Role of Health Technology Assessment in Pharmaceutical Market Access in Developed Countries

Kahveci, Rabia; Oortwijn, Wija; Godman, Brian; Koç, Esra Meltem; Tibet, Birol

doi:10.7175/747.ch15

Cited by 2 publications

(3 citation statements)

References 114 publications

(218 reference statements)

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“…Countries have typically adopted different approaches to the pricing and reimbursement of new medicines (34, 92, 94, 141, 149, 150). These can be classified into those that first assess the level of innovation of new medicines against existing standards before negotiating prices, such as Austria, France, and Germany (34, 92, 115, 151, 152), as opposed to those countries that base reimbursement and funding decisions on economic criteria such as cost/quality adjusted life year (QALY), with or without threshold levels, as seen for instance in Belgium, Sweden and the United Kingdom (33, 34, 92, 110, 153, 154).…”

Section: Results—ongoing Initiativesmentioning

confidence: 99%

“…Whichever method is used, all incorporate approaches to assess the value of new medicines based on HTA principles and techniques with variable levels of uncertainty, with the concept of value based pricing (VBP) increasingly utilized (34, 66, 141, 160). However, whilst VBP is a well-established concept, there is no universal definition and its implementation has been challenging (129, 158, 161, 162).…”

Section: Results—ongoing Initiativesmentioning

confidence: 99%

“…Post launch activities (Figure 1) include (i) monitoring the effectiveness and safety of new medicines in routine clinical practice using information in either patient registries or Electronic Health Records, (ii) evaluating ongoing MEAs and (iii) monitoring physicians prescribing against agreed guidance or quality indicators (3, 116, 141, 148).…”

Section: Results—ongoing Initiativesmentioning

confidence: 99%

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Barriers for Access to New Medicines: Searching for the Balance Between Rising Costs and Limited Budgets

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Introduction: There is continued unmet medical need for new medicines across countries especially for cancer, immunological diseases, and orphan diseases. However, there are growing challenges with funding new medicines at ever increasing prices along with funding increased medicine volumes with the growth in both infectious diseases and non-communicable diseases across countries. This has resulted in the development of new models to better manage the entry of new medicines, new financial models being postulated to finance new medicines as well as strategies to improve prescribing efficiency. However, more needs to be done. Consequently, the primary aim of this paper is to consider potential ways to optimize the use of new medicines balancing rising costs with increasing budgetary pressures to stimulate debate especially from a payer perspective.Methods: A narrative review of pharmaceutical policies and implications, as well as possible developments, based on key publications and initiatives known to the co-authors principally from a health authority perspective.Results: A number of initiatives and approaches have been identified including new models to better manage the entry of new medicines based on three pillars (pre-, peri-, and post-launch activities). Within this, we see the growing role of horizon scanning activities starting up to 36 months before launch, managed entry agreements and post launch follow-up. It is also likely there will be greater scrutiny over the effectiveness and value of new cancer medicines given ever increasing prices. This could include establishing minimum effectiveness targets for premium pricing along with re-evaluating prices as more medicines for cancer lose their patent. There will also be a greater involvement of patients especially with orphan diseases. New initiatives could include a greater role of multicriteria decision analysis, as well as looking at the potential for de-linking research and development from commercial activities to enhance affordability.Conclusion: There are a number of ongoing activities across countries to try and fund new valued medicines whilst attaining or maintaining universal healthcare. Such activities will grow with increasing resource pressures and continued unmet need.

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