PATIENT ACCESS SCHEME ASSESSMENT GROUP (PASAG) - Guidance for NHS Boards
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PATIENT ACCESS SCHEME ASSESSMENT
GROUP (PASAG)
Guidance for NHS Boards
REVISED AUGUST 2013
Version 5 –– Revised August 2013 Page 1 of 29Contents – NHS Board Guidance 1. Introduction 3 2. Patient Access Schemes and the Patient Access Scheme Assessment Group 4 3. Submission and Assessment of Patient Access Schemes in NHS Scotland 5 4. Communication of PASAG decisions and implementation of PAS by NHS Boards 7 5. Confidentiality 8 Appendix 1: Process for PAS submission and assessment 11 Appendix 2: User Guide to NHS Scotland Standard Terms for Patient Access Schemes 13 Appendix 3: Key Principles for Patient Access Schemes 15 Appendix 4: Unique Patient Access Schemes (PAS) Patient Number 17 Appendix 5: Process for implementation of PAS by NHS Boards 19 Appendix 6: Example PAS Submission Form (Simple PAS) 21 Appendix 7: Example PAS Monitoring Template 23 Appendix 8: Example PAS Approval Letter (Simple PAS) 24 Appendix 9: Example PAS Approval Letter (for PAS with medicine use in Primary Care) 26 Appendix 10: Example PAS Approval Letter (Complex PAS) 28 Version 5 –– Revised August 2013 Page 2 of 29
1. Introduction The Patient Access Scheme Assessment Group (PASAG) was established in 2010 to assess proposed Patient Access Schemes (PAS) for acceptability in NHS Scotland against standard objective criteria. This guidance has been produced for NHS Boards to describe the process for submission and assessment of Patient Access Schemes (PAS) in NHS Scotland and communication of PASAG decisions. Version 5 –– Revised August 2013 Page 3 of 29
2. Patient Access Schemes and the Patient Access Scheme Assessment Group
Patient Access Schemes (PAS) are schemes proposed by a pharmaceutical company and agreed with
the Patient Access Scheme Assessment Group (PASAG) to improve the cost effectiveness of a drug
and enable patients to receive access to cost-effective innovative medicines using the usual existing
models for delivery of patient care within NHS Scotland. PASAG was established in 2010 to assess
proposed PAS for acceptability for implementation within NHS Boards in Scotland.
PASAG has a national focus, functioning under the auspices of NHS National Services Scotland (NSS).
It is composed of members from across NHS Scotland, with different specialist backgrounds:
• Director of Pharmacy (Co-Chair)
• Director of Finance (Co-Chair)
• Senior Clinician Acute care (X2), Primary care (X1)
• NHS Board Pharmacy operational representative
• NHS Board Finance operational representative
• NHS Board Business Manager representative
• NSS National Procurement representative (X2)
• Area Drug and Therapeutics Committee (ADTC) representative (X2)
• Association of the British Pharmaceutical Industry (ABPI) representative
• NHS Board Caldicott Guardian representative
• NHS Board Public Health representative
• NHS Board Medical Director representative
• NSS Information Services Division (ISD) representative
In addition, there are several observers who attend PASAG meetings or who are approached to provide
input on specialist areas as required. The key organisations represented by observers are:
• Scottish Government Health Directorates (SGHD) (X2)
• SMC (X2)
• Central Legal Office (CLO)
PASAG is supported by the PASAG Secretariat, which evaluates each PAS submitted, liaises with
pharmaceutical companies and NHS Boards as required, and presents issues for PASAG’s
consideration. The PASAG Secretariat is hosted by NSS National Procurement Division and comprises:
• Administration support
• Finance support
• Pharmaceutical support
• National Procurement support
Version 5 –– Revised August 2013 Page 4 of 293. Submission and Assessment of Patient Access Schemes in NHS Scotland
The submission and assessment process is outlined in Appendix 1.
In Scotland, pharmaceutical companies can propose a PAS:
a) As part of a Scottish Medicines Consortium (SMC) submission. PASAG assesses the PAS and
SMC assesses the clinical effectiveness and cost-effectiveness of the product. If the PAS is
accepted by PASAG then SMC considers the financial benefits of the proposed PAS as part of
the appraisal process. SMC normal assessment process follows usual timelines with clear
communication between SMC and PASAG.
b) In the context of a National Institute for Health and Care Excellence (NICE) Multiple Technology
Appraisal (MTA). PASAG assesses the PAS and Healthcare Improvement Scotland (HIS)
endorses the NICE recommendation as appropriate.
When making a PAS submission to PASAG, the pharmaceutical company is required to confirm their
acceptance of NHS Scotland Standard Terms for PAS, which were developed by the Central Legal
Office (CLO). The Standard Terms outline the terms under which a PAS in NHS Scotland will operate
and have been endorsed by ABPI and NHS Scotland. The Standard Terms are available on the SMC
website and a User Guide to the Standard Terms is available (Appendix 2).
The PAS submission completed by the company specifies: the drug and indication to which the PAS
relates; the relevant dosages and formulations; how the PAS will operate in NHS Scotland; the rebate
due to NHS Boards; and, data that the NHS Board will be required to maintain in order to confirm the
validity of any claims (the ‘Verification Record’) (see section 4 (i)).
All proposed schemes are assessed by PASAG in the context of an agreed set of Key Principles
(Appendix 3) and against standard objective criteria, which relate to whether or not the scheme is:
financially acceptable; robust ethically and legally; Caldicott compliant; and operationally practical.
Patient Access Schemes fall into one of two categories:
• Performance based schemes where the rebate or supply of stock is based on patient response to
treatment; or,
• Finance based schemes where the NHS receives a rebate or free supply based on usage. The
rebate may take the form of a straight discount from list price. This is generally available for all
purchases of a medicine for the indication under assessment although in some cases it may be
restricted to a particular preparation.
