Use this form for requests for licensed medicines to be added to the Highland Formulary. The main aim of this submission form is to define the place of the new product within the Highland Formulary, making reference to existing Formulary products.

COMPLETING THE SUBMISSION FORM

Please fill in this form electronically, completing all sections (the boxes will expand with the text). Where you do NOT have the relevant data please explain why in that section.

SECTION A:DRUG OVERVIEW

A1 – A2:The Formulary Subgroup of NHS Highland ADTC will review the medicine against other existing medicines available to treat the condition in question. This section provides an overview of the reason for requesting Formulary inclusion, including advantages over and important differences to existing equivalent Formulary treatment options if available. SMC advises on the clinical and cost-effectiveness of new medicines; if no SMC advice is available please provide this information. Add any additional useful information not included in the SPC, eg the routine dosage regime or important differences from current therapy.

A3: Please refer to SMC advice, if available, for information on Patient Access Scheme.

SECTION B:PLACE IN CLINICAL PRACTICE

B1 - B5: It is important to define how this drug will be used in Highland and estimate the number of people who might receive it. The source of the estimate should be stated, eg incidence, prevalence, historical data, Public Health dataset.

B6: It is important to define the impact of this drug on the level of use of current therapy. The financial benefits (or not) can be detailed later in the form.

B7 Many new therapies have other implications besides cost, eg monitoring costs/savings, service provision in terms of staffing, premises or equipment. Information on these implications will inform the decision-making process and helpmanage the overall impact.

SECTION C:INITIATION AND CONTINUATION OF PRESCRIBING

It is important to define whether the prescribing of this drug should be restricted and to assess whether a protocol for its use in hospital and/or primary care is required. Where a protocol is available please supply this.

SECTION D:SUMMARY OF FINANCIAL IMPACT

Complete the relevant sections to include costs incurred from using the drug and for any additional service costs (lab tests, staffing etc). Include savings that may occur from using this drug (where new drug is cheaper, fewer lab tests, reduction in use of disposables etc).

SECTION E:SUPPORTING SENIOR PRESCRIBING PRACTITIONER(S)

Please liaise with other appropriate senior prescribing practitioners and include the names of all those supporting this submission; only one signature is required.

SECTION F:DECLARATION OF INTERESTS

Please include a declaration of interests. Guidance on this is included with the submission form.

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THE HIGHLAND FORMULARY

Submission for inclusion of licensed medicine in the Highland Formulary

This form should be completed by a Senior Prescribing Practitioner (ie Consultant, GP, Specialist Nurse or Senior Hospital/CHP/Operational UnitPharmacist). Once completed (see preceding guidance) please forward the signed form and copies of any supporting literature to: Formulary Pharmacist, NHS Highland, John Dewar Building, Inverness Retail & Business Park, Highlander Way, Inverness, IV2 7GE.

Information on requested drug

Approved name:
Formulations andstrengthsrequested:
SMC advice reference
or if no SMC advice
Indications* applied for

* Indications must be included on the Summary of Product Characteristics (SPC).

Submission for Inclusion in the Highland Formulary

ADrug overview:

A1 Overview of reason for requesting Formulary inclusion (include advantages over and important differences to existing equivalent Formulary treatment options if available)?

Please refer to the the Scottish Medicines Consortium (SMC) advice, if available, at and the Summary of Product Characteristics (SPC) at There is no need to provide a copy of these documents with this submission unless the SPC is not available at in which case please supply a copy. If no SMC advice is available please also supply any supporting data/references (include a list at the end of the submission and one good quality copy).

A2 Other comments in support of application(include information supplementary to SPC, eg routine dosage regime)
A3 If SMC advice is available, does it take account of a Patient Access Scheme to improve cost-effectiveness?
YES/NO/no SMC advice available
If YES, please ensure section B2 is completed in full.

BPlace in clinical practice

Description of need (indications, types of patients, estimate of the number of patients who will be treated annually, duration of therapy).

B1 If SMC ‘Detailed Advice’ is available for this medicine:
Are the indication(s) for use and the criteria for patient selection the same as those statedin the SMC ‘Detailed Advice’ for this medicine?
YES/NO
If NO, please state any differences:
If no SMC advice is available:
a)Please define the indication(s) for use and the criteria for patient selection (eg national or local guidance/protocol)
b)Advantages in comparison to drugs within the class and others with similar effects, including any risk reduction (please make reference to, and supply copies of, published data where possible).
c)Disadvantages in comparison to drugs within the class and others with similar effects, (please make reference to, and supply copies of, published data where possible).
d)Published comparative data is available YES/NO (if YES please supply)
B2 Please define in detail the place of this drug in relation to existing therapy eg 1st choice and 2nd choice drugs for this indication. This MUST include its place in relation to the drugs already included in the Highland Formulary. Please clearly explain in words or pictures or refer to an existing algorithm.
If known, please provide:
Number Needed to Treat (NNT):
Number Needed to Harm (NNH):
(these must define the condition, treatment, comparator, duration of intervention and outcome)
B3 i) Estimate the total number of patients in Highland who have the condition for which you would like to use this drug to treat.
ii) Source of estimate (eg SMC ‘Detailed Advice’, clinic size, prevalence, etc).
iii) Estimate the total number of new patients in Highland who are likely to receive this drug EACH YEAR (contact Senior Hospital/LeadPharmacist for further advice).
1st Year / 2nd Year / 3rd Year / 4th Year / 5th Year
No. of patients:
iv) Source of estimate:
NB: the Scottish population is approximately 5,300,000. NHS Highland serves a population of over320,000 residents (within the Highland and Argyll & Bute Council boundaries).

