Safe Biologics

This initial guidance describes how CMS intends to implement the Negotiation Program for initial price applicability year 2026 (January 1, 2026 to December 31, 2026), and specifies the requirements that will be applicable to manufacturers of Medicare Part D drugs that are selected for negotiation and the procedures that may be applicable to manufacturers of Medicare Part D drugs, Medicare Part D plans (both Prescription Drug Plans (PDPs) and Medicare Advantage Prescription Drug Plans (MA-PDs)), and providers and suppliers (including retail pharmacies) that furnish Medicare Part D drugs.

The memo notes that CMS is not following the typical notice-and-comment requirements of the Administrative Procedure Act or the Medicare statute, citing both legislative direction and its own assessment: “CMS finds that notice and public procedure on this guidance would be impracticable, unnecessary, and contrary to the public interest”.

While some of the guidance is being issued as final, the announcement solicits offers just 30 days for concerned parties to comment on other portions of the guidance:
Please send comments pertaining to this memorandum to IRARebateandNegotiation@cms.hhs.gov with the following subject line “Medicare Drug Price Negotiation Program Guidance.” Comments received by April 14, 2023 will be considered.

“To undertake such a major change to the Medicare program outside of the notice-and-comment period is highly unusual and runs counter to long-established procedures”, says ASBM Executive Director Michael Reilly, who served for 6 years in the Office of the Secretary at the Department of Health and Human Services (HHS) as Medicare Part D was being developed and implemented. “Unfortunately, rushed policy made absent stakeholder input rarely results in good policy”.

Read the CMS Guidance Memo here. 
Send Comments on the Guidance to CMS here.

On March 28th, ASBM participated in the World Health Organization’s 76th Consultation on International Non-proprietary Names (INN) for Pharmaceutical Substances, held in Geneva, Switzerland. This was the twentieth INN Consultation in which ASBM has participated.

ASBM was represented at the session by Executive Director Michael Reilly, Esq., and Advisory Board Chair Philip Schneider, MS, FASHP.

The proceedings at the Consultation are bound by confidentiality pending the WHO’s publication of the Executive Summary. ASBM will share the Executive Summary when it is published in the coming months.

The recently-published Executive Summary from the 75th INN Consultation, at which ASBM presented in October 2022, summarizes ASBM’s position regarding the value of distinct biologic nomenclature:

One significant challenge to efficient global cooperation is the lack of harmonization. Significantly for the INN group, a 2020 WHO report identified inconsistent nomenclature as a remaining challenge as it is clear that naming and labelling are both very important for pharmacovigilance and prescribing. Indeed, surveys show that there remains a clear need for harmonization of distinguishable names with only two-thirds of ADR reports recording the brand name of the biologic, and even fewer recording the non-proprietary name. Other surveys show that only a small proportion of physicians record the non-proprietary name and extremely few use an officially recommended drug code number.

In conclusion, the ASBM urged the WHO to make a voluntary distinct naming standard available to facilitate international cooperation and harmonization. This will help speed approval, increasing access to biosimilars while promoting safety and building confidence through strong post-market monitoring.

Read the WHO’s summary of the 75th INN Consultation here.

On March 21st, the U.S. Department of Health and Human Services (HHS), with the U.S. Department of Commerce, announced the formation of an working group to develop an implementation framework for the government to exercise ‘march-in” rights as a tool to lower drug prices.

The announcement indicates a “whole-of-government approach” will be used to review its march-in authority as laid out in the Bayh-Dole Act, which promotes commercialization of research results, maximizes the potential for federally-funded technologies to become products, and serves the broader interest of the American public. From the press release:
The Interagency Working Group for Bayh-Dole will develop a framework for implementation of the march-in provision that clearly articulates guiding criteria and processes for making determinations where different factors, including price, may be a consideration in agencies’ assessments.

“The Biden-Harris Administration is committed to increasing access to health care and lowering costs. And march-in authority is a powerful tool designed to ensure that the benefits of the American taxpayer’s investment in research and development are reasonably accessible to the public,” said HHS Secretary Xavier Becerra. “We look forward to updates from the Bayh-Dole Interagency Working Group, and at my direction, HHS will review the findings, engage the public, and better define how HHS could effectively utilize our authority moving forward.”

Under the Bayh-Dole Act, adopted in 1980, the government can promote the commercialization and public availability of even partially government-funded inventions. But when it comes to using the law to drop the price of a drug under patent protection, the move has never been successful.

