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Hosp ita l Pharmaceut ical Assessment Template fo r D HB Hospita ls

The Hospital Pharmaceutical Assessment Process (HPAP) was developed as part of the Hospital Strategy. The process relies on DHB hospitals and pharmaceutical suppliers submitting applications on new hospital pharmaceuticals to PHARMAC for national assessment. This assessment form is designed for DHB hospitals to enable simple and consistent reporting of new hospital pharmaceuticals for national assessment by PHARMAC. As stated in the Hospital Strategy, national assessment by PHARMAC does not confer any obligation on DHBs to fund or not to fund new pharmaceuticals. Hospitals may commence funding of the new pharmaceuticals prior to any PHARMAC review and may continue to do so irrespective of any recommendation that PHARMAC may make following a review. Why complete this template? Under Section 4.2.2 of the Hospital Strategy, DHB hospitals are “expected to bring to PHARMAC’s attention any new pharmaceuticals being considered for introductory routine use in their hospital(s) or specific departments”. For further information, please refer to the final version of the National Hospital Strategy (http://www.pharmac.govt.nz/pdf/nhps.pdf). Participation in the national assessment reporting programme is consistent with the National Hospital Pharmaceutical Strategy and is intended to promote the following benefits: • reduced duplication of work between DHBs; • increased communication between DHBs; • shared knowledge and increase dialogue among DHBs and PHARMAC on clinical and financial issues relating to new pharmaceuticals; • facilitation review by a number of experts; and • improved national consistency of access to new pharmaceuticals. In order to achieve the aims of the process, DHB involvement is crucial in the following areas: • DHB hospitals need to notify PHARMAC of what pharmaceuticals they are assessing so that PHARMAC can prioritise pharmaceuticals for assessment. • DHB hospitals need to keep PHARMAC up-to-date with the outcomes of their own assessment process. • DHB hospitals can send PHARMAC their Drug and Therapeutic (D&T) committee submissions or minutes of meetings, to include on the Hospital Pharmaceutical Assessment Database (HPAD) website. This has the benefit of reducing duplication of work and sharing of knowledge. • DHBs are encouraged to review and provide input into PHARMAC assessments in order to obtain consensus on the appropriate use of new hospital pharmaceuticals. When should this template be completed? PHARMAC is interested in assessing the following pharmaceuticals: • those recently approved for use in New Zealand that are currently being considered for use within a hospital; • high cost pharmaceuticals (i.e. pharmaceuticals which have a substantial impact on the budget) – this includes both registered and unregistered pharmaceuticals; • pharmaceuticals which a number of DHBs are assessing; • new indications for pharmaceuticals.

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This assessment template should be completed in the following situations: • when notifying PHARMAC that your DHB hospital is assessing a new pharmaceutical or a new indication for a pharmaceutical; • when requesting PHARMAC to assess a pharmaceutical. Each submission from DHB hospitals will be prioritised for national assessment according to the criteria of the HPAP (i.e. highest priority given to those pharmaceuticals which a number of DHBs are assessing and those associated with very high costs to DHBs). This submission will not be directly distributed to other DHB hospitals without your prior consent, but information contained in the submission may be referred to in PHARMAC's assessment of the pharmaceutical pursuant to this application. The relevant information contained in the submission will also be used to update the Hospital Pharmaceutical Assessment Database (HPAD). It may be necessary for PHARMAC to disclose this information under the Official Information Act 1982 or otherwise pursuant to PHARMAC's public law or any other legal obligations. If you have any questions or would like further information on the HPAP, please contact the analyst for hospital pharmaceutical assessments, Rachel Grocott, at PHARMAC (rachel.grocott@pharmac.govt.nz or phone: (04) 916 7535).

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A.

Application Details

1.

DHB name:___________________________________________________________________

2.

Name of contact person:_________________________________________________________

3.

Contact details:________________________________________________________________

________________________________________________________________________________ ________________________________________________________________________________ Do you agree to have your contact details included in the database? Yes ¨ No ¨

B.

Pharmaceutical Details

1.

Chemical Name:________________________________________________________________

2.

Brand Name:__________________________________________________________________

3.

Current or proposed dose used in New Zealand:_______________________________________

4.

Price: $ per unit (please state units used) ____________________________________________

5.

Length of treatment: ____________________________________________________________

C.

DHB Assessment Details

If your DHB is currently assessing this pharmaceutical or have recently assessed this pharmaceutical, please answer the following questions:

1.

Date application received by DHB: ________________________________________________

2.

Date of assessment by DHB: _____________________________________________________

3.

Date decision was reached DHB (if applicable): _______________________________________

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4.

