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Ne w Hosp ital Pharmaceutica l Assessment Template for D HB Hosp ita ls
The New Hospital Pharmaceutical Assessment Process (NHPAP) was developed as part of the Hospital Strategy. The process relies on DHB hospital 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 chose not to fund new pharmaceuticals or 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: • reduce duplication of work between DHBs; • increase communication between DHBs; • share knowledge and increase dialogue among DHBs and PHARMAC on clinical and financial issues relating to new pharmaceuticals; • facilitate review by a number of experts; and • improve national consistency of access to new pharmaceuticals. In order to achieve the aims of the process, DHB involvement is crucial in the following areas: 1. DHB hospitals need to notify PHARMAC of what pharmaceuticals they are assessing in order that PHARMAC can prioritise what pharmaceuticals should be assessed. 2. DHB hospitals need to keep PHARMAC up-to-date with the outcomes of their own assessment process, so that PHARMAC can update the HPAD website. 3. DHB hospitals can send PHARMAC their D&T committee submissions or minutes of meetings, to include on the HPAD website. This has the benefit of reduce duplication of work and sharing of knowledge. 4. DHBs are encouraged to review and provide input into PHARMAC assessments in order to obtain consensus on the appropriate use of new hospital pharmaceuticals. 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. 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.
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Each submission from DHB hospitals will be prioritised for national assessment according to the criteria of the NHPAP (i.e. highest priority given to those pharmaceuticals which a number of DHBs are assessing and those associated with very high costs to DHBs). If you have any questions or would like further information on the NHPAP, please contact the Hospital Pharmaceutical Analyst, Rachel Grocott, at PHARMAC (rachel.grocott@pharmac.govt.nz or phone: (04) 916 7535).
A.
Application Details
1. 2.
DHB name: Name of contact person:
3.
Contact details:
Do you agree to have your contact details included in the database? Yes ¨ No ¨
B. 1.
Pharmaceutical Details Chemical Name:
2.
Brand Name:
3.
Dose currently used in New Zealand:
4.
Price: $ per unit (please state units used)
5.
Length of treatment:
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C.
DHB Assessment Details
If your DHB is currently assessing a pharmaceutical or have recently assessed a pharmaceutical, please answer the following questions: 1. Date application received by DHB:
2.
Date of assessment by DHB:
3. 4.
Date decision was reached DHB (if applicable): 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
7.
Would this pharmaceutical replace a pharmaceutical that is currently funded? Yes ¨ No ¨ If so, what pharmaceutical(s) would it replace?
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8.
Prescriber Restrictions (those who can prescribe this medicine): ¨ All Consultants ¨ Specialist Only - Type: ¨ All medical staff (including H/S, Registrars
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. Number of patients in the DHB who would benefit from the treatment per year:
11. 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 ¨
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 comparator
Advantages of proposed pharmaceutical
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Disadvantages of proposed pharmaceutical
Disadvantages of comparator
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 Hospital Pharmaceutical Analyst PO Box 10-254 Wellington Or email to: rachel.grocott@pharmac.govt.nz
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Metadata
Title
New Hospital Pharmaceutical Assessment Template
Abstract
The New Hospital Pharmaceutical Assessment Process (NHPAP) was developed as part of the Hospital Strategy. The process relies on DHB hospital 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.
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