THIS APPLICATION FORM MUST NOT BE FORWARDED TO THE PHARMACEUTICAL INDUSTRY
Application to the Wirral Drug & Therapeutics Committee for a Formulary Addition to the Wirral Wide Medicines FormularyWirral Drug & Therapeutics Committee (WDTC) is committed to effective medicines management. The Committee will endeavour to:
§ Ensure that both WUTH, Wirral Community Trust and NHS Wirral work in partnership on issues of disease and symptom management to ensure effective prescribing practice, best use of resources across the local health system and coherent management of change. In compliance with the Bribery Act 2010 WDTC is committed to ensuring an open, fair and transparent process
§ Make prescribing practice within Primary and Secondary care increasingly evidence-based
A responsibility of the WDTC is to manage the introduction of new medicines into the local health economy. This form must be completed for a medicine to be added to the Wirral-wide Medicines Formulary.
The process of reviewing a drug for inclusion in the wirral formulary is as follows:
1) Your Specialty/NHS Wirral Pharmacist is available to assist you in completing this form, for submission to the WDTC.
2) Applications from Primary Care must be forwarded to Dr Abhi Mantgani, Accountable Officer, Wirral Clinical Commissioning Group in the first instance.
3) The applicant (consultant or GP) must complete the application form electronically, and then email along with all supporting references/supporting documents to Chris Herring - Lead Pharmacist, Medicines Management, WUTH, . A signed hard copy of the application form should be forwarded to Chris Herring, Lead Pharmacist Medicines Management, Pharmacy Department, Clatterbridge Hospital. Section 3 (Evidence to support this application) is not required to be completed for medicines that are approved by NICE TA’s.
4) All new medicine applications should be discussed with your Divisional Finance Manager and they should complete and sign the section at the bottom of page 6.
5) Applicants should engage with their respective divisions prior to submitting the form. Signatures from the relevant Divisional Finance Manager (DFM), Clinical Head of Division (CHD) and Associated Director of Operations (ADO) should be obtained prior to submitting this form. NHS Wirral Head of Medicines Management will sign all PCT applications.
6) If forms are incomplete or if appropriate evidence is not provided, the application will not be considered.
7) The applicant will be invited to attend the next available WDTC meeting to present the application and relevant supporting data.
8) The medicine will be added to the Wirral-wide Medicines Formulary only if the evidence clearly supports such a decision.
9) For PBR excluded drugs to be funded by NHS Wirral, commissioning decisions may also be required following the clinical decision to use this medicine.
1. Medicine Details1.1 Approved name:
1.2 Is there a NICE Technology Appraisal for this drug?
YES (please state NICE TA number) □………………….NO □
DO NOT COMPLETE SECTION 3 IF ANSWERING YES IN THIS SECTION.
1.3 Strength and form: / 1.4 Usual dose range:
1.5 What is the licensed indication for this medicine? (Please state if unlicensed)
1.6 Intended indication (if different from above)
1.7 Anticipated duration of treatment:
(Please state when and how you will assess the patients response to treatment)
2. Formulary Implications
2.1 State place in therapy for which the product is proposed including any proposed restrictions in use : (P as appropriate )
1st line: r / 2nd line: r / 3rd line: r
Other (specify details e.g. clinical evaluation)
Is the product intended for a particular patient subgroup, particular directorate, consultant, etc – specify details:
Which medicine is this product intended to replace? (if applicable)
2.2 Include an algorithm/protocol outlining the medicines proposed place in therapy
3. Evidence to Support this Application (DO NOT COMPLETE THIS SECTION IF THE MEDICINE HAS BEEN APPROVED BY NICE TA:
Describe below how the medicine compares with the existing formulary medicines or treatment, in terms of (please fully reference your claims):
Enclose electronic copies of key supporting references.
The Committee will consider evidence in the form of double blind randomised controlled clinical trial, published in peer-reviewed journals as the strongest support for your application.
3.1 Efficacy:
3.2 Safety:
3.3 Patient acceptability:
3.4 Other relevant information:
4. Financial and Other Implications:
4.1 Cost per patient of current treatment?
4.2 Cost per patient of proposed new treatment?
4.3 Change in cost per patient? (per month, or per year)
4.4 Specify anticipated likely number of patients per annum: Please use current prescribing data to determine this number as accurately as possible.
4.5 Specify anticipated annual change to medicines expenditure:
In Secondary Care / In Primary Care
4.6 Specify any other costs incurred by change in treatment for Primary Care/Secondary Care income/expenditure:
e.g. therapeutic drug monitoring required, change in income from alterations in activity, specialist clinic needs to be set up etc.
