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SMC ID Date Medicine Submission Type Indication
SMC2287 07/09/2020 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
SMC2273 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.

SMC2272 07/09/2020 brolucizumab (Beovu) Full

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

SMC2262 07/09/2020 cannabidiol (Epidyolex) Full

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

SMC2263 07/09/2020 cannabidiol (Epidyolex) Full

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

SMC2266 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.

SMC2261 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.

SMC2258 07/09/2020 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.

SMC2260 07/09/2020 fluocinolone acetonide (Iluvien) Full

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

SMC2252 07/09/2020 gilteritinib (Xospata) Full

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

SMC2247 07/09/2020 pembrolizumab (Keytruda) Full

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

SMC2257 07/09/2020 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.

SMC2284 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.

SMC2282 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.

SMC2288 07/09/2020 sodium zirconium cyclosilicate (Lokelma) Resubmission

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

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.

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Publication due date SMC meeting date Medicine Submission Type Indication
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).

12/10/2020 01/09/2020 lenalidomide (Revlimid) Full

As monotherapy is indicated in multiple myeloma (MM) for the maintenance treatment of adult patients with newly diagnosed MM who have undergone autologous stem cell transplantation (ASCT).

12/10/2020 01/09/2020 carfilzomib (Kyprolis) Resubmission

In combination with lenalidomide and dexamethasone for the treatment of adult patients with multiple myeloma who have received at least one prior therapy

12/10/2020 01/09/2020 cerliponase alfa (Brineura) Ultra-orphan initial assessment

For the treatment of neuronal ceroid lipofuscinosis type 2 (CLN2) disease, also known as tripeptidyl peptidase 1 (TPP1) deficiency.

12/10/2020 01/09/2020 ibrutinib (Imbruvica) Full

In combination with rituximab for the treatment of adult patients with Waldenström's macroglobulinaemia.

09/11/2020 06/10/2020 romosozumab (Evenity) Full

Treatment of severe osteoporosis in postmenopausal women at high risk of fracture.

09/11/2020 06/10/2020 patiromer (Veltassa) Resubmission

For the treatment of hyperkalaemia in adults.

09/11/2020 06/10/2020 atezolizumab (Tecentriq) Full

In combination with carboplatin and etoposide, is indicated for the first-line treatment of adult patients with extensive-stage small cell lung cancer.

09/11/2020 06/10/2020 volanesorsen sodium (Waylivra) Ultra-orphan initial assessment

As an adjunct to diet in adult patients with genetically confirmed familial chylomicronaemia syndrome (FCS) and at high risk for pancreatitis, in whom response to diet and triglyceride lowering therapy has been inadequate.

09/11/2020 06/10/2020 trabectedin (Yondelis) Resubmission

Treatment of adult patients with advanced soft tissue sarcoma, after failure of anthracyclines and ifosfamide, or who are unsuited to receive these agents.  Efficacy data are based mainly on liposarcoma and leiomyosarcoma patients.

07/12/2020 03/11/2020 bempedoic acid (Nilemdo) Full

In adults with primary hypercholesterolaemia (heterozygous familial and non‑familial) or mixed dyslipidaemia, as an adjunct to diet:

  • in combination with a statin or statin with other lipid-lowering therapies in patients unable to reach LDL‑C goals with the maximum tolerated dose of a statin; or,
  • alone or in combination wtih other lipid-lowering therapies in patients who are statin-intolerant, or for whom a statis is contraindicated.
07/12/2020 03/11/2020 mexiletine (Namuscla) Resubmission

Symptomatic treatment of myotonia in adult patients with non-dystrophic myotonic disorders.

07/12/2020 03/11/2020 avatrombopag (Doptelet) Full

For the treatment of severe thrombocytopenia in adult patients with chronic liver disease who are scheduled to undergo an invasive procedure.

07/12/2020 03/11/2020 venetoclax (Venclyxto) Full

In combination with obinutuzumab (VenG) is indicated for the treatment of adult patients with previously untreated chronic lymphocytic leukaemia (CLL).

07/12/2020 03/11/2020 trastuzumab emtansine (Kadcyla) Full

As a single agent, for the adjuvant treatment of adult patients with HER2-positive early breast cancer who have residual invasive disease, in the breast and / or lymph nodes, after neoadjuvant taxane-based and HER2-targeted therapy.

11/01/2021 01/12/2020 daratumumab (Darzalex) Full

In combination with bortezomib, thalidomide and dexamethasone for the treatment of adult patients with newly diagnosed multiple myeloma who are eligible for autologous stem cell transplant.

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