List of Natioanl Advisory Group Recommendations Since April 2002
SMC Advice - Formulary Decisions February-March 2014
Scottish Medicines Consortium Recommendations
Date / Product/Manufacturer / SMC Advice / Decision of ADTC / RationaleFebruary 2014
799/12 / dapagliflozin 5mg and 10mg film-coated tablets (Forxiga®)
Bristol-Myers Squibb / AstraZeneca
Resubmission
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.
Comparator Medicines:
Alternative pharmacological approaches to insulin regimen intensification aimed at improving glycaemic control of patients with type 2 diabetes already taking insulin include adjunctive treatment with: GLP-1 agonists (exenatide, lixisenatide), DPP-4 inhibitors, or pioglitazone / dapagliflozin (Forxiga®) is accepted for restricted use within NHS Scotland.
Indication under review: For 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.
SMC restriction: In combination with insulin, when insulin with diet and exercise, does not provide adequate glycaemic control.
In a phase III randomised, controlled study, dapagliflozin treatment, when added to an insulin-containing regimen, was associated with: greater reductions in glycosylated haemoglobin (HbA1c), in body weight, and similar rates of hypoglycaemia when compared with placebo.
Dapagliflozin is also licensed for use as monotherapy when diet and exercise alone do not provide adequate glycaemic control in patients for whom use of metformin is considered inappropriate due to intolerance. The companies’ submission related only to the use of dapagliflozin when used in combination with insulin. SMC cannot recommend the use of dapagliflozin as monotherapy. SMC has previously accepted dapagliflozin for restricted use in combination with metformin / Included on the Fife Formulary for restricted use.
Dapagliflozin is only approved for use in combination with insulin, when insulin with diet and exercise, does not provide adequate glycaemic control.
Cheaper oral alternative to addition of a GLP-1 agonist e.g. lixisenatide, exenatide, liraglutide.
Dapagliflozin is not approved for use as monotherapy or in combination with metformin.
Specialist initiation / recommendation. / SMC dapagliflozin (Forxiga)
February 2014
942/14 / lenalidomide 2.5mg, 5mg, and , 10mg, hard capsules (Revlimid®)
Celgene Ltd
For the treatment of 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
Comparator Medicines:
There are no other medicines licensed for the treatment of low to intermediate-1 risk MDS. Therefore the most relevant comparator for lenalidomide is best supportive care, comprising RBC transfusions, iron chelation and possibly erythropoiesis stimulating agents. Azacitidine is indicated for treatment of adult patients who are not eligible for haematopoietic stem cell transplantation (SCT) with intermediate-2 and high-risk myelodysplastic syndrome (MDS) and therefore not an appropriate comparator. / lenalidomide (Revlimid®) is accepted for use within NHS Scotland.
Indication under review: for the treatment of 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.
Lenalidomide therapy significantly increased the proportion of patients achieving sustained red blood cell transfusion independence compared with best supportive care. However, there was no significant improvement in overall survival. / Included on the Fife Formulary for the indication in question.
Hospital use only. / SMC lenalidomide (Revlimid)
January 2014 (Issued February 2014) 940/14 / teriflunomide, 14mg, film-coated tablets (Aubagio®)
Genzyme Ltd
Treatment of adults with relapsing remitting multiple sclerosis (MS).
Comparator Medicines:
Interferon beta-1a, interferon beta-1b, glatiramer acetate. Fingolimod and natalizumab are licensed for use only in highly active disease. / teriflunomide (Aubagio®) is accepted for restricted use within NHS Scotland.
Indication under review: treatment of adults with relapsing remitting multiple sclerosis (MS).
SMC restriction: as an alternative to treatment with interferon beta or glatiramer acetate. Teriflunomide is not expected to be used for the treatment of patients with highly active disease.
In two phase III, randomised, double-blind, placebo-controlled, parallel-group studies in adult patients with relapsing MS, teriflunomide significantly reduced the annualised relapse rate. In a phase III, randomised, single-blind, parallel-group study, teriflunomide showed similar efficacy to interferon beta.
This SMC advice takes account of the benefits of a Patient Access Scheme (PAS) that improves the cost-effectiveness of teriflunomide. This SMC advice is contingent upon the continuing availability of the Patient Access Scheme in NHS Scotland or a list price that is equivalent or lower. / Included on the Fife Formulary as an alternative to beta interferon or glatarimer as a 1st line treatment option for relapsing remitting multiple sclerosis.
