The Patient Access Scheme Assessment Group (PASAG) reviews and advises NHSScotland on the feasibility of proposed schemes for implementation. It operates separately from SMC to maintain the integrity of the assessment process. Guidance on PAS
Full Answer
What are patient access schemes?
Companies can submit Patient Access Schemes (PAS) to improve the cost effectiveness of a medicine. The Patient Access Scheme Assessment Group (PASAG) reviews and advises NHSScotland on the feasibility of proposed schemes for implementation.
What is the patient access schemes Liaison Unit?
The Patient Access Schemes Liaison Unit is part of our Centre for Health Technology Evaluation. It was set up when the Department of Health asked NICE to advise on the feasibility of patient access scheme proposals from companies.
When should a patient access scheme be submitted to Nice?
As a general rule, companies should include a patient access scheme when making their initial evidence submission to NICE. This means that any patient access scheme proposal should be sent to NHS England long before the evidence submission for the NICE appraisal.
How does the paslu assess a patient access scheme proposal?
When assessing a patient access scheme proposal, the PASLU considers the key principles for implementing patient access schemes in England as outlined in the 2014 PPRS. The PASLU process is not part of the appraisal process.
What is the complexity of NHS schemes?
When was the voluntary scheme for branded medicines introduced?
What is PASLU in healthcare?
How long does it take to submit advice to NHSE&I?
Can companies submit a patient access scheme proposal?
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About this website
What is the patient access scheme?
Patient access schemes are innovative pricing agreements proposed by pharmaceutical companies. They aim to improve cost-effectiveness and enable patients to gain access to high cost drugs and treatments. Companies may submit a patient access scheme proposal for any technology going through the NICE appraisal process.
What is Patient Access scheme scotland?
Companies can submit Patient Access Schemes (PAS) to improve the cost effectiveness of a medicine. The Patient Access Scheme Assessment Group (PASAG) reviews and advises NHSScotland on the feasibility of proposed schemes for implementation.
What is Patient Access scheme NHS?
Patient Access Scheme(s) (PAS) are one way in which pharmaceutical companies can lower the acquisition cost of a medicine to the NHS, enabling patients to gain access to high cost medicine treatments. They are sometimes referred to as risk share schemes or market access schemes.
Is Patient Access the same as NHS app?
Unlike our current Patient Access system, you can even prove your identity using the App itself without needing to bring any ID to the surgery. If you are already a user of Patient Access, you will be able to access exactly the same information on the NHS App as you currently do on Patient Access.
Does patient access work in Scotland?
Ask your practice for a Patient Access registration letter. When you collect the letter from your practice, you'll need to take proof of identity (e.g. your driving licence or passport) with you. When you have a registration letter, use the steps below to set up your Patient Access account.
How do I find my NHS records Scotland?
To see your records you will have to apply to the organisation that is responsible for them, for example:your GP practice manager.your dental surgery manager.the records manager at your hospital.
How do I register with NHS Scotland?
How to registerStep 1: Find your local GP practice. You can use Scotland's Service Directory to find your nearest GP practice.Step 2: Complete the registration form. Once you have chosen a GP practice you should: ... Step 3: Registration confirmation.
How do you reset patient access?
To reset your password using Patient Access, you must have your email address and mobile number recorded. If you don't have these details recorded, you need to contact Patient Access support. Select Forgotten Password. Enter your Email address or User ID, then select Continue.
Simple discount template - National Institute for Health and Care ...
NATIONAL INSTITUTE FOR HEALTH AND CARE EXCELLENCE. Patient Access Scheme Liaison Unit (PASLU) Patient Access Scheme proposal template (Simple Discount scheme)
Patient Access Scheme: guidance for companies considering a proposal in ...
Following a review of the 2009 Pharmaceutical Price Regulation Scheme provisions on PAS in 2011, additional guidance has been developed, based on learning and experiences of the Department of ...
Patient Access Schemes Liaison Unit | What we do | About | NICE
Voluntary scheme for branded medicines pricing and access. The Voluntary Scheme for Branded Medicines Pricing and Access (VS) was introduced in January 2019. This will replace the 2014 Pharmaceutical Price Regulation Scheme (PPRS). Transition arrangements
Patient Access Scheme: guidance for companies considering a proposal in ...
Guidance for companies considering a Patient Access Scheme (PAS) proposal in England, has been published. Following a review of the 2009 Pharmaceutical Price Regulation Scheme provisions on PAS in ...
Hints and tips for companies considering a Patient Access Scheme (PAS ...
I think I want to make a PAS proposal. Where should I start? Some basics…. • Keep your PAS proposal as simple as possible – simple schemes are the preferred model because they add only minimal burden.
What is the complexity of NHS schemes?
The complexity of these schemes means that the review involves a high level of consultation with the NHS.
When was the voluntary scheme for branded medicines introduced?
Voluntary scheme for branded medicines pricing and access. The Voluntary Scheme for Branded Medicines Pricing and Access (VS) was introduced in January 2019. This will replace the 2014 Pharmaceutical Price Regulation Scheme (PPRS).
What is PASLU in healthcare?
The Patient Access Schemes Liaison Unit (PASLU) works with companies who are considering a patient access scheme for their drug or treatment.
How long does it take to submit advice to NHSE&I?
We will usually submit our advice to NHSE&I within 4 weeks of the expert panel meeting, with a total review period of at least 12 weeks.
Can companies submit a patient access scheme proposal?
