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SMC ID Date Medicine Submission Type Indication
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.

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

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

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%.

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.

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.

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.

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.

SMC2269 10/02/2020 daratumumab (Darzalex) Non submission

In combination with lenalidomide and dexamethasone for the treatment of adult patients with newly diagnosed multiple myeloma who are ineligible for autologous stem cell transplant.

SMC2268 10/02/2020 apalutamide (Erleada) Non submission

In adult men for the treatment of non-metastatic castration-resistant prostate cancer (NM-CRPC) who are at high risk of developing metastatic disease.

SMC2270 10/02/2020 ranibizumab (Lucentis) Non submission

Treatment of proliferative diabetic retinopathy in adults.

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.

SMC2228 10/02/2020 voretigene neparvovec (Luxturna) Ultra-orphan initial assessment

For the treatment of adult and paediatric patients with vision loss due to inherited retinal dystrophy caused by confirmed biallelic RPE65 mutations and who have sufficient viable retinal cells.

SMC2229 13/01/2020 brentuximab (Adcetris) Full

For the treatment of adult patients with CD30-positive cutaneous T-cell lymphoma (CTCL) after at least one prior systemic therapy.

SMC2226 13/01/2020 fremanezumab (Ajovy) Full

For the prophylaxis of migraine in adults who have at least four migraine days per month.

SMC2223 13/01/2020 ocrelizumab (Ocrevus) Full

For the treatment of adult patients with early primary progressive multiple sclerosis (PPMS) in terms of disease duration and level of disability, and with imaging features characteristic of inflammatory activity.

SMC2215 13/01/2020 abiraterone acetate (Zytiga) Full

with prednisolone for the treatment of adult men with newly diagnosed high-risk metastatic hormone-sensitive prostate cancer (mHSPC) in combination with androgen deprivation therapy (ADT)

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Publication due date SMC meeting date Medicine Submission Type Indication
13/04/2020 03/03/2020 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.

13/04/2020 03/03/2020 naldemedine (Rizmoic) Full

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

13/04/2020 03/03/2020 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.

13/04/2020 03/03/2020 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).

TBC 01/12/2015 oritavancin (Orbactiv) Full Treatment of acute bacterial skin and skin structure infections (ABSSSI) in adults.
TBC 04/07/2017 afamelanotide (Scenesse) Full for prevention of photoxicity in adult patients with erythropoietic protoporphyria (EPP). Scenesse is to be administered under a Post-Authorisation Safety Study (PASS) protocol in line with the approved European Medicines Agency Risk Management Plan.
TBC 02/10/2018 padeliporfin (TOOKAD) Full Indicated as monotherapy for adult patients with previously untreated, unilateral, low-risk, adenocarcinoma of the prostate with a life expectancy ≥ 10 years and: - Clinical stage T1c or T2a, - Gleason Score ≤ 6, based on high-resolution biopsy strategies, - PSA ≤ 10 ng/mL, - 3 positive cancer cores with a maximum cancer core length of 5 mm in any one core or 1-2 positive cancer cores with ≥ 50 % cancer involvement in any one core or a PSA density ≥ 0.15 ng/mL/cm3.
TBC TBC buprenorphine and naloxone (Zubsolv) Abbreviated Substitution treatment for opioid drug dependence.
TBC TBC oritavancin (Orbactiv) Full

For the treatment of acute bacterial skin and skin structure infections (ABSSSI) in adults.

TBC TBC 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.

TBC TBC budesonide (Jorveza) Full

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

TBC TBC semaglutide (Rybelsus) Full

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
TBC TBC sodium zirconium cyclosilicate (Lokelma) Resubmission

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

TBC TBC 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).

TBC TBC 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

TBC TBC fluocinolone acetonide (Iluvien) Full

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

TBC TBC 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.

TBC TBC patiromer (Veltassa) Resubmission

For the treatment of hyperkalaemia in adults.

TBC TBC 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.

TBC TBC 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.

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