List of Natioanl Advisory Group Recommendations since ...



|Scottish Medicines Consortium Recommendations | |

|Date |Product/Manufacturer |SMC Advice |Decision of ADTC |Rationale |

|February 2015 |fosfomycin 40mg/mL powder for solution for intravenous |fosfomycin (Fomicyt®) is accepted for restricted use within NHS Scotland. |Included on the Fife Formulary. |Scottish Medicines Consortium |

|1033/15 |infusion (Fomicyt®) | | |fosfomycin (Fomicyt) |

| |Nordic Pharma |Indication under review: for the treatment of the following infections in adults and|Restricted to use if recommended by a | |

| | |children including neonates: |microbiologist. | |

| |Product Update |- Acute osteomyelitis | | |

| | |- Complicated urinary tract infections |Add to restricted hospital antimicrobial | |

| | |- Nosocomial lower respiratory tract infections |list. | |

| | |- Bacterial meningitis | | |

| | |- Bacteraemia that occurs in association with, or is suspected to be associated |Hospital use only. | |

| | |with, any of the infections listed above | | |

| | | | | |

| | |Fosfomycin should be used only when it is considered inappropriate to use | | |

| | |antibacterial agents that are commonly recommended for the initial treatment of the | | |

| | |infections listed above, or when these alternative antibacterial agents have failed | | |

| | |to demonstrate efficacy. | | |

| | | | | |

| | |Consideration should be given to national guidance on the appropriate use of | | |

| | |antibacterial agents. | | |

| | | | | |

| | |SMC restriction: initiation by microbiologists or infectious disease specialists. | | |

| | | | | |

| | |Unlicensed preparations of intravenous fosfomycin are commonly used in the NHS in | | |

| | |Scotland to treat multi-drug resistant gram negative organisms. This provides a | | |

| | |licensed preparation. Estimated patient numbers are expected to be small. | | |

|February 2015 |ledipasvir/sofosbuvir, 90mg/400mg, film-coated tablet |ledipasvir/sofosbuvir (Harvoni®) is accepted for restricted use within NHS Scotland.|Included on the Fife Formulary. |Scottish Medicines Consortium |

|1030/15 |(Harvoni®) | | |ledipasvir-sofosbuvir (Harvoni)|

| |Gilead Sciences Ltd |Indication under review: treatment of chronic hepatitis C (CHC) in adults. |Restricted to use in patients with genotype| |

| | | |1 and genotype 4. | |

| |Treatment of chronic hepatitis C (CHC) in adults |SMC restriction: genotype 1 and 4 CHC only. | | |

| | | |Hospital use only. | |

| |Comparator Medicines: |In three, uncontrolled phase III studies conducted in treatment-naïve and | | |

| |Sofosbuvir, simeprevir, daclatasvir in |treatment-experienced non-cirrhotic and cirrhotic patients with genotype 1 CHC, | | |

| |peginterferon-free regimens or in combination with |ledipasvir/sofosbuvir ± ribavirin achieved sustained virological response (at 12 | | |

| |peginterferon plus ribavirin. Telaprevir and |weeks post treatment) rates of 93% to 99%, which were significantly superior to | | |

| |boceprevir in combination with peginterferon plus |historical control rates. | | |

| |ribavirin | | | |

| | |No clinical or economic data were presented for genotype 3 patients with cirrhosis | | |

| | |and/or prior treatment failure. | | |

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|February 2015 |idelalisib 100mg and 150mg tablets (Zydelig®) |idelalisib (Zydelig®) is accepted for restricted for use within NHS Scotland. |Included on the Fife Formulary. |Scottish Medicines Consortium |

|1026/15 |Gilead Sciences Ltd | | |idelalisib (Zydelig) |

| | |Indication under review: In combination with rituximab for the treatment of adult |Restricted to use in patients with relapsed| |

| |In combination with rituximab for the treatment of |patients with chronic lymphocytic leukaemia (CLL): |chronic lymphocytic leukaemia who are | |

| |adult patients with chronic lymphocytic leukaemia |• who have received at least one prior therapy, or |unsuitable for chemotherapy and treatment | |

| |(CLL): |• as first line treatment in the presence of 17p deletion or TP53 mutation in |naïve patients with 17p deletion or TP53 | |

| |who have received at least one prior therapy, or |patients unsuitable for chemo-immunotherapy. |mutation who are unsuitable for | |

