For the pharmaceutical and biotech industries, ensuring that their medical products are available in as many countries as possible and that they reach all patients is a complex and time-consuming process. Market access encompasses a variety of topics, including pricing and reimbursement (P&R) and health economics and payer (H&P).
For the last five to ten years, market access in pharma has become increasingly important as more expensive and hi-tech drugs come to the market.
Cost containment measures are continuously implemented across the healthcare sector in America, Europe, and across the world. More than ever before, it has become increasingly important to demonstrate product value. Not only are drug development functions focused on achieving reimbursement, there has been an increased focus on achieving regulatory approval, as well. But the evidentiary standards payers require are higher than before.
What payers want: All payers, from national agencies to private hospitals, face increasing demand for healthcare. But the budgets are dwindling and now payers are much more interested in Value for Money in new treatments, something different from the current standard of care.
Value in new treatment is determined by evaluating incremental cost-effectiveness divided by the difference in ineffectiveness measures (ICER).
The key strategic aim of initiating value evidence generation should begin as early as possible. There’s also a need for expert input because controlled clinical trials may not be sufficient to generate many value endpoints.
The economic burden of disease, which involves assessing the utilization of healthcare resources, costs, and the societal burden, can be built into clinical trials. Trial designs are needed to gather data at the point where patients would normally leave. That is meant to capture information on resource usage and the costs thereof.
Quality of life and utilities: Data related to health and preferences for health are essential. Clinical trials are vital in estimating utility, and that will drive cost-effectiveness model inputs. This forms the basis for mapping algorithms from disease-specific QoL measures to EQ-5D and other generic instruments.
Anticipating patient segmentation: Phase III trials are designed to achieve approval. But the population where reimbursement is done may be a subset of patients- here; value is easy to demonstrate.
Robust evidence of efficacy may also be provided by analyzing pre-specified groups.
Comparative evaluation preparation: Placebo is the common comparator in most phase II clinical trials and is different from the standard of care. However, to improve market access in pharma, payers need comparative evidence where there are no head-to-head trials; these use mixed-treatment or indirect comparisons. Thus, designing phase II trials to facilitate subsequent comparisons is of many benefits.
The clinical trial program may not be sufficient for building all of the required value evidence activities. Thus, there’s a need for complementary studies. There is also the need to consider early value evidence planning.
Disease burden: The current treatment algorithms need assessment and as well as providing up-to-date evidence of unmet need. This is done by identifying the patients’ proportion not effectively treated by the current standards of care.
To create market access in pharma, value-adding solutions in NHS and other companies, increasing product value, and differentiation should underpin the brand strategy.