The process by which a PAS provides a rebate may be either simple or complex.
• Simple schemes involve a straight discount on the list price of the product. The discount is
applied at the point of invoice, to the full duration of treatment and to all clinical indications of the
product (current and future). There is no requirement to identify and monitor the course of
treatment of individual patients.
• Simple schemes in primary care involve a retrospective discount on the product, paid directly to
the NHS Board, based upon the quantity of prescribed medicine dispensed in primary care as
reported by the Prescribing Team at Information Services Division (ISD), NHS National Services
Scotland (NSS).
• Complex schemes are varied. They include free stock / rebates at various stages of the patient
treatment or are schemes that only apply to specified subgroups of patients. Complex schemes
require Boards to monitor the course of treatment of individual patients whilst maintaining patient
confidentiality in line with Caldicott principles. To monitor the course of treatment, each patient
Version 5 –– Revised August 2013 Page 5 of 29who is prescribed a product under the terms of the PAS is assigned a Unique PAS Patient
Number by the NHS Board (Appendix 4). Any PAS which requires patient identifiable data to be
collected and reported will not be accepted by PASAG.
Performance based schemes are always ‘complex’ while finance based schemes may be either ‘simple’
or ‘complex’. Some proposed PAS offer a combination of rebates including a straight discount on list
price for some elements of the course of treatment. These should always be regarded as complex PAS
due to the additional administrative burden of administering such PAS.
Assessment of PAS includes an iterative process with the pharmaceutical company and NHS Boards to
deliver schemes that are efficient and to minimise any administrative burden associated with PAS for
NHS Boards.
Following assessment, PASAG advises SMC or Healthcare Improvement Scotland (HIS) whether the
PAS is acceptable for implementation or not recommended. If the PAS was proposed as part of a SMC
submission, then the product may be: accepted for use or accepted for restricted use with or without the
PAS; or, not recommended for use. If the PAS was proposed in the context of a NICE MTA, then HIS
may endorse the NICE recommendation with or without the PAS as appropriate.
Version 5 –– Revised August 2013 Page 6 of 294. Communication of PASAG decisions and implementation of PAS by NHS Boards
The process for implementation of PAS is outlined in Appendix 5.
The Directors of Pharmacy, the Directors of Finance and the Chairs of Area Drug and Therapeutics
Committees in each NHS Board are the main point(s) of contact for communication of PAS information.
The contact person(s) is responsible for ensuring that relevant PAS are implemented within the NHS
Board.
Table 1 describes the processes for managing different scenarios relating to PAS implementation.
(a) Patient Access Schemes accepted by PASAG
If a product is approved for use with a PAS by SMC, the SMC Detailed Advice Document (DAD) will
include brief, non confidential information relating to the PAS. Similarly, if a product (reviewed as part of
a NICE MTA) is endorsed with a PAS by HIS, the HIS advice will include brief, non confidential
information relating to the PAS.
The PASAG Secretariat produces an Implementation Pack for all products approved with a PAS by SMC
or HIS. The Pack contains confidential information and is issued to NHS Boards via SMC in strict
confidence, to facilitate implementation of the PAS by NHS Boards in Scotland. The Implementation
Pack specifies the PAS Number assigned to the PAS by PASAG and consists of the PAS Submission
Form, PAS Approval Letter, NHS Scotland Standard Terms for PAS, Guidance Notes and a Confidential
PAS Register as follows.
(i) PAS Submission Form (Appendix 6).
This is completed by the company and includes:
− A description of the scheme, cost reduction mechanism and claims procedure where
appropriate.
− Data that should be included in the Verification Record. Each NHS Board is responsible for
locally developing and maintaining a Verification Record to confirm the validity of any claims,
in line with NHS Scotland Standard Terms for PAS. Where appropriate, the Verification
Record, excluding any patient identifiable information, may be requested by the relevant
company to verify claims or by PASAG for audit purposes. If the company requests
additional information held by the Board to confirm a claim, it will be at the company’s
expense. To facilitate provision of this data, NHS Boards should maintain a PAS Monitoring
Database for each accepted PAS implemented. If required, the guidance notes (see below)
will include a PAS Monitoring Template (Appendix 7) to facilitate development of the PAS
Monitoring Database unless the PAS is a simple discount scheme.
− Confidential Information. The PAS Submission Form specifies any information the
disclosure of which could cause substantial commercial prejudice to either party and
outlines a process in the event of material breach. Refer to section 5 (“Confidentiality”)
below for further detail.
(ii) PAS Approval Letter
The format of the PAS Approval Letter depends on whether the PAS is simple or complex or whether
the scheme will operate in Primary Care.
− Simple PAS for medicine prescribed in secondary/tertiary care – direct supply to hospital or
via homecare (Appendix 8): the PAS Approval Letter is completed by National
Procurement, National Services Scotland, on behalf of NHS Scotland and sent to the
company to confirm that the PAS is approved for use in NHS Scotland. A copy of the
Version 5 –– Revised August 2013 Page 7 of 29completed PAS Approval Letter is retained by the PASAG Secretariat and is included in the
Implementation Pack for information.
− Simple PAS for medicine prescribed in Primary Care (Appendix 9) and Complex PAS
(Appendix 10): the PAS Approval Letter is completed by the NHS Board. It must be printed
on NHS Board notepaper and signed by the NHS Board Chief Executive, Director of
Finance or authorised officer. If required, the NHS Board enters bank details to enable the
company to make rebate payments to the appropriate account. The NHS Board also inserts
the details of individuals authorised to sign the PAS claim forms (and/or other forms as
appropriate) for complex PAS. The Board returns the completed PAS Approval Letter to the
company to confirm that the PAS has been approved for use within that NHS Board and
sends a copy to the PASAG Secretariat (NSS.NP-PASAG@nhs.net).
