The UK Payor Landscape
The payor landscape in the UK is complex and can be confusing. It is important to understand that the route to market after approval varies between each of the 4 countries that constitute the UK.
The payor landscape in the UK is complex and can be confusing. The Medicines and Healthcare Products Regulatory Agency (MHRA) is the government agency responsible for ensuring that medicines and medical devices work, and are acceptably safe. Pricing and reimbursement issues are not considered by the MHRA. It is important to understand that the route to market after approval varies between each of the 4 countries that constitute the UK. As a very top level summary:
England. 84% of UK Population Once approved products can in theory be prescribed immediately. In England there are essentially 2 budget holders who will decide if or when a product is used.
o A national body, NHS England, for Specialised and highly specialised services. Specialised services are those services which are provided from relatively few specialist centres. Conditions treated range from long-term conditions, such as renal services, to rarer conditions such as uncommon cancers, burn care, medical genetics, orphan diseases and specialised services for children.
o Clinical commissioning groups (CCGs) for everything else. These are groups of general practices which come together in each area to commission the best services for their patients and population. There are 209 CCGs in England.
Once approved there may or may not be a HTA review (usually by NICE). A doctor can prescribe a drug while NICE are evaluating it if the local CCG agrees that they can. Once NICE makes a decision, it replaces any decision made locally.
o If there is a HTA review uptake is likely to be very low before the outcome of the review.
o If the HTA review is negative then the product will not be available on the NHS in England.
o If the HTA review recommends restricted usage for a product which is not covered by the specialised service provisions, then then this is likely to be implemented in local guidelines by the CCGs but will depend on local budgets.
If the NICE recommends usage of a product which is covered by the specialised service provisions it is likely to be incorporated into national treatment guidelines though in practice usage might be further restricted at a regional or local level due to budgetary constraints. NHS England takes advice from bodies such as Clinical Reference Groups who have the remit to define clinical strategies that enable the commissioning of services based on clear evidence and to ensure that they are cost effective and patient focused. CRGs bring together groups of clinicians, commissioners, public health experts, patients and carers. They use their specific knowledge and expertise to advise NHS England on the best ways that specialised services should be provided. There are specific groups for particular diseases, for example Clinical Reference Group (CRG) A01 covers cystic fibrosis services. CCGs can use internal or external resources to help them procure services, manage contacts and facilitate service redesign. The main external resource is provided by commissioning support units (CSUs). Often there is an internal team with in the CCG who take the lead on prescribing protocols and formularies, the names of the teams vary but are often referred to as medicines management. The medicines management team will sometimes collaborate with neighbouring CCGs and the local acute hospital trusts in order to set up a shared formulary and/or treatment protocols for a regional geography.
Secondary care product uptake in in England.
CCGs commission all secondary care for their patients, other than the specialised services which are commissioned by NHS England. This means that there needs to be close collaboration between the acute trusts and the CCGs to ensure continuity of care. The acute trust will have a major role to play in deciding on the treatment protocols for patients, though it will be the CCGs that pay for hospital procedures and any continuing care in the community.
Scotland 8% of UK Population
The Scottish Medicines Consortium is the key body in deciding on which medicines are available to patients in Scotland. The SMC membership includes health professionals from the NHS Boards in Scotland, patient representatives, health service managers, economists, pharmacists and members of the Association of the British Pharmaceutical Industry (ABPI). Any new medicine can legally be prescribed once it has a licence if it is thought to be the most suitable treatment for an individual patient. However NHS Scotland would be expected to await the advice from the SMC before making a new medicine routinely available. The SMC therefore, aims to issue its advice at the time a new medicine becomes available. The SMC is the source of advice for Scotland on new drug therapies and the NICE process therefore has no status in Scotland. If NICE endorses a drug that was not recommended by the SMC, it is open to the manufacturers to resubmit the drug to SMC with new evidence.
Wales 5% of UK Population
The All Wales Medicines Strategy Group (AWMSG) makes the decisions about which medicines should be available within the NHS in Wales. Like NICE, the AWMSG is a group of specialist doctors, pharmacists, other health professionals, patients and drug company representatives. The AWMSG work with NICE and don’t usually review a medicine if NICE are planning to look at it in the next 12 months. If the AWMSG say that a medicine should not be available and then later NICE decides it should be, the NICE decision is the one that is followed.
Northern Ireland 3% of UK Population
The Department of Health, Social Services and Public Safety (HPSS) in Northern Ireland look at any guidance issued by NICE and decide if it is relevant for Northern Ireland. If NICE’s guidance isn’t relevant, or if the HPSS decide it’s only partly relevant, they advise on any changes that need to be made. The HPSS are likely to approve most NICE guidance. The Department usually makes a decision shortly after NICE has made their decision.
There are a number of cancer drugs available to patients living in England through the Cancer Drugs Fund (CDF). The Fund offers treatments that have not been approved by the National Institute for Health and Care Excellence (NICE) and are not routinely funded by the NHS.
In Scotland, changes have been made to its access to cancer drugs system, allowing patients and clinicians a greater say on what new medicines are approved by the Scottish Medicines Consortium (SMC) for use in the NHS for end of life care and treating rare conditions. The New Medicines Fund supports health boards to fund the cost of orphan, ultra-orphan and end-of-life drugs for patients in Scotland.
In Ireland there is an Individual Funding Request (IFR) process. The IFR process is intended to provide access to unapproved specialist drugs for patients where there is an agreed clinical need, but currently denies access to 95% of patients in the initial stages of their request. These drugs are only available by ‘exception’ to patients in Northern Ireland, mostly because they are deemed too costly by the approving body.
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