Market Access in the UK
Market Access in the UK will vary depending on which of the four devolved nations you wish to sell your product in. The pricing strategies (the Voluntary and Statutory Schemes) are consistent across England, Scotland, Wales and Northern Ireland however, the reimbursement routes vary country to country. MAP BioPharma not only provides you with detailed information on each route to reimbursement for each country, we also provide valuable insights into how best to approach each option; what factors may help you in obtaining a favourable recommendation, weighing up the advantages and disadvantages of each option, giving you all the information you need in deciding the best route to market.
Market Access Overview
Sample information taken from different sections within England
Funding in England is predominantly provided regionally by clinical commissioning groups (CCGs) and nationally through direct commissioning by NHS England. See the Structures and Finance page for more information.
There are five key routes to reimbursement for new products in England:
- National Institute for Health and Care Excellence (NICE)
- Commissioning policy
- Clinical Commissioning Group
- Individual funding requests (IFRs)
- Commissioning through evaluation
Unlocked PDF copies of flowcharts, including more detailed flowcharts and supporting presentations are available to MAP Online members on the full site
The most talked about route to reimbursement in England and Wales is via a NICE appraisal. However NICE does not review all new drugs (only around 50%), and many drugs do not fit the NICE agenda. The following are steps a company can take to increase the likelihood of a NICE review or improve the likelihood of gaining reimbursement through a commissioning policy:
Sample information taken from our NHS Tariffs section
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 and also the interventions (procedures) undertaken in hospitals, and the HRG system allows these to be simplified and grouped into diagnoses and interventions which consume similar levels of NHS resources (cost around the same amount). This system allows tariffs to be set a sensible and workable level.
The latest version of this coding system is HRG4, within which there are over 1,500 tariffs. Each HRG accounts for a spell of care through from the admission of the patient to their discharge.
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Sample information taken from different Scottish sections on MAP
The majority of medicines received by SMC have alternative treatments. While NHS Boards are expected to follow SMC advice, the implementation of SMC accepted medicines is subject to local NHS Board decision regarding whether or not to include these in their formularies. NHS Boards have to make their decision within 90 days of SMC publishing their advice to confirm whether the treatment is or is not available within the NHS Board formulary. The Board then has 14 days to publish their advice on the medicine.
Where the SMC has approved of a new medicine, the NHS Boards are expected to make the medicine (or its equivalent) available within their formularies. NHS Boards therefore have to review the medicine against competitor drugs that treat the same condition that are available within the Board formulary/approved. Funding for accepted medicines then comes from within the NHS Board’s general revenue allocations in the context of their local formulary/approved list.
If the medicine/treatment is unique i.e. there is no other treatment options for the condition, then NHS Boards are required to introduce it, to an agreed national programme (determined during the SMC appraisal with NHS Board representatives). However, there has only been one such instance of this, which was later annulled when another medicine became available to treat the same condition.
SMC Trends Analysis
Based on our up-to-date longitudinal database, below are two examples of a range of charts available to our members who can also download and use these charts for internal purposes. If the intended use is beyond internal company presentations, then this may be arranged on a case by case basis.
Also available are: type of guidance by year (n=x and %) and guidance for orphans by year (n=x and %).
Patient Access Schemes
Complex PAS can be varied. They include free stock / rebates at various stages of the patient treatment or are schemes which only apply to specified subgroups of patients.
Below is a table of the complex PAS’s submitted to the SMC.
|SMC No.||Company||ICER (SMC view)|
|Sunitinib (Sutent)||275/06||Pfizer Ltd||47,598||2009-11-09||Recommended|
|Bortezomib (Velcade)||302/06||Ortho Biotech||24,492||2009-11-09||Recommended|
|Ustekinumab (Stelara)||572/09||Janssen-Cilag Ltd||23,920 - 127,267||2010-02-08||Restricted|
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If what you need is not already on MAP, we will complete the additional work, usually at no extra charge