The Societal Impact of Inclisiran in England: Evidence From a Population Health Approach.

OBJECTIVES: As first-in-class cholesterol-lowering small interfering ribonucleic acid, inclisiran provides effective reductions in low-density lipoprotein-cholesterol to achieve better cardiovascular (CV) health. We estimate the health and socioeconomic effects of introducing inclisiran according to a population health agreement in England. METHODS: Building on the inclisiran cost-effectiveness model, a Markov model simulates health gains in terms of avoided CV events and CV deaths because of add-on inclisiran treatment for patients aged 50 years and older with pre-existing atherosclerotic CV disease. These are translated into socioeconomic effects, defined as societal impact. To that end, we quantify avoided productivity losses in terms of paid and unpaid work productivity and monetize them according to gross value added. Furthermore, we calculate value chain effects for paid work activities, drawing on value-added multipliers based on input-output tables. The derived value-invest ratio compares avoided productivity losses against the increased healthcare costs. RESULTS: Our results show that 138 647 CV events could be avoided over a period of 10 years. The resulting societal impact amounts to £8.17 billion, whereas additional healthcare costs are estimated at £7.94 billion. This translates into a value-invest ratio of 1.03. CONCLUSIONS: Our estimates demonstrate the potential health and socioeconomic value of inclisiran. Thereby, we highlight the importance to treat CVD and illustrate the impact that a large-scale intervention can have on population health and the economy.

The societal impact of early intensified treatment in patients with type 2 diabetes mellitus.

Aim: The current study estimates the societal impact of early intensified treatment compared with initial monotherapy with subsequent treatment intensification in newly diagnosed adults with type 2 diabetes mellitus in Mexico. Methods: An individual patient-level simulation and a static cohort model were employed to simulate the treatment pathway and the probability of experiencing complications of diabetes. The avoided number of events was translated into avoided productivity losses, which were monetized using wages. Results: Patients on early intensified treatment experienced approximately 13,000 fewer complication events over 10 years. This was translated into a societal impact of $54 million (USD). Conclusion: Early treatment intensification is likely to be of particular benefit to health outcomes and productivity losses.

The Societal Economic Impact of Secukinumab in First-Line Treatment of Moderate to Severe Plaque Psoriasis in Germany: An Open-Cohort Simulation.

OBJECTIVES: Moderate to severe plaque psoriasis is a chronic inflammatory disease. In Germany, guidelines recommend fumaric acid esters (FAEs) as first-line systemic treatment. Despite treatment with FAEs, disease burden remains high in Germany. Secukinumab, a fully human monoclonal antibody, has demonstrated greater efficacy and safety than FAEs in the PRIME trial. The aim of the current study, hence, is to quantify the potential societal economic impact of secukinumab in systemic treatment-naïve patients with moderate to severe plaque psoriasis in Germany. METHODS: We employed a semi-Markov model to capture health gains at an individual level and a dynamic population model to extrapolate the findings in the population of interest. We quantified the health outcomes in two scenarios: (i) patients receiving secukinumab and (ii) patients receiving FAEs. Using estimates on change in work productivity and societal economic parameters, we translated the health outcomes into paid and unpaid economic gains. We used gross value added (GVA) to value these gains and calculated the macroeconomic indirect and induced value-chain effects. RESULTS: Our calculations show that patients treated with secukinumab spend on average 94% of their time in Psoriasis Area and Severity Index (PASI) ≥ 75 state compared with 80% for patients in the FAEs scenario. When assuming that FAEs are the sole comparator to secukinumab, this difference could lead to 4.3 million active hours gained until 2030. These gained hours translate to a total societal economic impact of €308 million till 2030 for the whole patient population in GVA terms. CONCLUSION: This study demonstrated that using secukinumab instead of FAEs in moderate to severe plaque psoriasis could lead to substantial macroeconomic GVA gains.

Social Impact of Prophylactic Migraine Treatments in Germany: A State-Transition and Open Cohort Approach.

