Prescribed List (Jersey): Changes

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A decision made on 18 June 2010 to approve changes to the Prescribed List (Jersey)

Decision Reference: MD-S-2010-0029
Decision Summary Title :	Prescribed List (Jersey) 1 July 2010		Date of Decision Summary:	8 June 2010
Decision Summary Author:	Business Manager		Decision Summary: Public or Exempt?	Public
Type of Report: Oral or Written?	Written		Person Giving Oral Report:	N/A
Written Report Title :	Changes to be made to the Prescribed List (Jersey) as at 1 July 2010		Date of Written Report:	8 June 2010
Written Report Author:	Business Manager		Written Report : Public or Exempt?	Public
Subject: Changes to be made to the Prescribed List (Jersey) as at 1 August 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 April 2010. To be included from 1 August 2010: As detailed in the Table 1 of the appendix to the accompanying report. To be Generic Only from 1 September 2010 As detailed in Table 2 of the appendix to the accompanying report. Other amendments from 1 September 2010 As detailed in Table 3 of the appendix to the accompanying report.
Reason(s) for Decision: The Pharmaceutical Benefit Advisory Committee met on 13 April 2010 and provided the Minister with the recommended changes to the Prescribed List (Jersey), effective from 1 August 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 recommended changes represent an estimated saving to the fund of approximately £255,000 per annum.
Action required: Business Manager to issue a 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 (Jersey): Changes

RECOMMENDATIONS OF THE

PHARMACEUTICAL BENEFIT ADVISORY COMMITTEE

13 APRIL 2010

1. Summary

The Pharmaceutical benefit Advisory Committee (PBAC) met on 13 April 2010 to consider applications for changes to the Prescribed List. The PBAC recommended the addition of five items; five items to be listed for reimbursement as generic products only; and three entries to be amended for clarification.

2. Items to be added to the Prescribed List

2.1.2. Fluticasone furoate, 27.5 micrograms /actuation nasal spray (Avamys) - open order – correspondence from Drs Luksza, Shah, Siodlak

The Committee at the meeting on 22 October 2010 discussed this item and recommended that it should not be approved.

Subsequently, three letters have been received from H&SS consultants (Drs Luksza, Siodlak, and Shah) requesting a review of this decision. The consultants advocate that the device is superior to other items available as approved medicines; however, this is based on clinical opinion rather than clinical evidence. The approval of the item would provide a further option for the treatment of allergic rhinitis but offered no significant advantage over available treatments.

The Committee examined prescriptions dispensed in Jersey for nasal steroids (refer to table one)

Table One: Prescriptions dispensed in Jersey (Feb 09-Jan 10) for nasal steroids

Product	Number of items dispensed	Total net drug cost	Average cost per item
Mometasone Fur_Aq N/Spy 50mcg (140 D)	6,196	£48,737.19	£7.87
Beclomet Diprop_Nsl Spy 50mcg (180 D)	1,934	£11,102.16	£5.74
Budesonide_Aq Nsl Spy 64mcg (120 D)	1,528	£7,143.59	£4.68
Beconase_Aq Nsl Spy 50mcg (200 D) 22g	649	£1,548.33	£2.39
Beclomet Diprop_Nsl Spy 50mcg (200 D)	588	£1,726.32	£2.94
Nasonex_Aq N/Spy 50mcg (140 D)	543	£4,267.20	£7.86
Rhinocort Aqua 64_Nsl P/Spy 64mcg (120D)	222	£1,064.13	£4.79
Budesonide_Aq Nsl Spy 100mcg (200D)	175	£1,134.26	£6.48
Beconase_H/Fever Relief NslSpy50mcg(100D	5	£18.40	£3.68
Rhinocort Aqua_Nsl P/Spy 100mcg 5ml 100D	1	£5.85	£5.85

The examination of the data highlighted that the item was similar in price to other items on the prescribed list. In addition, the Committee also noted the different reimbursement prices for beclometasone products, which differ only in their pack size.

