The TOP 10 trends in health economics and outcome research for 2018
About the author
Prof. Matthias P. Schönermark, M.D., Ph.D.
Founder and Managing Director
Founder and Managing Director
Fon: +49 511 64 68 14 – 0
Fax: +49 511 64 68 14 18
Fax: +49 511 64 68 14 18
Currently, personalized medicine is rapidly evolving and has achieved to address many unmet medical needs by the development of transformative and curative therapies. However, at individual patient level, such as societal and health plan (payers) level, the challenge remains to provide best possible health outcomes at affordable costs.
- Hence, drug pricing and spending was identified as the no.1 topic, prospectively having most impact on the field of HEOR in 2018. For the coming year the development of a multitude of scientific and regulatory frameworks for the assessment of therapeutic value and subsequent value-based drug pricing is expected – among them approaches such as performance-based or indication-specific pricing.
- Especially for the funding and reimbursement of advanced therapeutics like gene therapies and speciality drugs for orphan or chronic diseases, novel ways of funding and reimbursement are required to sustain the provision of patients. Often, the development of such innovative and curative therapies (trend no. 2) is complex, leading to immense production and administration cost per patients, while the availability is limited to a small number of patients.
- In line with the increasing demand for new drugs addressing unmet medical needs, programs for accelerated regulatory approvals (trend no. 3) have been initiated by the FDA and EMA. However, criticism was raised on expedited approval at the expense of evidence required for reimbursement. Hence, the emergence of further outcome-based risk-sharing agreements and evidence development schemes is expected. Additionally, novel research on surrogate markers or simulations from real-world data might support the prediction of clinical outcomes.
- While in countries like Germany universal health coverage (UHC, trend no. 4) is yet established, for other countries the adoption of UHC including decisions on funding, covered benefit, healthcare resources and governing authorities still lie ahead. However, the WHO is strongly supporting the global commitment and UHC progress is expected for 2018.
- The provision of affordable, high quality healthcare services is particularly challenging regarding the aging populations (trend no. 5). Here, the development of prevention programs for the most prevalent chronic diseases (such as diabetes), in addition to measures on patient preferences, may aid the provision of cost-effective health care services.
- With new mobile health mHealth (trend no. 6) technologies such as fitbits, health apps and telemedicine, massive real-world evidence is available. Improved standards for the evaluation of such data may improve our understanding on the (cost-)effectiveness and safety of mHealth applications, bearing the potential for clinical adoption and reimbursement.
- For specialized and cost-intense personalized treatments in oncology, accurate companion and complementary diagnostics (trend no. 7) are required. Joint diagnostics development programs could help to achieve the most accurate identification of patients with best benefit. Hence, diagnostics may support the reduction of health care costs, by enabling disease prevention, less invasive care and slower progression.
- In the context of rising healthcare cost, the further development and marketing of biosimilars (trend no. 8) will play an important role for saving health care costs in 2018, also, to provide patients with additional therapeutic options. Hence, the EMA yet initiated an abbreviated registration process in 2005/06. Still, the evaluation and management of biosimilars must carefully consider country-specific differences in regulatory requirements and potential savings, such as potential differences to the original.
- Preventive medicine of e.g. chronic diseases like diabetes, heart disease, chronic respiratory disease was identified as the no. 9 trend for 2018, since every year they cause the death of millions of people worldwide. Therefore, the development of strategies to assess the (health economic) value of disease prevention and patient-centred behaviour change programs is of major importance.
- The benefit of disruptive innovators (trend no. 10), such as CRISPR and CART T-Cell technologies, is evident from the patient’s perspective, but beyond that they create novel scientific knowledge which may enhance the development of other new therapies. However, standard economic evaluations often don’t capture the full value of such breakthroughs. Still, group-based deliberative processes, such as multiple criteria decision analysis, may pave the way for these new technologies.
SKC is an attractive partner to support companies in addressing the top trends in HEOR for 2018. Many years of expertise allow SKC to guide companies in the placement of their product on the German market - from the evaluation of the product/company portfolio, the preparation of a value dossier, negotiation training and strategic pricing, to stakeholder and public affairs management.
Especially for innovative gene therapies or orphan drugs, SKC develops appropriate strategies for market access, AMNOG procedure and reimbursement, specifically adapted to the demands and challenges of the German market and the individual client’s situation. Potential reimbursement strategies for highly innovative therapies, in particular for gene therapies, are outlined in an article by Prof. Matthias Schönermark and Frau Thora Mrosowsky from SKC.
BY Prof. Matthias P. Schönermark, M.D., Ph.D., Founder and Managing Director of SKC Beratungsgesellschaft mbH and Dr. rer. nat. Anja Baigger, SKC Beratungsgesellschaft mbH
Sources:
ISPOR 2018 Top 10 HEOR trends