endstream endobj 148 0 obj <>/Metadata 9 0 R/Pages 145 0 R/StructTreeRoot 13 0 R/Type/Catalog/ViewerPreferences 165 0 R>> endobj 149 0 obj <>/MediaBox[0 0 595.32 842.04]/Parent 145 0 R/Resources<>/Font<>/ProcSet[/PDF/Text/ImageB/ImageC/ImageI]/XObject<>>>/Rotate 0/StructParents 0/Tabs/S/Type/Page>> endobj 150 0 obj <>stream In the UK, healthcare is provided by the National Health Service (NHS) and is free at the point of service. ensuring there is equitable access to treatment for NHS patients; and. The Budget Impact Test was a controversial measure, as many felt it undermined NICE’s independent role and brought it closer to helping to manage the NHS’ budget. The main exceptions to this are where the NHS has “black- listed”4 a product in the Drug Tariff (the monthly list of reimbursement prices in primary care) or has placed conditions on reimbursement (e.g., through the so-called “Selected List” in the Drug Tariff).5. 0 The NHS’ internal structure and policies often incentivise local organisations to purchase “best value” products, particularly generics and biosimilars. These are not subject to NICE’s standard procedures and methodologies and are continuing to evolve. How are drug prices set? In response to COVID-19, NICE has published a number of rapid-review guidelines, which can focus on the use of products during the epidemic. This means there is no single pathway to securing NHS reimbursement for a new product. endstream endobj startxref The NHS ultimately funds the vast majority of POMs supplied to patients in the UK. However, this is principally to manage the current health crisis and may not be sustainable in the longer term, particularly as the UK enters into a deep forecasted recession. The importance of those aspects has grown in recent years, which reflects the increasingly multi-layered landscape for drug pricing in the UK. The Voluntary and Statutory Schemes have so far delivered savings to the public purse. NICE will usually recommend HSTs that have an ICER of less than £100,000. Similarly, there is a growing expectation that NHS bodies that enter into commercial agreements with suppliers will share this information within the NHS with a view to deriving the best value nationally. However, unless other funding arrangements are in place, it provides commissioners with a basis to resist or delay funding. The condition is chronic and severely disabling. The CDF has provided a route to NHS funding for a number of highly-innovative, high-cost oncology technologies, including CAR-T and certain immuno-oncology therapies. These uncertainties have had an indirect effect on availability of medicines. Schedule 1 to the NHS (General Medical Services Contracts) (Prescription of Drugs, etc.) That represents a 4.1% increase on the prior year and is broadly consistent with an average 5% annual growth rate since 2010/11. The Office for National Statistics projects the UK’s population to increase from approximately 66.4 million people in 2018 to approximately 69.4 million people by 2028. From April 2019, NICE charges companies up to £126,000 for conducting technology appraisals. NICE’s aim is to conduct a health technology appraisal for all new significant drugs and indications launched in the UK. We’ll send you a link to a feedback form. So far, 79 new oncology drugs treating 160 different indications have benefitted from CDF review. 30% marginal rate rule for emergency admissions, National tariff payment system 2014 to 2015: impact assessment, Local price setting and contracting for NHS services without a national price, The reimbursement system for NHS-funded care: an evaluation, Patient Level cost collection 2012/13: review and lessons for the future, Costing NHS patient care: Monitor's approach, Strategic options for costing in the NHS: improving cost data, 2014/15 National Tariff Payment System: responses to questions, Estimating NHS and social care spend: a tool for commissioners, The NHS payment system: a guide for patients, About Monitor: an introduction to our role, Coronavirus (COVID-19): guidance and support, Transparency and freedom of information releases, by offering more freedom, to encourage the development of new service models, by providing greater financial certainty, to help NHS providers and commissioners plan better, by maintaining incentives to provide care more efficiently. Similarly, in some therapeutic areas, the NHS publishes internal “reference prices” that limit the amount that an NHS hospital receives from central NHS funding if the hospital purchases products that exceed the relevant reference price. As such, this chapter does not provide a detailed commentary on these rapid-review guidelines. All content is available under the Open Government Licence v3.0, except where otherwise stated, If you use assistive technology (such as a screen reader) and need a Mary is a seventy-year-old woman who has to have long-term intravenous antibiotics for a recurring pneumonia infection. However, sales of those products will still contribute to calculating expenditure grown across the scheme. Ɛ:|胺� GZ��Z�|��W^�D ��ݙ]f��>�Z9}�A4�h���0�@opW�ĜJ%܊�}kH���. Often, the discounts that a company is prepared to offer the NHS will affect its level of uptake and use. There is a specific assessment pathway for “Highly Specialised Technologies” (“HST”), which treat rare and specialist conditions. You can change your cookie settings at any time. The co-ordinated approach has led to medicines procurement litigation and this is likely to be a growing trend. Population and demographic changes are major contributing factors. The concept of a “reimbursement amount” is less relevant in secondary care because the NHS usually operates a payment by results model. The Account Number is used together with the customer’s PIN. It will take only 2 minutes to fill in. NHS drug expenditure continues to increase, albeit growth rates vary significantly