Summary of points:
- It is vital that patients get access to new medicines, particularly when they have been involved in their development, either by funding research through donations or taxation, or have participated in the clinical trials. The introduction of a budget impact threshold of £20M per annum in any of the first 3 years is rationing by delay.
- We have real concern that these proposals will act as a deterrent to industries and other sectors including charities, that wish to carry out research in the UK, and thus affect the nascent industrial strategy where life sciences are such an important part (as described in the accelerated access review). The proposal is a disincentive for industry and others to invest in the NHS. It sends a signal that the NHS is not open to innovation, due to the strict and arbitrary parameters of the proposal. Disincenitvising investment in the NHS is to the detriment of patient outcomes and care. The lack of information about how drugs that pass the budget impact threshold will be paid for by NHS England and adopted across the NHS creates another barrier to allowing patients to access new innovations.
- The budget impact threshold of £20M per annum in any of the first 3 years does not take into account interventions that might affect large patient populations, creating a disincentive for researchers to bring new treatments to people affected by conditions such as hypertension (8 million), asthma (3 million), diabetes (3 million), chronic kidney disease (2 million) or COPD (1 million).
- For therapies targeting rare conditions, the £100,000 QALY threshold and £20M budget impact threshold create a complex scheme, where in practice, most new treatments will pass directly into the annual specialised commissioning prioritization process. AMRC is very concerned that the NHS England prioritization process is an arbitrary and inequitable decision-making process that pits groups of patients against each other to access treatments.
- The proposed new arrangements make no mention of WHEN treatments that are above the budget threshold, might be made available. We understand informally, that this could be within ‘short’ time scales and ‘possibility less than 18 months’, but this has not been clearly outlined. There is also no information about how patients and their advocates might be involved in these discussion, or how their views would be tensioned against the desire of NHS England to curtail costs. This obfuscation runs counter to NICE and NHS England stated desire to develop a transparent system.
We are concerned that the introduction of thresholds, emphasis on QALYs, and rerouting of ultimate decision making into NHSE will have negative impact on patients with common and rare diseases, and will significantly undermine the role and value of NICE.