Hospital use only. / SMC teriflunomide (Aubagio)
February 2014 944/14 / ustekinumab 45mg solution for injection in pre-filled syringe (Stelara®)
Janssen-Cilag Ltd
Alone or in combination with methotrexate, for the treatment of active psoriatic arthritis in adult patients when the response to previous non-biological disease-modifying anti-rheumatic drug therapy has been inadequate
Comparator Medicines:
Anti -TNF drugs licensed for this indication: adalimumab, etanercept, golimumab and infliximab / ustekinumab (Stelara®) is accepted for restricted use within NHS Scotland.
Indication under review: Alone or in combination with methotrexate, for the treatment of active psoriatic arthritis in adult patients when the response to previous non-biological disease-modifying 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.
Significantly more patients with active psoriatic arthritis who were treated with ustekinumab achieved at least 20% response on American College of Rheumatology criteria (ACR 20) at 24 weeks compared with those treated with placebo. / Included on the Fife Formulary for indication in question.
Restricted to use in psoriatic arthritis after failure with other biologics.
Hospital use only. / SMC ustekinumab_Stelara
February 2014
878/13 / aflibercept 25mg/mL concentrate for solution for infusion (Zaltrap®)
Sanofi
Resubmission
In combination with irinotecan/5-fluorouracil/folinic acid (FOLFIRI) chemotherapy, aflibercept is indicated in adults with metastatic colorectal cancer (mCRC) that is resistant to or has progressed after an oxaliplatin-containing regimen.
Comparator Medicines:
FOLFIRI chemotherapy regimen. / aflibercept (Zaltrap®) is accepted for use within NHS Scotland.
Indication under review: in combination with irinotecan/5-fluorouracil/folinic acid (FOLFIRI) chemotherapy, aflibercept is indicated in adults with metastatic colorectal cancer (mCRC) that is resistant to or has progressed after an oxaliplatin-containing regimen.
In one randomised, double-blind, phase III study, aflibercept plus FOLFIRI chemotherapy regimen resulted in statistically significant longer overall survival compared with placebo plus FOLFIRI chemotherapy regimen. However the effect was of relatively modest clinical benefit.
This SMC advice takes account of the benefits of a Patient Access Scheme (PAS) that improves the cost-effectiveness of aflibercept. This SMC advice is contingent upon the continuing availability of the patient access scheme in NHS Scotland or a list price that is equivalent or lower. / Not included pending protocol. / SMC aflibercept (Zaltrap)
Await Lothian Formulary Committee decision following SCAN submission.
February 2014
945/14 / solifenacin succinate plus tamsulosin hydrochloride 6mg / 0.4mg modified release tablet (Vesomni®)
Astellas Pharma Ltd
Product Update / solifenacin succinate plus tamsulosin hydrochloride 6mg / 0.4mg modified release tablet (Vesomni®) is accepted for use within NHS Scotland.
Indication under review: for the 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.
In patients for whom concomitant use of solifenacin succinate and tamsulosin hydrochloride is appropriate, Vesomni® allows administration of a single tablet at a lower cost compared to the individual components administered separately. / Not included on the Fife Formulary because the NHS Board decision is that Vesomni® does not represent sufficient added benefit to other comparator medicines to treat the condition in question. / SMC solifenacin and tamsulosin (Vesomni)
‘Not preferred.
Formulary choices for urge incontinence –
1st choice - Tolterodine
2nd choice – Oxybutyinin XL (Lyrinel® XL)
Solifenacin (Vesicare®)
Restricted use – Mirabegron (Betmiga®)
http://www.fifeadtc.scot.nhs.uk/formulary/sections/7%20Gynae.pdf
February 2014
948/14 / darunavir 400mg, 800mg film-coated tablets and oral suspension 100mg/mL (Prezista®)
Janssen-Cilag Ltd
Product Update / darunavir (Prezista®) is accepted for restricted use within NHS Scotland.
Indication under review: darunavir co-administered with low dose ritonavir in combination with other antiretroviral medicinal products for the treatment of human immunodeficiency virus (HIV-1) infection in paediatric patients 12 to 17 years of age and at least 40kg body weight who are: antiretroviral therapy (ART) naïve; or, ART-experienced with no darunavir resistance associated mutations and who have plasma HIV-1 RNA <100,000 copies/mL and CD4+ cell count ≥100 cells/mm3.
SMC restriction: in patients <18 years, to be prescribed under the supervision of specialists in paediatric HIV.
The Scottish Medicines Consortium has previously accepted darunavir for use in this indication in adults and in highly pre-treated children and adolescents, from the age of 6 years and at least 20kg body weight, who have failed on more than one regimen containing a protease inhibitor. Darunavir is listed in the British National Formulary for Children in combination with other antiretroviral drugs, for HIV infection resistant to other protease inhibitors in children previously treated with antiretrovirals. / Not included on the Fife Formulary for this indication. / SMC darunavir (Prezista)
Tertiary centre use.
http://www.fifeadtc.scot.nhs.uk/formulary/sections/5%20Infections.pdf
February 2014
949/14 / zonisamide 25mg, 50mg and 100mg capsules (Zonegran®)
Eisai Limited
Product Update / zonisamide (Zonegran®) is accepted for restricted use within NHS Scotland.
