Form A: Initial appraisal submission. November 2017Page 1 of 8

FORM A: INITIAL APPRAISALSUBMISSION

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 Administrationfor the AWMSG secretariat (the All Wales Therapeutics and Toxicology Centre [AWTTC]) on 029 20716900 or email .

1.Product information

1.1General 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

1.2Regulatory status

Authorising body
Hyperlink to relevant page on authorising body website (if available)
DateMA 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

2.1Overview

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 finalguidance(Single Technology Appraisal [STA] / Multiple Technology Appraisal [MTA] / Highly Specialised Technology [HST]) for the same product and indication(s) within 12 monthsfrom the date of marketing authorisation

a)Has the medicine been referred to NICE(STA, MTAor HST)? / Yes / No
b) Title of NICE TA/MTA or HST
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.

2.3Exclusion criterion 6: Product is a new formulation of an established medicine

a)Details of alternative formulation(s) available

b)Price based on maximum dose perpatient 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 (excludingVAT) between the product in this submission and the alternative formulation(s), based on list price

2.4Exclusion 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)

b)Price based on maximum dose per patient per year/treatment course (excludingVAT) for existing product, based on list price

c)Difference in price based on maximum dose per patient per year/treatment course (excludingVAT) between the product in this submission and existing product, based on list price

3.Cost and patient eligibility

3.1Patient Access Scheme (PAS)

a)Are you considering reviewing an existing Wales Patient Access Scheme (WPAS) for this medicine? / Yes / No
b) Are you considering submitting a WPAS for this medicine? / Yes / No
c) If YES, is the WPAS a simple or complex scheme? / Simple / Complex
d) Are you considering submitting a Department of Health (DOH) patient access scheme(PAS) for this medicine? / Yes / No
e) Does the medicine have a DOHPAS which has subsequently been included in a NICE Final Appraisal Determination (FAD)? / Yes / No
f) If YES, is the DOH PAS a simple or complex scheme? / Simple / Complex
g) Will the same DOH PAS be made available for the indication in this submission? / Yes / No
h) Will the WPAS/DOH PAS apply to primary care? / Yes / No

3.2Cost

a)Proposed price based on maximum dose per patient per year/treatment course (excludingVAT), based on list price

b)Proposed price based on maximum dose per patient per year/treatment course (excludingVAT), based on WPAS/DOH PAS price (if applicable)

c)Additional costs associated with use of new medicine per year/treatment course

3.3Patient 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.

4.1Overview

a) Is this submission for a new medicine (chemical entity)? / Yes / No
b) Is this submission for a new licensed therapeutic indication (new target disease)? / Yes / No
c) Is there a complex PAS associated with this medicine? / Yes / No

If you have answered YES to any of the above questions then a FULL submission is likely to be required.

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

  1. A new minor licensed extension (e.g. paediatric indication)

  1. Anticipated minimal budgetary impact in NHS Wales

  1. 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.

4.2Limited 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 (excludingVAT) for other available formulations, based on list price

b)Difference in price based on maximum dose per patient per year/treatment course (excludingVAT) of the product in this submission and other available formulations

4.3Limited 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

4.4Limited 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

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 medicinesand medicines developed specifically for rare diseases

a) In your view, doesthe medicine have orphan or ultra‐orphan status or has it been developed specifically for a rare disease? (see AWMSG policy fororphan 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 life-extending, end-of-life treatments? / Yes / No

7.Contact details

Person compiling the submission

Name
Position
Department
Telephone
Email address
Signature
Date of submissionof Form A
Date of resubmission of Form A
(if applicable)

Main contact(this neednot 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 . Include the Summary of Product Characteristics (SPC) or draft SPC with your submission.

Direct any enquiries to Ruth Lang ator 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. November 2017Page 1 of 8