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.
What is a Patient Access Scheme (PAS)?
Patient access schemes are pricing agreements proposed by pharmaceutical companies to enable patients to gain access to these high costs drugs. The Patient Access Scheme Liaison Unit (PASLU) has been set up by NICE to work with companies who are considering a patient access scheme for their drug or treatment.
Is nice the gatekeeper to NHS reimbursement?
Nonetheless, NICE is often considered the gatekeeper to reimbursement because a positive recommendation for a product or treatment from NICE obliges the NHS to make funding available for it, usually within three months of the recommendation. 7 A negative recommendation from NICE does not necessarily mean a product is ineligible for reimbursement.
How will the NICE review change the way it evaluates medicines?
The outcome of the review will undoubtedly change the way NICE evaluates the cost-effectiveness of medicines, and by extension which products receive a positive recommendation for NHS funding and at what price. The changes may include how NICE could accommodate clinical or outcome uncertainty; and an acknowledgment of disease severity.
What is the complexity of NHS schemes?
How long does it take to submit advice to NHSE&I?
What is PASLU in healthcare?
Is it possible to use expensive drugs in the NHS?
Can companies submit a patient access scheme proposal?
See 2 more
About this website
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 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.
Guide to the processes of technology appraisal - National Institute for ...
4 Patient access schemes, commercial access agreements and flexible pricing. 4.1 The Pharmaceutical Price Regulation Scheme (PPRS) 2014 allows companies who are members of the scheme to submit proposals for patient access schemes and flexible pricing proposals as part of an ongoing or published NICE technology appraisal.. 4.2 In the context of the Cancer Drugs Fund, companies can also agree ...
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Details
Guidance for companies considering a Patient Access Scheme (PAS) proposal in England, has been published.
What is a PAS scheme?
They are sometimes referred to as risk share schemes or market access schemes. PAS have been available via NICE since 2002 and also more recently via the CDF. Although PAS unequivocally aim to improve access to new medicines for NHS patients, it is essential that the costs of operating them and the financial benefits actually realised locally are assessed as carefully as the clinical benefits of the medicines themselves to ensure that they offer the NHS genuine value for money. If PAS are not implemented the NHS may incur unnecessary costs. Implementation of NICE-approved PAS also ensures local compliance with NICE technology appraisal guidance.
What is PAS in healthcare?
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.
How to sign up for Operational PAS Update?
To sign up for the NICE-maintained Operational PAS Update e-mail list, send an e-mail to [email protected] with 'Operational PAS Update' in the subject line.
Is LPP a PAS?
LPP is continuing the PAS project initiated in 2013, which has now been expanded to encompass all non-cancer and cancer PAS, both NICE-approved and those in the CDF.
When did Leela Barham start the patient access review?
Leela Barham takes a look behind the schemes for patient access in England and puts the case for a review to bring them up to date, in the light of changes since they began in 2009.
What are the two main classifications of PPRS?
There were two main classifications: financially-based schemes and outcome-based schemes. But these were further sub-divided. Financially-based schemes included:
Is it easy to discover what happens from the point that a company makes a submission and when that final Nice?
It’s not easy to discover what happens from the point that a company makes a submission and when that final NICE ‘yes’ comes through. Some insights can be gleaned from comparing data from the DH and what is available from NICE (figure 4).
Is PAS a simple scheme?
Over time, though, PAS have been divided into those that are ‘simple discount schemes’ and those that are ‘complex schemes’ as recognised by the dropping of the taxonomy in the 2014 PPRS. And indeed it does follow practice in the market; analysis of schemes approved by NICE shows the dominance of simple schemes in recent years (Figure 1).
What is PAS in medical?
What are Patient Access Schemes (PAS)? As Andrew explains, “these are schemes that help moderate the price of a new technology for a given disease as considered in the NICE Technology Appraisal process. In these arrangements the list price of the drug remains unchanged, while the actual price of the drug is discounted in order to facilitate patient access.” Their rationale is in the context of the UK list price being used as a reference price in a range of countries.
Can a Pharma company use outcomes based PAS?
Although the PPRS does allow the use of outcomes-based PASs there are relatively few such proposals in England and Wales as such schemes often generate new activity for NHS and the manufacturer. However, it does offer clear evidence of the success of a medicine. In this way a Pharma company can provide a direct demonstration of the value of its medicines. This might also be facilitated through the use of other activities such as a register or another existing ways of monitoring patient outcomes and tie the scheme into that. Using such approaches can allow schemes to operate with adding additional burden to the NHS. These are the approaches the more imaginative manufacturers are using in their schemes proposals. A manufacturer thinking of sponsoring a patient register or monitoring scheme should follow best practice to ensure it is operated in an open-access and transparent way, such that the relevant and anonymised information is open to those with legitimate interests, including the pharma companies themselves. This may be a route by which a company might use to develop an outcomes-based PAS for use in the NHS.”
