Application for the use of a new medicine, or new indication for an existing medicine

(includes unlicensed/off label use)

Completed form to be sent to:- Gillian Sturrock, Pharmacy Department (Secondary Care)

Mrs Dorothy McCulloch, PA to Medical Director or Mrs Lorna Currie, PA to Chief Pharmacist,

(Primary Care)

Section 1: Please read through section 2 before completing form to ensure you need to proceed

with completion

1.1 / Approved name
1.2 / Brand name
1.3 / Manufacturer
1.4 / Formulation (eg tablet/injection)
1.5 / Indication for this application
1.6 / Daily dose for this indication

Section 2

2.1 / Is the medicine and formulation licensed for the indication in this application?
Note: If the product is unlicensed, see Unlicensed Medicines Policy / Yesgo to Section 2.7

Nogo to Section 2.2
2.2 / If no, can an alternative licensed medicine be used? / Yesuse alternative

Nogo to Section 3
2.3 / Is this an unlicensed formulation?
(eg a special liquid not normally available) / Yesgo to Section 2.4
Nogo to Section 3
2.4 / If yes, can an alternative be used? / Yesuse alternative

Nogo to Section 3
2.5 / Is the medicine licensed but being used in a non-licensed situation (ie ‘off-label’)? / Yesgo to Section 2.6

Nogo to Section 3
2.6 / If yes, can a licensed alternative be used? / Yesuse alternative
No
2.7 / Is the medicine accepted for use in Scotland by SMC for this indication?

(only for new medicines/formulations considered by SMC) / Yes
Nofollow the Individual Patient
Treatment Request (IPTR) process
2.8 / Is there a PAS (Patient Access Scheme) available for this medicine? / YesNo

Section 3: Is this:

3.1 /
  • a novel medicine? (ie first in class)
  • a new medicine in a class?
  • an existing medicine?
Is the medicine for
  • a recognised indication/condition?
    (ie COPD, hypertension etc)
  • a ‘novel’ indication/condition?
    (ie social phobia)
  • a recognised condition for which treatment is not available? (ie hiccups)
/ YesNo
YesNo
YesNo

YesNo
YesNo
YesNo
3.2 / Will it be:
  • ‘add-on’ therapy?
  • used instead of a current
    therapy?
/
YesNo

YesNo

Section 4

4.1 / Is this required as treatment for an individual patient due to their specific clinical need? / YesNo
go to section 4.2go to section 4.3
4.2 / Patient name
Patient CHI No
Estimated duration of therapy
Consultant signature
Please print name: / ......
......
......
......
......
4.3 / Cost per patient
State whether per course/month/year
Include Loading doses
min & max doses
titrations etc
4.4 / Estimated number of patients per year in D&G
Note: SMC Impact Estimates do not necessarily reflect NHS D&G situation.
4.5 / Cost of current/existing therapy (if any)
4.6 / Total annual cost. (4.3 x 4.1 or 4.4)
4.7 / Added cost, or saving, compared to existing therapies (if any)
4.8 / Are there any services implications, e.g. impact on in-patient beds, waiting time, / YesIf yes, state impact
(and cost implications if known)
No
4.9a / Is this medicine available via the Homecare Route (avoids VAT)? / Yes

NoNot applicable
4.10 / Are there any other costs (or savings)?
(eg giving sets if IV etc). Indicate how much / YesNo
4.11 / Will this medicine be initiated in:
Secondary care?
Primary Care? /
YesNo

YesNo
4.12 / Will this medicine be predominantly used in:Primary Care?
Secondary Care? /
YesNo

YesNo

Section 5

5.1 / Evidence supporting use of this medicine (for this indication)
SMC accepted:
SIGN guidelines:
NICE guidelines:
Other (please attach or provide link) / YesNo
Yes(quote number)No
Yes(quote number)No
Please specify

Section 6

6.1 / Is this to be considered for addition to the formulary? / Yesgo to section 6.2

Nogo to section 7
6.2 / Will it replace an existing formulary drug?
If the drug is to be used regularly, but infrequently, it will not be added to the formulary (usually secondary care drugs) / Yeswhich drug(s) will it replace?

Nogo to section 7

Section 7: Additional comments/considerations

Section 7: Conflict of interest declaration (please see examples below)

Name(s) of applicant(s)
Please print name
Designation(s) of applicant(s)
Conflicts of interest / Indicate Yes/No / Indicate Yes/No / Indicate Yes/No / Indicate Yes/No
Specific/personal
Specific/Non-personal
Non-specific/personal
Non-specific/Non-personal
Signature(s) of applicant(s)
Date
Nature of interest / Examples (Not exhaustive)
Specific/personal / Company sponsored attendance at a meeting about this drug
Attended company sponsored advisory board about this drug
Specific/Non-personal / Department involved in clinical trials of this drug
Non-specific/personal / Involved with the company but not this drug
Have shares in the company (includes spouse)
Non-specific/Non-personal / Department involved in clinical trials with the company but not this drug

Section 8: This section to be completed by a pharmacist

Non Parenteral Product

Are there any risks associated with the introduction of this medicine?

Eg. Cytotoxic, similar name to existing product, similar packaging?

For Guidance please see:

YesNo

If yes, please outline risks and any measures you have introduced to reduce the risk.

Parenteral Product

Please complete parenteral risk assessment (available on Pharmacy Shared Drive)

Risk Assessment Completed by (Pharmacist):

Name......

Signature......

Date......

Is the medicine accepted for use as specified in this application?YesNo

Signed on behalf of the ADTC......

Print Name......

Designation......

Date......

For assistance with preparation of this document please contact:

Any member of the Pharmacy/Prescribing Support Team OR

Prescribing Accountant

Pharmacy Department, DGRI

For dates of ADTC meetings and timetable for submission of papers please contact:

PA to Medical Director (01387 244002 or ext 34002) OR

PA to Chief Pharmacist (01387 244397 or ext 34397)

S:\Primary Care Development Shared Area\Prescribing\ADTC\Business case template\Template_for_Business_Case_for_a_new_drug_PBSR_4.docx

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