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NHS Borders: New Medicines Decisions APRIL 2019 – MARCH 2020

Please note: We are happy to consider requests for other languages or formats. Please contact Pharmacy Admin Office [email protected]

In Scotland, a newly licensed medicine is routinely available in a health board only after it has been: • accepted for use in NHSScotland by the Scottish Medicines Consortium (SMC), and • accepted for use by the health board’s Area Drug and Therapeutics Committee (ADTC).

All medicines accepted by SMC are available in Scotland, but may not be considered ‘routinely available’ within a particular health board because of available services and preferences for alternative medicines. ‘Routinely available’ means that a medicine can be prescribed by the appropriately qualified person within a health board.

Each health board has an ADTC. The ADTC is responsible for advising the health board on all aspects of the use of medicines. Medicines routinely available within a health board are usually included in the local formulary. The formulary is a list of medicines for use in the health board that has been agreed by ADTC in consultation with local clinical experts. It offers a choice of medicines for healthcare professionals to prescribe for common medical conditions. A formulary can help improve safety as prescribers are likely to become more familiar with the medicines in it and also helps make sure that standards of care are consistent across the health board.

How does the health board decide which new medicines to make routinely available for patients? The ADTC in a health board will consider national and local guidance before deciding whether to make a new medicine routinely available.

What national guidance does the ADTC consider? • SMC advice: The SMC considers newly licensed medicines and advises health boards in Scotland whether they should be available. When SMC considers a new medicine for the NHS in Scotland, it looks at: o how well the medicine works, o which patients might benefit from it , o whether it is as good or better than medicines the NHS already uses to treat the medical condition, and o whether it is good value for money. In the table below, national guidance usually refers to SMC advice. Links to SMC advice for individual medicines are also included in the table. • In some cases, other agencies may also provide guidance on how medicines should be used. For example, Healthcare Improvement Scotland issues alerts to advise if National Institute for Health and Care Excellence Multiple Technology Appraisals (NICE MTAs) are applicable in Scotland.

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What local guidance does the ADTC consider? • Advice from local clinical experts who would be expected to prescribe a particular medicine, where that service is available in a health board.

Why is a particular medicine not routinely available in my health board? • This is usually because the medicine is not recommended for use in NHSScotland by the SMC. • The medicine may not be routinely available in a health board, particularly in smaller health boards, because there is not a suitable specialist who may use the medicine. • There may also be differences in which medicines are preferred in health boards. Sometimes SMC accepts more than one medicine for treating a specific medical condition. Clinical experts in each health board consider whether to add new medicines to their formulary and advise the ADTC. Sometimes it is agreed that established medicines are a better choice than new medicines.

What happens if a particular medicine is not routinely available in my health board? • If a medicine is not routinely available and included on your health board’s formulary and there are no suitable alternatives on the formulary, a healthcare professional can request to prescribe a medicine that is not on the formulary if they think you will benefit from using it. All health boards have procedures in place to consider requests when a healthcare professional feels a medicine that is not on the formulary would be right for a particular patient.

NHS Borders board decisions – six options:

• Routinely available in line with national guidance (link to SMC advice) • Routinely available in line with local guidance for prescribing (link, if desired, to local or regional guidance) • Routinely available from a specialist centre in another NHS board • Not routinely available as not recommended for use in NHSScotland (link to relevant SMC advice) • Not routinely available as local clinical experts do not wish to add the medicine to the formulary at this time or there is a local preference for alternative medicines (link to local or regional guidance) • Not routinely available as local implementation plans are being developed or the ADTC is waiting for further advice from local clinical experts – decision expected by (enter date)

The following table lists NHS Borders decisions on new medicines, ordered by MONTH of decision and then A-Z. If you need more information on medicines decisions in NHS Borders, please email Formulary Pharmacist [email protected].

