ABHB Joint Formulary (31 Jan 2012)
1
Aneurin Bevan Health Board Joint Formulary
This Edition updated 31st January 2012
IF USING A PRINTED VERSION OF THIS FORMULARY PLEASE
CHECK WHETHER THERE IS NOT A MORE UP-TO-DATE
VERSION AT:
http://www.wales.nhs.uk/sites3/page.cfm?orgid=814&pid=38068
CONTENTS
TO GO TO THE REQUIRED SECTION CLICK ON THE PAGE NUMBER
MEDICINES NOT RECOMMENDED FOR USE IN GWENT........................................... 2
EMERGENCY TREATMENT OF POISONING ............................................................... 6
1 GASTROINTESTINAL SYSTEM ................................................................................. 6
2 CARDIOVASCULAR SYSTEM .................................................................................... 6
3 RESPIRATORY SYSTEM ........................................................................................... 6
4 CENTRAL NERVOUS SYSTEM .................................................................................. 6
5 INFECTIONS ............................................................................................................... 6
6 ENDOCRINE SYSTEM ............................................................................................... 6
7 OBSTETRICS, GYNAECOLOGY AND URINARY TRACT DISORDERS..................... 6
8 MALIGNANT DISEASE AND IMMUNOSUPPRESSION .............................................. 6
9 NUTRITION AND BLOOD ........................................................................................... 6
10 MUSCULOSKELETAL AND JOINT DISEASES ......................................................... 6
11 EYE ........................................................................................................................... 6
12 EAR, NOSE AND OROPHARYNX............................................................................. 6
13 SKIN .......................................................................................................................... 6
14 IMMUNOLOGICAL PRODUCTS AND VACCINES .................................................... 6
15 ANAESTHESIA ......................................................................................................... 6
16 OTHER AGENTS ...................................................................................................... 6
APPENDIX 1 - UNLICENSED DRUGS ........................................................................... 6
INDEX OF PRODUCTS.................................................................................................. 6
ABHB Joint Formulary (31 Jan 2012)
2
MEDICINES NOT RECOMMENDED FOR USE IN GWENT
This list includes medicines that have been appraised nationally (by
AWMSG1 or NICE2) or locally (by the Gwent Partnership Medicines &
Therapeutics Committee or by the Specialist Prescribing Advisory
Group) and considered unsuitable for prescribing on the NHS by those
committees. All medicines are consequently non-formulary in Gwent.
More information on the medicines appraisal process in Wales was
provided in the May 2010 WeMeReC bulletin:
http://www.wemerec.org/Documents/Bulletins/DrugAppraisal2010Onlin
e.pdf
As this list is periodically updated prescribers should check the
GPMTC website for the latest version at:
http://www.gpmtc.wales.nhs.uk
Q&As
Does the list apply to both Primary and Secondary Care?
Yes – Note some of the more specialist non-recommendations
from NICE/AWMSG/T-PAG (e.g. anti cancer agents) have not
been included in this list.
Does the list prohibit all use of these medicines?
No. Inclusion in this List should not be regarded as a complete
ban. However prescribers should consider the implications of
prescribing a medicine (or recommending others to do so)
judged by accomplished committees as unsuitable for NHS
prescribing and should be prepared to explain and justify any
decision not to follow that advice.
Exceptional use may be justified where it is in a particular
patient’s best interests (e.g. for an indication not appraised by
the national or local committee3); such use requires individual
patient case approval from the appropriate Health Board
Locality.
How will the list be managed?
The list will be reviewed formally by the GPMTC every six
months.
Local prescribing levels of all the included medicines will also
be closely scrutinised by the GPMTC and prescribers will
receive feedback on the extent to which they prescribe drugs
on this list.
