For many nations, the principles of evidence-based medicine are now at the heart of reimbursement decision making. Minimising bias and maximising transparency, this requires payers to have the best-available evidence at their fingertips. More than that, it requires manufacturers of new products to prepare these data in advance and be ready to answer payers’ questions with systematically collected evidence.
A systematic literature review represents the best-available evidence answering a specific research question, and has become an essential market access activity supporting a new product launch. The process involves the structured interrogation of medical literature databases, filtering through thousands of records, selecting a final data set (based on explicit inclusion and exclusion criteria) and appraising the quality of included studies. This can take several months and requires careful management to ensure the review is academically robust and fit for use.
Using systematic reviews
Systematic reviews can answer key questions at all stages of the product life cycle. At an early stage, companies need to assess the target market and understand how a potential new intervention will add value. Activities such as strategic payer landscaping can help companies understand how decisions are made and what factors need to be considered.
A systematic review and gap analysis can then assess what type of evidence is needed from the developing clinical programme and set appropriate benchmarks for trial outcomes.
Nearing launch, preparations for national health technology assessment (HTA) and reimbursement processes should start. For many regions, HTA remains the highest of hurdles for new products attempting to gain market access, and research has shown that the presence of a systematic review in manufacturers’ submissions correlates with a successful outcome.
In the UK, NICE now requires multiple systematic literature reviews to support the efficacy, safety and economic claims associated with a new product. In Germany, the Gemeinsamer Bundesausschuss has similar evidence requirements under the new Arzneimittelmarktneuordnungsgesetz (AMNOG) law.
A common reason for failure at the HTA/reimbursement hurdle is choosing the wrong comparator during the submission process. Statistical analyses, such as indirect comparison and network meta-analysis, now allow comparisons to be made between several interventions in the absence of direct head-to-head data. To be valid, however, these analyses need to ‘stand on the shoulders’ of high-quality systematic reviews in order to minimise bias and optimise the accuracy of decision-making.
Prepare evidence platform early
Successful market access depends on having the right evidence at the right time. At the earliest stage, preparation of a comprehensive systematic review and meta-analysis can become the evidence platform for a successful global market access campaign.
To manage and maintain this evidence platform over time, use of database technology to both conduct the review and host the resultant data set, can allow the systematic review to be updated easily and evolve as payers’ questions become increasingly specific to their locale. This flexible, adaptable approach can be a key instrument in determining success in today’s evidence-based market environment.
The Author
Dr Sarah Collins, Director – Systematic Review, Abacus International
She can be contacted at: sarah.collins@abacusint.com