Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1

Cytomegalovirus infection and disease

Patient must have received a hematopoietic stem-cell transplant; or

Patient must have received a solid-organ transplant; AND

Patient must have a cytomegalovirus infection or cytomegalovirus disease that is resistant, refractory or intolerant/contraindicated to appropriately dosed ganciclovir, valganciclovir, cidofovir or foscarnet; or

Patient must have received and is intolerant to continued use of appropriately dosed ganciclovir, valganciclovir, cidofovir or foscarnet; AND

The treatment must be used as monotherapy for this condition under this restriction; AND

Patient must not have previously demonstrated resistance to this drug; AND

Patient must not have cytomegalovirus disease that involves the central nervous system; AND

Patient must not have cytomegalovirus retinitis.

For the purpose of administering this restriction:

(i) A patient is determined to be refractory if after at least two weeks of appropriately dosed ganciclovir, valganciclovir, cidofovir or foscarnet, they fail to achieve a greater than 1log10 decrease in cytomegalovirus DNA level.

(ii) A patient is determined to be resistant by the identification of a genetic alteration that decreases susceptibility to ganciclovir, valganciclovir, cidofovir or foscarnet.

(iii) A patient with Grade 3 neutropenia (an absolute neutrophil count less than 1000 cells per cubic millimetre) or impaired renal function (creatinine clearance less than 50 mL/min) is determined to be intolerant/contraindicated.