Download March 2014 - NHS Ayrshire and Arran.

Area Drug & Therapeutics Committee
NHS Ayrshire & Arran Formulary Bulletin
March 2014
Edition
In this issue:
Dapagliflozin tablets (Forxiga®)
Fluocinolone acetonide intravitreal implant (Iluvien®)
Levonorgestrel 1500microgram tablet (Upostelle®)
Timolol eye gel for single-dose container (Tiopex®)
Ustekinumab solution for injection in pre-filled syringe (Stelara®)
Solifenacin succinate plus tamsulosin hydrochloride modified release tablet (Vesomni®)
Axitinib tablets (Inlyta®)
Crizotinib capsule (Xalkori®)
Enzalutamide capsules (Xtandi®)
SMC Not recommended for use medicines
Discontinued medicines
Area Drug & Therapeutic Committee updates
Medicines under review by ADTC
Medicines under review by FMG
Medicines under review by MRG
The following medicines were considered by the Formulary Management Group and Area Drug & Therapeutics
Committee (ADTC) and recommendations made regarding their use within primary and secondary care.
SMC
Number
SMC Accepted Medicine
Indication
(click on SMC number for more detailed advice)
799/12
resub
Dapagliflozin 5mg and
10mg film-coated tablets
(Forxiga®)
Use in adults aged 18 years and older with type 2
diabetes mellitus to improve glycaemic control in
combination with other glucose-lowering medicinal
products including insulin, when these, together with diet
and exercise, do not provide adequate glycaemic
control.
NHS Ayrshire &
Arran Formulary
Decision
Include
Consultant initiation
SMC restriction: In combination with insulin, when
insulin with diet and exercise, does not provide adequate
glycaemic control.
864/13
resub
938/14
941/14
Include
Pending protocol
Case by case form
requires to be
completed before
treatment initiation
Fluocinolone acetonide
190 micrograms
intravitreal implant
(Iluvien®)
Treatment of vision impairment associated with chronic
diabetic macular oedema, considered insufficiently
responsive to available therapies.
Levonorgestrel
1500microgram tablet
(Upostelle®)
Timolol, 1mg/g eye gel for
single-dose container
(Tiopex®)
Emergency contraception within 72 hours of unprotected
sexual intercourse or failure of a contraceptive method
Include
Reduction of the elevated intraocular pressure in
patients with:
- ocular hypertension,
- chronic open angle glaucoma.
Include
Specialist initiation
SMC restriction:
only in patients in whom the affected eye is
pseudophakic (has an artificial lens after cataract
surgery) and;
retreatment would take place only if the patient had
previously responded to treatment with fluocinolone
acetonide and subsequently best corrected visual
acuity had deteriorated to less than 20/32.
SMC restriction: to use in patients who have proven
sensitivity to preservatives.
NHS Ayrshire & Arran Formulary Bulletin, Medicines Utilisation Unit
March 2014
Page 1 of 5
944/14
Ustekinumab 45mg
solution for injection in
pre-filled syringe
(Stelara®)
Alone or in combination with methotrexate, for the
treatment of active psoriatic arthritis in adult patients
when the response to previous non-biological diseasemodifying anti-rheumatic drug therapy has been
inadequate.
SMC restriction: for use in patients with active psoriatic
arthritis who have failed on, or are unsuitable for,
treatment with an anti-TNF drug.
Include
Consultant initiation
Case by case form
requires to be
completed before
treatment initiation
945/14
Solifenacin succinate plus
tamsulosin hydrochloride
6mg / 0.4mg modified
release tablet (Vesomni®)
Treatment of moderate to severe storage symptoms
(urgency, increased micturition frequency) and voiding
symptoms associated with benign prostatic hyperplasia
in men who are not adequately responding to treatment
with monotherapy.
Include
855/13
resub
Axitinib, 1mg and 5mg,
film-coated tablets
(Inlyta®)
Treatment of adult patients with advanced renal cell
carcinoma (RCC) after failure of prior treatment with
sunitinib or a cytokine
865/13
resub
Crizotinib, 200mg and
250mg, hard capsule
(Xalkori®)
Treatment of adults with previously treated anaplastic
lymphoma kinase (ALK)-positive advanced non-small
cell lung cancer (NSCLC).
