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Patient Access Scheme (PAS)
Full Application
NOTE: Complete this full application for proposed simple schemes that do not comply with all pre-defined
clauses of the Standard “PAS Submission” for Simple Scheme and for proposed complex schemes. Refer to
‘NHS Scotland Patient Access Scheme (PAS) Guidance’ document for further information and guidance on
completion. Completed application to be saved as a Microsoft Word® document using following naming
convention: Generic Drug Name (Brand Name) PAS Application Pack YYYYMMDD V0.1 (Initial)
General Information
Brand name:
Insert brand name of medicine ®
Approved name:
Insert approved name of medicine
Company name:
Insert company name
HTA submission type:
Select HTA submission type
Submission date:
Insert submission date
Anticipated PAS start date:
Insert anticipated effective date
PAS indication:
Insert indication being reviewed within HTA submission or
specific indication for PAS population (if different)
Preparations not included in PAS:
Enter details including pack sizes that have marketing
authorisation but not marketed within UK or enter N/A
Existing PAS in Scotland:
Indicate if existing PAS
Stated discount will be available if
HTA outcome is ‘not recommended’:
Indicate if stated discount will be available to individual
Boards should outcome of HTA be that general prescribing
for PAS indication is not recommended (e.g. PACS requests)
Additional information:
Enter other additional information or enter N/A
Company contact details:
Insert name
Insert position
Insert address
Insert contact no.
Insert email address
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Details of Proposed PAS
Proposed PAS type:
Please indicate the type of proposed PAS:

Simple PAS with amendment to Standard “PAS Submission” for Simple Scheme
Insert response

Complex scheme
Insert response
Proposed cost reduction mechanism (with all stated prices excluding VAT):
The cost reduction mechanism will be Choose an item
For simple PAS only
Strength
Form
Pack
Size
NHS List
Price (£)
Discount
(%)
PAS Price (£)
strength
form
size
£XXXX.XX
XX.X%
£XXXX.XX
strength
form
size
£XXXX.XX
XX.X%
£XXXX.XX
strength
form
size
£XXXX.XX
XX.X%
£XXXX.XX
strength
form
size
£XXXX.XX
XX.X%
£XXXX.XX
strength
form
size
£XXXX.XX
XX.X%
£XXXX.XX
strength
form
size
£XXXX.XX
XX.X%
£XXXX.XX
For proposed complex schemes, outline the details of the cost reduction mechanism and
associated processes / funding flow, or enter N/A
The following supporting documents have been enclosed with the application:

