Safe Biologics

On January 27th, ASBM joined other patient advocacy organizations and physician groups in submitting a coalition letter to the U.S. Department of Health and Human Services (HHS), urging the Department to prohibit the practice of copay accumulator adjustment policies. The coalition letter was submitted as part of the comment period on the HHS Notice of Benefit and Payment Parameters for 2023 Proposed Rule (BPPR).

The letter was branded by the All Copays Count Coalition (ACCC), which is composed of groups serving the interests of people with chronic and serious health conditions that rely on copay assistance in various forms to make medically necessary drugs affordable.The comment letter was signed by 126 patient advocacy and physician organizations.

From the letter:

We are extremely disappointed that the proposed 2023 NBPP rule does not include any reference to copay accumulator adjustment policies, which financially benefit insurance issuers and pharmacy benefit managers while making crucial treatments unaffordable for patients. We strongly urge you to address this issue in the final rule by requiring that insurers and Pharmacy Benefit Managers (PBMs) count all copayments made by or on behalf of an enrollee toward the enrollee’s annual deductible and out-of-pocket limit. 

The proposed NBPP for 2023 seeks to refine Section 156.125 of the Affordable Care Act (ACA), directly addressing the issue of discriminatory benefit design, intending to ensure that insurance plans do not discriminate against people living with chronic illness. While we support CMS’ intention to ensure that benefit design reflects clinical evidence rather than an effort to discriminate against people with high health care needs, we strongly urge CMS to also prohibit use of copay accumulator adjustment policies, which discriminate against people living with chronic illness. 

Copay accumulator adjustment policies undermine ACA protections prohibiting insurers from charging people with pre-existing conditions more than healthier enrollees. Copay assistance is generally only available for specialty or medications without a medically equivalent generic, which are used by people with serious, complex chronic illness. These policies subvert the benefit of co-pay assistance, thereby discriminating against people living with chronic conditions. 

Read the full letter here.

Read more about the Benefit and Payment Parameters for 2023 Proposed Rule here.

On January 27th, ASBM joined other patient advocacy organizations and physician groups in submitting a coalition letter to the U.S. Department of Health and Human Services (HHS), urging the Department to prohibit the practice of copay accumulator adjustment policies. The coalition letter was submitted as part of the comment period on the HHS Notice of Benefit and Payment Parameters for 2023 Proposed Rule (BPPR).

The letter was branded by the All Copays Count Coalition (ACCC), which is composed of groups serving the interests of people with chronic and serious health conditions that rely on copay assistance in various forms to make medically necessary drugs affordable.The comment letter was signed by 126 patient advocacy and physician organizations.

From the letter:

We are extremely disappointed that the proposed 2023 NBPP rule does not include any reference to copay accumulator adjustment policies, which financially benefit insurance issuers and pharmacy benefit managers while making crucial treatments unaffordable for patients. We strongly urge you to address this issue in the final rule by requiring that insurers and Pharmacy Benefit Managers (PBMs) count all copayments made by or on behalf of an enrollee toward the enrollee’s annual deductible and out-of-pocket limit. 

The proposed NBPP for 2023 seeks to refine Section 156.125 of the Affordable Care Act (ACA), directly addressing the issue of discriminatory benefit design, intending to ensure that insurance plans do not discriminate against people living with chronic illness. While we support CMS’ intention to ensure that benefit design reflects clinical evidence rather than an effort to discriminate against people with high health care needs, we strongly urge CMS to also prohibit use of copay accumulator adjustment policies, which discriminate against people living with chronic illness. 

Copay accumulator adjustment policies undermine ACA protections prohibiting insurers from charging people with pre-existing conditions more than healthier enrollees. Copay assistance is generally only available for specialty or medications without a medically equivalent generic, which are used by people with serious, complex chronic illness. These policies subvert the benefit of co-pay assistance, thereby discriminating against people living with chronic conditions. 

Read the full letter here.

Read more about the Benefit and Payment Parameters for 2023 Proposed Rule here.

From March 9-11, ASBM will participate in the Festival of Biologics USA 2022, held in San Diego, California. Two ASBM representatives will be presenting on a variety of topics, and moderating several discussion panels at the three-day conference.

On March 9th, ASBM Advisory Board Chair Philip Schneider will give a Plenary Presentation on the current biosimilars landscape, highlighting factors which are contributing to biosimilars gaining market share in the U.S.

