This is the text extract for Consultation on a proposal to replace the Special Authority dexamphetamine and methylphenidate, and amend the criteria for subsidy, browse documents here.

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23 November 2007 To interested parties

Consultation on a proposal to replace the Special Authority dexamphetamine and methylphenidate, and amend the criteria for subsidy

Outline of proposal

for

There is currently one (non-interchangeable) Special Authority applying to dexamphetamine and methylphenidate in Section B of the Pharmaceutical Schedule. Following consultation with HealthPAC and the Mental Health Subcommittee of PTAC (the Pharmacology and Therapeutics Advisory Committee), PHARMAC is proposing to: · · · add a “Retail pharmacy – Specialist” restriction to the listing of dexamphetamine and methylphenidate, to bring the subsidy requirements in line with the Misuse of Drugs Regulations 1977; replace the existing Special Authority with two separate Special Authorities, one for each pharmaceutical; and amend the criteria relating to specialist treatment recommendation.

It is proposed that the first two changes would take effect from 1 April 2008, and the amendment relating to the specialist treatment recommendation would take effect from 1 August 2008. Feedback sought PHARMAC welcomes feedback on this proposal. If you wish to submit feedback on this proposal please submit it in writing by 17 December 2007 to: Geraldine MacGibbon Therapeutic Group Manager PHARMAC PO Box 10-254 Wellington 6143 Details of proposal · The restriction applying to the listing of dexamphetamine and methylphenidate would be amended as follows (additions in bold): METHYLPHENIDATE HYDROCHLORIDE – Special Authority see SAxxxx below – Retail pharmacy - Specialist DEXAMPHETAMINE SULPHATE – Special Authority see SAxxxx below – Retail pharmacy - Specialist This means that the name of the recommending Specialist and date of recommendation must be written on the prescription. This is a current legal requirement for Ministerial Approval under the Misuse of Drugs Regulations 1977. A165049 Email: geraldine.macgibbon@pharmac.govt.nz Fax: (04) 460 4995

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·

·

The existing Special Authority would be deleted and a separate Special Authority would apply to each of dexamphetamine and methylphenidate. The criteria for the new Special Authorities would be essentially the same as the existing criteria with the following exceptions:

o

the criteria reading:

Applicant is a GP and Provide name of specialist. a specialist has recommended treatment; and

would be replaced with:

Applicant is a GP and the patient has been seen in person within the previous 18 months by a relevant specialist who has recommended treatment.

o

renewal applications for Attention Deficit and Hyperactivity Disorder (ADHD) in patients aged 5 or over would only be able to be made by a paediatrician, psychiatrist or general practitioner on the recommendation of a relevant specialist (as for initial applications).

· ·

Current approvals for the existing Special Authority would continue to be valid for the applicable pharmaceutical until the expiry date of the approval. When current approvals expire it would be necessary to make individual initial applications for either dexamphetamine or methylphenidate on the new form (initial application criteria for these patients would be the same as the renewal criteria). All new patients would need an initial application on the relevant new form under normal initial application criteria. Draft versions of the proposed new Special Authorities are attached to this consultation letter.

· ·

Yours sincerely

Geraldine MacGibbon, PhD Therapeutic Group Manager

A165049 -

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HealthPAC Ministry of Health Phone 0800 243 666 APPLICANT (stamp or sticker acceptable)

APPLICATION FOR SUBSIDY BY SPECIAL AUTHORITY

PATIENT NHI: ...................................................... REFERRER

Page 1

Form SA####

DRAFT

Name: ................................................................... First Names: ......................................................... Name: ................................................................... Address: ............................................................... Surname: .............................................................. Address: ............................................................... ............................................................................... DOB: ..................................................................... ............................................................................... ............................................................................... Address: ............................................................... ............................................................................... Fax Number: ......................................................... ............................................................................... Fax Number: ......................................................... NZMC No: ............................................................. ............................................................................... NZMC No: .............................................................

Methylphenidate Hydrochloride

INITIAL APPLICATION - Narcolepsy – new patients Applications only from a neurologist or respiratory specialist. Approvals valid for 24 months. Prerequisites (tick box where appropriate)

u

The patient suffers from narcolepsy

INITIAL APPLICATION - Narcolepsy - patient has had an approval for methylphenidate for narcolepsy prior to 1 April 2008 Applications only from a neurologist or respiratory specialist. Approvals valid for 24 months. Prerequisites (tick box where appropriate)

u

The treatment remains appropriate and the patient is benefiting from treatment.