In another letter dated the same day, HHS, which oversees the National Institutes of Health (NIH) declined to use “march-in” rights to lower the price of Astellas’ and Pfizer’s prostate cancer drug Xtandi (enzalutamide).

From the letter:
“Given the remaining patent life and the lengthy administrative process involved for a march-in proceeding, NIH does not believe that use of the march-in authority would be an effective means of lowering the price of the drug.”

Read the press release here. 
Read the letter declining to exercise march-in rights in the case of Xtandi(enzalutamide) here.

On May 3rd, ASBM and the Generics and Biosimilars Initiative (GaBI) will host the first of two webinars examining the implications for patients and healthcare providers of the recently-passed Inflation Reduction Act (IRA). The webinars will focus on unintended consequences that may result from the implementation of IRA provisions regarding biologic and biosimilar medicines.

The first webinar, tentatively scheduled for May 3rd, will focus on the IRA’s price negotiation provisions, which allow the Centers for Medicare and Medicaid to negotiate prices of certain costly drugs, including many biologic medicines. Webinar presenters will discuss cost containment efforts in different countries and examine the impact these policies have had on patient care and on the practice of healthcare professionals including physicians and pharmacists.

More information will be available in the coming weeks.

On March 5th-6th, ASBM Chairman Ralph McKibbin, MD, FACP, FACG, AGAF participated in the 33rd annual Digestive Disease National Coalition public policy forum in Washington, DC March 5th and 6th.

The advocacy conference brought together patient advocates, health care providers, and industry representatives from the major national voluntary and professional societies concerned with digestive diseases. This year’s theme was “Improving Patient Care.”

Live panelists included Dr. Stephen James, Director, Division of Digestive Diseases and Nutrition at the National Institute for Diabetes, Digestive and Kidney Diseases and Brenda Rodriguez, Senior Engagement Officer at the Patient-Centered Outcomes Research Institute. Both highlighted the need for focusing on patient outcomes in this age of rising inflation and medication costs.

ASBM Chairman Ralph McKibbin MD; DDNC President Carrol Koscheski; and Brad Conway, VP of Legislative Affairs and Advocacy for the American College of Gastroenterology were among the physicians who met with lawmakers on PBM reform and other issues.

Dr. McKibbin, along with DDNC leadership, met with Representative Buddy Carter of Georgia – a champion for pharmacy benefit manager (PBM) reform – to discuss the need legislation in this area. Rep. Carter is a pharmacist who ran a chain of local pharmacies prior to becoming a congressional representative and is well informed on the issues. He has produced an educational booklet on the subject entitled “Pulling Back the Curtain on PBMs: A Path Towards Affordable Prescription Drugs”.

On March 21st, the FDA approved a citrate-free, high-concentration formulation (HCF) of the adalimumab biosimilar Hyrimoz (adalimumab-adaz) manufactured by Sandoz.

The injection (100 mg/mL) is approved to treat 7 indications covered by the reference product, Humira, including: rheumatoid arthritis, juvenile idiopathic arthritis, psoriatic arthritis, ankylosing spondylitis, Crohn disease, ulcerative colitis, and plaque psoriasis.

Sandoz intends to launch the biosimilar in the United States on July 1, 2023.

The first biosimilar for Humira, Amejevita (adalimumab-atto) was launched in February by Amgen and is expected to be the only adalimumab biosimilar on the market until July, although several more are expected to launch this year.
Read about the approval here.
 

On March 21st, the U.S. Food and Drug Administration (FDA) released three new educational resources about biosimilars, targeted at patients:

Biosimilars: What Patients Need to Know

Biosimilars: What Patients With Diabetes Need to Know

Biosimilar Basics Infographic

The materials answer basic questions that patients might have about biologic medicines and biosimilars, including:

• What are biologic medications?
• How are they different from other types of medications?
• What are interchangeable biosimilars?
• Why aren’t biosimilars identical to the original biologics?
• Why would a patient switch from an original biologic to a biosimilar?

For more information about biosimilars and additional resources for patients, visit the FDA’s “Biosimilar Basics for Patients” educational site here.

Read it Here.

