Service Insight: Submission development and market access
pharmafile | June 28, 2011 | Feature | Sales and Marketing | Service Insight
SERVICE INSIGHT
A successful health technology assessment is critical for market access in the UK. However, submissions that don’t follow the provided template and guidance notes risk omitting information which is vital to the assessment process.
UK HTA bodies such as NICE (STA process), SMC and AWMSG all rely on the manufacturer to submit the evidence for the technology undergoing assessment.
The management and preparation of the submission document can be extremely time consuming and demanding for those individuals who are tasked with the responsibility.
As an example, in addition to the completion of the STA submission template, the manufacturer is also required to submit an economic model and conduct a number of systematic reviews. As the process is designed to ‘fast track’ assessment the timeframe for completion of the manufacturer’s submission is very short.
From the date the final scope is published on the NICE website, manufacturers have just two weeks to submit Section A (The Decision Problem) to NICE. Six weeks later, Section B (Clinical and Cost-Effectiveness), Section C (Implementation) and the economic model must also be submitted. Only eight weeks in total for the full STA submission!
For those tasked with the completion of an STA submission, some practical points for consideration are mapped out below.
1. Read the STA submission template
Sounds simple! However, there are a number of activities that need to be undertaken in order to complete the template in full.
The template is provided with instructions for completion. Additional activities that are required include:
• Systematic reviews – clinical (intervention and comparator RCT and non-RCTs), cost-effectiveness, quality of life, adverse events and resource use
• Quality assessment of the included studies – clinical and cost- effectiveness (criteria for assessment is outlined in the template)
• Statistical analyses. Meta-analyses when one more than one study is available and the methodology is comparable. Indirect/mixed treatment comparisons if no head-to-head studies of the intervention/comparator(s) are available
• Development of a cost-utility model.
If you are commissioning an agency to complete activities to support your STA then understanding the content of the template will also enable you to:
• Write detailed requests for proposals to ensure the end deliverables are fit for purpose
• Define budget requirements
• Plan sufficient time for completion of activities.
2. Consider agency support
Agency support may be required if you do not have the necessary internal resources to complete medical writing, health economic modelling, systematic reviews and statistical analyses.
There are a number of agencies that can provide you with the deliverables you require for robust completion of your STA submission. However, it should be noted that service offerings differ across agencies. Some can provide:
• Part of the submission deliverables such as writing or economic modelling
• All submission deliverables but rely on sub-contracting to other agencies for the elements that can’t be completed in-house
• All submission deliverables in-house. In essence a ‘one-stop shop’, without the need to sub-contract to other agencies.
The most experienced and successful agencies are extremely sought after and in order to secure their services you will need to plan ahead of time. Many of the experienced agencies will refuse to compromise on the quality of their deliverables and may not be able to help if you contact them just eight weeks ahead of the submission deadline.
3. Obtain expert clinical input
Recruiting external clinical key opinion leaders (KOLs) at an early stage can provide benefits before, during and after the submission. In preparation, assessment of current clinical practice is very important and will inform modelling decisions.
Expert panel meetings can be facilitated to achieve consensus statements in the absence of published data such as resource use and patient numbers. Involvement of KOLs at mock advisory boards will help you in validating key messages and help address weaknesses in the data, ahead of submission.
4. Understand the manufacturer’s guidance
NICE publishes guidance for manufacturers on how submissions should be completed. The ‘Guide to the methods of technology appraisal’, stipulates the methodology required for economic evaluations in addition to how NICE expect the clinical evidence to be presented. There is also a process guideline specifically for the STA, which will inform you about the timelines and the manufacturer’s requirements at each stage of the STA submission process.
Consideration of the above points together with effective project management should help to minimise the risk of omitting vital evidence, and relieve some of the pressures associated with submission development.
Linda Harrison is associate director, HTA, at Abacus International. For more information visit: www.abacusint.com
For more information on Service Insight features contact InPharm’s sales team on +44 (0)1243 772 010 or email pharmafilesales@wiley.com
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