A Review of Current Approaches to Defining and Valuing Innovation in Health Technology Assessment.

OBJECTIVES: The growing focus on the value of new drugs for patients and society has led to a more differentiated notion of innovation in the context of pharmaceutical products. The goal of this article is to provide an overview of the current debate about the definition and assessment of innovation and how innovation is considered in reimbursement and pricing decisions. METHODS: To compile the relevant literature, we followed a 2-step approach. First, we searched for peer-reviewed literature that deals with the definition of pharmaceutical innovation. Second, we reviewed health technology assessment (HTA) guidelines of 11 selected countries (Australia, Belgium, Canada, England, France, Germany, Italy, Japan, Norway, Sweden, and The Netherlands) regarding aspects of innovation that are currently considered as relevant by the respective HTA bodies. RESULTS: All countries in our sample use 1 of 2 types of reward mechanism for novel drugs that they consider provide some sort of benefit. Generally, the focus is on the therapeutic benefit of a drug, whereas, depending on the exact arrangement, other aspects can also be taken into account. A reduction in side effects and aspects of treatment convenience can be invoked in some of the countries. Mostly, however, they are not considered unless they are already captured in the clinical outcomes used to measure the therapeutic benefit. CONCLUSION: Our review shows that although the health economic literature discusses a range of aspects on how innovation may generate value even without providing an immediate added therapeutic benefit (or on top of it), these are only selectively considered in the reviewed HTA guidelines. For most part, only the added therapeutic value is crucial when it comes to pricing and reimbursement decisions.

The societal impact of a biologic treatment of ankylosing spondylitis: a case study based on secukinumab.

Aim: This study estimates the societal benefits of using biologics like secukinumab (SEC) instead of nonsteroidal anti-inflammatory drugs for treating patients with ankylosing spondylitis in Germany. Materials & methods: A Markov and a population model were used to predict the functional impairment of German ankylosing spondylitis patients using SEC or nonsteroidal anti-inflammatory drugs. This was translated into avoided productivity losses, which were valued according to gross value added. Results: The productivity impairment of SEC users was predicted to decrease by 20 percentage points, corresponding to 12.8 and 32.7 million hours in paid and unpaid work and a monetary value of €1.6 billion from 2016 to 2030. Accounting for economic spillover effects increases the societal value to € 3.3 billion. Conclusion: The improvements in functional impairment due to biologics could lead to sizable productivity effects.

The socioeconomic burden of migraine: An evaluation of productivity losses due to migraine headaches based on a population study in Germany.

BACKGROUND: This study estimates the socioeconomic impact of migraine headaches on paid and unpaid work productivity in the adult German population in 1 year. METHODS: We used data on headache frequency (days per month) from a longitudinal population-based study. Prevalence estimates of migraine were derived from the Global Burden of Disease Collaborative Network. Demography data were derived from official statistics in 2017. Aggregate headache days in 1 year were translated to losses in paid and unpaid productive hours based on estimates of presenteeism and absenteeism along with other socioeconomic parameters. Paid hours lost were distributed across the industry sectors. In this way, an age-, gender- and industry sector-specific monetary value was calculated for paid hours lost. Unpaid hours lost were valued by assigning the unpaid activities to their nearest market substitute. In a last step, value-added multipliers derived from input-output tables were used to calculate the economic value chain effects. RESULTS: A total of 15.5 million persons (20 years or older) suffer from migraine in Germany. Our analysis shows that 60% of those have three or fewer headache days per month, while patients suffering chronic migraine (15+ headache days per month) account for 5.4% of the adult migraine population. Females bear 65% of the total 836 million headache days per year. The socioeconomic losses due to migraine amount to €100.4 billion (€6493 on average per patient) in one year. CONCLUSION: In addition to time losses in paid work, migraine causes substantial socioeconomic losses to unpaid work activities due to its disproportionate prevalence among females. Economic value chain effects provide a novel perspective on losses beyond a patient's time loss. Overall, the elements of socioeconomic burden provide a strong rationale that innovative migraine therapies could be of high value to society.