ࡱ> ;?JL|"8 <>@npFHJNTX x¸¸0JjUmH  jUmH mH  0JCJmH0JCJj0JCJUCJ jUmH5B*CJOJQJB*CJOJQJ5B*CJ(OJQJ5B*CJ$OJQJ 5OJQJj5OJQJUmHB*mH  5B*mH B*53 8 July, 2008 Geraldine MacGibbon Therapeutic Group Manager PHARMAC PO Box 10-254 Wellington  HYPERLINK mailto:Geraldine.macgibbon@pharmac.govt.nz Geraldine.macgibbon@pharmac.govt.nz Dear Geraldine; Proposal for Risperdal (risperidone), Topamax (topriamate), Concerta (methylphenidate extended release), Eprex (erythropoietin alpha) and Recormon (erythropoietin beta) This submission has been prepared by Dr Rosemary Marks, President of the Paediatric Society of New Zealand in consultation with members of the Society. Risperidone PSNZ welcomes the improved access to risperidone, especially to risperdal quicklets, which are useful in managing severe behavioural problems in children with Autism Spectrum Disorder and Disruptive Behavioural Disorder. The use of risperidone for these indications has a good evidence base. Topiramate PSNZ welcomes improved access to topiramate. However, we make the following comments in relation to wider access. Access to topiramate for migraine prophylaxis is welcomed. We note that topiramate is a useful anticonvulsant but has significant side-effects, and should not be used as a first line anti-epileptic drug by Paediatricians or General Practitioners. Children being considered for topiramate for refractory epilepsy or refractory migraine should also be referred for neurological assessment by a paediatrician with experienced in management of refractory epilepsy and/or migraine and ideally by a paediatric neurologist. We recommend continuing Special Authority status on application by a Paediatric Neurologist or Paediatrician with the addition of refractory migraine as one of the Special Authority criteria. We anticipate there will be a significant increase in the number of prescriptions for topiramate as migraine prophylaxis if the current Special Authority status is removed. Concerta PSNZ welcomes access to Concerta as an alternative funded option to the Rubifen SR brand of methylphenidate. We note the criterion for Concerta of risk of diversion or abuse of short-acting methylphenidate. We would question whether there is any evidence that Concerta represents a lower risk of diversion or abuse in the New Zealand context. PSNZ notes that practitioners managing children with ADHD in New Zealand only have access to stimulant medications as funded and registered drugs for this indication. Clonidine is used relatively infrequently in children with ADHD, but is not registered for this indication. Clonidine is therefore used off-label for this indication. Clonidine has adverse effects which are of concern, including sedation and rebound hypertension. The latter is of particular concern in a patient population with a significant rate of disadvantage and problems of compliance with medication. Atomoxetine is not funded, but is registered for use in children with ADHD and represents a useful and evidence based alternative to stimulant medications. PSNZ would like to see atomoxetine funded as a second line treatmentfor this indication. We note that atomoxetine was approved for recommendation for funding nearly two years ago at a high level of priority. We understand that PTAC has dropped the priority to medium, which is of concern to the Society. Erythropoietin PSNZ welcomes the improved access to erythropoietin. Rosemary Marks 04 July 2008 THE PAEDIATRIC SOCIETY OF NEW ZEALAND Secretariat: Email:Denise Tringham P O Box 22 234 Wellington 6441 Tel: (04) 938 4827 Fax: (04) 976 4827 psnz@paradise.net.nz  Paediatric Society of New Zealand Submission to Pharmac re Risperdal Proposal Page  PAGE 2 Health of our children: Wealth of our nation ^_xyBDO8 C D N =>?VW !|j0JCJUCJ jUmH5B*CJOJQJB*CJOJQJ5B*CJ(OJQJ5B*CJ$OJQJ 5OJQJj5OJQJUmH B*CJmH 5B*CJmH B*CJ5CJ0JCJjCJUmH jCJUmH CJmH CJ0#=ES^xyDEQ 8 9 C $#=ES^xyDEQ 8 9 C >?LMNOPWgv+,-123be      K >?LM $ !Sn# $ !Sn# $x$ $ H$7$8$MNOPWgv+,-. $ !n# ! $$ u+#$ $  $ !Sn# $ !Sn#+DyK $Geraldine.macgibbon@pharmac.govt.nzyK nmailto:Geraldine.macgibbon@pharmac.govt.nzyX;H,]ą'c+DyK $Geraldine.macgibbon@pharmac.govt.nzyK nmailto:Geral̮"8 *hjln¼ļƼʼмԼz|x׻~{0JjUmH  jUmH mH  0JCJmH0JCJj0JCJUCJ jUmH5B*CJOJQJB*CJOJQJ5B*CJ(OJQJ5B*CJ$OJQJ 5OJQJj5OJQJUmHCJ B*CJmH 5B*CJmH B*CJ/+ 0&P . A!"#$%n+ 0&P . A!"#$%n 8 July, 2008 Geraldine MacGibbon Therapeutic Group Manager PHARMAC PO Box 10-254 Wellington  HYPERLINK mailto:Geraldine.macgibbon@pharmac.govt.nz Geraldine.macgibbon@pharmac.govt.nz Dear Geraldine; Prop+ 0&P . A!"#$%n+ 0&P . A!"#$%n 8 July, 2008 Geraldine MacGibbon Therapeutic Group Manager PHARMAC PO Box 10-254 Wellington  HYPERLINK mailto:Geraldine.macgibbon@pharmac.govt.nz Geraldine.macgibbon@pharmac.govt.nz Dear Geraldine; Proposal for Risperdal (risperidone), Topamax (topriamate), Concerta (methylphenidate extended release), Eprex (erythropoietin alpha) and Recormon (erythropoietin beta) This submission has been prepared by Dr Rosemary Marks, President of the Paediatric Societosal for Risperdal (risperidone), Topamax (topriamate), Concerta (methylphenidate extended release), Eprex (erythropoietin alpha) and Recormon (erythropoietin beta) This submission has been prepared by Dr Rosemary Marks, President of the Paediatric Society of New Zealand in consultation with members of the Society. Risperidone PSNZ welcomes the improved access to risperidone, especially to risperdal quicklets, which are useful in managing severe behavioural problems in children with Autism Spectrum Disor+ 0&P . A!"