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Taking on Europe’s Health Technology Assessment Harmonization

by Katie Hayes , Product Marketing Life Sciences March 28, 2018

Has Your Business Adopted a Global Approach?

We’re already three months into 2018 and the life sciences industry has been navigating through the possible side effects to U.S. tax reform, determining how to best take advantage of emerging digital technologies, and is considering increased consumer pressures for greater price transparency. Perhaps the most notable to occur in these first few months of the new year is the proposal to harmonize the European Union’s (EU) Health Technology Assessment (HTA) process.

Under the current system, life sciences companies are required to perform HTAs in each EU Member State. The valuable tool evaluates the medical, economic, social, and ethical impacts of a health technology, which can include drugs, medical devices, procedures, or systems. The assessments, along with payers, influence market access for drug products across Europe, though each country might have different perspectives on the same drug’s benefits.

For example, if a manufacturer wants to introduce a health technology in multiple Member States, they are required to wade through several different data and evidence requests based on each state’s processes. This fragmented system often leads to duplicated clinical assessments and repeated resources used on the same product, as the results are not shared at the national level.

With the new system, there would be a joint EU HTA used for all new products requiring authorization from the European Medicines Agency (EMA). Effective by 2020, the joint HTA will determine the uniform clinical value that impacts other non-clinical facets of the assessment, criteria crucial for making overall national pricing and reimbursement decisions. EUnetHTA, an organization consisting of a number of government-appointed organizations that produces or contributes to an assessment in Europe, has continued to work with the EMA to strengthen EU cooperation.

At its core, the harmonization initiative is expected to combine HTA resources in an effort to improve efficiency and business predictability. The combined resources include joint clinical assessments that focus on the most innovative health technologies with the greatest expected impact for patients in addition to joint scientific consultations that encourage developers to seek advice from HTA authorities. Furthermore, EU Member States will work collaboratively to identify emerging health technologies early on.

That said, individual Member States will continue to be responsible for all non-clinical functions of a product, such as the economic, social, and ethical impacts it might have. The joint HTA guidance will be used for national level pricing and reimbursement decisions.

For life sciences manufacturers, there are a number of expected benefits to this harmonization. For example, a singular standard assessment could mean that innovative, effective drug products reach patients faster as manufacturers will no longer have to navigate each EU Member State’s HTA and associated evidence and data requests. Moreover, with this resource-consuming activity lifted, companies will be able to focus efforts on generating real world evidence throughout the product lifecycle, which has been cited as a major market access challenge.

Patients will also benefit from the HTA standardization. Apart from gaining access to innovative treatments faster, the new system is expected to better connect patients with information surrounding the added clinical value of the new technologies.

Maximizing Global Revenue with Model N

With the expectation that the harmonization will result in greater efficiency, along with projections that ex-North American pharmaceutical sales will experience a 19.9% growth by 2020, manufacturers must ensure their submissions are accurate and that their business is optimized globally.

Model N’s global product suite can mitigate the potential challenges to market access that can coincide with vast growth. With Global Pricing Management (GPM), users have the power to optimize 100% of their global revenue along with the flexibility to continuously adjust throughout the entire lifecycle of their products. Being able to continuously adjust is even more lucrative considering that manufacturers will be expected to take a more proactive role in generating real world evidence at every stage of the product’s lifecycle.

Additionally, with 60% of tender professionals citing new legislations, higher specification standards, and increasing payer purchasing power consolidation as a main barrier to revenue, having visibility into those changes is especially crucial during the typical growing pains the harmonization might incur. Model N’s Global Tender Management (GTM) product centralizes all information from inception of a tender to its fulfillment therefore accelerating the information gathering process while ensuring complete accuracy.

As the EU continues to develop plans for HTA harmonization, we look forward to navigating any barriers you might encounter in your business.

Learn more about Model N’s global product suite at and find us at the Commercial Pricing and Innovation Forum, June 12-14 in Stresa, Lake Maggiore, Italy.

Sources: European Commission, European Network for Health Technology Assessment (EUnetHTA), WHO

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