| Comment Period on NIOSH Hazardous Drugs List Extended to July 30th
The National Institute for Occupational Safety and Health (NIOSH) has extended the comment period regarding its proposed Hazardous Drugs List additions for 2020. The comments on the proposed list are now due July 30th.
Several biologic medicines have been proposed- in ASBM’s view inappropriately- for inclusion on the 2020 NIOSH Proposed List of Hazardous Drugs in Healthcare Settings.
Drugs listed on this NIOSH list compel healthcare workers to take extraordinary precautions including stringent facility, personal protective equipment, training, and waste disposal requirements specified in standards such as USP chapter 800. This increases the cost of using drugs listed as hazardous substances, and may limit the sites at which these critical medications are available and can be administered such as infusion clinics and a physician’s office setting.
More information about the Proposed List of Hazardous Drugs may be found here. Comments may be submitted online here or mailed to:
NIOSH Docket Office
1090 Tusculum Avenue
MS-C34
Cincinnati, OH 45226-1998
Reference: Docket # CDC-2020-0046 and # NIOSH-233-C
|
|
ASBM Chair Featured in Webinar on Rebate Walls and Step Therapy
On June 24th, ASBM Chair Madelaine Feldman, MD, FACR, participated in a webinar on the topic of pharmaceutical rebate walls and step therapy. These policies and utilization management techniques used by pharmacy benefit managers (PBMs) often pose impediments to patients accessing the therapies they and their doctors have chosen.
The webinar was sponsored by the Coalition to Protect Patient Choice. In addition to Dr. Feldman, the event also featured a diverse group of speakers from the healthcare space, including: -Robin Feldman, Professor, UC Hastings Law
-Steven Newark, Director of Policy and General Counsel, Global Healthy Living Foundation
-Jennifer Snow, VP for Reimbursement Policy, Xcenda, LLC
-Holly Vedova, Attorney Advisor to the Commissioner, Federal Trade Commission
“Biosimilars can provide substantial health and savings benefit to patients, but they may not be available to patients based on PBM policies and utilization management techniques. These practices interfere with the physician-patient relationship, and generally do not result in savings to the patient but rather, profit for the PBM.” said Dr. Feldman.
View the webinar presentations here. |
Biosimilar Working Group Sends Letter to Manitoba Opposing Forced Substitution
In a letter dated June 18, the Canada-based Biosimilar Working Group (BWG) urged the Canadian province of Manitoba to reject the forced-substitution policies some provinces are implementing to increase biosimilar uptake. The letter was addressed to Cameron Friesen, Manitoba’s Minister of Health, Seniors, and Active Living.
From the letter:
We have concerns regarding implementation of any policies that would switch patients stable on an originator biologic medication to its biosimilar. We have strong medical reasons and unaddressed issues that underpin our thoughts and conclusions.
In your upcoming deliberations, we request full consultations with patient groups before you reach any conclusions. This way, policy can be forged in a manner that keeps Canadians safe, especially during this current pandemic and beyond. There can be no one-size-fits-all approach and developing policy with fulsome input from those who will be directly impacted will help achieve the desired outcomes effectively.
A recent report from INESSS, the Quebec health technology assessment body, concludes that there are certain populations on biologics for which very little or no data are available regarding the safety of biologics switching, and identifies significant concerns that clinicians have about non-medical switching. Most of the available scientific data have methodological limitations and raise significant uncertainties. Therefore, conducting adequate clinical studies with a larger number of individuals from these populations and greater homogeneity in the participants’ baseline characteristics would be useful for better determining the impact of switching between biologics.
The Biosimilars Working Group, of which ASBM is a member, is a key collaboration of diverse non-profit organizations, registered health charities, and healthcare advocacy coalitions who are dedicated to ensuring that good outcomes for patients are at the centre of health policy in Canada, specifically in the biologic medication treatment areas.
Read the full letter here.
Learn more about the Biosimilars Working Group here.
|
WHO Releases Executive Summary of WHO 70th INN Consultation
In June, the World Health Organization released an Executive Summary of its 70th Consultation on International Nonproprietary Names (INN) for Pharmaceutical Substances, held in Geneva, Switzerland on April 21st. ASBM presented virtually at this conference, represented by Executive Director Michael Reilly, Esq., and Advisory Board Chair Philip Schneider, MS, FASHP.
From the Executive Summary:
The Covid-19 pandemic highlights the leadership that WHO has in global health, and ASBM believes that this leadership is critical also for the naming of biosimilars, as it has repeatedly stated, especially as the number of biosimilars is increasing each year. It is also important to recognise that the biological qualifier (BQ) is still valid and that broad support for the BQ remains. The US FDA is supportive of unique identifiers for biologics and has instigated its own random 4-letter suffix. Health Canada (HC) has been a past supporter and is willing to harmonise, similarly the Australian TGA.
The ASBM noted that many other countries including Denmark, Japan and Jordan also support the BQ, while physicians are also supportive. However, despite this support, countries have developed their own systems but would have used a WHO system if WHO had moved ahead with the BQ.
The most common objection to a distinct suffix is that it implies biosimilars are inferior products and the US Federal Trade Commission (FTC) has raised the possibility that the current FDA naming system deters prescribers from using biosimilars, and impedes competition and price reduction. Some state pharmacists also feel that way. This false impression of inferiority has prompted two recent high-level meetings in Washington DC. The first was a joint FDA/FTC workshop, to address accusations that there had been disinformation to undermine physicians’ confidence in biosimilars, to address a perceived need for education on biosimilar safety, and a need to address patent regulation that has held back the use of biosimilars in the USA.
However, market share data suggest little, if any, lack of confidence in biosimilar use; for example, the market share of biosimilar ZARXIO (filgrastim-sndz) surpasses that of the reference product NEUPOGEN (filgrastim) in both the EU and the USA. So, the argument that the suffix creates a lack of confidence is false.
View ASBM’s presentation to the WHO INN Committee here:
Read the Executive Summary of the 70th INN Consultation here.
|
ASBM Presents Poster on EU Physician Survey at DIA 2020
From June 14-18, ASBM presented a poster abstract entitled “European Physician Perspectives on Biosimilars” at the DIA 2020 Global Annual Meeting, which was held virtually. ASBM Advisory Board Chair Philip Schneider, MS, FASHP, FFIP, who co-authored the poster, recorded a video walk-through of the poster which may be viewed here.
Data was drawn from the 2019 survey of 579 prescribers of biologic medicines from 10 practice areas in 6 Western European countries. This is also the first time the full survey findings have been made publicly available. Topics included physician perspectives on prescribing biosimilars, physician-led biosimilar substitution, third party substitution, adverse event reporting, and design of government tenders.
Among the survey’s key findings were that European physicians have increased their familiarity with biosimilars since last surveyed in 2013, but as their familarity increased, so has the importance of maintaining control of treatment decisions.
- 82% consider maintaining physician control of treatment decisions to be very important or critical, representing a 10% increase from the 2013 survey.
- Physicians are also highly uncomfortable with a non-medical substitution initiated by a third party. This figure has also increased sharply since the 2013 survey: 73% are uncomfortable with this, compared to 58% in 2013.
- A strong majority (63%) consider it highly important for governments to make multiple therapeutic choices available in tenders, and a very strong majority (83%) believe these tenders should take into account factors besides price.
As with previous ASBM physician surveys, the European survey data will be the subject of a forthcoming article in the GaBI Journal, which will examine its results in even greater detail.
View the DIA 2020 poster here.
View Dr. Schneider’s video walkthrough here.
View the full European physician survey results here.
|
| ASBM Exhibits in BIO DIgital’s Virtual Patient Advocacy Pavilion
From June 8-12, ASBM exhibited virtually as part of BIO Digital in the event’s Virtual Patient Advocacy Pavilion. ASBM’s online presence at the pavilion featured links to numerous resources on key biosimilar policy issues.
These included educational one-pagers on non-medical switching and automatic substitution; physician survey data from 13 countries, and recent whitepapers including “Policy recommendations for a sustainable biosimilars market: lessons from Europe”, appearing in the June edition of GaBI Journal.
|
| ASBM Presents E-Poster on European Rehumatologist Perspectives at EULAR E-Congress
On June 3rd, ASBM presented a poster abstract entitled “European Prescribers’ Perspectives on Biosimilars” at the 2020 Congress of the European League Against Rheumatism (EULAR), the group’s annual meeting, held virtually this year. The poster abstract’s authors were ASBM Chair Madelaine Feldman, MD, FACR; and executive director Michael Reilly.
The poster specifically highlighted rheumatologist perspectives, with data drawn ASBM’s 2019 survey of 579 European physicians in France, Germany, Italy, Spain, Switzerland, and the UK. Topics included physician attitudes on prescribing biosimilars, non-medical switching, and design of government tenders. Key findings included:
- Rheumatologists were the most with familiar with biosimilars among the practice areas surveyed (99% familiar).
- They had a higher than average comfort level prescribing biosimilars to new patients: 60% of rheumatologists were “very comfortable” doing so, while the average figure across the ten specialties surveyed was 34%.
- Rheumatologists were also the least comfortable with a third party switching their patient for non-medical reasons (e.g. cost): 49% were “very uncomfortable” with this practice, compared to an average of 29% across all specialties.
View the EULAR 2020 poster here.
|
| UPCOMING EVENTS
World Drug Safety Congress 2020
Virtual – September 1-2, 2020
WHO 71st Consultation on International Nonproprietary Names
Geneva, Switerland – October 20-23, 2020
World Biosimilar Congress Europe 2020
Basel, Switzerland – November 3-5, 2020
|
|
|
|
|
|
