It was written by Brian O’TOULE
The National Institute for Health and Care Excellence (NIC) highly specialized technology (HST) program is designed to evaluate innovative treatments on rare and complex conditions. On March 19, 2025, NICE announced some improvements on HST routing standards, and a process that technology does not meet or meet HST routing. This improvement is the result of consultation between NICE and stakeholders to provide clarity and ensure more efficient routing processes.
Summary and meaning of good sophistication
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- Technology must meet all four criteria to route through HST.
- Fixed criteria have been fixed to provide additional clarity and obvious definition of phrases and terms.
- The HST routing evaluation checklist is used to determine whether the technology should be routed through the HST process.
- NICE reviews the HST routing criteria after three years of publishing to evaluate the need for further improvement (although the review may start faster)
- Figure 1 shows how the context of the HST approach is connected to the HST routing criteria and describes in more detail below.
Figure 1: Figure 1. Summary of the wonderful HST program †
refined Good standards
Routing Reference 1: This disease is very competitive and weak. 1A. 1A) In the UK, it is defined that there is a point prevalence of less than 1: 50,000. 1B) Since it is now a lifetime after diagnosis of treatment, there is an excellent negative impact and burden on people with ultra -light disease.
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- ‘Disease’ refers to the condition that can be diagnosed using the International Disease Classification (ICD-11) developed by the World Health Organization (WHO). Diagnosis is based on the inherent signs and symptoms (characteristics) identified using clinical tests. ii) Patient troops; III) Video or laboratory test found in the National Health Service (NHS) in the UK.
- ‘Disease’ does not refer to a sub -group based on age, gender, serious or genetic sub -type. These are considered only if they are clinically meaningful.
- Point prevalence refers to the prevalence of the British disease. It calculates the number of people who have a diagnosis of diseases that are considered to be alive in the UK compared to the total population (denominator) of the British at that time.Nhs English).
- ‘Lifetime’ indicates that this disease requires continuous clinical care, support treatment or both.
- ‘Exceptional negative impacts’ are seriously damaged by the period of life or the quality of life. The exact evaluation of this requires a subject of subjective judgment.
Routing Standard 2: This technology is an innovation of high -speed disease.
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- ‘INNOVATION’ refers to technologies or medicines such as ATMP (Advanced Therapy Medicinal Product), new chemical or biological organs (a combination of new drug devices that provide additional health promotion in comparison with existing treatment or best support).
- To ensure that this technology is very innovative of competitive diseases, technology should not be a technology that includes use. And signs of technology should not expand significantly from other populations or diseases.
- Technology with use refers to a new use of medicines that are beyond the range of licenses. It is usually used to take existing medicines with marketing or licenses for a particular state and then treat other states. This may include general treatment or treatment that withdrew marketing approval, and developers are looking for new indicators.
Routing Standards 3: The UK is eligible to receive technology and license labeling, and the technology is not individualized medicines.
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- ‘Eligibility’ refers to everyone who can have skills according to marketing approval (or acquisition process) in the UK.
- ‘Technology’ should be developed only for very competitive diseases, so the eligible population is small. technology :
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- It should be the first licensed treatment specified for super-competitive diseases in consideration.
- It should not be expanded from other sub -groups considering other sub -groups with other relevant population, disease, or the same superline disease.
- It will not be suitable for other sub -groups of the population suffering from super -large diseases in the future.
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- ‘Individualized Medicine’ is a drug developed based on a person’s unique genetic profile (N of 1) or a single junction twin or triple -triple genetic profile.
Routing Standard 4: This technology is likely to provide significant additional benefits to those who are very competitive than conventional clinical management, and the existing clinical management is considered inappropriate.
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- ‘Practical additional benefits’ means that, as illustrated by research data on research data (PROM) for the period of reduced life or clinically related measurements, it is possible to show practical improvements in seriously damaged quality of life due to humiliation.
- ‘Technology’ means:
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- If this technology is a disease fertilization (including treatment), the UK’s NHS does not have any other diseases that can be used for the same ultra -strong disease at the time of the route decision.
- If this technology deals with a very competitive disease or symptom, there is no other treatment for the same symptoms as the technology is displayed at the time of the path decision.
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conclusion
It is clear that the improvement of the HST routing criteria adds a lot of clarity surrounding the specific phrases and terms used by NICE. Prior to this improvement, the lack of justice meant that these standards were subject to considerable subjectivity and interpretation. The availability of the HST Routing Evaluation Example provides additional transparency and clearly emphasizes the location that does not meet the criteria for the technology to meet, partially or route the HST program. Importantly, NICE says that technology must meet all four criteria to consider for HST routing. Previously, some techniques were possible (not all).
Source Health Economics will work with customers in 2019 to provide ‘recommended’ NICE HST submissions to help British patients access innovative treatment.
To learn more about HTA submissions (including systematic review, health economy modeling and medical writing), contact Source Health Economics, a hergard that specializes in creating evidence, health economy and communication.
