September 2019 Newsletter
October 1, 2019
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ASBM Releases Preliminary Findings from European Prescribers Survey at ESMO 2019
October 1, 2019
September 30, 2019 – Barcelona, Spain – The Alliance for Safe Biologic Medicines (ASBM) this week shared preliminary findings from a survey of 575 biologic prescribers in six Western European countries, covering several key policy issues including biosimilar substitution practices, adverse event reporting, and government tendering criteria. Since 2010, the group has routinely surveyed physicians in 13 countries to gather empirical data that can serve as a guide to policymakers on how to increase physician confidence in biosimilars.
The results were presented in a poster and discussion session at the 2019 Congress of the European Society of Medical Oncology (ESMO 2019). Survey respondents were drawn in equal proportion from France, Germany, Italy, Spain, Switzerland, and the United Kingdom. They came from 10 practice areas: Dermatology, Endocrinology, Gastroenterology, Hematology Oncology, Immunology, Nephrology, Neurology, Oncology, Ophthalmology, and Rheumatology. The survey is a follow-up to the group’s 2013 survey of 479 European prescribers.
One policy issue examined in the survey is physician control over biologic treatment decisions, including automatic substitution and non-medical-switching. As governments worldwide seek to control health costs, use of lower cost biosimilars can be an effective tool. Yet unlike generics, biosimilars are not identical copies of the originator product. For this reason, automatic substitution of biologics is rare, and indeed banned in the majority of European Union countries.
“With 13 years of experience prescribing biosimilars, Europe’s physicians have become most knowledgeable and familiar with biosimilars in the world,” said Michael Reilly, executive director of ASBM and poster co-author. While 76% of physicians considered themselves familiar with biosimilars in the 2013 survey, that figure has risen to 90% in 2019.
Mr. Reilly presented the poster at ESMO with fellow co-author Andrew Spiegel, executive director of the Global Colon Cancer Association. “Countries looking to duplicate Europe’s success with biosimilars may look to these results for guidance. Note that the importance of maintaining physician and patient control of treatment decisions – including the decision to switch a stable patient to a biosimilar – has also increased since they were last surveyed six years ago,” said Mr. Reilly.
A strong majority of respondents (82%) considered it “Very Important” or “Critical” to decide which biologic medicine is dispensed to their patients, an increase from 72% in the 2013 survey. In addition, 84% consider the authority to prevent a substitution either “Very Important” or “Critical”, an increase from 74% in the 2013 survey.
While 84% of physicians were comfortable prescribing biosimilars to new patients, the comfort level drops to 60% when switching stable patients to a biosimilar. 58% of physicians were uncomfortable switching patients to a biosimilar for economic rather than health reasons. If the decision to do so were made by a third party, 73% would be uncomfortable.
The ability to choose between several different medicines was also highly important to prescribers: With regard to the awarding of government tenders, a majority of respondents (63%) feel that it is either “Very Important” or “Critical” that tenders to be awarded to multiple suppliers. 83% feel that it is either “Very Important” or “Critical” for national tender offers to consider factors besides price.
“While comfortable with prescribing biosimilars, Europe’s physicians want to have multiple options to choose from, so they can make the best medical decision for their patients – whether that’s the originator product, or one of its biosimilars,” emphasized Mr. Spiegel.
ASBM will be sharing the full results of the survey in a series of meetings with regulators throughout Europe this fall. This will include sharing country-specific data with several national health ministries, as was done with ASBM’s 2013 survey.
Contact: Media@safebiologics.org
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Biosimilars Working Group Responds to Phase II of the BC PharmaCare Biosimilars Initiative
September 23, 2019
Biosimilars Working Group Responds to Phase II of the BC PharmaCare Biosimilars Initiative
VANCOUVER, BC – Wednesday, September 18, 2019. On September 5, 2019, the BC government announced phase two of its Biosimilars Initiative, informing patients prescribed the originator biologic drug, Remicade® (infliximab), to treat inflammatory bowel disease (Crohn’s disease and ulcerative colitis) that this medication will no longer be covered by the province, and that they must switch to a biosimilar infliximab, either Inflectra® or Renflexis®.1 This means that patients have only six months to meet with their gastroenterologist to discuss switching their medication and to start a replacement product. The sweeping change in coverage is driven by the government’s decision to generate significant healthcare savings from switching patients’ medication rather than negotiating with the makers of the originator biologic to lower their prices.
Biologics are medicines created from living cells and are used to treat a variety of conditions, such as Crohn’s disease, ulcerative colitis, diabetes, rheumatoid arthritis, cancer, osteoporosis, psoriasis, HIV, multiple sclerosis, and growth deficiencies, to name a few. Biosimilars are highly similar to an originator biologic, but different enough to be sold under their own brand name. Because these drugs are made from living cells, it is impossible to create an identical copy regardless of the use of the exact same manufacturing conditions, ingredients, and process.2 This is a stark comparison to generic drugs, which are made up of chemicals that can be reproduced with the same active ingredient as the original brand name product.3
Health Canada considers a biosimilar to be safe, effective, and of good quality, and highly similar to the originator biologic it references. For a number of reasons, including that the biosimilar companies do not have to invest in discovery and clinical trials, these medicines provide lower-cost options for public payers. However, as the originator biologics are now off-patent, the companies that own these products are willing to negotiate lower prices. Unfortunately, public drug plans prefer to support a biosimilar market.
It is important to note that biosimilars, unlike generic medications, are not interchangeable with the innovator biologic medication. Health Canada set the bar, saying, “Biosimilars are not generic biologics and many characteristics associated with the authorization process and marketed use for generic pharmaceutical drugs do not apply. Authorization of a biosimilar is not a declaration of pharmaceutical equivalence, bioequivalence or clinical equivalence to the reference biologic drug.” Be wary of anyone who calls biosimilars “biogeneric”, as this is an unacceptable, made-up word for these products.
Health Canada further states that the treating physician, in consultation with the patient, should make the decision to switch a patient after taking into account available clinical evidence.
Canada is the only country in the world to have comprehensive patient support programs paid for by the pharmaceutical companies. This means patients receiving intravenous infusions will need to switch to another group and location to receive their treatment, which could add further stress as they adjust to a new location of care and a new support staff.
The change in coverage is estimated to affect 1,700 patients. This is in addition to about 20,400 British Columbians diagnosed with ankylosing spondylitis, diabetes, plaque psoriasis, psoriatic arthritis, and rheumatoid arthritis affected from phase one of the Biosimilars Initiative. This population includes pediatric patients, while pregnant patients may be provided exceptional coverage following approval of request from PharmaCare’s Special Authority branch.4
The Biosimilars Working Group, a diverse cohort of health patient groups dedicated to ensuring the best outcomes for patients, welcomes the BC government’s expansion for access to healthcare services, such as full coverage for the fecal calprotectin test and increased funding for nursing support. However, the cost-driven objective of the forced-switch policy is worrisome as it fails to put physician wisdom, patient choice, appropriateness of care, accessibility, and affordability at the forefront of health policy. Patients should only switch if they decide that this is the best course of action for their conditions, with consultation from their treating physician.
Gail Attara, President & CEO of the Gastrointestinal Society, and member of the Biosimilars Working Group, shared that, “Every disease area is unique and each needs to be treated differently. Patients with limited therapeutic options should not be lumped together with those who have a broader range of options available to them. Many people depend on public coverage and only a select few have private health plans that do better.”5
Surveys conducted on various healthcare stakeholders, including patients, physicians, family caregivers, and the public, in Canada and abroad, reveal synonymous conclusions that treatment decisions should remain between a patient and their physician. Health Canada also encourages patients to speak with their treating physician about switching.6
In 2017, five patient organizations collaborated on a project that surveyed Canadian patients with inflammatory diseases about their perspectives on biologics and biosimilars. Of the 657 individuals surveyed, a vast majority reported being opposed to a forced switch for non-medical reasons.
“We are deeply concerned about the risks associated with a switch. Already, patients with loss of vision depend on accessibility and informed consent when being administered treatments. Furthermore, patients who are stable on a biologic treatment should not be made to potentially jeopardize their safety and quality of life with a mandated switch,” said Louise Gillis, National President of the Canadian Council of the Blind.
Biosimilars in oncology are expected to increase in the Canadian market and the implementations made by the BC government concern many cancer patients. “While we are aware of the value of biosimilars, the Canadian Cancer Survivor Network believes that patients who are being successfully treated by biologics should not be forced to switch. Any such decisions should be made by patients in consultation with their clinicians,” shared Jackie Manthorne, President & CEO of the Canadian Cancer Survivor Network.
The BC Ministry of Health precipitates the need to increase biosimilar uptake due to best practices in the European market, having had over a decade of experience with these products. The Alliance for Safe Biologic Medicines (ASBM), an international and multi-stakeholder organization comprised of healthcare groups, patients, physicians, and biotechnology companies, responded to the BC announcement by releasing a fact sheet analyzing the claims purported by the provincial government.7 “European countries, for example, enjoy robust biosimilar markets and higher uptake rates, yet the vast majority leave the decision on what biologic medicine to use with the treating physician, in consultation with their patient. No country in Europe has ceased the reimbursement of originator biologics by a government decree such as that issued in BC and only very few countries use a procurement process that will reimburse a single product that wins the bid,” said Michael Reilly, Executive Director of ASBM.8
The Biosimilars Working Group will continue to raise the importance of patient choice and evidence-based decision making with policymakers. To stay up-to-date with biosimilars research and policies, please visit www.biosimilaroptions.ca and follow @BiosimilarsWG on Twitter.
About the Biosimilars Working Group:
The Biosimilars Working Group 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. We create up-to-date and evidence-based educational material for patients and healthcare professionals as a basis to inform our advocacy work on behalf of the patients who we serve.
Working Group Members Participating in This Media Release:
Alliance for Safe Biologic Medicines
Canadian Cancer Survivor Network
Canadian Council of the Blind
Canadian Society of Intestinal Research
Gastrointestinal Society
For more information, please contact Gail Attara, president & chief executive officer of the Gastrointestinal Society, at gail [at] badgut.org, 604-873-4876.
1. Biosimilars Initiative for Patients. Province of British Columbia page. Available at: https://www2.gov.bc.ca/gov/content/health/health-drug-coverage/pharmacare-for-bc-residents/what-we-cover/drug-coverage/biosimilars-initiative-patients. Accessed 2019-09-11.
2. Biologics and Biosimilars. GI Society page. Available at: https://badgut.org/information-centre/a-z-digestive-topics/biosimilars-pamphlet/. Accessed 2019-09-11.
3. Biosimilar biologic drugs in Canada: Fact Sheet. Government of Canada page. Available at: https://www.canada.ca/en/health-canada/services/drugs-health-products/biologics-radiopharmaceuticals-genetic-therapies/applications-submissions/guidance-documents/fact-sheet-biosimilars.html#a17. Accessed 2019-09-11.
4. Biosimilars Initiative for Patients. Province of British Columbia page. Available at: https://www2.gov.bc.ca/gov/content/health/health-drug-coverage/pharmacare-for-bc-residents/what-we-cover/drug-coverage/biosimilars-initiative-patients. Accessed 2019-09-11.
5. Gail Attara, “Balancing Act: Cost Containment vs. Patient Health Outcomes,” GI Society Canadian Society of Intestinal Research, available at https://badgut.org/balancing-act/, Accessed 2019-09-11.
6. Biosimilar biologic drugs in Canada: Fact Sheet. Government of Canada page. Available at: https://www.canada.ca/en/health-canada/services/drugs-health-products/biologics-radiopharmaceuticals-genetic-therapies/applications-submissions/guidance-documents/fact-sheet-biosimilars.html#a17 Accessed 2019-09-11.
7. ASBM Releases Fact Sheet on British Columbia vs EU Substitution Policies. Alliance for Safe Biologic Medicines page. Available at: https://safebiologics.org/wp-content/uploads/2019/08/ASBM-Factsheet-BC-vs-EU-Substitution.pdf. Accessed 2019-09-11.
8. ASBM Raises Concerns for Patients as BC Gov’t Expands Biologics Forced-Switch Policy. Alliance for Safe Biologics page. Available at: https://safebiologics.org/2019/09/asbm-raises-concerns-for-patients-as-bc-govt-expands-biologics-forced-switching-policy/. Accessed 2019-09-12.
ASBM Raises Concerns for Patients as BC Gov’t Expands Biologics Forced-Switching Policy
September 11, 2019
Erosion of Physician and Patient Treatment Choice Continues – Alliance for Safe Biologic Medicines Raises Concerns for Patients as British Columbia Expands Biologics Forced Switching Policy
September 10, 2019
VANCOUVER, B.C.- On September 5th, the Government of British Columbia (BC) announced that it would be forcibly switching 1,700 patients with Inflammatory Bowel Disease (IBD) from their current biologic medicine to alternative versions of the treatment, the government’s choice of preferred “biosimilar” products, and cease the reimbursement of their current biologic medicine. The announcement follows a May 27th mandate that 20,700 arthritis, psoriasis, and diabetes patients would be forcibly switched from their existing medicines to the government’s choice of preferred biosimilar products. This forced switching policy was presented as a trade-off for the government’s agreement to grant reimbursement for new innovative medicines, although no new IBD medications have been added to the B.C. public formulary. The policy disregards important scientific considerations for patients on biologic medicines and most alarmingly, eliminates patient choice, 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.
Biologics are made using living cells and as a result, may inspire unwanted immune reactions. For that reason, changing from one product to another is widely considered to be a decision to be made by the treating doctor in consultation with the patient. Biosimilars are highly similar, but not identical, to the original medicines, thus, the forced switch of them is a rarity among advanced nations and banned throughout much of Europe and the United States.
“Biosimilar competition and the use of biosimilars can be an effective way to reduce health costs, but potential savings need not, and should not, override patient and physician control of treatment decisions” says ASBM executive director Michael Reilly. “European countries, for example, enjoy robust biosimilar markets and higher uptake rates, yet the vast majority leave the decision on what biologic medicine to use with the treating physician, in consultation with their patient. Switching from an originator to a biosimilar or between biosimilars remains a clinical decision best made by the treating physician.”
Higher uptake rates of biosimilars in Europe have been touted by B.C. Health Minister Adrian Dix as a rationale for the force-switching policy, but it is important to note that Europe has almost universally rejected forced switching as a cost-control mechanism, says Reilly: “No country in Europe has ceased the reimbursement of originator biologics by a government decree such as that issued in B.C. and only very few countries use a procurement process that will reimburse a single product that wins the bid.” He directs interested parties to a fact sheet developed by ASBM, which contrasts the B.C. policy to those of Europe and dispels misconceptions.
ASBM has twice conducted large-scale surveys of European physicians on biosimilar policy issues. In 2013, ASBM surveyed 479 prescribers in 5 countries, and shared the results with several Ministries of Health, the European Commission, and the World Health Organization as these regulators developed biosimilar policy. Results from a 2019 survey of 575 physicians in six countries will be released this fall.
Reilly emphasized the sharp contrast between the unique forced-switching policy of B.C. and biosimilar policies in Western Europe, which are built on the principles of education, competition, and physician autonomy:
“Nearly all of Western Europe allows physicians to choose between multiple competing products, while encouraging the voluntary prescribing of biosimilars. Only in Denmark and in a few Eastern European countries do we find forced biosimilar switching policies with physician and patient choice eliminated and only one product reimbursed. Canadian patients deserve first-rate health care; this policy moves them in the opposite direction and we respectfully urge the B.C. government to reconsider it.”
Other patient advocacy organizations have echoed these concerns. The Gastrointestinal Society, representing the quarter-million Canadians with IBD, released a statement supporting physician and patient control of treatment decisions: “While cost is an important factor for a sustainable healthcare system, when it comes to the selection of treatment, reimbursement policies must recognize and respect the physician’s right to prescribe based on clinical evidence and a patient’s right to choose the therapy that is best for them.” The statement also emphasized the organization’s belief “that the onus is on payers (government or private) to negotiate with manufacturers of innovative biologics and their biosimilars to protect options for patient care.”
According to the Better Pharmacare Coalition, a group composed of 28 B.C. based patient advocacy organizations and charities, “B.C. is one of the only jurisdictions paying list price [the price before negotiated rebates and discounts are applied] for Remicade® in Canada, as the negotiated listing price agreement ended and BC PharmaCare refuses to negotiate with the manufacturer on a discounted rate.”
Crohn’s and Colitis Canada, which recently conducted cross-Canada surveys of patients and caregivers, gastroenterologists and IBD nurses, also released a statement citing concerns with the B.C. policy. “Crohn’s and Colitis Canada is a research-based organization. We took the time to carefully review our position on biosimilars and particularly on related non-medical switching policy in order to represent our patients thoughtfully and responsibly,” says Mina Mawani, President and CEO of Crohn’s and Colitis Canada. “Our position that a non-medical switch policy is not in the best interest of patients is based on what we’ve learned these past few months.”