1
http://www.wales.nhs.uk/sites3/page.cfm?orgid=371&pid=24773
http://www.nice.org.uk/guidance/type
3
Where this is outside of the terms of the drug’s license GMC guidance should be
noted: http://www.gmc-uk.org/guidance/ethical_guidance/prescriptions_faqs.asp#10
2
ABHB Joint Formulary (31 Jan 2012)
Drug
1. Agomelatine
(▼Valdoxan®)
2. Aliskiren
(▼Rasilez®)
3. Beclometasone
M/R tablets
5mg (Clipper®)
4. Benzalkonium
chloride 0.5%
shampoo
(Dermax®)
5. Bepanthen®
ointment
6. Bimatoprost
0.01% eye
drops
(Lumigan)
7. Chondroitin
8. Co-careldopa
intestinal gel
(Duodopa®)
9. Escitalopram
(Cipralex®)
10. Estradot® patch
(Estradiol)
3
Committe
e & date
Detail of non-recommendation
GPMTC
Jan 2010
Insufficient evidence (particularly the lack of
studies with an active comparator) and the
unfavourable balance of cost versus benefit.
NICE TA231 was also unable to recommend the
use in the NHS of agomelatine for the treatment of
major depressive episodes because no evidence
submission was received.
Not recommended for use within NHS Wales for
the treatment of essential hypertension. The
clinical and cost effectiveness data presented was
insufficient for AWMSG to recommend its use.
The level of evidence (particularly the lack of any
published trials comparing Clipper® with other oral
steroids) was insufficient for Gwent Joint formulary
inclusion.
The level of published controlled trial evidence
supporting Dermax® was insufficient for its Gwent
Joint formulary inclusion.
AWMSG
Jul 2009
GPMTC
Nov 2008
GPMTC
Jul 2009
GPMTC
Nov 2005
ABHB
MTC
Jan 2011
NICE
CG59
Feb 2008
AWMSG
Aug 2007
GPMTC
Jun 2006
GPMTC
Sep 2006
The level of evidence was insufficient for Gwent
Joint formulary inclusion and that other
preparations already available on the Formulary
were suitable for use in premature infants where
there were concerns over the use of sensitising
agents (such as lanolin).
In consideration of the evidence available and the
additional annual costs per patient involved, the
MTC agreed unanimously that bimatoprost 0.01%
eye drops should not be added to the ABHB Joint
Formulary. It was the Committee’s view that there
was insufficient evidence to support a clinically
meaningful advantage over the existing formulary
prostamide (bimatoprost 0.03%).
R19 The use of glucosamine or chondroitin
products is not recommended for the treatment of
osteoarthritis.
Co-careldopa intestinal gel (Duodopa®) should not
be recommended for use within NHS Wales for the
treatment of advanced levodopa-responsive
Parkinson’s disease. The clinical and cost
effectiveness data presented was not sufficient for
AWMSG to recommend its use.
The extent of the cost benefits over the existing
Gwent Joint Formulary options for the treatment of
major depressive episodes and social /
generalised anxiety disorders were not judged to
be sufficient.
The level of evidence (particularly the lack of
comparative trials against Evorel or Estraderm)
was insufficient for Gwent Joint formulary
inclusion. There was also a wide range of products
(inc. 4 patches) already included.
ABHB Joint Formulary (31 Jan 2012)
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Drug
Committe
e & date
11. Gamolenic acid
MCA/CS
M
Oct 2002
The product licences for Epogam and
Efamast, were withdrawn in October 2002.
Epogam and Efamast contain gamolenic
acid derived from evening primrose oil.
Epogam was licensed for the symptomatic
relief of atopic eczema in children and
adults and
Efamast was licensed to treat mastalgia.
The withdrawal followed a review by the
MCA/Committee on Safety of Medicines
(CSM) of all the relevant information, which
did not support the standard of efficacy
required for the authorisation of these
products as medicines for the treatment of
eczema and mastalgia.
NICE
CG59
Feb 2008
NICE
CG59
Feb 2008
GPMTC
Mar 2009
R19 The use of glucosamine or chondroitin
products is not recommended for the treatment of
osteoarthritis.
ABHB
MTC Jul
2011
NICE
TA203
Oct 2010
Insuficient patient-orientated evidence and an
unfavourable balance of additional cost versus
benefit (over existing Formulary LABAs).