911/13
Enzalutamide 40mg soft
capsules (Xtandi®)
Treatment of adult men with metastatic castrationresistant prostate cancer (mCRPC) whose disease has
progressed on or after docetaxel therapy
Include
Consultant initiation
as per West of
Scotland Cancer
Network protocol
Include
Consultant initiation
as per West of
Scotland Cancer
Network protocol
Case by case form
must be completed
before prescribing
can be initiated
Include
Consultant initiation
as per West of
Scotland Cancer
Network protocol
Case by case form
must be completed
before prescribing
can be initiated
The following products have been not recommended for use in NHS Scotland and are excluded from the NHS Ayrshire
& Arran formulary. Click on SMC number for detailed SMC advice
Scottish Medicines Consortium advice: not recommended for use within NHS Scotland
Insulin degludec (Tresiba®) 100units/mL solution for injection in pre-filled pen or cartridge and
856/13
200units/mL solution for injection in pre-filled pen
resub
Treatment of diabetes mellitus in adults.
937/14
958/14
×
Exclude
Alogliptin, 25mg, 12.5mg, 6.25mg, film-coated tablets (Vipidia®)
Adults aged 18 years and older with type 2 diabetes mellitus to improve glycaemic control in combination
with other glucose lowering medicinal products including insulin, when these, together with diet and
exercise, do not provide adequate glycaemic control
Saxagliptin (Onglyza ®) 2.5mg & 5mg film-coated tablets
Monotherapy in adult patients aged 18 years and older with type 2 diabetes mellitus to improve
glycaemic control inadequately controlled by diet and exercise alone and for whom metformin is
inappropriate due to contraindications or intolerance.
ADTC Decision – exclude from the formulary
Implication for all A & A Prescribers - not for prescribing within NHS Ayrshire & Arran
Discontinued medicines
Non-formulary medicines
®
Doxapram (Dopram ) intravenous infusion
Forceval Junior capsules
®
Hydromol HC Intensive (Hydrocortisone 1%/Urea 10%) cream
Meted shampoo 3% and 5%
Pentrax shampoo 4.3%
NHS Ayrshire & Arran Formulary Bulletin, Medicines Utilisation Unit
March 2014
Page 2 of 5
Area Drug & Therapeutics Committee (ADTC) issues
1. Approved prescribing guidelines
The following guidelines have been approved by the ADTC and are available on the ADTC intranet section within
AthenA (accessed via AthenA front page → Prescribing guidelines)
Anaesthesia,
Surgery & Acute
Pain Service
Central nervous
system
Clinical
Decisions unit
Endocrine
system
Nutrition and
blood
Obstetrics,
gynaecology and
urinary tract
disorders
Rapid
tranquilisation
Respiratory
system
ADTC 66: Remifentanil PCA for labour analgesia guideline and patient information leaflet
(updated)
ADTC 76: Buccal Midazolam for Dental Use (updated)
ADTC 49: Renal Colic Pathway – treatment guideline (updated)
ADTC 235: Minor Upper GI Bleed Pathway – treatment guideline (new)
ADTC 100: Glucose/Potassium/Insulin (GKI) regimen in adults (≥16 years of age) guideline
and flow chart (updated)
ADTC 238: Guidelines for the management of Diabetes in Adult (non-obstetric) elective
surgical patients (updated)
ADTC 234: Protocol for the use of cinacalcet in secondary and tertiary hyperparathyroidism
(updated)
ADTC 106: Guideline for the use of Botulinum Toxin Type A (Botox®) in the management of
