How Outcomes Evaluations Can Increase NHS Access to Innovative Drugs
By: Paul Sutton | March 31, 2015
Both outcomes audits and outcomes evaluations are powerful research tools designed to collect and interpret real-world data for a specific patient population. Whereas an outcomes audit uses data extraction retrospectively to view a patient’s progression on a drug treatment, an outcomes evaluation is more of a prospective process – comparing initial measurements from a patient with measurements taken at intervals during the course of their treatment.
Previously, we have written how an outcomes evaluation can benefit biopharma, however in this article we will examine how outcomes evaluations can help the NHS to optimally manage its patients by tracking clinical and economic drug outcomes.
Real-world data challenges facing the NHS
The NHS is under pressure to deliver efficient and safe outcomes to a larger cohort of patients than ever before, while also reducing costs. With constrained budgets, payers are looking for cost effective drugs that are suitable for maintaining a sustainable healthcare system. As a result, the burden of proving a drug’s effectiveness is greater than ever. The NHS needs evidence of clinical outcomes, including quality of life and patient reported outcomes measures, in order to validate the commissioning of a drug. These outcomes should be real world rather than theoretical, and payers and clinicians would prefer for them to be from their own locality.
The NHS wants observational data to make informed decisions regarding drug funding. But, due to the needs of the local health economy, sometimes it cannot wait for biopharma to run large scale post marketing observational studies. An outcomes evaluation can be commissioned and carried out promptly, mapping out concisely how a drug is performing along the care pathway.
How can an outcomes evaluation benefit the NHS?
Using clinical and real-word data, an outcomes evaluation can provide the NHS with all of the information it needs to make an informed decision about the value of a drug treatment in the local health economy. This outcomes data can help the NHS to see differentiation between a new drug and alternative therapies.
Outcomes evaluations can also identify positive changes to a treatment pathway as the result of a new drug. By giving the NHS time to plan for such change, local providers or clinical commissioning groups can better understand any implications that may arise and resource investment if required.
If an outcomes evaluation identifies groups of patients with unmet needs along the pathway, the NHS then has access to related resources that could help to support further analysis into specific parts of the pathway. This could lead to the creation of nurse review clinics for example, or similar initiatives that improve outcomes for more groups of patients.
Another major benefit of an outcomes evaluation is having the clinical expertise of an in-the-field nurse who is trained in the specific disease area. When the nurse is going through patient notes, they bring a wealth of knowledge to the data from their own experiences. This allows them to delve deeper and make informed connections between seemingly unrelated statistics. The in-the-field nurse is available to speak to NHS staff and give them feedback around reporting inconsistencies, allowing for staff to explain the reasons for them – and highlighting issues to the hospital as a whole. This support can help the NHS standardize and improve its reporting process.
Delivering NHS results in practice
Let’s take a hypothetical scenario of why and how the NHS would benefit from an outcomes evaluation. With clinical trial programs more suitable for regulatory acceptance rather than NHS approval, an outcomes evaluation can provide real-world data to support informed decision making around an innovative new drug.
We can use a new innovative treatment for rheumatoid arthritis as an example. In this scenario the NHS has access to strong clinical measure data around the new drug, but needs more patient outcomes data in order to evaluate its effects on quality of life. However the Trust does not have ‘like-for-like’ data with the drug’s competitors, which is up to date and current. This data is vital in order for the drug to stand out to payers and clinicians.
At this point the drug is taken to the Area Prescribing Committee (APC) where the treatment is reviewed based on the existing data. If at this point the APC is not satisfied with the drug’s lack of differentiation and its costs compared to other rheumatology drugs, the application will be rejected even though the NHS Trust could still see a place for the drug in its pathway.
Joint working with biopharma can be of most benefit to ensure the needs of the patients in the local health economy are met. Here, the chief pharmacist at the Trust may begin working with biopharma to carry out an outcomes evaluation in order to ensure access to the drug. In an outcomes evaluation, clinical trial data is utilized in order to allow the APC to make an informed decision – presenting the drug’s outcomes in the trial period. The selection of patients based on highly targeted profiling ensures that the right group of patients are included in the outcomes evaluation, which gives the APC a deeper understanding of the type of patient the drug could benefit.
For example, as the innovative drug is often more expensive than other treatment options, the outcomes evaluation provides evidence to prove that it could still add value for a specific cohort of patients who had not benefited from an alternative therapy.
The outcomes evaluation also uses data that was taken from a specific patient pathway and could therefore be compared easily with the outcomes of other drugs on that pathway. This clinical experience of the drug – in addition to clinical data – further demonstrates its value to the APC in a real-world environment, as well as how it will improve the local health economy.
By undertaking an outcomes evaluation, the NHS can benefit from:
Outcomes evaluations can maximize the probability of a positive outcome for the NHS when looking to gain access to a drug. By supporting the development of a local value story, outcomes evaluations provide real-world data from a patient outcomes perspective – supporting the NHS to position a drug for optimized prescribing in a local health economy. The support provided by in-the-field nurses and a project manager also offers specialist knowledge when communicating information between the NHS, biopharma and APC committees. By harnessing the knowledge gained from using outcomes evaluations, the NHS can enable access to the most innovative drugs that will best serve the local health economy.
> To learn more about how outcome audits can help biopharma and healthcare providers gain a clearer understanding of how to best support patient pathways, please watch 'Outcomes audits and evaluations: demonstrating values and outcomes at a local level'