The Board of treatment rather than the Board of residence is responsible for implementing the
PAS. If a patient transfers to another (receiving) Board to continue treatment, and the terms of
the PAS are still applicable, then the receiving Board should also complete the PAS Approval
Letter.
(iii) Guidance notes.
The guidance notes outline the process for implementation of the PAS and include an operational
flow chart and PAS Monitoring Template (Appendix 7) where required to facilitate development of the
PAS Monitoring Database.
(iv) NHS Scotland Standard Terms.
These were developed by the Central Legal Office (CLO) to underpin the PAS assessment process.
The Standard Terms outline the terms under which a PAS in NHS Scotland will operate and are
endorsed by ABPI Scotland and NHS Scotland. A User Guide to the Standard Terms has been
produced (Appendix 2).
(v) Confidential PAS Register for NHS Boards.
This document summarises all the medicines accepted and not recommended for use with PAS in
NHS Scotland. Additional confidential information prepared by SMC on the cost effectiveness of the
medicines with and without PAS is also included.
Where a PAS is accepted by PASAG but the medicine is not recommended by SMC or not accepted as
part of a NICE MTA submission, an Implementation Pack will not be available. In this case, the medicine
should not be prescribed in NHS Boards. NHS Boards will have systems in place to consider Individual
Patient Treatment Requests (IPTR). Where these IPTR are approved the NHS Board may wish to liaise
directly with the pharmaceutical company to discuss a locally negotiated price.
(b) Patient Access Schemes not recommended by PASAG
Any PAS which is not recommended by PASAG should not be implemented in NHS Scotland. Where a
PAS is not recommended but the medicine is accepted for use or restricted use in NHS Scotland, an
Implementation Pack will not be available. In this case, the medicine may be prescribed in NHS Boards
without the PAS. NHS Boards may wish to liaise directly with the pharmaceutical company to discuss a
locally negotiated price.
5. Confidentiality
It is the responsibility of NHS Boards to ensure that confidentiality of PAS information is maintained.
Recipients of PAS confidential information should only pass this information on to key named individuals
Version 5 –– Revised August 2013 Page 8 of 29employed by the Board in a confidential manner and on a strictly need to know basis. PAS papers and/or
PAS confidential information should not be circulated in meeting papers unless done in a manner that
maintains the confidential nature of the information. PAS documentation should not be posted on internal
or external Board websites. PAS documentation that should be maintained as confidential includes:-
− The Patient Access Scheme Submission Form.
− Guidance notes for implementation of the PAS in Boards.
− The PAS Approval Letter.
− PAS Register.
The PAS Submission Form specifies any information that, if disclosed, could cause substantial
commercial prejudice to the company or the NHS (paragraph 10 of the PAS Submission Form “Supplier
Confidential Information”). A proven material breach may ultimately lead to a pharmaceutical company
terminating their PAS in NHS Scotland for all NHS Boards in accordance with the process outlined in
paragraph 5 of the PAS Submission Form (“Material Breach”). Any Freedom of Information (FOI)
requests should be handled in accordance with the Board’s local FOI protocol.
Version 5 –– Revised August 2013 Page 9 of 29Table 1: Scenarios relating to implementation of Patient Access Schemes
Scenario PASAG SMC or PROCESS
HIS
PAS accepted by PASAG. The medicine may be prescribed in NHS Boards and the PAS may be implemented. A PAS
Medicine accepted for use or implementation pack is produced.
restricted use by SMC or MTA
endorsed for use by HIS.
PAS accepted by PASAG. x The medicine should not be prescribed in NHS Boards. PASAG will not produce an
Medicine not recommended by implementation pack for the PAS as the PAS does not apply when SMC have not
SMC or MTA not endorsed for recommended the medicine or HIS have not endorsed an MTA. NHS Boards will have
use by HIS. systems in place to consider Individual Patient Treatment Requests (IPTR). Where these
IPTR are approved the NHS Board may wish to liaise directly with the pharmaceutical
company to discuss a locally negotiated price.
PAS not recommended by X The medicine may be prescribed in NHS Boards without the PAS. PASAG will not produce
PASAG. Medicine accepted for an implementation pack for the PAS as the PAS does not apply when PASAG have not
use or restricted use by SMC or recommended the PAS. NHS Boards may wish to liaise directly with the pharmaceutical
MTA endorsed for use by HIS company to discuss a locally negotiated price.
PAS not recommended by X X The medicine should not be prescribed in NHS Boards. PASAG will not produce an
PASAG. Medicine not implementation pack for the PAS as the PAS does not apply when:
recommended by SMC or MTA • PASAG have not recommended the PAS, or
not endorsed for use by HIS. • SMC have not recommended the medicine, or
• HIS have not endorsed the MTA.
NHS Boards will have systems in place to consider Individual Patient Treatment Requests
(IPTR). Where these IPTR are approved the NHS Board may wish to liaise directly with the
pharmaceutical company to discuss a locally negotiated price.
Advice from SMC or HIS Not Where a medicine has been accepted by SMC or HIS have endorsed an MTA prior to the
predates PASAG. Prices assessed. establishment of PASAG, and the pharmaceutical company has offered a locally negotiated
negotiated locally should not be price to individual NHS Boards then this is a local agreement and should not be termed a
termed a PAS. PAS. Only agreements that have been assessed by PASAG should be termed a PAS.
Key
PASAG : PAS accepted by PASAG.
x: PAS not recommended by PASAG.
SMC or HIS : Medicine accepted for use or restricted use by SMC, or MTA (Multiple Technology Appraisal) endorsed by HIS.
x: Medicine not recommended by SMC or MTA not endorsed by HIS
Version 5 –– Revised August 2013 Page 10 of 29Appendix 1: Process for PAS submission and assessment
1. Any company intending to submit a SMC New Product Assessment Form with a PAS or a NICE
MTA which involves a medicine with a PAS in Scotland can access the PAS documentation on
the SMC website (www.scottishmedicines.org.uk).