primary detrusor instability Refractory to medical treatment in adults (updated)
ADTC 237: Aspirin prophylaxis in patients at risk of pre-eclampsia (new)
ADTC 219: Rapid Tranquilisation: General Principles and Monitoring (new )
ADTC 220: Acute Hospital Wards: Rapid Tranquilisation of Adults (age 18-64 years) with
lorazepam (updated)
ADTC 221: Acute Hospital Wards: Rapid Tranquilisation of Adults (Age 18-64 years) with
midazolam (updated)
ADTC 222 Acute Hospital Wards: Rapid Tranquilisation of Older Adults (age 65 years and
over) with lorazepam (new)
ADTC 223: Acute Hospital Wards: Rapid Tranquilisation of Older Adults (age 65 years and
over) with midazolam (new)
ADTC 224: Mental Health Wards: Rapid Tranquilisation of Adults (age 18-64 years) with
lorazepam (updated)
ADTC 225: Mental Health Wards: Rapid Tranquilisation of Adults (age 18-64 years) with
midazolam (updated)
ADTC 226: Mental Health Wards: Rapid Tranquilisation of Older Adults (age 65 years and
over) with lorazepam (new)
ADTC 227 Mental Health Wards: Rapid Tranquilisation of Older Adults (age 65 years and
over) with midazolam (new)
ADTC 228 Community Settings (Psychiatric Emergency Plan): Rapid Tranquilisation of Adults
(age 18-64 years) with lorazepam (new)
ADTC 229 Community Settings (Psychiatric Emergency Plan): Rapid Tranquilisation of Adults
(age 18-64 years) with midazolam (new)
ADTC 230 Community Settings (Psychiatric Emergency Plan): Rapid Tranquilisation of Older
Adults (age 65 years and over) with lorazepam (new)
ADTC 231 Community Settings (Psychiatric Emergency Plan): Rapid Tranquilisation of Older
Adults (age 65 years and over) with midazolam (new)
ADTC 239: Protocol for home intravenous antibiotic therapy for the treatment of infective
exacerbations of bronchiectasis with ceftazidime, meropenem or piperacillin/tazobactam (new)
2. Guidelines removed from AthenA
The following prescribing guidelines have been removed from AthenA, after consultation with the authors:
Guideline/ protocol name
Shared care protocols for heart transplant –
azathioprine, ciclosporin, mycophenolate, tacrolimus
Transgender special prescribing agreements
ADTC20: Stop smoking guidance
Alternative/ rational for removal
Shared cares will be provided direct from tertiary centres
Replaced by National Gender Reassignment Protocol
Replaced with enhanced notes within formulary section
NHS Ayrshire & Arran Formulary Bulletin, Medicines Utilisation Unit
March 2014
Page 3 of 5
Medicines under review by Area Drug & Therapeutics Committee (ADTC)
NHS Ayrshire and Arran – Area Drug and Therapeutics Committee
The medicines listed below are still being considered by the ADTC. A final decision will be communicated in the
near future but in the meantime they are excluded from the NHS Ayrshire & Arran formulary
Dalteparin injection (Fragmin®) – extended treatment of venous thromboembolism and prevention of recurrence
in pts with a solid tumour (SMC 683/11)
Medicines under review by the Formulary Management Group
NHS Ayrshire and Arran – Formulary Management Group (FMG)
The medicines listed have been considered by the ADTC and their formulary status is currently being reviewed by
the FMG below. A final decision will be communicated in the near future but in the meantime they are excluded
from the NHS Ayrshire & Arran formulary.
