PCSK9 field: Amgen vs Sanofi, price war is about to be staged

Source: at the end of August 13, 2015, bio exploration achieved a major milestone in the field of lipid reduction First, on July 21, repatha (evolocumab), a PCSK9 inhibitor developed by Amgen, was approved by the European Union, marking the successful birth of the world's first new generation of lipid-lowering drugs Only three days later, the company, which was jointly developed by Sanofi and regeneron, won FDA approval without any doubt and became the first new generation of PCSK9 inhibitors in the U.S market, the largest single market in the world In addition, Amgen's repatha is likely to get FDA approval by the end of this month, which means that a fierce battle in the field of PCSK9 in the U.S market is imminent Praluent is likely to be approved by the European Union in the next 2-3 months, which also indicates that the fierce confrontation between the two giants will be fully staged in the European and American markets Praluent was developed by Sanofi in collaboration with regenerant and was approved by FDA on July 25 for use in a relatively small patient population However, the price of praluent is about US $15000 per year Compared with the current treatment cost of 50 yuan / month (US $600 per year) of statins, praluent can be regarded as the "sky high" drug in the field of lipid-lowering The industry speculates that the repatha of Amgen is likely to adopt a price tag similar to that of praluent The price tag of these new drugs is so high that there has been a heated debate among health insurance companies Aetna and United Health, the two largest insurance giants in the United States, have different opinions on which patients are eligible for praluent treatment In fact, this difference is related to fuzzy restrictions when FDA Approves praluent Praluent has been approved for use in adults with heterozygous familial hypercholesterolemia, or in adults with atherosclerotic cardiovascular disease (ASCVD), including strokes, heart attacks, and the need to further reduce cholesterol levels Recently, CVS Health urged cardiologists to revise guidelines for the treatment of high cholesterol CVS noted that the current guidelines include a consensus on assessing heart risk, but do not recommend the best and most economical treatment options for LDL levels CVS said authorities need to clearly set cholesterol levels and differentiate between groups of patients who are eligible for the two drugs, making it easier for doctors to identify patients who need to prescribe them Traditional management techniques, such as step therapy and prior authorization, were noted by three CVS health executives in the Journal of the American Medical Association on Monday ）It requires patients to try a low-cost evidence-based treatment first If they fail to reach the clinical treatment goal, they can upgrade to a more intensive and expensive treatment plan For PCSK9 inhibitors, this strategy will become infeasible if the guidelines do not specify which patients need to be treated with these drugs Due to the fuzzy restriction, the pharmacy welfare management organization has set its own limit standard According to the American Heart Association, 73 million adults in the United States have elevated cholesterol levels, with an average LDL of 115 Aetna has announced that it will allow praluent to be used in patients with heart disease and LDL levels above 70 United Health, on the other hand, has adopted a stricter standard, which will allow praluent to be used in patients who have received statins but whose LDL level is still higher than 130 Impact of the price war: once clear guidelines are released on which patients are eligible for PCSK9 inhibitor treatment, health insurance companies and pharmacy benefit managers will begin to focus on the price of drugs Troyen Brennan, chief medical officer of CVs, has announced that the company accepts only lower priced drugs Similar strategies have been applied to hepatitis C drugs Some analysts believe that the inevitable price war may lead to the decline of PCSK9 inhibitor R & D companies, in addition to Amgen and Sanofi, as well as pharmaceutical giant Pfizer.