A patient access scheme (PAS) is a confidential discount agreement between a pharmaceutical manufacturer and a payer. The term is similar to drug rebates in the US, but PAS is more commonly used in areas with single payer systems and especially the UK.
What is a patient access scheme for drugs?
Drugs or treatments that are expensive and do not have a significant benefit over existing treatments are unlikely to be approved by NICE for use in the NHS. Patient access schemes are pricing agreements proposed by pharmaceutical companies to enable patients to gain access to these high costs drugs.
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 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 PAS start?
Patient Access Schemes (PAS) have been a formal part of the pricing and reimbursement environment in the UK since they were added into the Pharmaceutical Price Regulation Scheme (PPRS) in 2009. They’re defined in the 2014 PPRS as: ‘facilitat [ing] patient access to a medicine where the National Institute for Health and Care Excellence’s (NICE) assessment of value, on the current evidence base, is unlikely to support the list price’. (They’re called lots of other names too, such as risk-sharing schemes).
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:
When is a review needed for PPRS?
With the 2014 PPRS including a provision that a review, ‘if needed’, has to be initiated no later than within two years of the new scheme, one needs to be started now to ensure that the opportunity is not missed.
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 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.
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.
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.
Can a simple discount patient access scheme be accepted at other times in the NICE process?
In exceptional circumstances, a simple discount patient access scheme may be accepted at other times in the NICE process. A simple discount scheme can be proposed:
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 ).
Does NICE make public announcements?
4.24 Although NICE will include patient access scheme proposals submitted for rapid review on the relevant committee meeting agenda, NICE makes no public announcement about the specific topics. Scheme proposals submitted as a rapid review are treated by NICE as commercial in confidence and all matters about the proposed scheme (except the existence of the scheme proposal) will usually remain confidential unless consideration by the appraisal committee results in a change to guidance recommendations. In this situation, NICE will issue a FAD for appeal (see section 3.5.44 onwards). NICE releases information during the FAD appeal stage so that the proposed scheme and its impact on the clinical effectiveness, cost effectiveness and the recommendations can be understood.
What is patient access?
Patient access (or risk-sharing) schemes are alternative market access agreements between healthcare payers and medical product manufacturers for conditional coverage of promising health technologies. This study aims to identify and characterize patient access schemes to date in the Asia-Pacific region.
Which country has the most patient access schemes?
Australia has the most experience with patient access schemes and its experience may provide useful insights for other Asia-Pacific countries. The main targets are pharmaceuticals likely to have high budget impact (due to high per-patient costs and/or large volumes of use), and pharmaceuticals that may be adopted more widely than indicated. With the proliferation of high-cost medicines, the use of schemes may increase to address rising cost pressures, consumer demands, and uncertainties, while attempting to provide patient access to innovative care within finite budgets. Future research is warranted to evaluate the performance of patient access schemes.
How many schemes were there in South Korea?
We identified 3 schemes in South Korea, 5 in New Zealand, and 98 in Australia. Most (97.2%; n = 103) schemes focused on pharmaceuticals, few on medical technologies. More than half of the schemes related to treatments for cancer and inflammatory diseases such as rheumatoid arthritis. The majority (77.4%; n =82) involved pricing arrangements. Evidence generation schemes were rarely used. About half (41.8%; n = 41) of schemes in Australia were hybrid by nature, consisting of pricing arrangements with a conditional treatment continuation component.
What is price volume agreement?
Price volume agreements; manufacturer committed to pay for the drug if the sales exceed a fixed threshold
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Details
Guidance for companies considering a Patient Access Scheme (PAS) proposal in England, has been published.
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.
What is PPRS in healthcare?
A voluntary agreement between the Pharma industry body, the Association of the British Pharmaceutical Industry (ABPI) and the Department of Health, the Pharmaceutical Price Regulation Scheme (PPRS) included agreed principles for Patient Access Schemes in 2009. The PPRS defines the main types of schemes: which range from the simplest type ...
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.”
Where do patient assistance programs come from?
PAPs are most often sponsored by pharmaceutical companies. There are also state programs and nonprofit-sponsored programs.
How to sign up for a med program?
To sign up, you will either call the program or sign up online. You will need to submit forms like your taxes and residence status to prove your eligibility. Most programs also require your health provider to fill out a form. Once you apply and enroll, there may be limits on how much medication you can get or how long the program lasts.
Does GlaxoSmithKline offer assistance?
For example, GlaxoSmithKline offers an assistance program for its medications Benlysta and Nucala. Here, under their qualification section, they show what your maximum monthly gross income must be under, depending on your household size and where you live.
Can a patient assistance card help you?
Like manufacturer copay cards, patient assistance programs have received some criticism. But, they can and do help you if you are struggling to afford your medications. Keep reading to find out more about PAPs.
Is there a standard enrollment process for a college?
Unfortunately, there is no standard enrollment process. Each program defines and sets their own qualification standards.
Do you have to pay for prescription drugs out of pocket?
And those without health insurance or adequate prescription drug coverage must pay for their medications out of pocket.