NHS Ayrshire & Arran Formulary Bulletin - NHS Ayrshire and Arran.
NHS Ayrshire & Arran Formulary Bulletin - NHS Ayrshire and Arran.
NHS Ayrshire & Arran Formulary Bulletin - NHS Ayrshire and Arran.
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Area Drug & Therapeutics Committee<br />
August &<br />
September 2011<br />
<strong>NHS</strong> <strong>Ayrshire</strong> & <strong>Arran</strong> <strong>Formulary</strong> <strong>Bulletin</strong><br />
In this issue:<br />
• Alzheimer’s disease medicines<br />
• Filgrastim injection (Zarzio®)<br />
• Retigabine tablets (Trobalt®)<br />
• Methotrexate prefilled syringes (Metoject®)<br />
• Histrelin acetate implant (Vantas®)<br />
• Degarelix injection (Firmagon®)<br />
• Triptorelin injection (Decapeptyl SR®)<br />
• Rivaroxaban tablets (Xarelto®)<br />
• Bemiparin injection (Zibor®)<br />
• Tapentadol prolonged-release tablets (Palexia® SR)<br />
• Calcium, cholecalciferol tablets (Kalcipos-D 500mg/800 IU chewable tablets®)<br />
• Golimumab injection (Simponi ®)<br />
• SMC Not recommended for use medicines<br />
• Discontinued preparations<br />
• Area Drug & Therapeutic Committee updates<br />
• Medicines under review by AMT<br />
• Medicines under review by FMG<br />
• Medicines under review by MRG<br />
Endorsement of these decisions will be obtained at the November 2011 Area Drug & Therapeutics Committee<br />
(ADTC) meeting.<br />
NICE TA217: Donepezil, galantamine, rivastigmine <strong>and</strong> memantine for the treatment of Alzheimer’s<br />
disease<br />
The guidance issued by NICE in March 2011 <strong>and</strong> the SMC advice issued on galantamine, memantine <strong>and</strong><br />
rivastigamine with regards Alzheimer’s disease has therefore been superceded. These recommend:<br />
1. The three acetylcholinesterase (AChE) inhibitors donepezil, galantamine <strong>and</strong> rivastigmine are<br />
recommended as options for managing mild to moderate Alzheimer’s disease under all of the conditions<br />
specified in 3 <strong>and</strong> 4.<br />
2. Memantine is recommended as an option for managing Alzheimer’s disease for people with:<br />
• moderate Alzheimer’s disease who are intolerant of or have a contraindication to AChE inhibitors or<br />
• severe Alzheimer’s disease<br />
3. Treatment should be under the following conditions:<br />
• Only specialists in the care of patients with dementia (that is, psychiatrists including those<br />
specialising in learning disability, neurologists, <strong>and</strong> physicians specialising in the care of older<br />
people) should initiate treatment. Carers’ views on the patient’s condition at baseline should be<br />
sought<br />
• Treatment should be continued only when it is considered to be having a worthwhile effect on<br />
cognitive, global, functional or behavioural symptoms.<br />
• Patients who continue on treatment should be reviewed regularly using cognitive, global, functional<br />
<strong>and</strong> behavioural assessment. Treatment should be reviewed by an appropriate specialist team,<br />
unless there are locally agreed protocols for shared care. Carers’ views on the patient’s condition at<br />
follow-up should be sought<br />
If prescribing an AChE inhibitor (donepezil, galantamine or rivastigmine), treatment should normally be<br />
started with the drug with the lowest acquisition cost (taking into account required daily dose <strong>and</strong> the price<br />
per dose once shared care has started). However, an alternative AChE inhibitor could be prescribed if it is<br />
considered appropriate when taking into account adverse event profile, expectations about adherence,<br />
medical comorbidity, possibility of drug interactions <strong>and</strong> dosing profiles<br />
√<br />
Include<br />
(restricted)<br />
ADTC Decision – galantamine, memantine <strong>and</strong> rivastigmine are include in the formulary for<br />
consultant initiation, as per NICE TAG217<br />
Implication for all A & A Prescribers - for Consultant initiation within <strong>NHS</strong> <strong>Ayrshire</strong> & <strong>Arran</strong>,<br />
as per NICE TAG217.<br />
<strong>NHS</strong> <strong>Ayrshire</strong> & <strong>Arran</strong> <strong>Formulary</strong> <strong>Bulletin</strong>, Medicines Utilisation Unit August & September 2011 Page 1 of 8
The following products have been recommended for use in <strong>NHS</strong> Scotl<strong>and</strong> <strong>and</strong> included in the <strong>NHS</strong> <strong>Ayrshire</strong><br />