| |as first line treatment in the presence of 17p deletion| |chemo-immunotherapy. | |

| |or TP53 mutation in patients unsuitable for |SMC restriction: patients with relapsed CLL who are unsuitable for chemotherapy and | | |

| |chemo-immunotherapy. |treatment naïve patients with 17p deletion or TP53 mutation who are unsuitable for |Hospital use only. | |

| | |chemo-immunotherapy. | | |

| |Comparator Medicines: | | | |

| |For patients with 17p deletion and/or TP53 mutation |Idelalisib in combination with an anti-CD20 antibody significantly improves | | |

| |unsuitable for chemo-immunotherapy, first-line |progression free survival compared with an anti-CD20 antibody alone in patients with| | |

| |treatment would be alemtuzumab (unlicensed) plus pulsed|relapsed CLL. The treatment effect across subgroups with 17p deletion and/or TP53 | | |

| |high dose corticosteroids. For patients with relapsed |mutation was consistent with that of the total study population. | | |

| |CLL treatment options include FCR, chlorambucil ± high | | | |

| |dose steroids, chlorambucil ± rituximab, bendamustine ±|This SMC advice takes account of the benefits of a Patient Access Scheme (PAS) that | | |

| |rituximab, alemtuzumab (unlicensed) ± high dose |improves the cost-effectiveness of idelalisib. It is contingent upon the continuing | | |

| |steroids, rituximab plus high dose steroids, or high |availability of the patient access scheme in NHS Scotland or a list price that is | | |

| |dose steroids alone. As noted previously, the |equivalent or lower | | |

| |marketing authorisation for alemtuzumab (Mabcampath®) | | | |

| |for treatment of CLL was withdrawn by the company for | | | |

| |commercial reasons. It is now available through a | | | |

| |patient access programme. | | | |

|February 2015 |ruxolitinib (as phosphate), 5mg, 15mg, & 20mg tablets |ruxolitinib (Jakavi®) is accepted for use within NHS Scotland. |Included on the Fife Formulary. |Scottish Medicines Consortium |

|867/13 |(Jakavi®) | | |ruxolitinib (Jakavi) |

| |Novartis Pharmaceuticals UK Ltd |Indication under review: the treatment of disease-related splenomegaly or symptoms |Hospital use only. | |

| | |in adult patients with primary myelofibrosis (also known as chronic idiopathic | | |

| |The treatment of disease-related splenomegaly or |myelofibrosis), post polycythaemia vera myelofibrosis or post essential | | |

| |symptoms in adult patients with primary myelofibrosis |thrombocythaemia myelofibrosis. | | |

| |(also known as chronic idiopathic myelofibrosis), post | | | |

| |polycythaemia vera myelofibrosis or post essential |In patients with myelofibrosis, a significantly greater proportion of patients | | |

| |thrombocythaemia myelofibrosis |achieved a spleen response (reduction in spleen volume of at least 35% from | | |

| | |baseline) at 48 weeks when treated with ruxolitinib compared with best available | | |

| |Comparator Medicines: |therapy. Ruxolitinib was also associated with a greater proportion of patients | | |

| |There are no currently available licensed treatments |reporting a clinically significant reduction in myelofibrosis-related symptoms when | | |

| |for myelofibrosis. Hydroxycarbamide is the predominant |compared with placebo. | | |

| |pharmacological treatment used for splenomegaly and |This advice takes account of the benefits of a Patient Access Scheme (PAS) that | | |

| |other agents such as anagrelide, thalidomide, danazol |improves the cost effectiveness of ruxolitinib. It is contingent upon the continuing| | |

| |are used to manage haematological manifestations of |availability of the Patient Access Scheme in NHS Scotland or a list price that is | | |

| |myelofibrosis. None are specifically licensed for use |equivalent or lower. | | |

| |in myelofibrosis. |This advice takes account of the views from a Patient and Clinician Engagement | | |

| | |(PACE) meeting. | | |

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|February 2015 |apixaban, 2.5mg & 5mg, film-coated tablets (Eliquis®) |apixaban (Eliquis®) is accepted for use within NHS Scotland. |Not included on the Fife Formulary as the |Scottish Medicines Consortium |

|1029/15 |Bristol-Myers Squibb and Pfizer | |medicine does not represent sufficient |apixaban (Eliquis) |

| | |Indication under review: treatment of deep vein thrombosis (DVT) and pulmonary |added benefit to other comparator medicines| |

