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SMC ID Date Medicine Submission Type Indication
SMC2197 07/10/2019 pertuzumab (Perjeta) Full

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.

SMC2195 07/10/2019 enzalutamide (Xtandi) Full

For the treatment of adult men with high-risk non-metastatic castration-resistant prostate cancer (nmCRPC). High-risk is defined as prostate specific antigen (PSA) doubling time (PSADT) ≤10 months and PSA ≥2 ng/mL.

SMC2186 07/10/2019 triptorelin acetate (Decapeptyl) Full

Triptorelin (Decapeptyl SR 3 mg), a gonadotropin-releasing-hormone (GnRH) agonist, is indicated as adjuvant treatment, in combination with tamoxifen or an aromatase inhibitor, of endocrine responsive early stage breast cancer in women at high risk of recurrence who are confirmed as pre-menopausal after completion of chemotherapy.

SMC2196 07/10/2019 risankizumab (Skyrizi) Full

For the treatment of moderate to severe plaque psoriasis in adults who are candidates for systemic therapy.

SMC2207 07/10/2019 pembrolizumab (Keytruda) Resubmission

In combination with pemetrexed and platinum chemotherapy, is indicated for the first-line treatment of metastatic non-squamous NSCLC in adults whose tumours have no EGFR or ALK positive mutations.

SMC2189 07/10/2019 axicabtagene ciloleucel (Yescarta) Resubmission

Treatment of adult patients with relapsed or refractory diffuse large B cell lymphoma (DLBCL) and primary mediastinal large B cell lymphoma (PMBCL), after two or more lines of systemic therapy.

SMC2236 07/10/2019 eculizumab (Soliris) Non submission

Treatment of adults with refractory generalised myasthenia gravis who are anti-acetylcholine receptor antibody-positive. 

SMC2237 07/10/2019 glibenclamide (Amglidia) Non submission

Treatment of neonatal diabetes mellitus, for use in newborns, infants and children.

SMC2187 09/09/2019 pembrolizumab (Keytruda) Full

In combination with carboplatin and either paclitaxel or nab-paclitaxel, is indicated for the first-line treatment of metastatic squamous NSCLC in adult.

SMC2231 09/09/2019 eribulin (Halaven) Non submission

Treatment of adult patients with unresectable liposarcoma who have received prior anthracycline containing therapy (unless unsuitable) for advanced or metastatic disease.

SMC2205 09/09/2019 dolutegravir lamivudine (Dovato) Abbreviated

Treatment of Human Immunodeficiency Virus type 1 (HIV-1) infection in adults and adolescents above 12 years of age weighing at least 40 kg, with no known or suspected resistance to the integrase inhibitor class, or lamivudine.

SMC2200 09/09/2019 tisagenlecleucel (Kymriah) Resubmission

For the treatment of adult patients with relapsed or refractory (r/r) diffuse large B cell lymphoma (DLBCL) after two or more lines of systemic therapy.

SMC2185 09/09/2019 dapagliflozin (Forxiga) Full

In adults for the treatment of insufficiently controlled T1DM as an adjunct to insulin in patients with BMI ≥ 27 kg/m2, when insulin alone does not provide adequate glycaemic control despite optimal insulin therapy.

SMC2170 09/09/2019 ospemifene (Senshio) Full

For the treatment of moderate to severe symptomatic vulvar and vaginal atrophy in post-menopausal women who are not candidates for local vaginal oestrogen therapy.

SMC2184 09/09/2019 dacomitinib (Vizimpro) Full

As monotherapy for the first-line treatment of adult patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) with epidermal growth factor receptor (EGFR)-activating mutations.

SMC2168 09/09/2019 melatonin (Slenyto) Full

Treatment of insomnia in children and adolescents aged 2-18 with autism spectrum disorder (ASD) and / or Smith-Magenis syndrome, where sleep hygiene measures have been insufficient.

SMC2171 09/09/2019 osimertinib (Tagrisso) Full

As monotherapy for the first-line treatment of adult patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) with activating epidermal growth factor receptor (EGFR) mutations.

SMC2219 12/08/2019 pomalidomide (Imnovid) Non submission

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

SMC2217 12/08/2019 lenalidomide (Revlimid) Non submission

As combination therapy with bortezomib and dexamethasone for the treatment of adult patients with previously untreated multiple myeloma who are not eligible for transplant.