On March 11th,  Schneider will give a presentation in the conference’s “Real World Evidence” (RWE) track entitled “Problems with pharmacovigilance programs: Opportunities for improvement.” This presentation will highlight some of the unique pharmacovigilance challenges of biosimilars, highlight areas of concern, and discuss strategies for improving biosimilar pharmacovigilance globally.

On March 11th, Schneider will moderate one of the conference’s two closing panel discussions, on “Promoting biosimilar uptake”. This discussion will examine the impact of interchangeable biosimilars on the biosimilar landscape and the role of competition in an increasingly active biosimilars pipeline.

The second closing panel discussion will be moderated by ASBM Steering Committee Member Andrew Spiegel, Executive Director of the Global Colon Cancer Association. It is entitiled “Market access dynamics and the future across different therapeutic areas” and will examine (e.g. arthritis, oncology, opthalmology, hematology, etc)

Learn more about the Festival of Biologics USA 2022 and register for the conference here. 

On January 25th, ASBM’s Immediate Past Chair Madelaine Feldman, MD FACR participated in a webinar entitiled “What’s the Hold-Up? Overcoming Barriers to the Use of Biosimilars,” hosted by The Center for Biosimilars. At the forum, Dr. Feldman discussed the role of payers like insurance companies and pharmacy benefit managers (PBMs) in contributing to higher drug costs.

Although there are cases where providers choose not to prescribe biosimilars, in others it may be due to physicians ultimately losing the ability to choose a therapy for their patients based on what is the lowest priced product or what is in the practice’s inventory, according to Dr. Feldman, who is president of the Coalition of State Rheumatology Organizations.

Savings and rebates that payers negotiate with manufacturers are often not designed to save patients money, Dr. Feldman explains, but are instead intended to increase profits for payers, who often negotiate contracts with companies to place more expensive products on formularies:

“Cost and price are 2 different things and when the middlemen talk about why we choose the lowest net costs, that actually means the highest profit. Their fiduciary responsibility is to their shareholders. It’s unfortunate but it’s the truth. It is not to the health care system, it is not to patients, and it is not to providers. And anything that they can do to increase their profit involves using higher price drugs because…all of the price concessions are a percentage of the list price.”

Dr. Feldman recently testified about PBM practices testified at a public hearing of the Congressional Oversight Committee entitled “Reviewing the Role of Pharmacy Benefit Managers in Pharmaceutical Markets”, held November 17th, 2021. From Dr. Feldman’s testimony:
The out-of-pocket costs for these miraculous RA medications – as well as medications for many other serious, chronic illnesses – have risen to levels where many patients simply can no longer afford them, and that is true even for biosimilars. Clearly, something is not working the way Congress intended. That something begins with the formulary…
High drug prices are not a mere byproduct of this system; they are at the heart of its design, since a drug’s list price must be high so as to offer “headroom” for these discounts, rebates, and fees to the PBM. This creates a broken market in which competition actually raises prices. In this way, our drug pricing system is more akin to selling a house [winner = highest bidder] than building a house [winner = lowest bidder].

Learn more about Center for Biosimilars webinar here.

Read Dr. Feldman’s testimony about PBM practices here. 

On January 25th, ASBM’s Immediate Past Chair Madelaine Feldman, MD FACR participated in a webinar entitiled “What’s the Hold-Up? Overcoming Barriers to the Use of Biosimilars,” hosted by The Center for Biosimilars. At the forum, Dr. Feldman discussed the role of payers like insurance companies and pharmacy benefit managers (PBMs) in contributing to higher drug costs.

Although there are cases where providers choose not to prescribe biosimilars, in others it may be due to physicians ultimately losing the ability to choose a therapy for their patients based on what is the lowest priced product or what is in the practice’s inventory, according to Dr. Feldman, who is president of the Coalition of State Rheumatology Organizations.

Savings and rebates that payers negotiate with manufacturers are often not designed to save patients money, Dr. Feldman explains, but are instead intended to increase profits for payers, who often negotiate contracts with companies to place more expensive products on formularies:

“Cost and price are 2 different things and when the middlemen talk about why we choose the lowest net costs, that actually means the highest profit. Their fiduciary responsibility is to their shareholders. It’s unfortunate but it’s the truth. It is not to the health care system, it is not to patients, and it is not to providers. And anything that they can do to increase their profit involves using higher price drugs because…all of the price concessions are a percentage of the list price.”

