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Ne w Hosp ital Pharmaceutica l Assessment Template for Pharmaceutica l Supp liers

The New Hospital Pharmaceutical Assessment Process (NHPAP) was developed as part of the Hospital Strategy and requires that pharmaceutical suppliers 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 national assessment by PHARMAC. 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 choose 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. The NHPAP 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, supplier involvement is crucial in the following areas: • Suppliers need to notify PHARMAC of new hospital pharmaceuticals available, or which 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 completed the draft analysis it is sent to DHBs and the supplier for comment. All comments are addressed or incorporated in the final version of the analysis. Suppliers are encouraged to send comments on the analysis to PHARMAC in order to have an influence on the final version that will be sent to DHBs and placed on Hospital Pharmaceutical Assessment Database (HPAD) website. The results of the analysis will also be 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 required 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). This assessment template should be completed in the following situations: • when making a submission for national assessment of a new hospital pharmaceutical or new indication for a hospital pharmaceutical; • when making a submission for PHARMAC consideration following notification that PHARMAC is assessing a pharmaceutical. Involvement in the NHPAP has the following benefits: • input into PHARMAC’s assessment of the pharmaceutical; • wide circulation of information regarding the cost-benefit of a new pharmaceutical; • inclusion of a hospital pharmaceutical in Part III of Section H of the Pharmaceutical Schedule.

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Each submission will be prioritised for national assessment according to the criteria of the NHPAP (i.e. highest priority given to those pharmaceuticals which are 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. If you have any questions, please contact Rachel Grocott at PHARMAC (DDI: (04) 916 7535).

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A.

Pharmaceutical Details

1.

Chemical Name:

2.

Brand Na me:

3.

Strength(s):

4.

Dosage form(s):

5.

Pack size:

6.

Registered Indications:

7.

Contraindications:

8.

Drug interactions:

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7. Pharmacode (if available):

9.

Price: $

B.

Clinical Details

1.

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

2.

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

3.

What are the main comparator(s)?

4.

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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C.

Evidence

1.

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:

2.

What was the research question asked?

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3.

Please complete the following table on the key studies:

Study Authors and Year

Study Design

Sample size

Interv ention

Comparator

Eligibility criteria

Study duration

Primary Outcomes

Secondary Outcomes

4.

Attach key publications that provide evidence of the safety, effectiveness and cost-effectiveness of the pharmaceutical, and any other evidence.

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D. 1.

Effectiveness Outcomes Please complete the following table on the outcomes of the studies: Notes: • Please indicate p-values for all outcomes • Please indicate if analysis is based on intention-to-treat population

Study Authors and Year

Primary Outcomes

Secondary Outcomes

Total Adverse Events

Serious Adverse Events

Total Withdrawals

Withdrawals due Adverse Events

to

2.

Based on the evidence, what is the answer to the research question?

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3.

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

Benefits of comparator

Risks of proposed pharmaceutical

Risks of comparator

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E.

Quality of Life and Other Outcomes

1.

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

2.

Utility values:

3.

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

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F.

Costs - Pharmaceutical

1. Dose:

2. Daily cost per patient:

3.

Cost/day of comparator treatment:

4.

Side effects:

5.

Pharmaceuticals/procedures used to treat these side-effects:

6.

Estimated cost of treatment for side-effects:

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7.

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

8.

Costs of these pharmaceuticals:

G.

Costs – Hospital

1.

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

2.

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

3.

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?

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4.

Are there likely to be any savings to the hospital from funding this pharmaceutical?

5.

Additional hospital costs:

H.

Costs – Other

1.

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

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2.

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

Please complete the following cost summary table:

Cost item Cost of pharmaceutical Cost of significant side-effects Cost of hospital admissions Cost of other hospital resources Community medication cost

Data source

Cost per patient

Number Patients

of

Total Cost

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

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I.

Patient Population

1.

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.)?

2.

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

3.

If possible, what is the estimated number of patients per DHB that could benefit from this treatment: Waitemata Auckland

Northland

Counties Manukau

Waikato

Lakes

Bay of Plenty

Tairawhiti

Taranaki

Hawkes Bay

MidCentral

Whanganui

Capital and Coast

Hutt

Wairarapa

Nelson Marlborough

West Coast

Canterbury

South Canterbury

Otago

Southland

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4.

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:

J.

Cost-effectiveness

1.

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.

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K.

Implementation

1.

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

2.

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

3.

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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