Indication(s) assessing/assessed:

___________________________________________________________________________________ __________________________________________________________________________________ __________________________________________________________________________________

5.

What are the main comparator(s) (i.e. what alternative treatment(s) is currently available)?

___________________________________________________________________________________ ___________________________________________________________________________________ ___________________________________________________________________________________ ___________________________________________________________________________________

6.

What is the reason for the assessment? Please tick appropriate box: ¨ ¨ ¨ ¨ ¨ ¨ ¨ New pharmaceutical for standard use in hospital New pharmaceutical for restricted use in hospital New pharmaceutical for short-term trial period The pharmaceutical is currently unregistered in NZ (Section 29 use only) New indication Addition of a new dose form or presentation Other – please specify __________________________________________________ ____________________________________________________________________

7.

Would this pharmaceutical replace a pharmaceutical that is currently funded? Yes ¨ No ¨ If so, what pharmaceutical(s) would it replace?

_____________________________________________________________________

8. Prescriber Restrictions (those who can prescribe this medicine): ¨ ¨ ¨ ¨ All Consultants Specialist Only - Type: All medical staff (including H/S, Registrars) Other – please specify:

___________________________________________________________________________

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9.

Does your DHB have a protocol that defines the use of this pharmaceutical with inclusion and exclusion criteria? Yes ¨ No ¨ If so, please enclose the protocol.

___________________________________________________________________________________ ___________________________________________________________________________________ ___________________________________________________________________________________

10. What assessment/audit measures are being proposed to assess response to treatment? ___________________________________________________________________________________ ___________________________________________________________________________________ ___________________________________________________________________________________ ___________________________________________________________________________________ ___________________________________________________________________________________

11. Estimated number of patients in the DHB who would benefit from the treatment per year: ___________________________________________________________________________________

12. If applicable, on what basis was the outcome reached regarding the funding of the pharmaceutical in the DHB? Please attach the submission, minutes of the meeting, and any further information that may be of assistance. ___________________________________________________________________________________ ___________________________________________________________________________________ ___________________________________________________________________________________ ___________________________________________________________________________________ ___________________________________________________________________________________ ___________________________________________________________________________________ ___________________________________________________________________________________ ___________________________________________________________________________________ ___________________________________________________________________________________ ___________________________________________________________________________________

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D.

Request for National Assessment

If you would like national assessment of this pharmaceutical, please answer the following questions:

1.

What indication(s) would you like assessed?

___________________________________________________________________________________ ___________________________________________________________________________________ ___________________________________________________________________________________ ___________________________________________________________________________________ ___________________________________________________________________________________ ___________________________________________________________________________________ ___________________________________________________________________________________ ___________________________________________________________________________________ ___________________________________________________________________________________ ___________________________________________________________________________________

2.

Ideally, when do you require the assessment to be completed?

___________________________________________________________________________________ ___________________________________________________________________________________ ___________________________________________________________________________________ ___________________________________________________________________________________

3.

Would you like to apply for fast-tracking the application (note that to fast-track an application the pharmaceutical must be high cost and hence may cause financial risk to the DHB)? Yes ¨ No ¨

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E.

Evidence

1.

Based on the evidence, what do you consider are the advantages and disadvantages of the pharmaceutical compared to existing treatment? Please complete the following tables. If possible, please provide abstracts/citations/articles to support these claims.

Advantages of proposed pharmaceutical 1. 2. 3. 4. 5. 6. 7. 8. 9. 10. Disadvantages of proposed pharmaceutical 1. 2. 3. 4. 5. 6. 7. 8. 9. 10.

Advantages of comparator 1. 2. 3. 4. 5. 6. 7. 8. 9. 10. Disadvantages of comparator 1. 2. 3. 4. 5. 6. 7. 8. 9. 10.

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F.

Other details

1.

Do you have any further comments?

___________________________________________________________________________________ ___________________________________________________________________________________ ___________________________________________________________________________________ ___________________________________________________________________________________ ___________________________________________________________________________________ ___________________________________________________________________________________ ___________________________________________________________________________________ ___________________________________________________________________________________ ___________________________________________________________________________________ ___________________________________________________________________________________ ___________________________________________________________________________________ ___________________________________________________________________________________ ___________________________________________________________________________________ ___________________________________________________________________________________ ___________________________________________________________________________________ ___________________________________________________________________________________ ___________________________________________________________________________________

Thank you for completing this assessment form. The assessment of new hospital pharmaceuticals is an important component of the national hospital pharmaceutical strategy. Please send this application to: PHARMAC c/o Rachel Grocott Senior Analyst, Hospital Pharmaceuticals Assessment PO Box 10-254 Wellington Or email to: rachel.grocott@pharmac.govt.nz

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