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SMC ID Date Medicine Submission Type Indication
SMC2276 10/08/2020 vedolizumab (Entyvio) Abbreviated

Treatment of adult patients with moderately to severely active ulcerative colitis who have had an inadequate response with, lost response to, or were intolerant to either conventional therapy or a tumour necrosis factor-alpha (TNFα) antagonist.

SMC2251 10/08/2020 neratinib (Nerlynx) Full

Extended adjuvant treatment of adult patients with early-Etage hormone receptor positive HER2-overexpressed/amplified breast cancer and who completed adjuvant trastuzumab-based therapy less than one year ago.

SMC2277 10/08/2020 vedolizumab (Entyvio) Abbreviated

Treatment of adult patients with moderately to severely active Crohn’s disease who have had an inadequate response with, lost response to, or were intolerant to either conventional therapy or a tumour necrosis factor-alpha (TNFα) antagonist.

SMC2271 10/08/2020 hydroxycarbamide (Xromi) Abbreviated

For the prevention of vaso-occlusive complications of Sickle Cell Disease in patients over 2 years of age.

SMC2235 13/04/2020 insulin glargine/lixisenatide (Suliqua) Full

In combination with metformin for the treatment of adults with type II diabetes mellitus (T2DM), to improve glycaemic control when this has not been provided by metformin alone or metformin combined with another oral glucose-lowering medicinal product or with basal insulin.

SMC2242 13/04/2020 naldemedine (Rizmoic) Full

For the treatment of opioid-induced constipation (OIC) in adult patients who have previously been treated with a laxative.

SMC2250 13/04/2020 ustekinumab (Stelara) Full

For the treatment of adult patients with moderately to severely active ulcerative colitis who have had an inadequate response with, lost response to, or were intolerant to either conventional therapy or a biologic or have medical contraindications to such therapies.

SMC2253 13/04/2020 fampridine (Fampyra) Resubmission

For the improvement of walking in adult patients with multiple sclerosis (MS) with walking disability (EDSS [expanded disability status scale] 4 to 7).

SMC2224 09/03/2020 rucaparib (Rubraca) Full

As monotherapy for the maintenance treatment of adult patients with platinum-sensitive relapsed high-grade epithelial ovarian, fallopian tube, or primary peritoneal cancer who are in response (complete or partial) to platinum-based chemotherapy.

SMC2234 09/03/2020 blinatumomab (Blincyto) Full

As monotherapy for the treatment of adults with Philadelphia chromosome negative CD19 positive B-precursor ALL in first or second complete remission with minimal residual disease (MRD) greater than or equal to 0.1%.

SMC2241 09/03/2020 mexiletine hydrochloride (Namuscla) Full

For the symptomatic treatment of myotonia in adult patients with non-dystrophic myotonic disorders (NDM).

SMC2239 09/03/2020 lorlatinib (Lorviqua) Full

As monotherapy is indicated for the treatment of adult patients with anaplastic lymphoma kinase (ALK) positive advanced non-small cell lung cancer (NSCLC) whose disease has progressed after:

  • alectinib or ceritinib as the first ALK tyrosine kinase inhibitor (TKI) therapy; or
  • crizotinib and at least one other ALK TKI.
SMC2274 09/03/2020 ranibizumab (Lucentis) Non submission

In preterm infants for the treatment of retinopathy of prematurity (ROP) with zone I (stage 1+, 2+, 3 or 3+), zone II (stage 3+) or AP-ROP (aggressive posterior ROP) disease.

SMC2275 09/03/2020 cinacalcet hydrochloride (Mimpara) Non submission

Secondary hyperparathyroidism (HPT)

  • Treatment of secondary HPT in adult patients with end-stage renal disease (ESRD) on maintenance dialysis therapy.
  • Treatment of secondary HPT in children aged 3 years and older with ESRD on maintenance dialysis therapy in whom secondary HPT is not adequately controlled with standard of care therapy.

Parathyroid carcinoma and primary HPT in adults

  • Reduction of hypercalcaemia in adult patients with:
    - parathyroid carcinoma
    - primary HPT for whom parathyroidectomy would be indicated on the basis of serum calcium levels (as defined by   relevant treatment guidelines), but in whom
    parathyroidectomy is not clinically appropriate or is contraindicated
SMC2216 10/02/2020 cemiplimab (Libtayo) Full

As monotherapy for the treatment of adult patients with metastatic or locally advanced cutaneous squamous cell carcinoma (CSCC) who are not candidates for curative surgery or curative radiation.

SMC2225 10/02/2020 teduglutide (Revestive) Resubmission

Treatment of patients aged 1 year and above with short bowel syndrome (SBS). Patients should be stable following a period of intestinal adaptation after surgery.

SMC2233 10/02/2020 sodium zirconium cyclosilicate (Lokelma) Full

Treatment of hyperkalaemia in adult patients

SMC2240 10/02/2020 burosumab (Crysvita) Ultra-orphan initial assessment

For the treatment of X-linked hypophosphataemia (XLH) with radiographic evidence of bone disease in children 1 year of age and older and adolescents with growing skeletons.

SMC2238 10/02/2020 encorafenib (Braftovi) Resubmission

In combination with binimetinib for the treatment of adult patients with unresectable or metastatic melanoma with a BRAF V600 mutation.