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APRIL 2019 Date SMC Date NHSB Medicine Condition being treated Advice NHS BORDERS decision Decision Published Advice following a full submission Abemaciclib (Verzenios®) is accepted for use within NHSScotland. Indication under review: for the treatment of women with hormone receptor (HR) positive, human epidermal growth factor Not routinely available as local Abemaciclib receptor 2 (HER2) negative locally advanced or metastatic implementation plans are being developed or in combination with an aromatase inhibitor* as Verzenios the ADTC is waiting for further advice from initial endocrine-based therapy, or in women who have received local clinical experts prior endocrine therapy. In a phase III randomised study in SMC2135 - women with HR-positive, HER2-negative advanced breast 13/05/2019 https://www.scottishmedicines.org.uk/medicines- 12/06/2019 Indication 1 - in cancer, abemaciclib in combination with an aromatase inhibitor advice/abemaciclib-verzenios-full-submission- combination with an significantly increased progression-free survival compared with aromatase inhibitor aromatase inhibitor monotherapy. This SMC advice takes smc2135/ account of the benefits of a Patient Access Scheme (PAS) that improves the cost-effectiveness of abemaciclib. This advice is contingent upon the continuing availability of the PAS in NHSScotland or a list price that is equivalent or lower. *For SMC advice relating to the use of abemaciclib in combination with in this setting, please refer to SMC2179. Advice following a full submission assessed under the end of life process Abemaciclib (Verzenios®) is accepted for restricted use within NHSScotland. Indication under review: For the treatment of women with hormone receptor (HR) positive, human epidermal growth factor Not routinely available as local Abemaciclib receptor 2 (HER2) negative locally advanced or metastatic implementation plans are being developed or breast cancer in combination with fulvestrant* as initial the ADTC is waiting for further advice from endocrine-based therapy or in women who have received prior local clinical experts Verzenios endocrine therapy. SMC restriction: for use in women who have progressed on or after (neo) adjuvant endocrine therapy, or 13/05/2019 https://www.scottishmedicines.org.uk/medicines- 12/06/2019 SMC2179 - progressed during first-line endocrine-based therapy for advice/abemaciclib-verzenios-fullsubmission- advanced breast cancer. In a phase III randomised study in Indication 2 - in smc2179/ combination with women with HR-positive, HER2-negative advanced breast cancer who had received prior endocrine therapy, abemaciclib in fulvestrant combination with fulvestrant significantly increased progression- free survival compared with endocrine monotherapy. This SMC advice takes account of the benefit of Patient Access Schemes (PAS) that improve the cost effectiveness of abemaciclib and fulvestrant. This advice is contingent upon the continuing availability of these PAS in NHSScotland or list prices that are Page 3 of 11

equivalent or lower. This advice takes account of the views from a Patient and Clinician Engagement (PACE) meeting. * For SMC advice relating to the use of abemaciclib in combination with an aromatase inhibitor in this setting, please refer to SMC2135. Not routinely available as local clinical Advice following a full submission Cariprazine (Reagila®) is experts do not wish to add the medicine to accepted for restricted use within NHSScotland. Cariprazine the formulary at this time or there is a local Indication under review: the treatment of schizophrenia in adult preference for alternative medicines (link to patients. SMC restriction: for use as a second-line therapy in local or regional guidance) Reagila patients where predominantly negative symptoms have been 13/05/2019 12/06/2019 identified as an important feature. In patients with stable https://www.scottishmedicines.org.uk/medicines- schizophrenia with predominantly negative symptoms, SMC2137 advice/cariprazine-reagila-full-submission-smc2137/ cariprazine improved negative symptoms more than another second-generation antipsychotic.

