Guidance for Completion of Formulary Application Form 1 (FAF1)

Guidance for completion of Formulary Application Form 1 (FAF1)

SECTION 1:BACKGROUND INFORMATION

• Information obtained from Scottish Medicines Consortium (SMC) Detailed Advice Document supplied with letter requesting completion of a FAF1. Whilst the advice is in confidence an electronic version can be obtained from the Formulary Committee Administrator (email: )

• Summary of the recommendation is available from the SMC website once information is made public (

Prior to submission of the application form to Formulary Committee for consideration there must be confirmation that the appropriate budget required is in place. The Clinical Director signature is confirmation to Formulary Committee that this is in place. Formulary Committees role is to assess the clinical, comparative and cost effectiveness, not the affordability.

Where there is a problem with agreeing funding, this should be escalated up through management and potentially can be discussed at the Difficult Decisions Forum.

SECTION 2:Place of new medicine in Lothian and THE Lothian Joint Formulary (

Sources for prevalence and incidence data include:

• In-house/specialist/local information
• SMC report – take into account NHS Lothian population versus NHS Scotland population
• SIGN
• NHS Quality Improvement Scotland: national overview and local reports on the standards

• Local reports, e.g. from Public Health at Lothian Health Board
• Medical Records statistics
• Information Statistics Division (ISD)
• Health Information Unit, Public Health, NHS Lothian

Number of patients/year (primary and secondary care)

• Estimate from figures obtained from the prevalence and incidence data. Is it a ‘me-too’ medicine or a replacement treatment?

• For primary care prescribing,PRISMS data is available from ISD or the Medicines Management Team, Pentland House
• For secondary care, pharmacy stock management systems will provide supporting data

Protocol for use?

• What is consensus pan-Lothian opinion on place in therapy?

• Would use of new medicine require specific training?
• Would use of new medicine require specific guidelines for use?
• Will it replace an existing therapy, is it suitable as an alternative to existing therapy, is it a ‘me-too’ medicine?
• Where will prescribing take place? (primary/secondary/tertiary care)
• Would a shared care agreement be required?
• Is this consistent with SMC advice?

Place of medicine in the LJF

• Tick box for preferred option for use of new medicine in Lothian

SECTION 3:FINANCIAL INFORMATION

Add name of medicine (both generic and Brand name)

If the intention is to use a homecare service for the delivery/procurement of this medicine, please include this information.

Prior to submission of the application form to Formulary Committee for consideration there must be confirmation that the appropriate budget required is in place. The Clinical Director signature is confirmation to Formulary Committee that this is in place. Formulary Committees role is to assess the clinical, comparative and cost effectiveness, not the affordability.

Where there is a problem with agreeing funding, this should be escalated up through management and potentially can be discussed at the Difficult Decisions Forum.

Completion of Table - Columns

• No. of patients in Lothian eligible for treatment per annum in current financial year (refer to local data - see notes for Section 2, above)

• Cost per annum per patient (multiply for all patients) for the current financial year, calculated:

(treatment cost) x (average no. days treatment) x (1) OR (no. of patients in current financial year)

Completion of Table - Rows

• Secondary care costs (will include VAT)

• Primary care (GP practice, independent and supplementary prescribers) costs (will exclude VAT)

• Substitution effect (if any) from switching from current recommended therapy - evaluate cost implications (+) or (-) if this medicine is introduced in Lothian; specify which medicine will be replaced; calculate for secondary and primary care separately (taking account of VAT)

• Other cost implications - include any additional costs associated with medicine, i.e. additional lab tests, X-rays for monitoring purposes, training costs associated with new medicine, additional treatments needed (i.e. adding in treatments to minimise side effects)

• Total net cost of the introduction of thus new medicine.

SECTION 4:DECLARATION OF INTEREST

Ensure that all persons completing the FAF1 have completed declaration of interest prior to submission of form to the Formulary Committee.

Forms should be submitted to the address detailed on the back of the form.

June 2014