With rebate contracts between payers and drug firms on the rise in Germany, around patented drugs as well as generics, the hunt is on for more creative deal structures that avoid straight discounting.
Since Germany is a reference price market for many other European countries, drug firms don't typically want to lower prices, unless there are good strategic reasons for doing so. Those may include distinguishing a me-too drug (as for example Novartis is doing with epilepsy treatment oxcarzabepine (Trileptal), boosting sales at the end of patent-life (as Merck Sharp & Dohme is doing with blood pressure drug losartan (Lorzaar)) or kick-starting a languishing drug that has failed to gain market share. Among the first movers trialing a holistic approach to a drug's benefits, within a much broader treatment paradigm is Pfizer, with its dementia treatment donezepil (Aricept). Pfizer began a study in 2005 with partner Eisai Co. Ltd. and Germany's largest insurer, AOK, designed to assess whether a program of home visits and support to relatives, caregivers and doctors looking after home-based dementia patients can postpone their transfer to a nursing home. The trial—whose final results will be announced later this year—recruited 390 patients with mild or moderate Alzheimer’s disease and 129 GPs in the Mittelfranken region of Germany. As well as highlighting any potential impact of the support program on disease progression and on quality of life, both for patients and caregivers, the program will also be assessed for its cost-effectiveness from a wider societal perspective—including for instance through delaying or shortening hospital and care-home stays. Not all patients were on Aricept, according to a spokesperson at Pfizer Germany, who emphasizes that "this is not a drug study." The doctors in the study can decide whether to prescribe the drug or not. "They’ll be educated both on the medical and non-medical treatments available," says the spokesperson. But Pfizer/Eisai are clearly hoping that by supporting the study—they together fund 50%--they secure an integral role for their treatment in any future dementia treatment paradigm embraced by AOK (and potentially other sick funds, too, if the study’s results are compelling). It's fair to assume that study doctors aren't explicitly educated about alternative Alzheimer’s medications in the same class as Aricept, although Pfizer wouldn’t confirm this directly. The program may have already helped shelter the drug from any potential fallout from a somewhat lukewarm assessment in 2007 by Germany’s drug-effectiveness assessor, IQWiG. (Unlike the UK’s cost-effectiveness organization, National Institute of Clinical Excellence, IQWiG doesn’t yet take drug cost into account in its guidance.) The AOK isn’t obliged to follow IQWiG guidance, however, and the guidance wasn't exactly conclusive, either. Cholinesterase inhibitors (the class to which Aricept belongs) could slightly delay deterioration of cognitive function, the agency said, but they brought no benefit with regard to health-related quality of life or delaying placement into a nursing home. Top-line results from the Pfizer/Eisai study, dubbed the IDA project (Dementia Care in General Medicine Initiative) were released in May, showing that relatives supporting dementia patients found the program "extremely helpful". Further results this year will provide cost-savings information and will also, Pfizer confirms, single out which patients were on Aricept and which weren’t in its overall assessment of disease progression. Whether or not the study leads to widespread change in the dementia treatment paradigm, Pfizer has bought itself a more or less guaranteed period during which AOK will reimburse its drug. In that sense, the Big Pharma appears to have learned a lesson from its experience with lipid-lowerer atorvastatin (Lipitor, sold in Germany as Sortis). Pfizer refused to allow Sortis’ inclusion in a jumbo reference price group (with the resulting price cut) believing the drug to be superior to the other statins. The result: an almost total loss of market share in Germany in 2005. The company later went back in with a rebate contract. As such, the Aricept deal "is an effective defensive strategy" on Pfizer’s part, opines Peter Behner, VP and Partner in the Berlin office of consultancy firm Booz & Co. It's also one that others may follow, as payers around the globe increasingly demand cost-effectiveness data not just related to a drug, but also to the broader health care elements surrounding it. According to Booz, contracts like Pfizer/Eisai's with AOK represent "one of the most innovation-driven mechanisms in the German health care system." And if the US health reform effort succeeds in expanding insurance coverage to a substantial portion of the roughly 50 million uncovered or under-insured individuals, then there will be similar increased pressures on insurers in the US to consider new ways to look at costs more holistically--as a few, including Kaiser Permanente, already are.
Melanie Senior (m.senior@elsevier.com)
For more on this topic, including further case studies and interviews on the fast-changing reimbursement landscape in Germany, look out for the July/August issue of IN VIVO, which you can access here.