ASBM/GaBI IRA Webinar

May 3, 2023

Digestive Disease Week 2023
Chicago, IL – May 6-9

ASCO 2023

Chicago, IL – June 2-6, 2023

DIA Global Annual Meeting

Boston, MA – June 25-29, 2023

In April and May, ASBM and the Generics and Biosimilars Initiative (GaBI) will host two new webinars examining the implications of the recently-passed Inflation Reduction Act (IRA). The webinars will focus on the unintended consequences that may result from the implementation of IRA provisions. For example, provisions intended to reduce the expenses of biologic medicines in the short term may result in fewer medicines being introduced in the long term, reducing rather than increasing patient access to innovative treatments.

Presenters will discuss cost containment efforts in different countries and examine the impact these policies have had on patient care and healthcare professionals.

The new webinars build on the success of ASBM and GaBI’s Summer 2022 webinars, the first of which looked at factors which contributed to successful biosimilar uptake in the U.S. and Europe and was the basis for a whitepaper in GaBI Journal’s Q4 2022 issue. The second examined the controversial policy of non-medical switching and its implications for patients, physicians, and the long-term sustainability of biosimilar markets; a whitepaper based on the meeting will be featured in the Q1 2023 issue of GaBI Journal.

More information on the IRA webinars will be available in the coming weeks.

On February 28th, ASBM and the Ontario-based International Foundation on Ageing (IFA) released the results of a new survey of Canadian ophthalmologists that documents these specialists’ views on biosimilars and substitution practices.

The survey’s release comes on the heels of Ontario’s recent announcement that it would begin force-switching patients with a variety of conditions from their physician-prescribed products to government-chosen biosimilars, beginning March 31st.

The survey of 41 Canadian ophthalmologists, all of whom prescribe biologics in their practice revealed:

• 81% were not comfortable with a third party such as a government switching a patient’s medicine for non-medical reasons such as cost, as would occur under the Ontario plan.
• 90% said that having sole authority, with the patient, to decide which biologic medicine to use is very important or critical.
• 91% considered the ability to prevent a forced switch by a public or private payer very important or critical.

ASBM’s executive director, Michael Reilly, emphasized the stark contrast between Ontario’s plan and the more physician- and patient- centered substitution practices of Europe:
“The Ontario announcement cites 15 years of safe use of biosimilars in Europe as a justification for its forced-switching policy. What the success of biosimilars in European markets has actually shown is that countries need not sacrifice physician and patients’ choice to enjoy significant savings. Most European markets accomplish savings through competition between many reimbursed products, rather than forced switches. Patients and physicians in Canada deserve no less – yet they are increasingly seeing choice restricted rather than expanded. With the arrival of ophthalmic biosimilars, we see yet another group of physicians and their patients expressing concerns with unnecessary switching in pursuit of short-term savings.”

Seventy-eight percent of survey respondents said their patients would be best served by a European-style scenario where multiple products including innovator and biosimilars are reimbursed, with biosimilars encouraged for new patients but no automatic substitution.

Only 15% preferred a system similar to that of Ontario where only government-chosen biosimilars are reimbursed, new patients must be prescribed these products, and current patients are forced to switch.
Read the press release about the survey here.

View the full ophthalmologist survey here.

On February 28, IQVIA held a webinar entitled Biosimilars in the United States 2023-2027. The webinar featured findings from the recently-released report of the same name. Among the report’s key findings:

• The U.S. biologics market has grown 12.5% annually on average over the last five years on an invoice-price basis, faster than non-biologics, and now comprising 46% of spending.
• Recent biosimilars have achieved high volume shares, reaching more than 60% of the molecule’s volume within the first three years. Non-340B clinics have seen higher uptake of biosimilars than 340B clinics, likely due to reimbursement dynamics.
• The three molecules with biosimilar launches in 2019 — bevacizumab (82%), trastuzumab (80%), and rituximab (67%) — achieved significant uptake within the first three years. It is unclear if uptake of these recent oncology biosimilars is indicative of future biosimilar uptake, however, these have gained higher market share than earlier biosimilars in the U.S. and are similar to or higher than rates of uptake in Europe.
• Pegfilgrastim and epoetin alfa biosimilars, both launched in 2018, have seen moderate uptake achieving 37% share of molecule volume in the first three years. Pegfilgrastim biosimilar share has continued to rise slowly while epoetin alfa biosimilar share has fallen to 27% as of October 2022.
• Infliximab has seen the lowest adoption of biosimilars, with volume share at 3% after one year and rising slowly to 13% after three years. This has shifted significantly in more recent years as biosimilars now account for 44% of infliximab volume nearly six years after biosimilar entry.