PAS Patient Registration Form
Insert response

PAS Claim Form
Insert response

Other supporting documents
Insert response
List any additional supporting documents
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Setting:
Prescribing:
State the anticipated prescribing setting for scheme i.e. primary, secondary
and/or tertiary care. Please indicate if the scheme excludes any potential
future prescribing settings that may occur within the lifetime of the PAS
Supply:
State the anticipated supply route for scheme i.e. hospital pharmacy,
community pharmacy and/or medicines homecare arrangements. Please
indicate if the scheme excludes any potential future supply route that may
occur within the lifetime of the PAS
Medicines
Homecare:
State any medicines homecare arrangements including: (i) manufacturercommissioned homecare providers, and (ii) confirm access to PAS scheme
via other NHS-commission homecare providers
Identifying PAS population:
For complex schemes, state how it is intended that the NHS and company will identify the patient
population that the PAS applies as well as those patients where the PAS does not apply (e.g. other
licensed indications). Identify any equity or equality issues and how these have been addressed.
For simple schemes, enter N/A.
Patient numbers and estimated total discount
Year
Estimated no. new patients
Estimated total no. of patients
(including new patients)
Estimated total discount (£) [not
cumulative]
1
XX
XX
£XXXX
2
XX
XX
£XXXX
3
XX
XX
£XXXX
4
XX
XX
£XXXX
5
XX
XX
£XXXX
Please provide details about how the information above has been derived for NHS Scotland. In
addition, for complex PAS, please provide the equivalent simple discount and estimation of patient
numbers where the PAS does not apply (e.g. other licensed indications)
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Additional patient monitoring:
Outline any additional patient monitoring over and above what would be required if the PAS was
not in use
PAS uptake monitoring:
Describe how the uptake of this PAS will be monitored
NHS operational costs:
For complex schemes, outline the estimated costs across NHS Scotland to implement and operate
the scheme, including (i) initial set-up costs [e.g. developing local SOPs and verification record,
staff training and awareness] across 14 NHS Boards, and (ii) recurring costs [e.g. cost per patient
to administer scheme including registration, initiating claims and reconciling payments]. Please
provide as much details as possible, including basis of costs e.g. time per activity, NHS staff grade
and source of information.
Burden minimisation :
Outline what steps have been taken to minimise the operational burden of the scheme for the NHS
NHS engagement:
Describe any engagement with NHS Scotland in the PAS development
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PAS Operational Flow Diagram (for complex schemes only):
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Rationale for PAS:
Outline the rationale for submitting a patient access scheme and, if applicable, justification for the
complex cost reduction mechanism
Other PAS:
Outline if the proposed PAS (or identical rebate scheme) is currently in use or proposed for this
indication or other indications in NHS Scotland or elsewhere
Current position:
Describe any previous or current SMC or NICE advice for this medicines (including other
indications)
Future position:
Describe any anticipated SMC or NICE HTA submissions or future licenses within the next five
years
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Further clinical information
Posology:
Insert standard treatment dose, dosing schedule and duration of treatment
Posology
adjustments:
Insert any necessary posology adjustments (e.g. due to adverse effects or
due to hepatic / renal impairment)
Treatment
discontinuation:
Insert the percentage of patients expected to discontinue treatment and
provide a breakdown of when treatment is discontinued (if possible)
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“PAS Submission” for Insert scheme type
1. General Information
Drug:
Insert approved name of medicine (Insert brand name of medicine®)
Supplier name:
Insert company name
PAS indication:
Insert PAS indication for proposed complex schemes OR insert following
statement for simple schemes ‘To avoid the need for individual patient
tracking, the discount will apply to all purchases of the Drug, including
future licensed indications, without prejudice to paragraph 4 below.’
PAS No:
PAS No. XXX (Secretariat to complete)
The Common Services Agency (NHS NSS) acts for and on behalf of NHS Scotland Boards
(“Boards”) in the establishment of the Patient Access Scheme (PAS) Agreement.
2. Defined Terms
Defined terms employed in this PAS Submission as indicated by the use of initial capital letters have
the meanings ascribed to them in the NHS Scotland Standard Terms for Patient Access Schemes.
3. Constitution of PAS Agreement
The PAS Agreement between the Supplier and each Board for the above Drug will be established
by the issue of the PAS Approval Letter by NHS NSS on behalf of and with the authority of each
Board and such PAS Agreement will be constituted by and governed by the PAS Approval Letter,
this PAS Submission and the NHS Scotland Standard Terms for Patient Access Schemes
(“Terms”). It is acknowledged that Board approval for use of the Drug in the treatment of Patients
as described herein through the Scottish Medicines Consortium forum and / or National Institute for
Health and Care Excellence (NICE) Multiple Technology Appraisal (MTA) as endorsed by
Healthcare Improvement Scotland (HIS) is dependent on establishment of the PAS Agreement.
4. Duration
4.1
The PAS Agreement will commence on Insert anticipated effective date and applies to Supply of
the Drug by the Supplier after that date for the treatment of Patients in accordance with the following
clauses of this PAS Submission.
4.2
While it is anticipated that the PAS Agreement and Board approval as aforesaid will continue once
established, it may be necessary to review the situation due to changing circumstances. Accordingly,
without prejudice to paragraph 5 below, either Party may terminate the PAS Agreement at any time
after a period of five years from Insert anticipated effective date providing not less than three
months’ prior notice in Writing to the other, and the PAS Agreement will terminate on the expiry of
the notice period. NSS should be informed in Writing of the date of termination (addressed to the
Patient Access Scheme Assessment Group (PASAG) Secretariat).
5. Material Breach
The importance of maintaining the confidentiality of Supplier Confidential Information noted in
paragraph 10 below is acknowledged. Accordingly, disclosure by a Board, NSS or HIS of Supplier
Confidential Information will constitute a material breach entitling the Supplier to terminate the PAS
Agreement to which this PAS Submission relates by notice in Writing to NSS as representative of the
Board (addressed to the Patient Access Scheme Assessment Group (PASAG) Secretariat); And
Provided further that, in the event such a material breach negatively impacts, or is demonstrated by
the Supplier to be substantially likely to negatively impact the price achieved for the Drug out with
