Greater Glasgow and Clyde Medicines

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 protocols [NHS network access required] for the following indications:

Breast cancer

• As monotherapy for the treatment of adult patients with unresectable or metastatic human epidermal growth factor receptor 2 (HER2)-positive breast cancer who have received one or more prior anti-HER2-based regimens.
• As monotherapy for the treatment of adult patients with unresectable or metastatic HER2-low breast cancer who have received prior chemotherapy in the metastatic setting or developed disease recurrence during or within 6 months of completing adjuvant chemotherapy.

Prescribing Notes:

Trastuzumab deruxtecan is currently non-formulary for the following indications:

• Gastric or gastroesophageal junction adenocarcinoma: As monotherapy for the treatment of adult patients with advanced HER2-positive gastric or gastroesophageal junction (GEJ) adenocarcinoma who have received a prior trastuzumab-based regimen.
• Non-small cell lung cancer: As monotherapy for the treatment of adult patients with advanced non-small cell lung cancer (NSCLC) whose tumours have an activating HER2 (ERBB2) mutation and who require systemic therapy following platinum-based chemotherapy with or without immunotherapy.
• Treatment of adult patients with unresectable or metastatic HER2-positive (IHC3+) solid tumours who have received prior treatment or who have no satisfactory alternative treatment options.

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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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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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