#$%n+ 0&P . A!"#$%n 8 July, 2008 Geraldine MacGibbon Therapeutic Group Manager PHARMAC PO Box 10-254 Wellington  HYPERLINK mailto:Geraldine.macgibbon@pharmac.govt.nz Geraldine.macgibbon@pharmac.govt.nz Dear Geraldine; Proposal for Risperdal (risperidone), Topamax (topriamate), Concerta (methylphenidate extended release), Eprex (erythropoietin alpha) and Recormon (erythropoietin beta) This submission has been prepared by Dr Rosemary Marks, President of the Paediatric Society of New Zealand in consultation with members of the Society. Risperidone PSNZ welcomes the improved access to risperidone, especially to risperdal quicklets, which are useful in managing severe behavioural problems in children with Autism Spectrum Disorder and Disruptive Behavioural Disorder. The use of risperidone for these indications has a good evidence base. Topiramate PSNZ welcomes improved access to topiramate. However, we make the following comments in relation to wider access. Access to topiramate for migraine prophylaxis is welcomed. We note that topiramate is a useful anticonvulsant but has significant side effects, and should not be used as a first line anti-epileptic drug by Paediatricians or General Practitioners. Children being considered for topiramate for refractory epilepsy or refractory migraine should also be referred for neurological assessment by a paediatrician with experience in management of refractory epilepsy and/or migraine and ideally by a paediatric neurologist. We recommend continuing Special Authority status on application by a Paediatric Neurologist or Paediatrician with the addition of refractory migraine as one of the Special Authority criteria. We anticipate there will be a significant increase in the number of prescriptions for topiramate as migraine prophylaxis if the current Special Authority status is removed. Concerta PSNZ welcomes access to Concerta as an alternative funded option to the Rubifen SR brand of methylphenidate. We note the criterion for Concerta of risk of diversion or abuse of short-acting methylphenidate. We would question whether there is any evidence that Concerta represents a lower risk of diversion or abuse in the New Zealand context. PSNZ notes that practitioners managing children with ADHD in New Zealand only have access to stimulant medications as funded and registered drugs for this indication. Clonidine is used relatively infrequently in children with ADHD, but is not registered for this indication. Clonidine is therefore used  off-label for this indication. Clonidine has adverse effects, which are of concern, including sedation and rebound hypertension. The latter is of particular concern in a patient population with a significant rate of disadvantage and problems of compliance with medication. Atomoxetine is not funded, but is registered for use in children with ADHD and represents a useful and evidence based alternative to stimulant medications. PSNZ would like to see atomoxetine funded as a second line treatmentfor this indication. We note that atomoxetine was approved for recommendation for funding nearly two years ago at a high level of priority. We understand that PTAC has dropped the priority to medium, which is of concern to the Society. Erythropoietin PSNZ welcomes the improved access to erythropoietin. Rosemary Marks 04 July 2008 THE PAEDIATRIC SOCIETY OF NEW ZEALAND Secretariat: Email:Denise Tringham P O Box 22 234 Wellington 6441 Tel: (04) 938 4827 Fax: (04) 976 4827 psnz@paradise.net.nz  Paediatric Society of New Zealand Submission to Pharmac re Risperdal Proposal Page  PAGE 2  Health of our children: Wealth of our nation {J}L}|~~~~pr̈Έ "“JH$7$8$$der and Disruptive Behavioural Disorder. The use of risperidone for these indications has a good evidence base. Topiramate PSNZ welcomes improved access to topiramate. However, we make the following comments in relation to wider access. Access to topiraJLNPnڔܔ ,Jj$ $  $ !Sn# $ !Sn# $x$ $ mate for migraine prophylaxis is welcomed. We note that topiramate is a useful anticonvulsant but has significant side effects, and should not be used as a first line anti-epileptic drug by Paediatricians or General Practitioners. Children being considered for topiramate for refractory epilepsy or refractory migraine should also be referred for neurological assessment by a paediatrician with experience in management of refractory epilepsy and/or migraine and ideally by a paediatric neurologist. We recomnnnnoooooooopppppppqqxz{{{{{{{{{J}L}|~~ހ̈"8 }}}}}} B*CJmH 5B*CJmH B*CJ5CJ0JCJj+CJUmH jCJUmH CJmH CJ 0JCJmH0JCJj0JCJUCJ jUmH5B*CJOJQJB*CJOJQJ 5OJQJ5B*CJ(OJQJ5B*CJ$OJQJ1ooopppppppqqqq\zvzxzzzz{{{{{{{$ ! ! $ !n#y of New Zealand in consultation with members of the Society. Risperidone PSNZ welcomes the improved access to risperidone, especially to risperdal quicklets, which are useful in managing severe behavioural problems in children with Autism Spectrum Disorder and Disruptive Behavioural Disorder. The use of risperidone for these indications has a good evidence base. Topiramate PSNZ welcomes improved access to topiramate. However, we make the following comments in relation to wider access. Access to topiramate for migraine prophylaxis is welcomed. We note that topiramate is a useful anticonvulsant but has significant side effects, and should not be used as a first line anti-epileptic drug by Paediatricians or General Practitioners. Children being considered for topiramate for refractory epilepsy or refractory migraine should also be referred for neurological assessment by a paediatrician with experience in management of refractory epilepsy and/or migraine and ideally by a paediatric neurologist. We recommend continuing Special Authority status on application by a Paediatric Neurologist or Paediatrician with the addition of refractory migraine as one of the Special Authority criteria. We anticipate there will be a significant increase in the number of prescriptions for topiramate as migraine prophylaxis if the current Special Authority status is removed. Concerta PSNZ welcomes access to Concerta as an alternative funded option to the Rubifen SR brand of methylphenidate. We note the criterion for Concerta of risk of diversion or abuse of short-acting methylphenidate. We would question whether there is any evidence that Concerta represents a lower risk of diversion or abuse in the New Zealand context. PSNZ notes that practitioners managing children with ADHD in New Zealand only have access to stimulant medications as funded and registered drugs for this indication. Clonidine is used relatively infrequently in children with ADHD, but is not registered for this indication. Clonidine is therefore used  off-label for this indication. Clonidine has adverse effects, which are of concern, including sedation and rebound hypertension. The latter is of particular concern in a patient population with a significant rate of disadvantage and problems of compliance with medication. Atomoxetine is not funded, but is registered for use in children with ADHD and represents a useful and evidence based alternative to stimulant medications. PSNZ would like to see atomoxetine funded as a second line treatmentfor this indication. We note that atomoxetine was approved for recommendation for funding nearly two years ago at a high level of priority. We understand that PTAC has dropped the priority to medium, which is of concern to the Society. Erythropoietin PSNZ welcomes the improved access to erythropoietin. Rosemary Marks 04 July 2008 THE PAEDIATRIC SOCIETY OF NEW ZEALAND Secretariat: Email:Denise Tringham P O Box 22 234 Wellington 6441 Tel: (04) 938 4827 Fax: (04) 976 4827 psnz@paradise.net.nz  Paediatric Society of New Zealand Submission to Pharmac re Risperdal Proposal Page  PAGE 2  Health of our children: Wealth of our nation |X~XXZZZ__parabbbcceelmmmmmFnHnJnLnjnnH$7$8$nnnnnnnnnno(oFofooooooo ! $$ u+#$ $  $ !Sn# $ !Sn# $x$ $ Jؔڔܔ  xΡСJL|ަؼ뎅ytp5CJ0JCJjVCJUmH jCJUmH CJmH  0JCJmH0JCJj0JCJUCJ jUmH5B*CJOJQJB*CJOJQJ5B*CJ(OJQJ5B*CJ$OJQJ 5OJQJj5OJQJUmHCJB*CJ B*CJmH 5B*CJmH ,+ 0&P . A!"#$%n+ 0&P . A!"#$%n 8 July, 2008 Geraldine MacGibbon Therapeutic Group Manager PHARMAC PO Box 10-254 Wellington  HYPERLINK mailto:Geraldine.macgibbon@pharmac.govt.nz Geraldine.macgibbon@pharmac.govt.nz Dear Geraldine; Proposal for Risperdal (risperidone), Topamax (topriamate), Concerta (methylphenidate extended release), Eprex (erythropoietin alpha) and Recormon (erythropoietin beta) This submission has been prepared by Dr Rosemary Marks, President of the Paediatric SocietIIIIIIIJJJJJJJKKxTUUUUUUUUUJWLW|XXZZZ[bbceffj0jlmmFnnnnnŢŞŃj5OJQJUmH B*CJmH 5B*CJmH B*CJ5CJ0JCJjCJUmH jCJUmH CJmH CJ 0JCJmH0JCJj0JCJUCJ jUmH 5OJQJ5B*CJOJQJB*CJOJQJ1IJJJJJJJKKKK\TvTxTTTTUUUUUUUJWLW|X$$ ! !mend continuing Special Authority status on application by a Paediatric Neurologist or Paediatrician with the addition of refractory migraine as one of the Special Authority criteria. We anticipate there will be a significant increase in the number of pre+DyK $Geraldine.macgibbon@pharmac.govt.nzyK nmailto:Geraldine.macgibbon@pharmac.govt.nzyX;H,]ą'c+DyK $Geraldine.macgibbon@pharmac.govt.nzyK nmailto:Geraldine.macgibbon@pharmac.govt.nzyX;H,]ą'cscriptions for topiramate as migraine prophylaxis if the current Special Authority status is removed. Concerta PSNZ welcomes access to Concerta as an alternative funded option to the Rubifen SR brand of methylphenidate. We note the criterion for Concerta of risk of diversion or abuse of short-acting methylphenidate. We would question whether there is any evidence that Concerta represents a lower risk of diversion or abuse in the New Zealand context. PSNZ notes that practitioners managing children with JrļƼȼʼҼԼ\vx$ ! $ !n# ! $$ u+# $ !Sn#$ $ + 0&P . A!"