Hospital Pharmaceutical Assessment Template for Pharmaceutical Suppliers (text extract)

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Hosp ita l Pharmaceut ical Assessment Template fo r Pharmaceutica l Supp liers

The Hospital Pharmaceutical Assessment Process (HPAP) was developed as part of the Hospital Strategy. Pharmaceutical suppliers are asked to inform PHARMAC and hospitals of new hospital pharmaceuticals that are available. This assessment form is designed for suppliers to enable simple and consistent reporting of new hospital pharmaceuticals for consideration by PHARMAC for national assessment. Please note that this differs from the information that is required when submitting an application to PHARMAC for inclusion in Sections B to G of the Pharmaceutical Schedule. 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. The HPAP is intended to promote the following benefits: • facilitate the introduction of economic analysis into hospital pharmaceutical assessments; • reduce duplication of work; • promote dialogue between DHBs and PHARMAC on clinical and fiscal issues; • facilitate review; • improve the consistency and quality of assessments; and • improve consistency of access to pharmaceuticals. In order to achieve the aims of the process, supplier involvement is crucial in the following areas: • Suppliers need to notify PHARMAC of new hospital pharmaceuticals available, or pharmaceuticals that are likely to be available within the next year. • Suppliers can assist PHARMAC with assessments of their pharmaceuticals, and have an input into the process by completing this assessment template. • When PHARMAC has comp leted the draft analysis it is sent to DHBs and the supplier of the pharmaceutical for comment. All comments are addressed or incorporated in the final version of the analysis. The final version of the analysis is then distributed to DHBs and placed on the Hospital Pharmaceutical Assessment Database (HPAD) website. Results of the analysis are also included in Part III of Section H of the Pharmaceutical Schedule. Why complete this template? Under Section 4.2.2 of the Hospital Strategy, pharmaceutical suppliers are asked to submit applications to PHARMAC for the listing of pharmaceuticals in Section H (note that this includes Part III of Section H). For further information, please refer to the final version of the National Hospital Strategy (http://www.pharmac.govt.nz/pdf/nhps.pdf). Involvement in the HPAP has the following benefits: • input into PHARMAC’s assessment of pharmaceuticals; • wide circulation of information regarding the cost-benefit of new pharmaceuticals; • inclusion of hospital pharmaceuticals in Part III of Section H of the Pharmaceutical Schedule. 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 that have a substantial impact on the budget) – this includes both registered and unregistered pharmaceuticals;

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• •

pharmaceuticals that a number of DHBs are assessing; new indications for pharmaceuticals.

This assessment template should therefore be completed in the following situations: • when making a submission to a DHB hospital for the addition of a new hospital pharmaceutical on the hospital formulary, or the addition of a new indication to an existing pharmaceutical; • when a listing in Section B is not requested but the pharmaceuticals are used in the community as well as hospitals; • when making a submission for PHARMAC consideration following notification that PHARMAC is assessing a pharmaceutical. Each submission will be prioritised for national assessment according to the criteria of the HPAP (i.e. highest priority given to those pharmaceuticals that a number of DHBs are assessing and those associated with very high costs to DHBs). Individual suppliers will be kept informed of the progress of the assessment of their pharmaceutical. As there could potentially be a number of new hospital pharmaceuticals, it is recommended that pharmaceutical suppliers prioritise what pharmaceutical assessments to send to PHARMAC, according to expected population numbers and cost. If unsure, please contact PHARMAC staff before beginning the assessment, so that we can discuss where the pharmaceutical would be placed on the priority list for assessment, whether PHARMAC would assess the pharmaceutical and, if so, the timeframe for the assessment. When does this template not need to be completed? This assessment template does not need to be completed in the following situations: • applications for listing in Section B of the Pharmaceutical Schedule (supplier submission template should be completed); • applications for cancer drugs – the Cancer Treatment Subcommittee of PTAC (CaTSOP) needs to evaluate applications for cancer treatments, hence the applications should be completed using the supplier submission template; • rare and unusual indications (less than 10 patients per year nationally). A flowchart outlining when this template needs to be completed and its relationship to other PHARMAC processes is at the end of this document. How do we get the pharmaceutical listed in Part II of Section H? If desired, a proposal for a national contract involving listing of the pharmaceutical in Part II of Section H of the Pharmaceutical Schedule can be included with the submission. The proposal should include the following information as a separate document: • chemical name, • strengths, • forms, • brand name, • pack size, • packaging type, • pharmacode, • price, and • an indication of potential national volumes used and savings achievable at the submitted price. PHARMAC would assess this proposal and consult the Hospital Pharmaceuticals Advisory Committee (HPAC) on any potential value this proposal could provide DHB hospitals. If the assessment were favourable, PHARMAC would then contact the supplier with a standard terms hospital provisional agreement. PHARMAC would then consult on this provisional agreement and seek a decision from the PHARMAC Board or the Chief Executive under Delated Authority to approve the agreement. Subject

