Safe Biologics

 

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.

On June 24th, ASBM Executive Director Michael Reilly presented at the 15th Biosimilars Congregation. The event was organized to provide insight into the current state of play in the EU with respect to biosimilars and stimulate debate, in a multi-stakeholder setting, on the vital role of biosimilar medicines in the sustainability of healthcare systems. It also highlighted key recent developments in regulatory science and regulatory policy in the EU and other international jurisdictions.

View Mr. Reilly’s presentation here:

 

Mr. Reilly’s presentation was entitled “Biosimilars: Patient and Physician Perspectives” and drew heavily from ASBM’s surveys of physicians in Australia, Canada, Europe, Latin America, and the U.S.; as well as discussing recent biosimilar policy trends globally.

 

The presentation focused on three key policy areas: 1) Interchangeability and Substitution; 2) Non-Medical Switching, and 3) Distinguishable Naming.

 

Reilly emphasized the cautious nature of physicians, who while strongly supportive of biosimilars, are reluctant to change medicines for patients who are doing well on their current therapy. This is evident from European survey data showing high comfort levels prescribing biosimilars to new patients (84%), but also high discomfort with a third-party-initiated switch to a biosimilar for non-medical reasons such as cost (73%).

 

While automatic substitution is rarely practiced in Europe, such policies have been enacted in Australia over physician and patient objections. In addition, several Canadian provinces have begun forced-switching policies.

 

British Columbia and Alberta have already implemented forced switching policies, and in April, New Brunswick announced it would follow them. In May, Quebec announced its intention to become the fourth province to require patients to switch to biosimilars.

 

Quebec’s National Institute of Excellence in Health and Social Services (INESS) had previously released a report called “Safety of switching biologics and their interchangeability”. It found strong opposition to forced switching:

 

 

All the learned [physician] societies are clearly opposed to non-medical switching of a biologic drug, and instead favour medical switching, by which the decision to switch a patient’s treatment rests with the individual and his or her doctor…this position is shared by all the clinicians consulted for this project, who stress that the physician is the best person to assess the risk of treatment switching in a given patient.

 

Finally, Mr. Reilly discussed the issue of biologic nomenclature. Lack of an international standard was identified by the World Health Organization as a key policy challenge in a 2020 report. In 2014, the WHO’s International Nonproprietary Names (INN) Programme’s Expert Group proposed a distinct naming system built around a Biologic Qualifier (BQ), a four-letter suffixed affixed to an INN shared by an innovator biologic and all biosimilars to that product.

 

Despite early broad support from many countries including the U.S., Australia, Canada, and Japan; the voluntary standard was never made available to national regulatory authorities.

 

Currently several countries, including the U.S. and Japan, use distinct suffix systems, while Europe relies on INN and brand name for product identification. Early supporters of the BQ including Australia and Canada have also followed the latter approach, but expressed willingness to harmonize with the WHO standard if it is made available.

 

 

On June 24th, ASBM Executive Director Michael Reilly presented at the 15th Biosimilars Congregation. The event was organized to provide insight into the current state of play in the EU with respect to biosimilars and stimulate debate, in a multi-stakeholder setting, on the vital role of biosimilar medicines in the sustainability of healthcare systems. It also highlighted key recent developments in regulatory science and regulatory policy in the EU and other international jurisdictions.

View Mr. Reilly’s presentation here:

 

Mr. Reilly’s presentation was entitled “Biosimilars: Patient and Physician Perspectives” and drew heavily from ASBM’s surveys of physicians in Australia, Canada, Europe, Latin America, and the U.S.; as well as discussing recent biosimilar policy trends globally.

 

The presentation focused on three key policy areas: 1) Interchangeability and Substitution; 2) Non-Medical Switching, and 3) Distinguishable Naming.

 

Reilly emphasized the cautious nature of physicians, who while strongly supportive of biosimilars, are reluctant to change medicines for patients who are doing well on their current therapy. This is evident from European survey data showing high comfort levels prescribing biosimilars to new patients (84%), but also high discomfort with a third-party-initiated switch to a biosimilar for non-medical reasons such as cost (73%).

 

While automatic substitution is rarely practiced in Europe, such policies have been enacted in Australia over physician and patient objections. In addition, several Canadian provinces have begun forced-switching policies.

 

British Columbia and Alberta have already implemented forced switching policies, and in April, New Brunswick announced it would follow them. In May, Quebec announced its intention to become the fourth province to require patients to switch to biosimilars.

 

Quebec’s National Institute of Excellence in Health and Social Services (INESS) had previously released a report called “Safety of switching biologics and their interchangeability”. It found strong opposition to forced switching:

 

 

All the learned [physician] societies are clearly opposed to non-medical switching of a biologic drug, and instead favour medical switching, by which the decision to switch a patient’s treatment rests with the individual and his or her doctor…this position is shared by all the clinicians consulted for this project, who stress that the physician is the best person to assess the risk of treatment switching in a given patient.

 

Finally, Mr. Reilly discussed the issue of biologic nomenclature. Lack of an international standard was identified by the World Health Organization as a key policy challenge in a 2020 report. In 2014, the WHO’s International Nonproprietary Names (INN) Programme’s Expert Group proposed a distinct naming system built around a Biologic Qualifier (BQ), a four-letter suffixed affixed to an INN shared by an innovator biologic and all biosimilars to that product.

 

Despite early broad support from many countries including the U.S., Australia, Canada, and Japan; the voluntary standard was never made available to national regulatory authorities.

 

Currently several countries, including the U.S. and Japan, use distinct suffix systems, while Europe relies on INN and brand name for product identification. Early supporters of the BQ including Australia and Canada have also followed the latter approach, but expressed willingness to harmonize with the WHO standard if it is made available.

