applied to the scalp daily. The duration of the therapy is usually 4 weeks. The cost of a 50g tube is £36.50. The product is formulated for use on the scalp and so complements Dovobet ointment (60g tube -£35.00) which is contained in the Prescribed List for the treatment of psoriasis. (Green drug)
2.4. Calcium and vitamin D (choice of products) (Green items)
The licensed indication is for the treatment of calcium and vitamin D deficiency and for use as an adjunct to other treatments for osteoporosis. Calcichew D3 Forte chewable tablet is the only product containing high-dose calcium and vitamin D on the Prescribed List.
Additional further items containing high-dose calcium and vitamin D added to the Prescribed List will provide patients with alternative formulations that may be better tolerated. These formulations are:
- Calfovit D3 (once daily, solution),
- Calceos (least expensive, used at Jersey General),
- Adcal D3 (different flavour to lemon)
2.5. Levodopa 200 mg, carbidopa 50mg, entacapone200mg (Stalevo, Orion Pharma) tablets (open order).
Licensed indication is for the treatment of Parkinson’s disease. All other strengths of Stalevo are contained in the Prescribed List for use under shared-care agreement. This strength completes the range available (Amber drug).
2. 6. Estradiol (Vagifem, Novo Nordisk) vaginal tablets 25mcg (open order).
Licensed indication is a hormone replacement therapy for the treatment of vaginal atrophy due to oestrogen deficiency. Estradiol tablets were incorrectly reported as discontinued and so removed from the Prescribed List in March 2008. The product has not been discontinued and should be reinstated (Green drug).
2.7. Olanzapine (Zyprexa, Lilly) tablets 15mg, 20mg; orodispersible tablets 15mg,20mg (open order)
Licensed indication is for the treatment of schizophrenia and mania. All other strengths of olanzapine are contained in the Prescribed List. These strengths complete the range of doses available (Green drug).
2.8. Metronidazole (Acea,Ferndale; Rosiced, Fabre) topical gel 0.75% (brand name only) (Green drug).
Licensed indication is for the treatment of rosacea. Acea and Rosiced brands of topical metronidazole are both licensed for the treatment of rosacea and are the least expensive of those available.
Acea 40g £9.95
Rosiced 30g £7.50
2.9. Topiramate (Topamax, Janssen-Cilag) sprinkle capsules 15mg, 25mg
Extends the range of formulations available to patients (Green drug)
2.10. Telmisartan (Micardis, Boehringer Ingelheim) tablets 20mg, 40mg, 80mg (open order). Group (BNF): 2.5.5.2 Angiotensin-II receptor antagonists
Licensed indication is for the treatment of essential hypertension in adults. The annual cost range for Telmisartan 40mg once daily (range is 20-80mg daily) is £163 (but may range from £104 to £222).
Alternatives available on Prescribed List:
Ramipril 5mg once daily £17
Candesartan 8mg once daily £129
Irbesartan 150mg once daily £157
Telmisartan offers no significant clinical or financial advantage over other drugs in the same class that are currently available for use in Jersey. However, there is a small cohort of patients already established on treatment with this medicine by Dr Kumar (H&SS Consultant) Dr Kumar believes that it offers a further option for selected patients. After further consideration, the Committee recommended approval by a 5:3 majority.
2.11. Beclometasone dipropionate 100mcg/ formoterol fumarate dehydrate 6mcg pressurised metered-dose inhaler (Fostair)
Fostair is indicated in the regular treatment of asthma where use of a combination product (inhaled corticosteroid and long-acting beta2-agonist) is appropriate. It provides an effective alternative to other combination products containing a long-acting bronchodilator and a corticosteroid but at a lower cost.
Approximate annual cost at recommended dose
Fostair 100/6 pMDI 2 puffs twice daily £357
Symbicort 200/6 Turbohaler 2 puffs twice daily £425
Seretide 125/25 Evohaler 2 puffs twice daily £462
2.12. Oxybutinin 3.9mg/24h transdermal patch (Kentera) (GREEN drug).
Licensed indication, dose and cost: Symptomatic treatment of urge incontinence and/or increased urinary frequency and urgency as may occur in patients with unstable bladder.
Alternatives available include:
Oxybutinin tablets 2.5mg, 5mg £40-90
Oxybutinin m/r tablets 5mg, 10mg £150-£600
Tolterodine tablets 1mg £380-400
Tolterodine m/r capsules 4mg £380
Solifenacin tablets 5mg, 10mg £340-£440
Oxybutinin patch 3.9mg £350
Oxybutinin patch is no more effective than other treatments available for urinary incontinence on the Prescribed List. However, it provides a different route of administration and may be less likely to cause troublesome anticholinergic effects compared with oral treatments. It, therefore, provides a useful 3rd-line option for some patients who cannot tolerate oral therapies.
2.13. Dimeticone 4% lotion (Hedrin)
Licensed indication, dose and cost: Treatment of headlice
Lotion 50mL £2.98
Spray 120mL £7.14; 150mL £6.83
Alternatives available:
Malathion aqueous liquid 0.5% £2.27 (50mL)
Permethrin cream rinse 1% £2.38 (59mL)
Dimeticone is an effective treatment for head lice and appears to be as effective as other available treatments.
2.14. Prednisolone 0.5% preservative free single use eye drops (Minims)
Licensed indication, dose and approximate annual cost (GREEN drug).
