SOUTH AFRICAN ONCOLOGY CONSORTIUM
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Bulletin Board 


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29/01/2016

Policy Statement Approval and Administration of Ipilimumab (Yervoy®)

The SAOC is notably concerned by submissions from treating physicians for approval of Ipilimumab in metastatic melanoma and subsequent requests from medical schemes regarding approval of Ipilimumab. Please make careful note of the following principles relating to immunotherapy when requesting treatment and approving treatment.

Treating Physicians

1. Please note that prior to administering Ipilimumab a patient should have been on NO MORE than 5mg of prednisone a day for a MINIMUM of 14 days prior to the first dose of treatment – if possible preferably no corticosteroids should be administered to the patient for 14 days prior to administration.
2. Patients with disease having required the administration of corticosteroids (brain metastases or spinal cord compression) should have that disease controlled and have finished the treatment with corticosteroids prior to commencing treatment with Ipilimumab.
3. Administration of corticosteroids prior to or at the same time as the first treatment with Ipilimumab is counter-productive and essentially nullifies the effects of this expensive treatment.
4. Please do not request concomitant administration of dexamethasone as a pre-medication with Ipilimumab – all such requests in future will be rejected by the SAOC panel – this demonstrates a lack of understanding of the mechanism of action of the medication.

Funders

1. When approving Ipilimumab for administration to patients all 4 requested cycles of treatment need to be approved and authorised – there is absolutely NO VALUE in requesting a response assessment after 2 of the 4 cycles of treatment – once again the mechanism of action of the treatment requires all 4 treatments to be administered.
2. A response assessment can essentially ONLY be made 6 to 8 weeks after administration of the last of the 4 cycles of treatment – in fact assessing response after 2 cycles of treatment is counter-productive and carries unnecessary expense as there may initially be an increase in disease burden when treatment is commenced which only reduces once treatment has ended.

Other forms of interactions

Corticosteroids
The use of systemic corticosteroids at baseline, before starting YERVOY™, should be avoided because of their potential interference with the pharmacodynamic activity and efficacy of YERVOY™. However, systemic corticosteroids or other immunosuppressants can be used after starting YERVOY™ to treat immune-related adverse reactions. The use of systemic corticosteroids after starting YERVOY™ treatment does not appear to impair the efficacy of YERVOY™.



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