8.2. Drugs affecting the immune response
8.2.1. Antiproliferative immunosuppressants
Restrictions:
Restricted to specialist initiation. Azathioprine should only be used instead of mycophenolate for renal transplantation if there is a low perceived immunological risk.
Prescribing Notes:
Near Patient Testing (NPT) arrangements for GPs may be in place for this medicine. See the relevant section in the Prescribing Resources page for current information.
Restrictions:
Restricted to specialist initiation. Restricted to use by transplant specialists as part of an immunosuppressive regimen.
Prescribing Notes:
The preferred brand in NHSGGC is Ceptava®
Restrictions:
Restricted to specialist initiation. Mycophenolate mofetil is restricted to specialist use in selected patients who are at high risk of organ transplant rejection. Mycophenolate mofetil injection is restricted to use on specialist advice in exceptional cases e.g. patients who are nil by mouth.
8.2.2. Corticosteroids and other immunosuppressants
Restrictions:
Restricted to specialist use only. Restricted to specialist use in selected patients who are at high risk of renal transplant rejection or for kidneys expected to have significant ischaemic damage.
Prescribing Notes:
Formulations should not be substituted in individual patients due to varying bioavailability. Prescribe by brand name.
Restrictions:
Restricted to specialist use in renal transplant for patients with intolerance to calcineurin inhibitors.
Prescribing Notes:
Non-formulary indication:
Treatment of sporadic lymphangioleiomyomatosis with moderate lung disease or declining lung function is not recommended by SMC and remains non-formulary.
Restrictions:
Restricted to specialist initiation. Restricted to patients who are unable to swallow capsules or small changes in dosing increments.
Prescribing Notes:
Tacrolimus preparations should be prescribed and dispensed by brand name to minimise the risk of inadvertent switching between products, which has been associated with previous reports of toxicity and graft rejection.
Restrictions:
Restricted to specialist initiation.
Prescribing Notes:
Please prescribe the preferred brand used in the relevant specialist service. The preferred brand for use in patients who have undergone a liver or renal transplant is current Adoport.
Tacrolimus preparations should be prescribed and dispensed by brand name to minimise the risk of inadvertent switching between products, which has been associated with previous reports of toxicity and graft rejection.
Restrictions:
Restricted to specialist use in combination with mycophenolate mofetil for the treatment of adult patients with active class III, IV or V (including mixed class III/V and IV/V) lupus nephritis.
8.2.3. Anti-lymphocyte monoclonal antibodies
Restrictions:
- Use for the treatment of B-cell chronic lymphontic leukaemia is restricted to specialist use according to regional protocol.
- Use for adults with relapsing-remitting multiple sclerosis (RRMS) with active disease is restricted to specialist use only.
Prescribing Notes:
Alemtuzumab for use in CLL is available on a named-patient basis.
Restrictions:
Restricted to specialist use in accordance with regional protocol for use in combination with pomalidomide and dexamethasone for patients receiving fourth-line therapy (with prior therapies including lenalidomide and a proteasome inhibitor) and have demonstrated disease progression on the last therapy.
Click here for regional protocol [NHS network access required]
Prescribing Notes:
Non-formulary indication:
- In combination with carfilzomib and dexamethasone, for the treatment of adult patients with multiple myeloma who have received at least one prior therapy has not been recommended by SMC for use in NHS Scotland.
Restrictions:
Restricted to specialist use in accordance with regional protocols for the following indications:
- CLL: In combination with chlorambucil, obinutuzumab for the treatment of adult patients with previously untreated chronic lymphocytic leukaemia (CLL) and with comorbidities making them unsuitable for full-dose fludarabine based therapy (regional protocol)
- Follicular Lyphoma: In combination with bendmustine followed by obinutuzumab maintenance is indicated for the treatment of patients with follicular lymphoma who did not respond or who progressed during or up to six months after treatment with rituximab or a rituximab-containing regimen (in development).
Prescribing Notes:
Obinutuzumab is currently non-Formulary for the following indications:
- Follicular Lymphoma: in combination with chemotherapy followed by obinutuzumab maintenance therapy in patients achieving a response, for the treatment of patients with previously untreated advanced follicular lymphoma is not recommended by SMC and remains non-formulary.
Restrictions:
Restricted to specialist use in accordance with regional protocol 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 is restricted to specialist use in accordance with regional protocol 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.
Restrictions:
Use in haemato-oncology is restricted to accordance with regional protocols.
- The maintenance treatment of follicular lymphoma in previously untreated patients responding to induction therapy is restricted in accordance with regional protocol.
- The treatment of patients with previously untreated and relapsed/ refractory chronic lymphotic leukaemia (CLL) in combination with chemotherapy is restricted to use in accordance with regional protocol.
- The use in combinatation with glucocorticoids for the induction of remission in adult patients with severe, active granulomatosis with polyangiitis (Wegener’s) (GPA) and microscopic polyangiitis (MPA) is restricted to specialist use in patients who have relapsed following treatment with cyclophosphamide or who are intolerant to or unable to receive cyclophosphamide.
- The subcutaneous injection formulation is restricted to use only in accordance with regional protocols.