Advice in the absence of a submission from the holder of the marketing authorisation Chenodeoxycholic acid Not routinely available as not recommended Chenodeoxycholic (Chenodeoxycholic acid Leadiant®) is not recommended for for use in NHSScotland (link to relevant SMC acid use within NHSScotland. advice) Indication under review: for the treatment of inborn errors of Chenodeoxycholic primary bile acid synthesis due to sterol 27 hydroxylase 13/05/2019 https://www.scottishmedicines.org.uk/medicines- 12/06/2019 acid Leadiant deficiency (presenting as cerebrotendinous xanthomatosis) in advice/chenodeoxycholic-acid-chenodeoxycholic-acid- infants, children and adolescents aged 1 month to 18 years and leadiant-non-sub-smc2190/ SMC2190 adults. 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. Advice in the absence of a submission from the holder of the marketing authorisation is not Daratumumab (Darzalex®) Not routinely available as not recommended Daratumumab recommended for use within NHSScotland. for use in NHSScotland (link to relevant SMC Indication under review: in combination with , advice) Darzalex and prednisone for the treatment of adult patients 13/05/2019 12/06/2019 with newly diagnosed multiple myeloma who are ineligible for https://www.scottishmedicines.org.uk/medicines- autologous stem cell transplant. The holder of the marketing advice/daratumumab-darzalex-non-sub-smc2191/ SMC2191 authorisation has not made a submission to SMC regarding this product in this setting. As a result we cannot recommend its use within NHSScotland. Advice in the absence of a submission from the holder of the Not routinely available as not recommended marketing authorisation Dasatinb (Sprycel®) is not for use in NHSScotland (link to relevant SMC recommended for use within NHSScotland. 13/05/2019 advice) 12/06/2019 Sprycel Indication under review: the treatment of paediatric patients with newly diagnosed Philadelphia chromosome positive acute https://www.scottishmedicines.org.uk/medicines-

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SMC2192 lymphoblastic leukaemia in combination with . The advice/dasatinib-sprycel-non-sub-smc2192/ holder of the marketing authorisation has not made a submission to SMC regarding this product in this setting. As a result we cannot recommend its use within NHSScotland. Advice following a full submission Doxylamine succinate and pyridoxine hydrochloride (Xonvea®) is not recommended for Not routinely available as not recommended Doxylamine use within NHSScotland. succinate/pyridoxi for use in NHSScotland (link to relevant SMC Indication under review: the treatment of nausea and vomiting of ne hydrochloride advice) pregnancy in women who do not respond to conservative 13/05/2019 12/06/2019 management. Doxylamine in combination with pyridoxine https://www.scottishmedicines.org.uk/medicines- Xonvea significantly improved symptoms of nausea and vomiting advice/doxylamine-succinate-and-pyridoxine- compared with placebo in women with nausea and vomiting of hydrochloride-xonvea-full-submission-smc2140/ SMC2140 pregnancy. The submitting company did not present a sufficiently robust clinical or economic analysis to gain acceptance by SMC. Advice following a full submission considered under the orphan equivalent process Pembrolizumab (Keytruda®) is accepted for use within NHSScotland. Indication under review: As monotherapy for the adjuvant treatment of adults with Stage III melanoma and lymph node Not routinely available as local Pembrolizumab involvement who have undergone complete resection. implementation plans are being developed or Recurrence-free survival was significantly longer in the the ADTC is waiting for further advice from Keytruda pembrolizumab group compared with placebo in a phase III 13/05/2019 local clinical experts 12/06/2019 study of adult patients with completely resected, stage III melanoma with lymph node involvement. This SMC advice https://www.scottishmedicines.org.uk/medicines- SMC2144 takes account of the benefits of a Patient Access Scheme (PAS) advice/pembrolizumab-keytruda-full-submission- that improves the cost-effectiveness of pembrolizumab. This smc2144/ advice is contingent upon the continuing availability of the PAS in NHSScotland or a list price that is equivalent or lower. This advice takes account of views from a Patient and Clinician Engagement (PACE) meeting. Advice in the absence of a submission from the holder of the Not routinely available as not recommended marketing authorisation Rituximab (MabThera®) is not recommended for use within NHSScotland. for use in NHSScotland (link to relevant SMC advice) MabThera Indication under review: treatment of patients with moderate to 13/05/2019 12/06/2019 severe pemphigus vulgaris. The holder of the marketing https://www.scottishmedicines.org.uk/medicines- authorisation has not made a submission to SMC regarding this advice/rituximab-mabthera-non-sub-smc2193/ SMC2193 product in this setting. As a result we cannot recommend its use within NHSScotland.