& <strong>Arran</strong> formulary for specialist consultant initiation.<br />
704/11 Filgrastim, 30 million units (300 micrograms)/0.5mL, 48 million units (480<br />
micrograms)/0.5mL, solution for injection or infusion in pre-filled syringe (Zarzio®)<br />
Reduction in the duration of neutropenia <strong>and</strong> the incidence of febrile neutropenia in patients<br />
treated with established cytotoxic chemotherapy for malignancy (with the exception of chronic<br />
myeloid leukaemia <strong>and</strong> myelodysplastic syndromes) <strong>and</strong> reduction in the duration of<br />
neutropenia in patients undergoing myeloablative therapy followed by bone marrow<br />
transplantation considered to be at increased risk of prolonged severe neutropenia. The safety<br />
<strong>and</strong> efficacy of filgrastim are similar in adults <strong>and</strong> children receiving cytotoxic chemotherapy.<br />
· Mobilisation of peripheral blood progenitor cells (PBPC).<br />
· In children <strong>and</strong> adults with severe congenital, cyclic, or idiopathic neutropenia with an<br />
absolute neutrophil count (ANC) of ≤ 0.5 x 109/l, <strong>and</strong> a history of severe or recurrent<br />
infections, long term administration of filgrastim is indicated to increase neutrophil counts<br />
<strong>and</strong> to reduce the incidence <strong>and</strong> duration of infection-related events.<br />
· Treatment of persistent neutropenia (ANC ≤ 1.0 x 109/l) in patients with advanced HIV<br />
infection, in order to reduce the risk of bacterial infections when other therapeutic options are<br />
inappropriate.<br />
Filgrastim (Zarzio®) is a biosimilar product to a reference granulocyte colony stimulating factor,<br />
filgrastim (Neupogen®). The British National <strong>Formulary</strong> advises that it is good practice to<br />
prescribe biological medicinal products by br<strong>and</strong> name.<br />
Other granulocyte colony stimulating factor products are available at lower cost.<br />
712/11 Retigabine, 50mg, 100mg, 200mg, 300mg <strong>and</strong> 400mg film-coated tablets<br />
(Trobalt®)<br />
Indication under review: Adjunctive treatment of partial onset seizures with or without<br />
secondary generalisation in adults aged 18 years <strong>and</strong> above with epilepsy.<br />
SMC restriction: patients with refractory epilepsy. Treatment should be initiated only by<br />
physicians who have appropriate experience in the treatment of epilepsy.<br />
In two placebo-controlled studies in patients with refractory epilepsy retigabine was superior to<br />
placebo in terms of the proportion of patients experiencing ≥ 50% reduction in partial seizure<br />
frequency per 28 days. An indirect comparison indicates that retigabine has similar efficacy to<br />
two other antiepileptic drugs used as adjunctive therapy.<br />
724/11 Methotrexate 50mg/mL solution for injection (Metoject®) prefilled syringes 12.5mg,<br />
17.5mg, 22.5mg, 27.5mg <strong>and</strong> 30mg<br />
Indication under review: polyarthritic forms of severe active juvenile idiopathic arthritis, when<br />
the response to non-steroidal anti-inflammatory drugs has been inadequate.<br />
For patients in whom treatment with disease modifying drugs is indicated <strong>and</strong> parenteral<br />
administration of methotrexate is appropriate, this adds to the range of pre filled syringes<br />
available.<br />
The Scottish Medicines Consortium has previously accepted methotrexate for the treatment of<br />
severe active rheumatoid arthritis in adult patients where treatment with disease modifying<br />
drugs is indicated. Methotrexate injection is listed in the British National <strong>Formulary</strong> for Children<br />
2010 -11 for the treatment of juvenile idiopathic arthritis.<br />
√<br />
Include<br />
(restricted)<br />
ADTC Decision – include in the formulary for specialist consultant initiation, as per any SMC<br />
restrictions<br />
Implication for all A & A Prescribers - for prescribing within <strong>NHS</strong> <strong>Ayrshire</strong> & <strong>Arran</strong>, on the<br />
recommendations of a consultant<br />
<strong>NHS</strong> <strong>Ayrshire</strong> & <strong>Arran</strong> <strong>Formulary</strong> <strong>Bulletin</strong>, Medicines Utilisation Unit August & September 2011 Page 2 of 8
The following products have been recommended for use in <strong>NHS</strong> Scotl<strong>and</strong> <strong>and</strong> included in the <strong>NHS</strong> <strong>Ayrshire</strong><br />