2. All points of clarification with regards to PAS documents should be raised with the PASAG
Secretariat by emailing NSS.NP-PASAG@nhs.net
3. The company will complete the PAS documents and submit these to the PASAG Secretariat via
the SMC Secretariat. For SMC submissions this will be at the same time as the SMC New
Product Assessment Form is submitted.
4. PASAG Secretariat initiates rapid review and assessment of the PAS in line with the assessment
process (see diagram 1). This may require dialogue with the submitting company and / or NHS
Service providers in order to obtain clarification of key points of the proposed PAS. If, for
whatever reason, clarification cannot be secured within four days of receipt of the PAS
application, then the PAS will be scheduled as complex for the purposes of assessment
timelines.
5. SMC or HIS as appropriate will send generic PAS questions to clinical experts and will forward
the responses to the PASAG Secretariat. If the PASAG Secretariat has further additional
questions, then the PASAG administrator will send the additional questions to clinical experts
direct.
6. The PASAG Secretariat will send PAS questions to service providers in NHS Boards to obtain
feedback on the operational feasibility of the PAS as appropriate.
7. A PAS Assessment Proforma will be completed by the PASAG Secretariat and submitted to
PASAG for decision.
8. The company and SMC or HIS as appropriate will be notified of PASAG’s decision.
9. If the PAS is not recommended, the company may resubmit a revised PAS. For SMC assessed
medicines this should be at the same time as the New Product Assessment Form is resubmitted.
10. For SMC submissions. SMC meetings will be held to review the SMC New Product Assessment
Form with the accepted PAS.
11. When a product with a PAS is accepted for use in NHSScotland advice will be issued to NHS
Boards. This will include brief, non confidential information relating to the PAS.
12. Where a product with an accepted PAS is accepted for use or restricted use in NHSScotland, the
PASAG Secretariat will prepare an Implementation Pack to support implementation of the PAS
by NHS Boards. The Implementation Pack will be issued to NHS Boards via SMC. Other than
where the PAS is a simple discount scheme the Implementation Pack will include a PAS
Monitoring Template to facilitate development of the PAS Monitoring Database by NHS Boards.
Version 5 –– Revised August 2013 Page 11 of 29Diagram1:Flowchart for the submission and assessment of Patient Access Schemes in NHS Scotland : Version 5 –– Revised August 2013 Page 12 of 29
Appendix 2: User Guide to NHS Scotland Standard Terms for Patient Access Schemes
The Standard Terms to be applied to Patient Access Schemes (PAS) introduced in Scotland have been
developed by the Central Legal Office as part of an integrated package of documentation. This includes
the Standard Terms, the PAS Approval Letter and the PAS Submission. The Standard Terms have been
developed as an addition to the conditions of contract for the supply of the drug and do no not cover any
issues relating to the supply of that drug. The conditions of contract governing the sale and purchase of
the drug are agreed between the Supplier and the Board or National Procurement in the normal manner.
The key points covered by the Standard Terms are:
1. Any variation to the Standard Terms must be agreed in writing between the Board’s authorised
representative and the Supplier’s authorised representative.
2. The PAS Approval Letter which is signed by or on behalf of the Board will state the drug and the
indication to which the PAS applies. It will be printed on Health Board headed notepaper addressed to
the company and will be authorised by the Health Board Chief Executive, Director of Finance or other
authorised officer. It will list the names and job titles of the individuals authorised to sign PAS registration
and claim forms where appropriate.
3. The PAS Submission is completed by the company and will detail:
- the drug
- the indication to which the PAS applies
- all relevant dosages and formulations
- the commencement date of the PAS Agreement
- review date (minimum period of PAS)
- details of rebate or other method of reducing the cost of treatment
- claims procedure
4. The Board is required to maintain a Verification Record for each PAS. The information to be
included in the Verification record is detailed in the PAS Submission. The Board will record and check
the rebate or other cost reduction mechanism prior to submitting a claim form. The Board will provide the
Supplier with a copy of the Verification Record (excluding any patient identifiable data) on reasonable
request. If the Supplier requests additional information and substantiating evidence held by the Board to
confirm a claim it will be at the Supplier’s cost. The Board will use all reasonable endeavours to
minimise the cost of providing such information. This is subject to the Boards’ obligations in respect of
patient confidentiality.
5. Any additional stock provided following a claim will be subject to the conditions of contract that
applied to the original supply of the drug.
6. Scottish Medicines Consortium (SMC) approval of the drug is dependent on the operation of the
PAS Agreement.
7. The representatives of the Board and the Supplier for the purposes of administering the PAS will
be notified in writing by one party to the other from time to time.
8. All queries and day to day communications regarding the operation of the PAS will be dealt with by
these representatives in the first instance. They will directly liaise for the purposes of monitoring and
reviewing the operation and performance of the PAS Agreement.
9. The PAS Agreement is subject to the Freedom of Information (Scotland) Act 2002. The PAS
Submission must detail any information which the Supplier regards as Confidential Information,
Version 5 –– Revised August 2013 Page 13 of 29disclosure of which could cause substantial commercial damage to the company. The Board is unable
to release such information under a Freedom of Information request without the prior written consent of
the Supplier. This restriction does not apply where:
- The information becomes available in the public domain through other channels.
- The Board is legally required to release the information.
- The Board is required to release specific information to a regulatory or government authority.
- The Board discloses such information in confidence in connection with the operation of the PAS.
The Board and the recipients of the Confidential Information shall ensure that this information remains
confidential.
10. The Board and the Supplier will take all necessary steps to maintain full compliance with the Data
Protection Act 1998. No patient identifiable information will be provided to the Supplier.
11. The Board can agree to assign the PAS Agreement to a third party when requested to do so by
the Supplier.
12. The PAS Agreement will automatically devolve to the statutory successors of the Board. The
Board will give the Supplier reasonable notice of such changes.
13. Where either the Board or the Supplier is affected by a major disruption which impacts on the
operation of the PAS (Force Majeure) they will promptly notify the other party in writing. In such
circumstances neither party shall be deemed to be in breach of the terms of the Agreement.
14. Any notice required to be given under the Standard Terms or PAS Agreement will be made in
writing and addressed to the registered office or principal place of business of the other party. This
address may be changed provided that notice of the change has been given.
15. If either the Board or the Supplier agrees to waive a breach of the PAS Agreement this does not set
a precedent for any subsequent breach.
16. If any part of the PAS Agreement is found to be invalid the remainder of the Agreement is
unaffected.
17. Where the Board and the Supplier are unable to reach agreement on any matter it shall be referred
to their respective Chief Executives. They will consider how best to resolve the dispute or difference by
undertaking interviews and obtaining expert advice where appropriate. Independent experts can be
invited to report on the dispute where agreed by both parties.
18. The Standard Terms and PAS Agreement are governed by the laws of Scotland.
Version 5 –– Revised August 2013 Page 14 of 29Appendix 3: Key Principles for Patient Access Schemes
All proposed schemes will be assessed in the context of an agreed set of key principles:
1. Patient Access Schemes (PAS) will be considered by NHS Scotland to facilitate access by
patients in Scotland to medicines that are not, or might not in the first instance be, found to be
cost-effective by the Scottish Medicines Consortium (SMC) or where a PAS has been accepted
in the context of a National Institute for Health and Care Excellence (NICE) Multiple Technology
Appraisal (MTA).
2. It is recognised that while such schemes can facilitate access to new medicines on cost-effective
terms there will be implications for NHS Scotland in implementing them effectively. In order to
ensure this is manageable, these schemes should be the exception rather than the rule. It is
reasonable for NHS Scotland to prioritise schemes that deliver most benefit to patients, for
example, for medicines that address a previously unmet need. The full costs to NHS Scotland of
operating such a scheme must be taken into account in the assessment process.
Any proposal for a patient access scheme must originate from the relevant pharmaceutical
company that holds the UK marketing authorisation for the medicine under review and should
reflect the following principles:
2.1 Through partnership between the NHS and the pharmaceutical industry, patients in NHS
Scotland should benefit from any such scheme through improved access to new
treatments on an equitable basis across Scotland.
2.2 Schemes must be clinically robust, plausible, practical and monitorable.
2.3 The assessment of any proposed scheme must take place within a robust national
framework, not on the basis of local negotiation, and must be consistent with SMC or
NICE assessment arrangements and timelines as appropriate. Schemes submitted by
pharmaceutical companies must be agreed with PASAG. SMC / NICE, as appropriate will
assess the impact of any proposed scheme on the product’s cost-effectiveness.
2.4 The integrity of the existing health technology assessment process must be maintained
i.e. SMC/NICE will continue to assess the clinical and cost-effectiveness of medicines and
PASAG will assess the acceptability of the PAS on behalf of NHS Scotland.
2.5 Any scheme should be operationally manageable for the NHS without unduly complex
monitoring, disproportionate additional costs and bureaucracy. Any burden for the NHS
should be proportionate to the benefits of the scheme for the NHS and patients.
2.6 There should be no risk of perverse incentives. For example, the ability to access a
medicine through a patient access scheme may have unintended adverse consequences
on the pattern of patient care.
2.7 Compliance must be assured with NHS Scotland probity, governance and legislative
requirements including formal agreements between the NHS and the pharmaceutical
company regarding respective responsibilities including burden of costs and protection of
commercial-in-confidence information.
Version 5 –– Revised August 2013 Page 15 of 292.8 Patient information must be protected. No patient-identifiable data should be shared as
part of these schemes. Schemes must not infringe the patient’s right to confidentiality
according to the requirements of the Data Protection Act 1998 and Caldicott principles.
2.9 Data obtained through the implementation of a PAS remains the property of NHS
Scotland which retains the right to publish, subject to 2.7 and 2.8 above.
2.10 The duration of the scheme must be explicit and exit strategies for both parties must be
clear. Continuity of care for patients must be explicitly addressed for both a scheduled
completion of a scheme or should a scheme end prematurely. Any change to an
accepted scheme must be submitted to the PASAG Secretariat and must not be to the
financial detriment of NHS Scotland.
2.11 Schemes must be consistent with existing financial flows in NHS Scotland.
3. Whilst Patient Access Schemes are intended to help secure access for NHS patients to
medicines that might otherwise not have been deemed cost effective, it is important that
arrangements for proposing and agreeing such schemes do not in turn jeopardise the timeliness
of SMC or NICE advice (in the case of MTA’s endorsed by Healthcare Improvement Scotland). It
is also important that the timing of discussions on schemes does not encourage ‘gaming’ of the
appraisal system by any party (i.e. where either the company or health technology assessment
organisation attempts to exploit the system to ensure the most desirable outcome from their own
perspective).
4. Where a company wishes to propose a PAS for a new medicine, this may be done
• with a submission for a medicine which has been assessed by SMC and ‘not
recommended’ or ‘restricted’ advice has been issued for the product
• for a product that has not yet been assessed by SMC, at the same time as the
submission is made to SMC
OR
• In the context of a NICE MTA submission
5. There will be a requirement to review the experience with PAS in NHS Scotland. This will be
undertaken on an ongoing basis.