After due consideration, the Committee voted and recommended approval by a 3:4 majority. Concerning the beclometasone products, the Committee also recommended that the Prescribed List should be amended to specify the least expensive, 200 dose pack sized product only.

Table Two: Record of Vote for the approval of Fluticasone furoate

Yes	No
Dr C Budd Dr D Balbes; Mr G Jones; Dr S Turnbull;	Mr P McManus; Mr R. Lang (written submission); Mr P McCabe

Recommendations:

i. To approve Fluticasone furoate, 27.5 micrograms /actuation nasal spray (Avamys) and add to the Prescribed List.

ii. beclometasone nasal spray products amended to specify the least expensive, 200 dose pack sized product only.

3. Items requested by an Approved Medical Practitioner

None received

4. Formulations to be added to the Prescribed List

4.1. Applications from Approved Medical Practitioner

4.1.1.Montelukast granules 4mg sachets (open order)

Licensed indication, dose and approximate annual cost:

Montelukast is indicated in the treatment of asthma as add-on therapy in those 6 months to 5 year old patients with mild to moderate persistent asthma who are inadequately controlled on inhaled corticosteroids and in whom “as-needed” short acting βagonists provide inadequate clinical control of asthma. It may also be an alternative treatment option to low-dose inhaled corticosteroids for 2 to 5 year old patients with mild persistent asthma who do not have a recent history of serious asthma attacks that required oral corticosteroid use, and who have demonstrated that they are not capable of using inhaled corticosteroids.

Montelukast is also indicated in the prophylaxis of asthma from 2 years of age and older in which the predominant component is exercise-induced bronchoconstriction.

Recommended dose: 4mg once daily in the evening

Cost: £25.69 for 28 day supply (this is the same as for the 4mg chewable tablets currently on the Prescribed List.

Table three: Prescriptions for montelukast dispensed in Jersey Feb 09 – Jan 10

BNF Name	Total Items	Total net drug cost
Montelukast_Tab 10mg	3,086	£81,157.22
Montelukast_Tab Chble 4mg S/F	275	£6,989.67
Montelukast_Tab Chble 5mg S/F	244	£6,479.53
Singulair_Tab 10mg	154	£4,174.61

Addition of this product is not expected to impact on expenditure for this group of medicines and it provides an alternative to the chewable tablets already available.

Recommendation:

To approve Montelukast granules 4mg sachets (open order) and add to the prescribed list.

4.2. Applications from Approved Pharmacist

4.2.1.Diclofenac sodium 50 mg, misoprostol 200 micrograms (Arthrotec 50); diclofenac sodium 75 mg, misoprostol 200 micrograms (Arthrotec 75) (brand only)

Licensed indication, dose and approximate annual cost:

Arthrotec 50 is indicated for patients who require the non-steroidal anti-inflammatory drug diclofenac together with misoprostol. The diclofenac component of Arthrotec is indicated for the symptomatic treatment of osteoarthritis and rheumatoid arthritis. The misoprostol component is indicated for patients with a special need for the prophylaxis of NSAID-induced gastric and duodenal ulceration

Recommended dose: To be taken two or three times daily to a maximum daily diclofenac dose of 150mg.

Cost (approximate annual cost at recommended dose)

Arthrotec 50 three times daily £219

Arthrotec 75 twice daily £193

Diclofenac 50mg plus misoprostol 200mcg three times daily £203

Diclofenac 75mg plus misoprostol 200mcg twice daily £135

Arthrotec is a single tablet that contains two drugs, currently available on the Prescribed List. It offers convenience for patients and reduced dispensing fees, assuming patients currently receiving misoprostol are also currently receiving a NSAID, such as diclofenac.

There is good evidence that misoprostol reduces the frequency of NSAID-induced gastrointestinal bleeding and ulcers although side effects, such as diarrhoea, limit its use. Use of a fixed-dose combination product, while aiding compliance, also prevents individualisation of each component.

Recommendation - Arthrotec should not be added to the Prescribed List.

