VIDEO: Canadian Physicians on Non-Medical Switching, Biosimilar Naming
December 7, 2017
New Leadership Means New Opportunities for Better Policy
November 15, 2017
By Michael Reilly
Executive Director, ASBM
Prior to serving as ASBM’s Executive Director, I worked from 2002-2008 at the U.S. Department of Health and Human Services (HHS), including three years as Associate Deputy Secretary under Alex M. Azar, who was nominated recently as HHS Secretary. As a former health regulator, I understand the challenges we face when trying to make health policy. Generally speaking, it is important to seek the input of many stakeholders and use this input to guide your approach. When regulators fail to do this effectively, it can result in a failure both of policy and of leadership.
Earlier this month, the U.S. Centers for Medicare and Medicaid (CMS) issued its 2018 Physician Fee Schedule, which governs how the agency reimburses physicians for their services. In a major reversal of policy beginning January 1, 2018, CMS will no longer permit multiple biosimilar products to share a billing code. The original policy was finalized in 2015 over near-unanimous opposition from a diverse group of stakeholders including patient groups, physician and pharmacist organizations, and both innovator biologic and biosimilar manufacturers. ASBM was among the policy’s vocal opponents, and joined with them in citing safety and pharmacovigilance concerns as well as the possibility of discouraging further biosimilar development and higher prices overall.
CMS acknowledged this in its Final Rule:
“Most of these [more than 75] commenters stated that the CMS proposal will create access issues…Other concerns included a belief that as a result of the proposal, prescribers’ choices will be limited, that tracking or pharmacovigilance activities will be impaired, and that innovation and product development will be harmed, leading to increased costs for biosimilar products.”1
With the new Administration, however came new leadership, new ideas and a new willingness to revisit a contentious issue. In a victory for patients, incoming CMS Administrator Seema Verma reversed the previous Administration’s policy, replacing it with one that better reflects the concerns of those whom it most affects.
New leadership creates opportunities for positive change. For this reason, in advance of the World Health Organization’s 65th Consultation on International Nonproprietary Names (INNs) last month, ASBM wrote a letter to incoming WHO Director-General Dr. Tedros Adhanom Ghebreyesus urging him to act on biologic naming.
In 2014, after years of consultation with national regulatory authorities worldwide, the WHO’s INN Expert Group recommended the WHO make available a voluntary global standard for the naming of biologics and biosimilars to that product. This took the form of the “Biologic Qualifier” (BQ)- a four-letter suffix tied to the manufacturer or marketing authorization holder, appended to a root name shared by the originator product and all biosimilars to that product.
The advantages of the BQ are many; clear product identification, reducing inadvertent substitution, ensuring accurate attribution of adverse events, improved pharmacovigilance, and increased manufacturer accountability are but a few. In 2015, the FDA adopted a BQ-compatible naming system, and Health Canada and Australia’s Therapeutic Goods Administration (TGA) have indicated their support for the WHO’s plan.
Yet to date, the INN Expert Group’s recommendation has not been implemented, and regulators worldwide await the WHO’s leadership on biologic naming.
I met with the Australian TGA in February and Health Canada in October to share survey results of biologic prescribers in those countries, and they remain supportive of the WHO, if frustrated by the delay in implementation.
Around the world, ASBM has found broad support for distinct naming among physicians. 68% of Canadian physicians support distinct naming, as do 76% of their Australian counterparts. In the U.S., 66% of physicians and 68% of pharmacists support it.
In Latin America, where pharmacovigilance systems are often less robust than in the wealthiest countries, an astonishing 94% of physicians surveyed support the BQ as a useful tool for ensuring their patients receive the correct medicine.
The BQ is a well-considered and practicable solution to the global problem of biologic naming. The WHO has the world’s confidence and is unquestionably the best situated to facilitate global harmonization. Yet regulators recognize the need for action is immediate, and in frustration, are looking elsewhere. The TGA recently solicited input on whether they should harmonize instead with the U.S., or create their own distinct naming system. So today we are witnessing the beginning of the fragmentation the BQ was created precisely to avoid. Further delay in BQ implementation risks undermining harmonization efforts and additional proliferation of country-specific naming schemes.