The presentation was followed by a panel discussion featuring Sameer Awsare, MD, Associate Executive Director, the Permanente Medical Group; Alex Brill, MA, CEO, Matrix Global Advisors, Luke Greenwalt, MBA VP and Lead, Market Access Center of Excellence, IQVIA; Chad Pettit, MBA, Executive Director, Marketing, Global Biosimilars Commercial Lead, Amgen; Marta Wosinska, Ph.D. Visiting Fellow, The Brookings Institution; Murray Aitken, Executive Director, IQVIA Institute for Human Data Science; and Michael Kleinrock, Research Director, IQVIA Institute for Human Data Science.

Read the full report here here. 

View a recording of the webinar here. 

On February 28th, the U.S. Food and Drug Administration and the Federal Trade Commission released two documents related to biosimilars and interchangeable biosimilars – an educational resource for consumers and patients and a summary report from the 2020 public workshop titled “FDA/FTC Workshop on a Competitive Marketplace for Biosimilars.”

Three ASBM representatives participated in the joint FDA/FTC: Immediate Past Chair Madelaine Feldman, MD; Advisory Board Chair Schneider, FASHP FFIP and Andrew Spiegel provided comments at the meeting.

One presenter identified the chief barriers to biosimilar uptake as physicians (who needed educational outreach to increase their familiarity and comfort with biosimilars) and payers (whose policies can sometimes impede utilization, and need to be addressed). ASBM Advisory Board Chair Philip Schneider addressed these concerns in his remarks at the workshop:

Our recent survey of 579 European biologic prescribers shows high knowledge and high confidence in biosimilars. Depending on country, between 82% and 93% of prescribers considered themselves familiar or very familiar with biosimilars. Between 80% and 99% would feel comfortable prescribing a biosimilar to a new treatment-naïve patient. Between 46-76% would be comfortable switching a stable patient.

if the premise behind today’s proceedings is valid – that biosimilar uptake is strongly tied to physician confidence, the high physician confidence in biosimilars across the board should correlate with a consistently high uptake across the board.

Yet if we look at the biosimilar market shares across the six countries we surveyed, there is a wide variation among biosimilars in different product classes. For example, market share for the Epoetin biosimilar ranged from 6-84%.  There are similar ranges for other biosimilars.

Clearly there are other factors besides physician confidence, which is uniformly high across the countries. These factors likely include differences between each country’s payer policies, differences in the length of time a biosimilar has been on the market, the number of biosimilars in a given product class, the discount of each product relative to the originator product, and other factors.

Read the testimony and comments provided to the FDA/FTC by Dr. Feldman, Dr. Schneider, and Mr. Spiegel.

Read the Summary Meeting Report here.
Read the FDA’s Educational Resource on Biosimilars here.
Visit www.fda.gov/biosimilars for more resources and information about biosimilars.

According to a study released in February by Cardinal Health, while most providers think that biosimilars will positively impact care, few feel that the economic benefits of biosimilars to date are enough to motivate switching.

As reported in Medscape Medical News, the new survey of over 350 dermatologists, gastroenterologists, ophthalmologists, and rheumatologists, clinicians shared their opinions on the rapidly evolving landscape of biosimilars, detailing top concerns about prescribing these medications and how they presently use biosimilars in clinical practice.

Out of 103 surveyed rheumatologists, 62% said they were very comfortable prescribing biosimilars to patients, and 32% said they were somewhat comfortable. Providers said they would be most likely to prescribe a biosimilar to new patients (40%) or if biosimilars were mandated by a patient’s health plan (41%). Nearly one-third (31%) of rheumatologists said that a discount of 21%-30% from a reference product would be necessary to consider switching a patient to a biosimilar.

There are several reasons why a rheumatologist may be wary of switching patients to biosimilars, said Marcus Snow, MD, chair of the American College of Rheumatology’s Committee on Rheumatologic Care. “Rheumatologists will always express concern about changing medications that work well for their patients. It is not ideal to ‘force switch’ to a different product, even if it is almost identical,” he told Medscape Medical News in an email. “Also, we must remember that a patient on a biologic has failed traditional medications, which speaks to the struggle a patient must endure to get their disease under control. Fail-first situations can cause a rheumatologist to be initially resistant or hesitant to any changes.”
Read the full Medscape Medical News article here. (free signup required)

Read a Healio article breaking out the rheumatologist responses in the Cardinal survey here. 