Local, short-term treatment of inflammation
Apply every 1-2 hours until inflammation controlled then reduce frequency.
20 x 0.5mL £5.75
Prednisolone 0.5% preservative free Minims are occasionally required for patients in the community who cannot tolerate preparations containing preservatives
2.15. Dexamethasone 500mcg tablets (GREEN drug).
Licensed indication, dose and approximate annual cost:
Suppression of inflammatory and allergic disorders; diagnosis of Cushing’s disease, congenital adrenal hyperplasia; cerebral oedema associated with malignancy; croup; nausea and vomiting with chemotherapy; rheumatic disease; eye disorders; adjunct to cancer therapies
Recommended dose depends on indication but is generally in the range 0.5mg – 10mg daily.
Dexamethasone 500mcg tablet was removed from the List when it was discontinued and the oral solution added to replace it. However, dexamethasone tablets 500mcg are now available and this product should be added to the Prescribed List.
3. Items/brands to be deleted from the prescribed List
3.1. Beclazone Easi-Breathe (CFC-containing beclometasone dipropionate) inhalers 50mcg, 100mcg and 250mcg – discontinued.
Item to be deleted with 3 months notice 1st March 2010
4. Items to be listed as generic only with 3 months notice 1st March 2010
4.1. Pantoprazole tablets 20mg, 40mg
4.2. Venlafaxine tablets 37.5mg, 75mg; modified-release (m/r) 75mg, 150mg.
Approximate annual cost at recommended daily dose
Item | Generic price | Brand price |
Pantoprazole 20mg (20mg daily) | £141 | £154 |
Pantoprazole 40mg (40mg daily) | £245 | £268 |
Venlafaxine 37.5mg (37.5mg twice daily) | £60 | £293 |
Venlafaxine 75mg (75mg twice daily) | £86 | £489 |
Venlafaxine m/r 75mg | £293 | £293 |
Venlafaxine m/r 150mg | £489 | £489 |
5. Cumulative effect on annual expenditure for all recommendations
This is estimated to be £31,000 (Refer to Appendix One for summary of all recommendations and estimated costs).
- The recommendations detailed in Table One represent an additional £41,000 cost to the Fund
- The recommendations detailed in Table Two represent an estimated saving of £250, 000 to the Fund.
6. RECOMMENDATION
Referring to Appendix One, the Minister is asked to approve items detailed in Table One and Table Two to take effect from 1st January 2010. The cost is an estimated £209, 000 saving to the Fund.
Appendix One
Estimated effect on annual expenditure for proposed changes
Table One: Additional items
Number | item | Cause | Net effect per annum |
2.1.1. | Strontium ranelate (Protelos, Servier) granules 2g/sachet | Additional cost | £30,000 |
2.1.2 | Tripotassium dicitratobismuthate (De-Noltab) tablets 120mg | Low use, low cost | £0 |
2.1.3 | Betamethasone dipropionate 0.05%, calcipotriol 50 micrograms/g (Xamiol) scalp gel | Alternative product – similar price | £0 |
2.1.4 | Calceos Tablets (chewable), Calfovit D3 Powder, Adcal D3 Tablets | Alternative products – similar price | £0 |
2.1.5. | Levodopa/carbidopa/entacapone (Stalevo) tablets 125/31.75/200mg, 75/18.75/200mg, 200/50/200mg, 200/50/200mg | Flat price structure – no additional cost | £0 |
2.1.6 | Estradiol (Vagifem) vaginal tablets 25mcg | Removed in error from List – no additional cost | £0 |
2.1.7. | Olanzapine (Zyprexa) tablets 15mg, 20mg; orodispersible tablets 15mg,20mg | Extended dose range for existing product – no additional cost | £0 |
2.1.8 | Metronidazole (Acea; Rosiced) topical gel 0.75% | Alternative product – low use | £0 |
2.1.9 | Topiramate (Topamax) sprinkle capsules 15mg, 25mg | Extended product range for existing product | £0 |
2.1.10 | Telmisartan (Micardis) tablets 20mg, 40mg, 80mg | Alternative product – similar cost, low use | £0 |
2.1.11 | Beclometasone dipropionate 100mcg/ formoterol fumarate dehydrate 6mcg pressurised metered-dose inhaler (Fostair) | Lower cost than alternatives but uptake likely to be low | £0 |
2.1.12 | Oxybutinin 3.9mg/24h transdermal patch (Kentera) | Additional cost | £10,000 |
2.1.13 | Dimeticone 4% lotion (Hedrin) | No similar products on List | £1,000 |
2.1.14 | Prednisolone 0.5% preservative free single use eye drops (Minims) | Additional cost but low use | £1,000 |
2.1.15 | Dexamethasone 500mcg tablets | Less expensive than existing product but low use | -£1,000 |
| | Sub Total | £41,000 |
Table Two: Items Generic only and deleted items
Number | item | Cause | Net effect per annum |
3.1 | Beclazone Easi-Breathe (CFC-containing beclometasone dipropionate) inhalers 50mcg, 100mcg and 250mcg | Alternative product – similar price | £0 |
4.1. | Generic pantoprazole | Assuming price reduction similar to other drugs in class | -£200,000 |
4.2. | Generic venlafaxine | Assuming minimal reduction in price of m/r products | -£50,000 |
| | Subtotal | - £250,000 |
gov.je