As in the CMS example, new leadership brings with it the chance to revisit and correct the errors of the past, to listen to stakeholders, and to get health policy right for those it affects most.
It remains our hope that under Dr. Tedros’ leadership, the WHO will act soon to extend the many protections of distinct naming to patients worldwide.
1 80 Fed. Reg. 71093 (November 16, 2015)
FDA Launches Biosimilar Education Site for Prescribers
November 5, 2017
|
On October 23rd, the FDA launched a robust online resource center aimed at educating prescribers on biosimilars. The website includes fact sheets which explain regulatory terminology such as, “reference product” and “interchangeability”. The fact sheets also detail the biosimilar approval process as well as explain how these medicines are prescribed and substituted.
Sections include: Biosimilar and Interchangeable Products; Biosimilar Development, Review, and Approval; Prescribing Biosimilar and Interchangeable Products; Biosimilar Product Information; Industry Information and Guidance; Online Courses, Webinars, and Presentations; and Patient and Prescriber Outreach Materials. Drop in content, such as a newsletter article for prescribers, as well as social media posts are also made available by the FDA for circulation.
ASBM surveys of physicians worldwide have consistently shown the need for further education on biosimilars.
Visit the full FDA biosimilars site here. |
FDA Launches Biosimilar Education Site for Prescribers
November 5, 2017
|
On October 23rd, the FDA launched a robust online resource center aimed at educating prescribers on biosimilars. The website includes fact sheets which explain regulatory terminology such as, “reference product” and “interchangeability”. The fact sheets also detail the biosimilar approval process as well as explain how these medicines are prescribed and substituted.
Sections include: Biosimilar and Interchangeable Products; Biosimilar Development, Review, and Approval; Prescribing Biosimilar and Interchangeable Products; Biosimilar Product Information; Industry Information and Guidance; Online Courses, Webinars, and Presentations; and Patient and Prescriber Outreach Materials. Drop in content, such as a newsletter article for prescribers, as well as social media posts are also made available by the FDA for circulation.
ASBM surveys of physicians worldwide have consistently shown the need for further education on biosimilars.
Visit the full FDA biosimilars site here. |
New York Becomes 36th State to Pass Biosimilar Substitution Law
November 5, 2017
|
On Monday, October 23rd, Governor Andrew Cuomo signed biosimilars legislation (S.4788A/A.7509A) regarding the pharmacy substitution of interchangeable biosimilar medical products—a measure ASBM and others have pursued in New York over the past two years.
New York is now the 36th state to pass biosimilars substitution legislation. This law (Chapter 357 of the Laws of 2017) will pave the way for interchangeable biologic substitution in the State of New York while enhancing patient access to biosimilars. It ensures pharmacy-physician communication by requiring that the pharmacist notify the physician which biologic the patient received without posing undue or onerous burdens on pharmacists. It also requires a pharmacist to inform the patient which product, innovator or biosimilar, he or she has been prescribed. Lastly, it allows for physicians to prohibit substitution should they deem it necessary. This legislation keeps treatment decisions within the purview of the physician and the patient.
This legislation would not have passed without the overwhelming support of the physician and patient communities in the state.
See ASBM’s recent letter to the NY Governor here. |
New York Becomes 36th State to Pass Biosimilar Substitution Law
November 5, 2017
|
On Monday, October 23rd, Governor Andrew Cuomo signed biosimilars legislation (S.4788A/A.7509A) regarding the pharmacy substitution of interchangeable biosimilar medical products—a measure ASBM and others have pursued in New York over the past two years.
New York is now the 36th state to pass biosimilars substitution legislation. This law (Chapter 357 of the Laws of 2017) will pave the way for interchangeable biologic substitution in the State of New York while enhancing patient access to biosimilars. It ensures pharmacy-physician communication by requiring that the pharmacist notify the physician which biologic the patient received without posing undue or onerous burdens on pharmacists. It also requires a pharmacist to inform the patient which product, innovator or biosimilar, he or she has been prescribed. Lastly, it allows for physicians to prohibit substitution should they deem it necessary. This legislation keeps treatment decisions within the purview of the physician and the patient.
