Market Access Strategy

Market Access Strategy

In a complex, constantly changing market access environment, these are the questions we can help you to answer:

  • What makes a good HTA submission?
  • Can I avoid an HTA submission? How, and what is the alternative?
  • Will I be treated as an ultra/orphan and does this help or hinder?
  • What is the funding flow in the country>
  • Which country should I gain pricing and reimbursement in first?
  • Which policies/processes affect bringing my product to market?
  • When do I need to start thinking about my market access plan?
  • How do I negotiate and submit a discount or risk sharing scheme?
  • How do I increase my price?
  • What are my options if I get a “no” from HTA agencies?
  • How can I apply legal and political leverage to market access?

Market Access head’s checklist

(Tools to support this are available in the MAP Tools section)

For each topic listed below, a series of assumptions should be populated for each country that is targeted for commercialisation as follows:

  • Base case
  • Best case
  • Worst case
  • Comments on these assumptions and dependencies (where relevant)
  • Primary responsibility within the organisation
  • Support required outside the organisation

Market Access Activities – High Level Overview of Key Dates

  • Pricing & Reimbursement – Key dates
    • Start date for P&R dossier preparation
    • Submission date of P&R dossier
    • Decision date/ conclusion of P&R
    • Date for first promotional sales
  • Early Access Programme (Paid for) – Key dates (where applicable)
    • Start date for EAP preparation (including any dossier requirements)
    • End date of EAP preparation / submission date of EAP dossier (where required)
    • Decision date for EAP and roll out

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Policy & Public Affairs Strategy

Policy & Public Affairs Strategy

As a first step in thinking about your Policy & Public Affairs Strategy, we encourage you find out more about UKTI (UK Trade & Investment) for Life Sciences. Alongside the Strategy for UK Life Sciences One Year On Report, UKTI launched a UK Life Sciences Prospectus aimed at industry. This includes the announcement of the Government’s ten-year Strategy for UK Life Sciences; this may be helpful to review so that you gain broader insights into the UK strategy and then align your own strategy to improve the chances of success.

The following information should be seen as an introductory guide to helping you navigate your way through the complex pricing & reimbursement, political and legislative processes in the UK. It should act as a simple, easy to follow guide to the steps you need to take and the questions you need to consider when bringing your product to market in the UK and Ireland.

Download our outline slide deck for Developing a Policy & Public Affairs Strategy to support your internal discussions

Step One:

  • Who do I need to approach to gain marketing approval, a price and supportive guidance?
  • Where do I look to find out whom I need to approach?

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What is the process to follow in each case?

Step Two:

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Step Three:

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Effective Engagement

Making the right approach

The key things to have in place when developing your Policy & Public Affairs plan are:

  • Clear objectives
  • An understanding of the policy environment you are operating in
  • Key stakeholders identified

From these you can build a strategy for engagement that is tailored to your audience and timed to support key milestones in the policy environment and/or your market access calendar.

Below we have outlined the two key stages in developing your Policy & Public Affairs programme and actions you should take under them. The first stage can take anywhere between 1-3 months to develop, but the second stage should only take 1 month to complete. Timing depends mostly on your ability to gather information effectively and to draw insight and support from across different internal functions as required.

Stage One: Developing Your Strategy

  1. Define your strategic objectives as a company i.e. objectives for the brand, portfolio or wider company
  2. Define the objectives of a Policy & Public Affairs programme – as these relate to the strategic objectives for the portfolio, brand or wider company i.e. consistency of access to high quality devices in X therapeutic area across England, NICE recommendation etc.
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Stage Two: Developing Core Materials for Engagement

  1. Hold cross-functional meeting to agree key messages
  2. Identify evidence/proof points to support key messages and draw up a message bank listing all key messages and the proof points – this will be a useful reference tool when developing any materials for use with stakeholders

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The NHS Tariff

The NHS Tariff – Payment by Results

Payment by results is the system in England which allows commissioners to pay the providers of healthcare for every patient that they see or treat. This payment system is able to account for the complexity of the treatment needs of the patient, and this relies on the two fundamental features of the payment by results schemes, which are nationally determined “currencies” and also tariffs.

  • Currencies are described as the unit of healthcare which a payment is made for and this unit can take various forms and cover different time periods of care required from outpatient appointments, stays in hospital through to care for long-term conditions.
  • A tariff is the set of prices which are paid for each currency.

The payment by results approach currently covers a large proportion of acute healthcare in hospitals with national tariffs in place for admitted patient care, outpatient attendance, some outpatient procedures and also A&E.

For admitted care and A&E the currency is the healthcare resource group (HRG). This is a system whereby HRGs are clinically meaningful groups of diagnoses and interventions which all consume similar amounts of NHS resources.

There are over 26,000 codes which can be used to define the various diagnoses.
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The Five Main Routes to the NHS

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1a) Selling Direct to Trusts

If a company has a specific product or service which means that it can be matched easily to an NHS organisation then they can use this process to sell directly to the healthcare service provider of their choosing.

This often involves having to identify the right people/person within the selected NHS organisation to deal with. This tends to be clinicians, the procurement team and the finance team.

