Brentuximab vedotin [BRE12]
The treatment of CD30+ cutaneous T cell lymphoma following at least 1 prior systemic therapy in CHILD patients where the following criteria are met: Note: there is a separate Blueteq form the use of brentuximab vedotin in adults with cutaneous T cell lymphoma
- 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.
- The patient is a child* and please mark as to whether the chid is pre- or post-pubescent:
- is post-pubescent or
- is pre-pubescent and will receive brentuximab vedotin at the paediatric dosage described in the brentuximab vedotin literature in Hodgkin lymphoma. *note there is a separate Blueteq form to be used for brentuximab vedotin in this indication in adults
- The patient has relapsed or refractory CD30+ cutaneous T cell lymphoma which is 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 only these 3 subtypes of cutaneous T cell lymphoma (CTCL) and NICE has restricted 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.
- The patient has been treated with at least 1 prior systemic therapy for his/her CTCL. for
- The patient has never previously received brentuximab vedotin unless it has been given as part of a compassionate access scheme and the patient meets all the criteria set out here including the maximum treatment duration of 16 cycles as set out in brentuximab vedotin’s Summary of Product Characteristics.
- No more than 16 cycles of brentuximab vedotin will be administered to this patient
- The patient has an ECOG performance status of 0 or 1 or 2
- This sequence of cycles of treatment with brentuximab vedotin will be the sole sequence of cycles of treatment with brentuximab vedotin ie there will be no future re-treatment with brentuximab vedotin once this current sequence of cycles (up to 16 cycles) of brentuximab vedotin has ended.
- The use of brentuximab has been discussed at a multi-disciplinary team (MDT) meeting which must include at least two consultants in the subspecialty with active and credible expertise in the relevant field of whom at least one must be a consultant paediatrician. The MDT should include a paediatric pharmacist and other professional groups appropriate to the disease area.
- Brentuximab vedotin will only be requested by and administered in principal treatment centres.
- 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
- Trust policy regarding unlicensed treatments has been followed as brentuximab vedotin is not licensed in this indication in patients aged less than 18 years.
- Brentuximab vedotin 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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