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.
What are patient access schemes?
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 the commercial and Managed Access Programme at Nice?
4.7 The Commercial and Managed Access Programme at NICE will provide companies with opportunities to engage in commercial and managed access conversations with both NICE and NHS England. The relevant stages for commercial dialogue are:
What is a patient access scheme for macular degeneration?
Patient access schemes often help a medicine to meet NICE’s cost effectiveness criteria. Lucentis was approved with a patient access scheme to treat wet age-related macular degeneration and diabetic macular oedema. A particular challenge when appraising new treatments, is that NICE only has the limited information arising from clinical trials.
What is the complexity of NHS schemes?
How long does it take to submit advice to NHSE&I?
What is PASLU in healthcare?
When was the voluntary scheme for branded medicines introduced?
Is it possible to use expensive drugs in the NHS?
Can companies submit a patient access scheme proposal?
See 3 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 ...
Good planning is essential • Consult NHS customers widely about the design of your PAS: – Commissioners and different provider types (secondary and tertiary care, private providers), as well as clinicians and pharmacists
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 ...
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.
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.
What is NICE 4.12?
4.12 If the appraisal committee recommends a technology with an outcomes -based patient access scheme or commercial access agreement, it is essential that arrangements are in place to collect and analyse the relevant outcomes. If the actual outcomes differ significantly from those assumed during the original appraisal, NICE may decide to bring forward a review of the recommendations.
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 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.
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:
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.
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 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 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.
Why do pharmaceutical companies offer patient access schemes?
In addition pharmaceutical companies can propose patient access schemes to the Department of Health to improve the cost effectiveness of a treatment. These confidential agreements guarantee a discount when the drug is sold to the NHS. Patient access schemes often help a medicine to meet NICE’s cost effectiveness criteria. Lucentis was approved with a patient access scheme to treat wet age-related macular degeneration and diabetic macular oedema.
What is the first step in a NICE treatment?
The first step is to gather evidence to get a full picture about a proposed treatment. NICE talks to anyone who will be affected by the decisions: patients, manufacturers of the treatment, and the manufacturers of any treatment that might be displaced by the proposed new one, and to clinicians and other professional groups affected.
What is a nice number cruncher?
NICE number crunchers need a formula that can compare the cost effectiveness of very different treatments, whether it’s a hip replacement or an injection to stop the deterioration in vision. Their aim is to fairly prioritise the treatments that will most benefit the health of the nation.
What does Goodall say about patient statements?
Goodall stressed how powerful patient statements can be, “as it is vital that the appraisers understand the impact of having a condition, and of having or not having the treatment.”
What is Nice technology appraisal?
A “technology” is generally a drug treatment, but could be any intervention with the potential to improve health.”
What is the challenge of Nice?
A particular challenge when appraising new treatments , is that NICE only has the limited information arising from clinical trials. Uncertainty about prevalence of a condition or the frequency of treatment, can have enormous cost implications when the treatment is made available to the population at large. NICE looks at the clinical trial data and produces mathematical models to predict the likely costs.
How to compare two treatments?
So to compare two treatments, NICE calculates the difference in cost (the extra spend), and divides it by the difference in effect (the extra benefit). This is known as an incremental cost effectiveness ratio or ICER.
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.
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).
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.
Introduction
- Patient access schemes (PASs), sometimes referred to as risk-sharing schemes or market access schemes, allow pharmaceutical companies to offer discounts or rebates to reduce the cost of a drug to the NHS. They are regarded as a way of improving access to new medicines for NHS patients. Drug pricing is complex and is controlled in the UK by the Phar...
Aims
- The aims of this research were: to assess the impact of the introduction of PASs for cancer medicines on front-line NHS staff; to identify problems; to gather feedback on how the schemes are working; and to identify what makes a good scheme.
Method
- A survey (online questionnaire) was used to gather data on the uptake of schemes, impact on service capacity and suggestions for improving schemes. The questionnaire asked about PASs for four cancer medicines that were in operation for at least 12 months between 2007 and 2009: erlotinib (Tarceva; pre-NICE appraisal) for lung cancer; sunitinib (Sutent) for renal cell cancer or …
Limitations
- It was not possible to draw statistically significant conclusions about the impact of PASs UK-wide from the data collected — only 37 out of 131 NHS trusts in England responded. This could be due to difficulties in collecting data on medicines use in the NHS or to the wariness of provider trusts to share information that might demonstrate failure to deliver the benefits of PASs to the commissio…
Results
- The estimated sample size was 131 NHS trusts. A return rate of 28% was achieved with responses from 37 trusts. Data were collected for 756 patients treated in PASs. The research showed: 1. Refunds for two of the common PASs (sunitinib and bortezomib) may not have been passed on to the funding PCT in 50% of cases 2. 73% of respondents reported that they did not …
Discussion
- Use of PASs is part of a series of measures designed to improve access to high-cost medicines. 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.The impact of PASs can already be seen. Box 2 lists ca…
Capacity For Schemes
- The research confirms that pharmacy staff play a key role in implementing and managing these schemes. However, it is clear that PASs also have an impact on nursing, medical, administration and finance department time. Some 80% of respondents agreed that risk-sharing schemes should not be accepted unless the capacity to manage them is properly resourced and has been includ…
Conclusions
- It appears that pharmacy departments are trying to implement and manage PASs at a local level, but are doing so within a complex NHS that does not yet collect data on individual patients routinely. The retrospective nature of rebates also means that PASs can be difficult to manage within current NHS financial arrangements. This, in turn, means that much NHS staff time seem…