England’s health institutions — the National Institute of Health and Care Excellence (NICE) in particular – are key influencers not only in other UK countries, but across Europe and the rest of the world. England’s payer decision makers seek to reward innovation while ensuring “value for money spent.” This occurs through several appraisal processes, which are used depending on the type of medicine.
Since January 2002, it has been mandatory for National Health Service (NHS) organisations in England (and Wales) to provide funding for medicines and treatment recommended by NICE in its Technology Appraisal guidance. Furthermore, NHS organisations must review clinical management following publication of NICE clinical guidelines.
The most frequently used process is the NICE Health Technology Assessment (HTA). However, a positive HTA does not always mean a medicine will see full uptake locally, even with NICE stating that local payers have a statutory responsibility to make funding available within the recommended timeframe.
And when NICE determines a medicine is not cost-effective, manufacturers must be prepared to work even harder to get medicine uptake through seeking patient access schemes (PAS), risk-sharing agreements and in-confidence discounts with payers.
England’s Payer Stakeholders
Once NICE determines a new drug to be cost effective, local-level stakeholders in clinical commissioning groups (CCGs) and hospital trusts implement NICE’s guidance. CCGs, led by general practitioners, organise the delivery of approximately £75bn of England’s NHS budget. Specialised commissioning (approximately £20bn of the NHS budget) is delivered nationally instead of regionally through NHS England. NHS England, run by the UK Department of Health, is legally in charge of the UK-wide NHS budget and decision making. The NHS in England spends approximately £16bn on drugs, split between GP prescriptions (~£9bn) and hospital treatment (~£7bn), of which about half is directly reimbursed by NHS England’s specialised services budget.
Working with NICE
While NICE does not have a formal role in price setting, the panel gives the critical stamp of approval leading to National Health System use and reimbursement. NICE is the main health technology assessment (HTA) body in England, determining clinical and cost effectiveness of pharmaceutical and biopharmaceutical products. NICE uses quality-adjusted life years (QALYs) to measure burden of illness in terms of shortfall of life and length, and is derived via an incremental cost-effectiveness ratio, or ICER.
The need to prove cost effectiveness to NICE before a drug can be recommended for use by the National Health Service encourages companies to negotiate the price paid to satisfy NICE’s criteria. This has also prompted companies to offer deals that have an impact on pricing.
Important Points to Keep in Mind
Medicines that have been approved but have not yet received NICE guidance see little-to-no uptake, known as “NICE blight.” NHS organisations can technically start using the drug but many wait for NICE guidance, which can take between six months to, in some cases, two years.
For most new medicines, the decisions on use are made at a local level by drugs and therapeutic committees, which include healthcare providers as well as commissioners. Medicines are then further assessed within local health economies before being approved for CCG and hospital drug formularies. With around 200 CCGs, this model means medicine uptake can be inequitable and slower than anticipated.
New medicines where decision on use is made at the national level, through specialised commissioning, also have their own problems. In many cases, this national process is seen as a ‘you only get one chance at approval’ route.
Implications for Industry
Demonstrating the value of a new drug relative to standard of care, which can differ between countries and global regions, and creating effective market access and communications strategies are critical to realising maximum commercial value in England. The Pharmaceutical Price Regulation Scheme (PPRS) plays an important role in shaping the relationship between industry, the NHS and the English healthcare landscape. Knowing the ins and outs of this policy and how it plays out at a local, regional, national and UK-wide level is essential. Finally, identifying and communicating to all relevant key market stakeholders is equally important.
NICE’s Ongoing Assessment
During NICE’s HTA appraisal process, manufacturer data is submitted from protocol-driven clinical trials, which are closely monitored under ideal conditions. Post approval, NICE will undertake ongoing assessment at regular intervals and if it finds that the negotiated patient access scheme or criteria differ from real-world outcomes, your product could get dropped from formulary lists. Therefore, it is critical to continue to communicate the value of your product throughout its lifecycle.
Having the right value communications strategy before, during and post-launch is vital for commercial success and maintenance of drug list position. The GLOBALHealthPR team has years of experience in England, the UK and EU markets, and can offer valuable insights to your teams.
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