OBJECTIVES: Migraine is a highly prevalent neurological disorder. The most characteristic symptom of migraine is moderate to severe recurrent headache along with other neurological symptoms. In this study, we modeled the potential reduction in migraine days and corresponding avoided productivity losses if erenumab was prescribed to the patient population indicated for prophylactic migraine treatment (≥ 4 monthly migraine days [MMDs]) in Germany from 2020 to the end of 2027. METHODS: We simulated the incremental benefits of erenumab against the standard of care. Response rates, transition probabilities, discontinuation rates, and productivity estimates were derived from the erenumab clinical trial program. Patients had a probability of residing in 1 of 7 states, given the MMDs in addition to the probability of death. Based on accrued MMDs in every cycle, days of absenteeism and presenteeism for paid and unpaid work were derived. Paid work was monetized according to gross value added using the human capital approach, whereas unpaid work was valuated according to the proxy good method. In addition, downstream macroeconomic effects were captured using value-added multipliers. Direct medical costs were concomitantly calculated. RESULTS: Our results show that prescribing erenumab for the indicated population in Germany could lead to a reduction of 166 million migraine days annually and reduce productivity losses in the range of €27 billion. This includes €13.1 billion from direct productivity and €13.5 billion from economic value chain effects. CONCLUSIONS: This study highlights the macroeconomic effects of a systematic introduction of novel inhibitors of the calcitonin gene-related peptide pathway for migraine in Germany.

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.

Budget impact analysis of the use of oral and intravenous therapy regimens for the treatment of relapsed or refractory multiple myeloma in Germany.

BACKGROUND: In Germany, several triplet therapies for treating relapsed or refractory multiple myeloma (rrMM) patients have recently been approved. While most of them are administered intravenously, ixazomib-based combination is the only orally bioavailable regimen. OBJECTIVE: To conduct a 1-year and 3-year budget impact analysis (BIA) of different novel triplets to treat patients with rrMM in second or subsequent therapy lines accounting for costs covered by German statutory health insurance (SHI). METHODS: A 3-state partitioned survival model (PSM) was developed to evaluate the budget impact of the following regimens: carfilzomib plus lenalidomide plus dexamethasone (KRd), elotuzumab plus lenalidomide plus dexamethasone (ERd), daratumumab plus lenalidomide plus dexamethasone (DRd), and ixazomib plus lenalidomide plus dexamethasone (IRd). The analysis included direct medical costs such as drug acquisition, comedication and preparation for parenteral solutions, drug administration and other 1-time costs, adverse event management costs and direct non-medical costs, such as transportation costs. RESULTS: Based on current drug market shares in German healthcare market, the estimated costs after 1 year of treatment was €551 million (KRd), €163 million (ERd), €584 million (DRd), and €95 million (IRd). The total budget impact of €1393 million is mainly driven by drug acquisition and subsequent therapy costs. CONCLUSION: Among the regimens of interest, the oral-based therapy regimens offered cost advantages over intravenous-based therapy regimens. The higher overall costs of intravenous therapy regimens were attributed primarily to higher drug acquisition costs.

Cost Effectiveness of Secukinumab Versus Other Biologics and Apremilast in the Treatment of Active Psoriatic Arthritis in Germany.

INTRODUCTION: Psoriatic arthritis (PsA) is a chronic inflammatory arthritis that occurs in people affected by the autoimmune disease psoriasis. The cost effectiveness of secukinumab in PsA has not been evaluated in Germany. OBJECTIVE: The purpose of this study was to conduct a cost-utility analysis of secukinumab in three adult populations with active PsA in Germany: biologic naïve without moderate or severe plaque psoriasis, biologic naïve with moderate or severe plaque psoriasis, and biologic experienced. Comparators included other disease-modifying antirheumatic drugs (DMARDs), including biosimilar versions as well as standard of care. METHODS: The analysis took the viewpoint of the German statutory health insurance. We adapted a decision analytic semi-Markov model to evaluate the cost effectiveness of secukinumab over a lifetime horizon. Treatment response was assessed based on PsA Response Criteria at 12 weeks. Nonresponders or patients discontinuing the initial-line DMARD were allowed to switch to subsequent-line DMARDs. Model input parameters (Psoriasis Area Severity Index, Health Assessment Questionnaire (HAQ), withdrawal rates, costs, and resource use) were collected from clinical trials, published literature, and official reports. Health benefits were expressed as quality-adjusted life-years. An annual discount rate of 3% was applied to costs and benefits. The robustness of the study findings was evaluated via sensitivity analyses. RESULTS: In the biologic-naïve population without moderate or severe plaque psoriasis, secukinumab 150 mg either strictly dominated other DMARDs (certolizumab pegol, golimumab, and ustekinumab) or yielded favorable incremental cost-effectiveness ratios (ICERs) (vs. etanercept, adalimumab, and infliximab). In the biologic-naïve population with concomitant moderate to severe plaque psoriasis and in the biologic-experienced population, secukinumab 300 mg was more effective and had a lower ICER than other DMARDs, thus leading to extended dominance. Deterministic sensitivity analyses indicated that the results were most sensitive to the discount rate for costs and health outcomes as well as the HAQ score as an input to utility values. CONCLUSIONS: Secukinumab appears to be cost effective compared with other DMARDs for the treatment of active PsA in biologic-naïve and biologic-experienced populations in Germany.

