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 a Cancer Drugs Fund commercial access agreement?
4.5 A commercial access agreement between a company and NHS England supports use of a technology for which at least 1 indication is currently, or has been, considered as part of the Cancer Drugs Fund.
Can a company agree commercial access agreements with NHS England?
4.2 In the context of the Cancer Drugs Fund, companies can also agree commercial access agreements with NHS England. Such arrangements will be considered in the NICE technology appraisal. 4.3 A patient access scheme is a scheme proposed by a company that is a member of the 2014 PPRS.
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?
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 cancer drug fund UK?
The Cancer Drugs Fund (CDF) is a source of funding for cancer drugs in England, which: Provides patients with faster access to the most promising new cancer treatments. Helps to ensure more value for money for taxpayers.
What is Patient Access Pharma?
Patient access is controlled by complex interactions between governmental and third-party payers, pharmacy benefit managers (PBMs), distributors, pharmaceutical manufacturers, health systems, and pharmacies that together control the receipt of goods by patients after prescription by clinicians.
What is the innovative medicines fund?
The Innovative Medicines Fund supports the government's Rare Diseases Action Plan to ensure people living with rare conditions benefit from faster diagnosis, treatments and support to manage their conditions.
What is Project Orbis?
Project Orbis is a programme to review and approve promising cancer drugs helping patients access treatments faster. From: Medicines and Healthcare products Regulatory Agency Published 10 December 2020 Last updated 7 July 2022 — See all updates.
What is the difference between patient access and market access?
Patient access focuses on actual product usage. Market access is oftentimes tasked with obtaining strong pricing and favorable reimbursement status, but this mindset ignores real product uptake.
What is pricing and reimbursement in Pharmaceuticals?
For a pharmaceutical manufacturer launching a new product, pricing and reimbursement broadly refers to establishing a price and obtaining a positive reimbursement decision, or formulary listing status, for their product.
What is market access and pricing?
The Pricing and Market Access (P&MA) function plays a critical role throughout a drug's lifecycle. During clinical development, P&MA input is crucial for prioritizing drugs which deliver the highest value and for shaping clinical trials based on payer requirements.
Does the CDF still exist?
The CDF process changed in July 2016. It is now part of the NICE process that decides which cancer drugs are available on the NHS.
Is Avastin available on the NHS 2021?
Avastin is available to NHS patients with some types of cancer through the Cancer Drugs Fund (CDF).
What is the name of the new cancer drug?
The drug, called abemaciclib – brand name Verzenio – is now approved for patients with the HR+, HER2-early breast cancer, which makes up 70% of all breast cancers. The drug was already approved for advanced, or metastatic, breast cancer.
What are the names of cancer drugs?
The list includes chemotherapy, hormone therapies, targeted cancer drugs and bisphosphonates....BBEACOPP.BEAM.Bendamustine (Levact)Bevacizumab (Avastin)Bexarotene (Targretin)Bicalutamide (Casodex)Bleomycin.Bleomycin, etoposide and platinum (BEP)More items...
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).
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.
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.
Why are HCMs so expensive?
High-cost medicines (HCMs) have been largely defined based on monetary value because of their potential to increase pharmaceutical spending for either the individual patient or healthcare systems. One of the biggest challenges encountered by many healthcare systems around the globe is to provide equitable access to HCMs while maintaining the sustainability of systems that are already constrained in resources. The global medicine spending is expected to increase with growing use of HCMs for an increasing number of diseases. Many newly developed medicines that offer therapeutic advantages for a range of diseases are reported to be efficacious, but are expensive for healthcare systems and/or patients compared to traditional medicines. Country’s wealth and/or affordability of the healthcare system has a direct relationship with patients’ access to HCMs. The developed markets are better resourced than developing countries and therefore are more likely to meet the demands for access to and use of HCMs. Nevertheless, all countries are facing the challenges of rationing and prioritising access to HCMs. Disproportional access to HCMs, particularly in nations where patient out-of-pocket costs largely support their treatment, might be particularly concerning.
What are the challenges of HCMs?
Countries across the globe are facing the challenges of significant increases in medicines spending and providing populations with affordable and equitable access to HCMs. Many healthcare systems are struggling with high out-of-pocket costs and restricted, delayed or denied access to HCMs. During the last decade, countries have witnessed and utilised a range of approaches that increase access to HCMs. This book covers accessibility and affordability issues related to HCMs in low-income, middle-income and high-income countries. Uganda is an example of a low-income country, whereas Portugal, Europe, Australia and New Zealand are examples of middle-income and high-income countries. Coverage and reimbursement decisions for HCMs should be based on scientific evidence and value-based pharmaco-economic evaluation with engagement of stakeholders in the process to account for patient and public preferences. With the proliferation of HCMs indicated for an increasing number of patients, it is important that countries share lessons learned in order to improve patient access to innovative care within finite budgets. The book aims to facilitate that exchange of knowledge and experience.
What is HTA in healthcare?
Health technology assessment (HTA) refers to the systematic evaluation of properties, effects and/or impacts of health technology, which in its broadest context, includes pharmaceuticals, vaccines, medical devices, medical and surgical procedures, and the systems within which health is protected and maintained ( WHO,2017a ). Since it would be impossible for health systems to financially support every new health technology that is being introduced onto the market, HTA serves to direct funding, in the form of reimbursement, to health technologies that address clinical needs and are efficacious, safe and cost-effective. Therefore, with well-performed HTA, patient access to HCMs that improve health outcomes would be made possible. HTA could ensure value for money investments in HCMs within the setting of limited healthcare resources.
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.
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.
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.
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.
How many articles were published between 1998 and 2012?
Using the search terms in PubMed and Google Scholar, we found 2229 articles published between 1998 and July 2012. Reviewing article titles and abstracts, we excluded commentaries and articles that did not describe specific patient access schemes. Next, we reviewed the references of remaining articles and grey literature sources for additional examples of patient access schemes. Our search identified 299 schemes described in 146 publicly available sources (92 scientific articles, 18 electronic articles, 14 reports, 9 websites, and 13 conference presentations). From these we selected the 106 examples from the Asia-Pacific region.
What is price volume agreement?
Price volume agreements; manufacturer committed to pay for the drug if the sales exceed a fixed threshold
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.
Is Adalimumab overstated?
Adalimumab spending is probably overstated due to a risk sharing agreement between the sponsor and PHARMAC, which involves rebates paid by the sponsor once Government spending reaches a certain level
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.