Read it Here.

Festival of Biologics 2022 USA

San Diego, CA – March 20-22, 2023

WHO 76th INN Consultation

Geneva, Switzerland – March 28, 2023

DIA Global Annual Meeting

Boston, MA – June 25-29, 2023

On January 31st, the first biosimilar for adalimumab (Humira) launched in the U.S. market. Amjevita (adalimumab-atto) will launch at a 55% discount over its originator product’s Wholesale Acquisition Cost (WAC). Due to discounts and rebates, insurers seldom pay that price, however. According to Amgen, a second list price 5% below Humira’s will also be available to some payers to account for rebating and discounting practices by pharmacy benefits managers.

Adalimumab is approved to treat a variety of diseases: rheumatoid arthritis, juvenile idiopathic arthritis, psoriatic arthritis, plaque psoriasis, ankylosing spondylitis, Crohn’s disease, and ulcerative colitis.

Amjevita (adalimumab-atto) was the first adalimumab biosimilar approved by the FDA, in September 2016. Its launch represents the first of up to nine adalimumab biosimilars expected to enter the U.S. market this year.

Read more about the launch here. 

On January 20th, the European Medicines Agency released a Q&A document intended to provide clarity regarding its “Statement on the scientific rationale supporting interchangeability of biosimilar medicines in the EU,” published in September 2022. That joint statement from the EMA and the Heads of Medicines Agencies (HMA) declared the interchangeability of all biosimilar medicinal products approved in the EU. Since its publication, both the EMA and National Competent Authorities (NCAs) in EU Member States have received questions about the statement which the new document is intended to address.

For example, the Q&A document clarifies that biosimilar substitution policies, including policies any potential automatic substitution of biosimilars, remain the purview of the Member States:

Q3: Does the joint EMA-HMA statement on interchangeability of biosimilars mean that switching to or between biosimilars are allowed in my country?

A3: No, EMA does not regulate prescribing practices or issue clinical guidance; these matters fall under national remit and are issued by the relevant bodies in each Member State. The statement on interchangeability of biosimilars is a general statement on the scientific principle highlighting that biosimilars can be used interchangeably and detailing the scientific references supporting this position. The statement is meant to advise those Member States that want to allow for biosimilar prescribing, including any national decision on switching and/or (automatic) substitution. However, each Member State will decide on how this is applied in their territories, e.g. which biological medicines are available for prescribing in their country and whether automatic substitution with biosimilars is allowed at pharmacy level.

Read the EMA/HMA Joint Statement here.

Read the full Q&A statement here.

In January, drug manufacturers Eli Lilly and AbbVie announced they have left the UK’s voluntary scheme for branded medicines pricing and access (VPAS), a long-standing agreement between the Government, NHS and medicine manufacturers designed to limit the cost of drugs for the health service. But these policies may jeopardize patients’ access to new treatments over time. As explained in the Telegraph:

The scheme caps the health service’s branded medicines bill, meaning that all drug manufacturers face a charge if the bill rises more than two per cent annually. The cost of that charge has risen rapidly in recent years as demand for NHS treatment has grown. As of Dec 2022, the payback rate was set at 26.5 per cent. Before the pandemic, the rate was about five per cent.

The Association of the British Pharmaceutical Industry (ABPI), the medicines trade body, said the increase puts the UK “out of step” with global competitors, with European countries such as Germany having rates of just nine per cent.

Eli Lilly, which has operated in the UK since the Forties, said that VPAS has “harmed innovation” in the UK and will turn it into a “global outlier”. Laura Steele, Eli Lilly’s president and general manager for northern Europe, said: “We simply cannot stay signed up to a scheme which has such a punishing impact on innovation.

Todd Manning, the general manager of AbbVie UK – which is currently manufacturing innovative drugs for lung cancer and inflammatory bowel disease – said that its decision to leave VPAS was not taken lightly and that the revenue clawbacks had a “demonstrable impact on our ability to operate sustainably in the UK”. He added: “Without a positive signal that the future scheme will deliver more reasonable rates, I fear it will be increasingly difficult to advocate for the UK and what I believe is our shared ambition of securing investment, jobs and, ultimately, delivering improved health outcomes for UK patients.”

