Mogamulizumab [MOG2]

Mogamulizumab as 2nd line systemic therapy or beyond 2nd line systemic therapy for patients with stage IVA to IVB Sezary syndrome where the following criteria have been met:

  1. This application is being made by and the first cycle of systemic anti-cancer therapy with mogamulizumab will be prescribed by a consultant specialist specifically trained and accredited in the use of systemic anti-cancer therapy.
  2. The prescribing clinician is fully aware of the management of and the treatment modifications that may be required for adverse reactions to mogamulizumab and the prescribing clinician understands the need for testing for hepatitis B before mogamulizumab treatment commences and the risk of tumour lysis syndrome in patients with rapidly proliferating disease and high tumour burden.
  3. The patient has a diagnosis of Sezary syndrome. Please note that there is a separate form MOG1 for patients with mycosis fungoides.
  4. The disease stage of Sezary syndrome is stage IVA to IVB. Please mark below the stage of disease that applies to this patient:
  • stage IVA1 Sezary syndrome
  • stage IVA2 Sezary syndrome
  • stage IVB Sezary syndrome
  1. The patient has received at least 1 line of systemic treatment for Sezary syndrome. Note: mogamulizumab is only recommended by NICE if the patient has received at least 1 line of systemic therapy.
  2. The patient has received 1st line systemic therapy for Sezary syndrome. Please mark below which 1st line systemic therapy was received by the patient:
  • bexarotene
  • interferon
  • methotrexate
  • another type of chemotherapy
  • extracorporeal photopheresis
  1. If the patient has CD30 positive Sezary syndrome, the patient has either been treated with brentuximab vedotin or its use in this patient is contraindicated. Please mark below which of the following applies to this patient:
  • the patient has CD30 negative disease and hence use of brentuximab vedotin is inappropriate
  • the patient has CD30 positive disease and has been treated with brentuximab vedotin
  • the patient has CD30 positive disease and the use of brentuximab vedotin in this patient is contraindicated.
  1. The patient has an ECOG performance status (PS) of 0 or 1.
  2. The patient has not received any prior treatment with mogamulizumab unless the patient has received mogamulizumab via a company early access scheme and the patient meets all the other treatment criteria on this form
  3. Mogamulizumab will be used as monotherapy.
  4. Mogamulizumab will be stopped at whichever of the following events occurs first: disease progression or unacceptable toxicity or withdrawal of patient consent.
  5. A formal medical review as to how mogamulizumab is being tolerated and whether mogamulizumab should continue or not will be scheduled to occur at least by the end of the second month of treatment.
  6. When a treatment break of more than 6 weeks beyond the expected 4-weekly cycle length is needed, the prescribing clinician will complete a treatment break approval form to restart treatment, including as appropriate if the patient has had an extended break on account of Covid-19.
  7. Mogamulizumab will otherwise be used as set out in its Summary of Product Characteristics (SPC) with the exception of criteria 4 and 5 above.

[NHS funded]{.badge .rounded-pill .bg-success} From: 15 March 2022

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CDF Managed Access: NA

NICE Technology Appraisal: TA754 (15 December 2021)

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