| |Treatment of deep vein thrombosis (DVT) and pulmonary |embolism (PE) and prevention of recurrent DVT and PE in adults. |to treat the condition in question. |

| |embolism (PE), and prevention of recurrent DVT and PE | | |/formulary/2-cardiovascular.asp|

| |in adults |Two phase III studies demonstrated efficacy and safety of apixaban. One study | |x |

| | |showed non-inferiority of apixaban versus standard anticoagulant therapy including a| | |

| |Comparator Medicines: |low molecular weight heparin in combination with a vitamin K antagonist for | |Not preferred. |

| |Dabigatran, rivaroxaban, low molecular weight heparin |treatment of DVT/PE with a lower rate of major and clinically relevant non-major | | |

| |and warfarin |bleeding. In a 12 month study apixaban demonstrated superiority versus placebo for | |Formulary choice NOAC is |

| | |the prevention of recurrent DVT/PE with a similar bleeding profile to placebo | |rivaroxaban. |

|February 2015 |dabrafenib, 50mg and 75mg hard capsules (Tafinlar®) |dabrafenib (Tafinlar®) is accepted for restricted use within NHS Scotland. |Not included pending protocol. |Scottish Medicines Consortium |

|1023/15 |GlaxoSmithKline | | |dabrafenib (Tafinlar) |

| | |Indication under review: monotherapy treatment of adult patients with unresectable | | |

| |Dabrafenib monotherapy for the treatment of adult |or metastatic melanoma with a BRAF V600 mutation. | |Await SCAN submission to |

| |patients with unresectable or metastatic melanoma with | | |Lothian Formulary Committee. |

| |a BRAF V600 mutation |SMC restriction: for use in patients with unresectable or metastatic BRAFV600 | | |

| | |mutation-positive metastatic melanoma who have received no prior therapy. | | |

| |Comparator Medicines: | | | |

| |Vemurafenib, ipilimumab. |In a phase III randomised open-label study, treatment with dabrafenib extended | | |

| | |median progression free survival by 4.2 months compared with chemotherapy. | | |

| | | | | |

| | |This SMC advice takes account of the benefits of a Patient Access Scheme (PAS) that | | |

| | |improves the cost-effectiveness of dabrafenib. It is contingent upon the continuing | | |

| | |availability of the patient access scheme in NHS Scotland or a list price that is | | |

| | |equivalent or lower. | | |

| | | | | |

| | |This advice takes account of the views from a Patient and Clinician Engagement | | |

| | |(PACE) meeting. | | |

|February 2015 |cabozantinib 20mg and 80mg hard capsules (Cometriq®) |cabozantinib (Cometriq®) is not recommended for use within NHS Scotland. |Not recommended. |Scottish Medicines Consortium |

|1022/15 |Swedish Orphan Biovitrum Ltd |Indication under review: for the treatment of adult patients with progressive, | |cabozantinib (Cometriq) |

| | |unresectable locally advanced or metastatic medullary thyroid carcinoma. |Requires submission and approval of an IPTR| |

| |For the treatment of adult patients with progressive, |In one pivotal, phase III study, cabozantinib was associated with a significant |before prescribing. |Lack of evidence of health |

| |unresectable locally advanced or metastatic medullary |advantage in progression-free survival over placebo. However, the difference between| |benefits compared to cost. |

| |thyroid carcinoma. For patients in whom Rearranged |cabozantinib and placebo did not reach statistical significance in the subgroup of | | |

| |during Transfection (RET) mutation status is unknown or|patients with Rearranged during Transfection (RET) negative tumours. The summary of | | |

| |is negative, a possible lower benefit should be taken |product characteristics therefore notes that for patients in whom RET mutation | | |

| |into account before individual treatment decision |status is unknown or is negative, a possible lower benefit should be taken into | | |

| | |account before individual treatment decision. | | |

| |Comparator Medicines: |The submitting company did not present a sufficiently robust economic analysis and | | |

| |The only other medicine licensed for use for medullary |in addition their justification of the treatment’s cost in relation to its benefits | | |

| |thyroid cancer is vandetanib which has not been |was not sufficient to gain acceptance by SMC. | | |

| |recommended for use in NHS Scotland by SMC |This advice takes account of the views from a Patient and Clinician Engagement | | |