#$%n+ 0&P . A!"#$%n 8 July, 2008 Geraldine MacGibbon Therapeutic Group Manager PHARMAC PO Box 10-254 Wellington  HYPERLINK mailto:Geraldine.macgibbon@pharmac.govt.nz Geraldine.macgibbon@pharmac.govt.nz Dear Geraldine; Proposal for Risperdal (risperidone), Topamax (topriamate), Concerta (methylphenidate extended release), Eprex (erythropoietin alpha) and Recormon (erythropoietin beta) This submission has been prepared by Dr Rosemary Marks, President of the Paediatric Society of New Zealand in consultation with members of the Society. Risperidone PSNZ welcomes the improved access to risperidone, especially to risperdal quicklets, which are useful in managing severe behavioural problems in children with Autism Spectrum Disorder and Disruptive Behavioural Disorder. The use of risperidone for these indications has a good evidence base. Topiramate PSNZ welcomes improved access to topiramate. However, we make the following comments in relation to wider access. Access to topiramate for migraine prophylaxis is welcomed. We note that topiramate is a useful anticonvulsant but has significant side-effects, and should not be used as a first line anti-epileptic drug by Paediatricians or General Practitioners. Children being considered for topiramate for refractory epilepsy or refractory migraine should also be referred for neurological assessment by a paediatrician with experienced in management of refractory epilepsy and/or migraine and ideally by a paediatric neurologist. We recommend continuing Special Authority status on application by a Paediatric Neurologist or Paediatrician with the addition of refractory migraine as one of the Special Authority criteria. We anticipate there will be a significant increase in the number of prescriptions for topiramate as migraine prophylaxis if the current Special Authority status is removed. Concerta PSNZ welcomes access to Concerta as an alternative funded option to the Rubifen SR brand of methylphenidate. We note the criterion for Concerta of risk of diversion or abuse of short-acting methylphenidate. We would question whether there is any evidence that Concerta represents a lower risk of diversion or abuse in the New Zealand context. PSNZ notes that practitioners managing children with ADHD in New Zealand only have access to stimulant medications as funded and registered drugs for this indication. Clonidine is used relatively infrequently in children with ADHD, but is not registered for this indication. Clonidine is therefore used  off-label for this indication. Clonidine has adverse effects, which are of concern, including sedation and rebound hypertension. The latter is of particular concern in a patient population with a significant rate of disadvantage and problems of compliance with medication. Atomoxetine is not funded, but is registered for use in children with ADHD and represents a useful and evidence based alternative to stimulant medications. PSNZ would like to see atomoxetine funded as a second line treatmentfor this indication. We note that atomoxetine was approved for recommendation for funding nearly two years ago at a high level of priority. We understand that PTAC has dropped the priority to medium, which is of concern to the Society. Erythropoietin PSNZ welcomes the improved access to erythropoietin. Rosemary Marks 04 July 2008 THE PAEDIATRIC SOCIETY OF NEW ZEALAND Secretariat: Email:Denise Tringham P O Box 22 234 Wellington 6441 Tel: (04) 938 4827 Fax: (04) 976 4827 psnz@paradise.net.nz  Paediatric Society of New Zealand Submission to Pharmac re Risperdal Proposal Page  PAGE 2  Health of our children: Wealth of our nation 244499n;p;<<<==??FGGGGGDHFHHHJHhHHHH$ H$7$8$HHHHHHHHI&IDIdIIIIIIIII $ !n# ! $$ u+#$ $  $ !Sn# $ !Sn#$  $x$ + 0&P . A!"#$%n+ 0&P . A!"#$%n 8 July, 2008 Geraldine MacGibbon Therapeutic Group Manager PHARMAC PO Box 10-254 Wellington  HYPERLINK mailto:Geraldine.macgibbon@pharmac.govt.nz Geraldine.macgibbon@pharmac.govt.nz Dear Geraldine; Proposal for Risperdal (risperidone), Topamax (topriamate), Concerta (methylphenidate extended release), Eprex (erythropoietin alpha) and Recormon (erythropoietin beta) This submission has been prepared by Dr Rosemary Marks, President of the Paediatric Society of New Zealand in consultation with members of the Society. Risperidone PSNZ welcomes the improved access to risperidone, especially to risperdal quicklets, which are useful in managing severe behavioural problems in children with Autism Spectrum Disor!'()*+dex./////////J1L1|224445<<=?@@D.DFGGDHHHHHHHHII徶壝w5B*CJOJQJB*CJOJQJ5B*CJ(OJQJ5B*CJ$OJQJ 5OJQJj5OJQJUmH B*CJmH 5B*CJmH B*CJ5CJ0JCJj+CJUmH jCJUmH CJmH CJCJ 0JCJmHj0JCJU0JCJ../0123bcde\.v.x....