Formulary Group Decisions 18th December 2012 - published *31/12/2012


*unless otherwise stated

Approved for use in NHS Grampian

Botulinum toxin type A (50-unit, 100-unit vial)
Management of anal fissures BNF 1.7.4
Botulinum toxin type A (50-unit, 100-unit vial) is included on the Grampian Joint Formulary for the indication in question, restricted use.
Indication under review: off-label use as a treatment option for adults with a diagnosis of chronic anal fissure and who have failed to respond to licensed/unlicensed medicines used to treat chronic anal fissure. Available for restricted use under specialist supervision (for internal anal sphincter injection and may only be administered by physicians with appropriate qualifications, and expertise in the use of botulinum toxin and in the use of the required equipment); recommended for hospital use only.

Dexamethasone 700 microgram intravitreal implant (Ozurdex®) Black Triangle symbol indicating that the CHM and MHRA are intensively monitoring this product - SMC 652/10  
Corticosteroids, intravitreal corticosteroids BNF 11.4.1
Dexamethasone intravitreal implant (Ozurdex®) Black Triangle symbol indicating that the CHM and MHRA are intensively monitoring this product is included on the Grampian Joint Formulary for the indication in question, restricted use. 
Indication under review: treatment of adult patients with macular oedema following either branch retinal vein occlusion or central retinal vein occlusion.
SMC restriction: for use in adult patients with macular oedema (i) following central retinal vein occlusion (CRVO) and (ii) in patients with branch retinal vein occlusion (BRVO) who are not clinically suitable for laser treatment including patients with dense macular haemorrhage or patients who have received and failed on previous laser treatment.
In two phase III studies dexamethasone 700 microgram intravitreal implant was superior to sham administration at day 90 for the proportion of patients with a best corrected visual acuity improvement of ≥15 letters. Longer-term effectiveness of treatment is uncertain. Available for restricted use for intravitreal injection only and must be administered by a qualified ophthalmologist experienced in intravitreal injections, hospital use only.

 

Not approved for use in NHS Grampian

Aclidinium 322 micrograms inhalation powder (Eklira Genuair®) Black Triangle symbol indicating that the CHM and MHRA are intensively monitoring this product - SMC 810/12
Bronchodilators BNF 3.1
Aclidinium 322 micrograms inhalation powder (Eklira Genuair®) Black Triangle symbol indicating that the CHM and MHRA are intensively monitoring this product is not included on the Grampian Joint Formulary for the indication in question. This advice is superseded by the February 2013 Formulary Group decision - link to advice. 
Indication under review: as a maintenance bronchodilator treatment to relieve symptoms in adult patients with chronic obstructive pulmonary disease (COPD).
In two phase III studies, aclidinium was statistically superior to placebo in improving lung function (forced expiratory volume in 1 second [FEV1]) after 12 weeks and 24 weeks.
Not included on the Grampian Joint Formulary because clinicians have not responded to an invitation to apply for formulary inclusion for this medicine for the indication in question.

Fluticasone proprionate and formoterol fumarate metered dose inhaler, 50microgram/5microgram, 125microgram/5 microgram 250microgram/10 microgram (Flutiform®) Black Triangle symbol indicating that the CHM and MHRA are intensively monitoring this product - SMC 736/11 [Published 06/12/2012]
Corticosteroids BNF 3.2  
Fluticasone proprionate and formoterol fumarate metered dose inhaler (Flutiform®) Black Triangle symbol indicating that the CHM and MHRA are intensively monitoring this product is not included on the Grampian Joint Formulary for the indication in question. This advice is superseded by the January 2013 Formulary Group decision - link to advice. 
Indication under review: in the regular treatment of asthma where the use of a combination product [an inhaled corticosteroid (ICS) and a long-acting beta2-agonist (LABA)] is appropriate: 

  • for patients not adequately controlled on ICS and 'as required' inhaled short-acting beta2-agonist or 
  • for patients already adequately controlled on both an ICS and a LABA.

Flutiform® should be used in patients for whom fluticasone and formoterol are appropriate choices of corticosteroid and long-acting beta-agonist, respectively, and for whom a metered dose inhaler is an appropriate delivery device. It has demonstrated clinical non-inferiority to another combination product containing a corticosteroid and long-acting beta2-agonist and may offer cost savings.
Not included on the Grampian Joint Formulary because clinicians have not responded to an invitation to apply for formulary inclusion for this medicine for the indication in question. 