& <strong>Arran</strong> formulary for consultant initiation, as per the West of Scotl<strong>and</strong> Cancer Network (WoSCAN) Prostate<br />
Cancer Guidelines.<br />
557/09 Histrelin acetate, 50mg subcutaneous implant (Vantas®)<br />
For palliative treatment of advanced prostate cancer. Histrelin is restricted to use in patients<br />
with an anticipated life expectancy of at least one year in whom annual administration will offer<br />
advantages.<br />
In a single-arm study, histrelin provided effective suppression of testosterone levels in patients<br />
with advanced prostate cancer. It requires less frequent administration than other leutenising<br />
hormone releasing hormone (LHRH) agonists. Other LHRH agonists are available at a lower<br />
acquisition cost.<br />
560/09<br />
Resubmission<br />
Degarelix 120mg <strong>and</strong> 80mg powder <strong>and</strong> solvent for solution for injection (Firmagon®)<br />
Indication under review: degarelix is a gonadotropin-releasing hormone (GnRH) antagonist<br />
indicated for the treatment of adult male patients with advanced hormone-dependent prostate<br />
cancer.<br />
In one study that included patients with all stages of prostate cancer, degarelix was shown to<br />
be non-inferior to a luteinising hormone releasing hormone (LHRH) agonist in suppressing<br />
testosterone levels over a one year treatment period without an initial testosterone flare.<br />
This SMC advice takes account of the benefits of a patient access scheme (PAS) that<br />
improves the cost-effectiveness of degarelix. This SMC advice is contingent upon the<br />
continuing availability of the patient access scheme in <strong>NHS</strong> Scotl<strong>and</strong>.<br />
705/11 Triptorelin (Decapeptyl SR®) 22.5mg powder <strong>and</strong> solvent for suspension for injection<br />
Indication under review:<br />
· Treatment of patients with locally advanced, non-metastatic prostate cancer, as an<br />
alternative to surgical castration.<br />
· Treatment of metastatic prostate cancer.<br />
√<br />
Include<br />
(restricted)<br />
This new preparation of triptorelin allows 6-monthly administration (as triptorelin pamoate in a<br />
22.5mg dose). Triptorelin 11.25mg (as acetate) is administered every 3 months <strong>and</strong> has<br />
previously been accepted by SMC. Bioequivalence of the pamoate <strong>and</strong> acetate salts has been<br />
demonstrated <strong>and</strong> the new preparation is cost neutral.<br />
Note: The indication for triptorelin 11.25mg formulation was reworded in 2007 to achieve<br />
consistency Europe-wide <strong>and</strong> now reads as per the indication for triptorelin 22.5mg<br />
ADTC Decision – include in the formulary for consultant initiation, as per WoSCAN Prostate<br />
Cancer Guidelines<br />
Implication for all A & A Prescribers - for prescribing within <strong>NHS</strong> <strong>Ayrshire</strong> & <strong>Arran</strong>, on the<br />
recommendations of a consultant<br />
Rivaroxaban 10mg film-coated tablets (Xarelto®)<br />
Indication<br />
Prevention of venous thromboembolism (VTE) in adult patients undergoing elective hip or knee replacement<br />
surgery.<br />
Comment<br />
Scottish Medicines Consortium No 519/08: accepted for use within <strong>NHS</strong> Scotl<strong>and</strong><br />
In three large phase III studies in patients undergoing either total knee or total hip replacement surgery,<br />
rivaroxaban was superior to low molecular weight heparin in reducing the incidence of VTE <strong>and</strong> all cause<br />
mortality with patients while having a similar incidence of major bleeding events.<br />
√<br />
restricted<br />
ADTC Decision – include in formulary for initiation as per <strong>NHS</strong> <strong>Ayrshire</strong> & <strong>Arran</strong> orthopaedic<br />
thromboprophylaxis guidelines<br />
Implication for all <strong>NHS</strong> A & A Prescribers – for prescribing within <strong>NHS</strong> <strong>Ayrshire</strong> & <strong>Arran</strong> as per<br />
orthopaedic thromboprophylaxis guidelines<br />
<strong>NHS</strong> <strong>Ayrshire</strong> & <strong>Arran</strong> <strong>Formulary</strong> <strong>Bulletin</strong>, Medicines Utilisation Unit August & September 2011 Page 3 of 8
The following products have been recommended for use in <strong>NHS</strong> Scotl<strong>and</strong> <strong>and</strong> excluded from the <strong>NHS</strong><br />
<strong>Ayrshire</strong> & <strong>Arran</strong> formulary.<br />
Scottish Medicines Consortium advice: recommended for use within <strong>NHS</strong> Scotl<strong>and</strong><br />
Bemiparin 3,500 IU in 0.2ml solution for injection in prefilled<br />
syringes (Zibor®)<br />
204/05<br />
Resubmission<br />
654/10<br />
Resubmission<br />
For the prevention of thromboembolic disease in patients undergoing orthopaedic surgery.<br />
Bemiparin was associated with a lower incidence of thromboembolic complications than<br />
unfractionated heparin <strong>and</strong> was non-inferior to another low molecular weight heparin.<br />
Tapentadol, 50, 100, 150, 200 <strong>and</strong> 250mg prolonged-release tablets (Palexia® SR)<br />
Indication under review: the management of severe chronic pain in adults, which can be<br />
adequately managed only with opioid analgesics.<br />
SMC restriction: patients in whom morphine sulphate modified release has failed to provide<br />
adequate pain control or is not tolerated.<br />
Results of a meta-analysis of three, 12-week studies suggest that tapentadol prolonged release<br />
has improved gastrointestinal tolerability <strong>and</strong> similar efficacy compared to another long-acting<br />
opioid included as an active control.<br />
The manufacturer’s submission related only to the use of tapentadol prolonged release in<br />
severe chronic pain. SMC has not yet received a submission for tapentadol immediate release<br />
tablets for the relief of moderate to severe acute pain in adults, which can be adequately<br />
managed only with opioid analgesics. Tapentadol immediate release tablets are not<br />
recommended for use in <strong>NHS</strong> Scotl<strong>and</strong>.<br />
718/11 Calcium carbonate equivalent to 500mg calcium, cholecalciferol (vitamin D3) 800 IU (20<br />
microgram) tablets (Kalcipos-D 500mg/800 IU chewable tablets®)<br />
Indications under review:<br />
• Prevention <strong>and</strong> treatment of calcium <strong>and</strong> vitamin D deficiency in the elderly<br />
• Vitamin D <strong>and</strong> calcium supplement in addition to specific osteoporosis treatment of patients<br />
who are at risk of vitamin D <strong>and</strong> calcium deficiency.<br />
This is a new combination product with a different ratio of calcium to cholecalciferol than<br />
alternative combination preparations. It is a similar price to an alternative product containing<br />
800IU of cholecalciferol per tablet but is more expensive than some other calcium <strong>and</strong><br />
cholecalciferol combinations. Any overall budget impact is likely to be small<br />
721/11 Golimumab 50mg solution for injections prefilled pen (auto-injector) or pre-filled syringe<br />
(Simponi ®)<br />
Indication under review: Treatment of severe, active ankylosing spondylitis in adult patients<br />
who have responded inadequately to conventional therapy.<br />
SMC restriction: golimumab is restricted to use in accordance with the British Society for<br />
Rheumatology (BSR) guidelines for anti-TNF_ agents in adults with ankylosing spondylitis.<br />
Golimumab is restricted to use at a dose of 50mg only.<br />
In a placebo controlled study golimumab 50mg <strong>and</strong> 100mg were superior to placebo given<br />
every four weeks in terms of the proportion of patients who achieved at least 20% improvement<br />
in the Assessment in AS International Working group Criteria at week 14. An indirect<br />
comparison indicates that golimumab has similar efficacy to two other anti-TNF-α agents used<br />
in the treatment of ankylosing spondylitis.<br />
The economic case was demonstrated for golimumab when used at a dose of 50mg. The<br />
economic case was not demonstrated for the 100mg dose of golimumab.<br />
×<br />
Exclude<br />
ADTC Decision – exclude from the formulary<br />
Implication for all A & A Prescribers - not for prescribing within <strong>NHS</strong> <strong>Ayrshire</strong> & <strong>Arran</strong><br />
<strong>NHS</strong> <strong>Ayrshire</strong> & <strong>Arran</strong> <strong>Formulary</strong> <strong>Bulletin</strong>, Medicines Utilisation Unit August & September 2011 Page 4 of 8
The following products have not been recommended for use in <strong>NHS</strong> Scotl<strong>and</strong> <strong>and</strong> are therefore excluded<br />
from the <strong>NHS</strong> <strong>Ayrshire</strong> & <strong>Arran</strong> formulary.<br />
Scottish Medicines Consortium advice: not recommended for use within <strong>NHS</strong> Scotl<strong>and</strong><br />
647/10<br />
resubmission<br />
Glucosamine sulphate 1,500mg powder for oral solution (Glusartel®)<br />
Relief of symptoms in mild to moderate osteoarthritis of the knee.<br />
In a placebo- <strong>and</strong> active-comparator study, glucosamine sulphate 1,500mg once daily was<br />
significantly better than placebo in the treatment of symptoms associated with osteoarthritis of<br />
the knee.<br />
Overall the submitting company did not present a sufficiently robust clinical <strong>and</strong> economic<br />
analysis to gain acceptance by SMC<br />
715/11 Collagenase clostridium histolyticum 0.9mg powder <strong>and</strong> solvent for solution for<br />
injection (Xiapex®)<br />
Treatment of Dupuytren’s contracture in adult patients with a palpable cord.<br />
Collagenase clostridium histolyticum compared to placebo significantly reduces primary joint<br />
contracture in adults with Dupuytren’s contracture <strong>and</strong> a palpable cord.<br />
The submitting company did not present a sufficiently robust economic analysis to gain<br />
acceptance by SMC.<br />
729/11 Glucosamine sulphate (Dolenio®)<br />
Symptomatic treatment of mild to moderate osteoarthritis (OA) of the knee.<br />
The holder of the marketing authorisation has not made a submission to SMC regarding this<br />
product in this indication. As a result we cannot recommend its use within <strong>NHS</strong>Scotl<strong>and</strong>.<br />
730/11 Bilastine (Ilaxten®)<br />
Symptomatic treatment of allergic rhino-conjunctivitis (seasonal <strong>and</strong> perennial) <strong>and</strong> urticaria.<br />
The holder of the marketing authorisation has not made a submission to SMC regarding this<br />
product in this indication. As a result we cannot recommend its use within <strong>NHS</strong>Scotl<strong>and</strong>..<br />
719/11 Abatacept 250mg powder for concentrate for solution for infusion (Orencia ® )<br />
In combination with methotrexate, for the treatment of moderate to severe active rheumatoid<br />
arthritis in adult patients who responded inadequately to previous therapy with one or more<br />
disease-modifying anti-rheumatic drugs including methotrexate or a tumour necrosis factor<br />
(TNF)-alpha inhibitor.<br />
There is no head to head study comparing abatacept with other biologic or conventional<br />
disease-modifying anti-rheumatic drugs. In combination with methotrexate, abatacept reduced<br />
the progression of joint damage <strong>and</strong> improved physical function more than placebo in patients<br />
with moderate to severe rheumatoid arthritis who responded inadequately to previous therapy<br />
with methotrexate alone.<br />
The submitting company’s justification of the treatment’s cost in relation to its health benefits<br />
was not sufficient <strong>and</strong> in addition, the company did not present a sufficiently robust economic<br />
analysis to gain acceptance by SMC.<br />
×<br />
Exclude<br />
ADTC Decision – exclude from the formulary<br />
Implication for all A & A Prescribers - not for prescribing within <strong>NHS</strong> <strong>Ayrshire</strong> & <strong>Arran</strong><br />
Discontinued Preparations<br />
Non-formulary items<br />
Cortisone acetate 25mg tablets<br />
Digibind injection<br />
Predsol-N eye drops <strong>and</strong> ear drops<br />
Area Drug & Therapeutics Committee (ADTC) issues<br />
The following guidelines have been approved by the ADTC <strong>and</strong> are available on the ADTC intranet section<br />
within AthenA (accessed via AthenA home page → Policies <strong>and</strong> patient information tab → Drug &<br />
Therapeutic clinical guidelines, or electronically below)<br />
ADTC 130: Guidelines for the management of constipation (adults) (new guideline))<br />
<strong>Formulary</strong> updates<br />
• Movicol® oral powder has been replaced with Laxido® Orange oral powder as the br<strong>and</strong> of choice on<br />
the <strong>NHS</strong> <strong>Ayrshire</strong> & <strong>Arran</strong> formulary.<br />
• <strong>Formulary</strong> position of Movicol® Half <strong>and</strong> Movicol® Paediatric Plain oral powders remain unaffected.<br />
<strong>NHS</strong> <strong>Ayrshire</strong> & <strong>Arran</strong> <strong>Formulary</strong> <strong>Bulletin</strong>, Medicines Utilisation Unit August & September 2011 Page 5 of 8
Medicines under review by Area Drug & Therapeutics Committee (ADTC)<br />
<strong>NHS</strong> <strong>Ayrshire</strong> <strong>and</strong> <strong>Arran</strong> – Area Drug <strong>and</strong> Therapeutics Committee<br />
The medicines listed below are still being considered by the ADTC. A final decision will be communicated in<br />