 

 

On June 29th, Minnesota Governor Tim Walz signed his state’s HHS Omnibus  budget for 2022-2023. The legislature had considered but ultimately rejected language aimed at boosting uptake of biosimilars – provisions which many patient groups believed might inadvertently increase out-of-pocket costs.

 

Since April, ASBM and other organizations including the Lupus and Allied Diseases Association (LADA, Inc.), the Global Colon Cancer Association (GCCA), and individual patients in Minnesota communicated to legislators their concerns with the language. In a letter to Minnesota legislators dated April 26, 2021 and co-written with LADA, Inc, ASBM laid out how the provisions might negatively impact prescription costs for patients:

 

The legislation assumes that products with lower wholesale acquisition cost (WAC) or “list” price translates into lower costs for healthcare payers and patients. However, list price is the price before any rebates, discounts, or other price concessions are offered by the drug manufacturer. In practice, manufacturers of biologics must compete on net cost in order to secure a preferred formulary position, but due to negotiated discounts with health plans and PBMs, the net price of a reference product may end up being substantially lower than the net price of a biosimilar with a lower WAC/list price.

 

The availability of biosimilars currently places downward pressure on net prices by forcing reference product manufacturers to discount their products heavily in order to compete. By focusing on the WAC rather than the true (net) cost of the medicine after rebates and discounts, the bill’s language removes the incentive to compete on net prices. We believe that this is counterintuitive to the intent of the legislation and will result in higher rather than lower costs for Minnesota patients.

 

“ASBM, like most patient advocacy organizations, is strongly supportive of legislation written with the goal of realizing cost savings through competition between multiple biologic products” said Executive Director Michael Reilly. “However, the language contained in HF 2128 would have undermined this objective by removing current incentives to compete on price and would have reduced, rather than promoted, affordability of biologics.”

 

Read one of ASBM’s several letters here. 

Read LADA, Inc.’s letter here.

Read GCCA’s letter here. 

Read Minnesota cancer patient Jason Randall’s letter here. 

View the final Minnesota omnibus health and human services bill here.

On June 29th, Minnesota Governor Tim Walz signed his state’s HHS Omnibus  budget for 2022-2023. The legislature had considered but ultimately rejected language aimed at boosting uptake of biosimilars – provisions which many patient groups believed might inadvertently increase out-of-pocket costs.

 

Since April, ASBM and other organizations including the Lupus and Allied Diseases Association (LADA, Inc.), the Global Colon Cancer Association (GCCA), and individual patients in Minnesota communicated to legislators their concerns with the language. In a letter to Minnesota legislators dated April 26, 2021 and co-written with LADA, Inc, ASBM laid out how the provisions might negatively impact prescription costs for patients:

 

The legislation assumes that products with lower wholesale acquisition cost (WAC) or “list” price translates into lower costs for healthcare payers and patients. However, list price is the price before any rebates, discounts, or other price concessions are offered by the drug manufacturer. In practice, manufacturers of biologics must compete on net cost in order to secure a preferred formulary position, but due to negotiated discounts with health plans and PBMs, the net price of a reference product may end up being substantially lower than the net price of a biosimilar with a lower WAC/list price.

 

The availability of biosimilars currently places downward pressure on net prices by forcing reference product manufacturers to discount their products heavily in order to compete. By focusing on the WAC rather than the true (net) cost of the medicine after rebates and discounts, the bill’s language removes the incentive to compete on net prices. We believe that this is counterintuitive to the intent of the legislation and will result in higher rather than lower costs for Minnesota patients.

 

“ASBM, like most patient advocacy organizations, is strongly supportive of legislation written with the goal of realizing cost savings through competition between multiple biologic products” said Executive Director Michael Reilly. “However, the language contained in HF 2128 would have undermined this objective by removing current incentives to compete on price and would have reduced, rather than promoted, affordability of biologics.”

 

Read one of ASBM’s several letters here. 

Read LADA, Inc.’s letter here.

Read GCCA’s letter here. 

Read Minnesota cancer patient Jason Randall’s letter here. 

View the final Minnesota omnibus health and human services bill here.

From June 27-July 1, 2021, ASBM virtually presented present a poster the DIA Global Annual Meeting 2021 entitled “A Review of Problems with Pharmacovigilance Programs and Biologics”. The poster is authored by ASBM Executive Director Michael Reilly and Advisory Board Chair Philip Schneider. Dr. Schneider presented the poster in a video recording available to conference attendees for the duration of the four-day event.

The poster examines a variety of published literature on global pharmacovigilance of biologic medicines, with a focus on difficulties in accurately identifying biologics at the product level in Adverse Drug Reaction (ADR) reports and self reporting surveys (SRS). For example, in a 2019 analysis of European ADR reports for infliximab in 2018, 35% did not provide a brand name, despite this being required by EU law since 2012.

Lack of a consistent international standard for biologic naming was identified as a barrier to biosimilar adoption in a recent WHO-sponsored 20-country study. “There is still no consensus among countries on the naming and labeling of biosimilars,” its authors observed, “and the WHO does not provide specific nomenclature for biosimilars.”

In 2014 the WHO’s INN Expert Group proposed a voluntary naming standard to promote accurate biologic identification. But despite early support for the standard from many countries including the US, Canada, Australia, and Japan, it has not yet been made available to national regulatory authorities.

DIA 2021 ran from June 27-July 1, 2021. EPosters were featured in an online gallery within the virtual meeting platform that is hosting DIA 2021.

View the poster presentation here.

Learn more about DIA 2021 and see the draft Program Agenda here.