The service providers (this includes all Trusts) can make their own purchasing decisions and are able to purchase directly from the manufacturer or the distributor within the purchasing rules and arrangements. For more information on NHS authorities and Trusts click here.

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Reimbursement of medical devices for use in secondary care in England and Wales is primarily based on procurement procedures and negotiation with hospital trusts providing care to patients and/or clinical commissioning groups (CCGs) which commission care from any qualified provider including hospitals. This can be supported by NICE guidance if you can persuade NICE to conduct a review (note limited capacity) and if they do not conclude that the product should be used ‘only in research’ or if there is insufficient evidence to support a positive recommendation.
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Medical Technologies Evaluation Programme

The NICE medical technologies evaluation programme (MTEP) selects and evaluates new or innovative medical technologies (including devices and diagnostics). MTEP helps the NHS adopt efficient and cost effective medical devices and diagnostics more rapidly and consistently.

The types of products which might be evaluated are medical devices that deliver treatment such as those implanted during surgical procedures.
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Diagnostics Assessment Programme (DAP)

Process for producing NICE Diagnostic Technologies guidance

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Wales NHS Financial Flows & Structure

Funding of the NHS in Wales

The National Health Service is mainly paid for from general taxation with a small proportion raised through national insurance contributions. There are a number of other options for funding health services including social insurance, which is used in the vast majority of European countries and private insurance and payment at the point of delivery, which shapes health care services in the United States. NHS Wales
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Reimbursement of medical devices for use in primary care in England and Wales is primarily based on Part IX of the Drug Tariff

In the first instance, it is imperative to discuss your specific technology and where it is likely to be provided to patients. The reason this is important is that some products will not be suitable for the drug tariff process and, while gathering the evidence and cost data may be similar, it may avoid undue work if you establish relevance of the tariff for your product early in the market access process. This should be done through email or phone and we provide the contact details here.

For further details please contact:

The Drug Tariff Team
NHS Business Services Authority
NHS Prescription Services
Drug Tariff Team
3rd Floor Annex
Bridge House
152 Pilgrim Street Newcastle upon Tyne NE1 6SN
Telephone: 0300 330 1349

See links on our Wales pages to the NHS guide, followed by our process map to support your planning and a range of additional links to helpful sources of information.

Medical Devices Reimbursement Flowchart

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Northern Ireland

Northern Ireland


Northern Ireland has the fastest growing population in the UK. Currently there are approximately 1.8m people in the province, a figure which is expected to rise to 1.937m by 2022. From a health and social care perspective, possibly the most significant aspect of this increase is the rising number of older people.

Up to 2022 the number of people aged 65 years and over is estimated to increase to 348,000. This is 18% of the total population compared with 15% now. The area of highest growth is in the west of the province whilst the area projected to have the highest number in this age bracket is the South Eastern locality.
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Funding of the NHS in Northern Ireland

The annual revenue budget is around £4bn, almost 40% of the total NI block funding (from UK government). Despite the significant scale of this investment there are very real and increasing pressures on resources across all areas of Health and Social Care. These include demographic funding pressures arising from a growing elderly population, increasing numbers with chronic health conditions and the cost of new technologies and drugs.
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The NHS in Scotland has a number of key roles in the development and uptake of new technologies to improve and enhance the delivery of healthcare interventions.
Life Sciences Scotland (LSS) is the Industry Leadership Group (ILG) for the Scottish Life Sciences Sector. LSS signalled the importance of companies developing medical technologies (MedTech) in Scotland being able to work collaboratively with NHS Scotland. This is to ensure that there are appropriate opportunities for the development and introduction of new products in Scotland, supported and informed by the clinical and service needs of the NHS.

There are certain key contacts within the system who can be approached at particular stages in the process. A summary is provided below.

Stage Issue Contact
Developing and Scoping Ideas Initial feedback on an idea NHS R&D Directors

NHS Research Scotland

NHS National Procurement

Engaging with R&D in the NHS
Needs and opportunities in the NHS
Testing and Development in Clinical and Service Settings Testing and trialling products
Advice and support for practical application
Assessment and Evaluation Assessing cost and clinical effectivenessDeveloping an evidence base NHS Quality Improvement Scotland Scottish Health Technologies Group
Adoption, Ongoing Assessment and Displacement Engaging with national and local procurement arrangements NHS Scotland National ProcurementNHS Board Procurement Specialists
Support and Networking Information about the Life Sciences Sector in Scotland Scottish EnterpriseScottish LifeSciences Association

BioIndustry Association Scotland

Information about the NHS in each area of Scotland NHS Boards

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Scottish MedTech Tariff – Healthcare Information Group

The Scottish Drug Tariff can be found here.

Parts 2-6 of the Tariff lists the appliances that may be ordered by authorised prescribers on the appropriate prescribing lists of Health Boards, and indicate the specifications and tariff prices of such appliances. The items in these parts that may not be prescribed on form GP10 (N) by Nurse Prescribers are indicated by the symbol ‘Nx’. Stoma appliances are no longer published in the Drug Tariff. See separate list – Reimbursement prices for stoma appliances for further details.

Appliances not included in Parts 2-6 of this tariff may not be ordered. Suppliers of appliances are under no obligation to supply any such appliance that
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Introducing New Technologies into NHS Scotland

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