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to consultation and final PHARMAC Board approval, PHARMAC would list the pharmaceutical in Part II of Section H of the Pharmaceutical Schedule as soon as practicable. Note however that PHARMAC would be unable to provide any market exclusivity provisions (such as Hospital Supply Status) for the pharmaceutical, as the proposal would have been received outside of the competitive process timetable. Does any other information need to be provided? A submis sion need not restrict itself to answering only those questions specified in this template. Pharmaceutical suppliers are welcome to provide any further information relating to the pharmaceutical assessed or comparator pharmaceutical. Even though pharmaceutical suppliers are not required to undertake a full cost-utility analysis, it may be useful to provide a perspective on the cost-benefit of the pharmaceutical. If you have any questions, please contact Rachel Grocott, Senior Hospital Pharmaceutical Analyst, at PHARMAC (DDI: (04) 916 7535).

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Pharmaceutical Details

Chemical Name: _________________________________________________________________

Brand Name: ____________________________________________________________________

Strength(s): _____________________________________________________________________

Dosage form(s) (e.g. oral, intravenous, long-acting infusion etc.): __________________________

Pack size: ______________________________________________________________________

Registered Indications:

Contraindications:

Drug interactions:

7. Pharmacode (if available): __________________________________________________________

Price: $_________________________________________________________________________

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Clinical Details

Describe the clinical indication(s) for which funding is proposed?

Is this a licensed indication in NZ? Yes ¨ No ¨

What are the main comparator(s)?

How long will patients require the proposed pharmaceutical compared to the comparator (i.e. what is the course of the treatment for both pharmaceuticals)?

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Evidence on Efficacy

Does the clinical evidence come from: ¨ Randomised controlled trials ¨ Cohort study ¨ Systematic review ¨ Meta-analysis ¨ Cross-sectional study ¨ Case-control study ¨ Diagnostic studies ¨ Other Any additional comments:

___________________________________________________________________________________ ___________________________________________________________________________________ ___________________________________________________________________________________ ___________________________________________________________________________________ __________________________________________________________________________________ ___________________________________________________________________________________ ___________________________________________________________________________________ ___________________________________________________________________________________ ___________________________________________________________________________________ ___________________________________________________________________________________ ___________________________________________________________________________________ ___________________________________________________________________________________ ___________________________________________________________________________________ ___________________________________________________________________________________ ___________________________________________________________________________________ ___________________________________________________________________________________ ___________________________________________________________________________________ ___________________________________________________________________________________ ___________________________________________________________________________________ ___________________________________________________________________________________ ___________________________________________________________________________________ ___________________________________________________________________________________ ___________________________________________________________________________________ ___________________________________________________________________________________ ___________________________________________________________________________________

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2. 3.

Attach key publications that provide evidence of the safety, effectiveness and cost-effectiveness of the pharmaceutical, and any other evidence. Please complete the following table on the key studies: • • • Please indicate p-values for all outcomes Please indicate if analysis is based on intention-to-treat population Please state if there is more there are more than three key studies.

Study Authors and Year Study design Sample size Intervention Comparator Eligibility criteria Study duration Primary outcome results Secondary outcome results Total rate of adverse events Rate of serious adverse events Total number of withdrawals Number of withdrawals due to adverse events

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Based on the evidence, what are the benefits and risks of the pharmaceutical compared to existing treatment? Please complete the following tables:

Benefits of proposed pharmaceutical 1. 2. 3. 4. 5. 6. 7. 8. 9. 10. 11. 12.

Benefits of comparator 1. 2. 3. 4. 5. 6. 7. 8. 9. 10. 11. 12.

Risks of proposed pharmaceutical 1. 2. 3. 4. 5. 6. 7. 8. 9. 10. 11. 12.

Risks of comparator 1. 2. 3. 4. 5. 6. 7. 8. 9. 10. 11. 12.

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Quality of Life and Other Outcomes

What effect does the pharmaceutical have on patients’ quality of life?

Utility values:

Patient group

Utility value

Source

Are there any other important outcomes that need to be considered? Yes ¨ No ¨ If so, please describe:

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Costs - Pharmaceutical

Dose:

__________________________

Daily cost per patient:

__________________________

Cost/day of comparator treatment:

__________________________

What side effects are associated with treatment? What pharmaceuticals/procedures are used to treat these side effects, and what is the estimated cost of the treatment for side effects? Please list in the following table:

Side-effects 1. 2. 3. 4. 5. 6. 7. 8.

Treatment for side-effects Intervention

Cost $ $ $ $ $ $ $ $

Comparator treatment(s) 1. 2. 3. 4. 5. 6. 7. 8. $ $ $ $ $ $ $ $

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Are there any additional pharmaceuticals that need to be co-administered with the treatment and/or after the treatment? What is the cost of these pharmaceuticals?