Scotland as a result of Confidential Information being used as a reference price, the Supplier shall be
entitled to terminate the PAS Agreement to which this PAS Submission relates with each and every
Board; Provided that no notice of termination shall be given unless and until the Supplier has
submitted evidence of the alleged material breach and afforded NSS and the Board or Boards in
PAS for Insert brand name of medicine®
PAS No. XXX (Secretariat to complete)
Insert anticipated effective date
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question an opportunity to consider the evidence and respond thereto and the Supplier shall have
regard to the process for dealing with matters arising in relation to the application of PAS described
in section 9 (Unresolved Matters) of the NHS Scotland Standard Terms for Patient Access Schemes.
6. Effect of Early Termination
In the event of early termination, the Supplier will work with NSS and individual Boards to ensure
continuity of care for those patients already initiated on treatment.
7. Scope of Agreement and Cost Reduction Mechanism
The PAS agreement is for Patient treated with Insert approved name of medicine (Insert brand
name of medicine®). The cost reduction mechanism will be Choose an item.
Outline details of the cost reduction mechanism, relevant prices (excluding VAT), patient population,
the setting that the PAS is offered and any other relevant information. Refer to Standard “PAS
Submission” for Simple Scheme within Concise Application for recommended formatting of clauses.
8. Claims Procedure
Insert the following statement or variation for proposed simple schemes: ‘No claims procedure is
required by the Board when the Drug is supplied though secondary and tertiary care, and medicines
homecare arrangements as the PAS discount is provided at the point of invoice. When the Drug is
supplied in primary care then a rebate will be claimed (as outlined in paragraph 7).’ OR insert claims
procedure for proposed complex schemes (including reference to any patient registration or claim
forms, timeframes for claims and any requirement for Boards to provide list of authorised persons).
9. Verification Record
Insert the following statement for proposed simple schemes: ‘The Board is not required to maintain a
Verification Record for PAS Agreements for simple schemes. No additional patient monitoring is
required over and above what would be required if the PAS agreement was not in use.’ OR insert the
following statement for proposed complex scheme: ‘The Board shall maintain the following
Verification Record for a period of six years’ and specify any required information to be maintained
by the Board to validate claims, when this will be done and any audit requirements. The Supplier will
provide PAS monitoring data to the Patient Access Scheme Assessment Group (PASAG) Secretariat
on request and may be shared with the relevant NHS Board subject to the obligation of confidence
contained in NHS Scotland Standard Terms for Patient Access Schemes.
10. Supplier Confidential Information
Insert supplier confidential information is subject to the obligation of confidence contained in NHS
Scotland Standard Terms for Patient Access Schemes.
11. Supplier Representative
The Supplier’s Representative for the purposes of the PAS Agreement is Insert name or such other
person as may be notified to the Board in accordance with the Standard Terms.
To be signed by director or company secretary or authorised signatory of Supplier. In case of
execution by authorised signatory, Board minute or other document confirming authority
should be exhibited and a copy retained with the PAS Submission.
Signature:
Print name:
Insert name
Position:
Insert position
Date:
Insert date
“PAS Approval Letter” for Insert scheme type
PAS for Insert brand name of medicine®
PAS No. XXX (Secretariat to complete)
Insert anticipated effective date
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National Procurement
NHS Scotland
National Distribution Centre
Canderside
2 Swinhill Avenue
Larkhall
ML9 2QX
Telephone 01698 794400
Fax 01698 794403
Insert date
NOTE: PASAG Secretariat to add date if PAS approved and medicine accepted for use
Insert name
Insert position
Insert company name
Insert address
Insert email address
Dear Insert name,
The Patient Access Scheme (PAS) proposed by Insert company name (the “Supplier”) for Insert approved
name of medicine (Insert brand name of medicine®) (the “Drug”) has been accepted for use in NHS
Scotland by PASAG and the medicine accepted for use by SMC and / or NICE and endorsed by HIS. The
PAS is for Patients treated for Insert PAS indication for proposed complex schemes OR insert following
statement for proposed simple schemes ‘those indications accepted for use by SMC and / or NICE and
endorsed by HIS, and in addition the discount will apply to all purchases of the Drug, including future
licensed indications.’
I am pleased to confirm that the Common Services Agency (commonly known as NHS National Services
Scotland) has approved the establishment of the PAS Agreement on behalf of and with the authority of each
Board. As such the individual Boards’ representatives need not be listed. The PAS shall be governed by the
following terms and conditions:a)
b)
c)
The NHS Scotland Standard Terms for Patient Access Schemes
the Supplier’s PAS Submission
this PAS Approval Letter
The date on which the PAS shall come into effect is Insert anticipated effective date.
If you require any further information relating to the approval of the Patient Access Scheme however, please
contact the PASAG Secretariat at nss.np-pasag@nhs.net.
Yours sincerely
Director of Procurement, Commissioning & Facilities
NOTE: PASAG Secretariat to add signature if PAS approved and medicine accepted for use
Chair
Chief Executive
Director
Professor Elizabeth Ireland
Ian Crichton
Colin Sinclair
NHS National Services Scotland is the common name of the Common
Services Agency for the Scottish Health Service.
PAS for Insert brand name of medicine®
PAS No. XXX (Secretariat to complete)
Insert anticipated effective date
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For PASAG Secretariat use only
Enter other additional information or issues for consideration
Reviewed by:
Insert name
Checked by:
Insert name
Date of scheduled PASAG Meeting: Insert date
The decision of the PASAG is as follows:
PAS approved
PAS not recommended unless the following modifications to scheme made:
PAS not recommended due to following reason(s):
I/We (delete as appropriate) confirm the decision above and that I/we (delete as appropriate) have no
declarations of interest relevant to this patient access scheme.
Signed:
PASAG Co-chair
Date: Insert date
PASAG Co-chair
Date: Insert date
National Procurement Approval
I recommend that the “PAS Approval Letter” for Simple Scheme is approved for signing by the Director of
Procurement, Commissioning and Facilities on behalf of all the Boards.
Director of Procurement, Commissioning and Facilities
Date: Insert date
SMC recommended / NICE accepted and HIS endorsed:
Yes
If recommended, PAS Number:
PAS No. XXX (Secretariat to complete)
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No