Ivabradine 5 and 7.5mg film-coated tablets (Procoralan®) - SMC 805/12  [Published 06/12/2012]
Other antianginal drugs BNF 2.6.3
Ivabradine (Procoralan®) is not included on the Grampian Joint Formulary for the indication in question. This advice is superseded by the January 2013 Formulary Group decision - link to advice. 
Indication under review: Chronic heart failure New York Heart Association (NYHA) II to IV class with systolic dysfunction, in patients in sinus rhythm and whose heart rate is ≥75 beats per minute (bpm), in combination with standard therapy including beta-blocker therapy or when beta-blocker therapy is contra-indicated or not tolerated.
SMC restriction: for initiation only in patients whose resting heart rate remains ≥75 beats per minute despite optimal standard therapy.
In a post-hoc subgroup analysis of the pivotal study in patients meeting the licensed indication, ivabradine was significantly more effective than placebo at reducing the risk of a composite of cardiovascular death or hospitalisation for worsening heart failure. However, in patients on the target dose of beta-blocker, ivabradine was not significantly more effective.
Not included on the Grampian Joint Formulary because clinicians have not responded to an invitation to apply for formulary inclusion for this medicine for the indication in question.

Nepafenac 1mg/mL eye drops, ophthalmic suspension (Nevanac®) - SMC 813/12
Ocular peri-operative drugs BNF 11.8.2 - link to Grampian Joint Formulary choices
Nepafenac 1mg/mL eye drops, ophthalmic suspension (Nevanac®) is not included on the Grampian Joint Formulary for the indication in question.
Indication under review: reduction in the risk of postoperative macular oedema associated with cataract surgery in diabetic patients.
In the pivotal study which included diabetic patients who had undergone cataract surgery, nepafenac eye drops significantly reduced the incidence of macular oedema compared to vehicle.
Not included on the Grampian Joint Formulary because clinicians have not responded to an invitation to apply for formulary inclusion for this medicine for the indication in question.

Pazopanib 200mg, 400mg film-coated tablets (Votrient®) Black Triangle symbol indicating that the CHM and MHRA are intensively monitoring this product - SMC 820/12
Other antineoplastic drugs, protein kinase inhibitors BNF 8.1.5 - link to Grampian Joint Formulary choices
Pazopanib 200mg, 400mg film-coated tablets (Votrient®) Black Triangle symbol indicating that the CHM and MHRA are intensively monitoring this product is not recommended for use within NHS Scotland.
Indication under review: For the treatment of adult patients with selective subtypes of advanced soft tissue sarcoma (STS) who have received prior chemotherapy for metastatic disease or who have progressed within 12 months after (neo) adjuvant therapy. Efficacy and safety has only been established in certain STS histological tumour subtypes.
In a pivotal study, pazopanib significantly improved progression-free survival compared with placebo in adult patients with selective subtypes of advanced STS. However there was no significant improvement in overall survival.
The submitting company's justification of the treatment's cost in relation to its health benefits was not sufficient to gain acceptance by SMC, and in addition the submitting company did not present a sufficiently robust economic analysis to gain acceptance by SMC.
Not recommended by SMC for use within NHS Scotland - Not included on the Grampian Joint Formulary for the indication in question.

Racecadotril 10mg, 30mg granules for oral suspension (Hidrasec Infants®, Hidrasec Children®) Black Triangle symbol indicating that the CHM and MHRA are intensively monitoring this product - SMC 818/12
Acute diarrhoea BNF 1.4 - link to Grampian Joint Formulary choices
Racecadotril (Hidrasec Infants®, Hidrasec Children®) Black Triangle symbol indicating that the CHM and MHRA are intensively monitoring this product is not recommended for use within NHS Scotland.
Indication under review: Complementary symptomatic treatment of acute diarrhoea in infants older than three months and in children, together with oral rehydration and the usual support measures, when these measures alone are insufficient to control the clinical condition.
Racecadotril was significantly better than placebo in reducing mean stool output at 48 hours in children with acute diarrhoea treated in hospital. There is insufficient evidence that it improves recovery rate.
The submitting company did not present a sufficiently robust clinical and economic analysis to gain acceptance by SMC.
The licence holder has indicated their intention to resubmit.
Not recommended by SMC for use within NHS Scotland - Not included on the Grampian Joint Formulary for the indication in question.

In the absence of a submission from the holder of the marketing authorisation
Racecadotril 100mg capsules (Hidrasec®) Black Triangle symbol indicating that the CHM and MHRA are intensively monitoring this product - SMC 832/12
Acute diarrhoea BNF 1.4 - link to Grampian Joint Formulary choices
Racecadotril 100mg capsules (Hidrasec®) Black Triangle symbol indicating that the CHM and MHRA are intensively monitoring this product is not recommended for use within NHS Scotland.
Indication under review: Symptomatic treatment of acute diarrhoea in adults when causal treatment is not possible.
The holder of the marketing authorisation has not made a submission to SMC regarding this product in this indication. As a result we cannot recommend its use within NHS Scotland
Not recommended by SMC for use within NHS Scotland - Not included on the Grampian Joint Formulary for the indication in question.

Sildenafil 20mg film-coated tablets and 10mg/mL powder for oral solution (Revatio®) Black Triangle symbol indicating that the CHM and MHRA are intensively monitoring this product - SMC 809/12
Vasodilator antihypertensive drugs BNF 2.5.1
Sildenafil (Revatio®) Black Triangle symbol indicating that the CHM and MHRA are intensively monitoring this product is not included on the Grampian Joint Formulary for the indication in question (prescription and supply from National Specialist Service).  
Indication under review: Treatment of paediatric patients aged 1 year to 17 years old with pulmonary arterial hypertension. Efficacy in terms of improvement of exercise capacity or pulmonary haemodynamics has been shown in primary pulmonary hypertension and pulmonary hypertension associated with congenital heart disease.
SMC restriction: restricted to use on the advice of specialists in the Scottish Pulmonary Vascular Unit and from the Scottish Adult Congenital Cardiac Service.
SMC has previously accepted this orphan indication for oral sildenafil for restricted use within NHS Scotland for the treatment of adult patients with pulmonary arterial hypertension classified as WHO functional class II and III, to improve exercise capacity. Efficacy has been shown in primary pulmonary hypertension and pulmonary hypertension associated with connective tissue disease.
Sildenafil is listed in the British National Formulary for Children 2011-2012 for use in pulmonary hypertension after cardiac surgery, weaning from nitric oxide, idiopathic pulmonary arterial hypertension, persistent pulmonary hypertension of the newborn.
Not included on the Grampian Joint Formulary because sildenafil (for pulmonary arterial hypertension) is limited to initiation, prescribing and supply from the  Link opens in new windowNational Specialist Service for pulmonary arterial hypertension (Scottish Pulmonary Vascular Unit or similar specialists) - clinicians do not support the formulary inclusion for the indication in question.

Velaglucerase alfa 400 units powder for solution for infusion (VPRIV®) Black Triangle symbol indicating that the CHM and MHRA are intensively monitoring this product - SMC 681/11  [Published 06/12/2012]
Drugs used in metabolic disorders, Gaucher's disease BNF 9.8.1
Velaglucerase alfa (VPRIV®) Black Triangle symbol indicating that the CHM and MHRA are intensively monitoring this product is not included on the Grampian Joint Formulary for the indication in question.
Indication under review: Long-term enzyme replacement therapy in patients with type 1 Gaucher disease.
Velaglucerase alfa has been shown to be non-inferior to another enzyme replacement treatment in patients with type 1 Gaucher disease.
This SMC advice takes account of the benefits of a Patient Access Scheme (PAS) that improves the cost-effectiveness of velaglucerase. This SMC advice is contingent upon the continuing availability of the patient access scheme in NHS Scotland.
Not included on the Grampian Joint Formulary because the incidence of type 1 Gaucher disease is unpredictable and sporadic - clinicians do not support the formulary inclusion for the indication in question. If local need identified NSD Orphan drug risk-share arrangement may apply, see http://www.nsd.scot.nhs.uk/services/riskshare/.

Vemurafenib 240mg film-coated tablet (Zelboraf®) Black Triangle symbol indicating that the CHM and MHRA are intensively monitoring this product - SMC 792/12  [Published 06/12/2012]
Other antineoplastic drugs, protein kinase inhibitors BNF 8.1.5 - link to Grampian Joint Formulary choices
Vemurafenib (Zelboraf®) Black Triangle symbol indicating that the CHM and MHRA are intensively monitoring this product is not recommended for use within NHS Scotland.
Indication under review: as monotherapy for the treatment of adult patients with BRAF V600 mutation-positive unresectable or metastatic melanoma.
A phase III, open-label study has demonstrated a significant improvement for the co-primary endpoints of overall survival and progression free survival for vemurafenib relative to an intravenous single agent chemotherapy regimen, in patients with previously untreated unresectable stage IIIC or stage IV melanoma with V600E BRAF mutation.
The submitting company did not present a sufficiently robust economic analysis and in addition their justification of the treatment's cost in relation to its health benefits was not sufficient to gain acceptance by SMC. 
Not recommended by SMC for use within NHS Scotland - Not included on the Grampian Joint Formulary for the indication in question.

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