Safe Biologics

On July 28th, ASBM sent a letter to Congressional leaders expressing our  opposition to H.R.2815, the BIOSIM Act, a bill “to amend title XVIII of the Social Security Act to provide for a temporary payment increase under the Medicare program for certain biosimilar biological products to encourage the development and use of such products.”

The bill proposes to artificially incentivize biosimilar uptake by increasing reimbursement for biosimilars in Medicare Part B to ASP plus 8%, up from the current ASP plus 6%. This troubling proposal is not new, and has wisely been rejected by the Senate several times. In 2019 alone, this policy was defeated in the Prescription Drug Pricing Reduction Act, The BIOSIM Act (H.R. 4455) and The Lower Drug Costs Now Act (H.R. 3). From the letter:

We, the undersigned patient advocates and health care practitioners, have serious concerns with the potential negative impacts of this policy on patient care. It would create financial incentives for physicians to prescribe biosimilars; in effect, it would provide the doctor a 33% bonus for using a biosimilar instead of an originator product.

Treatment decisions can and should take into consideration a number of factors, including economic factors such as the affordability of the drug for the patient, but the physician-patient relationship could be seriously undermined when physicians are rewarded financially for choosing one medicine over another. Every patient should be confident that their physician will prescribe the product that is in their best interest, not the one that is the most profitable to the physician personally.

We share the goal of increasing biosimilar uptake and increasing patient access to biologic therapies. We also firmly believe this proposal is unnecessary, misguided, and potentially harmful.

Read the full letter here. 

On July 28th, ASBM sent a letter to Congressional leaders expressing our  opposition to H.R.2815, the BIOSIM Act, a bill “to amend title XVIII of the Social Security Act to provide for a temporary payment increase under the Medicare program for certain biosimilar biological products to encourage the development and use of such products.”

The bill proposes to artificially incentivize biosimilar uptake by increasing reimbursement for biosimilars in Medicare Part B to ASP plus 8%, up from the current ASP plus 6%. This troubling proposal is not new, and has wisely been rejected by the Senate several times. In 2019 alone, this policy was defeated in the Prescription Drug Pricing Reduction Act, The BIOSIM Act (H.R. 4455) and The Lower Drug Costs Now Act (H.R. 3). From the letter:

We, the undersigned patient advocates and health care practitioners, have serious concerns with the potential negative impacts of this policy on patient care. It would create financial incentives for physicians to prescribe biosimilars; in effect, it would provide the doctor a 33% bonus for using a biosimilar instead of an originator product.

Treatment decisions can and should take into consideration a number of factors, including economic factors such as the affordability of the drug for the patient, but the physician-patient relationship could be seriously undermined when physicians are rewarded financially for choosing one medicine over another. Every patient should be confident that their physician will prescribe the product that is in their best interest, not the one that is the most profitable to the physician personally.

We share the goal of increasing biosimilar uptake and increasing patient access to biologic therapies. We also firmly believe this proposal is unnecessary, misguided, and potentially harmful.

Read the full letter here. 

On July 28th, the U.S. Food and Drug Administration (FDA) announced the long-awaited approved of the first interchangeable biosimilar, Mylan’s SemgleeⓇ. Under the Biologic Price Competition and Innovation Act (BPCIA) of 2009, which governs U.S. biosimilar development, an interchangeable biosimilar may be substituted in place of its reference product (in this case, Sanofi’s insulin glargine LantusⓇ) at the pharmacy without the need for prior physician authorization. The approval is a victory for patients and healthcare providers years in the making, according to the Alliance for Safe Biologic Medicines (ASBM). As the FDA press release states:

An interchangeable biosimilar product may be substituted for the reference product without the intervention of the prescriber. The substitution may occur at the pharmacy, a practice commonly called “pharmacy-level substitution”—much like how generic drugs are substituted for brand name drugs, subject to state pharmacy laws, which vary by state. Biosimilar and interchangeable biosimilar products have the potential to reduce health care costs, similar to how generic drugs have reduced costs. Biosimilars marketed in the U.S. typically have launched with initial list prices 15% to 35% lower than comparative list prices of the reference products.

The FDA announcement comes on the heels of Oklahoma becoming the 50th and final state to permit substitution of interchangeable biosimilars this past April. As with similar laws nationwide, patients and the prescribing physician must be made aware of the substitution, and one may be prevented by the physician if deemed medically necessary.

