Safe Biologics

From November 2nd-4th, ASBM representatives participated in the Festival of Biologics 2022 Europe, held in Basel, Switzerland.

ASBM Advisory Board Chair Philip Schneider, MS, FASHP, FFIP gave a presentation entitled “Key Factors for Improving Sustainability in Biosimilar Markets”. The presentation reflected the findings from a recent webinar ASBM held on this subject with GaBI Journal. Among the factors identified in the webinar were the ability for physicians to choose freely between multiple products- innovators and biosimilars- when prescribing.

Professor Schneider also presented a poster session on the topic featuring data from ASBM’s recent survey of 401 US physicians. Findings included:

• 71% of respondents considered it highly important that payers (public and private) should reimburse multiple products in a given class- including originator and biosimilars.
• 81% believe their patients would be best served under the biosimilar access scenario popular throughout most of Western Europe- in which biosimilars and originator products are both reimbursed, biosimilars may be encouraged for new patients, but automatic or pharmacy-level substitution is not permitted.
• Only 8% supported the access scenario implemented by several Canadian provinces, in which only a preferred, government-chosen product is reimbursed and to which both new and stable patients must be switched. 11% were unsure.

ASBM Steering Committee Member Andrew Spiegel, Executive Director of the Global Colon Cancer Association, gave the Day 3 opening keynote address on the topic: “Protecting the future of biosimilars”. Mr. Spiegel also chaired a panel entitled “Biosimilar Communication and Patient Engagement Strategies – How Can Stakeholders Work Together to Effectively Communicate About Biosimilars in the Clinic?” on which Professor Schneider appeared as a panelist.

View ASBM’s recent webinar “Key Factors for Successful Biosimilar Uptake: Europe and US” here.

Read the GaBI Journal report of the webinar here.

View Professor Schneider’s Festival of Biologics presentation here.

View ASBM’s Festival of Biologics poster here. 

From November 2nd-4th, ASBM representatives participated in the Festival of Biologics 2022 Europe, held in Basel, Switzerland.

ASBM Advisory Board Chair Philip Schneider, MS, FASHP, FFIP gave a presentation entitled “Key Factors for Improving Sustainability in Biosimilar Markets”. The presentation reflected the findings from a recent webinar ASBM held on this subject with GaBI Journal. Among the factors identified in the webinar were the ability for physicians to choose freely between multiple products- innovators and biosimilars- when prescribing.

Professor Schneider also presented a poster session on the topic featuring data from ASBM’s recent survey of 401 US physicians. Findings included:

• 71% of respondents considered it highly important that payers (public and private) should reimburse multiple products in a given class- including originator and biosimilars.
• 81% believe their patients would be best served under the biosimilar access scenario popular throughout most of Western Europe- in which biosimilars and originator products are both reimbursed, biosimilars may be encouraged for new patients, but automatic or pharmacy-level substitution is not permitted.
• Only 8% supported the access scenario implemented by several Canadian provinces, in which only a preferred, government-chosen product is reimbursed and to which both new and stable patients must be switched. 11% were unsure.

ASBM Steering Committee Member Andrew Spiegel, Executive Director of the Global Colon Cancer Association, gave the Day 3 opening keynote address on the topic: “Protecting the future of biosimilars”. Mr. Spiegel also chaired a panel entitled “Biosimilar Communication and Patient Engagement Strategies – How Can Stakeholders Work Together to Effectively Communicate About Biosimilars in the Clinic?” on which Professor Schneider appeared as a panelist.

View ASBM’s recent webinar “Key Factors for Successful Biosimilar Uptake: Europe and US” here.

Read the GaBI Journal report of the webinar here.

View Professor Schneider’s Festival of Biologics presentation here.

View ASBM’s Festival of Biologics poster here. 

On November 3rd, ASBM submitted comments to the Minnesota Department of Commerce on two mandated health benefit bills, as part of a public comment period.

The first proposal was SF 990, mandating coverage of multiple biologic products, which ASBM opposed. ASBM had previously led patient advocacy organization opposition to the measure last summer. From the comment letter: 

It is our view that HF 1516/SF 990 while intended to promote competition and lower prices, may result in unintended negative consequences- such as actually increasing, rather than lowering, drug costs for Minnesota patients.

