Value | Commercial | Access

Precision medicine and complex care environments.

Dynamics in market access and reimbursement.

by Henrike Granzow

The health technology space has never been that exciting… and challenging at the same time. Gene therapies, microbiome products, digital therapeutics –  2023 was full of exciting market entries from the emerging healthtech field. 

In terms of commercialisation, reimbursement and market access, stakeholders and institutions are reacting to this fast-paced evolving world of innovation and its related challenges. Many trends and themes have been identified and have seen reactions from payers, patients, industry, etc. From patient centricity to real-world evidence, there are a lot of moving parts and continuing developments [1]. 

But amongst all this, what are the major dynamics you want to consider while the commercial stage does still seem far away? What do you need to plan for as you craft your asset and commercial strategy, as well as your development programme? What needs the extra bit of consideration to convince partners and investors, and to shape an asset that shows broad value to all stakeholders?  

Here we look at the key developments to keep an eye on in order to better understand and prepare for your commercial outlook….

More complex care environments  

The way in which care is being delivered and how different types of health technologies are being used together is changing significantly: there are three broad elements to this: 1) personalised care, 2)  the overall patient journey/experience, and 3) complex care & treatment regimens. 

Personalised or precision medicine is one of the developments in healthcare that has been with us for some time, more closely interlacing diagnostic and treatment modalities and driving use of high-value targeted therapies. Diagnosis and patient identification are becoming key elements in making treatments (cost-)effective, and are adding additional complexity to evaluating and financing these technologies. Similarly, this may lead to change in the overall patient journey, work-up and follow-up compared to “one size fits all” treatments. 

Digitalisation and eHealth is amongst the more recent themes that is significantly shaping patient care:  With value claims to not only improve patient outcomes but to accompany patients along their care journey and to change the way health care professionals (HCPs) and healthcare systems go about their work. Many digital medicines or e-health interventions are no stand-alone solutions; they work together with medication, devices and health interventions. Care is becoming more holistic: not just a medicine, not just an app, but a pathway and a programme to fit with increased patient demands and expectations. To understand, evaluate and value the impact of these technologies is not always a straightforward undertaking for companies and healthcare systems. In particular companies will have to consider how to value effects such as “broadening care” and “providing access” through digital health, while justifying add-on costs to other treatments. Patient expectations of higher quality of care, remote care and quality of life will also have to further be taken into account by health tech innovators. 

While a more holistic approach to patient management can create complex care situations, in and of themselves combination therapies and synergistic treatments are further on the rise. Combination oncology and emerging microbiome add-on treatments are amongst the most prominent examples of ever more sophisticated therapies and powerful associations of treatments.  For companies this means having to provide answers to questions such as  “What does a given product contribute to the overall treatment effect?” and “How do we define appropriate value, access and pricing?”; “What are the right business and partnering models to develop and commercialise?” 

There are tremendous opportunities to improve patient care and create unique value. The three main themes here are connected, but have different drivers and might merit to be further pulled apart. Digital health and combination treatments in particular are not just a phenomenon in care delivery, but therapeutic approaches in themselves.  

What does this actually mean ? 

  • Increasing patient expectations for easier access, holistic care and remote care  
  • Increased price pressure for high-cost combination therapies (oncology) 
  • “Value attribution” and “value of access” are becoming bigger questions for reimbursement and access

Healthcare systems under increasing pressure

An unprecedented rate of innovation in health is driving cost and healthcare budget pressure. At the same time, the COVID19 crisis has pushed healthcare resources to their limits. Affordability is becoming  more important than ever.  

Gene therapies are typically what comes to mind when financing and affordability are cited these days. Recent approvals of high-cost one-off therapies have made the headlines for their million-$ price tags, but the above paragraphs have already outlined that innovation and cost drivers  in healthcare are far more complex. 

Affordability, cash flow and budget impact also increase in importance in the light of aging populations, personalised medicines and intensified interest in population health and prevention, both in the context of the COVID19 pandemic, as well as within the antimicrobial resistance and oncology context. 

While clearly “value for money” or cost-effectiveness considerations alone will no longer suffice for reimbursement decision makers, there is additional scrutiny of the definition of value itself. Adding value is becoming harder, and undifferentiated technologies see increasing price pressure. For example, the latest pricing policy reforms in Germany and the anticipated price benchmarking experiments for medicines in France [2,3] are going to further build hurdles to achieve parity and premium pricing for products that fail to have convincing value propositions and appropriate evidence in their therapeutic field. Healthcare systems will be looking harder for savings to fund true value and innovations.

What does this actually mean?  

  • Increasing importance of budget impact considerations 
  • Tougher pricing where benefit is not clearly demonstrated with solid evidence

Additional uncertainty in Health Technology Assessment (HTA)  

Despite the fact that recent research with HTA bodies suggests that evidence packages – rather than methodologies  – present the biggest challenge for complex technologies [4], the two are closely linked, and ongoing changes in HTA processes, methods and reimbursement evaluation will occupy companies’ minds as the countdown to the European Union (EU) Joint Clinical Assessment (JCA) has started. The JCA is the EU-wide review of clinical data to be used by national HTA bodies applicable for advanced therapies and oncology products in 2025. Methodology guides and process details are still in development, drafts emerge, followed by concerns from stakeholders [5]. At this point, early advice meetings to prepare for the new process are extremely limited.  