Dr Richard Torbett, the chief executive at the ABPI, said “We have already seen the UK lose almost half of its global share of R&D over the past decade. For this trend to be reversed, we must develop a more internationally competitive scheme with the Government that can genuinely support the life sciences vision.”

The number of clinical trials initiated in the UK each year has fallen by more than two-fifths between 2017 and 2021. ABPI and its members said that the level will have further impacts on patients’ access to new and innovative drugs.

Read the full Telegraph article here.

Both Diabetes Canada and Crohn’s and Colitis Canada have stated they disagree with the changes, saying medication switches need to be made in conversation with the patients.

Some residents in other provinces that made the switch have reported the new drugs not being effective, while others were concerned about the resurfacing of painful flare ups they had before being put on their current medication.

Arthritis patient Megan MacLeod said she is frustrated the government is focused more “on their collective wallet than what this is going to do to people who are living with these kinds of conditions.”

Read the CBC article here.

On January 11th, the U.S. Department of Health and Human Services (HHS) announced its plan for Medicare to begin to negotiate prices for drugs as part of the recently-passed Inflation Reduction Act. As USA Today reports:

• By Sept. 1, Medicare will announce 10 retail drugs to negotiate maximum prices.
• In 2024, the agency will bargain with drug manufacturers and publish prices by September for prices that will take effect Jan. 1, 2026.
• Over the following two years, the federal health program will target another 30 retail and physician-administered drugs.
• Beginning in 2029, Medicare will negotiate prices on up to 20 drugs each year.
• Retail drugs are eligible only after they have been on the market for nine years without a competing generic version.
• Physician-administered drugs will have 13 years before being subject to negotiation.

The Centers for Medicare and Medicaid Services (CMS) released a 2-page document providing a more detailed timeline, which may be read here. 

Read USA Today’s coverage of the announcement here. 

In December, the Generics and Biosimilar Initiative (GaBI) published a whitepaper entitled “US prescribers’ attitudes and perceptions about biosimilars”, based on the findings from ASBM’s survey of 401 U.S. physicians fielded in late 2021. The paper was authored by ASBM’s Chairman Ralph McKibbin, MD, FACP, FACG, AGAF; and Executive Director Michael S. Reilly, Esq. The survey examines physician attitudes toward a wide variety of biosimilar policy issues including approval standards, non-medical switching, interchangeability, and reimbursement practices. While U.S. physicians were highly confident in the safety and efficacy of biosimilars, the survey revealed that maintaining control over treatment choices- including the ability to prevent substitution by a third party- was extremely important to the respondents. From the abstract:

Most physicians are comfortable prescribing biosimilars and comfortable switching stable patients to biosimilar products. Over half of physicians are more likely to prescribe biosimilars with interchangeable status and they are comfortable with pharmacy level substitution of these products. However, the majority want to keep the authority to prevent pharmacy level substitution if they specify so. When it came to switching patients to a biosimilar for non-medical reasons, the majority were comfortable doing this but fewer than half were comfortable with third party switching. In addition, most physicians favored a scenario where multiple products, including innovator and biosimilars are reimbursed, and biosimilars may be encouraged for new patients with no automatic substitution permitted.
The paper was published in GaBI Journal, Volume 11, Year 2022, Issue 3.

Read the full paper online here. 

Missed last month’s ASBM Newsletter? Read it Here.

In December, ASBM recorded the seventh and final module in its biosimilar Continuing Education (CE) Course on Biosimilars, presented with the Ohio State University College of Pharmacy. The latest module is entitled “PBMs and Payer Practices” and is presented by ASBM’s Immediate Past Chair Madelaine Feldman, MD, FACR.

In this module Dr. Feldman explains unique features of the U.S. drug distribution system, with an emphasis on payer and pharmaceutical benefit manager (PBM) practices regarding biologic medicines and biosimilars. The bifurcated U.S. system (provider-administered vs. self-administered/pharmacy side) is examined in detail and the differences in these two sub-markets are highlighted: in particular, the degree to which savings can be achieved, and the role played by middlemen and manufacturer rebates in driving up rather than lowering costs. Utilization management tools used by payers (including non-medical switching and step therapy) are described, as are proposed regulations and legislation to restrict such practices.

1. Discuss the role of pharmaceutical benefit managers (PBMs) in the U.S. drug distribution system
2. Explain the effects of competition on drug pricing under provider-administered and patient-administered drugs.
3. Identify several utilization management techniques used by PBMs to influence which medicine the patient receives.
4. Describe concerns that patients and physicians have regarding these PBM practices.
5. Discuss potential legislative approaches under consideration to address concerns with these PBM practices.