This legislation would not have passed without the overwhelming support of the physician and patient communities in the state.
See ASBM’s recent letter to the NY Governor here. |
CMS Reverses Course on Shared Billing Codes for Biosimilars
November 5, 2017
|
On November 2nd, 2017, the Centers for Medicare and Medicaid Services (CMS) issued a final rule for the 2018 Physician Fee Schedule, which governs reimbursement rates for physicians.
In a significant development, beginning in 2018 CMS will update payment for biosimilars. Under the previous rule finalized in 2015 under the Obama Administration, all of the biosimilars sharing one reference product shared a single billing code. The initial policy had faced broad opposition from manufacturers of biologics and biosimilars, as well as representatives of the physician, pharmacist, and patient communities. ASBM was among these opponents.
On September 11, 2017, ASBM submitted comments to CMS which reiterated our concerns in detail and urged CMS to reconsider the policy. From the comments:
[The use of shared billing codes] disproportionately prioritizes cost among the many factors that go into making a treatment decision. These include whether or not a biosimilar was approved for a particular indication; whether its comparability to the reference product was ever demonstrated by studies in that indication or whether its effects were merely extrapolated from studies in different indications; whether the FDA determined the biosimilar is “interchangeable” with its reference product (producing the same effects without additional risks); product features such as ease and frequency of administration; the quality of patient support programs; the degree of discomfort associated with injections; whether it can it be administered at home; and whether it will be consistently available (not subject to shortages).
Second, the use of a shared identifier for multiple different biologic products implies an identicality between them which does not exist and an interchangeability between them that may or may not have been demonstrated…
Finally, shared codes may also have the unintended consequence of disincentivizing biosimilar development itself. Regardless of whether a manufacturer develops a less expensive manufacturing process or a delivery system that makes compliance more likely or reduces waste but costs more, they will be paid at the same rate. Reduced biosimilar development means reduced price competition, which could jeopardize any potential cost savings to patients and payers.
This shift in policy promotes competition to ensure millions of patients will have access to new lower cost therapies. Michael Reilly, Executive Director of ASBM praised the move: “Under the leadership of Administrator Verma, CMS has adopted a policy that makes sense for patients. It promotes the development of new therapeutic options, brings down costs, and improves pharmacovigilance. It’s a major victory for patients.” Read more about the CMS decision here. |
ASBM Presents at 65th WHO Naming Meeting
October 20, 2017
|
On October 17th, ASBM Chair, Madeline Feldman, M.D., FACR; Advisory Board Chair, Philip Schneider, MS, FASHP; and Executive Director, Michael Reilly, Esq. appeared before the 65th Consultation on International Nonproprietary Names (INN) for Pharmaceutical Substances in Geneva, Switzerland.
ASBM has regularly appeared before the INN Consultation since 2013 and continues to advocate for distinguishable naming of biologics — more recently in support of the adoption of a Biological Qualifier (BQ) proposal as a solution on naming. The BQ proposal is a random, non-memorable 4-letter consonant only suffix that would be assigned to all biological active substances.
Should the WHO advance the BQ proposal, it would give other nations around the world a model that they may choose to adopt, thereby creating a world standard. ASBM surveys have shown strong support for distinct naming among physicians worldwide. Sixty-six percent of U.S. physicians surveyed support distinct naming for all biologics including biosimilars, as do 68% of Canadian and 79% of Australian physicians. Among physicians in Latin America, 94% believe the WHO’s BQ proposal would be helpful in ensuring their patients receive the correct medicine.
In advance of the trip to Geneva, ASBM submitted a letter to the Director General ASBM’s letter stated:
Read full letter here. |
Alliance for Safe Biologic Medicines Releases 2017 Canadian Prescriber Survey
October 17, 2017
For Immediate Release
~National survey reveals physician attitudes on key policy issues related to
originator biologics and biosimilars ~
Ottawa, Ontario (November 22, 2017) A new national survey conducted by the Alliance for Safe Biologic Medicines (ASBM) found that Canadian physicians overwhelmingly support distinguishable names for all biologics, including biosimilars. Survey results also found that Canadian physicians are open to substituting biosimilars for non-medical reasons, only when they are the ultimate decision maker for their patient, not a third-party.
