The rising popularity of health technology assessments (HTAs) and similar framework agreements is presenting new challenges for the pharmaceutical industry.
Several countries, including Ukraine, Moldova, Kazakhstan, and Saudi Arabia, are planning to adopt an HTA framework in the short to medium term. In the United States, the Biden administration has floated the idea of creating an HTA entity that would be able to advise on pricing and reimbursement.
HTA frameworks typically share a similar goal: to evaluate the value of medical treatments and products and establish pricing and reimbursement policies that reflect that. However, the way in which HTAs determine that value can differ greatly. Some countries, for example, include cost effectiveness evaluations and price negotiations in their HTA recommendations, while others do not.
As a result, access and reimbursement for the same drug can vary widely, even when drugmakers take the burdensome step of adapting and tailoring their evidence packages to each country’s HTA criteria.
Recent efforts to harmonize HTAs at a regional level have gained some traction of late. After more than three years of talks, the European Union recently reached a provisional agreement to unify clinical level HTAs across the 27-member bloc; and earlier this year, the UK joined two large joint marketing review initiatives, the Access Consortium, and Project Orbis.
In theory, collaborations across sovereign states should be a win-win scenario: country-level regulators can share workloads and reduce duplicative efforts, thus enabling medicines to come to market at a faster pace. In practice, however, such agreements oftentimes fall victim to political compromises that can dilute or complicate collaborative efforts. Furthermore, even within the European Union reimbursement decisions remain a national competence and countries use different approaches to cost-effectiveness analysis, which means that most collaborations remain limited to clinical effectiveness assessments.
For individual drug applications within both the Access Consortium and Project Orbis, for instance, member agencies can decide whether they wish to participate in the review. What’s more, each country-level agency retains complete autonomy on approval decisions, as well as the specific indications and labels, regardless of whether they participated in the review.
Meanwhile, the EU deal, announced in June, is seen as a diluted version of the European Commission’s original plan, and purportedly is pockmarked with regulatory ambiguities.
As the European Federation of Pharmaceutical Industries and Associations (EFPIA) argued, the extent of EU compromise has created the risk of creating “an unpredictable system” that “will create unnecessary administrative and regulatory barriers.”
With time, refinements to the deal may lead to a less fragmented HTA system in the EU eventually, but the interim uncertainty leaves the industry with little clarity.
Pharma companies likely will face more of these challenges as the push for HTAs and HTA-like agreements expands. For the industry to stay ahead of these changes, and to capitalize on them, it is imperative that drugmakers rethink their pricing models.
Responding to the challenge
To be useful, models today need to incorporate a plethora of new data at a much more granular level. It has become increasingly important to have access to a database that tracks in detail key information, such as pricing, time-to-market, reimbursements, and indication-specific costs.
Drugmakers also need to conduct more advanced market analysis that tracks HTA requirements on a near daily basis, as well as risk assessment scoring that uses both qualitative and quantitative factors to evaluate stability in market access systems at the country level.
These and other tools can help market access and planning professionals keep pace with global HTA developments and make informed pricing decisions.
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