View all available modules of the ASBM/OSU Biosimilars Course here. 

In December, the Generics and Biosimilar Initiative (GaBI) published a whitepaper entitled “US prescribers’ attitudes and perceptions about biosimilars”, based on the findings from ASBM’s survey of 401 U.S. physicians fielded in late 2021. The paper was authored by ASBM’s Chairman Ralph McKibbin, MD, FACP, FACG, AGAF; and Executive Director Michael S. Reilly, Esq. The survey examines physician attitudes toward a wide variety of biosimilar policy issues including approval standards, non-medical switching, interchangeability, and reimbursement practices. While U.S. physicians were highly confident in the safety and efficacy of biosimilars, the survey revealed that maintaining control over treatment choices- including the ability to prevent substitution by a third party- was extremely important to the respondents. From the abstract:

Most physicians are comfortable prescribing biosimilars and comfortable switching stable patients to biosimilar product. Over half of physicians are more likely to prescribe biosimilars with interchangeable status and they are comfortable with pharmacy level substitution of these products. However, the majority want to keep the authority to prevent pharmacy level substitution if they specify so. When it came to switching patients to a biosimilar for non-medical reasons, the majority were comfortable doing this but fewer than half were comfortable with third party switching. In addition, most physicians favored a scenario where multiple products, including innovator and biosimilars are reimbursed, and biosimilars may be encouraged for new patients with no automatic substitution permitted.
The paper was published in GaBI Journal, Volume 11, Year 2022, Issue 3.

Read the full paper online here. 

In December, the Ontario government announced that it would follow other Canadian provinces including British Columbia, Alberta, Quebec and require mandatory switching to biosimilars.  a mandatory switching in 2020, but implementation was delayed due to the COVID-19 pandemic. A nine-month transition period will begin March 31st. From the government’s announcement:
Ontarians receiving coverage under the ODB program for Copaxone®, Enbrel®, Humalog®, Humira®, Lantus®, NovoRapid®, Remicade®, and Rituxan®, will be required to transition to the biosimilar version by December 29, 2023. During the transition period between March 31 and December 29, 2023, patients are encouraged to discuss a transition plan with their health care provider through in-person, telephone or virtual visits. Exemptions will be considered for patients in certain clinical circumstances on a case-by-case basis in consultation with their health care provider.

While the Ontario announcement justifies the policy by citing 15 years of successful use of biosimilars in Europe, it is important to note that in nearly every European country physicians retain free choice between multiple reimbursed products and forced substitution is rare. A 2017 survey of 403 Canadian physicians revealed that Canadian physicians are generally opposed to forced substitution: 

• 64% were not comfortable with a third party switching a patient’s medicine for non-medical reasons, as would occur under the Ontario policy. 28% were somewhat comfortable, and only 6% were completely comfortable.
• 83% considered it “very important” or “critical” that the prescribing physician decide the most suitable biologic for their patients.
• 79% considered it “very important” or “critical” to have the authority to designate on a prescription for a biologic medicine “Dispense as Written” or “Do Not Substitute”.

Read the announcement from the Ontario government here. 

On December 13th, the US Food and Drug Administration (FDA) approved its eighth biosimilar for Humira (adalimumab): Idacio (adalimumab-aacf).

Idacio is a tumor necrosis factor (TNF) blocker that blocks the production of TNF-alpha to reduce inflammation in the joints and skin. Idacio is indicated to treat a range of autoimmune disorders such as ankylosing spondylitis, Crohn’s disease, juvenile idiopathic arthritis, hidradenitis suppurativa, plaque psoriasis, psoriatic arthritis, rheumatoid arthritis, ulcerative colitis and uveitis. It is expected to launch in the US in July 2023 as self-administered prefilled syringes and self-administered prefilled pens (autoinjectors).

The approval brings the total number of biosimilars approved in the U.S. to forty.

Read more about the approval here.

Missed last month’s ASBM Newsletter? Read it Here.

The 2023 Treatment Choice Summit

Washington, DC – January 31, 2023

Festival of Biologics 2022 USA

San Diego, CA – March 20-22, 2023

WHO 76th INN Consultation

Geneva, Switzerland – March 28, 2023