The results of the survey were recently presented at the Drug Information Association (DIA) Annual Canadian meeting in Ottawa by ASBMs immediate past chairman, Harry Gewanter, M.D.
Distinguishable non-proprietary naming for all biologic medicines is important for the appropriate use of originator biologics and biosimilars, as well as pharmacovigilance, said Gewanter. Further, Canadian physicians believe it is critical that the physician-patient relationship remains central when deciding which treatments their patients will utilize.”
The 2017 ASBM Canadian physician survey is a follow-up to a previous survey conducted in 2014 and includes 403 physicians across 13 major therapeutic specialties all of whom prescribe biologics. ASBMs first Canadian survey was commissioned by ASBM in 2014 to provide empirical data to Health Canada, provincial policymakers, and other health regulators.
Survey results show that Canadian physicians knowledge of biosimilars has improved significantly over the last three years, with a nearly-threefold increase in respondents stating they were very familiar with biosimilars (10 per cent in 2014 increasing to 28 per cent in 2017).
On the clinical implications of public policy issues concerning originator biologics and biosimilars, survey results showed:
On the naming of originator biologics and biosimilars:[1]
- 68 per cent of physicians support Health Canada implementing distinguishable names, yet there was no consensus as to best method.
- 54 per cent believe a biosimilar which shares an INN with its reference product implies the two are structurally identical, which is not the case; and
- 63 per cent believe a biosimilar which shares an INN with its reference product implies the two were approved for the same indications, which may or may not be the case.
On pharmacy substitution of a biosimilar in place of a prescribed originator biologic:[2]
- 83 per cent considered it very important or critical that the prescribing physician decide the most suitable biologic for their patients;
- 79 per cent 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;
- 78 per cent considered it very important or critical to be notified in the event a biosimilar is substituted at the pharmacy; and
- 82 per cent of physicians support switching studies before a third party may automatically substitute biosimilars.
The results of our survey provide important insight and evidence to regulators and policymakers on the perspectives of Canadian prescribers of biologic medicines,” said Michael Reilly, Executive Director of ASBM. For originator biologics and biosimilars to be used successfully, decision makers should rely on the input and opinions of those who prescribe them, working collaboratively to develop policies that minimize potential safety or efficacy issues.
For nearly seven years, ASBM has commissioned physician surveys to gather the perspectives of biologic prescribers worldwide. The full results of the 2017 Canadian survey, as well as ASBM’s other surveys, may be viewed at www.SafeBiologics.org/surveys.
About the Survey
The Alliance for Safe Biologic Medicines (ASBM) surveyed 403 Canadian prescribers of biologics with a 15-minute web survey. Respondents were selected from selected from 13 therapeutic specialties, including: Allergy/Immunology (3 per cent), Dermatology (21 per cent), Endocrinology (9 per cent), Gastroenterology (9 per cent) Hematology/Oncology (5 per cent), Infectious Diseases (1 per cent), Internal Medicine (19 per cent), Nephrology (3 per cent), Neurology (5 per cent), Oncology (9 per cent), Respiratory/Pulmonology (6 per cent), Rheumatology (10 per cent), and Urology (2 per cent). All prescribe biologic medicines in their practice.
About the Alliance for Safe Biologic Medicines
The Alliance for Safe Biologic Medicines (ASBM) is an organization composed of diverse healthcare groups and individuals from patients to physicians, innovative medical biotechnology companies, and others who are working together to ensure patient safety is at the forefront of the biosimilars policy discussion. Visit us at www.SafeBiologics.org.
For more information, please contact:
Sunil Suvarna
Hill+Knowlton Strategies
1-778-772-5133
[1] Alliance for Safe Biologic Medicines (ASBM). 2017 Canadian Prescriber Survey.
[2] Alliance for Safe Biologic Medicines (ASBM). 2017 Canadian Prescriber Survey.
