[Clinical courses and costs for hospitalizations of potentially immunocompromised COVID-19 patients in Germany]. / Klinische Verläufe und Kosten für Hospitalisierungen von COVID-19-Patienten mit potenziell eingeschränktem Immunsystem in Deutschland.

BACKGROUND: Patients at increased risk of inadequate immune response to COVID-19 vaccinations due to their underlying disease or therapy are potentially vulnerable to severe COVID-19 courses. The aim is to assess the population size, clinical courses and hospitalization costs of these patients in Germany. METHODS: This retrospective cohort study is based on extrapolations of a representative sample of statutory health insurance (SHI) claims data from 2020. Clinical COVID-19 courses, hospitalization costs and durations are compared between the insured group at increased risk for inadequate immune response to COVID-19 vaccinations (risk group) and the insured group without this risk. RESULTS: There are approximately 1.82 million SHI-insured individuals in the risk group, of whom an estimated 240 000 insured individuals do not develop a humoral immune response after 3 COVID-19 vaccinations. The risk group shows higher proportions with COVID-19 (relative risk [RR] 1.21; 95 % confidence interval [95 % CI] 1.20-1.23), hospitalizations for COVID-19 (RR 3.40; 95 % CI 3.33-3.48), hospitalizations for COVID-19 with intensive care treatment (RR 1.36; 95 % CI 1.30-1.42), and mortality (RR 5.14; 95 % CI 4.97-5.33) compared with the group without risk. In addition, hospitalizations in the risk group are on average 18 % longer (15.36 days vs. 13.00 days) and 19 % more expensive (12 371 € vs. 10 410 €). Expected hospitalization costs in the risk group are four times greater than in the group without risk (4115 € vs. 1017 €). CONCLUSIONS: The risk group is vulnerable to COVID-19 and requires additional resources in the German hospital sector. This results in a need for further protective measures. Further studies are needed to evaluate the impact of different viral variants, active and passive immunizations, and therapies on clinical COVID-19 courses and their costs.

Lessons From The Impact Of Price Regulation On The Pricing Of Anticancer Drugs In Germany.

Worldwide spending on prescription drugs has increased dramatically in recent years. Although this increase has been particularly pronounced in the US, it remains largely unaddressed there. In Europe, however, different approaches to regulating drug prices have been implemented. Under the 2011 German Pharmaceutical Market Restructuring Act (Arzneimittelmarktneuordnungsgesetz, or AMNOG), for example, manufacturers freely set the prices of newly authorized drugs during their first year on the market. Benefit assessments are carried out during this year and then used in price negotiations between manufacturers and representatives of the country's statutory health insurers. Using data on fifty-seven anticancer drugs launched in Germany from 2002 to 2017, we found that implementation of AMNOG was associated with drug prices being more closely aligned with clinical benefit. Introducing price negotiations led to a 24.5 percent decrease in negotiated prices relative to launch prices. We did not find evidence that manufacturers responded by setting higher launch prices. AMNOG is an example of how government price negotiation can be designed to better align prices with clinical benefit without delaying patient access.

Pharmaceutical Pricing in Germany: How Is Value Determined within the Scope of AMNOG?

OBJECTIVES: To analyze how value is determined within the scope of the German Pharmaceutical Restructuring Act, which came into effect in 2011. METHODS: Using data from all pharmaceuticals that had undergone assessment, appraisal, and price negotiations in Germany before June 30, 2016, we applied generalized linear model regression to analyze the impact of added benefit on the difference between negotiated prices and the prices of comparators. Data were extracted from the Federal Joint Committee's appraisals and price databases. We specified added benefit in various ways. In all models, we controlled for additional criteria such as size of patient population, European price levels, and whether the comparators were generic. RESULTS: Our regression results confirmed the descriptive results, with price premiums reflecting the extent of added benefit as appraised by the Federal Joint Committee. On the substance level, an added benefit was associated with an increase in price premium of 227.2% (P < 0.001) compared with no added benefit. Moreover, we saw increases in price premium of 377.5% (P < 0.001), 90.0% (P < 0.001), and 336.8% (P < 0.001) for added benefits that were "considerable," "minor," and "not quantifiable," respectively. Beneficial effects on mortality were associated with the greatest price premium (624.3%; P < 0.001), followed by such effects on morbidity (174.7%; P < 0.001) and adverse events (93.1%; P = 0.019). CONCLUSIONS: Price premiums, or "value," are driven by health gain, the share of patients benefiting from a pharmaceutical, European price levels, and whether comparators are generic. No statement can be made, however, about the appropriateness of the level of price premiums.