Pharmaceutical Price Regulation Scheme

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The Pharmaceutical Price Regulation Scheme (PPRS) is the mechanism used by the UK Department of Health to ensure that the NHS has access to good quality branded medicines at reasonable prices. It involves a non-contractual agreement between the UK Department of Health and The Association of the British Pharmaceutical Industry (ABPI). The scheme applies to all branded, licensed medicines available on the NHS. The purpose of the scheme is to achieve a balance between reasonable prices for the NHS and a fair return for the pharmaceutical industry.

National Health Service publicly funded healthcare systems within the United Kingdom

The NHS in England, NHS Scotland, NHS Wales, and the affiliated Health and Social Care (HSC) in Northern Ireland were established together in 1948 as one of the major social reforms following the Second World War. The founding principles were that services should be comprehensive, universal and free at the point of delivery. Each service provides a comprehensive range of health services, free at the point of use for people ordinarily resident in the United Kingdom, apart from dental treatment and optical care. The English NHS also requires patients to pay prescription charges with a range of exemptions from these charges.

Association of the British Pharmaceutical Industry organization

The Association of the British Pharmaceutical Industry (ABPI) is the trade association for over 120 companies in the UK producing prescription medicines for humans, founded in 1891. It is the British equivalent of America's PhRMA, however the member companies research, develop, manufacture and supply 80% of the medicines prescribed through the National Health Service.

The pharmaceutical industry in the United Kingdom directly employs around 73,000 people and in 2007 contributed £8.4 billion to the UK's GDP and invested a total of £3.9 billion in research and development. In 2007 exports of pharmaceutical products from the UK totalled £14.6 billion, creating a trade surplus in pharmaceutical products of £4.3 billion.

Contents

The current PPRS scheme, using a value-based pricing mechanism, came into effect on 1 January 2014, to run for no less than five years. [1] It replaced an earlier scheme running from 2009 to 2013. [2]

Value-based price is a pricing strategy which sets prices primarily, but not exclusively, according to the perceived or estimated value of a product or service to the customer rather than according to the cost of the product or historical prices. Where it is successfully used, it will improve profitability through generating higher prices without impacting greatly on sales volumes.

In December 2014 Hoffmann-La Roche successfully appealed against a decision of the National Institute for Health and Care Excellence appraisal committee in respect of Kadcyla on the basis that it should have considered that under the scheme, the industry had agreed to cap growth in the drugs bill to 0–1.9% a year for the next five years. Roche said this had “fundamentally changed” the nature of how NICE should consider cost effectiveness. [3]

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On the 23rd August 2017, the UK Government launched a consultation relating to the PPRS, following legislation that was recently passed.

Purpose and objectives

As the primary buyer of medicines in the UK, the Department of Health has an interest in ensuring medicines are available at reasonable prices. However it is also important that pharmaceutical companies, represented by the ABPI, are able to maintain sufficient levels of profit and competitiveness to enable them to invest in sustained research and development. The 2009 PPRS agreement outlines its primary objectives as to:

In economics, profit in the accounting sense of the excess of revenue over cost is the sum of two components: normal profit and economic profit. All understanding of profit should be broken down into three aspects: the size of profit, the portion of the total income, and the rate of profit. Normal profit is the profit that is necessary to just cover the opportunity costs of the owner-manager or of the firm's investors. In the absence of this profit, these parties would withdraw their time and funds from the firm and use them to better advantage elsewhere. In contrast, economic profit, sometimes called excess profit, is profit in excess of what is required to cover the opportunity costs.

Company competition, or competitiveness, pertains to the ability and performance of a firm, sub-sector or country to sell and supply goods and services in a given market, in relation to the ability and performance of other firms, sub-sectors or countries in the same market. It involves one company trying to figure out how to take away market share from another company.

Research and development general term for activities in connection with corporate or governmental innovation

Research and development, known in Europe as research and technological development (RTD), refers to innovative activities undertaken by corporations or governments in developing new services or products, or improving existing services or products. Research and development constitutes the first stage of development of a potential new service or the production process.

  1. Deliver value for money
  2. Encourage innovation
  3. Promote access and uptake for new medicines
  4. Provide stability, sustainability and predictability

Patient access schemes

The 2009 PPRS agreement allows for patient access schemes. These allow for the provision of a drug which would not otherwise be supported by NICE and available on the NHS due to insufficient evidence of its cost-effectiveness. Patient access schemes can be either financially based or outcome-based. Financially based schemes are where the company does not alter the list price of the drug but offers discounts or rebates linked to numbers or types of patients treated, response of patients treated, or the number of doses required. Or, alternatively, the company may alter the list price. Outcome-based schemes take place when a company agrees to a later increase in price, or a rebate, once the value of the drug has been proven. Alternatively risk-sharing agreements can be put in place whereby outcomes are measured and price adjustments take place accordingly.

The list price, also known as the manufacturer's suggested retail price (MSRP), or the recommended retail price (RRP), or the suggested retail price (SRP), of a product is the price at which the manufacturer recommends that the retailer sell the product. The intention was to help to standardize prices among locations. While some stores always sell at, or below, the suggested retail price, others do so only when items are on sale or closeout/clearance.

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The incremental cost-effectiveness ratio (ICER) is a statistic used in cost-effectiveness analysis to summarise the cost-effectiveness of a health care intervention. It is defined by the difference in cost between two possible interventions, divided by the difference in their effect. It represents the average incremental cost associated with 1 additional unit of the measure of effect. The ICER can be estimated as:

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The Pharmaceutical Benefits Scheme (PBS) is a program of the Australian Government that provides subsidised prescription drugs to residents of Australia, as well as certain foreign visitors covered by a Reciprocal Health Care Agreement. The PBS seeks to ensure that Australian residents have affordable and reliable access to a wide range of necessary medicines. The PBS has faced increased scrutiny as its cost has increased. The scheme assumes responsibility for the cost of drugs to patients in the community setting rather than while in hospital which is the responsibility of each state and territory. Together with Medicare the PBS is a key component of health care in Australia.

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References

  1. "Pharmaceutical price regulation scheme 2014 - GOV.UK". www.gov.uk. Retrieved 4 March 2017.
  2. Department of Health The Pharmaceutical Price Regulation Scheme 2009
  3. "Appeal finds NICE decision on £90k breast cancer drug 'unfair'". Health Service Journal. 16 December 2015. Retrieved 11 January 2015.