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SMC ID Date Medicine Submission Type Indication
SMC2561 13/11/2023 efgartigimod alfa (Vyvgart) Full

As an add on to standard therapy for the treatment of adult patients with generalised myasthenia gravis (gMG) who are anti-acetylcholine receptor antibody positive (AChR-Ab+).

SMC2582 13/11/2023 durvalumab (Imfinzi) Full

In combination with gemcitabine and cisplatin for the first-line treatment of adults with locally advanced, unresectable, or metastatic biliary tract cancer (BTC).

SMC2591 13/11/2023 pegunigalsidase alfa (Elfabrio) Full

Long-term enzyme replacement therapy (ERT) in adult patients with confirmed diagnosis of Fabry disease (FD) (deficiency of alpha galactosidase).

SMC2630 13/11/2023 progesterone vaginal capsules (Utrogestan®) Non submission

Prevention of preterm birth in women with a singleton pregnancy who have a short cervix (mid-trimester sonographic cervix ≤25 mm) and/or a history of spontaneous preterm birth.

SMC2534 13/11/2023 risankizumab (Skyrizi) Abbreviated

For treatment of people 16 years and older with moderately to severely active CD who have had an inadequate response to, lost response to, or were intolerant to conventional therapy or a biologic therapy, or if such therapies are not advisable

SMC2585 13/11/2023 tafamidis (Vyndaqel) Resubmission

For the treatment of wild‑type or hereditary transthyretin amyloidosis in adult patients with cardiomyopathy (ATTR-CM)

SMC2571 13/11/2023 mercaptamine (Procysbi) Resubmission

Treatment of proven nephropathic cystinosis (NC). Mercaptamine reduces cystine accumulation in some cells (e.g. leukocytes, muscle and liver cells) of NC patients and, when treatment is started early, it delays the development of renal failure.

SMC2578 13/11/2023 avacopan (Tavneos) Full

In combination with a rituximab or cyclophosphamide regimen for the treatment of adult patients with severe, active granulomatosis with polyangiitis (GPA) or microscopic polyangiitis (MPA).

SMC2573 13/11/2023 selpercatinib (Retsevmo) Full

As monotherapy for the treatment of adults with advanced RET fusion‑positive non‑small cell lung cancer (NSCLC) not previously treated with a RET inhibitor.

SMC2605 13/11/2023 bimekizumab (Bimzelx) Abbreviated

Alone or in combination with methotrexate (MTX), is anticipated to be indicated for the treatment of active psoriatic arthritis (PsA) in adults who have had an inadequate response or who have been intolerant to one or more disease-modifying antirheumatic drugs (DMARDs).

SMC2604 09/10/2023 darolutamide (Nubeqa) Resubmission

Treatment of adults with metastatic hormone-sensitive prostate cancer (mHSPC) in combination with docetaxel

SMC2600 09/10/2023 zanubrutinib (Brukinsa) Abbreviated

As monotherapy for the treatment of adult patients with chronic lymphocytic leukaemia (CLL)

SMC2599 09/10/2023 atogepant (Aquipta) Abbreviated

Prophylaxis of migraine in adults who have at least four migraine days per month.

SMC2576 09/10/2023 maribavir (Livtencity) Full

The treatment of cytomegalovirus (CMV) infection and/or disease that are refractory (with or without resistance) to one or more prior therapies, including ganciclovir, valganciclovir, cidofovir or foscarnet in adult patients who have undergone a haematopoietic stem cell transplant (HSCT) or solid organ transplant (SOT).

SMC2570 09/10/2023 voclosporin (Lupkynis) Full

In combination with mycophenolate mofetil for the treatment of adult patients with active class III, IV or V (including mixed class III/V and IV/V) lupus nephritis (LN).

SMC2569 09/10/2023 fenfluramine (Fintepla) Full

Treatment of seizures associated with Dravet syndrome as an add-on therapy to other anti-epileptic medicines for patients 2 years of age and older.

SMC2518 09/10/2023 olaparib (Lynparza) Full

As monotherapy for the adjuvant treatment of adult patients with germline BRCA1/2-mutations who have HER2-negative, high-risk early breast cancer who have previously been treated with neoadjuvant or adjuvant chemotherapy.

SMC2517 09/10/2023 lutetium (177Lu) vipivotide tetraxetan (Pluvicto) Full

Treatment of adult patients with prostate-specific membrane antigen (PSMA)-positive metastatic castration-resistant prostate cancer (mCRPC) who have been treated with androgen receptor (AR) pathway inhibition and taxane-based chemotherapy or who are not medically suitable for taxanes.

SMC2587 09/10/2023 belzutifan (Welireg) Full

Treatment of adult patients with von Hippel-Lindau (VHL) disease who require therapy for VHL associated renal cell carcinoma (RCC), central nervous system (CNS) hemangioblastomas, or pancreatic neuroendocrine tumours (pNET), and for whom localised procedures are unsuitable or undesirable.

SMC2548 09/10/2023 brexucabtagene autoleucel (Tecartus) Full

Treatment of adult patients 26 years of age and above with relapsed or refractory B-cell precursor acute lymphoblastic leukaemia (ALL).