How precisely the shift in responsibilities for (part of) HTA assessment will trickle down to national (and regional) HTA bodies is also less clear. Questions are going beyond the JCA process itself: Will HTA bodies re-focus their capacity and align with JCA findings? Or will they seek new ways to maintain control over HTA?  In this context, we also need to try to understand developments such as AIFA HTA committees in Italy being merged [6] or the rumours of cost-effectiveness analysis to be introduced in Germany… 

The questions that will persist for companies are how to prepare for the instances where an EU-level assessment does not fit with every Member State’s healthcare practice?  Companies are wondering what evidence generation decisions that they make now are going to be worth in the future. 

What does that actually mean?

  • Increased stakeholder and process uncertainty for access planning, in particular for oncology and advance therapy products 
  • Broader impact where benefit is not clearly demonstrated

The new evidence life-cycle 

The focus is shifting from simply demonstrating value at launch to constantly re-inventing it. 

Health Technology Assessment bodies and payers are becoming more involved in the product life-cycle, especially being aware that evidence packages at launch seem to become flimsier, in particular for emerging technologies and where regulators are moving to accept “faster” approvals. Single-arm trials or non-RCT evidence was at best acceptable in the rarest and severest of indications, but will no longer present a ticket to full reimbursement and “final” pricing. One-off advanced therapy treatments are arriving on HTA bodies desks with their own unique data gaps when it comes to prove duration of effect. 

In a different corner of the industry, in line with payer expectations, investors are expecting more from digital health start-ups in terms evidence packages [7]; the distinction between wellness apps and actual medical technologies will become clearer and starker, and evidence demonstration will drive the kind of support and funding a company can expect to develop their technology. 

Initiatives such as the Innovative Medicines Fund in the UK or the RWE collection for orphan medicines and conditionally approved medicines in Germany (Anwendungsbegleitende Datenerhebung) show that HTA bodies and payers are looking for more data for initially reimbursed medicines to potentially revise funding. In France, the approach to value demonstration and value maintenance post launch may take a different route: de-reimbursement is envisioned for tele-health technologies that cannot keep up with the market in terms of features and evidence packages as new competitor technologies enter. 

While these mechanisms are to be considered opportunities compared to outright reimbursement refusals, they bring additional requirements and steps into development and commercialisation activities. 

What does this actually mean?

  • Stricter evidence requirements, even for technologies such as orphan drugs 
  • Increased need for long-term evidence
  • More conditional reimbursement and re-evaluation of reimbursement 

Cost-of-living crisis/inflation 

The current cost of living crisis will particularly leave its mark on the healthcare consumer and OTC market. This also means the greatest impact will be seen in the out-of-pocket markets and high deductible healthcare systems such as the US and emerging economies.  

Beyond these markets, the macroeconomic dynamics will be of particular relevance for companies in the emerging healthtech space that are planning and building their business models in areas such as digital health, diagnostics or microbiome therapies, where third-party reimbursement has not necessarily been the first or only way to generate revenue. While  consumer willingness to pay for health and wellness will certainly be affected by decreased purchase power, for healthtech, this does not only translate into limited revenue from this market segment, but may also mean longer time to market and limited customer/patients feedback during product development; this will be of particular relevance for the digital medicines space, where different business and distribution models have been coexisting.

What does this actually mean? 

  • Direct-to-consumer sales will decrease, in particular for more medical focused (vs wellness) technologies  
  • Minimal viable product releases and real-world feedback can see delays or limited patient numbers

More complexity and higher uncertainty in product development and commercial planning are certainly to be anticipated. But this goes together with an environment of innovation and opportunities to change patients’ lives as well as care approaches in an unprecedented way.

How to respond to these commercial and access implications? How to plan and de-risk development programmes and commercials strategies in this less certain environment? I am looking forward to answering your questions – so get in touch!

Henrike Granzow, Founder & Managing Director,  Apersy Strategy Consulting: granzow@apersy.com 


  1. ISPOR, ISPOR 2022-2023 Top 10 HEOR Trends Report. https://www.ispor.org/heor-resources/about-heor/top-10-heor-trends#:~:text=Real%2Dworld%20evidence%20(RWE),the%202022%2D2023%20trends%20list 
  2. Apersy News & Insights, November 2022: October Market Access news: HTA & pricing policy updates 
  3. Apersy News & Insights, October 2022: France PLFSS 2023: Social security financing bill puts pressure on medicine pricing 
  4. Hogervorst MA, Vreman RA, Mantel-Teeuwisse AK, Goettsch WG. Reported Challenges in Health Technology Assessment of Complex Health Technologies. Value Health. 2022;25(6):992-1001. doi:10.1016/j.jval.2021.11.1356  
  5. EUCOPE, October 2022: EUCOPE/EFPIA Joint Statement: Concerns over the implementation of the EU HTA Regulation https://www.eucope.org/eucope-efpia-joint-statement-eu-hta-regulation/ 
  6. ABOUTPHARMA, December 2022: Riforma Aifa: rivoluzione o ritorno al passato https://www.aboutpharma.com/sanita-e-politica/riforma-aifa-rivoluzione-o-ritorno-al-passato/  
  7. Mobi Health News. December 2022: Survey: Digital health investments will rely on ROI and clinical validation in 2023

Other recent posts: