CONECPT OF OUTCOME PLATFORM
Concept
Historically, health care reimbursement has been based on volume rather than value and outcomes. Value-based contracting (VBC) is increasingly seen as a viable and sustainable way of aligning payment to value. VBC compensates life sciences companies and providers for delivering prespecified, real-world results and solutions based on three health outcome pillars: clinical efficacy, patient-reported outcomes and health care system efficiencies.
Benefits
Adopting an outcomes-based commissioning model could result in improved patient outcomes: contributing to earlier access to medicines, driving better value for money and reducing the risks for the NHS, facilitating more personalised prescribing and offering clearer incentives to invest in the UK’s health economy and in innovative treatments.
Objectives
The Outcomes Platform is designed to address the critical need for value-based contracting, which reimburses life sciences companies and providers for delivering prespecified, real-world results and solutions. Value-based contracts have the potential to align the interests of patients, payers, providers, life sciences companies and society around a shared goal: reducing health care spending trajectories to more acceptable and accessible levels while continuing to reward important innovation.
Solutions
Chellsy Analytica digital technology is making it easier to collect, analyse and share results, doing so securely.
We develop and provide support for all types of clinical outcome assessments (COAs), including patient-reported outcome (PRO), observer-reported outcome (ObsRO), clinician-reported outcome (ClinRO), and performance-based outcome (PerfO) measures.
DESIGN OF OUTCOME-BASED PLATFORM
DEFINE OUTCOMES
DATA
COLLECTION
- Support an unlimited number of participants and questions
- Support more than 80 different languages in a study
- Accept 28 types of questions (e.g. multi-choice, single-choice, drag and drop, ranking, open box, put image/video, radio question, date/time, slider and etc.)
- Define advanced conditions (e.g. Randomization, Skip Logic, Branching, Piping and Micro-tailoring and mathematical calculations)
- Record/capture geo-location, photo and video from participants, interviewers and/or researchers
- Take the signature of participants, interviewers and/or researchers
- Customise font, logo and colours of form or survey
- Ability to upload file (i.e. image, text or video)
- Responsive system; works very well on mobile, tablet or desktop
- Sending of invitations, reminders and tokens by email
- Embed the form or survey on your website without any further installation
- Export raw data file in Excel, CSV, Stata or R (data file) formats
- Automatically take a backup from all studies on daily bases
- End to end encryption and store data on dedicated servers
- Access to the admin page for editing question or options
- Define different level of access to the admin page for researchers
REAL-TIME
REPORT
- Ready to be used as soon as data collection starts
- Update/refresh the report every 2 hours
- Insert 6 types of charts including Time series, Combo, Pie, Bar, Area and Linear charts
- Insert geo-map and pivot tables
- Define filters on the report (e.g. time frame, site, location or any other variable)
- Download the report in PDF or CSV format
- Share the report with colleagues
- Customize font, logo and colours of the report
- Import and combine raw data from external sources (e.g. Cloud SQL or Excel)
- Embed the report on your website without any further installation
STATISTICAL
ANALYSIS
- Data analyses, modelling data to understand risk, benefit and effectiveness of treatments
- Data management and cleansing
- Descriptive: frequencies, mean, SD, tables and etc.
- Analytical: modelling data (Logistic, Linear, Cox or Poisson regressions)
CONDITIONAL ALERT
NOTIFICATION
- Customize the conditions to detect anomalies or AEs or any problematic situation (e.g. Life-threatening situation, bleeding or allergic reaction)
- Triggers instantly (less than few seconds) once the system detects them
- Send email(s) instantly to the researcher team or sponsor
- Customize email text for each pre-defined scenario(s) and specify list of email receivers
Save Money
- No hidden fees, we only charge you for usage of software
- No need to hire employees or outsource to companies for programming
- There is not cost installation
- Do not require training to use
Save Time
- You just need to send the form or questionnaire to us and Chellsy Analytica do the programming in less than one day
- Instant access to the results and reports
- No need to spend time for training or installing any extra software or your computer or server
OUR SOLUTIONS
NON-INTERNATIONAL
Chellsy Analytica offers great solutions to measure patient-reported outcomes and quality of life as well as gathering health care system costs.
CLINICAL
Capturing and managing clinical data and connect to Electronic Healthcare Records (e.g. hospital records).
Chellsy Analytica provides accurate patients’ screening to meet objectives of the study for ePRF, eCRF, ePRO and EDC.
PRINCIPLES TO BE CONSIDED
Specifications of the contract
The aim of an outcome-based scheme is to link the remuneration that firms receive to the actual performance of their product, in terms of the real benefits that it brings to the patient and wider society. In so doing, such an approach has a number of particular attractions:
• It should ensure that patients are able to access new and innovative medicines as early as possible whilst facilitating good value for money for the NHS and hence the taxpayer.
• It should ensure that the value created by treatments to patients and society is captured and rewarded so that the pharmaceutical sector is encouraged to develop treatments that are of the greatest value to society.
• It should ensure that investors receive clear signals to develop and introduce new treatments by ensuring that there is a strong and clear incentive to invest.
• It should fit properly within a wider outcomes-focused NHS so that commissioners are able to choose the optimal combination of interventions through the care pathway whether that is primary, secondary or community care, social care, medical devices or medicines.
Unmet needs and Eligibility
Delays in access to new treatments: This dilemma is particularly marked in relation to drugs that are highly innovative – because the outcomes are harder to predict and there could be uncertainty surrounding the clinical data, commissioners may decide that the risks are too great to make the drug available. Success is heavily reliant on good design scheme, including how outcomes should be measured and assessed, how evidence will be gathered and how results will be reported and governed.
In the context of increasing co-morbidities, extended lives and rising costs of healthcare, there is growing interest across the wider NHS in personalised care, value-based healthcare and outcome-based commissioning. We must move away from a supply driven health care system organized around what physicians do and toward a patient-centered system organized around what patients need.
| Step | Description |
| Qualifying criterion: Does the drug address an ‘Unmet’ need? | Based on evidence provided by the manufacturer, any clinical trials and other existing data, NICE and the NHS are likely to be more interested in drugs that can meet ‘unmet need’. |
| Alternative qualifying criterion: Does the drug provide wider value that the QALY does not always capture? | The manufacturer has relevant evidence that the drug can achieve high levels of wider benefits not always captured in QALY. |
| Practical checks: Is outcomes-based scheme practicable? | The purchaser (for example NHS, clinicians, commissioners, NICE) and the manufacturer agree on the practicalities of an outcome-based approach, for example: Which outcomes are relevant. |
| • Whether relevant outcomes can be easily observed and measured, including whether the data is available and from what sources. Absolute clarity is needed on what will be measured and when, so as to reduce the likelihood of disputes. | |
| • Whether the patient group is large enough to provide results that are definitive and statistically robust, providing the commissioner with requisite evidence on which to make payments. | |
| • Whether likely expenditure on the drug is large enough to make administrative costs of the process proportionate. • Where is the scheme implemented – i.e. locally, regionally or nationally. | |
| Decision on most appropriate route: Should the outcome agreement be part of the Health Technology Appraisal assessment? | If a national scheme is being considered, then appropriate agreements should be in place that allow the appraising body (e.g. NICE) to consider the outcomes-based scheme as part of the overall HTA evaluation if appropriate. The decision on whether to implement an outcomes based scheme could occur at a number of points during the appraisal process, as is the case when deciding on whether drugs should be available through the CDF. |
| Agreement terms: how should risks be shared and what are the payment terms? | The NHS sets the terms on which the drugs can be procured, including: |
| • The outcomes that need to be met (e.g. patient health and well-being, hospital admissions), when they need to be met and how they will be observed. | |
| • The commercial agreement covering when the outcome is achieved/not achieved. | |
| • How risks will be shared. | |
| • The flow of money. | |
| • Any other commercial considerations such as confidentiality. | |
| Drug is made available to patients | • Assuming an effective risk-sharing agreement is put in place, it should be in the interests of both the commissioner and the drug company to ensure that the drug is used appropriately on the right target patients. |
| • The firm is likely to be of assistance in recommending how products fit into care pathways and patient selection. | |
| • At the same time, data collection processes are established and agreed to ensure that outcomes can be tracked. | |
| Relevant outcomes measured | At the end of the outcome period, the outcomes are measured and recorded. It is important to consider who has responsibility for collecting the data and who subsequently owns the data. |
| Reimbursement contingent on the agreed outcomes being met/not met | The reimbursement is completed on the basis of the agreement. Payment will be made based on health value multiplied by number of patients or on the basis of a rebate as previously agreed. |
| Past evidence suggests that it is important to institute mechanisms to ensure that reimbursement functions effectively especially if this relies on information gathered by third parties. | |
| The process could be led by NHS England’s Strategic Commercial Unit. | |
| Schemes will need independent oversight and governance. |
Risk sharing and financial aspects
This section assesses the main design considerations that policymakers would have to make in developing an outcome-based reimbursement model (OBRM) and how these could be managed. These include:
1. How to share outcome risk between the NHS and the manufacturer?
2. How the initial costs of drugs are shared.
3. What outcomes to pay for?
4. What drugs should be made available through the scheme?
Currently, outcome risk sits with the Government. Under OBRM, the risks could be shared between the NHS and the manufacturer. From a theoretical perspective, risks should only be passed to the manufacturer when the latter has some control over the outcomes.
In a scenario where outcome risk is passed to the manufacturer, the drug company would walk away with no revenue from the drug if the agreed outcomes were not achieved. From the state’s perspective, this ‘pure’ version of payment by results would protect taxpayer resources. However, it may be beneficial for the purchaser and manufacturer to share the risks. If the drugs achieved better outcomes than expected, the manufacturer would benefit from the situation, which would help align incentives. Existing international and other public sector applications of the principle of payment for outcomes (or results) suggest that getting the correct distribution of risks is important.
In instances where outcome risks are passed to the manufacturer of the medicine, the state could decide to defer paying for the drugs until it has observed the outcomes. There are good reasons for considering such a step, although there are also associated risks that would have to be managed and that may make it inappropriate.
Outcome-based commissioning schemes typically deploy one of two methods of payment schedule.
First, the NHS may cover the immediate costs of the interventions – in other words, the NHS finances the interventions. In the event that the manufacturer achieves the outcomes or better, then it retains the money it has already received with the potential for a performance benefit. In the event that the outcomes are not achieved, then the NHS claws back a portion of its initial expenditure as a penalty from the manufacturer.
The second approach is for the manufacturer to cover the immediate costs and to finance the interventions. The NHS then pays the manufacturer when / if the agreed outcomes are observed.
1. Putting additional value on ‘unmet need’
2. Putting greater weight on quality of life and qualitative improvements
3. Paying more for indirect benefits and positive externalities: a) Medical costs b) Indirect costs c) Weighing up broader outcomes
ABOUT US
Chellsy offers a fully automated data collection and analytics services to help you conduct your research studies easier and faster. His services aid your data collection and analytics and letting you focus on the design of study.
Medy Ehtesham
Consultant and Founder
Medy studied Public Health and Epidemiology and he has experience of conducting both primary and secondary research studies in healthcare, academic and commercial sectors. He worked closely with wide array of clients including but not limited to Department of Health and Social Care, NHS, Johnson & Johnson, Novartis, Roche, Pfizer, AstraZeneca, GSK and Amgen in a diverse therapeutic areas.
CONTACT US
Phone: +44(0)2087317027
Email: contact@chellsy.com