Indication under review: as adjunctive therapy in the treatment of partial seizures, with or without secondary generalisation, in adolescents, and children aged 6 years and above.
SMC restriction: on advice from specialists (paediatric neurologists or paediatricians with an expertise in epilepsy).
The Scottish Medicines Consortium has previously accepted zonisamide for restricted use in adult patients with partial seizures, with or without secondary generalisation. It was restricted to initiation by physicians with appropriate experience in the treatment of epilepsy and should be used principally in patients who have not benefited from treatment with an older anti-convulsant drug such as carbamazepine or sodium valproate, or for whom these drugs are unsuitable because of contra-indications, interaction or poor tolerance / Not included on the Fife Formulary for this indication. / SMC zonisamide (Zonegran)
Tertiary centre use.
http://www.fifeadtc.scot.nhs.uk/formulary/sections/4%20CNS.pdf
November 2013 (issued February 2014)
920/13 / afatinib 20mg, 30mg, 40mg, 50mg film-coated tablets (Giotrif®)
Boehringer Ingelheim International GmbH
As monotherapy for the treatment of epidermal growth factor receptor (EGFR) tyrosine kinase inhibitor-naïve adult patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) with activating EGFR mutation(s).
Comparator Medicines:
Erlotinib and gefitinib (which is not recommended by SMC for treatment of advanced or metastatic NSCLC with activating mutations of EGFR-TK). / afatinib (Giotrif®) is accepted for use within NHS Scotland.
Indication under review: As monotherapy, for the treatment of epidermal growth factor receptor (EGFR) tyrosine kinase inhibitor-naïve adult patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) with activating EGFR mutation(s).
In two phase III studies, in patients with EGFR mutation positive adenocarcinoma of the lung, afatinib was significantly superior to the chemotherapy regimen comparators for the primary endpoint of progression free survival. Overall survival data are immature. A mixed treatment comparison provides indirect comparative data versus other tyrosine kinase inhibitors.
This SMC advice takes account of the benefits of a Patient Access Scheme (PAS) that improves the cost-effectiveness of afatinib. This SMC advice is contingent upon the continuing availability of the Patient Access Scheme in NHS Scotland or a list price that is equivalent or lower. / Not included on the Fife Formulary because clinicians do not support formulary inclusion. / SMC afatinib (Giotrif)
‘Not preferred.’
The preferred regional choice for this indication is erlotinib.
http://www.fifeadtc.scot.nhs.uk/formulary/sections/8%20Malignancy.pdf
February 2014
958/14 / saxagliptin (Onglyza ®) 2.5mg & 5mg film-coated tablets
Bristol Myers Squibb / Astra Zeneca / saxagliptin (Onglyza®) is not recommended for use within NHS Scotland.
Indication under review: 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.
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 NHSScotland. / Not recommended for monotherapy use.
Requires submission and approval of an IPTR for this indication. / SMC saxagliptin (Onglyza)
Non-submission
Saxagliptin is a 2nd choice gliptin in the Fife Formulary.
February 2014
856/13 / insulin degludec (Tresiba®) 100units/mL solution for injection in pre-filled pen or cartridge and 200units/mL solution for injection in pre-filled pen (No: 956/14)
Novo Nordisk
Resubmission
Treatment of diabetes mellitus in adults.
Comparator Medicines:
Other long-acting insulins: isophane insulin (NPH), insulin detemir and insulin glargine. SMC has accepted insulin glargine and insulin detemir for restricted use, targeted at patients attempting to achieve better hypoglycaemic control or, for insulin glargine, at people who experience unacceptable rates of nocturnal hypoglycaemia. / Insulin degludec (Tresiba®) is not recommended for use within NHS Scotland.
Indication under review: treatment of diabetes mellitus in adults.
Insulin degludec is non-inferior to other long-acting insulin analogues for treatment of type 1 and type 2 diabetes mellitus in adults assessed via glycosylated haemoglobin (HbA1c).
The submitting company did not present a sufficiently robust economic analysis to gain acceptance by SMC. / Not recommended.
Requires submission and approval of an IPTR. / SMC insulin_degludec_Tresiba_Resubmission
Lack of evidence of economic benefits.
January 2014 (issued February 2014)
937/14 / alogliptin, 25mg, 12.5mg, 6.25mg, film-coated tablets (Vipidia®)
Takeda Pharma A/S
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