HARROGATE & RURAL DISTRICT AREA PRESCRIBING COMMITTEE (HaRD APC) Application for a new product to be added to the formulary

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1 Guidance on completing the form Your submission should be comprehensive and indicate which, if any, information has been supplied by a pharmaceutical company. The application must be completed with the input from the Lead Pharmacist in your speciality or area. The application must reflect consensus from your directorate, speciality or area. Each submission must be countersigned by the relevant Clinical Director. Send a signed hard copy to Sarah Abbas, Lead Medicines Information & Formulary Pharmacist, HDFT. an electronic copy to sarah.abbas@hdft.nhs.uk (cc emma.keating@hdft.nhs.uk ) Submission to HaRD APC APC meetings are scheduled for the 4 th Friday of each month. Applications must be submitted at least two weeks before the meeting whenever possible otherwise the submission is likely to go to the following APC meeting. The Formulary Pharmacist will notify you of the date of the meeting when the application will be considered. You are invited to attend that meeting to put forward the case for inclusion and answer any questions the Group may have. If you are unable to attend the meeting you may send a representative on your behalf or request to defer to a later meeting date. Decision-making process The HaRD APC will base their decisions on the following areas: clinical effectiveness and cost effectiveness/ resource impact strength of evidence patient safety place in therapy relative to available treatments national guidance and priorities local health priorities equity of access stakeholder views Decision Summary (completed after the HaRD APC meeting) Name of Product: Indication: Date of Decision Other approval required before use HaRD APC Decision

2 Section 1: Product details and intended place in therapy Product (Generic and Brand Name) Strength and Formulation Licensed Indication Dosage and Administration Intended indication and dose (if different from above) Course length (if applicable) What are the other treatment options? Option 1 Option 2 Option 3 Place in therapy relative to alternative treatments listed above Does this product replace a medicine already on the formulary? If so, which one? List any additional benefits of the new product (route, side effects, reduced need for community input) Patient safety/adverse effect profile Please provide a brief summary of the condition being treated (including morbidity, quality of life and mortality estimates)

3 Traffic light list classification Tick relevant box (see p for full definitions) Has the support of the Harrogate & Rural District CCG been obtained for prescribing in Primary Care? (Pharmacy to consult with the HaRD CCG Pharmacist/ Commissioning Support Unit representative) Stakeholder views (if available) Stakeholders = specialist doctors, patients, public, manufacturers) Green Both Primary & Secondary Care Amber 2 Hospital initiation, then refer to GP Amber 1 Hospital initiation, then refer to GP under shared care protocol Red Hospital only HDFT Consultants: Specialist Groups:

4 Section 2: Supporting Information & Evidence: New Medicine for Review: BNF Category: Organisation Date Comments NICE (state if TA): Scottish Medicines Consortium (SMC): All Wales Medicines Strategy Group (AWMSG): Other specialist centres Points for consideration

5 Change process How would change or implementation of new therapy be communicated? Will the product be incorporated into relevant policies, protocols, pathways? How and when would you propose to audit/monitor use of the new therapy? (Pharmacy will usually prompt a 6 month review) Other processes / approval required before use (e.g. IV safety review group, antimicrobial subgroup etc.) References

6 Section 3: Financial impact Use costing statements and templates in NICE if available Comparative drug costs Product Monthly Secondary care cost ( ) Monthly Primary care cost ( ) Cost implications (product) Budget holder Secondary care Primary Care Patients/ year (a) Product cost / year ( ) (b) Total cost per year ( ) (a x b) Comparative product cost / year ( ) Comments Other costs and considerations Commissioning (Tariff / non-tariff etc.)

7 Section 4: Declaration of conflict of interest Do you have any conflict of interest to declare? Examples include: Consultancy with the drug company Department receives research funds from the drug company Staff within the department are funded by the drug company You or your staff receive funding for attendance at scientific meetings from this company Please tick only one box below No I have no conflict of Interest. Yes Please give details:... Applicants Details / Counter-signatory Details Name of requesting Clinician, Pharmacist or Independent Prescriber: Department / Specialty: Signature: Date: Name of Clinical Director: Signature: Date: