December 2019 Newsletter
December 24, 2019
|
November 2019 Newsletter
December 13, 2019
|
ASBM Newsletter
Alliance for Safe Biologic Medicines
PO Box 3691 202-870-1480
Arlington, VA 22203
Alberta Announces Forced Biosimilar Substitution Policy for Half its Patients
December 13, 2019
Health Minister Tyler Shandro Announces Policy that Eliminates Physician and Patient Choice of Biologic Medicine for Half of Albertans
EDMONTON- the Government of Alberta announced that it will begin forcibly switching 26,000 patients from their physician-chosen biologic medicines to government-chosen biosimilars beginning July 1st, 2020. These patients include 22,000 Albertans with diabetes, 2,000 with Crohn’s disease or ulcerative colitis, 1,400 with rheumatic diseases, 750 with multiple sclerosis, 450 with low white-blood cell counts and 35 with plaque psoriasis, according to the Alliance for Safe Biologic Medicines (ASBM).
ASBM is a global coalition of physicians and patient advocates, including 14 Canadian organizations and more than 50 European patient advocacy groups, that has worked closely with Canadian advocacy organizations in recent years to share physician and patient perspectives with policy makers.
Only half of Albertan patients- those on public pharmacare plans- will be subject to the forced-switching policy. Patients on private health plans, including Ministry of Health officials, will not be forced to switch. Children and pregnant women are also exempted. “For the affected patients, Health Minister Tyler Shandro is supplanting the role traditionally played by their physician’s medical judgment” says ASBM executive director Michael Reilly. “In effect this creates two groups of Albertans- one who get medicine prescribed by their physician, and another who get medicine prescribed by politicians.’
The decision follows a similar announcement from British Columbia last May which has drawn sharp criticism from physician and patient advocacy organizations, who object to the switching of stable patients for non-medical reasons. Representatives from the gastroenterology specialty and main GI patient groups were notably absent at the scheduled announcement. According to Crohn’s and Colitis Canada, which held a rally December 1st to raise awareness of the impending policy announcement, patients have sent in more than 11,000 letters urging the Alberta government to reconsider its position.
While biosimilars are safe and effective near-copies of the biologic medicines they mimic, unlike generics, they are not identical to their originator products. This fact means that their automatic substitution is rarely practiced among the advanced nations of the world. In a 2017 survey, 83% of Canadian physicians considered it very important or critical that they decide the most suitable biologic for their patient. 64% were uncomfortable with a third party switching a patient’s biologic medicine for non-medical (e.g. cost) reasons, as occurs in the B.C. and Alberta policies.
In its interview with Minister Shandro on the policy, the Globe and Mail cites the success of biosimilars in Europe, but fails to note that European countries overwhelmingly reject forced substitution policies like those of B.C. and Alberta.
“In the vast majority of European countries, the decision of which biologic product to prescribe remains with the physician and the patient, and they are free to choose between multiple products, including the originator, and these are reimbursed. ” says Reilly. “Building physician and patient confidence in biosimilars has been the key to their success, not forced switching. Simply ending reimbursement of the originator product by a government fiat is not a policy in European countries.”
Europe is the global leader in biosimilar approvals and commercialization, with more than 60 biosimilar products approved and the largest share of the world’s biosimilar market. European countries have seen market shares as high as 43% for biosimilars approved post-2013, and as high 91% for older products.
“Minister Shandro says this policy is intended to help create a sustainable biosimilar market, yet it moves Alberta in precisely the opposite direction from the thriving biosimilar markets of Europe,” Reilly observes. “Canadian provinces wishing to emulate Europe’s success should reject forced-substitution and instead look to Europe’s proven substitution policies- in which many products are reimbursed and allowed to compete, creating downward price pressures and high biosimilar uptake rates without sacrificing physician and patient control of treatment decisions.”
###
contact: media@safebiologics.org
New White Paper To Detail European Biosimilar Evolution and Policy Principles
November 9, 2019
November 6, 2019 – Gatineau, Quebec – The Alliance for Safe Biologic Medicines (ASBM) today released an abstract from a forthcoming white paper that provides a comprehensive overview of the evolution of the European biosimilars market. The abstract was released in conjunction with the Drug Information Association (DIA) Annual Canadian Meeting, an annual meeting of Canadian health regulators and pharmaceutical manufacturers, held this year in Gatineau, Quebec. The full whitepaper will be published in the Journal of the Generics and Biosimilars Initiative (GaBI Journal) later this month.
As the world leader in biosimilar approval and commercialization, Europe comprises more than half of the global biosimilar market with more than 60 approved biosimilars. Average biosimilar uptake rates across European countries is 43% for complex biosimilars such as monoclonal antibodies, first approved in 2013. For older biosimilars approved before 2013 the average market share is 91%, according to the whitepaper. From the abstract:
“European countries, with their diverse healthcare systems and their experience to date, serve as real world examples of different approaches of biosimilar policies to build an efficient and sustainable biosimilar market, and thus offer an opportunity for other countries to learn and to avoid mistakes which may put short but in particular long-term savings at risk.”
In the vast majority of European countries, the payer reimburses multiple products, including the originator. This ensures a sustainable biosimilar market with multiple suppliers competing in a given product class. Even in Norway with its national tender system, physicians retain the option to prescribe any of the available products but are strongly encouraged to choose the lowest priced product, in particular for newly treated patients.
ASBM Executive Director, Michael Reilly expressed his hope that the white paper will serve as an educational resource for countries outside of Europe seeking to build robust and sustainable biosimilars programs and policies for their patients that are similar to those found across European Union Member States.
Contact: Media@safebiologics.org
###
ASBM Exhibits at DIA Annual Canadian Meeting
November 8, 2019
On November 5th and 6th, ASBM exhibited at the (Drug Information Association (DIA) Annual Canadian Meeting, a meeting of Canadian regulators, researchers, health professionals and pharmaceutical manufacturers. Held in Gatineau, Quebec, just outside the Canadian capital of Ottawa, the meeting’s purpose is to present a comprehensive overview of the current bio-pharma and device landscape in Canada, while sharing insights into Canada’s broader role in global healthcare product development. Session topics included the patient experience, international collaboration, and the use of real-world evidence in safety and efficacy monitoring.
ASBM was represented at the conference by Advisory Board Chair Philip Schneider, MS FASHP FFIP. At ASBM’s booth, Schneider met with conference attendees, including several Health Canada officials, to discuss ASBM’s work. Policy issues discussed included the importance of distinct biologic nomenclature in pharmacovigilance, efforts toward international harmonization of biologic nomenclature, and emerging biosimilar substitution policies in Canada.
With Canadian provinces beginning to adopt their own biosimilar substitution policies, ASBM also used the Meeting as an opportunity to discuss potential lessons that could be learned from European countries. While at DIA Canada, ASBM released the abstract of a forthcoming whitepaper on the European biosimilars experience, co-authored by Dr. Schneider and ASBM executive director Michael Reilly. The paper examines the policies which led to Europe’s success- including preserving physician choice and promoting competition between multiple products:
“Due to its global leadership in biosimilar regulation and approvals, the biosimilar market in Europe has been the largest market to date, representing approximately 60% of the global biosimilar market and growing consistently year over year. As a result, European countries with their diverse healthcare systems and their experience to date serve as real world examples of different approaches of biosimilar policies to build an efficient and sustainable biosimilar market and thus offer an opportunity for other countries to learn and to avoid mistakes which may put short but in particular long-term savings at risk.”
The abstract was available at the ASBM booth, as was a new fact sheet, entitled “What Can Canada Learn From the European Biosimilar Experience?”, which incorporates findings from the whitepaper, data from ASBM’s recent survey of 579 European physicians, and the perspectives of Canadian physicians and patient advocacy organizations on substitution policy.
ASBM Advisory Board Chair Philip Schneider (right) discusses biosimilar policy with a Health Canada official.
October 2019 Newsletter
November 1, 2019
|
This message was sent to email@example.com from media@safebiologics.org
ASBM Newsletter
Alliance for Safe Biologic Medicines
PO Box 3691 202-870-1480
Arlington, VA 22203
October 2019 Newsletter
November 1, 2019
|
This message was sent to email@example.com from media@safebiologics.org
ASBM Newsletter
Alliance for Safe Biologic Medicines
PO Box 3691 202-870-1480
Arlington, VA 22203
ASBM Presents to WHO, Urging International Harmonization of Biologic Nomenclature
October 28, 2019
On October 22nd, ASBM presented at the World Health Organization’s (WHO’s) 69th Consultation on International Nonproprietary Names (INN) for Pharmaceutical Substances in Geneva, Switzerland. This was the thirteenth INN Consultation at which ASBM has presented. ASBM was represented by Executive Director Michael Reilly, Esq., and Advisory Board Chair Philip Schneider, MS, FASHP.
While the discussions in the Open Session at which ASBM presented are bound by confidentiality agreements pending the publication of an Executive Summary by the INN Programme, the Executive Summary from the 68th INN Consultation – held on April 2, 2019 and in which ASBM also participated – may be viewed here.
