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SMC ID Date Medicine Submission Type Indication
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.

SMC2214 11/11/2019 glecaprevir/pibrentasvir (Maviret) Abbreviated

For treatment of chronic hepatitis C virus (HCV) infection in adults and in adolescents aged 12 to <18 years.

SMC2222 11/11/2019 trientine tetrahydrochloride (Cuprior) Abbreviated

For the treatment of Wilson's disease in adults, adolescents and children ≥ 5 years intolerant to D-penicillamine therapy.

SMC2244 11/11/2019 ibrutinib (Imbruvica) Non submission

In combination with obinutuzumab for the treatment of adult patients with previously untreated chronic lymphocytic leukaemia.

SMC2245 11/11/2019 ibrutinib (Imbruvica) Non submission

As a single agent for the treatment of adult patients with Waldenström’s macroglobulinaemia who have received at least one prior therapy, or in first line treatment for patients unsuitable for chemo-immunotherapy.

SMC2246 11/11/2019 ramucirumab (Cyramza) Non submission
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.

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.

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.

SMC2196 07/10/2019 risankizumab (Skyrizi) Full

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

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.

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.

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.

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.

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Publication due date SMC meeting date Medicine Submission Type Indication
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 06/08/2019 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.

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 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.

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.
Q4 2019 Q4 2019 ruxolitinib (Jakavi) Full The treatment of adult patients with polycythaemia vera (PV) who are resistant to or intolerant of hydroxyurea (HU).
Q1 2020 Q4 2019 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)

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.

Q1 2020 Q4 2019 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.
Q1 2020 Q1 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.

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