4.2.2. Diclofenac m/r tablets 75mg, 100mg (for consideration as generic only or specified brands)

Diclofenac modified-release capsules are available and commonly prescribed Modified-release tablets are also available but were removed from the Prescribed List because of the lack of a Drug Tariff price for reimbursement and the wide range in reimbursement costs that were incurred. This situation remains with current reimbursement prices for diclofenac m/r tablets 75mg ranging from £2.23 - £10.75 for 28 tablets, and from £6.72 - £14.05 for 28 diclofenac m/r 100mg tablets. To ensure that the Health Fund reimburses for the lowest cost brand of diclofenac m/r tablet, products would need to be listed by brand name, preferably for only those products with the lowest price.

Recommendation - Diclofenac m/r tablets 75mg, 100mg should not be added to the Prescribed List.

5. Items/brand names to be deleted from the Prescribed List

5.1. Items to be deleted

5.1.1. None proposed

5.2. Table Four: Items to be listed as Generic Only

		Annual expenditure	Estimated annual saving if Generic Only
5.2.1	Clopidogrel tablets 75mg	£175,835.16	£122,304.90
5.2.2	Trazodone capsules 50mg, 100mg; tablets 150mg	£5,016.00	£2,113.80
5.2.3	Timolol eye drops 0.25%, 0.5%	£6,397.62	£2,158.77
5.2.4	Mirtazapine tablets 15mg, 30mg, 45mg; orodispersible tablets 15mg, 30mg, 45mg	£55,570.97	£29,910.41
5.2.5	Finasteride tablets 5mg	£48,288.00	£24,829.65
5.2.6	Bicalutamide tablets 50mg, 150mg	£81,580.16	£70,900
Totals		£366,290	£250,059

The Committee were advised of the difficulties in obtaining generic Timolol eye drops

Recommendation: All items except Timolol eye drops 0.25%, 0.5% to be generic with 3 months notice

6. Amendments to current entries on the Prescribed List

6.1. Hydrocortisone suspension for injection 25mg/mL (open order) – to be reinstated following removal in error

6.2. Chlordiazepoxide capsules 5mg, 10mg (generic only) – to be reinstated following removal in error (NB tablets correctly removed)

6.3. Pregabalin capsules 75mg – to add as not included in original application/approval

6.4. Flupentixol – all preparations. Remove FLUANXOL brand from Prescribed List. Allow all products as open order.

6.5. Fluticasone/Salmeterol – clarification of Prescribed List entry to show that both Seretide Evohaler and Seretide Accuhaler are allowed.

Appendix

Estimated effect on annual expenditure for proposed changes

Table 1: Items to be added to the Prescribed List

Item	Reason for change	Net effect on annual expenditure
Fluticasone furoate, 27.5 micrograms /actuation nasal spray (open order)	Similar price to product most commonly prescribed	£0
Montelukast (as sodium salt) granules 4mg sachets (open order)	Alternative formulation; same price as existing preparations	£0
Hydrocortisone suspension for injection 25mg/mL (open order)	Removed from List in error	£0
Chlordiazepoxide capsules 5mg, 10mg (generic only)	Removed from List in error	£0
Pregabalin capsules 75mg	All other strengths available	£0

Table 2: Items to be made Generic Only

Clopidogrel tablets 75mg	Cost reduction	-£122,305
Trazodone capsules 50mg, 100mg; tablets 150mg	Cost reduction	-£2,114
Mirtazapine tablets 15mg, 30mg, 45mg; orodispersible tablets 15mg, 30mg, 45mg	Cost reduction	-£29,910
Finasteride tablets 5mg	Cost reduction	-£24,830
Bicalutamide tablets 50mg, 150mg	Cost reduction	-£70,900

Table 3: Other amendments

Beclometasone nasal spray – reimburse 200 dose unit only	Restrict to least expensive pack size	-£5,320
Flupentixol – remove FLUANXOL brand from Prescribed List and allow all items as open order	Clarification	£0
Fluticasone/Salmeterol – clarification of Prescribed List entry to show that both Seretide Evohaler and Seretide Accuhaler are allowed	Clarification	£0