the near future but in the meantime they are excluded from the <strong>NHS</strong> <strong>Ayrshire</strong> & <strong>Arran</strong> formulary<br />
Dalteparin sodium injection (Fragmin ® ) – extended<br />
treatment of symptomatic venous thromboembolism<br />
<strong>and</strong> prevention of its recurrence in patients with solid<br />
tumour (SMC 683/11)<br />
Urokinase (Syner-KINASE ® ) – lysis of blood clots<br />
Antimicrobial Management Team<br />
<strong>NHS</strong> <strong>Ayrshire</strong> <strong>and</strong> <strong>Arran</strong> – Antimicrobial Management Team (AMT)<br />
The medicines listed below are still being considered by the AMT. A final decision will be communicated in<br />
the near future but in the meantime they are excluded from the <strong>NHS</strong> <strong>Ayrshire</strong> & <strong>Arran</strong> formulary<br />
Moxifloxacin injection (Avelox ® ) – community<br />
acquired pneumonia (SMC 650/10)<br />
Temocillin (Negaban ® ) inj. – treatment of<br />
septicaemia, urinary tract <strong>and</strong> lower respiratory tract<br />
infections<br />
Medicines under review by the <strong>Formulary</strong> Management Group<br />
<strong>NHS</strong> <strong>Ayrshire</strong> <strong>and</strong> <strong>Arran</strong> – <strong>Formulary</strong> Management Group (FMG)<br />
The medicines listed below have been considered by the ADTC <strong>and</strong> their formulary status is currently being<br />
reviewed by the FMG. A final decision will be communicated in the near future but in the meantime they are<br />
excluded from the <strong>NHS</strong> <strong>Ayrshire</strong> & <strong>Arran</strong> formulary.<br />
Alteplase (Actilyse Cathflo®) injection – thrombolytic<br />
treatment of occluded central venous access devices<br />
(SMC 717/11)<br />
Atazanavir (Reyataz ® ) capsules - HIV adults (SMC<br />
520/08), children (SMC 656/10)<br />
Atomoxetine (Strattera ® ) capsules – ADHD (children<br />
≥6 years & adolescents (SMC 153/05)<br />
Botulinum toxin type A injection (Botox ® ) – focal<br />
spasticity associated with stroke (SMC 80/03)<br />
Brinzolamide/timolol (Azarga ® ) eye drop- open-angle<br />
glaucoma or ocular hypertension (SMC 568/09)<br />
Capecitabine (Xeloda®) tablets - adjuvant treatment<br />
of stage III (Dukes stage C) colon cancer in<br />
combination with oxaliplatin (SMC 716/11)<br />
Darunavir (Prezista ® ) tablets – HIV infection in<br />
antiretroviral naïve adults.(SMC 566/09), highly<br />
pretreated children <strong>and</strong> adolescents (SMC 604/10),<br />
HIV in antiretroviral therapy experienced adults<br />
(SMC 707/11)<br />
Denosumab injection (Prolia ® ) – osteoporosis in<br />
postmenopausal women (SMC 651/10)<br />
Enoxaparin (Clexane ® ) syringes/ multidose vials –<br />
treatment of STEMI (SMC 380/07)<br />
Etravirine (Intelence ® ) tablets – HIV (SMC 530/09)<br />
Fentanyl (Instanyl ® ) nasal spray – breakthrough pain<br />
in adults on maintenance opioid therapy for chronic<br />
cancer pain. (SMC 579/09)<br />
Fentanyl (PecFent ® ) nasal spray – breakthrough pain<br />
in adults on maintenance opioid therapy for chronic<br />
cancer pain. (SMC 663/10)<br />
Ferric carboxymaltose (Ferinject ® ) - iron deficiency<br />
anaemia (haemodialysis pts excluded) (SMC 463/08)<br />
Fosamprenavir (Telzir ® ) suspension <strong>and</strong> tablets<br />
(SMC 431/07)<br />
Fosaprepitant dimeglumine infusion (IVEmend ® ) -<br />
prevention of acute <strong>and</strong> delayed nausea <strong>and</strong><br />
vomiting associated with cisplatin-based<br />
chemotherapy (SMC 678/11)<br />
Iron isomaltoside 1000 (Monofer ® ) – iron deficiency<br />
anaemia (haemodialysis pts excluded) (SMC 697/11)<br />
Lamivudine/zidovudine (Combivir ® ) – HIV-1 in<br />
paediatric patients (SMC 569/09)<br />
Methylphenidate (Equasym XL ® & Medikinet XL ®<br />
br<strong>and</strong>s) – ADHD (SMC 99/04 <strong>and</strong> 388/07)<br />
Prasugrel (Efient ® ) tablets – prevention of atherothrombotic<br />
events in patients with ACS or STEMI<br />
undergoing or delayed PCI (SMC 562/09)<br />
Prilocaine hydrochloride (Priloketal ® ) hyperbaric<br />
solution – spinal anaesthesia (SMC 665/10)<br />
Raltegravir tablets (Isentress ® ) – HIV in adults (SMC<br />
613/10)<br />
Sildenafil citrate injection (Revatio ® ) – pulmonary<br />
arterial hypertension (SMC 688/11)<br />
Tacrolimus ointment – maintenance in atopic<br />
eczema in children (SMC 608/10) <strong>and</strong> adults (SMC<br />
609/10)<br />
Tenofovir disoproxil tablet (Viread ®) chronic<br />
hepatitis B (SMC 720/10)<br />