Raltegravir tablets (Isentress®) – HIV (SMC 613/10)
Atazanavir capsules (Reyataz ) - HIV adults (SMC
520/08)
Rilpivirine tablets(Edurant®) – HIV (SMC 758/12)
Darunavir tablets (Prezista ) – HIV infection in antiretroviral naïve adults.(SMC 566/09),anti-retroviral
therapy experienced adult (SMC 707/11)
Darunavir tablets, suspension - co-administered with
Tenofovir tablets (Viread®) - hepatitis B (SMC 720/11)
low dose ritonavir in combination with other antiretroviral medicinal products for HIV- 1 infection in
paediatric patients 12 to 17 years (SMC 948/14)
Emtricitabine, tenofovir disoproxil, rilpivirine tablets
Zonisamide capsules (Zonegran®) - adjunctive therapy
(Eviplera®) – HIV (SMC 759/12)
of partial seizures, with or without secondary
generalisation in children ≥6 years (SMC 949/14)
Etravirine tablets (Intelence ) – HIV (SMC 530/09)
Medicines under review by the Medicines Resource Group
NHS Ayrshire & Arran: Medicines Resource Group (MRG)
The medicines listed below have been considered by the ADTC and are currently being considered by the
MRG. Recurring funding has not yet been identified for the medicine and a final decision on their formulary
status has not been made by the MRG. However the medicines listed below may be requested on a case by
case basis, according to SMC access criteria. Requests should be sent to the Director of Pharmacy for
consideration. Where it is intended to use the medicines out with SMC access criteria an Individual Patient
Treatment Request application must be completed
Afatinib tablets (Giotrif®) - as monotherapy, for the treatment of epidermal growth factor receptor tyrosine
kinase inhibitor-naïve adults with locally advanced or metastatic non-small cell lung cancer (SMC 920/13)
Aflibercept infusion (Zaltrap®) - in combination with irinotecan/5-fluorouracil/folinic acid (FOLFIRI)
chemotherapy, aflibercept is indicated in adults with metastatic colorectal cancer that is resistant to or has
progressed after an oxaliplatin-containing regimen (SMC 878/13 resubmission)
Lenalidomide capsules (Revlimid®) - patients with transfusion-dependent anaemia due to low- or
intermediate-1-risk myelodysplastic syndromes associated with an isolated deletion 5q cytogenetic
abnormality when other therapeutic options are insufficient or inadequate.(SMC 942/14)
Teriflunomide tablets (Aubagio®) – treatment of relapsing remitting multiple sclerosis (SMC 940/14)
SMC approved medicines available on a Case by case basis in NHS Ayrshire & Arran
Full list of all medicines which are available within NHS Ayrshire & Arran on a case by case basis according to
SMC criteria can be located on the Joint Formulary website (via NHS Ayrshire & Arran intranet). These can be
accessed via “Bulletin downloads and Area Drug & Therapeutics Committee minutes“, then click on “managed
entry of new drugs”.
Scottish Medicines Consortium – Medicines “Not Recommended for Use”
Full list of medicines which are not recommended for use within NHS Scotland for specific indications can be
located on the Joint Formulary website, located on the NHS Ayrshire & Arran intranet. These can be accessed
via “Bulletin downloads and Area Drug & Therapeutics Committee minutes “, then click on “managed entry of
new drugs”. For access to these medicines an Individual Patient Treatment Request must be completed.
For further information please refer to the SMC website www.scottishmedicines.org
NHS Ayrshire & Arran Formulary Bulletin, Medicines Utilisation Unit
March 2014
Page 4 of 5
Medicines launched, not yet reviewed and not for prescribing
The following are medicines that have been launched or have had an extension to their licensed indications but have
not as yet been considered by the ADTC. Since they have yet to be considered by the SMC, they are therefore NOT
recommended for prescribing within NHS Ayrshire & Arran until a decision is communicated from the ADTC. They
are however available on an Individual Patient Treatment Request application basis.