SMC2249 10/02/2020 plerixafor (Mozobil) Abbreviated

In combination with granulocyte-colony stimulating factor (G-CSF) to enhance mobilisation of haematopoietic stem cells to the peripheral blood for collection and subsequent autologous transplantation in children aged 1 year to <18 years with lymphoma or solid malignant tumours, either:
- pre-emptively, when circulating stem cell count on the predicted day of collection after adequate mobilisation with G-CSF (with or without chemotherapy) is expected to be insufficient with regards to desired hematopoietic stem cells yield, or
- who previously failed to collect sufficient haematopoietic stem cells.

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Publication due date SMC meeting date Medicine Submission Type Indication
10/08/2020 semaglutide (Rybelsus) Abbreviated

For the treatment of adults with insufficiently controlled type 2 diabetes (T2D) to improve glycaemic control as an adjunct to diet and exercise:

  • As monotherapy when metformin is considered inappropriate due to intolerance or contraindications
  • In combination with other medicinal products for the treatment of diabetes
07/09/2020 caplacizumab (Cablivi) Full

For the treatment of adults experiencing an episode of acquired thrombotic thrombocytopenic purpura (aTTP), in conjunction with plasma exchange and immunosuppression.

07/09/2020 04/08/2020 cannabidiol (Epidyolex) (LGS) Full

As adjunctive therapy of seizures associated with Lennox‑Gastaut syndrome (LGS) in conjunction with clobazam, for patients 2 years of age and older.

07/09/2020 04/08/2020 cannabidiol (Epidyolex) (DS) Full

As adjunctive therapy of seizures associated with  Dravet syndrome (DS) in conjunction with clobazam, for patients 2 years of age and older.

07/09/2020 04/08/2020 pembrolizumab (Keytruda) Full

As monotherapy or in combination with platinum and 5-fluorouracil (5-FU) chemotherapy, is indicated for the first-line treatment of metastatic or unresectable recurrent head and neck squamous cell carcinoma (HNSCC) in adults whose tumours express PD-L1 with a CPS ≥ 1.

07/09/2020 04/08/2020 pembrolizumab (Keytruda) Full

In combination with axitinib, is indicated for the first-line treatment of advanced renal cell carcinoma (RCC) in adults.

07/09/2020 04/08/2020 gilteritinib (Xospata) Full

Monotherapy for the treatment of adult patients who have relapsed or refractory acute myeloid leukaemia (AML) with a FLT3 mutation.

07/09/2020 04/08/2020 esketamine (Spravato) Full

In combination with a selective serotonin reuptake inhibitor (SSRI) or serotonin–norepinephrine reuptake inhibitor (SNRI), for adults with treatment-resistant major depressive disorder, who have not responded to at least two different treatments with antidepressants in the current moderate to severe depressive episode.

07/09/2020 04/08/2020 fluocinolone acetonide (Iluvien) Full

For prevention of relapse in recurrent non-infectious uveitis affecting the posterior segment of the eye (NIU-PS).

07/09/2020 ex vivo expanded autologous human corneal epithelial cells containing stem cells (Holoclar) Full

For the treatment of adult patients with moderate to severe limbal stem cell deficiency (defined by the presence of superficial corneal neovascularisation in at least two corneal quadrants, with central corneal involvement, and severely impaired visual acuity) due to physical or chemical ocular burns. A minimum of 1-2 mm2 of undamaged limbus is required for biopsy.

07/09/2020 andexanet alfa (Ondexxya) Full

For adult patients treated with a direct factor Xa (FXa) inhibitor (apixaban or rivaroxaban) when reversal of anticoagulation is needed due to life-threatening or uncontrolled bleeding.

07/09/2020 polatuzumab vedotin (Polivy) Full

In combination with bendamustine and rituximab for the treatment of adult patients with relapsed/refractory diffuse large B-cell lymphoma (DLBCL) who are not candidates for haematopoietic stem cell transplant.

07/09/2020 brolucizumab (Beovu) Full

For the treatment of neovascular (wet) age-related macular degeneration (wAMD).

07/09/2020 pertuzumab (Perjeta) Resubmission

In combination with trastuzumab and chemotherapy for the adjuvant treatment of adult patients with human epidermal growth factor receptor 2 (HER2)-positive early breast cancer (eBC) at high risk of recurrence.

07/09/2020 sodium zirconium cyclosilicate (Lokelma) Resubmission

For the treatment of hyperkalaemia (HK) in adult patients.

12/10/2020 01/09/2020 avelumab (Bavencio) Full

In combination with axitinib is indicated for the first-line treatment of adult patients with advanced renal cell carcinoma (RCC).

12/10/2020 01/09/2020 siponimod (Mayzent) Full

For the treatment of adult patients with secondary progressive multiple sclerosis (SPMS) with active disease evidenced by relapses or imaging features of inflammatory activity.

12/10/2020 meropenem/vaborbactam (Vaborem) Full

For the treatment of the following infections in adults:

  • Complicated urinary tract infection (cUTI), including pyelonephritis
  • Complicated intra-abdominal infection (cIAI)
  • Hospital-acquired pneumonia (HAP), including ventilator associated pneumonia (VAP)

Treatment of patients with bacteraemia that occurs in association with, or is suspected to be associated with, any of the infections listed above.

The treatment of infections due to aerobic Gram-negative organisms in adults with limited treatment options.

Consideration should be given to official guidance on the appropriate use of antibacterial agents.

12/10/2020 budesonide (Jorveza) Full

For the treatment of eosinophilic esophagitis (EoE) in adults (older than 18 years of age).

12/10/2020 lenalidomide (Revlimid) Full

In combination with rituximab (anti-CD20 antibody) for the treatment of adult patients with previously treated Follicular Lymphoma (Grade 1 - 3a).

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