| | |(PACE) meeting. | | |

|March 2015 |aclidinium/formoterol fumarate dihydrate 340/12 |aclidinium/formoterol fumarate dihydrate (Duaklir Genuair®) is accepted for use |Included on the Fife Formulary. |Scottish Medicines Consortium |

|1034/15 |micrograms inhalation powder (Duaklir Genuair®) |within NHS Scotland. | |aclidinium/formoterol fumarate |

| |Almirall / AstraZeneca | |For use in patients requiring a LABA/LAMA |dihydrate (Duaklir Genuair) |

| | |Indication under review: Maintenance bronchodilator treatment to relieve symptoms in|combination when treatment with aclidinium | |

| |Maintenance bronchodilator treatment to relieve |adult patients with chronic obstructive pulmonary disease. |or formoterol has been ineffective. | |

| |symptoms in adult patients with chronic obstructive | | | |

| |pulmonary disease. |In two 24-week comparator- and placebo-controlled phase III studies, treatment with | | |

| | |aclidinium/formoterol 340/12 microgram resulted in statistically significant | | |

| |Comparator Medicines: |improvements in FEV1 % predicted pre-dose (versus a LABA) and post-dose (versus a | | |

| |Relevant comparators to umeclidinium/vilanterol are |LAMA). | | |

| |combination treatments with an inhaled LABA and an | | | |

| |inhaled LAMA: formoterol, indacaterol, salmeterol | | | |

| |(LABAs) and aclidinium, umeclidinium, glycopyrronium, | | | |

| |tiotropium (LAMAs). The combination products, | | | |

| |indacaterol/glycopyrronium (Ultibro Breezhaler®) and | | | |

| |umeclidinium/vilanterol (Anoro®) are also licensed. | | | |

|March 2015 |fingolimod 0.5mg hard capsules (Gilenya®) |fingolimod (Gilenya®) is accepted for use within NHS Scotland. |Included on the Fife Formulary for the new |Scottish Medicines Consortium |

|1038/15 |Novartis Pharmaceuticals UK | |indication. |fingolimod (Gilenya) |

| |As single disease modifying therapy in highly active |Indication under review: as a single disease modifying therapy in highly active | | |

| |relapsing remitting multiple sclerosis (RRMS) for the |relapsing remitting multiple sclerosis (RRMS) for the following adult patient |Hospital use only. | |

| |following adult patient groups: |groups: | | |

| |Patients with high disease activity despite treatment | | | |

| |with at least one disease modifying therapy (for |- Patients with high disease activity despite treatment with at least one disease | | |

| |exceptions and information about washout periods see |modifying therapy. | | |

| |sections 4.4 and 5.1 of summary of product | | | |

| |characteristics [SPC]). |Analysis of a subgroup of patients who had high disease activity despite prior | | |

| |These patients may be defined as those who have failed |disease modifying therapy in the year before study entry found that over a 12 month | | |

| |to respond to a full and adequate course (normally at |period fingolimod reduced the annualised relapse rate compared with another disease | | |

| |least one year of treatment) of at least one disease |modifying therapy by 61% in patients who received prior interferon beta, and by 50% | | |

| |modifying therapy. Patients should have had at least 1 |in patients who had received any prior disease modifying therapy. | | |

| |relapse in the previous year while on therapy, and have| | | |

| |at least 9 T2-hyperintense lesions in cranial magnetic |This advice takes account of the benefits of a Patient Access Scheme (PAS) that | | |

| |resonance imaging (MRI) or at least 1 |improves the cost effectiveness of fingolimod. This advice is contingent upon the | | |

| |Gadolinium-enhancing lesion. A “non-responder” could |continuing availability of the patient access scheme, or a list price that is | | |

| |also be defined as a patient with an unchanged or |equivalent or lower, in NHS Scotland. | | |

| |increased relapse rate or ongoing severe relapses, as | | | |

| |compared to the previous year. | | | |

| |or Patients with rapidly evolving severe RRMS defined | | | |

| |by 2 or more disabling relapses in one year, and with 1| | | |

| |or more Gadolinium-enhancing lesions on brain MRI or a | | | |

| |significant increase in T2 lesion load as compared to a| | | |

| |previous recent MRI | | | |

| |Comparator Medicines: | | | |

| |Intramuscular interferon-beta 1a (Avonex,®) | | | |

| |subcutaneous interferon-beta 1a (Rebif®); subcutaneous | | | |

| |interferon-beta 1b (Betaferon,® Extavia®); dimethyl | | | |

| |fumarate. | | | |

|March 2015 |levonorgestrel 13.5mg intrauterine delivery system |levonorgestrel (Jaydess®) is accepted for use within NHS Scotland. |Included on the Fife Formulary. |Scottish Medicines Consortium |

|1036/15 |(Jaydess®) | | |levonorgestrel (Jaydess) |

| |Bayer |Indication under review: Contraception for up to 3 years. |2nd line formulary choice - only for use in| |

| | | |patients where the Mirena® IUS is | |

| |Contraception for up to 3 years. |A phase III, open-label, randomised study confirmed the contraceptive efficacy of |considered unsuitable. | |

| | |levonorgestrel 13.5mg intrauterine delivery system according to the Pearl Index. | | |

| |Comparator Medicines: | | | |

| |Progestogen-only LARCS: levonorgestrel 52mg IUS | | | |

| |(Mirena®), medroxyprogesterone acetate contraceptive | | | |

| |injection (Depo-Provera® and Sayana Press®), | | | |

| |etonogestrel contraceptive implant (Nexplanon®).7 | | | |

| | | | | |

| |Other contraceptives: combined hormonal contraceptives,| | | |

| |progestogen-only contraceptives, intrauterine devices | | | |

| |(e.g. copper devices). | | | |

|March 2015 |ponatinib 15mg, 45mg film-coated tablets (Iclusig®) |ponatinib (Iclusig®) is accepted for use within NHS Scotland. |Included on the Fife Formulary – additional|Scottish Medicines Consortium |

|1032/15 |ARIAD pharmaceuticals, Inc | |list. |ponatinib (Iclusig) |

| | |Indication under review: Adult patients with | | |

| |Adult patients with |Chronic phase, accelerated phase, or blast phase chronic myeloid leukaemia (CML) who|Restricted use for patients with a T3151 | |

| |Chronic phase, accelerated phase, or blast phase |are resistant to dasatinib or nilotinib; who are intolerant to dasatinib or |mutation or when imatinib, dasatinib and | |

| |chronic myeloid leukaemia (CML) who are resistant to |nilotinib and for whom subsequent treatment with imatinib is not clinically |nilotinib are unsuitable. | |

| |dasatinib or nilotinib; who are intolerant to dasatinib|appropriate; or who have the T315I mutation. | | |

| |or nilotinib and for whom subsequent treatment with |Philadelphia chromosome positive acute lymphoblastic leukaemia (Ph+ALL) who are |Hospital use only. | |

| |imatinib is not clinically appropriate; or who have the|resistant to dasatinib; who are intolerant to dasatinib and for whom subsequent | | |

| |T315I mutation. |treatment with imatinib is not clinically appropriate; or who have the T315I | | |

| |Philadelphia chromosome positive acute lymphoblastic |mutation. | | |

| |leukaemia (Ph+ALL) who are resistant to dasatinib; who | | | |

| |are intolerant to dasatinib and for whom subsequent |A non-comparative phase II study of ponatinib was conducted with primary outcomes of| | |

| |treatment with imatinib is not clinically appropriate; |major cytogenetic response in patients with baseline chronic phase CML and major | | |

| |or who have the T315I mutation. |haematologic response in patients with baseline accelerated or blast phase CML or | | |

| | |Ph+ALL. Ponatinib demonstrated efficacy in heavily pre-treated CML and Ph+ALL | | |

| |Comparator Medicines: |patients who had received dasatinib/nilotinib as second line or further line | | |

| |Current drug treatments for CML include the first |tyrosine kinase inhibitor therapy or who had the T315I mutation. | | |

| |generation tyrosine kinase inhibitor, imatinib | | | |

| |(commonly used first-line) and the second generation |This advice takes account of the views from a Patient and Clinician Engagement | | |

| |tyrosine kinase inhibitors, nilotinib (used first- or |(PACE) meeting. | | |

| |second-line) and dasatinib (which is not recommended by| | | |

| |National Institute for Health and Care Excellence | | | |

| |[NICE] multiple technology appraisals [MTA] 241 and 251| | | |

| |and this advice has been endorsed in Scotland).2,3 | | | |

| |Options in patients with CML and the T315I mutation who| | | |

| |are not suitable for allogenic SCT are considered to be| | | |

| |palliative/supportive therapy and include | | | |

| |hydroxycarbamide and interferon alfa. | | | |

|March 2015 |sucroferric oxyhydroxide 500mg chewable tablets |sucroferric oxyhydroxide (Velphoro®) is accepted for use within NHS Scotland. |Not included on the Fife Formulary as |Scottish Medicines Consortium |