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MAY 2019 Date SMC Date NHSB Medicine Condition being treated Advice NHS BORDERS decision Decision Published Advice in the absence of a submission from the holder of the marketing authorisation Alirocumab (Praluent®) is not recommended for use within NHSScotland. Indication under review: In adults with established atherosclerotic cardiovascular disease to reduce cardiovascular Not routinely available as not recommended Alirocumab risk by lowering LDL-C levels, as an adjunct to correction of other risk factors: • in combination with the maximum tolerated for use in NHSScotland (link to relevant SMC dose of a statin with or without other lipid-lowering therapies or, advice) Praluent • alone or in combination with other lipid-lowering therapies in 13/06/2019 10/07/2019 patients who are statin-intolerant, or for whom a statin is https://www.scottishmedicines.org.uk/medicines- SMC2201 contraindicated. The holder of the marketing authorisation has advice/alirocumab-praluent-nonsubmission-smc2201/ not made a submission to SMC regarding this product in this setting. As a result we cannot recommend its use within NHSScotland in adults with established atherosclerotic cardiovascular disease outwith the restriction specified in SMC advice (1147/16). Note that SMC advice (1147/16) remains valid. Advice following a full submission Benralizumab (Fasenra®) is accepted for restricted use within NHSScotland. Indication under review: As an add-on maintenance treatment in adult patients with severe eosinophilic asthma inadequately controlled despite high-dose inhaled corticosteroids plus long- Not routinely available as local clinical acting β-agonists. SMC restriction: patients with blood experts do not wish to add the medicine to Benralizumab eosinophils ≥150 cells/microlitre, and either ≥4 prior asthma the formulary at this time or there is a local exacerbations needing systemic corticosteroids in the previous preference for alternative medicines (link to Fasenra 12 months or treatment with continuous oral corticosteroids over 13/06/2019 10/07/2019 the previous 6 months. Benralizumab, compared with placebo, local or regional guidance) reduced asthma exacerbation rates and was associated with SMC2155 greater reductions in continuous oral corticosteroid dose while https://www.scottishmedicines.org.uk/medicines- maintaining stable asthma in patients with severe eosinophilic advice/benralizumab-fasenra-fullsubmission-smc2155/ asthma. This SMC advice takes account of the benefit of a Patient Access Scheme (PAS) that improves the cost effectiveness of benralizumab. This advice is contingent upon the continuing availability of the PAS in NHSScotland or a list price that is equivalent or lower. Brentuximab Not routinely available as not recommended Advice in the absence of a submission from the holder of the 13/06/2019 10/07/2019 vedotin marketing authorisation (Adcetris®) is for use in NHSScotland (link to relevant SMC Page 6 of 11

