Implementing Coverage With Evidence Development
Managed entry agreements (MEAs)—contractual agreements that allow market access for drugs by distributing the risk of uncertainty between the budget holder and the pharmaceutical, device, or diagnostics manufacturer—are used in many countries to control financial risk. We take a look at these agreements and the implications for key stakeholders.
HTA QUARTERLY | SPRING 2018
Market Trends and Updates: Is There Consensus on Implementing Coverage With Evidence Development?
The decision to provide coverage can be associated with research to be conducted alongside product use (OWR) or only when the product is used in the context of research (OIR). Following the data collection period, there may be a pre-agreed adjustment or renegotiation to modify price or coverage.
When to Consider CED?CED agreements are best suited in situations where a treatment or technology demonstrates promise for significant benefits, yet uncertainties remain regarding its future clinical or economic impact at the time of approval (Figure 2).
For budget holders, CED offers an option to make a technology available in a controlled manner while allowing them to predetermine which evidence will be needed to ensure coverage of the technology. Budget holders can gain greater certainty and greater value for the money spent when employing a CED.
For manufacturers, CED provides the opportunity to introduce a new and promising technology which otherwise might be rejected or delayed. Through CED arrangements, manufacturers can hasten the availability of promising therapies to address unmet patient needs. Given that the funding for additional evidence generation associated with CED may be covered in full or in part by public sources, rather than by the manufacturer, these arrangements may also provide a means for data collection at a reduced cost.
For both patients and clinicians, CED results in earlier access to new and promising diagnostic tests and medicines, leading to an increase in available treatment options.
Implementation and Challenges
While potentially beneficial across stakeholders, CED arrangements can also pose substantial challenges (Figure 3).
For a CED agreement to be successful, the evidence gap and resulting uncertainty must be overcome through prospective gathering of additional evidence, generated within an appropriate time frame, and addressing the element(s) of uncertainty for recommending coverage. It is also beneficial to have a clearly laid out and formalized process with all stakeholders regarding how and when future decisions will be tied to the additional evidence that is generated. CED can employ observational studies and RCTs in either an OWR setting or an OIR setting, as applicable and appropriate.
Global Perspective: Updates and Disparities in CED Agreements
A number of countries are using or have used CED in their reimbursement approval processes. The United States and the United Kingdom both updated their CED programs in the last 5 years (2016 and 2013, respectively), and the Netherlands introduced a new approach to CED agreements in 2012. Other countries using CEDs include Sweden, Australia, Italy, Belgium, China, and France. While use of CED agreements is widespread, the approach to their implementation is not consistent across countries. In many instances, country-specific information on the process for establishing a CED is limited, which can pose difficulties for manufacturers.
Implementation of CED agreements provides earlier access to therapies and technologies for which some aspects of the evidence are still uncertain at the time that efficacy and safety are established. Challenges do remain in funding sources, operational issues with respect to data collection, and managing competing interests of the various stakeholders. However, when these challenges can be overcome, CED agreements help distribute and mitigate risk and enhance the available evidence base for further coverage decisions. Moreover, they may allow manufacturers to introduce drugs that might otherwise be rejected or delayed, and offer patients earlier access to often much-needed innovative treatments.
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