Prescribing Notes:
SMC advice for various indications for rituximab can be found here
Please note: The subcutaneous preparation is not licensed for all the indications that the IV infusion is licensed for.
The following indications are not recommended by SMC and are non-Formulary:
- Use in combination with glucocorticoids, for the treatment of adult patients with severe, active granulomatosis with polyangiitis (Wegener’s) (GPA) and microscopic polyangiitis (MPA)
- Treatment of patients with moderate to severe pemphigus vulgaris (non-submission to SMC)
8.2.4. Other immunomodulating drugs
Restrictions:
Restricted to specialist use only in combination with a rituximab or cyclophosphamide regimen, for the treatment of adult patients with severe, active granulomatosis with polyangiitis (GPA) or microscopic polyangiitis (MPA).
Restrictions:
Treatment of adult patients with relapsed or refractory diffuse large B cell lymphoma (DLBCL) and primary mediastinal large B cell lymphoma (PMBCL), after two or more lines of systemic therapy, is restricted to specialist use only as part of the national service. Patients must be identified via the national MDT.
Prescribing Notes:
Non-formulary indications:
- Treatment of adult patients with relapsed or refractory follicular lymphoma (FL) after three or more lines of systemic therapy was not recommended for use in NHS Scotland by SMC (non-submission).
Restrictions:
Restricted to specialist use in the treatment of patients aged 12 years and older with chronic graft-versus-host disease (chronic GvHD) who have received at least two prior lines of systemic therapy. It is available via the ultra-orphan pathway.
Restrictions:
Restricted to specialist use only. Restricted to use by consultant urologists.
Restrictions:
Treatment of adult patients 26 years of age and above with relapsed or refractory B-cell precursor acute lymphoblastic leukaemia (ALL), is restricted to specialist use only as part of the national specialist service.
Restrictions:
Restricted to specialist use in patients with rapidly evolving severe relapsing-remitting Mutltiple Sclerosis (MS) in accordance with local guidelines in the following subgroups:
- Patients with two or more relapses in the prior year whether on treatment or not, and at least one T1 gadolinium-enhancing lesion.
- Patients with sub-optimal therapy relapsing-remitting MS (defined as patients with one or more relapses in the previous year while on disease modifying therapy, and at least one T1 gadolinium-enhancing lesion or nine T2 lesions).
Restrictions:
Restricted to specialist use for the treatment of relapsing remitting multiple sclerosis in accordance with local guidelines.
Restrictions:
The treatment of adult patients with relapsing remitting multiple sclerosis is restricted to specialist use in accordance with local guidelines.
Restrictions:
Use is restricted in accordance to prescribing notes below.
Prescribing Notes:
Use as a single therapy in highly active relapsing remitting multiple sclerosis (RRMS) is restricted to use in the following adult patient groups:
- Patients with high disease activity despite treatment with at least one disease modifying therapy
- Patients with rapidly evolving severe relapsing remitting multiple sclerosis (defined by two or more disabling relapses in one year, and with one or more Gadolinium enhancing lesions on brain MRI or a significant increase in T2 lesion load as compared to a previous recent MRI.)
Restrictions:
Combination therapy with daunorubicin and cytarabine for the treatment of patients ≥15 years of age with previously untreated, de novo CD33 positive acute myeloid leukaemia (AML), except acute promyelocytic lekaemia (APL) is restricted to specialist use in accordance with regional protocol (click here) in patients with a favourable, intermediate or unknown cytogenetic profile.
Restrictions:
Restricted to specialist use only. Restricted to use under the provision of the ‘Risk Sharing Scheme’ between the Scottish Executive Health Department and the manufacturers (NHS HDL (2002)6).
Restrictions:
Restricted to specialist use only. Not approved for non-Hodgkin’s lymphoma or malignant melanoma.
Restrictions:
Restricted to specialist use only. Restricted to use under the provision of the ‘Risk Sharing Scheme’ between the Scottish Executive Health Department and the manufacturers (NHS HDL (2002)6). Treatment of a single demyelinating event with an active inflammatory process has not been accepted by SMC and is non-Formulary.
Restrictions:
Formulary indications and restrictions on use are detailed in the Prescribing Notes below.
Prescribing Notes:
Muliple myeloma
For regional protocols click here [NHS network access required]
- Use for the third line treatment of multiple myeloma in combination with dexamethasone, or for patients who have received at least one prior therapy, is restricted in accordance with regional protocol.
- Adult patients with previously untreated multiple myeloma who are not eligible for transplant. It is restricted to specialist use in accordance with regional protocol for use in patients unsuitable for thalidomide-containing regimens.
- Use as monotherapy for the maintenance treatment of adult patients with newly diagnosed multiple myeloma who have undergone autologous stem cell transplantation (ASCT) is restricted to use in accordance with regional protocol.
- Use in combination with dexamethsone for the treatment of adult patients with previously untreated multiple myeloma who are not eligible for transplant, and are suitable for thalidomide-containing regimen (off label use)
Lymphoma
- In combination with rituximab (anti-CD20 antibody) for the treatment of adult patients with previously treated follicular lymphoma (Grade 1 to 3a) is restricted to specialist use in accordance with regional protocol click here [NHS network access required].