///////J1L1|2~22$$ ! !y of New Zealand in consultation with members of the Society. Risperidone PSNZ welcomes the improved access to risperidone, especially to risperdal quicklets, which are useful in managing severe behavioural problems in children with Autism Spectrum Disorder and Disruptive Behavioural Disorder. The use of risperidone for these indications has a good evidence base. Topiramate PSNZ welcomes improved access to topiramate. However, we make the following comments in relation to wider access. Access to topiramate for migraine prophylaxis is welcomed. We note that topiramate is a useful anticonvulsant but has significant side effects, and should not be used as a first line anti-epileptic drug by Paediatricians or General Practitioners. Children being considered for topiramate for refractory epilepsy or refractory migraine should also be referred for neurological assessment by a paediatrician with experience in management of refractory epilepsy and/or migraine and ideally by a paediatric neurologist. We recommend continuing Special Authority status on application by a Paediatric Neurologist or Paediatrician with the addition of refractory migraine as one of the Special Authority criteria. We anticipate there will be a significant increase in the number of prescriptions for topiramate as migraine prophylaxis if the current Special Authority status is removed. Concerta PSNZ welcomes access to Concerta as an alternative funded option to the Rubifen SR brand of methylphenidate. We note the criterion for Concerta of risk of diversion or abuse of short-acting methylphenidate. We would question whether there is any evidence that Concerta represents a lower risk of diversion or abuse in the New Zealand context. PSNZ notes that practitioners managing children with ADHD in New Zealand only have access to stimulant medications as funded and registered drugs for this indication. Clonidine is used relatively infrequently in children with ADHD, but is not registered for this indication. Clonidine is therefore used  off-label for this indication. Clonidine has adverse effects, which are of concern, including sedation and rebound hypertension. The latter is of particular concern in a patient population with a significant rate of disadvantage and problems of compliance with medication. Atomoxetine is not funded, but is registered for use in children with ADHD and represents a useful and evidence based alternative to stimulant medications. PSNZ would like to see atomoxetine funded as a second line treatment for this indication. It may also have utility in Oppositional Defian Disorder which is an entity with limited options otherwise. We note that atomoxetine was approved for recommendation for funding nearly two years ago at a high level of priority. We understand that PTAC has dropped the priority to medium, which is of concern to the Society. Erythropoietin PSNZ welcomes the improved access to erythropoietin. Rosemary Marks 04 July 2008 THE PAEDIATRIC SOCIETY OF NEW ZEALAND Secretariat: Email:Denise Tringham P O Box 22 234 Wellington 6441 Tel: (04) 938 4827 Fax: (04) 976 4827 psnz@paradise.net.nz  Paediatric Society of New Zealand Submission to Pharmac re Risperdal Proposal Page  PAGE 2  Health of our children: Wealth of our nation ҡԡ֡JL|~pr̮ή "H$7$8$$der and Disruptive Behavioural Disorder. The use of risperidone for these indications has a good evidence base. Topiramate PSNZ welcomes improved access to topiramate. However, we make the following comments in relation to wider access. Access to topira*,.0Nhjnֻػڻܻ޻ *J $ !Sn# $ !Sn# $x$ $ mate for migraine prophylaxis is welcomed. We note that topiramate is a useful anticonvulsant but has significant side effects, and should not be used as a first line anti-epileptic drug by Paediatricians or General Practitioners. Children being considered for topiramate for refractory epilepsy or refractory migraine should also be referred for neurological assessment by a paediatrician with experience in management of refractory epilepsy and/or migraine and ideally by a paediatric neurologist. We recom \vxԠҡ$ ! $ !n# ! $$ u+#bbon@pharmac.govt.nzyK nmailto:Geraldine.macgibbon@pharmac.govt.nzyX;H,]ą'c+DyK $Geraldine.macgibbon@pharmac.govt.nzyK nmailto:Geraldine.macgibbon@pharmac.govt.nzyX;H,]ą'c+DOh+'0p   , 8 DPX`h TAX INVOICEAX racpNVOacp Normal.dotDenised19iMicrosoft Word 8.0@@\$Ƀ@@8MJ7 msg723vidc.M263vidc.M261msacm.msaudio1msacyK $Geraldine.macgibbon@pharmac.govt.nzyK nmailto:Geraldine.macgibbon@pharmac.govt.nzyX;H,]ą'c+DyK $Geraldine.macgibbon@pharmac.govt.nzyK nmailto:Geraldine.macgibbon@pharmac.govt.nzyX;H,]ą'c՜.+,< hp  racpG   TAX INVOICE TitleL(RZ _PID_GUID _PID_HLINKSAN{792604B6-65F6-47F3-82ED-7C0FC3A40D78}A՜.+,D՜.+,< hp  racpm   TAX INVOICE Title(RZ _PID_GUID _PID_HLINKSAN{792604B6-65F6-47F3-82ED-7C0FC3A40D78}A` JL|"8        L N P ~  V X Z ^ d h  "$xԸjUmH  0JCJmH0JCJj0JCJUCJ jUmH5B*CJOJQJB*CJOJQJ5B*CJ(OJQJ5B*CJ$OJQJ 5OJQJj5OJQJUmHB*mH  5B*mH B*5mH  jUmH 4+ 0&P . A!"#$%n+ 0&P . A!"#$%n 8 July, 2008 Geraldine MacGibbon Therapeutic Group Manager PHARMAC PO Box 10-254 Wellington  HYPERLINK mailto:Geraldine.macgibbon@pharmac.govt.nz Geraldine.macgibbon@pharmac.govt.nz Dear Geraldine; Proposal for Risperdal (risperidone), Topamax (topriamate), Concerta (methylphenidate extended release), Eprex (erythropoietin alpha) and Recormon (erythropoietin beta) This submission has been prepared by Dr Rosemary Marks, President of the Paediatric Society of New Zealand in consultation with members of the Society. Risperidone PSNZ welcomes the improved access to risperidone, especially to risperdal quicklets, which are useful in managing severe behavioural problems in children with Autism Spectrum Disormend continuing Special Authority status on application by a Paediatric Neurologist or Paediatrician with the addition of refractory migraine as one of the Special Authority criteria. We anticipate there will be a significant increase in the number of prescriptions for topiramate as migraine prophylaxis if the current Special Authority status is removed. Concerta PSNZ welcomes access to Concerta as an alternative funded option to the Rubifen SR brand of methylphenidate. We note the criterion for Concerta of risk of diversion or abuse of short-acting methylphenidate. We would question whether there is any evidence that Concerta represents a lower risk of diversion or abuse in the New Zealand context. PSNZ notes that practitioners managing children with ~\vxJL|~p$$ !ADHD in New Zealand only have access to stimulant medications as funded and registered drugs for this indication. Clonidine is used relatively infrequently in children with ADHD, but is not registered for this indication. Clonidine is therefore used  off-label for this indication. Clonidine has adverse effects, which are of concern, including sedation and rebound hypertension. The latter is of particular concern in a patient population with a significant rate of disadvantage and problems of compliance with&+mailto:Geraldine.macgibbon@pharmac.govt.nzOMC:\Documents and Settings\Denise\WORK\PSNZ Docs\Letterheads and Logos\RM.JPG@\$Ƀ@@8MJ7 msg723vidc.M263vidc.M261msacm.msaudio1msac medication. Atomoxetine is not funded, but is registered for use in children with ADHD and represents a useful and evidence based alternative to stimulant medications. PSNZ would like to see atomoxetine funded as a second line treatment for this indication. It may also have utility in Oppositional Defiant Disorder, which is an entity with limited options otherwise. We note that atomoxetine was approved for recommendation for funding nearly two years ago at a high level of priority. We understand that PTAC has dropped the priority to medium, which is of concern to the Society. Erythropoietin Access to erythropoietin will be formally addressed by the National Renal Advisory Board/New Zealand Nephrology Group. Rosemary Marks 04 July 2008 ADHD in New Zealand only have access to stimulant medications as funded and registered drugs for this indication. Clonidine is used relatively infrequently in children with ADHD, but is not registered for this indication. Clonidine is therefore used  off-label for this indication. Clonidine has adverse effects, which are of concern, including sedation and rebound hypertension. The latter is of particular concern in a patient population with a significant rate of disadvantage and problems of compliance with medication. Atomoxetine is not funded, but is registered for use in children with ADHD and represents a useful and evidence based alternative to stimulant medications. PSNZ would like to see atomoxetine funded as a second line treatment for this indication. It may also have utility in Oppositional Defian Disorder which is an entity with limited options otherwise. We note that atomoxetine was approved for recommendation for funding nearly two years ago at a high level of priority. We understand that PTAC has dropped the priority to medium, which is of concern to the Society. Erythropoietin Access to erythropoietin will be formally addressed by the National Renal Advisory Board/New Zealand Nephrology Group. Rosemary Marks 04 July 2008 THE PAEDIATRIC SOCIETY OF NEW ZEALAND Secretariat: Email:Denise Tringham P O Box 22 234 Wellington 6441 Tel: (04) 938 4827 Fax: (04) 976 4827 psnz@paradise.net.nz  Paediatric Society of New Zealand Submission to Pharmac re Risperdal Proposal Page  PAGE 2  Health of our children: Wealth of our nation xJL|~prH$7$8$$der and Disruptive Behavioural Disorder. The use of risperidone for these indications has a good evidence base. Topiramate PSNZ welcomes improved access to topiramate. However, we make the following comments in relation to wider access. Access to topira ">@Z\^ $ !Sn# $ !Sn# $x$ $ H$7$8$dine.macgibbon@pharmac.govt.nzyX;H,]ą'c+DyK $Geraldine.macgibbon@pharmac.govt.nzyK nmailto:Geraldine.macgibbon@pharmac.govt.nzyX;H,]ą'c+DyK $Geraldine.macgimate for migraine prophylaxis is welcomed. We note that topiramate is a useful anticonvulsant but has significant side effects, and should not be used as a first line anti-epileptic drug by Paediatricians or General Practitioners. Children being considerTHE PAEDIATRIC SOCIETY OF NEW ZEALAND Secretariat: Email:Denise Tringham P O Box 22 234 Wellington 6441 Tel: (04) 938 4827 Fax: (04) 976 4827 psnz@paradise.net.nz  Paediatric Society of New Zealand Submission to Pharmac re Risperdal Proposal Page  PAGE 2  Health of our children: Wealth of our nation R^T^V^X^^^yyyzzzz||||~B*mH B*5CJj0JCJU 0JCJmH^`bpHJLNVX  $ !n# ! $$ u+#$ $  $ !Sn# $ !Sn#ed for topiramate for refractory epilepsy or refractory migraine should also be referred for neurological assessment by a paediatrician with experience in management of refractory epilepsy and/or migraine and ideally by a paediatric neurologist. We recommend continuing Special Authority status on application by a Paediatric Neurologist or Paediatrician with the addition of refractory migraine as one of the Special Authority criteria. We anticipate there will be a significant increase in the number of pre`^b^d^^^^^yyzz||$ ! !JL|&&')**.".8. 