Global reimbursement requirements and payer needs are more demanding and confusing than ever before. How can you be ready to address reimbursement demands upon launch?   

When you need expert guidance and thorough support to ensure commercial readiness, It Takes Avania

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Industry Leading MedTech and Diagnostic Reimbursement Consultants  

Avania’s team of experienced experts has managed product launch strategies and market access across all therapeutic areas and can help you both plan and execute the best strategy for your product. From the latest implantable neurostimulator to genomic in vitro diagnostic (IVD) testing, we understand the challenges you face in global MedTech launches and how to address evidence requirements in each target market.  

With the acquisition of Hull Associates in 2023, Avania expanded its extensive team to include internationally renowned reimbursement experts such as Stephen Hull and Eric Lam, Ph.D., developing even more expansive global Health Economics and Market Access (HEMA) and Health Economics and Reimbursement (HEOR) capabilities. We collaborate with you to develop and execute comprehensive strategies that link coverage, coding, and payment to improve your product’s reimbursement and market opportunities — just like we’ve done for 450+ of the industry’s leading companies.  

Our U.S. patient support team is comprised of certified clinical coders with unmatched hotline proficiency who provide premiere service.  

Global MedTech Market Access Expertise  

With seasoned local expertise, key relationships in target markets, and agile solutions, our MedTech reimbursement consultants help companies navigate the demands of global product launches. There is no partner better equipped to maximize your MedTech and diagnostic reimbursement potential. 

Whether we’re helping you navigate the complexity of the U.S. CPT coding process, or designing a global evidence plan across the U.S., Europe, and Asia, our specialized expertise will prepare your company for launch and then support every step in each target market.  

Avania regularly supports clients to design and execute market access strategies in the U.S., with targeted solutions that address provider economics and payer demands related to coverage, coding, and payment, including: 

  • Development of comprehensive evidence strategies to support product coverage 
  • Health economic support, including cost effectiveness models and peer-reviewed publications 
  • Coding submissions to the committees of both the American Medical Association and the Centers for Medicare and Medicaid Services (CMS) 
  • Advocacy for payment including supplemental hospital outpatient and inpatient payments in the Medicare program 
  • Reimbursement related liaison and advocacy work with specialty societies, providers, and key commercial and public payers 

Avania has extensive experience with medical device reimbursement, offering: 

  • Strategy for reimbursement pathways in Australia 
  • In-depth command of the PLAC application requirements 
  • Creation of PLAC applications, including cost analyses and literature reviews 
  • Experience obtaining new PLAC rebate codes for novel technologies 
  • Medicare Benefits Scheme (MBS) item number selection or application

Companies entering Brazil need to anticipate the need to demonstrate cost effectiveness in a Brazilian context for the right target populations. Avania will seamlessly navigate the Classificação Brasileira Hierarquizada de Procedimentos Médicos (CBHPM) private sector coding process as well as the requirements of the Agência Nacional de Saúde Suplementario (ANS) for listing in the “ROL” List of Health Procedures and Events, designating mandatory private insurer coverage listing, easing your Brazilian market entry.  

In China, Avania helps companies navigate the provincial level process for product review, assignment of local Greenbook coding and, ultimately, reimbursement under permanent coding. We:  

  • Regularly design cost effectiveness models to help support product evaluations in a Chinese context 
  • Engage with provincial health bureaus to help navigate appropriate reimbursement 
  • Work with hospital customers to support the optimum submissions 

Avania regularly supports innovations seeking to enter the Diagnose Behandeling Combinatie (DBC) system. Our local experts:  

  • Assess and design the critical evidence needed to satisfy administering private payers as well as hospital review committees 
  • Support product Health Technology Assessments by the National Health Care Institute (Zorginstituut Nederland) 
  • Help companies navigate the process for issuance and modifications of Care Activity procedure codes and Care Product payment groups 

With experience supporting companies seeking listing in the Liste de Produits et Prestations Reduit (LPPR) before the Haute Autorite de Sante (HAS) and Forfeit Innovation payment, Avania can:  

  • Engage with French specialty societies to help support Classification Commune Des Actes Medicaux (CCAM) procedure codes 
  • Communicate with the HAS and other experts to help anticipate the ideal evidence to optimize both coverage and payment in the French system 
  • Plan and design the optimal submission dossiers with the right evidence you need to succeed 

Our German experts: 

  • Assist with hospital reimbursement under the German Diagnosis Related Group (G-DRG) payment system, including OPS procedure coding and “Innovation Clause” payment under the Neue Untersuchungs- und Behandlungsmethoden (NUB) pathway 
  • Navigate special contracts with Statutory Health Insurances 
  • Support dialogue with the Joint Federal Committee (G-BA) for Trial Regulation dialogue on evidence requirements 
  • Help novel outpatient reimbursement strategies under the Einheitlicher Bewertungsmaßstab (EBM) catalogue and new Digital Health Applications (DIGA) pathway for patient use software solutions 

HTAs can play a key role in success in markets such as Italy and Spain, and Avania has a long history of supporting positive submissions. Our in-country teams:  

  • Help design the optimum product dossiers for evaluation and hospital and regional healthboard levels 
  • Work with clients to develop economic models, engage with leading clinicians and hospitals, and navigate the local demands for positive reimbursement 

Avania has extensive experience in navigating the Special Treatment Materials (STM) pathway for functional category assignment for single use and other medical devices. Because we understand the demands of the A2, C1, and C2 pathways and the needs for both evidence and society Gaihoren support, we:  

  • Advise clients on the best way to optimize regulatory strategies and reimbursement strategies 
  • Help companies anticipate the needs of the Japanese reimbursement process so they can develop needed evidence before product launch 

Our experts have a deep understanding of introducing novel products onto the High-Cost Tariff-Excluded Device list and have supported successful strategies for listing onto Part IX of the Drug Tariff for GP prescribed innovations. As such, we assist companies:  

  • Seeking NICE appraisal as well as optimal commissioning strategies 
  • Developing their core business case for presentation to hospital trusts and Integrated Care Systems 

Purpose-Built MedTech and Diagnostic Market Access Services  

Featuring unequaled global experience across all therapeutic areas, our integrated approach to product development, regulatory strategy, and market access is what you need to successfully develop and launch products in the USA and around the world. Our fully integrated Market Access solution features services that prepare you for your ultimate goal: successful product launch and adoption.  

Ensure your product obtains reimbursement and enhance its market opportunity with top-tier service that encompasses everything from developing an early evidence plan and advocating for novel coding to submitting HTA dossiers and managing the review and evaluation for payment:  

  • Market access and reimbursement assessments 
  • Evidence planning 
  • Data analytics and health economics 
  • Pricing analysis 
  • Assessment and validation of clinical trial design 
  • In-country reimbursement strategy and support 
  • Coverage and coding support in 22 markets around the world

In the U.S. market, give your customers day-to-day support for their reimbursement issues with a top-tier patient call center. There is no substitute for experience and direct customer service:  

  • Post launch claim processing 
  • Insight into the proper billing codes 
  • Denied claims appeals  

Advance your MedTech product with the team who has what it takes. It takes specialized expertise. It takes global resources. It takes integrated solutions. It Takes Avania.

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