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SMC ID Date Medicine Submission Type Indication
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)

SMC2232 13/01/2020 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

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.

SMC2206 09/12/2019 lanadelumab (Takhzyro) Full

For routine prevention of recurrent attacks of hereditary angioedema (HAE) in patients aged 12 years and older.

SMC2209 09/12/2019 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.

SMC2213 09/12/2019 ruxolitinib (Jakavi) Full

The treatment of adult patients with polycythaemia vera (PV) who are resistant to or intolerant of hydroxyurea (HU).

SMC2227 09/12/2019 lusutrombopag (Mulpleo) Full

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

SMC2210 09/12/2019 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.

SMC2254 09/12/2019 atezolizumab (Tecentriq) Non submission

In combination with nab-paclitaxel and carboplatin for the first-line treatment of adult patients with metastatic non-squamous non-small cell lung cancer (NSCLC) who do not have EGFR mutant or ALK-positive NSCLC.

SMC2255 09/12/2019 prasterone (Intrarosa) Non submission

Treatment of vulvar and vaginal atrophy in postmenopausal women having moderate to severe symptoms.

SMC2256 09/12/2019 ceftolozane/tazobactam (Zerbaxa) Non submission

In adults for the treatment of hospital acquired pneumonia, including ventilator-associated pneumonia.

SMC2204 09/12/2019 zanamivir (Dectova) Abbreviated

Treatment of complicated and potentially life-threatening influenza A or B virus infection in adult and paediatric patients (aged ≥ 6 months) when: • The patient’s influenza virus is known or suspected to be resistant to anti-influenza medicinal products other than zanamivir, and/or • Other anti-viral agents for treatment of influenza, including inhaled zanamivir, are not suitable for the individual patient.

SMC2194 11/11/2019 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.

SMC2198 11/11/2019 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.

SMC2199 11/11/2019 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.

SMC2208 11/11/2019 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.

SMC2211 11/11/2019 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.

SMC2212 11/11/2019 clostridium botulinum neurotoxin type A (Xeomin) Full

Adult patients with chronic sialorrhoea due to neurological conditions.

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Publication due date SMC meeting date Medicine Submission Type Indication
10/02/2020 07/01/2020 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.

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.

10/02/2020 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.

09/03/2020 04/02/2020 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%.

09/03/2020 04/02/2020 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.

09/03/2020 04/02/2020 mexiletine hydrochloride (Namuscla) Full

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

09/03/2020 04/02/2020 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.

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).

11/05/2020 07/04/2020 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.

08/06/2020 05/05/2020 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.

08/06/2020 05/05/2020 fluocinolone acetonide (Iluvien) Full

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

13/07/2020 02/06/2020 patiromer (Veltassa) Resubmission

For the treatment of hyperkalaemia in adults.

13/07/2020 02/06/2020 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.

Q1 2020 Q4 2019 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.

Q2 2020 Q2 2020 pembrolizumab (Keytruda) Full

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

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