While we strongly support legislation that is written with the goal of realizing cost savings through competition between multiple biologic products, we believe that HF 1516/SF 990 undermines this objective by removing current incentives to compete on price and will ultimately reduce rather than promote affordability of biologics. For this reason, we strongly urge the Department of Commerce to oppose SF 990.

ASBM’s comments offered support for the second bill, HF 4899, which would mandate health plan coverage for biomarker testing: 

Patients with serious and chronic conditions such as cancer or rheumatoid arthritis must often try multiple treatments before finding the one that works best for them. Biomarker testing helps ensure that patients receive the right treatment for them in a timely manner.

But health care coverage for biomarker testing too often fails to keep pace with these scientific advancements. HF 4899 will work to remedy this by requiring health plans in Minnesota to cover biomarker testing when supported by medical and scientific evidence, including nationally-recognized clinical practice guidelines and FDA approval.

Timely access to appropriate biomarker testing helps achieve better health outcomes, improves quality of life for patients, and reduces costs to our health system. For these reasons, we strongly urge the Department of Commerce to support HF4899.

Read ASBM’s comment letter here.

On November 3rd, ASBM submitted comments to the Minnesota Department of Commerce on two mandated health benefit bills, as part of a public comment period.

The first proposal was SF 990, mandating coverage of multiple biologic products, which ASBM opposed. ASBM had previously led patient advocacy organization opposition to the measure last summer. From the comment letter: 

It is our view that HF 1516/SF 990 while intended to promote competition and lower prices, may result in unintended negative consequences- such as actually increasing, rather than lowering, drug costs for Minnesota patients.

While we strongly support legislation that is written with the goal of realizing cost savings through competition between multiple biologic products, we believe that HF 1516/SF 990 undermines this objective by removing current incentives to compete on price and will ultimately reduce rather than promote affordability of biologics. For this reason, we strongly urge the Department of Commerce to oppose SF 990.

ASBM’s comments offered support for the second bill, HF 4899, which would mandate health plan coverage for biomarker testing: 

Patients with serious and chronic conditions such as cancer or rheumatoid arthritis must often try multiple treatments before finding the one that works best for them. Biomarker testing helps ensure that patients receive the right treatment for them in a timely manner.

But health care coverage for biomarker testing too often fails to keep pace with these scientific advancements. HF 4899 will work to remedy this by requiring health plans in Minnesota to cover biomarker testing when supported by medical and scientific evidence, including nationally-recognized clinical practice guidelines and FDA approval.

Timely access to appropriate biomarker testing helps achieve better health outcomes, improves quality of life for patients, and reduces costs to our health system. For these reasons, we strongly urge the Department of Commerce to support HF4899.

Read ASBM’s comment letter here.

ASBM’s recent survey of 401 U.S. physicians was featured in the October issue of the journal Oncology Practice Management. The article discussed a poster presentation given by ASBM Chairman Ralph McKibbin, MD, FACP, FACG, AGAF at the Drug Information Association Global Annual Meeting (DIA 2022) on June 20th, in Chicago, IL. View the poster here.  The survey findings consistently reflected the high importance to respondents of preserving patient and physician choice regarding treatment decisions. From the article:

Despite expressing a high level of confidence when it comes to switching to or prescribing a biosimilar, 58% of survey respondents said they were uncomfortable with third-party substitution for nonmedical reasons related to cost or coverage. In addition, 69% of respondents said it was “very important or critical” that patients and physicians collaborate on the decision to choose the most suitable biosimilar and 67% said that it was “very important or critical” that they were able to prevent a substitution they considered inappropriate.

Results of the survey also showed that the majority (71%) of physicians felt that payers should reimburse several biologics in a specific class, including the reference drug with its biosimilars, and 74% felt that private and public payers should base their decisions regarding biosimilars coverage on factors other than cost.

