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Biosimilar Products

Biosimilars, the AOA, and Patient Access

 

At the 2019 AOA House of Delegates, Resolution H-334 was passed to support policies that strengthen the biosimilar market while preserving the physician-patient relationship and protecting patient safety. In supporting physician discretion over patient treatment plans, specific when therapies may be substituted in consideration of the patient's condition and circumstance, the resolution acknowledges that the entrance of biosimilars into drug markets has significant potential to reduce drug pricing where the cost of biologics are a significant factor in rising drug pricing.

 

Recently, Oregon US Representative Kurt Schrader introduced a bill to make biosimilar drugs more affordable for patients. The Bolstering Innovative Options to Save Immediately on Medicines Act (BIOSIM) would increase reimbursement for biosimilars with a goal of increasing use of biosimilars (as opposed to biologics), resulting in lower out-of-pocket costs to patients.

 

OPSO will be following this an other efforts  and provide information as it becomes available.

 

Latest News

July 31: PRI Center for Medical Economics and Innovation - The Biosimilar Opportunity In October 2019, the Center for Medical Economics and Innovation at the Pacific Research Institute, under the direction of Dr. Wayne Winegarden, released its second study documenting the savings potential enabled by biosimilars. The October 2019 study found that biosimilars still generate over $240 million in total savings. If biosimilars grew to 25 percent, 50 percent, and 75 percent of the market, the study found the potential savings would be $2.4 billion, $4.7 billion, and $7.0 billion, respectively based on data through the beginning of 2019. Due to the large potential savings, solving the obstacles preventing wider adoption of biosimilars is imperative. MORE - Summary in Biosimilars Forum

 

About Biosimilars

 

  • Biosimilars are hardly new to most health care providers.  Since Congress enacted the Biologics Price Competition and Innovation Act in 2009, the Food and Drug Administration (FDA) has offered an abbreviated licensure pathway for these biological treatments that can demonstrate that they are interchangeable with their reference product.
  • Biosimilars are essentially generic versions of medical treatments derived from biologics. While biosimilars can provide comparable cost savings to generic drugs, they differ in that they are not chemically-derived small-molecule drugs. These products are used to treat patients suffering from a wide range of health conditions, including cancer, kidney and autoimmune diseases, rheumatoid arthritis and lupus.
  • While biologics are the largest cost-driver of drug spending in the Medicare system, biosimilars can provide considerable cost savings patients and the broader health care system.
  • At its annual meeting last year, the American Osteopathic Association’s House of Delegates passed a resolution supporting policies to strengthen the biosimilar market while preserving the physician-patient relationship and protecting patient safety, noting that “FDA approved drugs should be accessible to patients, and the decision on which biologic or biosimilar should rest with the patient and physician.”
  • The first biosimilar was approved by the FDA in 2015.  The agency’s website notes that, “Prescribers and their patients can be assured that an FDA-approved interchangeable product has been thoroughly tested and has met FDA’s high standards for approval.  Meeting these standards means that health care professionals and patients can be assured of the safety and effectiveness of an interchangeable product, just as they would be for a reference product.”
  • The AOA supports payor coverage of all FDA-approved biologics and biosimilars to enhance patient access and choice.  While the organization has not endorsed any specific proposals, a variety of legislation has been proposed to leverage the cost savings that biosimilars can provide.
  • Oregon’s own Congressman Kurt Schrader has introduced the “Bolstering Innovative Options to Save Immediately on Medicines (BIOSIM) Act.  The bipartisan legislation will temporarily increase the reimbursement for biosimilar drugs from the average sales price (ASP) of the drug plus six percent to the average sales price (ASP) of the drug plus eight percent for five years to help increase their utilization by doctors. Currently, Medicare patients pay a twenty percent coinsurance on Part B drugs, including biologics and biosimilar.
  • “Biosimilars have long struggled to grow in utilization and the BIOSIM Act will help them gain market share by providing an incentive for biosimilars that are lower cost than the biologic,” Congressman Kurt Schrader stated in announcing the legislation. Costs for patients and the healthcare system will go down with the transition to greater use of lower cost biosimilar drugs. There is no doubt that this bill is a win-win for patients and providers.” 
  • Another piece of bipartisan legislation, the Acting to Cancel Copays and Ensure Substantial Savings for Biosimilars (ACCESS) Act, would eliminate a patient’s copay for a biosimilar if they normally would pay full cost of a biologic drug under Medicare Part B. The bill will drive down medical costs by increasing access to lower-cost biosimilar drugs and give Americans more treatment options.
  • The Congressional Research Service reports that while less than 2 percent of Americans use biologics, they account for 40 percent of total spending on prescription drugs. The RAND Corporation estimates biosimilars could save the United States as much as $54 billion over the next decade. The ACCESS Act advances the goals of the Biologics Price Competition and Innovation Act (BPCIA), which Congress passed in 2010 to provide a new regulatory pathway to license and approve biosimilars.

 

 

 

 

 

 

 

 

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