B4Specify acquisition cost? eg 28 days treatment or one course

B5a) Anticipated duration of therapy or number of treatments?

b)Location of treatment: (hospital, primary care, shared care)

B6 Will the addition of this product to the Highland Formulary affect the level of use of other products?
YES/NO If YES, please answer questions below:
Which products are affected?
What is the estimated impact?
Is removal from Formulary advised?
B7 Are there any implications for service provision associated with the introduction of this product, eg need for specialist assessment, initial and/or continuing extra laboratory tests (in either secondary or primary care)? Please specify for each category all additions or reductions per patient per year.
Service provision: addition or reduction
Category / Description of addition/reduction / Finance staff only Cost/patient/year (£)
Operating theatre sessions
Inpatient bed days/length of stay
Day cases
Outpatient attendances
GP appointments
Community nurse visits
Laboratory tests (describe)
Pathology
Pharmacy
Radiology
Other - describe

C Initiation and continuation of prescribing

Ci) Should the prescribing of this drug be restricted? (eg for initiation only by or on the advice of a hospital specialist, or only for a particular indication, or for continuation in hospital and/or primary care in accordance with a protocol)

YES/NO (If YES, please specify)

ii)Is there a protocol currently available?YES/NO (If YES, please supply)

DSummary of overall financial impact

Specify how the calculations have been made in terms of cost per use/frequency/number of patients etc:

New therapy Annual cost / Displaced therapy Annual cost / Total
Cost (+) or saving (-) / Specify how calculations made in terms of cost per use/frequency/number of patients etc.

Secondary care

Drugs
Service / Finance staff to complete

Primary care

Drugs
Service / Finance staff to complete
Other

EName(s) of supporting Senior Prescribing Practitioner(s)

Signature (one is sufficient):______

Please print name: ______

Date:______

FDeclaration of interests (see overleaffor guidance). Information in this section will

only be made available to members of Highland Formulary Subgroup of ADTC.

F1Do you have any current personal interests (eg share holding, consultancy fees, grants)?

No Yes If Yes, please specify:

F2Do you have any non-personal interests (which have arisen during the last 12 months)?

No Yes If Yes, please specify:

Nature of interestCurrentStart Terminate

F2Other relevant interests:

DECLARATION OF INTERESTS

The Formulary Subgroup operates a policy of requiring members to declare any interests relevant to the matters under consideration at its meetings. This policy also extends to include Senior Prescribing Practitioners requesting new drugs.

The following provides a guide to different kinds of interests which should be declared. Interests not specified below but which could be regarded as influencing offered advice should be declared.

DIFFERENT TYPES OF INTEREST

1.Personal interests:

A personal interest involves payment to a Senior Prescribing Practitioner personally. The main examples are:

a)Consultancies: any consultancy, directorship, position in or work for the pharmaceutical industry which attracts regular or occasional payments in cash or kind.

b)Fee-paid work: any work commissioned by the pharmaceutical industry for which the Senior Prescribing Practitioner is paid in cash or kind.

c)Shareholdings: any shareholding in or other beneficial interest in shares of the pharmaceutical industry. This does not include shareholdings through unit trusts or similar arrangements where the Senior Prescribing Practitioner has no influence on financial management.

2.Non-personal interests:

A non-personal interest involves payment which benefits a department for which a Senior Prescribing Practitioner is responsible, but is not received by the Senior Prescribing Practitioner personally. The main examples are:

a)Fellowships: the holding of a fellowship endowed by the pharmaceutical industry.

b)Support by the pharmaceutical industry: any payment, other support or sponsorship by the pharmaceutical industry which does not convey any pecuniary or material benefit to a Senior Prescribing Practitioner personally but which does benefit his/her position or department, eg:

i)a grant from a company for the running of a unit or department for which a Senior Prescribing Practitioner is responsible;

ii)a grant, fellowship or other payment to sponsor a post or a member of staff in the unit for which a Senior Prescribing Practitioner is responsible (does not include financial assistance for students);

iii)the commissioning of research or other work by, or advice from, staff who work in a unit for which the Senior Prescribing Practitioner is responsible.

Senior Prescribing Practitioners are under no obligation to seek out knowledge of work done for or on behalf of the pharmaceutical industry within departments for which they are responsible if they would not normally expect to be informed.

3.Other relevant interests:

This should include any matter which might reasonably be perceived as possibly affecting a member’s impartiality. Some examples are:

a) An individual, or their department, has done research work relating to a particular product, or class of products. Although the research has not been funded by any particular pharmaceutical company, the research has taken a particular line, eg in relation to the safety of the products or their efficacy.

b Attendance at conferences, scientific meetings or similar: expenses or hospitality provided by a pharmaceutical company beyond that reasonably required for accommodation, meals and travel to attend meetings and conferences should be declared.

For further information please see the Scottish Medicines Consortium ‘Code of Practice on Declarations of Interest’ on NHS Highland Intranet at

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Please send the final, signed submission to: Formulary Pharmacist, NHS Highland, John Dewar Building, Inverness. Tel: 01463 706828, Email: