Greater Glasgow and Clyde Medicines

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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Restrictions:

Use in combination with tamoxifen or an aromatase inhibitor, for adjuvant treatment of endocrine responsive early stage breast cancer in women at high risk of recurrence who are confirmed as pre-menopausal after completion of chemotherapy is restricted to specialist initiation in accordance with regional protocols [NHS network access required].

Prescribing Notes:

For other indications for triptorelin, see sections 6.7.2 and 8.3.4.2

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Restrictions:

The treatment of adult male patients with advanced hormone-dependent prostate cancer is restricted to specialist initiation in accordance with regional protocol [NHS network access required].

Prescribing Notes:

For the relevant SMC advice click here

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Restrictions:

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

• Treatment of high-risk localised and locally advanced hormone dependent prostate cancer in combination with radiotherapy.
• As neoadjuvant treatment prior to radiotherapy in patients with high-risk localised or locally advanced hormone dependent prostate cancer.

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Restrictions:

Chronic Kidney Disease:

Restricted to initiation by clinicians, either in primary or secondary care, experienced in the treatment of chronic kidney disease (CKD) for use in patients having individually optimised standard care (including angiotensin converting enzyme inhibitors or angiotensin II receptor blockers, unless these are contraindicated or not tolerated), and either, at the start of treatment:

• an estimated glomerular filtration rate (eGFR) of 20 mL/min/1.73m² up to 45 mL/min/1.73m², or
• an eGFR of 45 mL/min/1.73m² up to 90 mL/min/1.73m² and either:
  • A urine albumin-to-creatinine ratio (uACR) of 22.6 mg/mmol or more, or
  • Type 2 Diabetes Mellitus (T2DM). 

For use in chronic heart failure, see section 2.5.6

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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:

Restricted to specialist use only.

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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:

• 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.

The following indication for the solution for injection preparation is not recommended by SMC and is non-Formulary:

• Monotherapy for the treatment of adult patients with smouldering multiple myeloma at high risk of developing multiple myeloma.

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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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