When asked about preferred biosimilar access, 81% said that their patients could be best served under the type of scenario used throughout most of Western Europe, in which biosimilars and reference products are both reimbursed and biosimilars may be encouraged for new patients, but automatic or pharmacy-level substitution is not allowed. Only 8% supported an access scenario used in several Canadian provinces, in which only a preferred, government-selected product is reimbursed and to which both new and stable patients must be switched. Eleven percent said that they are unsure.

Read the Oncology Practice Management article here.

View Dr. McKibbin’s poster presentation here. 

View or download the poster here. 

ASBM’s recent survey of 401 U.S. physicians was featured in the October issue of the journal Oncology Practice Management. The article discussed a poster presentation given by ASBM Chairman Ralph McKibbin, MD, FACP, FACG, AGAF at the Drug Information Association Global Annual Meeting (DIA 2022) on June 20th, in Chicago, IL. View the poster here.  The survey findings consistently reflected the high importance to respondents of preserving patient and physician choice regarding treatment decisions. From the article:

Despite expressing a high level of confidence when it comes to switching to or prescribing a biosimilar, 58% of survey respondents said they were uncomfortable with third-party substitution for nonmedical reasons related to cost or coverage. In addition, 69% of respondents said it was “very important or critical” that patients and physicians collaborate on the decision to choose the most suitable biosimilar and 67% said that it was “very important or critical” that they were able to prevent a substitution they considered inappropriate.

Results of the survey also showed that the majority (71%) of physicians felt that payers should reimburse several biologics in a specific class, including the reference drug with its biosimilars, and 74% felt that private and public payers should base their decisions regarding biosimilars coverage on factors other than cost.

When asked about preferred biosimilar access, 81% said that their patients could be best served under the type of scenario used throughout most of Western Europe, in which biosimilars and reference products are both reimbursed and biosimilars may be encouraged for new patients, but automatic or pharmacy-level substitution is not allowed. Only 8% supported an access scenario used in several Canadian provinces, in which only a preferred, government-selected product is reimbursed and to which both new and stable patients must be switched. Eleven percent said that they are unsure.

Read the Oncology Practice Management article here.

View Dr. McKibbin’s poster presentation here. 

View or download the poster here. 

In October, Amgen released its full 2022 Biosimilar Trends Report. The report’s findings had been previewed earlier this year by Amgen’s Global Biosimilars Commercial Lead, Chad Pettit at a June 29th webinar hosted by ASBM and GaBI Journal.

View the webinar “Key Factors for Successful Uptake of Biosimilar Markets” here. Read GaBI Journal’s Meeting Report here. 

The full report further documents the tremendous success of the U.S. biosmilars program in promoting competition, increasing biosimilar uptake, and generating savings for the U.S. health system. From the report:

To date in the US, 39 biosimilars have received regulatory approval, and 22 products have been launched. These launches have helped create an estimated $21 billion in savings for the healthcare system over the past 6 years.

• Biosimilars have gained significant U.S. market share in the majority of therapeutic areas where they have been introduced: 80% for filgrastim trastuzumab and bevacizumab biosimilars; 60% for rituximab biosimilars; and 40% for infliximab, pegfilgrastim, and erythropoietin-stimulating agent (ESA) biosimilars.
• Biosimilars are attaining significant market share more quickly: for therapeutic areas with biosimilars launched in the last 3 years, the average share was 74%…prior to 2019, the average share after 3 years was 38%.

Medicare Part B reimburses providers for biosimilars at the biosimilar’s Average Sales Price (ASP) plus a 6% addon of the reference biologic’s ASP. In other words, Congress kept the field level by providing physicians the same add-on amount regardless of whether they prescribe a reference product or a biosimilar. This helps all manufacturers compete on equal terms.

The report also emphasized that continued stakeholder education was critical to the market’s continued success:

As biosimilars expand into new therapeutic areas and enter the pharmacy benefit, education will continue to be critical to instill patient, provider, and pharmacist confidence in the role of biosimilars as viable and integral treatment options.

Read the Amgen 2022 Biosimilar Trends Report here. 
View ASBM’s Key Success Factors Webinar here and access speaker presentations here. 
Read GaBI Journal’s Meeting Report about the webinar here.