Transfusion-dependent anaemia
Use for the treatment of patients with transfusion-dependent anaemia due to low- or intermediate-1-risk myelodysplastic syndromes associated with an isolated deletion 5q cytogenetic abnormality when other therapeutic options are insufficient or inadequate is restricted in accordance with regional protocol [NHS network access required].
Non-formulary indications:
- Treatment of adult patients with relapsed or refractory mantle cell lymphoma is not recommended by SMC and remains non-formulary.
- As combination therapy with bortezomib and dexamethasone for the treatment of adult patients with previously untreated multiple myeloma who are not eligible for transplant.
Restrictions:
The use in combination with other chemotherapy for the treatment of high-grade resectable non-metastatic osteosarcoma after macroscopically complete surgical resection is restricted to use in accordance with regional protocol.
Prescribing Notes:
For relevant SMC advice for osteosarcoma click here
Restrictions:
Restricted to specialist use only. Restricted to specialist use in accordance with agreed local protocol and SMC restrictions. Use of natalizumab as a single disease modifying therapy in highly active relapsing remitting multiple sclerosis (RRMS) is not recommended for use by the Scottish Medicines Consortium and is non-Formulary.
Restrictions:
Primary Progressive Multiple Sclerosis (PPMS):
- The treatment of early progressive multiple sclerosis (PPMS) is restricted to specialist use in accordance with local guidelines.
Relapsing-Remitting Multiple Sclerosis (RRMS):
- Restricted to specialist use in accordance with local guidelines for the treatment of remitting-relapsing multiple sclerosis (RRMS) in adults with active disease defined by clinical or imaging features who are contra-indicated or otherwise unsuitable for alemtuzumab.
Restrictions:
Restricted to specialist use for the treatment of relapsing-remitting multiple sclerosis (RRMS) with active disease defined by clinical or imaging features in accordance with local protocol (in development).
Prescribing Notes:
Ofatumumab is available for use in the same positioning of the treatment pathway as ocrelizumab.
Restrictions:
Treatment of adult patients with relapsing remitting multiple sclerosis (RRMS) with active disease as defined by clinical or imaging features is restricted to specialist use in patients suitable for, or requesting an oral treatment
Restrictions:
Use in combination with bortezomib and dexamethasone, for the treatment of adult patients with relapsed and/or refractory multiple myeloma who have received at least two prior regimens including bortezomib and an immunomodulatory agent is restricted to use in accordance with regional protocol.
Restrictions:
Restricted to specialist use for the treatment of relapsing remitting multiple sclerosis in adults.
Restrictions:
Restricted to specialist use only. Restricted to use in adults for the treatment of hepatitis C in combination with ribavirin in accordance with Hepatits MCN protocol.
Restrictions:
Restricted to specialist use only. Restricted to use for chronic hepatitis C in combination with ribavirin in accordance with Hepatitis MCN protocol.
Restrictions:
Restricted to specialist use in accordance with regional protoco for usel in combination with dexamethasone for the treatment of adult patients with relapsed and refractory multiple myeloma who have received at least two prior treatment regimens, including lenalidomide and bortezomib, and have demonstrated disease progression on the last therapy. To access regional protocol please click here.
Prescribing Notes:
Non-Formulary indication:
- Use in combination with bortezomib and dexamethasone for the treatment of adult patients with multiple myeloma who have received at least one prior treatment regimen including lenalidomide is not recommended by SMC.
Restrictions:
Restricted to specialist use in accordance with local guidelines in patients with relapsing-remitting multiple sclerosis (RRMS) with active disease defined by clinical or imaging features, suitable for or requesting an oral treatment.
Restrictions:
Restricted to specialist use in accordance with regional protocol for:
- Treatment of adult patients with unresectable locally advanced or metastatic triple-negative breast cancer (mTNBC) who have received two or more prior lines of systemic therapies, at least one of them given for unresectable locally advanced or metastatic disease.
Restrictions:
Restricted to specialist use in accordance with local guidelines for the treatment of adults with secondary progressive multiple sclerosis (SPMS) with active disease evidenced by relapses or imaging features of inflammatory activity
Restrictions:
Use in the treatment of adult patients with relapsed or refractory mantle cell lymphoma (MCL) after two or more lines of systemic therapy, including a Bruton’s tyrosine kinase (BTK) inhibitor is restricted to specialist use only on the advice of the relevant National Multidisciplinary Team (MDT).
Restrictions:
The treatment of adults with relapsing remitting multiple sclerosis (MS) is restricted to specialist use as an alternative to treatment with interferon beta or glatiramer acetate. Teriflunomide is not expected to be used for the treatment of patients with highly active disease.
Restrictions:
Restricted to specialist use only. Treatment of multiple myeloma is restricted to use in accordance with regional protocol.
Restrictions:
Treatment of adult patients with relapsed or refractory diffuse large B-cell lymphoma (DLBCL) after two or more lines of systemic therapy is restricted to specialist use only as part of the national service. Patients must be identified via the national MDT.