FORM A: INITIAL APPRAISAL SUBMISSION
Please refer to the process for industry engagement, guidance notes, exclusion
criteria and frequently asked questions available in the Pharmaceutical Industry
section of the AWMSG website. Please note that the guidance notes provide essential
information and failure to use them may result in an inadequate submission. Should
you have any queries in completing the form, please contact Ruth Lang, the Head of
Liaison and Administration for the AWMSG secretariat (the All Wales Therapeutics
and Toxicology Centre [AWTTC]) on 029 20716900 or email [email protected].
1.
Product information
1.1 General information
a) Marketing authorisation (MA)
holder
b) Approved name of medicine
c) Trade name
d) Formulation(s), strength(s)
and route(s) of
administration
e) Full licensed indication(s)
f) Indication covered in this submission (if different from the full licensed indication above)
g) If the licence has been amended, provide details of the change(s), e.g. new indication,
new target group, change in place of therapy
Form A: Initial appraisal submission. December 2015
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1.2 Regulatory status
Authorising body
Hyperlink to relevant page on
authorising body website (if
available)
Date MA applied for
Date of CHMP positive opinion
Anticipated MA date
Date MA granted
Anticipated UK launch date*
UK launch date*
*Launch date may be considered as part of the appraisal prioritisation process
Is the medicine likely to be included under the early access to medicines scheme (EAMS)?
2.
Exclusion criteria
2.1 Overview
In your view, does one or more of the AWMSG
exclusion criteria for appraisal apply?
Yes
No
If NO, move to section 3
If YES, which of the exclusion criteria apply?
If, in your view, exclusion criteria 2, 6 and 7 apply, please complete sections 2.2, 2.3 and/or
2.4 accordingly. If not, move to section 3.
2.2 Exclusion criterion 2: The National Institute for Health and Care Excellence
(NICE) intends to publish final guidance (Single Technology Appraisal [STA] /
Multiple Technology Appraisal [MTA] / Highly Specialised Technology [HST]) for
the same product and indication(s) within 12 months from the date of marketing
authorisation
a) Has the medicine been referred to NICE
(STA, MTA or HST)?
Yes
No
b) Title of NICE TA/MTA or HST
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c) NICE ID number (if known)
d) Hyperlink to relevant page
on NICE website
e) Anticipated publication date
of final NICE guidance
f) Number of months
anticipated from date of MA
to publication of NICE final
guidance
g) There are occasions where the AWMSG Steering Committee may request a submission
ahead of NICE advice. In the event that an accelerated appraisal would be beneficial for
your product, would your company be in a position to progress with a submission? Please
provide an estimated submission date.
2.3 Exclusion criterion 6: Product is a new formulation of an established medicine
a) Details of alternative formulation(s) available
b) Price based on maximum dose per patient per year/treatment course (excluding VAT) for
alternative formulation(s), based on list price
c) Difference in price based on maximum dose per patient per year/treatment course
(excluding VAT) between the product in this submission and the alternative
formulation(s), based on list price
2.4 Exclusion criterion 7: An equivalent generic or branded generic product is
available and the new product costs the same or less
a) Name of equivalent generic or branded generic product(s)
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b) Price based on maximum dose per patient per year/treatment course (excluding VAT) for
existing product, based on list price
c) Difference in price based on maximum dose per patient per year/treatment course
(excluding VAT) between the product in this submission and existing product, based on
list price
3.
Cost and patient eligibility
3.1 Patient Access Scheme (PAS)
a) Are you considering submitting a Wales
Patient Access Scheme (WPAS) for this
medicine?
b) If YES, is the WPAS a simple or complex
scheme?
Yes
Simple
No
Complex
c) Are you considering submitting a
Department of Health (DOH) patient access
scheme (PAS) for this medicine?
Yes
No
d) Does the medicine have a DOH PAS which
has subsequently been included in a NICE
Final Appraisal Determination (FAD)?
Yes
No
e) If YES, is the DOH PAS a simple or
complex scheme?