|1035/15 |(Velphoro®) | |clinicians do not support formulary |sucroferric oxyhydroxide |

| |Fresenius Medical Care (UK) Ltd. |Indication under review: For the control of serum phosphorus levels in adult chronic|inclusion. |(Velphoro) |

| | |kidney disease (CKD) patients on haemodialysis (HD) or peritoneal dialysis (PD). It | | |

| |For the control of serum phosphorus levels in adult |should be used within the context of a multiple therapeutic approach, which could | |

| |chronic kidney disease (CKD) patients on haemodialysis |include calcium supplement, 1,25-dihydroxy vitamin D3 or one of its analogues, or | |/formulary/9-nutrition-and-bloo|

| |(HD) or peritoneal dialysis (PD). It should be used |calcimimetics to control the development of renal bone disease. | |d.aspx |

| |within the context of a multiple therapeutic approach, | | | |

| |which could include calcium supplement, 1,25-dihydroxy |After 12 weeks, sucroferric oxyhydroxide was non-inferior to a non-calcium, | |Not preferred. |

| |vitamin D3 or one of its analogues, or calcimimetics to|non-aluminium-based phosphate binder at lowering serum phosphorus levels in adults | | |

| |control the development of renal bone disease |with CKD, receiving HD or PD. | |Current formulary choices are |

| | | | |Calcium salts |

| |Comparator Medicines: | | |lanthanum |

| |Medicines licensed to control serum phosphorus levels | | |sevelamer. |

| |include: calcium salts (calcium acetate and calcium | | | |

| |carbonate), lanthanum carbonate, sevelamer | | | |

| |(hydrochloride and carbonate), aluminium hydroxide and | | | |

| |colestilan. Colestilan is not recommended for use in | | | |

| |NHS Scotland by SMC | | | |

|1007/14 |infliximab, 100mg, powder for concentrate for solution |infliximab (Inflectra®) / Infliximab (Remsima®) is accepted for restricted use |Not included pending protocol. |Scottish Medicines Consortium |

|1006/14 |for infusion (Inflectra®) |within NHS Scotland. | |infliximab (Infectra) |

|November 2014 |Hospira UK Ltd | | |Scottish Medicines Consortium |

|(Issued March | |Indication under review: Rheumatoid arthritis: in combination with methotrexate, for| |infliximab (Remsima) |

|2015) |infliximab, 100mg, powder for concentrate for solution |the reduction of signs and symptoms as well as improvement in physical function in: | | |

| |for infusion (Remsima®) |adult patients with active disease when the response to disease-modifying | |Await finalisation of national |

| |Celltrion Healthcare Hungary Kft. |antirheumatic drugs (DMARDs), including methotrexate has been inadequate; | |biosimilar framework. |

| | |adult patients with severe, active and progressive disease not previously treated | | |

| | |with methotrexate or other DMARDs. | | |

| |Comparator Medicines: | | | |

| |Infliximab (Remicade®). Other biosimilars may become |Infliximab (Inflectra®) / Infliximab (Remsima®) is also indicated in the following | | |

| |available. |conditions: adult and paediatric Crohn’s disease and ulcerative colitis; adult | | |

| | |ankylosing spondylitis, psoriatic arthritis and psoriasis.1 | | |

| | | | | |

| | |SMC restriction: Infliximab (Inflectra®) / Infliximab (Remsima®) is accepted for use| | |

| | |in line with the current SMC and Healthcare Improvement Scotland advice for the | | |

| | |reference product infliximab [Remicade®]. | | |

| | | | | |

| | |A phase III, randomised, double-blind, parallel-group study demonstrated similar | | |

| | |efficacy and safety of biosimilar infliximab with originator infliximab in patients | | |

| | |with rheumatoid arthritis. | | |

| | | | | |

| | |Infliximab (Inflectra®) / Infliximab (Remsima®) is a biosimilar product to a | | |

| | |reference product (infliximab [Remicade®]). The British National Formulary advises | | |

| | |that it is good practice to prescribe biologic medicinal products by brand name. | | |