Version 5 –– Revised August 2013 Page 16 of 29Appendix 4: Unique Patient Access Scheme (PAS) Patient Number Purpose To advise NHS Boards in Scotland on the format and use of the Unique Patient Access Scheme (PAS) Patient Number. Background A Patient Access Scheme (PAS) is a scheme proposed by a pharmaceutical company in order to improve the cost-effectiveness of a medicine and enable patients to receive access to cost-effective innovative medicines. To receive a rebate, pharmaceutical companies may require NHS Boards to complete a registration form and/or claim form for eligible patients receiving treatment under the terms of a Complex PAS. In order to comply with Caldicott Guardian requirements, any PAS which requires patient identifiable data will not be accepted by PASAG. Use of the Unique PAS Patient Number Patients who receive treatment under the terms of a PAS where individual patient tracking is required to obtain a rebate are assigned a Unique PAS Patient Number by the Board to maintain patient confidentiality. Where a patient is registered for a PAS and transfers to a different location, the patient should retain the original Unique PAS Patient Number including the location code. This may happen when a patient is initially treated in a tertiary centre but is then transferred to their Board of residence for continuing treatment. Each NHS Board is responsible for maintaining a Verification Record for each PAS, to record and check the rebate or other cost reduction mechanism prior to submitting a claim form, and to confirm the validity of any claims. The information to be included in the Verification Record is detailed in the PAS Submission, and may consist of, for example, Unique PAS Patient Number and date of treatment. The Board will provide the pharmaceutical company with a copy of the Verification Record (excluding any patient identifiable data) on reasonable request, subject to the Boards’ obligations in respect of patient confidentiality. The Unique PAS Patient Number should be used by Finance to track receipt of the rebate and ensure this is allocated to the correct budget where necessary. Version 5 –– Revised August 2013 Page 17 of 29
Format of the Unique PAS Patient Number To facilitate collection of data for audit purposes in the future, the Patient Access Scheme Assessment Group (PASAG) advise that a standardised format of the Unique PAS Patient Number should be used, which takes the form: PAS Number/Location code/Patient Number (Figure 1). The ‘location code’ is obtained from the Location Code Directory, maintained by Information Services Division (ISD) and General Register Office (Scotland) (GROS). This directory provides a code for each NHS Scotland location including hospitals. The code consists of five characters: an alpha-prefix for the NHS board; a three-digit serial number; an alpha-suffix for the type of location. For example, 3/N101H/1 would be the Unique PAS Patient Number for the first patient (number 1) treated with a medicine under the terms of a PAS (PAS Number 3) at Aberdeen Royal Infirmary, Grampian (N101H). A list of location codes is available from the PASAG administrator on request (email: NSS.NP-PASAG@nhs.net). Figure 1: Format of the Unique PAS Patient Number PAS Number/ Location code/ Patient Number The PAS Number is allocated to an The location code relates to the The Patient Number is assigned by accepted scheme by PASAG after NHS Board of treatment. It is Boards to eligible patients receiving SMC has reviewed the PAS taken from the Location Code a medicine under the terms of a medicine. The PAS Number is Directory maintained by ISD and PAS. included in guidance notes sent to GROS. NHS Boards. Version 5 –– Revised August 2013 Page 18 of 29
Appendix 5: Process for implementation of PAS by NHS Boards (diagram 2)
1. When a product with a PAS is reviewed by SMC, the SMC Detailed Advice Document (DAD) will
include brief, non confidential information relating to the PAS. Where a product with a PAS is
reviewed as part of a NICE MTA and subsequently endorsed by HIS, the HIS advice will include
brief, non confidential information relating to the PAS. When a product with a PAS is accepted
for use or restricted use by SMC or endorsed by HIS, a PAS Implementation Pack will be issued
to NHS Boards via SMC. Each PAS will be assigned a PAS Number by PASAG, which will be
detailed in the PAS Implementation Pack.
2. The PAS Implementation Pack will include a confidential PAS Register for NHS Boards. This
document summarises all the medicines accepted and not recommended for use with PAS in
NHS Scotland. Additional confidential information prepared by SMC on the cost effectiveness of
the medicines with and without PAS is also included.
3. The PAS Implementation Pack will include a PAS Approval Letter. For Simple PAS a PAS
Approval Letter signed by National Procurement on behalf of NHS Scotland will be included for
information only. For Complex PAS or PAS in Primary Care the NHS Board will insert the details
of individuals authorised to sign the PAS claim form and/or other forms as appropriate. The PAS
Approval Letter will be printed on NHS Board notepaper and signed by NHS Board Chief
Executive, Director of Finance or authorised officer, and returned to the company. The Board will
also send a copy of the PAS Approval Letter to the PASAG Secretariat (email: NSS.NP-
PASAG@nhs.net).
4. The company will send claim forms and/or other forms to individuals, listed by the NHS Board, in
the PAS Approval Letter for distribution as appropriate.
5. The NHS Board will develop Standard Operating Procedures (SOP).
6. The PASAG Secretariat will require regular monitoring information on the uptake of PAS in each
NHS Board. To facilitate provision of this data, NHS Boards should maintain a PAS Monitoring
Database for each accepted PAS implemented. The database will include the ‘Verification
Record’ detailed in each PAS Submission Form.
7. Where individual patient tracking is required to obtain a rebate eligible patients, prescribed a PAS
medicine under the terms of the PAS, will be assigned a Unique PAS Patient Number. The
Unique PAS Patient Number is composed of the PAS Number assigned by PASAG, location
code and patient number. The Unique PAS Patient Number will be recorded on the PAS
Monitoring Database.
8. The claim forms and/or other forms will be completed by the NHS Board for the eligible patient as
appropriate.
9. The completed claim forms and/or other forms will be sent to the company and details will be
recorded on the PAS Monitoring Database as appropriate. The forms will be copied to Board
Finance where appropriate.
10. Details of any rebate or other data as specified in the Verification Record will be recorded on the
PAS Monitoring Database.
11. Where appropriate, the Verification Record, excluding any patient identifiable information, may be
requested by the relevant company to verify claims or by PASAG for audit purposes.
