Brentuximab vedotin [BRE11]

The treatment of CD30+ cutaneous T cell lymphoma following at least 1 prior systemic therapy in ADULT patients where the following criteria are met: Note: there is a separate Blueteq form the use of brentuximab vedotin in children with cutaneous T cell lymphoma

  1. This application has been made by and the first cycle of systemic anti -cancer therapy with brentuximab vedotin will be prescribed by a consultant specialist specifically trained and accredited in the use of systemic anti-cancer therapy.
  2. The patient has relapsed or refractory CD30+ cutaneous T cell lymphoma, the type of which is one of the following: advanced stage IIB-IVB mycosis fungoides or primary cutaneous anaplastic large cell lymphoma or Sezary syndrome. Please mark in the tick box below which of these 3 types of cutaneous T cell lymphoma applies to this patient:
  • stage IIB-IVB mycosis fungoides or
  • primary cutaneous anaplastic large cell lymphoma or
  • Sezary syndrome Note: Takeda restricted its submission to NICE for the consideration of the clinical and cost effectiveness of brentuximab vedotin in only these 3 subtypes of cutaneous T cell lymphoma (CTCL) and NICE has optimised its recommendations in CTCL accordingly. Brentuximab vedotin is therefore not approved for use in patients with other types of cutaneous lymphoma such as lymphomatoid papulosis, subcutaneous panniculitis-like T cell NHL and primary cutaneous peripheral T cell lymphoma.
  1. The patient has been treated with at least 1 prior systemic therapy for his/her CTCL.
  2. The patient has never previously received treatment with brentuximab vedotin unless it has been given as part of any compassionate use scheme and the patient meets all the other criteria set out here including the maximum for treatment duration of 16 cycles as set out in brentuximab vedotin’s Summary of Product Characteristics.
  3. No more than 16 cycles of brentuximab vedotin will be administered to this patient.
  4. The patient has an ECOG performance status of 0 or 1 or 2.
  5. No planned treatment breaks of more than 6 weeks beyond the expected cycle length are allowed (to allow any toxicity of current therapy to settle or intercurrent comorbidities to improve). *Requests for continuation of treatment after unplanned treatment breaks over this duration should be made via the treatment break approval process
  6. This sequence of cycles of treatment with brentuximab vedotin will be the sole sequence of cycles of treatment with bretuximab vedotin ie there will be no future re-treatment with brentuximab vedotin once this sequence of cycles (up to a maximum of 16 cycles) of brentuximab vedotin has ended.
  7. Brentuximab will otherwise be used as set out in its Summary of Product Characteristics (SPC).

[NHS funded]{.badge .rounded-pill .bg-success} From: 23 July 2019

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CDF Managed Access: NA

NICE Technology Appraisal: TA577 (24 April 2019)

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