Since 2013, ASBM has worked extensively on the issue of international harmonization of biologic nomenclature, most recently by hosting a series of meetings with FDA, Health Canada, and the WHO. Dr. Schneider also gave a presentation on the value of distinct biologic naming and the status of harmonization efforts at the DIA Global Annual Meeting in June. In 2014, the WHO proposed that all biologics sharing an INN be assigned a unique four-letter suffix called a “biological qualifier” or BQ. While initially supported by many national regulatory authorities including the FDA, Health Canada, and Australia’s Therapeutic Goods Administration (TGA), the BQ proposal has not yet been implemented. In 2015 the FDA adopted its own BQ-like suffix system, and until recently was in conversations with Canada about harmonizing nomenclature systems regionally.
ASBM surveys have consistently shown strong support for distinct naming among physicians worldwide. 66% 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.
Fact Sheet: What Can Canada Learn from the European Biosimilar Experience?
October 28, 2019
The undisputed leader in biosimilars with more than 60 products approved and the largest biosimilar market in the world, Europe has achieved impressive biosimilar uptake rates. These can be as high as 91% for older products (before the approval of the first monoclonal antibody biosimilar in 2013) and up to 43% for newer products (approved post-2013).
As Canadian provinces including British Columbia and Alberta look to duplicate Europe’s success, ASBM has prepared this fact sheet to serve as a resource.
The fact sheet contrasts the principles that Europe has embraced- which include preserving physician/patient choice, promoting competition between multiple products, and prohibiting automatic substitution- with the forced-switching policy announced by the government of British Columbia – and is being considered by other provinces.
B.C. Health Minister Adrian Dix cited Europe’s high biosimilar uptake rates as a justification for the [forced-switching] policy, but disregards the path and principles that led to Europe’s success:
- It was not accomplished through a reimbursement ban on originator biologics, i.e., the limitation of medicine choice and resulting forced-switching mandates.
- Instead, cost reductions were achieved by preserving choice for physicians and patients and promoting competition between all approved products based on many factors including cost, clinical evidence, delivery mechanism, patient history, and other factors.
- In nearly every European country, automatic substitution of biologic medicines is not permitted.
- Not only does the B.C. policy have no analogue among Western European countries, it is built upon principles Europe has overwhelmingly rejected.
European physicians have had 13 years of experience with biosimilars, and thus have high familiarity and confidence in them.
- Yet the majority (57%) are opposed to switching their patients to a biosimilar for non-medical (cost) reasons.
- They even more strongly oppose (73%) a third-party initiated non-medical switch of their patients’ biologic medicines, as occurs in the British Columbia policy, and which other provinces are considering.
ASBM’s 2017 survey of Canadian physicians showed similarly strong opposition (64%) to the third-party switching of stable patients for non-medical (e.g. cost) reasons.
Canadian physician groups and patient advocacy organizations have also raised concerns raised with the BC forced-switching policy.
Click here to read the fact sheet.
Fact Sheet: What Can Canada Learn from the European Biosimilar Experience?
October 28, 2019
The undisputed leader in biosimilars with more than 60 products approved and the largest biosimilar market in the world, Europe has achieved impressive biosimilar uptake rates. These can be as high as 91% for older products (before the approval of the first monoclonal antibody biosimilar in 2013) and up to 43% for newer products (approved post-2013).
As Canadian provinces including British Columbia and Alberta look to duplicate Europe’s success, ASBM has prepared this fact sheet to serve as a resource.
The fact sheet contrasts the principles that Europe has embraced- which include preserving physician/patient choice, promoting competition between multiple products, and prohibiting automatic substitution- with the forced-switching policy announced by the government of British Columbia – and is being considered by other provinces.
B.C. Health Minister Adrian Dix cited Europe’s high biosimilar uptake rates as a justification for the [forced-switching] policy, but disregards the path and principles that led to Europe’s success:
- It was not accomplished through a reimbursement ban on originator biologics, i.e., the limitation of medicine choice and resulting forced-switching mandates.
- Instead, cost reductions were achieved by preserving choice for physicians and patients and promoting competition between all approved products based on many factors including cost, clinical evidence, delivery mechanism, patient history, and other factors.
- In nearly every European country, automatic substitution of biologic medicines is not permitted.
- Not only does the B.C. policy have no analogue among Western European countries, it is built upon principles Europe has overwhelmingly rejected.
European physicians have had 13 years of experience with biosimilars, and thus have high familiarity and confidence in them.
- Yet the majority (57%) are opposed to switching their patients to a biosimilar for non-medical (cost) reasons.
- They even more strongly oppose (73%) a third-party initiated non-medical switch of their patients’ biologic medicines, as occurs in the British Columbia policy, and which other provinces are considering.
ASBM’s 2017 survey of Canadian physicians showed similarly strong opposition (64%) to the third-party switching of stable patients for non-medical (e.g. cost) reasons.
Canadian physician groups and patient advocacy organizations have also raised concerns raised with the BC forced-switching policy.
Click here to read the fact sheet.