not recommended for use within NHSScotland. advice) Adcetris Indication under review: treatment of adult patients with https://www.scottishmedicines.org.uk/medicines- previously untreated CD30+ Stage IV Hodgkin lymphoma in combination with , and . The advice/brentuximab-vedotin-adcetris-nonsubmission- SMC2202 holder of the marketing authorisation has not made a submission smc2202/ to SMC regarding this product in this setting. As a result we cannot recommend its use within NHSScotland. Advice following a full submission assessed under the end-of-life and ultra-orphan medicine process (Alunbrig®) is accepted for use within NHSScotland. Indication under review: as monotherapy for the treatment of Not routinely available as local clinical adult patients with anaplastic lymphoma kinase (ALK) positive experts do not wish to add the medicine to Brigatinib advanced non-small cell lung cancer (NSCLC) previously treated the formulary at this time or there is a local with . Brigatinib was associated with an objective preference for alternative medicines (link to Alunbrig response rate of 56% in a single-arm, open-label, phase II study 13/06/2019 10/07/2019 in patients with ALK-positive NSCLC who had progressed on local or regional guidance) first-line targeted treatment with crizotinib. This SMC advice SMC2147 takes account of the benefits of a Patient Access Scheme (PAS) https://www.scottishmedicines.org.uk/medicines- that improves the cost-effectiveness of brigatinib. This advice is advice/brigatinib-alunbrig-full-submission-smc2147/ contingent upon the continuing availability of the PAS in NHS Scotland or a list price that is equivalent or lower. This advice takes account of views from a Patient and Clinician Engagement (PACE) meeting. Advice following a full submission considered under the ultra- orphan and end of life process Durvalumab (Imfinzi®) is accepted for use within NHSScotland. Indication under review: as monotherapy for the treatment of locally advanced, unresectable non-small cell lung cancer Not routinely available as local clinical (NSCLC) in adults whose tumours express PD-L1 [programmed experts do not wish to add the medicine to Durvalumab cell death ligand 1] on ≥1% of tumour cells and whose disease has not progressed following platinum-based chemoradiation the formulary at this time or there is a local therapy. Durvalumab, compared with placebo, improved preference for alternative medicines (link to Imfinzi progression-free survival and overall survival in adults who have 13/06/2019 local or regional guidance) 10/07/2019 locally advanced unresectable NSCLC with PD-L1 expressed on SMC2156 ≥1% of tumour cells and disease that has not progressed https://www.scottishmedicines.org.uk/medicines- following platinum-based chemoradiation therapy. This SMC advice/durvalumab-imfinzi-fullsubmission-smc2156/ advice takes account of the benefits of a Patient Access Scheme (PAS) that improves the cost-effectiveness of durvalumab. This advice is contingent upon the continuing availability of the PAS in NHSScotland or a list price that is equivalent or lower. This advice takes account of views from a Patient and Clinician Engagement (PACE) meeting. Page 7 of 11

Advice following an abbreviated submission Fingolimod (Gilenya®) is accepted for use within NHSScotland. Indication under review: as a single disease modifying therapy in highly active relapsing remitting multiple sclerosis for the following groups of patients aged 10 to <18 years:- Patients with Fingolimod highly active disease despite a full and adequate course of May be routinely available from a specialist treatment with at least one disease modifying therapy. Or - centre in another NHS board Patients with rapidly evolving severe relapsing remitting multiple Gilenya 13/06/2019 10/07/2019 sclerosis defined by two or more disabling relapses in one year, https://www.scottishmedicines.org.uk/medicines- and with one or more gadolinium enhancing lesions on brain advice/fingolimod-gilenya-abb-paed-lic-ext-smc2154/ MRI or a significant increase in T2 lesion load as compared to a SMC2154 previous MRI. SMC has previously accepted fingolimod for use in adults in both of these patient groups. This SMC advice takes account of the benefits of a Patient Access Scheme (PAS) that improves the cost-effectiveness of fingolimod. This advice is contingent upon the continuing availability of the PAS in NHS Scotland or a list price that is equivalent or lower. Advice following an abbreviated submission Fluticasone propionate/formoterol fumarate (flutiform®) is accepted for Not routinely available as local clinical use within NHSScotland. experts do not wish to add the medicine to Fluticasone / Indication under review: the regular treatment of asthma in the formulary at this time or there is a local formoterol children aged 5 to 12 years where the use of a combination preference for alternative medicines (link to product (an inhaled corticosteroid and a long-acting β2 agonist) 13/06/2019 local or regional guidance) 10/07/2019 Flutiform is appropriate:• For patients not adequately controlled with inhaled corticosteroids and 'as required' inhaled short-acting β2 https://www.scottishmedicines.org.uk/medicines- agonist.Or • For patients already adequately controlled on both SMC2178 an inhaled corticosteroid and a long-acting β2 agonist. SMC has advice/fluticasoneformoterol-flutiform- previously accepted fluticasone propionate/formoterol fumarate abbreviatedpaediatriclicext-smc2178/ for use in adults and adolescents aged 12 years and above with asthma where the use of a combination product is appropriate. Advice in the absence of a submission from the holder of the marketing authorisation Golimumab (Simponi®) is not Not routinely available as not recommended Golimumab recommended for use within NHSScotland. for use in NHSScotland (link to relevant SMC Indication under review: in combination with for the advice) Simponi treatment of polyarticular juvenile idiopathic arthritis in children 2 13/06/2019 10/07/2019 years of age and older who have responded inadequately to https://www.scottishmedicines.org.uk/medicines- previous therapy with methotrexate. The holder of the marketing advice/golimumab-simponi-nonsubmission-smc2203/ SMC2203 authorisation has not made a submission to SMC regarding this product in this indication. As a result we cannot recommend its use within NHSScotland. Nivolumab Advice following a full submission assessed under the end of 13/06/2019 Not routinely available as local clinical 10/07/2019 Page 8 of 11

life process Nivolumab (Opdivo®) is accepted for use within experts do not wish to add the medicine to Opdivo NHSScotland. the formulary at this time or there is a local Indication under review: in combination with ipilimumab for the preference for alternative medicines (link to first-line treatment of adult patients with intermediate/poor-risk SMC2153 local or regional guidance) advanced renal cell carcinoma (RCC). Overall survival was significantly longer in the nivolumab plus ipilimumab group https://www.scottishmedicines.org.uk/medicines- compared with a multiple receptor tyrosine kinase inhibitor in a advice/nivolumab-opdivo-fullsubmission-smc2153/ phase III study in treatment naïve patients with intermediate/poor-risk advanced RCC. This SMC advice takes account of the benefits of a Patient Access Scheme (PAS) that improves the cost-effectiveness of nivolumab in combination with ipilimumab Advice following a full submission assessed under the ultra- orphan medicine process Patisiran (Onpattro®) is accepted for use within NHSScotland. Indication under review: the treatment of hereditary transthyretin- mediated amyloidosis (hATTR amyloidosis) in adult patients with Patisiran stage 1 or stage 2 polyneuropathy. In a phase III study of adults May be routinely available from a specialist with hATTR amyloidosis and polyneuropathy, patisiran was centre in another NHS board associated with significant improvements compared with Onpattro 13/06/2019 10/07/2019 placebo, measured by the change in modified neuropathy https://www.scottishmedicines.org.uk/medicines- impairment score +7 (mNIS+7) from baseline to 18 months. advice/patisiran-onpattro-fullsubmission-smc2157/ SMC2157 This SMC advice takes account of the benefit of a Patient Access Schemes (PAS) that improves the cost- effectiveness of patisiran. This advice is contingent upon the continuing availability of the PAS in NHSScotland or a list price that is equivalent or lower. This advice takes account of views from a Patient and Clinician Engagement (PACE) meeting.

JUNE 2019 Date SMC Date NHSB Medicine Condition being treated Advice NHS BORDERS decision Decision Published Advice following a resubmission Arsenic trioxide (Trisenox®) Not routinely available as local clinical is accepted for use within NHSScotland. experts do not wish to add the medicine to Indication under review: in combination with all-trans-retinoic Trisenox the formulary at this time or there is a local acid (ATRA []) for the induction of remission, and 08/07/2019 preference for alternative medicines (link to 10/07/2019 consolidation in adult patients with newly diagnosed, low-to- local or regional guidance) intermediate risk acute promyelocytic leukaemia (APL) (white blood cell count ≤10 x 103/µl), characterised by the presence of SMC2181 https://www.scottishmedicines.org.uk/medicines- the t(15;17) translocation and/or the presence of the Pro Page 9 of 11