Sacubitril/Valsartan (LCZ696): A Novel Treatment for Heart Failure and its Estimated Cost Effectiveness, Budget Impact, and Disease Burden Reduction in Germany.

BACKGROUND: Heart failure affects over 1 million people in Germany and contributes to morbidity, mortality, and high healthcare costs. A recent large randomized controlled trial compared the novel compound sacubitril/valsartan (LCZ696) with the angiotensin-converting enzyme (ACE) inhibitor enalapril and found a 16% reduction in mortality hazard. In Germany, sacubitril/valsartan was launched at the beginning of 2016. OBJECTIVE: The purpose of this study was to conduct a post hoc analysis of the cost effectiveness, budget impact, and disease burden reduction of sacubitril/valsartan compared with ACE inhibitors for patients with heart failure from the perspective of the German social health insurance (SHI), based on the results of this trial. METHODS: A Markov (cohort) state transition model was constructed to simulate treatment over a remaining lifetime. Based on the Markov model, a dynamic population model was developed that projects the incidence, prevalence, mortality, and healthcare costs of heart failure in the SHI population from 2017 to 2060. The population model follows prevalent and incident cohorts over time. Each year a new cohort is added, while the existing cohorts age by 1 year or die. To test for sensitivity of results, a Monte Carlo simulation was run. RESULTS: Based on the price negotiated between manufacturer and representatives of the SHI, the base-case incremental cost-effectiveness ratio (ICER) of sacubitril/valsartan versus ACE inhibitors is €23,401 per life-year gained (in 2018 Euros). At a price of zero, the cost-effectiveness ratio is already €9594 per life-year gained due to high background costs of heart failure. Annual budget impact and reduction of disease burden reach a maximum at 4-8 years after launch (€221 million and 2.9%, respectively, in the base case). CONCLUSIONS: The ICER of sacubitril/valsartan is projected to be at or below the level of other accepted interventions for the treatment of asymptomatic to severe heart failure in Germany. Projected budget impact leads to an increase in SHI expenditures by < 0.04% per year.

[Strength and weaknesses of the German digital health economy]. / Stärken und Schwächen der digitalen Gesundheitswirtschaft.

There are high expectations from digitalization of health care, ehealth and telemedicine. Nevertheless, the diffusion of these services falls short of expectations. This study analyses the strength and weaknesses of the German digital health economy. Thereby, we specially focus on small and medium-sized enterprises (SME). The study is based on a literature review, interviews of experts and a workshop. The digital health economy is influenced by a heterogeneous environment with both promotive and obstructive factors. One of the largest weaknesses results from a lack of business models. There is a lack of possibilities of reimbursement by the Statutory Health Insurance (SHI). In addition, private users only have a small willingness to pay for digital services. The large number of regulations makes the implementation even harder, especially for SMEs. Thus, the current environment hampers fast diffusion of digital services in the German health care market.

Using morbidity and income data to forecast the variation of growth and employment in the oral healthcare sector.

The perception of the health sector from an economic policy point of view is changing. In the past, health expenditure was mostly seen as a "cost" item, probably because many medical treatments are covered by public health insurance. However, policymakers are increasingly realizing that a growing health sector may be quite beneficial for an economy. It creates employment opportunities and it is relatively resistant to the fluctuations of the business cycle. Input-output analysis could be a useful tool to study the structural change resulting from the growth of the health sector. This paper quantifies for the first time the economic significance of the oral healthcare sector as a component of the German healthcare sector as a whole. The current data for the healthcare sector comes from Health Satellite Accounts, which while comprehensive do fail to answer important questions due to not incorporating certain sectors such as the oral healthcare sector. Therefore on the basis of the Health Satellite Account a specific Satellite Account for the oral healthcare sector is created by using billing data as well as epidemiological data, provided by several dental associations and the Institute of German Dentists. Based on this added information, gross value added data and the number of employees in the oral healthcare sector are computed. Gross value added in 2010 amounted to €13.4 billion, with around €4 billion being attributable to the secondary oral healthcare market; the market for solely out-of-pocket payments. In a second step the paper develops a model to forecast oral healthcare sector growth based on various explanatory variables such as demographic change, take-up behaviour, medical-technical progress, oral morbidity, aggregated supply (collective dental treatment times) as well as income levels and distribution, where the latter two are considered to be of particular importance. According to this model, by 2030 gross value added in the oral healthcare sector will amount to €15.9 million, which corresponds to a 19.2 % increase. The secondary oral healthcare market will be the key to this increase since the model predicts a disproportionately high growth of 60.3 % bringing the total to €6.3 million gross value added in 2030.