Who is responsible for commissioning primary care in England?
The main payers and payment structures in England are as follows: The NHS has responsibility for commissioning primary care in England, though these days there are many Clinical Commissioning Groups (“CCGs”) (discussed further below) co-commission primary care services with the NHS.
What is the NHS in the UK?
The UK has a large and complex healthcare system, under which the National Health Service (“NHS”) funds the vast majority of medicines prescribed to patients.
How many CCGs are there in the NHS?
Commissioning in secondary care is effectively the responsibility of approximately 100 local Clinical Commissioning Groups (“CCGs”). 6 CCGs receive funding from the NHS and, in principle, it is for each CCG to obtain value for money in terms of the products and services it makes available. That said, the NHS has become an increasingly centralised force in the way it obtains value.
Why is factoring important in the NHS?
Factoring in the NHS’ multi-layered approach to commissioning and procurement . It is critically important to appreciate the NHS’ multi-layered approach to medicines pricing and purchasing. The pricing and reimbursement framework in the UK often cumulatively “chips away” at the amount a company might receive for a product ( e.g., through the VPAS, the NICE process or tendering). Companies should therefore consider their pricing strategy in a holistic way, and be prepared for downward pressure from multiple angles. Companies should also be aware that the NHS is now likely to share pricing information internally.
How much of the NHS spends on medicines in 2019?
In 2019/20, spending on hospital medicines accounted for 55.9% of the NHS’s total expenditure on medicines, which increased by 14% on the previous year. Meanwhile, spending on medicines in primary care increased by a more modest 5.2% in 2019/20. This reflects spending priorities geared towards acute, specialist, hospital-based therapies.
What is the classification of a new medicine?
The regulatory classification of a new medicine will depend on a number of factors, including whether: (i) the marketing authorisation designates it as a POM, a General Sale Medicine or a Pharmacy Medicine; (ii) by statute the product must fall into a particular category; or (iii) a competent regulatory authority, such as the Medicines and Healthcare products Regulatory Agency (“MHRA”) has allocated the product to a particular category.
When will the NHS restructure?
In February 2021, the Government set out plans to restructure much of the NHS around an integrated care model. By April 2022, the proposals would see local Integrated Care Systems (“ICS”) replace CCGs and assume some of the commissioning responsibility from NHS England (discussed further below).
What is the VRS scheme?
The greatest amount of data was gathered on the bortezomib (Velcade) “VRS” scheme, which had been in operation the longest (see Box 3) and was approved by NICE. The scheme has issues around tracking and ensuring that monies for patients who stop bortezomib after non-response are claimed.
What did the National Cancer Director recommend?
In his November 2008 report to the Health Secretary, the national cancer director recommended that the DH should work with the pharmaceutical industry to promote more flexible approaches to the pricing and availability of new drugs. [9] The impact of PASs can already be seen.
Abstract
Health technology assessment (HTA) aims to provide a transparent framework within which normative judgements can be applied for decision making. Such transparency enables the public to understand the rationale for decision making, but conflicts with companies being able to offer commercially sensitive discounts.
Introduction
When health technology assessment (HTA) agencies such as the National Institute for Health and Care Excellence (NICE) assess the cost-effectiveness of new interventions, the incremental cost-effectiveness ratio (ICER) (or cost per quality-adjusted life year [QALY] gained) plays a pivotal role.
Methods
Guidance for technologies assessed by NICE are published on the NICE website ( http://www.nice.org.uk ), which includes guidance from the single technology appraisal (STA), multiple technology appraisal (MTA), and highly specialised technology (HST) appraisal programmes (in addition to other types of guidance relating to medical devices, surgical procedures and diagnostic tools).
Results
A list of all published NICE technology appraisal guidance was downloaded from the NICE website on 26 October 2018. The identification of STAs relevant to this study is presented in the form of a Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) diagram (Fig. 1 ).
Discussion
The results of our review demonstrate that at present censoring appears to be performed on an ad hoc basis with no consistent pattern in the information censored. This applies not just between companies, but also between submissions from the same companies.
Recommendations and Conclusions
Based on the results of our review, there are multiple ways in which redaction could be performed; none, however, by definition, offer both perfect transparency and the ability to maintain the confidentiality of PAS discounts.
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.
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.
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.
Is it possible to use expensive drugs in the NHS?
Drugs or treatments that are expensive and do not have a significant benefit over existing treatments are unlikely to be approved for use in the NHS.
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.