Alliance for Safe Biologic Medicines Releases 2017 Canadian Prescriber Survey
October 17, 2017
For Immediate Release
~National survey reveals physician attitudes on key policy issues related to
originator biologics and biosimilars ~
Ottawa, Ontario (November 22, 2017) A new national survey conducted by the Alliance for Safe Biologic Medicines (ASBM) found that Canadian physicians overwhelmingly support distinguishable names for all biologics, including biosimilars. Survey results also found that Canadian physicians are open to substituting biosimilars for non-medical reasons, only when they are the ultimate decision maker for their patient, not a third-party.
The results of the survey were recently presented at the Drug Information Association (DIA) Annual Canadian meeting in Ottawa by ASBMs immediate past chairman, Harry Gewanter, M.D.
Distinguishable non-proprietary naming for all biologic medicines is important for the appropriate use of originator biologics and biosimilars, as well as pharmacovigilance, said Gewanter. Further, Canadian physicians believe it is critical that the physician-patient relationship remains central when deciding which treatments their patients will utilize.”
The 2017 ASBM Canadian physician survey is a follow-up to a previous survey conducted in 2014 and includes 403 physicians across 13 major therapeutic specialties all of whom prescribe biologics. ASBMs first Canadian survey was commissioned by ASBM in 2014 to provide empirical data to Health Canada, provincial policymakers, and other health regulators.
Survey results show that Canadian physicians knowledge of biosimilars has improved significantly over the last three years, with a nearly-threefold increase in respondents stating they were very familiar with biosimilars (10 per cent in 2014 increasing to 28 per cent in 2017).
On the clinical implications of public policy issues concerning originator biologics and biosimilars, survey results showed:
On the naming of originator biologics and biosimilars:[1]
- 68 per cent of physicians support Health Canada implementing distinguishable names, yet there was no consensus as to best method.
- 54 per cent believe a biosimilar which shares an INN with its reference product implies the two are structurally identical, which is not the case; and
- 63 per cent believe a biosimilar which shares an INN with its reference product implies the two were approved for the same indications, which may or may not be the case.
On pharmacy substitution of a biosimilar in place of a prescribed originator biologic:[2]
- 83 per cent considered it very important or critical that the prescribing physician decide the most suitable biologic for their patients;
- 79 per cent 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;
- 78 per cent considered it very important or critical to be notified in the event a biosimilar is substituted at the pharmacy; and
- 82 per cent of physicians support switching studies before a third party may automatically substitute biosimilars.
The results of our survey provide important insight and evidence to regulators and policymakers on the perspectives of Canadian prescribers of biologic medicines,” said Michael Reilly, Executive Director of ASBM. For originator biologics and biosimilars to be used successfully, decision makers should rely on the input and opinions of those who prescribe them, working collaboratively to develop policies that minimize potential safety or efficacy issues.
For nearly seven years, ASBM has commissioned physician surveys to gather the perspectives of biologic prescribers worldwide. The full results of the 2017 Canadian survey, as well as ASBM’s other surveys, may be viewed at www.SafeBiologics.org/surveys.
About the Survey
The Alliance for Safe Biologic Medicines (ASBM) surveyed 403 Canadian prescribers of biologics with a 15-minute web survey. Respondents were selected from selected from 13 therapeutic specialties, including: Allergy/Immunology (3 per cent), Dermatology (21 per cent), Endocrinology (9 per cent), Gastroenterology (9 per cent) Hematology/Oncology (5 per cent), Infectious Diseases (1 per cent), Internal Medicine (19 per cent), Nephrology (3 per cent), Neurology (5 per cent), Oncology (9 per cent), Respiratory/Pulmonology (6 per cent), Rheumatology (10 per cent), and Urology (2 per cent). All prescribe biologic medicines in their practice.
About the Alliance for Safe Biologic Medicines
The Alliance for Safe Biologic Medicines (ASBM) is an organization composed of diverse healthcare groups and individuals from patients to physicians, innovative medical biotechnology companies, and others who are working together to ensure patient safety is at the forefront of the biosimilars policy discussion. Visit us at www.SafeBiologics.org.
For more information, please contact:
Sunil Suvarna
Hill+Knowlton Strategies
1-778-772-5133
[1] Alliance for Safe Biologic Medicines (ASBM). 2017 Canadian Prescriber Survey.
[2] Alliance for Safe Biologic Medicines (ASBM). 2017 Canadian Prescriber Survey.