Tipranavir (Aptivus ® ) -HIV-1 infection oral solution<br />
(SMC 602/10), soft capsules (SMC 616/10)<br />
<strong>NHS</strong> <strong>Ayrshire</strong> & <strong>Arran</strong> <strong>Formulary</strong> <strong>Bulletin</strong>, Medicines Utilisation Unit August & September 2011 Page 6 of 8
Medicines under review by the Medicines Resource Group<br />
<strong>NHS</strong> <strong>Ayrshire</strong> & <strong>Arran</strong>: Medicines Resource Group (MRG)<br />
The medicines listed below have been considered by the ADTC <strong>and</strong> are currently being considered by the<br />
MRG. Recurring funding has not yet been identified for the medicine <strong>and</strong> a final decision on their formulary<br />
status has not been made by the MRG. However the medicines listed below may be requested on a case<br />
by case basis, according to SMC access criteria. Requests should be sent to the Director of Pharmacy for<br />
consideration. Where it is intended to use the medicines out with SMC access criteria an exceptional case<br />
application must be completed <strong>and</strong> sent to the Medical Director for consideration.<br />
Most relevant to Primary Care:<br />
• None<br />
Most relevant to Secondary Care:<br />
• Azacitidine injection (Vidaza®) - treatment of adult patients who are not eligible for haematopoietic stem<br />
cell transplantation with; intermediate-2 <strong>and</strong> high-risk myelodysplastic syndrome, chronic<br />
myelomonocytic leukaemia or acute myeloid leukaemia (SMC 589/09)<br />
• Bendamustine hydrochloride infusion (Levact ® ) – first-line treatment of chronic lymphocytic leukaemia<br />
(Binet stage B or C) in patients fludarabine combination chemotherapy is not appropriate (SMC 694/11)<br />
• Betaine anhydrous oral powder (Cystadane ® ) - adjunctive treatment of homocystinuria involving<br />
deficiencies or defects in cystathionine beta-synthase, 5,10-methylene-tetrahydrofolate reductase or<br />
cobalamin cofactor metabolism (SMC 407/07)<br />
• Dabigatran etexilate capsules (Pradaxa ® ) - prevention of stroke <strong>and</strong> systemic embolism in patients with<br />
non-valvular atrial fibrillation (SMC 672/11)<br />
• Etanercept (Enbrel ® ) – chronic severe plaque psoriasis in children <strong>and</strong> adolescents (SMC 570/09)<br />
• Febuxostat tablets (Adenuric ® ) – chronic hyperuricaemia (SMC 637/10)<br />
• Mifamurtide infusion (Mepact®) - in combination with post-operative multi-agent chemotherapy for the<br />
treatment of high-grade resectable non-metastatic osteosarcoma (SMC 621/10)<br />
• Nilotinib capsules (Tasigna®) – treatment of adults with newly diagnosed Philadelphia chromosome<br />
positive chronic myelogenous leukaemia in the chronic phase (SMC 709/11)<br />
• Pazopanib tablets (Votrient ® ) – first line treatment of advanced renal cell carcinoma (SMC 676/11)<br />
• Rituximab infusion (MabThera ® ) – maintenance therapy in patients with follicular lymphoma responding<br />
to induction therapy (SMC 675/11)<br />
• Sunitinib capsules (Sutent ® ) – unresectable or metastatic, well-differentiated pancreatic neuroendocrine<br />
tumours with disease progression (SMC 698/11)<br />
• Ticagrelor tablets (Brilique ® ) - prevention of atherothrombotic events in adults with acute coronary<br />
syndromes (unstable angina, non ST elevation myocardial infarction or ST elevation myocardial<br />
infarction) (SMC 699/11)<br />
SMC approved medicines available on a Case by case or Exceptional case basis in <strong>NHS</strong> <strong>Ayrshire</strong> &<br />
<strong>Arran</strong><br />
Full updated lists of all the medicines which are available within <strong>NHS</strong> <strong>Ayrshire</strong> & <strong>Arran</strong> on a case by case<br />
basis according to SMC criteria or on an exceptional case basis can be located on the Joint <strong>Formulary</strong><br />
website, located on the <strong>NHS</strong> <strong>Ayrshire</strong> & <strong>Arran</strong> intranet. These can be accessed via “<strong>Bulletin</strong> downloads<br />
<strong>and</strong> Area Drug & Therapeutics Committee minutes “, then click on “managed entry of new drugs”.<br />
For further information please refer to the SMC website www.scottishmedicines.org<br />
Scottish Medicines Consortium – Medicines “Not Recommended for Use”<br />
A full updated list of medicines which are not recommended for use within <strong>NHS</strong> Scotl<strong>and</strong> for specific<br />
indications can be located on the Joint <strong>Formulary</strong> website, located on the <strong>NHS</strong> <strong>Ayrshire</strong> & <strong>Arran</strong> intranet.<br />