Canadian physicians surveyed have also expressed strong concerns: According to a 2017 survey of 403 Canadian biologic prescribers, 64% were not comfortable with a third party switching a patient’s biologic medicine for non-medical (e.g. cost) reasons. 83% considered it “very important” or “critical” that prescribing physicians decide the most suitable biologic for their patients.
“Physicians should have the option to prescribe biosimilars, or any other safe and effective biologic. What is at stake here is who gets to make that decision”, Reilly said. “Will it remain the physician and patient – as in Europe, the U.S., and most advanced nations – or will the government restrict choice and force stable patients to switch to a particular government -favored product du jour – whether it be an originator or a biosimilar?”
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ASBM Releases Fact Sheet on British Columbia vs EU Substitution Policies
August 5, 2019
As BC attempts to increase biosimilar use by force-switching 23,000 patients, Europe enjoys high uptake rates while preserving patient and physician choice.
ASBM Releases Fact Sheet on British Columbia vs EU Substitution Policies
August 5, 2019
As BC attempts to increase biosimilar use by force-switching 23,000 patients, Europe enjoys high uptake rates while preserving patient and physician choice.
June-July 2019 Newsletter
August 1, 2019
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June-July 2019 Newsletter
August 1, 2019
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ASBM Exhibits, Presents at DIA 2019 Annual Meeting
July 29, 2019
WHO INN Programme Lead Dr. Raffaella Balocco visits with Advisory Board Chair Philip Schneider (left) and Executive Director Michael Reilly (right) at ASBM’s booth.
From June 24th to June 26th, ASBM exhibited at the DIA 2019 Global Annual Meeting in San Diego, CA. ASBM was represented by Executive Director Michael Reilly and Advisory Board Chair Philip Schneider, who met with conference attendees to discuss ASBM’s work.
ASBM distributed literature on key biosimilar policy issues including: biosimilar basics, distinct naming, substitution and interchangeability, product labeling, indication extrapolation, and international harmonization of biologic nomenclature. Among the booth’s visitors was WHO INN Programme Lead Dr. Raffaella Balocco, who was a speaker at a DIA panel on pharmacovigilance.
On Thursday, June 27th, Dr. Schneider participated in a session entitled “Successes and Challenges in Pharmacovigilance for Biologics and Biosimilars“. In his presentation, Schneider discussed the importance of redundancy in high reliability systems, with respect to clear product identification and biologic naming. Schneider noted that in Europe, where multiple biosimilars share a nonproprietary name with the originator biologic upon which they are based, roughly a third of adverse event reports for infliximab products do not identify the specific product responsible by its brand name.
A system of distinct nonproprietary naming (such a the suffix systems proposed by WHO and enacted by FDA) would add an additional safeguard and minimize the risks of such pharmacovigilance problems, Schneider explained. View Dr. Schneider’s presentation here.
Other presenters in the session included Kalindi Hapani, MPharm of APCER Life Sciences; Brian Edwards, DrMed, of ACRES, NDA Group; and Lubna Merchant, PharmD, MS, of FDA.
ASBM Joins Patient Advocacy Groups in Opposing Shared CMS Billing Codes for Multiple Biologic Products
July 16, 2019
On July 16th, A group of patient advocacy organizations sent a letter to Senate Committee on Finance members Ron Wyden (D-OR) and Chuck Grassley (R-IA), opposing any changes to CMS policy that would result in the use of shared billing codes to cover multiple different products. The letter was organized by ASBM member Alliance for Patient Access (AfPA) and the Biologic Prescribers’ Collective (BPC), a project of AfPA.
ASBM and AfPA were among the many patient advocacy organizations that opposed the use of shared billing codes by CMS. Read ASBM’s September 2017 comment letter to CMS opposing the shared billing code policy here.
In November 2017, CMS announced the reversal of the policy, following a public comment period which found strong opposition among patient advocacy organizations, physician societies, and manufacturers of both originator biologics and biosimilars. It has been estimated that the adoption of unique billing codes will save $65 billion to Medicare over ten years.In an Inside Health Policy article published June 29th, Sen. Wyden had proposed returning to the policy of shared codes.
Read the full letter here.