Version 5 –– Revised August 2013 Page 19 of 29Diagram 2: Flowchart for implementation of Patient Access Schemes in NHS Scotland PAS Implementation Pack issued to NHS Boards via SMC for medicines that are accepted for use or restricted use with an accepted PAS in NHS Scotland. . Simple PAS - PAS Approval Letter completed and signed on behalf of NHS Scotland by Director of National Procurement, returned to company and copied to PASAG Secretariat. Complex PAS or Primary Care PAS - PAS Approval Letter completed and signed on behalf of the Board, returned to company and copied to PASAG Secretariat Complex PAS only On receipt of the signed PAS Approval Letter, company sends PAS claim forms and/or other forms as appropriate to person(s) identified by NHS Board in the PAS Approval Letter. NHS Board develops SOP and PAS Monitoring Database, which includes data specified in the Verification Record Complex PAS only. Where individual patient tracking is required eligible patients are identified and assigned a Unique PAS Patient Number, which is recorded in the PAS Monitoring Database PAS claim forms and/or other forms as appropriate are completed and signed in accordance with the SOP PAS claim forms and/or other forms as appropriate are sent to the company, copied to Board Finance, and details recorded on the PAS Monitoring Database in accordance with the SOP. Rebate or other information as appropriate is recorded on the PAS Monitoring Database. The Verification Record is provided to PASAG or the company on reasonable request, as appropriate, excluding any patient identifiable information. Version 5 –– Revised August 2013 Page 20 of 29
Appendix 6 – Example PAS Submission Form for Simple PAS
Patient Access Scheme Submission Form
1. General information
Applicant company:
Drug:
Date of Submission:
Patient population covered by the PAS:
The Common Services Agency (NSS) acts for and on behalf of NHS Scotland Boards
(“Boards”) in the administration of the Patient Access Scheme
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 Applicant and each Board for the above Drug will be
established by the issue of the PAS Approval Letter by National Procurement 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 is dependent on the
establishment of the PAS Agreement.
4. Duration
4.1 The PAS Agreement will commence on [specify date that advice will be posted
on SMC website] and applies to Drug Supplied by the Applicant after that date for
the treatment of Patients in accordance with the following clauses of this
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 [specify date that advice will be posted on SMC website] on
providing not less than [ ] 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
Version 5 –– Revised August 2013 Page 21 of 29Applicant 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 Applicant to
be substantially likely to negatively impact the price achieved for the Drug outwith
Scotland as a result of Confidential Information being used as a reference price, the
Applicant 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 Applicant has submitted evidence of the alleged material breach and
afforded NSS and the Board or Boards in question an opportunity to consider the
evidence and respond thereto and the Applicant shall have regard to the process for
dealing with matters arising in relation to the application of PAS described in section [ ] of
the Guidance
6. Effect of Early Termination
[Detail implications of such early termination for patients treated with Drug prior to
expiry]
7. Scope of Agreement and Cost Reduction Mechanism
The PAS Agreement is for patients treated with the Drug [complete as appropriate]
8. Claims Procedure
No claims procedure is required as the PAS discount is provided at the point of invoice.
9. Verification Record
The Board is not required to maintain a Verification Record as the PAS discount is provided
at the point of invoice.
10. Supplier Confidential Information
[Detail any information the disclosure of which could cause substantial commercial
prejudice to either party which is subject to the obligation of confidence contained in
the PAS Agreement standard terms (eg. level of discount and net price paid)]
11. Supplier Representative
The Applicant’s Representative for the purposes of the PAS Agreement is [ ] 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 applicant. In
case of execution by authorised signatory, Board minute or other document confirming
authority should be exhibited and a copy retained with the Submission.
Signature: ………………………………………………………………………….
Print name: ……………………………………………………………………
Position: ………………………………………………………………
Version 5 –– Revised August 2013 Page 22 of 29Appendix 7: Example PAS Monitoring Template to facilitate development of the PAS
Monitoring Database
NHS Boards should maintain a PAS Monitoring Database for each accepted PAS implemented.
Where the PAS is a simple discount at point of invoice which applies to all licensed indications a
monitoring report should be developed using the hospital pharmacy stock management system. This
should record purchases, issues and invoice price paid. For all other PAS rebate mechanisms each
Implementation Pack will include the relevant PAS Monitoring Template to facilitate development of
the PAS Monitoring Database by NHS Boards. An example of a PAS Monitoring Template, and
accompanying notes, is provided below.
Link to Unique Dose Date Date Date of Date Board of
Patient PAS treatment treatment claim credit residence
Record (this Patient started finished received where not
information Number Board of
must not be (refer to treatment
disclosed) guidance)
Notes
• Boards should adopt the standard format for the Unique PAS Patient Number. See user guide for
information.
• A credit will be applied to the Board's account within 30 business days
• The Unique PAS Patient Number should be used to track receipt of the credit.
• The monitoring database should be retained for a period of 6 years.
• The core data required for monitoring and audit purposes is shown above. The database format
can be adapted to meet local requirements.
• Where this information is linked to individual patient records, patient identifiable information such as
the CHI number must be removed prior to providing this information to the company, the PASAG
Secretariat or any other body. The responsibility for removing patient identifiable information lies
with the individual NHS Board.
• The Board of Residence is required for cross charging purposes where applicable. It is not part of
the Verification Record required by the company.
Version 5 –– Revised August 2013 Page 23 of 29Appendix 8 - Example PAS Approval Letter (for a Simple PAS)
Example for a simple scheme (discount applied at the point of invoice, to all current and any future licensed
indications for the full duration of treatment; no patient monitoring required for any reason)
National Procurement
PAS Approval Letter NHS Scotland
National Distribution Centre
Canderside
2 Swinhill Avenue
Larkhall
ML9 2QX
Telephone 01698 794400
Fax 01698 794403
RNID Typetalk: 18001 01698
794400/794410
Section A : Company to complete
[Contact Name/Department and return
address of company ]
for receipt of PAS Approval Letter
Patient Access Scheme for: [Drug Name] (“the Medicine”) when used for the clinical
Indication(s) as accepted by SMC / NICE (delete as appropriate)
In addition an identical discount will be made available for all other current and
future licensed indications.
