Cannabidiol (Epidyolex) accepted by SMC


The Scottish Medicines Consortium, (SMC), which advises on newly licensed medicines for use by NHSScotland, has published advice accepting fourteen new medicines.


Cannabidiol (Epidyolex) was accepted for the treatment of Lennox-Gastaut syndrome, a rare type of epilepsy that presents in early childhood.


Cannabidiol (Epidyolex) in combination with clobazam was also accepted for the treatment of Dravet syndrome, another rare type of epilepsy, following consideration through PACE.


Esketamine (Spravato) was accepted for treatment-resistant major depression in adults.


Pembrolizumab (Keytruda) was accepted for the treatment of head and neck squamous cell carcinoma (HNSCC) where the cancer has spread or cannot be removed.


The committee also accepted pembrolizumab (Keytruda) when given together with axitinib for the treatment of advanced renal cell carcinoma (kidney cancer) following consideration through PACE.


Also accepted through PACE was gilteritinb (Xospata) for the treatment of relapsed or refractory acute myeloid leukaemia (AML) in patients who have a particular change (mutation) in the gene for a protein called FLT3.


Fluocinolone acetonide intravitreal implant (Iluvien) was accepted to prevent relapse in recurrent non-infectious uveitis (inflammation and swelling) occurring in a specific area of the eye.


In addition to these medicines, SMC has also accepted the following medicines through an expedited approach to minimise delay in patient access following the early phase of the COVID-19 pandemic.


  • Pertuzumab (Perjeta) for the adjuvant treatment of early-stage breast cancer.
  • Caplacizumab (Cablivi) for a blood clotting disorder known as acquired thrombotic thrombocytopenic purpura (aTTP).
  • Sodium zirconium cyclosilicate (Lokelma) for the treatment of hyperkalaemia (high levels of potassium in the blood).
  • Brolucizumab (Beovu) for the treatment of the ‘wet’ form of age-related macular degeneration (AMD).


The following medicines have been accepted for interim use subject to ongoing evaluation and future reassessment by SMC.


  • Andexanet alfa (Ondexxya) to stop life-threatening or uncontrolled bleeding in adults taking certain medicines used to thin the blood.
  • Polatuzumab (Polivy) to treat a type of lymphoma in patients who are unsuitable for a stem cell transplant.
  • Holoclar, a stem-cell treatment used to replace damaged cells in the eye after chemical or physical burns.


SMC chairman Mark MacGregor said:


“I’m delighted that the committee was able to accept these medicines for use by NHSScotland.


“We know from the powerful testimony given by patients and clinicians in our PACE meetings that our decisions on cannabidiol for both Lennox-Gastaut syndrome and Dravet syndrome will be welcomed, and hopefully provide some relief for patients and their families.


“We were also pleased to accept esketamine. The Committee recognised the impact treatment-resistant depression has on people and the priority of addressing mental health challenges for the NHS.


“By offering the potential for improved disease control, pembrolizumab means patients with HSNCC can benefit from extra good quality time with their families. Our decision on pembrolizumab for renal cell carcinoma offers similar benefits for those patients.


“PACE participants for gilteritinib told us patients with relapsed or refractory AML face a poor prognosis. Our decision on this medicine will help improve survival rates for these patients and may offer some the potential for a cure through stem cell transplantation.


“Patient groups told us that those with uveitis fear the possibility of going blind, so we hope our decision on Illuvien will be of benefit to them.”



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