These can be accessed via “<strong>Bulletin</strong> downloads <strong>and</strong> Area Drug & Therapeutics Committee minutes “, then<br />
click on “managed entry of new drugs”. For access to these medicines an exceptional case application must<br />
be completed <strong>and</strong> sent to the Medical Director for consideration.<br />
For further information please refer to the SMC website www.scottishmedicines.org<br />
<strong>NHS</strong> <strong>Ayrshire</strong> & <strong>Arran</strong> <strong>Formulary</strong> <strong>Bulletin</strong>, Medicines Utilisation Unit August & September 2011 Page 7 of 8
Medicines launched, not yet reviewed <strong>and</strong> not for prescribing<br />
The following are medicines that have been launched or have had an extension to their licensed indications<br />
but have not as yet been considered by the ADTC. Since they have yet to be considered by the SMC, they<br />
are therefore NOT recommended for prescribing within <strong>NHS</strong> <strong>Ayrshire</strong> & <strong>Arran</strong> until a decision is<br />
communicated from the ADTC. They are however available on an exceptional case application basis.<br />
Requests should be sent to the Medical Director for consideration.<br />
Adalimumab (Humira ® ) - polyarticular juvenile Grass Pollen Extract (Grazax ® ) tabs – children<br />
idiopathic arthritis in children from 4 years-old<br />
Alemtuzumab (MabCampath ® ) inf – first line CLL Glatiramer (Copaxone ® ) injection – treatment first episode<br />
<strong>and</strong> those at high risk of developing MS<br />
Azithromycin (Azyter ® ) eyedrops – conjunctivitis Ipilimumab (Yervoy ® ) injection – advanced melanoma<br />
Aztreonam (Cayston ® ) nebs – cystic fibrosis L-carnitine (Carnitor ® ) tablets carnitine deficiency<br />
Boceprevir capsules (Victrelis ® ) – hepatitis C Midazolam (buccal) – status epilepticus<br />
Bortezomib (Velcade ® ) – untreated multiple Moxifloxacin (Avelox ® ) –complicated skin infections<br />
myeloma with melphalan & prednisolone<br />
Botulinum toxin type A (Xeomin ® ) – post stroke Olmesartan/ amlodipine <strong>and</strong> hydrochlorothiazide<br />
spasticity of the upper limb.<br />
(SEVIKAR HCT ® ) - hypertension<br />
Bromfenac (Yellox ® ) eye drops – cataract surgery Phenylephrine + tropicamide (Mydriasert ® ) Opthalmic<br />
insert – diagnostic eye surgery<br />
C1-Esterase inhibitor (Berinert ® ) – Hereditary Prednisone (Lodotra ® ) m/r tablets – moderate to severe<br />
angioedema type I <strong>and</strong> II (acute episode)<br />
active rheumatoid arthritis<br />
Cabazitaxel (Jevtana ® ) – prostate cancer<br />
Ramipril (Tritace ® ) – treatment of incipient glomerular<br />
diabetic neuropathy<br />
Carmellose/ Glycerine (Optive ® ) eyedrops – dry Ranibizumab (Lucentis ® ) intravitreal injection – retinal vein<br />
eyes<br />
occlusion<br />
Catumaxomab (Removab ® ) injection - malignant Recombinant Antithrombin (Atryn ® ) – prophylaxis of<br />
ascites<br />
Dasatinib (Sprycel ® ) - newly diagnosed Philadelphia<br />
chromosome positive chronic myelogenous<br />
leukaemia in the chronic phase<br />
Doripenem (Doribax) inj –complicated UTIs<br />
Doxycycline (Efracea ® ) capsules – treatment of<br />
rosacea<br />
Eribulin (Halaven ® ) injection – metastatic breast<br />
cancer<br />
Ertapenem (Invanz ® ) inj – community acquired<br />
pneumonia & acute gynaecological infections<br />
Exenatide once weekly injection (Bydureon ® ) – type<br />
2 diabetes mellitus<br />
Fingolimod (Gilenya ® ) capsules – multiple sclerosis<br />
venous thromboembolism<br />
Salicylic acid <strong>and</strong> fluorouracil (Actikerall ® ) topical solution –<br />
actinic keratosis<br />
Saxagliptin (Onglyza ® ) tabs – type 2 diabetes in<br />
combination with sulphonylureas or thiazolidinedione<br />
Sitagliptin (Januvia ® ) tabs – type 2 diabetes mellitus in<br />
combination with thiazolidinediones<br />
Somatropin (Humatrope ® ) inj – growth disturbance in short<br />
children. Growth failure associated with SHOX deficiency<br />
Temsirolimus (Torisel ® ) infusion – advanced renal cell<br />
cancer<br />
Travoprost (Travatan ® ) eye drops - benzalkonium chloride<br />
free multidose formulation<br />
Urofollitropin (Fostimon ® ) injection – infertility<br />
<strong>NHS</strong> <strong>Ayrshire</strong> & <strong>Arran</strong> <strong>Formulary</strong> <strong>Bulletin</strong>, Medicines Utilisation Unit August & September 2011 Page 8 of 8