| | | | | |

| | | | | |

|March 2015 |tacrolimus (as monohydrate) 0.75mg, 1mg and 4mg |tacrolimus (Envarsus®) prolonged release-tablets are accepted for use within NHS |Not included pending protocol. |Scottish Medicines Consortium |

|1041/15 |prolonged- release tablets (Envarsus®) |Scotland. | |tacrolimus (Envarsus) |

| |Chiesi Ltd |Indication under review: Prophylaxis of transplant rejection in adult kidney or | | |

| | |liver allograft recipients and treatment of allograft rejection resistant to | |Await Lothian and Greater |

| |Product Update |treatment with other immunosuppressive medicinal products in adult patients. | |Glasgow and Clyde Formulary |

| | |Tacrolimus (Envarsus®) is suitable for use by patients for whom tacrolimus is an | |Committee decisions. |

| | |appropriate choice of immunosuppressive therapy. It has increased bioavailability | | |

| | |compared with other tacrolimus preparations. Tacrolimus (Envarsus®) has | |Treatment will be initiated in |

| | |demonstrated non-inferiority to a tacrolimus immediate-release capsule and has a | |tertiary centres. |

| | |similar cost per equivalent dose. | | |

|March 2015 |nintedanib 100mg and 150mg soft capsules (Vargatef®) |nintedanib (Vargatef®) is accepted for use within NHS Scotland. |Not included pending protocol. |Scottish Medicines Consortium |

|1027/15 |Boehringer Ingelheim International GmbH | | |nintedanib (Vargatef) |

| | |Indication under review: in combination with docetaxel for the treatment of adult | | |

| |In combination with docetaxel for the treatment of |patients with locally advanced, metastatic or locally recurrent non-small cell lung | |Await SCAN submission to |

| |adult patients with locally advanced, metastatic or |cancer (NSCLC) of adenocarcinoma tumour histology after first-line chemotherapy. | |Lothian Formulary Committee. |

| |locally recurrent non-small cell lung cancer (NSCLC) of|Addition of nintedanib to second-line treatment of stage IIIb/IV NSCLC with | | |

| |adenocarcinoma tumour histology after first-line |docetaxel significantly increased overall survival in the subgroup patients with | | |

| |chemotherapy. |adenocarcinoma tumour histology. | | |

| | |This advice takes account of the benefits of a Patient Access Scheme (PAS) that | | |

| |Comparator Medicines: |improves the cost effectiveness of nintedanib and is contingent upon the continuing | | |

| |Docetaxel, erlotinib and pemetrexed. Gefitinib is not |availability of the PAS in NHS Scotland or a list price that is equivalent or lower.| | |

| |recommended by SMC. |This advice takes account of the views from a Patient and Clinician Engagement | | |

| | |(PACE) meeting. | | |

|March 2015 |regorafenib 40mg film-coated tablet (Stivarga®) |regorafenib (Stivarga®) is accepted for use within NHS Scotland. |Not included pending protocol. |Scottish Medicines Consortium |

|1031/15 |Bayer plc | | |regorafenib (Stivarga) |

| | |Indication under review: Treatment of adult patients with unresectable or metastatic| | |

| |Treatment of adult patients with unresectable or |gastrointestinal stromal tumors (GIST) who progressed on or are intolerant to prior | |Await SCAN submission to |

| |metastatic gastrointestinal stromal tumors (GIST) who |treatment with imatinib and sunitinib. | |Lothian Formulary Committee. |

| |progressed on or are intolerant to prior treatment with| | | |

| |imatinib and sunitinib. |In a study of patients with metastatic or unresectable GIST who had prior treatment | | |

| | |with imatinib and sunitinib, treatment with regorafenib prolonged the median | | |

| |Comparator Medicines: |progression free survival by 3.9 months when compared with placebo. | | |

| |There are no treatments specifically licensed for use | | | |

| |third-line following imatinib and sunitinib. Imatinib |This advice takes account of the benefits of a Patient Access Scheme (PAS) that | | |

| |re-challenge is recommended by Scottish guidelines for |improves the cost-effectiveness of regorafenib and is contingent upon the continuing| | |

| |symptomatic relief in the absence of any suitable |availability of the PAS in NHS Scotland or a list price that is equivalent or lower.| | |

| |clinical study. | | | |

| | | | | |

| | |This advice takes account of the views from a Patient and Clinician Engagement | | |

