Frustrations from pharma companies and the NHS toward NICE have been reported on since NICE was introduced in 1999, and as the governing body for quality standards and cost-benefit assessment for new treatments in the UK, the relationship is essential to ensuring patient access throughout the country. NICE have recently committed to reviewing some of their guidelines and ensuring a more transparent process for approval, which is set to assist both pharma companies and the NHS, after growing frustrations in recent years about the clarity of the current guidelines.
Introduced to provide guidance for public health practitioners, NICE develop quality standards and performance metrics to analyse the clinical and cost effectiveness of medicines a¬nd health technologies in the UK. They are the middle step between a pharmaceutical company and the NHS when there is any uncertainty over the treatment, and they ultimately make the decision as to whether the NHS should fund the technology. Pharma companies have a responsibility to demonstrate that their product is clinically appropriate whilst being cost effective, however as NICE takes into account a number of different factors, the current criteria is often criticised for being inaccessible and fragmented. With a complex approval process and limited information to information from clinical trials, it can be many years before a treatment is approved by NICE. The guideline review is set to provide a actionable set of protocols, thereby ensuring a more timely approval of new technologies.
As the budget holder for the majority of healthcare in the country, the relationship between the NHS and NICE is essential to maintaining market access for the country. Once NICE determines the cost-benefit the treatment offers is affordable and worthwhile, the NHS have a legal obligation to implement the treatment according to the guidelines given. Pharma companies benefit by being reimbursed from the NHS budget, and the treatment becomes available throughout the country. Rising costs and slow introduction of treatments is a frustration of the NHS, who together with the government are often under pressure regarding spending of the healthcare budget and treatments being publicly available. Current guidelines for the implementation of new treatments have been criticised for being unclear and not taking into account regional access differences, which makes access for patients nationwide less likely.
As well as frustrations from the NHS and pharma industry toward NICE, there are issues regarding mindset and culture between the NHS and pharma companies. NHS respondents have spoken out in the past regarding the ethics of life science industries, doubting their intent when it comes to putting the patient first. As the NHS are working with public funds, to pharma companies they could appear overly critical or selective when it comes to choosing not to fund a treatment. The NHS also seem inhibited from actively pursuing partnerships with pharma companies because of public perception, leaving life science industries unclear as to how to shape their offer in order to generate the conditions for a successful partnership.
NICE’s committal to reviewing the process and methods for the approval of a lot of new technologies is set to make the guidelines for drug commercialisation more accessible for pharma companies, and outline clearer standards for the approval of treatments and the post-approval implementation of the treatment. NICE are set to finalise the review for the Single Technology Appraisal (STA) and Highly Specialised Technology (HST) programmes by 2020/early 2021, they are involving stakeholders in the process and will be consulting on the updated content.
Without the relationship between NICE, the NHS and pharma companies the UK could be overpaying for medicines or supplying treatments that aren’t clinically effective. The market access professionals provide the link between clinical and commercialisation, and with advances in research and streamlined decision-making, can continue the vital work to ensure patient access in the UK and keep the patient in the forefront of their intentions.