Dr. Feldman recently testified about PBM practices testified at a public hearing of the Congressional Oversight Committee entitled “Reviewing the Role of Pharmacy Benefit Managers in Pharmaceutical Markets”, held November 17th, 2021. From Dr. Feldman’s testimony:
The out-of-pocket costs for these miraculous RA medications – as well as medications for many other serious, chronic illnesses – have risen to levels where many patients simply can no longer afford them, and that is true even for biosimilars. Clearly, something is not working the way Congress intended. That something begins with the formulary…
High drug prices are not a mere byproduct of this system; they are at the heart of its design, since a drug’s list price must be high so as to offer “headroom” for these discounts, rebates, and fees to the PBM. This creates a broken market in which competition actually raises prices. In this way, our drug pricing system is more akin to selling a house [winner = highest bidder] than building a house [winner = lowest bidder].

Learn more about Center for Biosimilars webinar here.

Read Dr. Feldman’s testimony about PBM practices here. 

On December 9th, ASBM participated in the 16th Biosimilar Congregation, which focused on the Indian biosimilars market. By 2030, India is expected to become the sixth-largest market for pharmaceuticals, and has already firmly established itself in the global biopharmaceutical market. Many Indian pharmaceutical companies are preparing to step into the global biosimilars market.

ASBM was represented at the conference by Advisory Board Chair Philip Schneider, who moderated a panel on Market Access. The panel, comprised largely of representatives from Indian pharmaceutical companies, examined key challenges to gaining market access and sought to identify best practices for successfully entering tomorrow’s biosimilar market.

Topics discussed included current trends in biosimilar markets, the importance of sustainable pricing and reimbursement practices, ethical concerns, and strategies for overcoming market barriers.

A major takeaway from the discussions was that buidling confidence among physicians and patients was critical to success. To that end, panelists were strongly supportive of providing data demonstrating safety and efficacy of Indian biosimilars, including studies which showed patients may switch safely between originator products and biosimilars.

Learn more about the 16th Biosimilars Congregation here.

On December 9th, ASBM participated in the 16th Biosimilar Congregation, which focused on the Indian biosimilars market. By 2030, India is expected to become the sixth-largest market for pharmaceuticals, and has already firmly established itself in the global biopharmaceutical market. Many Indian pharmaceutical companies are preparing to step into the global biosimilars market.

ASBM was represented at the conference by Advisory Board Chair Philip Schneider, who moderated a panel on Market Access. The panel, comprised largely of representatives from Indian pharmaceutical companies, examined key challenges to gaining market access and sought to identify best practices for successfully entering tomorrow’s biosimilar market.

Topics discussed included current trends in biosimilar markets, the importance of sustainable pricing and reimbursement practices, ethical concerns, and strategies for overcoming market barriers.

A major takeaway from the discussions was that buidling confidence among physicians and patients was critical to success. To that end, panelists were strongly supportive of providing data demonstrating safety and efficacy of Indian biosimilars, including studies which showed patients may switch safely between originator products and biosimilars.

Learn more about the 16th Biosimilars Congregation here.

On December 2nd, ASBM sent a letter to House leaders reiterating our opposition to a proposal that would undermine the patient-physician relationship and distort the making of treatment decisions. The U.S. House of Representatives Committee on Rules has released new language for H.R. 5376 containing a provision that would pay physicians a 33% bonus for prescribing their patient the government-preferred biosimilar.

The bill calls for a “temporary increase in Medicare Part B payments for certain biosimilars,” that would increase the reimbursement to physicians from 6% above average sale price (ASP) to 8%- if they prescribe the biosimilar.

Biosimilars have already achieved significant US market share, around 80% for filgrastim biosimilars, 70% for trastuzumab and bevacizumab biosimilars, and 55% for rituximab biosimilars. As more become available, the increased competition has driven down prices of both biosimilars and innovator biologics.

Despite these successes, supporters of artificially incentivizing biosimilar uptake have continued to insert this provision into several bills in recent years. From the letter:

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. Instead, all products should continue to compete on a level playing field. Advantaging one manufacturer’s product over another not only distorts the treatment-decision making process and undermines the physician-patient relationship, but also undermines the competition-based policies that are currently lowering prices and expanding patient access.

Read ASBM’s full letter here.

Read the current text of H.R. 5376 here.