Greater Glasgow and Clyde Medicines

Restrictions:

Restricted to specialist use in accordance with regional protocols [NHS network access required] for the following:

• AML: The treatment of adults with newly diagnosed, therapy-related acute myeloid leukaemia (AML) or AML with myelodysplasia related changes. 

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Restrictions:

Restricted to specialist use in accordance with regional protocols [NHS network access required] for the following indications:

• Unresectable or metastatic BRAF V600 mutation-positive metastatic melanoma who have received no prior therapy.
• In combination with trametinib for the adjuvant treatment of adults with stage III melanoma with a BRAF V600 mutation following complete resection.
• In combination with trametinib for the treatment of adults with locally advanced or metastatic anaplastic thyroid cancer with evidence of a BRAF V600E mutation and with no satisfactory locoregional treatment options (as approved by NCMAG). 

Prescribing Notes:

The following indications are not recommended for use by the SMC and are non-Formulary:

• In combination with trametinib for the treatment of adults with advanced non-small cell lung cancer with BRAF V600 mutation.

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Restrictions:

Monotherapy, for the first-line treatment of adult patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) with epidermal growth factor receptor (EGFR)-activating mutations, is restricted to specialist use only in accordance with regional protocol [NHS network access required].

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Restrictions:

Restricted to specialist use in accordance with regional protocols [NHS network access required] for the following indications:

Multiple Myeloma: 

• Use as monotherapy for the treatment of adults with relapsed and refractory multiple myeloma is restricted to use as a fourth-line treatment option. 
• In combination with bortezomib and dexamethasone, for the treatment of adult patients with multiple myeloma who have received one prior therapy only. 
• Use in combination with bortezomib, thalidomide and dexamethasone, for the treatment of adult patients with newly diagnosed multiple myeloma who are eligible for autologous stem cell transplant.
• In combination with lenalidomide and dexamethasone for the treatment of adult patients with newly diagnosed multiple myeloma who are ineligible for autologous stem cell transplant (ASCT).

Amyloidosis:

• Use in combination with cyclophosphamide, bortezomib and dexamethasone for the treatment of newly-diagnosed systemic light chain (AL) amyloidosis.

Prescribing Notes:

The following indications for the infusion preparation are not recommended by SMC and are non-Formulary:

Multiple Myeloma:

• In combination with bortezomib, melphalan and prednisone for the treatment of adult patients with newly diagnosed multiple myeloma who are ineligible for autologous stem cell transplant.
• Combination with pomalidomide and dexamethasone for the treatment of adult patients with multiple myeloma who have received one prior therapy containing a proteasome inhibitor and lenalidomide and were lenalidomide-refractory, or who have received at least two prior therapies that included lenalidomide and a proteasome inhibitor and have demonstrated disease progression on or after the last therapy.

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Restrictions:

Restricted to specialist use in accordance with regional protocols [NHS network access required] for the following indication:

• Non-metastatic castration-resistant prostate cancer (nmCRPC) in men who are at high risk of developing metastatic disease.
• Treatment of adults with metastatic hormone-sensitive prostate cancer (mHSPC) in combination with docetaxel.

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Restrictions:

Restricted to specialist use in accordance with regional protocols [NHS network access required] for the following:

• Treatment of adult patients with newly diagnosed Philadelphia chromosome positive (Ph+) chronic myelogenous leukaemia (CML) in the chronic phase.
• Treatment of adult patients with chronic, accelerated or blast phase chronic myelogenous leukaemia (CML) with resistance or intolerance to prior therapy including imatinib mesilate.
• Treatment of adult patients with Philadelphia chromosome–positive (Ph+) acute lymphoblastic leukaemia (ALL) with resistance or intolerance to prior therapy (as approved by NCMAG). 
• Treatment of adult patients with newly diagnosed Philadelphia chromosome–positive (Ph+) acute lymphoblastic leukaemia (ALL) integrated with chemotherapy (as approved by NCMAG). 

Prescribing Notes:

The following indications are not recommended by the SMC and are non-Formulary:

• ALL: Treatment of paediatric patients with newly diagnosed Philadelphia chromosome positive acute lymphoblastic leukaemia in combination with chemotherapy (non-submission to SMC).

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Restrictions:

Restricted to specialist use only. Use for adjuvant and metastatic breast cancer, metastatic prostate cancer, non-small cell lung cancer and cancer of the head and neck is restricted to use in accordance with regional protocols [NHS network access required]. 

Prescribing Notes:

The use of docetaxel in metastatic gastric adenocarcinoma has not been accepted by SMC and remains non-Formulary.

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Restrictions:

Restricted to specialist use in accordance with regional protocols [NHS network access required] for:

• Monotherapy for the treatment of adult patients with mismatch repair deficient (dMMR)/microsatellite instability-high (MSI-H) recurrent or advanced endometrial cancer (EC) that has progressed on or following prior treatment with a platinum-containing regimen.
• In combination with platinum-containing chemotherapy for the treatment of adult patients with mismatch repair deficient (dMMR)/microsatellite instability-high (MSI-H) primary advanced or recurrent endometrial cancer and who are candidates for systemic therapy.

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Restrictions:

Restricted to specialist use in accordance with regional protocols [NHS network access required] for the following indications:

• Lung cancer:
  • As monotherapy for the treatment of locally advanced, unresectable non-small cell lung cancer (NSCLC) in adults whose tumours express PD-L1 (programmed cell death ligand 1) on ≥1% of tumour cells and whose disease has not progressed following platinum-based chemoradiation therapy.
  • In combination with etoposide and either carboplatin or cisplatin for the first-line treatment of adults with extensive-stage small cell lung cancer (ES-SCLC). 
• Biliary tract cancer: In combination with gemcitabine and cisplatin for the first-line treatment of adults with locally advanced, unresectable, or metastatic biliary tract cancer. 

Prescribing Notes:

The following indication is not recommended by the SMC and is non-formulary:

• In combination with tremelimumab for the first-line treatment of adults with advanced or unresectable hepatocellular carcinoma (HCC).

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Restrictions:

Restricted to specialist use in accordance with regional protocol [NHS network access required] for the indication below:

• Use in combination with chlorambucil or bendamustine for the treatment of patients with chronic lymphocytic leukaemia (CLL) who have not received prior therapy and who are not eligible for fludarabine-based therapy in patients who would not be considered for bendamustine therapy and who would receive chlorambucil-based therapy.

Prescribing Notes:

The treatment of adults with relapsed CLL in combination with fludarabine and cyclophosphamide is not recommended by SMC and is non-Formulary.

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