ongoing dosing with IVIG. 49 Qualifying criteria Adult ITP The criteria have been revised HIV-associated ITP in line with the feedback. There needs to be a similar emphasis on bleeding. Would suggest this category be amended as follows:- Failure of anti-retroviral therapy AND One of the following:- 1. Intracranial haemorrhage and platelet count < 80-100 x 10^9/L 2. Other life-threatening haemorrhage and platelet count < 50 x 10^9/L 3. Risk of clinically significant bleeding with platelet count < 30 x 10^9/L 50 Review criteria Adult ITP Outcome data have been All indications revised in line with the Outcome date to be measured should include the following: feedback. Resolution of bleeding Prevention of bleeding Maximum platelet count achieved within 7 days of IVIG 51 Review criteria Newly diagnosed or persistent ITP - subsequent therapy (diagnosis ≤ 12 Agreed - the outcome and Review must be undertaken six monthly by haematologist. response data have been Response to qualify for ongoing therapy includes as any of the following:- revised in line with feedback. 1. Resolution of active bleeding 2. A reduction in evidence of bleeding correlating with a doubling of baseline platelet count or an increment in platelet count > 10^9/L within 7 days 3. In patients without active bleeding a doubling of baseline platelet count and a rise in platelet count > 30 x 10^9/L was demonstrated within 7 days of previous IVIG Ongoing use of IVIG should be primarily to prevent bleeding while other treatment options are explored including splenectomy. Approval for 6 months 52 Review criteria Chronic ITP - subsequent therapy (diagnosis > 12 months) Agreed - the outcome and Review must be undertaken six monthly by haematologist. response data have been Response to qualify for ongoing therapy includes as any of the following:- revised in line with feedback.
ongoing dosing with IVIG. 49 Qualifying criteria Adult ITP HIV-associated ITP There needs to be a similar emphasis on bleeding. Would suggest this category be amended as follows:- Failure of anti-retroviral therapy AND One of the following:- 1. Intracranial haemorrhage and platelet count < 80-100 x 10^9/L 2. Other life-threatening haemorrhage and platelet count < 50 x 10^9/L 3. Risk of clinically significant bleeding with platelet count < 30 x 10^9/L The criteria have been revised in line with the feedback. 50 Review criteria Adult ITP All indications Outcome date to be measured should include the following: Resolution of bleeding Prevention of bleeding Maximum platelet count achieved within 7 days of IVIG Outcome data have been revised in line with the feedback. 51 Review criteria Newly diagnosed or persistent ITP - subsequent therapy (diagnosis ≤ 12 Review must be undertaken six monthly by haematologist. Response to qualify for ongoing therapy includes as any of the following:- 1. Resolution of active bleeding 2. A reduction in evidence of bleeding correlating with a doubling of baseline platelet count or an increment in platelet count > 10^9/L within 7 days 3. In patients without active bleeding a doubling of baseline platelet count and a rise in platelet count > 30 x 10^9/L was demonstrated within 7 days of previous IVIG Ongoing use of IVIG should be primarily to prevent bleeding while other treatment options are explored including splenectomy. Approval for 6 months Agreed - the outcome and response data have been revised in line with feedback. 52 Review criteria Chronic ITP - subsequent therapy (diagnosis > 12 months) Review must be undertaken six monthly by haematologist. Response to qualify for ongoing therapy includes as any of the following:- Agreed - the outcome and response data have been revised in line with feedback.
feedback-to-the-proposed-changes-to-the-criteria-and-nba-responses2015-without-names.docx