“For eight years, patient advocacy organizations like ASBM worked with physician and pharmacist societies, manufacturers of both originator products and biosimilars, and state legislatures in fifty states to ensure that biosimilars could be safely substituted and patients nationwide could have access to lower-cost treatment options,” said ASBM’s executive director Michael Reilly.

ASBM’s efforts in this years-long campaign consisted of conducting three nationwide physician surveys, gathering dozens of patient testimonials, physician and pharmacist interviews, letters and legislator briefings, meetings with state medical and pharmacy societies, in-person expert testimony before state legislatures, educational videos, and holding educational forums at colleges of medicine and pharmacy.

Read more about the FDA’s approval here. 

On July 28th, the U.S. Food and Drug Administration (FDA) announced the long-awaited approved of the first interchangeable biosimilar, Mylan’s SemgleeⓇ. Under the Biologic Price Competition and Innovation Act (BPCIA) of 2009, which governs U.S. biosimilar development, an interchangeable biosimilar may be substituted in place of its reference product (in this case, Sanofi’s insulin glargine LantusⓇ) at the pharmacy without the need for prior physician authorization. The approval is a victory for patients and healthcare providers years in the making, according to the Alliance for Safe Biologic Medicines (ASBM). As the FDA press release states:

An interchangeable biosimilar product may be substituted for the reference product without the intervention of the prescriber. The substitution may occur at the pharmacy, a practice commonly called “pharmacy-level substitution”—much like how generic drugs are substituted for brand name drugs, subject to state pharmacy laws, which vary by state. Biosimilar and interchangeable biosimilar products have the potential to reduce health care costs, similar to how generic drugs have reduced costs. Biosimilars marketed in the U.S. typically have launched with initial list prices 15% to 35% lower than comparative list prices of the reference products.

The FDA announcement comes on the heels of Oklahoma becoming the 50th and final state to permit substitution of interchangeable biosimilars this past April. As with similar laws nationwide, patients and the prescribing physician must be made aware of the substitution, and one may be prevented by the physician if deemed medically necessary.

“For eight years, patient advocacy organizations like ASBM worked with physician and pharmacist societies, manufacturers of both originator products and biosimilars, and state legislatures in fifty states to ensure that biosimilars could be safely substituted and patients nationwide could have access to lower-cost treatment options,” said ASBM’s executive director Michael Reilly.

ASBM’s efforts in this years-long campaign consisted of conducting three nationwide physician surveys, gathering dozens of patient testimonials, physician and pharmacist interviews, letters and legislator briefings, meetings with state medical and pharmacy societies, in-person expert testimony before state legislatures, educational videos, and holding educational forums at colleges of medicine and pharmacy.

Read more about the FDA’s approval here. 

On June 15th, the American Medical Association (AMA) passed a resolution opposing the practice of insurers providing financial incentives for patients to switch to a payer-preferred treatment. The resolution was drafted by the American Colloge of Rheumatology (ACR) and passed during the AMA’s June 2021 Special Meeting.

The ACR drafted the resolution after learning Cigna was notifying patients on Cosentyx (secukinumab) that they could qualify for a $500 pre-paid debit card for their medical expenses if they agreed to switch to a Cigna-preferred alternative.

“We are grateful that, through the passage of this ACR-led AMA resolution, the larger house of medicine has agreed with us that financially incentivizing patients to switch medicines is wrong. In recent years, payers have become increasingly aggressive in the tactics they have used to direct patients to the preferred treatments on their formularies,” said Chris Phillips, MD, chair of ACR’s Insurance Subcommittee.

The ACR had previously outlined their concerns with non-medical switching of patients on biologics in an April 2021 letter to Cigna:

“Due to the complex nature of autoimmune diseases, two patients can have very different immune responses to the same medication in the same drug class…This can make finding the treatment that works a challenge, so the decision to choose one biologic over another requires careful clinical evaluation and consideration by a physician and patient. Factors such as an individual patient’s age, gender, diagnosis, medications, specific organ manifestations, antibody status, disease severity, comorbid conditions, and ability to tolerate the route of administration strongly influence the choice of each specific biologic.”

“We are hopeful the AMA’s new stance will increase scrutiny of these practices and encourage policy makers to pass legislation prohibiting financial payments for non-medical switching.” said the ACR statement. The ACR says it plans to work with the AMA to oppose legislation that would explicitly allow this practice.

Read the ACR’s press release about the AMA resolution here. 
Read the ACR’s April 2, 2021 letter to Cigna here.