Myelocytic Leukaemia/Retinoic-Acid-Receptor-alpha (PML/RAR- advice/arsenic-trioxide-trisenox-resubmission- alpha) gene. In a Phase III study in patients with newly smc2181/ diagnosed, low-to-intermediate risk APL, arsenic trioxide was non-inferior to -based chemotherapy (both in combination with tretinoin) measured by event-free survival. A significant difference in overall survival favouring arsenic trioxide was also demonstrated. Advice following a full submission considered under the orphan assessment process Daratumumab (Darzalex®) is accepted for restricted use within NHSScotland. Indication under review: In combination with lenalidomide and dexamethasone, or bortezomib and dexamethasone, for the treatment of adult patients with multiple myeloma who have Not routinely available as local clinical received at least one prior therapy. SMC restriction: in experts do not wish to add the medicine to Daratumumab combination with bortezomib and dexamethasone, for the the formulary at this time or there is a local treatment of adult patients with multiple myeloma who have preference for alternative medicines (link to received one prior therapy only. Progression-free survival was Darzalex significantly longer in patients who received daratumumab in 08/07/2019 local or regional guidance) 10/07/2019 combination with bortezomib and dexamethasone compared https://www.scottishmedicines.org.uk/medicines- SMC2180 with those who received bortezomib and dexamethasone in a phase III study in patients with multiple myeloma who had advice/daratumumab-darzalex-fullsubmission- received at least one prior therapy. This SMC advice takes smc2180/ account of the benefits of a Patient Access Scheme (PAS) that improves the cost-effectiveness of daratumumab. This advice is contingent upon the continuing availability of the PAS in NHSScotland or a list price that is equivalent or lower. This advice takes account of the views from a Patient and Clinician Engagement (PACE) meeting. Advice following a full submission assessed under the orphan medicine process Darvadstrocel (Alofisel®) is not recommended for use within NHSScotland. Indication under review: For the treatment of complex perianal Not routinely available as not recommended Darvadstrocel fistulas in adult patients with non-active / mildly active luminal for use in NHSScotland (link to relevant SMC Crohn’s disease, when fistulas have shown an inadequate advice) Alofisel response to at least one conventional or biologic therapy. In a 08/07/2019 10/07/2019 randomised, double-blind, phase III study, the rate of combined https://www.scottishmedicines.org.uk/medicines- remission at week 24 was significantly higher with darvadstrocel advice/darvadstrocel-alofisel-fullsubmission-smc2115/ SMC2115 than placebo in patients with Crohn’s disease and complex perianal fistulas. The submitting company did not present a sufficiently robust economic analysis to gain acceptance by SMC. This advice takes account of views from a Patient and Clinician Engagement (PACE) meeting. Page 10 of 11

Advice following a full submission assessed under the end of life and orphan medicine process (Braftovi®) is not recommended for use within NHSScotland. Not routinely available as not recommended Encorafenib Indication under review: In combination with for the treatment of adult patients with unresectable or metastatic for use in NHSScotland (link to relevant SMC melanoma with a BRAF V600 mutation. Progression-free advice) Braftovi survival was significantly longer in the encorafenib plus 08/07/2019 12/07/2019 binimetinib group compared with BRAF inhibitor monotherapy in https://www.scottishmedicines.org.uk/medicines- SMC2145 a phase III study of patients with unresectable or metastatic advice/encorafenib-braftovi-full-submission-smc2145/ BRAF V600 melanoma. The submitting company did not present a sufficiently robust economic analysis to gain acceptance by SMC. This advice takes account of views from a Patient and Clinician Engagement (PACE) meeting. Advice following a full submission considered under the end of life and orphan equivalent assessment process (Ibrance®) is accepted for use within NHSScotland. Indication under review: for the treatment of hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative locally advanced or metastatic breast cancer: Not routinely available as local clinical - in combination with an aromatase inhibitor; - in combination experts do not wish to add the medicine to Palbociclib with fulvestrant in women who have received prior endocrine the formulary at this time or there is a local therapy. In pre- or perimenopausal women, the endocrine preference for alternative medicines (link to therapy should be combined with a luteinizing hormone- local or regional guidance) Ibrance releasing hormone (LHRH) agonist. This submission relates to 08/07/2019 10/07/2019 use in combination with fulvestrant in women who have received https://www.scottishmedicines.org.uk/medicines- SMC2149 prior endocrine therapy. In a phase III study palbociclib plus advice/palbociclib-ibrance-full-submission-smc2149/ fulvestrant, compared with fulvestrant, prolonged progression- free survival in women with HR-positive HER2-negative locally

advanced or metastatic breast cancer who had received prior endocrine therapy. This SMC advice takes account of the benefits of Patient Access Schemes (PAS) that improve the cost-effectiveness of palbociclib and fulvestrant. This advice is contingent upon the continuing availability of these PAS in NHSScotland or list prices that are equivalent or lower.

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