Companies may submit a patient access scheme proposal for any technology going through the NICE appraisal process. We will look at the proposal to see if it is a scheme that would work in the NHS.
What is a patient access scheme?
4.3 A patient access scheme is a scheme proposed by a company that is a member of the 2014 PPRS. Up to January 2018, these were approved by the Department of Health and Social Care, but from January 2018 onwards they are approved by NHS England. Patient access schemes allow patients to have a technology when NICE's assessment of value, on the current evidence base, is unlikely to support the list price.
When can an appraisal committee consider a patient access scheme?
4.15 The appraisal committee can consider a patient access scheme or commercial access agreement proposal before formal approval from NHS England when the risk of non-approval is considered low (for example when the PASLU advice to NHS England supports the proposal). NICE must not release an ACD or FAD until approval of the patient access scheme is received from NHS England.
What is the purpose of the appraisal committee?
4.10 The appraisal committee considers the effect of a patient access scheme proposal on the clinical and cost effectiveness of the technology and clarifies relevant points with the company (see section 3.3 ). The ERG or the NICE team assesses the impact of the proposed scheme on clinical and cost effectiveness.
How long does it take to submit a simple discount proposal to NHS England?
The simple discount proposal must be submitted to NHS England in sufficient time for it to complete its consideration of the proposed scheme and notify NICE at least 14 calendar days before the next committee meeting, to allow sufficient time for ERG or NICE review.
What is 4.22 guidance?
4.22 The rapid review of guidance will be used for the consideration of a new patient access scheme proposal only. If the company wishes to submit additional new evidence other than for a patient access scheme proposal, NICE will consider whether this would be acceptable in the context of a rapid review or whether it would trigger a full review proposal (see section 6 ).
When should a company include a patient access scheme in the context of a NICE appraisal?
When companies wish to propose a patient access scheme in the context of a NICE technology appraisal, they should follow these rules: As a general rule, companies should include a patient access scheme when making their initial evidence submission to NICE.
Does Nice consider patient access schemes?
4.6 NICE can only consider patient access scheme proposals, flexible pricing proposals and commercial access agreements after NHS England has formally approved them (see figure 6 ).
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Details
Guidance for companies considering a Patient Access Scheme (PAS) proposal in England, has been published.
What is patient access?
Patient Access connects you to local health services when you need them most. Book GP appointments, order repeat prescriptions and discover local health services for you or your family via your mobile or home computer.
Is patient access available in the UK?
Patient Access is now available to any UK patient. Join today and benefit from a faster, smarter way to manage your healthcare.
How do I submit a request for Managed Access?
A request must be submitted by the treating physician on behalf of the patient . Requests can be submitted via our portal by clicking here:
Who is eligible for Novartis Managed Access programs?
Novartis considers granting managed access to investigational or pre-approval products when all of the following criteria are met:
What is Novartis Managed Access?
There are instances where a patient has a serious or life-threatening disease or condition, for which all currently available treatment options have been exhausted and enrollment into a clinical trial is not possible.
What is a submission for significant patient or public health need?
Submissions for significant patient or public health need; you are required to provide clearly defined evidence of a specific need (for example, a need for paediatric formulation, anti-microbial resistance), putting the need into the context of the current patient or public health setting.
What is the ILAP pathway?
The Innovative Licensing and Access Pathway ( ILAP) aims to accelerate the time to market, facilitating patient access to medicines. These medicines include new chemical entities, biological medicines, new indications and repurposed medicines.
What is an ILAP?
The ILAP is open to both commercial and non-commercial developers of medicines (UK based and or global). It comprises of an Innovation Passport designation, a Target Development Profile ( TDP) and provides applicants with access to a toolkit to support all stages of the design, development and approvals process.
What is the first step in the Ilap?
The first step in the ILAP is the Innovation Passport application . The Innovation Passport is the mandated entry point to the ILAP and is open to developers at the pre-clinical trial stage through to the mid-development programme point.
What is a passport in medicine?
The passport includes a broad and inclusive definition of innovation and both new and repurposed medicines are within scope. This designation is linked to a portfolio of activities through the creation of a product-specific Target Development Profile.
Why is it important to have a steering group in ILAP?
It is important that the activities and decisions of the ILAP partners are managed and coordinated effectively. To ensure effective governance and that patient involvement remains integral to how the pathway operates , a steering group and separate patient and public reference group has been set up.
How long does it take to get informed of the outcome of a MHRA meeting?
Following the meeting, the partners (AWTTC, MHRA, NICE and SMC) will jointly consider if the criteria have been fulfilled and you should be informed of the outcome within 4 weeks.
What is the complexity of NHS schemes?
The complexity of these schemes means that the review involves a high level of consultation with the NHS.
When was the voluntary scheme for branded medicines introduced?
Voluntary scheme for branded medicines pricing and access. The Voluntary Scheme for Branded Medicines Pricing and Access (VS) was introduced in January 2019. This will replace the 2014 Pharmaceutical Price Regulation Scheme (PPRS).
What is PASLU in healthcare?
The Patient Access Schemes Liaison Unit (PASLU) works with companies who are considering a patient access scheme for their drug or treatment.
How long does it take to submit advice to NHSE&I?
We will usually submit our advice to NHSE&I within 4 weeks of the expert panel meeting, with a total review period of at least 12 weeks.
Can companies submit a patient access scheme proposal?
Companies may submit a patient access scheme proposal for any technology going through the NICE appraisal process. We will look at the proposal to see if it is a scheme that would work in the NHS.