| | |(PACE) meeting. | | |

| |

|SMC Advice - Deferred Formulary Decisions |

|Date |Product/Manufacturer |SMC Advice |Decision of ADTC |Rationale |

|December 2014 |aztreonam lysine, 75mg, powder and solvent for |aztreonam lysine (Cayston®) is accepted for restricted use within NHS Scotland. |Included on the Fife Formulary for |Scottish Medicines Consortium |

|753/12 |nebuliser solution (Cayston®) | |restricted use in patients where |aztreonam lysine (Cayston) |

| |Gilead Life Sciences Limited |Indication under review: Suppressive therapy of chronic pulmonary infections due to |alternative treatments (colistimethate | |

| | |Pseudomonas aeruginosa in patients with cystic fibrosis aged six years and older. |sodium, inhaled tobramycin) are ineffective| |

| |Re-submission | |or not tolerated. | |

| | |SMC restriction: When inhaled colistimethate sodium and inhaled tobramycin are not | | |

| |Suppressive therapy of chronic pulmonary infections due|tolerated or not providing satisfactory therapeutic benefit (measured as ≥2% decline|Specialist initiation only. | |

| |to Pseudomonas aeruginosa in patients with cystic |in forced expiratory volume in 1 second [FEV1]). | | |

| |fibrosis aged six years and older. | |Formulary status of inhaled tobramycin and | |

| | |Aztreonam lysine has demonstrated superiority in improving lung function and |colistimethate sodium changed to specialist| |

| |Consideration should be given to official guidance on |respiratory symptoms in one active-controlled study and two 28-day |initiation. | |

| |the appropriate use of antibacterial agents. |placebo-controlled studies in patients with cystic fibrosis and chronic Pseudomonas | | |

| | |aeruginosa infection. | | |

| |Comparator Medicines: | | | |

| |Inhaled colistimethate sodium and tobramycin. |This advice takes account of the benefits of a Patient Access Scheme (PAS) that | | |

| | |improves the cost effectiveness of aztreonam lysine. It is contingent upon the | | |

| | |continuing availability of the Patient Access Scheme in NHS Scotland or a list price| | |

| | |that is equivalent or lower. | | |

| | | | | |

| | |This advice takes account of the views from a Patient and Clinician Engagement | | |

| | |(PACE) meeting. | | |

|Summary of Approved Lothian Formulary Committee Decisions for SCAN Medicines February 2015 - March 2015 |

|Product Name |SMC Advice |Place in therapy |Lothian formulary Committee Decision |Add to Fife Formulary |

| | | | |Yes / No |

|Pemetrexed (Alimta®) |Indication under review: monotherapy for the maintenance treatment of |Will be used in patients with performance status 0 |Include on the Additional List, for |Yes |

| |locally advanced or metastatic non-small cell lung cancer other than |or1, non-progression patients of advanced non-squamous|Specialist Hospital Use only, for the | |

| |predominantly squamous cell histology in patients whose disease has not |non-small cell lung |indication in question. |Hospital use only. |

| |progressed immediately following platinum-based chemotherapy. |cancer after 4 cycles of cisplatin and pemetrexed | | |

| | |first-line | | |

| |In patients with locally advanced or metastatic non-squamous non-small cell |chemotherapy. There are no existing treatments | | |

| |lung cancer, maintenance treatment with pemetrexed, following completion of |currently used for maintenance therapy in this | | |

| |first-line platinum-based chemotherapy, was associated with prolonged |setting. | | |

| |overall survival and progression-free survival when compared with placebo. | | | |

| | |The use of pemetrexed maintenance monotherapy has been| | |

| |This advice takes account of the views from a Patient and Clinician |shown to slightly reduce the use of second-line | | |

| |Engagement (PACE) meeting |systemic therapy for NSCLC from 72% to 64%. | | |

| | | | | |

| | |Evidence showed increased survival and added benefit. | | |

| | | | | |

| | |Response to therapy will be assessed by CT scan every | | |

| | |12 weeks (4 cycles). | | |

| | |Patient will attend for bloods (incld. FBC, U&E’s, | | |

| | |LFT’s) and treatment administration every 3 weeks. | | |

| | |Patients will receive the following supportive | | |

| | |treatments: | | |

| | |Dexamethasone PO 4mg BD for 3 days each cycle; | | |

| | |Folic acid PO 400mcg daily throughout treatment, | | |

| | |Vit B12 1mg IM every 9 weeks | | |

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