SMC2183 12/08/2019 tezacaftor-ivacaftor (Symkevi) Full

In a combination regimen with ivacaftor 150 mg tablets for the treatment of patients with cystic fibrosis (CF) aged 12 years and older who are homozygous for the F508del mutation or who are heterozygous for the F508del mutation and have one of the following mutations in the cystic fibrosis transmembrane conductance regulator (CFTR) gene: P67L, R117C, L206W, R352Q, A455E, D579G, 711+3A→G, S945L, S977F, R1070W, D1152H, 2789+5G→A, 3272-26A→G, and 3849+10kbC→T.

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Publication due date SMC meeting date Medicine Submission Type Indication
11/11/2019 01/10/2019 pentosan polysulfate sodium (Elmiron) Full

For the treatment of adults with bladder pain syndrome characterised by either glomerulations or Hunner’s lesions with moderate to severe pain, urgency and frequency of micturition.

11/11/2019 01/10/2019 trientine tetrahydrochloride (Cuprior) Abbreviated For the treatment of Wilson's disease in adults, adolescents and children ≥ 5 years intolerant to D-penicillamine therapy.
11/11/2019 01/10/2019 lenvatinib (Kisplyx) Full

In combination with everolimus for the treatment of adult patients with advanced renal cell carcinoma (RCC) following one prior vascular endothelial growth factor (VEGF)-targeted therapy.

11/11/2019 01/10/2019 ribociclib (Kisqali) Full

For the treatment of women with hormone receptor (HR) positive, human epidermal growth factor receptor 2 (HER2) negative locally advanced or metastatic breast cancer in combination with fulvestrant as initial endocrine-based therapy, or in women who have received prior endocrine therapy.

11/11/2019 01/10/2019 atezolizumab (Tecentriq) Full

In combination with bevacizumab, paclitaxel and carboplatin, is indicated for the first-line treatment of adult patients with metastatic non-squamous non‑small cell lung cancer (NSCLC). In patients with EGFR mutant or ALK-positive NSCLC, atezolizumab, in combination with bevacizumab, paclitaxel and carboplatin, is indicated only after failure of appropriate targeted therapies.

11/11/2019 01/10/2019 imiquimod (Zyclara) Full Topical treatment of clinically typical, nonhyperkeratotic, nonhypertrophic, visible or palpable actinic keratosis (AK) of the full face or balding scalp in immunocompetent adults when other topical treatment options are contraindicated or less appropriate.
11/11/2019 01/10/2019 clostridium botulinum neurotoxin type A (Xeomin) Full Adult patients with chronic sialorrhoea due to neurological conditions.
11/11/2019 01/10/2019 glecaprevir/pibrentasvir (Maviret) Abbreviated For treatment of chronic hepatitis C virus (HCV) infection in adults and in adolescents aged 12 to <18 years.
09/12/2019 05/11/2019 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.

09/12/2019 05/11/2019 lusutrombopag (Mulpleo) Full

For the treatment of severe thrombocytopenia in adult patients with chronic liver disease undergoing invasive procedures.

13/01/2020 03/12/2019 dupilumab (Dupixent) Abbreviated

For the treatment of moderate-to-severe atopic dermatitis in adult and adolescents 12 years and older who are candidates for systemic therapy

13/01/2020 03/12/2019 fremanezumab (Ajovy) Full

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

10/02/2020 07/01/2020 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.

10/02/2020 07/01/2020 sodium zirconium cyclosilicate (Lokelma) Full

Treatment of hyperkalaemia in adult patients

10/02/2020 07/01/2020 encorafenib (Braftovi) Resubmission

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

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 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.

Q4 2019 Q4 2019 lanadelumab (Takhzyro) Full For routine prevention of recurrent attacks of hereditary angioedema (HAE) in patients aged 12 years and older.
Q4 2019 Q4 2019 olaparib (Lynparza) Full As monotherapy for the maintenance treatment of adult patients with newly diagnosed advanced (FIGO stages III and IV) BRCA1/2‐mutated (germline and/or somatic) high‐grade epithelial ovarian, fallopian tube or primary peritoneal cancer who are in response (complete or partial) following completion of first line platinum‐based chemotherapy.
Q4 2019 Q4 2019 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.
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