On Thursday, November 2, the Centers for Medicare and Medicaid Services (CMS) announced they would reverse a policy determining how providers are paid for administeringbiosimilar drugs根据医疗保险b部分，生物仿制药是一种与生物参考产品“相似”的药物，由食品和药物管理局(FDA)批准;生物仿制药为患者提供了市场上更实惠的治疗方案，以解决他们的疾病。
Over the past twenty-four months, the Arthritis Foundation and other patient organizations have expressed our collective concerns with CMS’s biosimilars reimbursement policy and encouraged them to reverse it. This policy reversal is a crucial access to care victory for the arthritis community since there are two biosimilars on the market to treat arthritis. The regulatory change will foster competition and lower the cost of expensive biologic treatments, while encouraging innovation of new therapies – ultimately creating a robust marketplace of biosimilars. Read on to learn more about this important win for patients.
在医疗保险制度下，医生购买和给病人服用的药物可以报销。每一种药物都被分配一个与报销金额相关的代码。旧的CMS政策将所有生物仿制药与其对应的生物药组合在一个支付代码下。CMS使用这种方法对仿制药与其参考产品进行编码。但是仿制药和生物仿制药是不一样的，不应该这样对待。仿制药与其参考产品是相同的，而生物仿制药与生物参考产品是“相似的”，但其自身是独特的。
By grouping biosimilars together withbiologics, as the old policy required, CMS was taking two distinctly different therapies and coding them as equals. This policy discouraged manufacturers to invest the time and money necessary to obtain approval for biosimilars to treat new indications, in turn limiting the potential for biosimilars to treat a larger number of patients with different types of diseases. All in all, the old policy acted as a barrier to accessing this new generation of arthritis drugs for patients.
From the beginning, the Arthritis Foundation actively opposed the old policy and has been committed to achieving this policy reversal. When CMS had initially proposed the old policy, we submittedcomments in oppositionto vocalize our concern that the policy would be damaging to patient access. We were pleased when CMS decided to revisit the policy earlier this year, and submitted a follow upletter in August, as did many other patient and provider groups.
关节炎基金会并没有止步于此。我们与管理和预算办公室(OMB)召开了一次会议，讨论我们的立场。OMB审查拟议的监管变化，是总统执行办公室内最大的办公室。我们与美国风湿病学会、国家银屑病基金会和美国自身免疫和相关疾病协会一起会见了OMB，并加强了我们的观点，即目前的现状是不合适的。我们还向OMB提供了一个具体的例子:今天，有两种独特的生物仿制药在医疗保险B部分治疗关节炎，用于相同的参考生物产品。
Now that the policy has been reversed, the two biosimilars on the market for the same reference product to treat arthritis will have their own payment code.
This important change will help foster competition and help set the standard for other markets. Competition is critical to bringing down costs and making complex biological products more affordable. It will also promote more innovation as manufacturers strive to create a larger marketplace for biosimilars, and ultimately interchangeable biological products. For the arthritis community, it is critical to implement sound reimbursement policy for biosimilars, and we are thrilled CMS decided to reverse their policy and to see our efforts result in areal victory for our community.
Are you interested in Advocacy issues, at the national level or in your own state? Do you want to do more to advocate, but are not sure how?Learn more about our Arthritis Foundation Advocacy program and join us!
Related Resources:
- Our Position Statement on Interchangeable Biosimilar Substitution
- 胜利在纽约!生物仿制药立法签署成为法律
- 马里兰的胜利!Biosimilar Bill Signed by the Governor
- More About Biosimilars