Greater Glasgow and Clyde Medicines

Restrictions:

Atopic dermatitis:

The use in the treatment of moderate-to-severe atopic dermatitis in adults is restricted to use in accordance with local guidelines in patients who have had an inadequate response to existing systemic immunosuppressants such as ciclosporin, or in whom such treatment is considered unsuitable.

Prurigo nodularis:

Treatment of adults with moderate-to-severe prurigo nodularis (PN) who are candidates for systemic therapy.

Prescribing Notes:

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

• Treatment of chronic spontaneous urticaria (CSU) in patients aged 12 years and older whose disease is not adequately controlled with H1 antihistamine treatment.

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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 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. 
• Endometrial cancer: In combination with carboplatin and paclitaxel for the first-line treatment of adults with primary advanced or recurrent endometrial cancer who are candidates for systemic therapy, followed by maintenance treatment with:
  • durvalumab as monotherapy in endometrial cancer that is mismatch repair deficient (dMMR)
  • durvalumab in combination with olaparib in endometrial cancer that is mismatch repair proficient (pMMR).

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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