depending on product type. As noted above, the volume and cost of drugs used in and/or reimbursed by the NHS is on a steady upward trajectory. In light of this, there is a clear trend for the NHS and other state organisations to involve themselves directly and indirectly in drug pricing and policy. For medium-sized companies (i.e., essentially, those whose sales of branded products to the NHS total between £5 million and £25 million in the previous year), the first £5 million of sales may be exempt from Scheme Payments. The percentage payable is 7.4% for 2020 and will be 10.9% for 2021 and subsequent calendar years. Historically, the NHS in England spends approximately three-quarters of its drugs budget on branded products. We discuss some of the key trends below: The long-term impact of COVID-19 on the NHS and the medicines landscape is unknown. Note, the UK list price is often a benchmark for countries that operate reference pricing systems. The 2018 Regulations came into force on 1 April 2018 and were subject to further amendments between 1 January 2019–1 April 2020. We evaluated the Austrian, Belgian, French, Dutch, and Swedish drug reimbursement systems. The Secretary of State for Health has statutory power to limit the price of medicines supplied to the NHS (section 262, NHS Act 2006). NICE will recommend a product to receive funding from the CDF, at a negotiated price, if it has the potential to satisfy the criteria for routine commissioning, but there is clinical uncertainty that needs further investigation (i.e., through data collection in the NHS or clinical studies). As such, the landscape for pricing and reimbursement is increasingly multi-layered. hޔ��j�0Ee>�aƲ��rڴ�&���P��P�e���_?R覯��̝�92W In secondary care, eligibility for reimbursement is more localised and there is greater scope for variation. Also, pharmacy-level substitution is lawful if provided for under a “Serious Shortage Protocol” (which is a statutory mechanism that amends pharmacy dispensing rules if the Department of Health considers there is a serious shortage of one or many medicines in the UK). Historically, while the overall NHS budget continued to grow, this growth was outpaced by the rising cost of medicines (both in terms of volume and price). There are no specific product related codes that are used either. A number of factors affect drug pricing in the UK, ranging from Government and NHS policies, commercial arrangements between companies and the NHS, and marketplace competition. For the sake of simplicity, this chapter focuses primarily on the NHS in England, which is by far the largest market. As noted above, companies must price branded products in accordance with the Voluntary or Statutory Schemes. endstream endobj 272 0 obj <> endobj 273 0 obj <> endobj 274 0 obj <> endobj 275 0 obj <>stream Any product that NICE has assessed to be cost-effective but is likely to cost the NHS more than £20 million in any of the first three years of its use must be subject to further negotiations between the supplier and the NHS to bring the overall cost down. The NHS’ medicines policies aim to balance a number of interests, including: However, demographic change, an increase in spending on prescription medicines, and budgetary pressure, make it increasingly difficult to maintain this balance. The 2017/19 National Tariff Payment System came into effect on 1 April 2017. Where the clinical data supporting a NICE application are uncertain, NICE may recommend a product subject to a Managed Access Agreement. The percentage amounts that the Government claws-back from the industry under both schemes has fallen in 2020 from early projections, which suggests the rising cost of branded medicines is now better controlled. The NHS is almost entirely state-funded and mostly free to patients at the point of need. Full legal advice should be taken from a qualified professional when dealing with specific situations. NHS England and NHS Improvement Reimbursement for medical examiner systems in England during the non-statutory period February 2020 The medical examiner system is funded by the fee paid for a medical examiner completing cremation form 5s and a top-up from the Department for Health and Social Care via NHS England and NHS Improvement. Importantly, the rebates that the industry must pay back to the Department of Health are broadly aligned and have fallen from initial projections. Following its relaunch in 2016, the CDF aims for all new systemic cancer drugs to receive a fast-tracked NICE appraisal. These mechanisms allow the NHS to provide centralised funding for high-cost products that individual CCGs may be reluctant to fund. The UK comprises four constituent nations: England; Wales; Scotland; and Northern Ireland. This distinction is relevant throughout this chapter. endstream endobj startxref The NHS is committed to speeding-up access to promising technologies in specific, priority treatment areas. Added our proposals to reform top-up payments for specialised services. By contrast, spending on medicines in primary care fell by 2.8% in 2018/19. As noted above, the NHS funds treatments in a number of different ways. 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) the Medicines and Healthcare products Regulatory Agency (“MHRA”) or the European Commission has allocated the product to a particular category. You can change your cookie settings at any time. Request an accessible format. Many NHS organisations (such as CCGs or Hospital Trusts) also run programmes to switch patients from innovative to generic or biosimilar products. Added the NHS National Tariff Payment System 2015/16: engagement documents. The National Tariff is a shared responsibility between NHS England and NHS Improvement. You’ve accepted all cookies. NICE’s cost-per-QALY thresholds have remained fixed for a number of years. For example, substitution may be permitted in hospitals in some cases.