INITIAL APPLICATION - ADHD in patients 5 or over – new patients Applications only from a paediatrician, psychiatrist or general practitioner on the recommendation of a relevant specialist. Approvals valid for 24 months. Prerequisites (tick boxes where appropriate)

and and

u u u u

or

ADHD (Attention Deficit and Hyperactivity Disorder) patients aged 5 years or over Diagnosed according to DSM-IV or ICD 10 criteria

Applicant is a specialist Applicant is a GP and the patient has been seen in person within the previous 18 months by a relevant specialist who has recommended treatment

INITIAL APPLICATION - ADHD in patients 5 or over - patient has had an approval for methylphenidate for ADHD prior to 1 April 2008 Applications only from a paediatrician, psychiatrist or general practitioner on the recommendation of a relevant specialist. Approvals valid for 24 months. Prerequisites (tick boxes where appropriate)

and

u u u

or

The treatment remains appropriate and the patient is benefiting from treatment

Applicant is a specialist Applicant is a GP and the patient has been seen in person within the previous 18 months by a relevant specialist who has recommended treatment

Use next page for: Initial application - ADHD in patients under 5 – new patients, Initial application - ADHD in patients under 5 - patient has had an approval for methylphenidate for ADHD in patients under 5 prior to 1 April 2008, Renewal - Narcolepsy, Renewal - ADHD in patients 5 or over and Renewal - ADHD in patients under 5 I confirm the above details are correct and that in signing this form I understand I may be audited. Signed: .............................................................................. Date: ...............................................

Post application to Health Payments, Agreements and Compliance (HealthPAC), Private Bag 3015, Wanganui - Fax: 0800 100 131

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HealthPAC Ministry of Health Phone 0800 243 666 APPLICANT (stamp or sticker acceptable)

APPLICATION FOR SUBSIDY BY SPECIAL AUTHORITY

PATIENT NHI: ...................................................... REFERRER

Page 2

Form SA####

DRAFT

Name: ................................................................... First Names: ......................................................... Name: ................................................................... Address: ............................................................... Surname: .............................................................. Address: ............................................................... ............................................................................... DOB: ..................................................................... ............................................................................... ............................................................................... Address: ............................................................... ............................................................................... Fax Number: ......................................................... ............................................................................... Fax Number: ......................................................... NZMC No: ............................................................. ............................................................................... NZMC No: .............................................................

Methylphenidate Hydrochloride - continued

INITIAL APPLICATION - ADHD in patients under 5 – new patients Applications only from a paediatrician or psychiatrist. Approvals valid for 12 months. Prerequisites (tick boxes where appropriate)

and

u u

ADHD (Attention Deficit and Hyperactivity Disorder) patients under 5 years of age Diagnosed according to DSM-IV or ICD 10 criteria

INITIAL APPLICATION - ADHD in patients under 5 - patient has had an approval for methylphenidate for ADHD in patients under 5 prior to 1 April 2008 Applications only from a paediatrician or psychiatrist. Approvals valid for 12 months. Prerequisites (tick box where appropriate)

u

The treatment remains appropriate and the patient is benefiting from treatment

RENEWAL - Narcolepsy Current approval Number:............................................................... Applications only from a neurologist or respiratory specialist. Approvals valid for 24 months. Prerequisites (tick box where appropriate)

u

The treatment remains appropriate and the patient is benefiting from treatment

Note: If the patient had an approval for methylphenidate for narcolepsy prior to 1 April 2008 the applicant is required to submit a fresh initial application in the first instance, not a renewal application. Please phone HealthPAC on 0800 243 666 for clarification if needed.

RENEWAL - ADHD in patients 5 or over Current approval Number:............................................................... Applications only from a paediatrician, psychiatrist or general practitioner on the recommendation of a relevant specialist. Approvals valid for 24 months. Prerequisites (tick boxes where appropriate)

and

u u u

or

The treatment remains appropriate and the patient is benefiting from treatment

Applicant is a specialist Applicant is a GP and the patient has been seen in person within the previous 18 months by a relevant specialist who has recommended treatment

Note: If the patient had an approval for methylphenidate for ADHD prior to 1 April 2008 the applicant is required to submit a fresh initial application in the first instance, not a renewal application. Please phone HealthPAC on 0800 243 666 for clarification if needed.

Use next page for: Renewal - ADHD in patients under 5 I confirm the above details are correct and that in signing this form I understand I may be audited. Signed: .............................................................................. Date: ...............................................

Post application to Health Payments, Agreements and Compliance (HealthPAC), Private Bag 3015, Wanganui - Fax: 0800 100 131

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HealthPAC Ministry of Health Phone 0800 243 666 APPLICANT (stamp or sticker acceptable)

APPLICATION FOR SUBSIDY BY SPECIAL AUTHORITY

PATIENT NHI: ...................................................... REFERRER

Page 3

Form SA####

DRAFT

Name: ................................................................... First Names: ......................................................... Name: ................................................................... Address: ............................................................... Surname: .............................................................. Address: ............................................................... ............................................................................... DOB: ..................................................................... ............................................................................... ............................................................................... Address: ............................................................... ............................................................................... Fax Number: ......................................................... ............................................................................... Fax Number: ......................................................... NZMC No: ............................................................. ............................................................................... NZMC No: .............................................................

Methylphenidate Hydrochloride - continued

RENEWAL - ADHD in patients under 5 Current approval Number:............................................................... Applications only from a paediatrician or psychiatrist. Approvals valid for 12 months. Prerequisites (tick box where appropriate)

u

The treatment remains appropriate and the patient is benefiting from treatment

Note: If the patient had an approval for methylphenidate for ADHD in patients under 5 prior to 1 April 2008 the applicant is required to submit a fresh initial application in the first instance, not a renewal application. Please phone HealthPAC on 0800 243 666 for clarification if needed.

I confirm the above details are correct and that in signing this form I understand I may be audited. Signed: .............................................................................. Date: ...............................................

Post application to Health Payments, Agreements and Compliance (HealthPAC), Private Bag 3015, Wanganui - Fax: 0800 100 131

---

HealthPAC Ministry of Health Phone 0800 243 666 APPLICANT (stamp or sticker acceptable)

APPLICATION FOR SUBSIDY BY SPECIAL AUTHORITY

PATIENT NHI: ...................................................... REFERRER

Page 1

Form SA####

DRAFT

Name: ................................................................... First Names: ......................................................... Name: ................................................................... Address: ............................................................... Surname: .............................................................. Address: ............................................................... ............................................................................... DOB: ..................................................................... ............................................................................... ............................................................................... Address: ............................................................... ............................................................................... Fax Number: ......................................................... ............................................................................... Fax Number: ......................................................... NZMC No: ............................................................. ............................................................................... NZMC No: .............................................................

Dexamphetamine Sulphate

INITIAL APPLICATION - Narcolepsy – new patients Applications only from a neurologist or respiratory specialist. Approvals valid for 24 months. Prerequisites (tick box where appropriate)

u

The patient suffers from narcolepsy

INITIAL APPLICATION - Narcolepsy - patient has had an approval for dexamphetamine for narcolepsy prior to 1 April 2008 Applications only from a neurologist or respiratory specialist. Approvals valid for 24 months. Prerequisites (tick box where appropriate)

u

The treatment remains appropriate and the patient is benefiting from treatment.

INITIAL APPLICATION - ADHD in patients 5 or over – new patients Applications only from a paediatrician, psychiatrist or general practitioner on the recommendation of a relevant specialist. Approvals valid for 24 months. Prerequisites (tick boxes where appropriate)

and and

u u u u

or

ADHD (Attention Deficit and Hyperactivity Disorder) patients aged 5 years or over Diagnosed according to DSM-IV or ICD 10 criteria

Applicant is a specialist Applicant is a GP and the patient has been seen in person within the previous 18 months by a relevant specialist who has recommended treatment

INITIAL APPLICATION - ADHD in patients 5 or over - patient has had an approval for dexamphetamine for ADHD prior to 1 April 2008 Applications only from a paediatrician, psychiatrist or general practitioner on the recommendation of a relevant specialist. Approvals valid for 24 months. Prerequisites (tick boxes where appropriate)

and

u u u

or

The treatment remains appropriate and the patient is benefiting from treatment

Applicant is a specialist Applicant is a GP and the patient has been seen in person within the previous 18 months by a relevant specialist who has recommended treatment

Use next page for: Initial application - ADHD in patients under 5 – new patients, Initial application - ADHD in patients under 5 - patient has had an approval for dexamphetamine for ADHD in patients under 5 prior to 1 April 2008, Renewal - Narcolepsy, Renewal - ADHD in patients 5 or over and Renewal - ADHD in patients under 5 I confirm the above details are correct and that in signing this form I understand I may be audited. Signed: .............................................................................. Date: ...............................................

Post application to Health Payments, Agreements and Compliance (HealthPAC), Private Bag 3015, Wanganui - Fax: 0800 100 131

---

HealthPAC Ministry of Health Phone 0800 243 666 APPLICANT (stamp or sticker acceptable)

APPLICATION FOR SUBSIDY BY SPECIAL AUTHORITY

PATIENT NHI: ...................................................... REFERRER

Page 2

Form SA####

DRAFT

Name: ................................................................... First Names: ......................................................... Name: ................................................................... Address: ............................................................... Surname: .............................................................. Address: ............................................................... ............................................................................... DOB: ..................................................................... ............................................................................... ............................................................................... Address: ............................................................... ............................................................................... Fax Number: ......................................................... ............................................................................... Fax Number: ......................................................... NZMC No: ............................................................. ............................................................................... NZMC No: .............................................................

Dexamphetamine Sulphate - continued

INITIAL APPLICATION - ADHD in patients under 5 – new patients Applications only from a paediatrician or psychiatrist. Approvals valid for 12 months. Prerequisites (tick boxes where appropriate)

and

u u

ADHD (Attention Deficit and Hyperactivity Disorder) patients under 5 years of age Diagnosed according to DSM-IV or ICD 10 criteria

INITIAL APPLICATION - ADHD in patients under 5 - patient has had an approval for dexamphetamine for ADHD in patients under 5 prior to 1 April 2008 Applications only from a paediatrician or psychiatrist. Approvals valid for 12 months. Prerequisites (tick box where appropriate)

u

The treatment remains appropriate and the patient is benefiting from treatment

RENEWAL - Narcolepsy Current approval Number:............................................................... Applications only from a neurologist or respiratory specialist. Approvals valid for 24 months. Prerequisites (tick box where appropriate)

u

The treatment remains appropriate and the patient is benefiting from treatment

Note: If the patient had an approval for dexamphetamine for narcolepsy prior to 1 April 2008 the applicant is required to submit a fresh initial application in the first instance, not a renewal application. Please phone HealthPAC on 0800 243 666 for clarification if needed.

RENEWAL - ADHD in patients 5 or over Current approval Number:............................................................... Applications only from a paediatrician, psychiatrist or general practitioner on the recommendation of a relevant specialist. Approvals valid for 24 months. Prerequisites (tick boxes where appropriate)

and

u u u

or

The treatment remains appropriate and the patient is benefiting from treatment

Applicant is a specialist Applicant is a GP and the patient has been seen in person within the previous 18 months by a relevant specialist who has recommended treatment

Note: If the patient had an approval for dexamphetamine for ADHD prior to 1 April 2008 the applicant is required to submit a fresh initial application in the first instance, not a renewal application. Please phone HealthPAC on 0800 243 666 for clarification if needed.

Use next page for: Renewal - ADHD in patients under 5 I confirm the above details are correct and that in signing this form I understand I may be audited. Signed: .............................................................................. Date: ...............................................

Post application to Health Payments, Agreements and Compliance (HealthPAC), Private Bag 3015, Wanganui - Fax: 0800 100 131

---

HealthPAC Ministry of Health Phone 0800 243 666 APPLICANT (stamp or sticker acceptable)

APPLICATION FOR SUBSIDY BY SPECIAL AUTHORITY

PATIENT NHI: ...................................................... REFERRER

Page 3

Form SA####

DRAFT

Name: ................................................................... First Names: ......................................................... Name: ................................................................... Address: ............................................................... Surname: .............................................................. Address: ............................................................... ............................................................................... DOB: ..................................................................... ............................................................................... ............................................................................... Address: ............................................................... ............................................................................... Fax Number: ......................................................... ............................................................................... Fax Number: ......................................................... NZMC No: ............................................................. ............................................................................... NZMC No: .............................................................

Dexamphetamine Sulphate - continued

RENEWAL - ADHD in patients under 5 Current approval Number:............................................................... Applications only from a paediatrician or psychiatrist. Approvals valid for 12 months. Prerequisites (tick box where appropriate)

u

The treatment remains appropriate and the patient is benefiting from treatment

Note: If the patient had an approval for dexamphetamine for ADHD in patients under 5 prior to 1 April 2008 the applicant is required to submit a fresh initial application in the first instance, not a renewal application. Please phone HealthPAC on 0800 243 666 for clarification if needed.

I confirm the above details are correct and that in signing this form I understand I may be audited. Signed: .............................................................................. Date: ...............................................

Post application to Health Payments, Agreements and Compliance (HealthPAC), Private Bag 3015, Wanganui - Fax: 0800 100 131