-------------------------------------------------------------------------------------------------------------
Section B: NHS National Services
Scotland to complete
Approval Date: [Insert Date of medicine approved with PAS by SMC / NICE and
endorsed by Healthcare Improvement Scotland (HIS)] (“Effective Date”)
Name of Participant: [Supplier Name] (“the Company”)
The Patient Access Scheme (PAS) above has been accepted for use in Scotland by PASAG
and the medicine accepted for use by SMC / NICE and endorsed by HIS (delete as
appropriate).
I am pleased to confirm that the Common Services Agency (commonly known as NHS
National Services Scotland) (“Authority”) has signed up to the establishment of the Patient
Access Scheme in relation to the supply of the medicine for the indication agreed by SMC /
NICE and endorsed by HIS (delete as appropriate) on behalf of all purchasing sites in the
NHS in Scotland.
The Patient Access Scheme has been approved and shall be governed by the following
terms and conditions:-
a) the Standard Terms for Patient Access Schemes in Scotland
b) the Company’s PAS Submission form
c) this PAS Approval Letter
The date on which the Patient Access Scheme shall come into effect shall be [Insert
Version 5 –– Revised August 2013 Page 24 of 29“Effective Date”].
Under the Standard Terms and Conditions for the implementation of a simple PAS the
Director of National Procurement acts on behalf of the Health Boards and the individual
Boards’ representatives need not be listed.
If you require any further information relating to the approval of the Patient Access Scheme
however, please contact NP-PASAG at nss.np-pasag@nhs.net.
Yours sincerely
Director of National Procurement
Headquarters
Gyle Square, 1 South Gyle Crescent, EDINBURGH EH12 9EB
Chairman Professor Elizabeth Ireland
Chief Executive Ian Crichton
FS 507722
Version 5 –– Revised August 2013 Page 25 of 29Appendix 9: PAS Approval Letter for PAS in primary care PAS Approval Letter - Primary Care Use NB: This letter must be printed on the NHS Boards’ headed paper so as to validate the authenticity of the Boards’ bank details supplied. [Contact Name/Department and return address of company] Company to insert return address for receipt of PAS Approval Letter Dear Sirs, PAS APPROVAL LETTER FOR: [Drug Name] (“the Medicine”) when used for the clinical Indication(s) as accepted by SMC OR as accepted by NICE and endorsed by Healthcare Improvement Scotland (HIS) (delete as appropriate) Where the medicine is prescribed in primary care, the company is asked to provide the retrospective rebate by BACS transfer to the following account [insert details]: BACS Payment reference number: Bank Details Bank Address Bank account name Bank account number Sort code IBAN SWIFT/BIC Bank name VAT # (if applicable) Board contact for primary care usage (where other than Board Representative for the PAS Agreement below) is: Name: …….………………………………………………….. Title:………. ………………………………………………….. Contact number:….. ………………………………………… Email:................................................................................. (used to send remittance advice document – detailing rebate paid) I confirm on behalf of NHS [ ] that the details of the Boards’ account and contact details are accurate and that by this letter NHS [ ] instructs [insert Company name] to pay any rebates due under the primary care PAS mechanism to this account. I will give no less than 30 days’ notice to [insert Company name] of any changes to this account or to our contact details. Version 5 –– Revised August 2013 Page 26 of 29
On behalf of NHS [ ]I confirm the PAS Submission submitted by you on [ ] has been approved by NHS [ ] and this PAS Approval Letter confirms the establishment of the PAS Agreement for the above named drug for the treatment of Patients subject to the terms of the said PAS Submission and the NHS Scotland Standard Terms for Patient Access Schemes. NHS [ ] Representative for the purposes of the PAS Agreement is [ ] or such other person as may be notified to you in accordance with the Standard Terms. I confirm my authority to issue this PAS Approval letter in terms of NHS [ ] standing financial instructions [omit if signed by CE or DF] For and on behalf of: ……………….………………………………………………. NHS [ ] Signed: ………………………………………………………………….………..….. Print Name: ………..………………………………………………………………… Title: ……………………….…………………………………………………………. Version 5 –– Revised August 2013 Page 27 of 29
Appendix 10: Example PAS Approval Letter (for a Complex PAS) The company inserts the address that the NHS Board should return the PAS Approval Letter to, the medicine name and the patient population to which the PAS applies. The NHS Board will insert the details of those authorised to sign the PAS claim forms (and/or other forms as appropriate). The PAS Approval Letter will be printed on Health Board notepaper and signed by Health Board Chief Executive, Director of Finance or authorised officer, and returned to the company. The Board will send a copy to the PASAG Secretariat by emailing NSS.NP-PASAG@nhs.net . Where a patient transfers to another Board to continue treatment, and the terms of the PAS are still applicable, that Board should also complete the PAS Approval Letter. PAS Approval Letter –Complex PAS NB: This form must be printed on the NHS Boards’ headed paper so as to validate the authenticity of the details supplied. [Contact Name/Department and return address of company ] Company to insert return address for receipt of PAS Approval Letter Dear Sirs, PAS APPROVAL LETTER Patient Access Scheme for: [Drug Name] (“the Medicine”) when used for the clinical Indication(s) as accepted by SMC OR as accepted by NICE and endorsed by Healthcare Improvement Scotland (HIS) (delete as appropriate) Please circle preferred method of payment: Credit Note / BACS Transfer Where the Board requests rebate by BACS transfer, the company is asked to provide the retrospective rebate to the following account [insert details]: BACS Payment reference number: Bank Details Bank Address Bank account name Bank account number Sort code IBAN SWIFT/BIC Bank name VAT # (if applicable) List the names and job titles of the individuals authorised to complete and sign the registration form within each hospital or other NHS facility. 1 .................................................................................................................. 2 .................................................................................................................. 3 .................................................................................................................. Version 5 –– Revised August 2013 Page 28 of 29
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