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Publication due date SMC meeting date Medicine Submission Type Indication
26/10/2023 TBC budesonide/formoterol (Symbicort) Full

Symbicort Turbohaler 200/6 as reliever therapy for adults and adolescents ≥12 years with mild asthma 

11/12/2023 degarelix (Firmagon) Abbreviated
  • for treatment of high-risk localised and locally advanced hormone dependent prostate cancer in combination with radiotherapy

  • as neo-adjuvant treatment prior to radiotherapy in patients with high-risk localised or locally advanced hormone dependent prostate cancer
11/12/2023 bimekizumab (Bimzelx) Abbreviated

Adults with active non-radiographic axial spondyloarthritis with objective signs of inflammation as indicated by elevated C-reactive protein (CRP) and/or magnetic resonance imaging (MRI) who have responded inadequately or are intolerant to non-steroidal anti-inflammatory drugs (NSAIDs)
and
adults with active ankylosing spondylitis who have responded inadequately or are intolerant to conventional therapy.

11/12/2023 cipaglucosidase alfa (Pombiliti) Abbreviated

Long-term enzyme replacement therapy used in combination with the enzyme stabiliser miglustat for the treatment of adults with late-onset Pompe disease (LOPD; acid α-glucosidase [GAA] deficiency.

11/12/2023 07/11/2023 cemiplimab (Libtayo) Reassessment

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.

11/12/2023 07/11/2023 trastuzumab deruxtecan (Enhertu) Full

As monotherapy for the treatment of adult patients with unresectable or metastatic HER2‑low breast cancer who have received prior chemotherapy in the metastatic setting or developed disease recurrence during or within 6 months of completing adjuvant chemotherapy.

11/12/2023 deucravacitinib (Sotyktu) Full

Treatment of moderate to severe plaque psoriasis in adults who are candidates for systemic therapy.

11/12/2023 nivolumab (Opdivo) Full

In combination with platinum-based chemotherapy for the neoadjuvant treatment of resectable (tumours ≥ 4 cm or node positive) non-small cell lung cancer in adults.

15/01/2024 05/12/2023 burosumab (Crysvita) Ultra-orphan reassessment

Treatment of X-linked hypophosphataemia in children and adolescents aged 1 to 17 years with radiographic evidence of bone disease.

15/01/2024 05/12/2023 belantamab mafodotin (Blenrep) Full

Monotherapy for the treatment of multiple myeloma in adult patients, who have received at least four prior therapies and whose disease is refractory to at least one proteasome inhibitor, one immunomodulatory agent, and an anti-CD38 monoclonal antibody, and who have demonstrated disease progression on the last therapy.

12/02/2024 09/01/2024 loncastuximab tesirine (Zynlonta) Full

As monotherapy for the treatment of adult patients with relapsed or refractory diffuse large B-cell lymphoma (DLBCL) and high-grade B-cell lymphoma (HGBL), after two or more lines of systemic therapy.

12/02/2024 09/01/2024 dupilumab (Dupixent) Full

Treatment of adults with moderate-to-severe prurigo nodularis (PN) who are candidates for systemic therapy.

12/02/2024 09/01/2024 cabozantinib (Cabometyx) Full

As monotherapy for the treatment of adult patients with locally advanced or metastatic differentiated thyroid carcinoma (DTC), refractory or not eligible to radioactive iodine (RAI) who have progressed during or after prior systemic therapy.

TBC 07/02/2023 tebentafusp (Kimmtrak) Full

as monotherapy for the treatment of human leukocyte antigen (HLA)-A*02:01-positive adult patients with unresectable or metastatic uveal melanoma

TBC 10/01/2023 levodopa/carbidopa/entacapone (Lecigon) Full

For treatment of advanced Parkinson's disease with severe motor fluctuations and hyperkinesia or dyskinesia when available oral combinations of Parkinson medicinal products have not given satisfactory results

TBC TBC secukinumab (Cosentyx) Full

Treatment of active moderate to severe hidradenitis suppurativa (HS) in adults with an inadequate response to conventional systemic HS therapy.

TBC foslevodopa-foscarbidopa (Produodopa) Abbreviated

Treatment of advanced levodopa-responsive Parkinson’s disease (PD) with severe motor fluctuations and hyperkinesia or dyskinesia when available combinations of Parkinson medicinal products have not given satisfactory results.

TBC TBC talazoparib (Talzenna) Full

As monotherapy for the treatment of adult patients with germline BRCA1/2 mutations, who have HER2-negative locally advanced or metastatic breast cancer. Patients should have been previously treated with an anthracycline and/or a taxane in the (neo)adjuvant, locally advanced or metastatic setting unless patients were not suitable for these treatments. Patients with hormone receptor (HR)-positive breast cancer should have been treated with a prior endocrine-based therapy, or be considered unsuitable for endocrine-based therapy.

TBC TBC ritlecitinib (Litfulo) Full

Treatment of severe alopecia areata in adults and adolescents aged 12 years and over.

TBC TBC daridorexant (Quviviq) Full

Treatment of adult patients with insomnia characterised by symptoms present for at least 3 months and considerable impact on daytime functioning.

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