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Application Form for Community Exceptional Circumstances Approval

Exceptional Circumstances Panel Co-ordinator PHARMAC PO Box 10-254, Wellington Phone: 04-916-7553 Facsimile: 09-523-6870 Email: ecpanel@pharmac.govt.nz

Please refer to information sheet if necessary. Complete ALL relevant details. Please type or print CLEARLY. For a renewal complete this page and sections 7 and 8 only

Patient Details

Last Name: First Name: Address:

Details of Applying Practitioner

Last Name: First Name: Address:

Gender: Date of Birth: NHI No:

Male / Female

Phone: Facsimile: Email: Are you a GP or Specialist ? NZMC#:

Disease/Condition

*attach further information if appropriate, a clinical report is useful, be specific

Medicine/treatment sought:

Complete fully, attach additional information as necessary to cover all strengths required.

Brand Name: Chemical Name: Manufacturer: Form and Strength: Dosage to be used: Dosage regimen:

(where applicable)

Extemporaneously compound?:

(If Yes, attach a full list of ingredients)

Yes

No

Note that if this is not completed an approval cannot be issued

Nominated Pharmacy (if approval given from where will supplies be obtained? This will generally NOT be a hospital pharmacy.)

Name: Address: Phone: 1

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1. ENTRY CRITERIA

Complete the criteria to which this application applies. (a) Rare condition (rare is considered to be a prevalence of <10 nationally) What is the prevalence (not incidence) of the condition in NZ?

(b) Reaction to alternative treatment unusual (unusual is considered to be <10 nationally) List all treatments trialled, patient response to each treatment and how often this response to this treatment occurs in NZ. (Note that failure to respond to funded treatments is not generally exceptional. In order to obtain funding through Exceptional Circumstances the nature of the response would need to be considered exceptional).

Treatment

Response of this patient

Rarity (how often would you expect this to occur?)

(c) Unusual combination of clinical circumstance applies Describe the unusual combination of clinical circumstances and how often this combination occurs in NZ. (Note that end of spectrum treatments are not necessarily approved; patients must be clearly distinct):

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2. CLINICAL BENEFIT AND SUITABILITY

(a) attach evidence that it is a safe and efficacious treatment (e.g. full journal articles, not just references, conference proceedings or abstracts). Note that a higher degree of proof will be required for unregistered medications or registered medications for non-registered indications. (b) Is the pharmaceutical registered for this indication in NZ? If not, has patient consent been obtained for this use as a non-registered medicine ? Yes Yes No No

(c) Attach specialist opinion (if available) or provide contact details of the specialist the patient has seen and who can be contacted by the EC Panel.

Name of specialist: Address: (Note: the Exceptional Circumstances Panel reserves the right to seek any appropriate opinion)

3.

OTHER MEDICATIONS

Provide a full list of treatments for this condition that have been tried or considered.

Pharmaceutical Unsuitable due to:

Please list any other relevant medications that the patient is currently taking:

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4. OTHER ISSUES

Is there any other relevant information that should be considered?

5. ATTACHMENTS

Please attach any additional information which may help the Panel in assessing this application, such as relevant clinic letters, supporting references, lab results, hospital admissions record/s, management plan, and any other information which may be relevant. Please list in the table below the information which you are attaching to this application:

Additional information which is attached to this application (to be completed by applicant): 1. 2. 3. 4. 5.

(Please continue this list on an additional page if there is more information than the space provided here.)

6. COST ESTIMATE

(As this is an application for funding a cost estimate must be included. Failure to give a cost estimate may delay processing of the application. Note that applications in excess of $15,000 for the duration of treatment may undergo a cost utility analysis and will require PHARMAC approval). Cost per year (quoted by nominated pharmacy, based on dosage requested. Cost must be COST BRAND SOURCE without mark-ups or dispensing fees) Anticipated duration of requested treatment:

(Note that approval will generally be given for only 1 year, renewal would then have to be sought)

$

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7. RENEWAL (Complete for reNewals oNlY)

If this is an application for renewal please attach the following: 1. a full report including details of the patient’s clinical progress, the continuing need for the medication and the short and long term future management of this patient. 2. append any relevant and recent specialist review. 3. append any relevant investigations eg laboratory tests, radiology.

8. SIgNATURES

Signature of Medical Practitioner: Date of Request:

9. PATIENT CONSENT

Patient details

Last Name First Name

CONsENT BY PATIENT

For the purposes of this application form I consent to: information concerning my medical conditions being given to the Exceptional Circumstances Panel (and if required, to PHARMAC); and the Exceptional Circumstances Panel seeking further information from medical care providers or seeking further medical opinion as may be necessary for the consideration of my application.

signed:

Date:

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