®
Aflibercept (Eylea ) intravitreal injection - macular
Latanoprost eye drops - children with elevated intraocular
oedema secondary to central retinal vein occlusion
pressure and glaucoma
®
®
Alogliptin/ metformin (Vipdomet ) tablets - type 2
Levocarnitine (Carnitor ) tablets - carnitine deficiency
diabetes mellitus
®
Aripiprazole (Abilify MAINTENA ) prolonged release
Levocarnitine 30% oral solution - primary and secondary
injection - maintenance treatment of schizophrenia
carnitine deficiency children, infants and newborns
®
®
Azithromycin (Zedbac ) infusion - community-acquired
Lidocaine/tetracaine (Pliaglis ) cream - surface
pneumonia and pelvic inflammatory disease
anaesthesia of skin in dermatological procedures
®
®
Bortezomib (Velcade ) - monotherapy or combination
Lubiprostone (Amitiza ) - chronic idiopathic constipation
therapy with pegylated liposomal doxorubicin or
dexamethasone to treat progressive multiple myeloma
®
®
Botulinum Toxin type A (Botox ) - lower limb toxicity –
Macitentan (Opsumit ) tablets - pulmonary arterial
ankle disability due to lower limb spasticity associated
hypertension
with stroke in adults
®
®
Botulinum Toxin type A (Botox ) - moderate to severe
Methotrexate (Metoject ) injection - mild to moderate
lateral canthal lines (crow’s feet)
Crohns disease (adults)
®
®
C1-Esterase inhibitor (Berinert ) – hereditary
Naltrexone (Adepend ) tablets - maintenance of
angioedema type I and II (acute episode)
abstinence in alcohol dependence
®
®
C1-Esterase inhibitor (Cinryze ) – hereditary
Natalizumab (Tysabri ) - relapsing-remitting multiple
angioedema (prophylaxis and acute episode)
sclerosis with high disease activity despite glatiramer
®
®
Canagliflozin (Invokana ) - type 2 diabetes mellitus
Paclitaxel (Abraxane ) infusion - metastatic
adenocarcinoma of the pancreas
®
®
Carmellose/ Glycerine (Optive ) eyedrops – dry eyes
Phenylephrine + tropicamide (Mydriasert ) Opthalmic
insert – diagnostic eye surgery
®
®
Certolizumab pegol (Cimzia ) - axial spondyloarthitis,
Pixantrone (Pixuvri ) - refractory or multiply relapsed
psoriatic arthritis
aggressive non Hodgkin B-cell lymphomas
®
®
Cobicistat (Tybost ) tablets - HIV infection (adults)
Pomalidomide (Imnovid ) capsules - relapsed and
refractory multiple myeloma
®
®
Dabrafib (Tafinlar ) capsules - monotherapy for
Pomatinib (Iclusig ) tablets - chronic phase, accelerated
unresectable or metastatic melanoma with a BRAF
phase or blast phase chronic myeloid leukaemia that are
V600 mutation
resistant/intolerant to dasatinib or nilotinib and also
Philadelphia chromosome positive acute lymphoblastic
leukaemia who are resistant to dasatinib
®
®
Dapoxetine (Priligy ) - diagnosed premature ejaculation Regorafenib (Stivarga ) tablets - metastatic colorectal
in adult men
cancer
®
Dasatinib (Sprycel ) - newly diagnosed Philadelphia
Sodium hydrogen carbonate/sodium dihydrogen
®
chromosome positive chronic myelogenous leukaemia
(Lecicarbon A ) suppositories - constipation and for bowel
in the chronic phase
clearance prior to surgical or diagnostic procedures
®
®
Diamorphine (Ayendi ) nasal spray - acute severe
Sofosbuvir (Sovaldi ) tablets - chronic hepatitis C
nociceptive pain (children and adolescents 2-15 years)
®
®
Dimethyl Fumarate (Tecfidera ) capsules - adults with
Somatropin (Humatrope ) injection – growth disturbance
relapsing-remitting multiple sclerosis
in short children. Growth failure associated with SHOX
deficiency
®
®
Dolutegravir (Tivicay ) 50mg f/c tablets - HIV infected
Temsirolimus (Torisel ) infusion – advanced renal cell
adults and adolescents above 12 years of age
cancer
®
®
Doripenem (Doribax ) injection –complicated UTIs
Tetrabenazine (Tetmodis ) tabs - hyperkinetic motor
disorders with Huntington’s chorea
®
Doxycycline (Efracea ) capsules – treatment of rosacea Topotecan injection - metastatic ovarian carcinoma
(monotherapy)
®
®
Elvitegravir (Viteka ) tablets – HIV-1
Trastuzumab emtansine (Kadcyla ) infusion - HER2positive, unresectable locally advanced or metastatic
breast cancer who previously received trastuzumab and a
taxane, separately or in combination
®
Glatiramer (Copaxone®) inj – treatment of first episode
Travoprost (Travatan ) eye drops - benzalkonium chloride
and those at high risk of developing multiple sclerosis
free multidose formulation
®
Ipilimumab (Yervoy ) - first line treatment of adults with
advanced (unresectable or metastatic) melanoma
NHS Ayrshire & Arran Formulary Bulletin, Medicines Utilisation Unit
March 2014
Page 5 of 5