Co-administered pharmaceuticals

Cost

1. 2. 3. 4. 5. 6. 7. 8. 9. 10. 11. 12.

$ $ $ $ $ $ $ $ $ $ $ $

Pharmaceuticals after treatment Intervention 1. 2. 3. 4. 5. 6. 7. 8. 9. 10. 11. 12.

administered

Cost

$ $ $ $ $ $ $ $ $ $ $ $

1. 2. 3. 4. 5. 6. 7. 8. 9. 10. 11. 12.

Comparator treatment(s) $ 1. $ $ $ $ $ $ $ $ $ $ $ 2. 3. 4. 5. 6. 7. 8. 9. 10. 11. 12.

$ $ $ $ $ $ $ $ $ $ $ $

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Costs – Hospital

How long is the patient likely to remain in hospital compared to alternative treatment?

LOS - Intervention

LOS – Comparator(s)

What DRG code(s) will these patients be coded to?

Code 1. 2. 3. 4. 5. 6. 7. 8.

Code Description

Is there likely to be any flow-on costs or benefits to the hospital from the utilisation of this medicine? E.g. improved patient management, reduced hospital stay, reduction in monitoring/lab tests, or reduced nursing time.

Flow-on costs to the hospital 1. 2. 3. 4. 5. Flow-on benefits to the hospital 1. 2. 3. 4. 5.

Cost per patient $ $ $ $ $ Saving patient $ $ $ $ $ per

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Costs – Other

Are there likely to be any other flow-on costs or benefits from the utilisation of this medicine?

Other flow-on costs 1. 2. 3. 4. Other flow-on benefits to 1. 2. 3. 4.

Cost per patient $ $ $ $ Saving patient $ $ $ $ per

What other resources might these patients be anticipated to consume compared with the alternative treatment?

Other resource costs for intervention 1. 2. 3. 4. 5. Other resource cost for comparator treatment 1. 2. 3. 4. 5.

Cost per patient $ $ $ $ $ Cost per patient $ $ $ $ $

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Please complete the following cost summary table:

Cost item Cost pharmaceutical of

Data source

Cost patient

per

Number of Patients

Total Cost

Cost of significant side-effects Cost of hospital admissions Cost of other hospital resources Community costs

Total Cost of Proposed Treatment (a) Cost of alternative pharmaceutical Cost of significant side-effects Cost of hospital admissions Cost of other hospital resources Community costs

Total Cost of Existing Treatment (b) NET COST (a-b)

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Patient Population

Which patients are most likely to benefit from this treatment (i.e. what is the patient population – include any details you have on age, gender, risk factors, disease stage and severity etc.)?

Number of patients in New Zealand who would benefit from the treatment per year: ___________

Where relevant, what is the life expectancy of patients? Life expectancy of patients on pharmaceutical: Life expectancy of patients on comparator: Mortality rate of patients on pharmaceutical: Mortality rate of patients on comparator: _________________________ _________________________ _________________________ _________________________

Any additional comments: ___________________________________________________________________________________ ___________________________________________________________________________________ ___________________________________________________________________________________ ___________________________________________________________________________________ ___________________________________________________________________________________ ___________________________________________________________________________________ ___________________________________________________________________________________ ___________________________________________________________________________________ ___________________________________________________________________________________ ___________________________________________________________________________________ ___________________________________________________________________________________ ___________________________________________________________________________________

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Cost-effectiveness

If an analysis has been completed in New Zealand, what is the cost per life year gained, or cost per quality-adjusted life year gained of the pharmaceutical compared with the current treatment? Please attach details of assumptions and results.

Implementation

Should prescribing be restricted to certain clinicians? If so, who?

Who would most benefit from this pharmaceutical (i.e. to whom should access be targeted)?

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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 Pharmaceutical Assessments PO Box 10-254 Wellington Or email to: rachel.grocott@pharmac.govt.nz

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New Pharmaceutical

Complete Supplier Submission Template

Yes

Cancer drug?

Send to TGM responsible for cancer drugs

Yes

Used in community?

Apply for listing in Section B of the Schedule?

Yes

Complete Supplier Submission Template

CATSOP/PTAC process (including economic analysis)

Used in hospital?

Yes Yes

Send to relevant TGM

Also used in hospital? PTAC process (including economic analysis)

New Hospital Pharmaceutical Assessment Process

Yes

<10 patients nationally?

No need to send submission to PHARMAC

Complete HPAP Template

Send to Hospital Pharmaceutical Analyst

Proposal for listing in Section H?

Yes

List only in Part III of Section H

Application is referred to HPAC for assessment of proposal

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Metadata

Title

Hospital Pharmaceutical Assessment Template for Pharmaceutical Suppliers

Abstract

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.

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