4.7 Estimated NET cost to Primary/Secondary Care:
5. Continuing Care Arrangements:
5.1 Will GPs be requested to continue care with this drug? Yes / No (as appropriate)
5.2 When would GPs be expected to take on prescribing? e.g.s immediately, when patient stable on therapy for 1, 2, 3 months, etc
5.3 Are shared care arrangements needed? Yes / No (as appropriate)
6.0 Summary of Advantages to Proposed New Treatment
· Improved efficacy r (please tick all boxes that apply to this application)
· Reduced adverse effects r
· Reduced cost r
· Improved patient acceptability r
7. Conflicts of Interest:
Declaration of Competing Interests
Under the terms of the Bribery Act 2010 applicants are required to declare any competing interests. A competing interest exists when professional judgment concerning a primary interest (e.g. this application) may be influenced by a secondary interest (such as financial or other gain, involvement in trials or personal rivalry. This gain may be for yourself or another)
Please note, failure to declare a competing interest may result in criminal sanction
This section should be filled in by both the applicant and the Clinical Director
1. Have you in the past accepted the following from an organisation that may in any way gain or lose financially from the result of your application:
Applicant / Clinical Director (WUTH only)
Reimbursement for attending a symposium? / Yes/No / Yes/No
A fee for speaking? / Yes/No / Yes/No
A fee for organising education? / Yes/No / Yes/No
Funds for research? / Yes/No / Yes/No
Funds for a member of staff? / Yes/No / Yes/No
Fees for attending an advisory board? / Yes/No / Yes/No
Fees for consulting? / Yes/No / Yes/No
2. Have you in the past been employed by an organisation that may in any way gain or lose financially from the results of your application?
Yes/No / Yes/No
3. Do you hold any stocks or shares in an organisation that may in any way gain or lose financially from the results of your application?
Yes/No / Yes/No
4. Have you acted as an expert witness on the subject of your application?
Yes/No / Yes/No
5. Do you have any other competing financial interests?
Yes/No / Yes/No
If you have answered “yes” to any of the above 5 questions, we consider that you may have a competing interest, which, under the terms of The Bribery Act 2010, should be declared. Please draft a statement to be submitted with your application below. It might, for example, read:
‘Competing interest: RS has been reimbursed by Shangri La Products, the manufacturer of elysium, for attending several conferences; TD has been paid by Shangri La Products for running educational programmes and has her research registrar paid for by the company’.
Further information is available from Wirral Fraud & Probity Service, 0151 651 3917.
Please specify declaration here:
You are required to disclose any sort of competing interest that would embarrass you if it became generally known after consideration of your application. The following list gives some examples.
· A close relationship with, or a strong antipathy to, a person whose interests may be affected by your application i.e. family member, friend or business associate
· An academic link or rivalry with somebody whose interests may be affected by your application.
· Membership of a political party or special interest group whose interests may be affected by your application.
This is not an exhaustive list. If you want to declare such a competing interest then please add it to your statement.
Name of Applicant ………………………………. Signature ………………………… Date ……….
Name of Clinical Director ……………………….. Signature ………………………… Date ……….
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Wirral Drug & Therapeutics New Drug Application form V3 Author: Christopher Herring
Approved by: WDTC 14/11/2012 Review date: 16/11/2013
Signatures supporting Wirral Drug & Therapeutics Committee New Medicine application for:
Application for:
Name – Main applicant / Post and organisation / Signature / Date
Name / Post and organisation / Signature / Date
Name / Post and organisation / Signature / Date
Name / Post and organisation / Signature / Date
WUTH Divisional Finance Manager
r / Funding has been fully identified for all additional costs.r / No funding identified but additional costs expected.
r / No additional costs expected (i.e. cost neutral)
r / Additional financial implications/recommendations attached.
Name / Post / Signature / Date
Page 2 of 8
Wirral Drug & Therapeutics New Drug Application form V3 Author: Christopher Herring
Approved by: WDTC 14/11/2012 Review date: 16/11/2013
CHD & ADO Signatures authorising Wirral Drug & Therapeutics Committee New Medicine application for:
Application for:
Name / CHD / Signature: / Date
Name / ADO / Signature: / Date
10. Primary Care Authorisation
Name
Dr Abhi Mantgani / Accountable Officer, Wirral Clinical Commissioning Group / Signature: / Date
Page 2 of 8
Wirral Drug & Therapeutics New Drug Application form V3 Author: Christopher Herring
Approved by: WDTC 14/11/2012 Review date: 16/11/2013