(Epogam® &
Efamast®)
12. Glucosamine
(all salts)
13. Hyaluronic acid
14. Ibandronic acid
150mg tablet
(Bonviva®)
15. Indacaterol
(▼Onbrez
Breezhaler®)
16. Liraglutide
(Victoza®)
DOSES OF
1.8mg DAILY
ONLY
17. Mometasone
Furoate Dry
Powder
Twisthaler
(▼Asmanex®)
18. Nicotinic acid
M/R
(Niaspan®)
19. Olanzapine
depot
(ZypAdhera®)
GPMTC
Oct 2004
Detail of non-recommendation
Intra-articular hyaluronan injections are not
recommended for the treatment of osteoarthritis.
The level of evidence for hip fracture reduction and
the overall cost benefit for oral ibandronate did not
support its inclusion in the Gwent Joint Formulary.
NICE state: Taking into account the lack of clinical
trial evidence showing a significant benefit from
increasing the liraglutide dose from 1.2mg to
1.8mg, the widely varying ICERs and the
uncertainty in the economic analysis, the
Committee concluded that liraglutide 1.8mg would
not be a cost-effective use of NHS resources, and
therefore should not be recommended for the
treatment of type 2 diabetes.
Lack of substantial evidence of Asmanex’s
superiority to existing steroid inhalers on the
Gwent Joint Formulary.
GPMTC
Apr 2005
Limited studies published for Niaspan and its
poorer patient tolerance (compared to Omacor).
AWMSG
Oct 2010
Olanzapine depot (ZypAdhera®) is not
recommended for use within NHS Wales for
maintenance treatment of adult patients with
schizophrenia sufficiently stabilised during acute
treatment with oral olanzapine. The case for cost
effectiveness has not been proven
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ABHB Joint Formulary (31 Jan 2012)
Drug
20. Olopatadine
eye drops
(Opatanol®)
21. Omalizumab
(▼Xolair®)
Committe
e & date
Detail of non-recommendation
GPMTC
Aug 2004
Insufficient evidence of additional benefit over
existing preparations to approve Opatanol.
NICE
TA201
Oct 2010
GPMTC
Apr 2010
Omalizumab is not recommended for the treatment
of severe persistent allergic asthma in children
aged 6 to 11 years.
22. Oxycodone/nalo
xone
(▼Targinact®)
23. Reboxetine
(Edronax®)
ABHB
MTC
Jan 2011
Targinact® – see oxycodone
24. Tolterodine M/R
GPMTC
(Detrusitol
Jan 2006
XL®)
25. Tramacet®
May
(Tramadol +
2006
paracetamol)
Insufficient evidence (particularly the lack of any
study with an active comparator plus regular
laxative) and the unfavourable balance of cost
versus benefit.
A meta-analysis of published and unpublished
data on reboxetine for the acute treatment of major
depression found it, overall, to be an ineffective
and potentially harmful antidepressant. The
analysis included 13 acute treatment trials that
were placebo- or SSRI-controlled, or both and
included 4098 patients. Data on 74% (3033/4098)
of these patients were unpublished. In the
reboxetine versus placebo comparison, no
significant differences in remission rates were
shown (odds ratio 1.17, 95% confidence interval
0.91 to 1.51; P = 0.216).
Insufficient evidence for the benefit of M/R
tolterodine over the immediate release formulation.
Formulary application suspended by Chronic Pain
specialists in Gwent for cost-effectiveness reasons
DRUGS NO LONGER INCLUDED IN THE FORMULARY
Carteolol eye drops (Teoptic)
Oct.04
Danaparoid (Orgaran)
Dec.07
Dipivefrine eye drops (Propine)
Oct.04
Flurbiprofen (Froben)
Nov.04
Latanoprost with timolol eye drops (Xalacom)
Mai.07
Manesium glycerophosphate
ABHB Joint Formulary (31 Jan 2012)
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