02233:4<4>444444555555J6L6X6Z6\6^6`666x@AAAǽѵ 0JCJmH0JCJj0JCJUCJ jUmH5B*CJOJQJB*CJOJQJ5B*CJ(OJQJ5B*CJ$OJQJ 5OJQJj5OJQJUmHB*mH  5B*mH B*5mH 0J jUmH 6+ 0&P . A!"#$%n+ 0&P . A!"#$%n 8 July, 2008 Geraldine MacGibbon Therapeutic Group Manager PHARMAC PO Box 10-254 Wellington  HYPERLINK mailto:Geraldine.macgibbon@pharmac.govt.nz Geraldine.macgibbon@pharmac.govt.nz Dear Geraldine; Proposal for Risperdal (risperidone), Topamax (topriamate), Concerta (methylphenidate extended release), Eprex (erythropoietin alpha) and Recormon (erythropoietin beta) This submission has been prepared by Dr Rosemary Marks, President of the Paediatric Society of New Zealand in consultation with members of the Society. Risperidone PSNZ welcomes the improved access to risperidone, especially to risperdal quicklets, which are useful in managing severe behavioural problems in children with Autism Spectrum Disorder and Disruptive Behavioural Disorder. The use of risperidone for these indications has a good evidence base. Topiramate PSNZ welcomes improved access to topiramate. However, we make the following comments in relation to wider access. Access to topiramate for migraine prophylaxis is welcomed. We note that topiramate is a useful anticonvulsant but has significant side effects, and should not be used as a first line anti-epileptic drug by Paediatricians or General Practitioners. Children being considerscriptions for topiramate as migraine prophylaxis if the current Special Authority status is removed. Concerta PSNZ welcomes access to Concerta as an alternative funded option to the Rubifen SR brand of methylphenidate. We note the criterion for Concerta of risk of diversion or abuse of short-acting methylphenidate. We would question whether there is any evidence that Concerta represents a lower risk of diversion or abuse in the New Zealand context. PSNZ notes that practitioners managing children with ADHD in New Zealand only have access to stimulant medications as funded and registered drugs for this indication. Clonidine is used relatively infrequently in children with ADHD, but is not registered for this indication. Clonidine is therefore used  off-label for this indication. Clonidine has adverse effects, which are of concern, including sedation and rebound hypertension. The latter is of particular concern in a patient population with a significant rate of disadvantage and problems of compliance with medication. Atomoxetine is not funded, but is registered for use in children with ADHD and represents a useful and evidence based alternative to stimulant medications. PSNZ would like to see atomoxetine funded as a second line treatment for this indication. It may also have utility in Oppositional Defiant Disorder, which is an entity with limited options otherwise. We note that atomoxetine was approved for recommendation for funding nearly two years ago at a high level of priority. We understand that PTAC has dropped the priority to medium, which is of concern to the Society. Erythropoietin Access to erythropoietin will be formally addressed by the National Renal Advisory Board/New Zealand Nephrology Group. Rosemary Marks President Paediatric Society of New Zealand THE PAEDIATRIC SOCIETY OF NEW ZEALAND Secretariat: Email:Denise Tringham P O Box 22 234 Wellington 6441 Tel: (04) 938 4827 Fax: (04) 976 4827 psnz@paradise.net.nz  Paediatric Society of New Zealand Submission to Pharmac re Risperdal Proposal Page  PAGE 2  Health of our children: Wealth of our nation pr "              H$7$8$ed for topiramate for refractory epilepsy or refractory migraine should also be referred for neurological assessment by a paediatrician with experience in management of refractory epilepsy and/or migraine and ideally by a paediatric neurologist. We recom.2 JL|~##p%r%&&&'')).. .".00222H$7$8$$2333333333333:4>44444444444 $ !Sn# $ !Sn# $x$ $     N P j l n p r      . X Z \ ^  ! $$ u+#$ $  $ !Sn# $ !Sn# $x$ $ mend continuing Special Authority status on application by a Paediatric Neurologist or Paediatrician with the addition of refractory migraine as one of the Special Authority criteria. We anticipate there will be a significant increase in the number of prescriptions for topiramate as migraine prophylaxis if the current Special Authority status is removed. Concerta PSNZ welcomes access to Concerta as an alternative funded option to the Rubifen SR brand of methylphenidate. We note the criterion for ConcerR^T^V^X^^^yyyzzzz||||~B*mH B*5CJj0JCJU 0JCJmH!`^b^d^^^^^yyzz||$ ! !.Specialist2 It also has potential advantages over other stimulant medication in children with certain comorbidities. ADHD with comorbid OpAtomoxetine is also a medicine that has shown efficacy in those children with ADHD who have comorbid anxiety symptoms or disorder We recommend continuing Special Authority status on application by a Paediatrician or Paediatric Specialist with the addition of refractory migraine as one of the Special Authority criteria. 2  TAX INVOICEracpDenise [H`HNormal$*$d @OJQJmH 00 Heading 1$@&500 Heading 2$@&>* Heading 3m$$*$@& \R" b2> Y!r"B%(*-0R3"68;>bA2DGI56@CJ00 Heading 4$@&CJ44 Heading 5$@&5CJ44 Heading 6$@&5CJ88 Heading 7 $$@&5CJ44 Heading 8 $$@&5<A@<Default Paragraph Font<<Address$5OJQJhmH nH 0@0Header  !CJ0 0Footer  !CJ(U@!( Hyperlink>*B*8V@18FollowedHyperlink>*B* LBBL Body Text$*$1$ p@ @hnH F>RFTitle$*$1$ p@ 5CJ0hnH .Pb. Body Text 2CJXCrXBody Text Indent$*$ 0@CJ2Q2 Body Text 3$CJ W@ Strong5&)@& Page Number225 l-l#=ES^xyDEQNOuv`a ~ #EGmn{|}~XYZ\]^ta of risk of diversion or abuse of short-acting methylphenidate. We would question whether there is any evidence that Concerta represents a lower risk of diversion or abuse in the New Zealand context. PSNZ notes that practitioners managing children with ADHD in New Zealand only have access to stimulant medications as funded and registered drugs for this indication. Clonidine is used relatively infrequently in children with ADHD, but is not registered for this indication. Clonidine is therefore used  off-label for this indication. Clonidine has adverse effects, which are of concern, including sedation and rebound hypertension. The latter is of particular concern in a patient population with a significant rate of disadvantage and problems of compliance with medication. Atomoxetine is not funded, but is registered for use in children with ADHD and represents a useful and evidence based alternative to stimulant medications. PSNZ would like to see atomoxetine funded as a second line treatment for this indication. It may also have utility in Oppositional Defiant Disorder, which is an entity with limited options otherwise. We note that atomoxetine was approved for recommendation for funding nearly two years ago at a high level of priority. We understand that PTAC has dropped the priority to medium, which is of concern to the Society. Erythropoietin Access to erythropoietin will be formally addressed by the National Renal Advisory Board/New Zealand Nephrology Group.  Rosemary Marks President Paediatric Society of New Zealand THE PAEDIATRIC SOCIETY OF NEW ZEALAND Secretariat: Email:Denise Tringham P O Box 22 234 Wellington 6441 Tel: (04) 938 4827 Fax: (04) 976 4827 psnz@paradise.net.nz  Paediatric Society of New Zealand Submission to Pharmac re Risperdal Proposal Page  PAGE 2  Health of our children: Wealth of our nation v@x@@@@AAAAAAAJCLC|D~DDFFFKKpMrMNNNOO$@`@@@@@@@@@@@^ f h $&(*,.0\vx$ ! ! $ !n#@@@@@@@@@@@ !InAR^(;M`t M.2HI|Xno{JҡJx^ p ^ 24v@O\`^&')9:<LNO_absuvweUnknownDenise^X!Tt  ,R$@yV7e\]{W- Zl@&  ( =z43 N CE%"  8   BCqDELFVSS?-;lbn2qk\D@ORQ8Q* gw  W <b14\5q<O>B 1 8w1N/ : f 1  y?  u M  4  `6U:LsNA_cknkAehS)8Z' sZ' *b?@`CE%"   TB CnDExFf%Ip,0A  K *   8 h  L  D kk nPn&k X>>@@`4B "H2   #  #$H2   # | N  3  N  3  TB  c $DjJ|( ?   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Body Text 2CJXCrXBody Text Indent$*$ 0@CJ2Q2 Body Text 3$CJ W@ Strong5&)@& Page Number225 l-l#=ES^xyDEQ_` qr *4VX~  ijkmno@`@@@@@@@@@@@@@@@@@@@@@@ !InAR^(;M`t M.2HI|Xno{JҡJx^ p ^ 24v@s. Given the mean age of onset of anxiety disorders in the Maori population is 11 years, this medicine may be of particular efficacy for Maori. PSNZ would like to see Atomoxetine funded as a second line treatment for this indication. significant 2 We recommend continuing Special Authority status on application by a Paediatrician or Paediatric Specialist with the addition of refractory migraine as one of the Special Authority criteria. 2 24  TAX INVOICEracpDenise [H`HNormal$*$d @OJQJmH 00 Heading 1$@&500 Heading 2$@&>* Heading 3m$$*$@& \R" b2> Y!r"B%(*-0R3"68;>bA2DGI56@CJ00 Heading 4$@&CJ44 Heading 5$@&5CJ44 Heading 6$@&5CJ88 Heading 7 $$@&5CJ44 Heading 8 $$@&5<A@<Default Paragraph Font<<Address$5OJQJhmH nH 0@0Header  !CJ0 0Footer  !CJ(U@!( Hyperlink>*B*8V@18FollowedHyperlink>*B* LBBL Body Text$*$1$ p@ @hnH F>RFTitle$*$1$ p@ 5CJ0hnH .Pb. 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Submissions

The Paediatric Society believes all children and youth should, by right, attain optimal physical, mental and social health and wellbeing.  By working as a coordinated national network of health professionals the Society dedicates its efforts and resources to making official submissions to both Government and Non-Government organisations on issues that will impact on the health and wellbeing of children and young people.

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