Simple
Complex
f) Will the same DOH PAS be made
available for the indication in this
submission?
Yes
No
g) Will the WPAS/DOH PAS apply to primary
care?
Yes
No
3.2 Cost
a) Proposed price based on maximum dose per patient per year/treatment course
(excluding VAT), based on list price
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b) Proposed price based on maximum dose per patient per year/treatment course
(excluding VAT), based on WPAS/DOH PAS price (if applicable)
c) Additional costs associated with use of new medicine per year/treatment course
3.3 Patient eligibility
a) Estimated number of patients in Wales eligible for this medicine (for the indication
covered in the submission)
b) Source of estimated numbers of eligible patients
4.
Limited Submission details
If, in your view, your submission should be considered as a limited submission, please
complete this section. If not, move to section 5.
4.1 Overview
a) Is this submission for a new medicine
(chemical entity)?
b) Is this submission for a new licensed
therapeutic indication (new target
disease)?
c) Is there a complex PAS associated with
this medicine?
Yes
No
Yes
No
Yes
No
If you have answered YES to any of the above questions then a FULL submission is likely to
be required.
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Under which criteria do you consider a limited submission appropriate (please tick all that
apply)?
1. New formulation of existing medicine (e.g. slow release, new
chemical salt) which has a pro-rata or lower cost per treatment
2. A new minor licensed extension (e.g. paediatric indication)
3. Anticipated minimal budgetary impact in NHS Wales
4. Estimated small difference in cost compared to comparator(s)
For limited submission criteria 1, 3 and 4 please complete sections 4.2, 4.3 and/or 4.4
accordingly.
4.2 Limited submission criterion 1: Significant new formulation
If, in your view, criterion 1 applies, complete cost information below:
a) Price based on maximum dose per patient per year/treatment course (excluding VAT) for
other available formulations, based on list price
b) Difference in price based on maximum dose per patient per year/treatment course
(excluding VAT) of the product in this submission and other available formulations
4.3 Limited submission criterion 3: Anticipated minimal budgetary impact in NHS
Wales
If, in your view, criterion 3 applies, complete cost information below:
a) Estimated budget impact in NHS Wales and rationale
4.4 Limited submission criterion 4: Estimated small difference in cost compared to
comparator(s)
If, in your view, criterion 4 applies, complete cost information below:
a) Proposed comparator(s)
b) Price of comparator(s) based on maximum dose per patient per year/treatment course
(excluding VAT), based on list price
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c) Difference in price based on maximum dose per patient per year/treatment course
(excluding VAT) between the product in this submission and the comparator(s)
5.
Comparator and place in therapy
a) Company-proposed comparator treatment(s). Please provide justification.
b) Expected place in therapy (e.g. first line)
6.
End-of-life,
orphan/ultra-orphan
medicines
and
medicines developed specifically for rare diseases
a) In your view, does the medicine have
orphan or ultra‐orphan status or has it
been developed specifically for a rare
disease? (see AWMSG policy for orphan
and ultra‐orphan medicines and
medicines developed specifically for rare
diseases for definitions)
Yes
No
b) In your view, does the medicine meet the
AWMSG policy on appraising lifeextending, end-of-life treatments?
Yes
No
7.
Contact details
Person compiling the submission
Name
Position
Department
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Telephone
Email address
Signature
Date of submission of Form A
Date of resubmission of Form A
(if applicable)
Main contact (this need not be the person submitting Form A):
Name
Position
Address
Telephone
Email address
Additional Contact (e.g. Medical Director):
Name
Position
Address
Telephone
Email address
The completed form should be forwarded by email to [email protected]. Include
the Summary of Product Characteristics (SPC) or draft SPC with your submission.
Direct any enquiries to Ruth Lang at [email protected] or call 029 20716900.
All Wales Therapeutics and Toxicology Centre
Academic Centre
University Hospital Llandough
Penlan Road
Llandough
Vale of Glamorgan
CF64 2XX
Form A: Initial appraisal submission. December 2015
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