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Application Form for (Hospital and Community) Exceptional Circumstances Approval

Return completed form to: Exceptional Circumstances Panel Co-ordinator PHARMAC PO Box 10-254 Wellington Phone CEC: Phone HEC: Fax: Email: 04-916-7553 04-916-7521 09-523-6870 ecpanel@pharmac.govt.nz

Section I – General Application

Please refer to information sheet if necessary and complete ALL relevant details.

Please type or print CLEARLY.

Patient Details

Last Name: First Name: Address:

Details of Applying Practitioner

Last Name: First Name: Address:

Gender: Male/Female Date of Birth: NHI No: Phone No:

Phone: Facsimile: Email: Are you a GP ο or Specialist ο? 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: Extemporaneously compounded:?

(If Yes, provide full list of ingredients)

ο Yes

ο No

Eligibility under Hospital Exceptional Circumstances Policy

Are you a hospital physician, applying on behalf of an in-patient in a public hospital, for approval to fund from a hospital budget, an unsubsidised pharmaceutical for use in the community?

ο Yes

Please complete Sections I & II only

ο No

Please complete Sections I & III only


Section II - Hospital Exceptional Circumstances

Approval under Section II is to fund an unsubsidised pharmaceutical for a current inpatient in a public hospital for use in the community funded from a hospital budget. Sole criterion – demonstration that funding this pharmaceutical for this patient would be more cost-effective for the hospital than the most likely alternative intervention or outcome Completion of (D) and (E) only required if the answer to (B) is not the same as the answer to (C).

A: Duration of treatment for which funding approval is sought

B: In which DHB is the patient being treated?

C: In which DHB will the patient reside when discharged from hospital?

D: If the DHB named in response to (C) is different from that named in response to (B), which DHB has agreed to fund this treatment?

E: Would you like the response to this application copied to the DHB referred to in (C)?

Yes/No

Rationale

Please describe in your own words why you consider this pharmaceutical would be more cost-effective for the hospital than the most likely alternative scenario. Further comments may be provided as an attachment.


Specific costings.

Completion of the following table in addition to or instead of providing a written rationale may assist the panel to assess this application. (This may be completed by your Hospital Manager) Treatment for which funding approval is sought Description

(If pharmaceutical, please include name, form, strength, dose regimen and duration of treatment)

Most likely alternative intervention or outcome

Drug related costs

(May include requisition costs and/or value of applicable DRG payment associated with the treatment for its duration or 1 year (whichever is the lesser))

Other Costs

(May include other financial and/or nonfinancial costs (such as nurse time, bed availability etc) associated with the treatment) for its duration or 1 year (whichever is the lesser))

Clinical Risks and Benefits

Total Cost to Hospital

A-$

B-$

Net financial impact on hospital (A-B) $


Section III - Community Exceptional Circumstances

For a renewal complete sub-sections 3 and 4 only

1.

ENTRY CRITERIA Complete the criteria to which this application applies:

q

a) Rare Condition (rare is considered to be <10 nationally) What is the prevalence of the condition in NZ? __________________________________________________________________ __________________________________________________________________

q

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: Treatment Response of this patient Rarity (how often would you expect this to occur?)

q

c) Unusual combination of clinical circumstance applies

Describe the unusual combination of clinical circumstances and how often this combination occurs in NZ: __________________________________________________________________ __________________________________________________________________ __________________________________________________________________ __________________________________________________________________ __________________________________________________________________


2.

Clinical Benefit and Suitability a) Describe the demonstrated and significant clinical benefit to this patient that use of this pharmaceutical has shown. Note that Exceptional Circumstances cannot fund trials. __________________________________________________________________ __________________________________________________________________ __________________________________________________________________ __________________________________________________________________ __________________________________________________________________ __________________________________________________________________ b) If the treatment has not been tried in this patient, attach evidence that it is a safe and efficacious

treatment (e.g. Journal articles, not just references or abstracts)

Is the pharmaceutical registered for this indication in NZ?

Yes q

No q

If not, Patient consent has been obtained for the use of a non-registered medicine being obtained.

ο

c)

Please indicate that patient has been consulted.

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)

d)

The following subsidised pharmaceuticals have been trialled or considered: Complete if the information has not already been adequately supplied in Question 1 b). Unsuitable due to:

Pharmaceutical


3. Cost Benefit (as this is an application for funding a cost estimate must be included. Failure to give cost estimate may delay processing of the application.) Cost per year (quoted by nominated pharmacy, based on dosage requested) $ Note that applications in excess of $30,000 will be sent for a cost utility analysis.

Nominated Pharmacy (if approval given from where will supplies be obtained?

This will generally NOT be a hospital pharmacy.) Name: …………………………………………………………….………………………………. Address: ………………………………………………………….………………………………

…………………………………………………………………………………….

Phone:……………………………………………………………

4. Renewal (Complete for renewals ONLY) If this is an application for renewal please detail the patient’s clinical progress, the continuing need for the medication and the short and long term future management of this patient. Please append any relevant investigations eg laboratory tests, radiology. __________________________________________________________________ __________________________________________________________________ __________________________________________________________________ __________________________________________________________________ 5. Other Issues Is there any other relevant information that should be considered? __________________________________________________________________ __________________________________________________________________ __________________________________________________________________ __________________________________________________________________ Signature of Medical Practitioner: __________________________________________ Date of Request: _________________________________________________________ Practitioners Stamp:


Patient or Guardian To Complete This Section

Patient Income Criteria: I meet the income criteria for this application in that: I have a Community Services Card numbered as below: CSC No. AND Yes

οNo

ο

I am receiving the maximum WINZ benefit available (attach evidence) Yes

OR

ο

No

ο

Attached is a declaration stating that it is unreasonable to expect me to pay for this medication.

CONSENT BY PATIENT For the purposes of this application form I consent to: • • information concerning my medical conditions and financial information 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. Date:_________________________

Signed: _______________________

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Hospital & Community Exceptional Circumstances - application information & form

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