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