September 5, 2019
Gail Attara, President & Chief Executive Officer
Gastrointestinal Society
President, Canadian Society of Intestinal Research

 

Today, the BC Government announced a policy that will require inflammatory bowel disease (Crohn’s disease and ulcerative colitis) patients currently using originator infliximab (Remicade®) to switch to biosimilar infliximab (Inflectra® or Renflexis®), in consultation with their prescriber, to maintain PharmaCare coverage (with some exceptions).

If you want to know more about these changes, the Gastrointestinal Society is presenting a Biologic/Biosimilar Forum in Vancouver on September 30, 2019. Admission is free, but please register in advance.

 

For the person who has chronic disease, the most impending fear is whether wellness will ever be possible. Our benefit plans are the cushions on which we can softly fall, knowing that if we need a vital medication, we can have medication insurance coverage, both publicly and privately funded. Most patients try everything possible before turning to a medication, including dietary and lifestyle changes and natural products. When all that fails, or doesn’t achieve the required goals, they go through the ladder of treatments, beginning with the older, lower-cost drugs and then those with increasing side-effects, risks, and costs. For patients who have chronic inflammatory conditions, this could mean taking dreaded steroids before reaching what is currently at the top of the treatment ladder, biologic medications, which require infusion into a vein or injection under the skin.

 

What are Biologics and Biosimilars?

Biologics are very specific, highly effective medicines made in living cells. They have transformed the way we treat many complex conditions, including Crohn’s disease, ulcerative colitis, diabetes, rheumatoid arthritis, cancer, osteoporosis, psoriasis, HIV, multiple sclerosis, growth deficiencies, and many more. They are structurally complex proteins several hundred times larger than traditional chemically-made small molecule drugs. They also require expensive biotechnology methods to produce.

Biosimilars are highly similar copies of the innovator biologic (which is off-patent) on which they are based. Due to a number of reasons, these products come in at a lower price. Health Canada has the responsibility to review and, when appropriate, approve all drugs sold in Canada, including biosimilars. It is clear in its position, “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”.1

 

One Solution for Several Problems?

Despite the positive impact biologics have had on plan member health, drug plan sustainability remains top of mind with plan sponsors because these products come with a hefty price. Many cost containment solutions have been implemented, including annual or lifetime maximums, limits on specialty drugs being listed on formularies, and narrowing reimbursement to a small subset of a class of medications – all with the goal of limiting plan risk and containing costs, rather than focusing on improving plan member health outcomes.

So, can we switch or substitute these medicines for each other? It’s not that simple.

When designing a plan that will benefit patients and reduce the bottom line for employers or the public purse, once Health Canada has ensured quality, safety, and efficacy, we must consider appropriate use, accessibility, and affordability. We need to adhere to all of these principles. Appropriate use and accessibility cannot be sacrificed simply for affordability.

We believe the onus is on payers (government or private) to negotiate with manufacturers of innovative biologics and their biosimilars to protect options for patient care. It is reasonable to expect that manufacturers should lower prices when drugs are no longer on patent.

 

Managing Expectations

Why force a person from a medication that keeps them stable, hoping – but not knowing – there will be no consequences? Imagine you are designing a plan for someone whom you love. Keep that concept in mind for plan members. We need uniquely Canadian care for our population.

Aside from the medical risks of switching, there are emotional and mental risks to consider, such as the nocebo effect. When a patient is stable on one medication, telling them that they must change to another in order to maintain coverage sets up a negative mindset. These individuals often worry that the new treatment won’t be as effective, which can lead to actual negative side effects that would not necessarily have occurred otherwise. This is the nocebo effect, and while the symptoms are brought on by expectation, they are still real to the patient and negatively affect their lifestyle, productivity, and overall wellbeing. Healthcare practitioners, stakeholders, and media alike should not be inadvertently initiating a nocebo influence on patients.

We want you to step back for a minute and think about the life of the person who has a disease. In 2017, six patient organizations came together to learn what their constituents thought about biologics and biosimilars. This project consisted of a patient survey and several focus groups across Canada2 built on a previous patient survey conducted by the Gastrointestinal Society in 20153 and a companion survey of Canadian physicians by the Alliance for Safe Biologic Medicines.4 The bottom line? Patients strongly indicated that they want to make choices regarding the medicine they take in consultation with their physician. Physicians agree strongly. Simply put, patients don’t want a bureaucrat, elected official, or an administrator, however learned, to decide what medicine they should take. Patients want nuanced healthcare, not a cookie-cutter approach that can lead to extra costs to the healthcare system and extra costs to the employer.

What’s clear? There is no one-size-fits-all solution. As the private healthcare environment continues to evolve, many factors must be considered to ensure that plan members have continued access to evidence-based medication options, including innovative medications and biosimilars. 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.

 

Canada is Not Europe

Canada is the only country in the world to have comprehensive patient support programs paid for by the pharmaceutical companies. This is a key consideration when analyzing data from other countries. If a patient is required to change their biologic medication, they will also need to change to a different patient support program, with consequences to the continuum of patient care. Patients receiving intravenous infusions will need to switch to another group and location to receive their treatment, which could exacerbate the nocebo effect and add further stress as they adjust to a new location of care and a new support staff. They will no longer have the connection with the nurses and physicians that have been helping them manage their disease at their previous patient support program. In addition, evidence shows that patients who are forced to switch to a biosimilar are more likely to have decreased adherence, resulting in significant additional costs to the healthcare system.

The Alliance for Safe Biologic Medicines prepared a fact sheet5 comparing Canada to the European model that the BC government is holding up as a gold standard. There are some significant considerations we need to recognize. The fact sheet addresses misconceptions about the market share of biosimilars in Europe. While the rates of biosimilar use for older biosimilars (those approved before 2013) can be as high as 91%, rates for biosimilars approved after 2013 vary from country to country, ranging from 0% to 43%. (All but one of the biosimilars approved in Canada fall into this latter group.) The European and Canadian healthcare systems are structured differently, especially for biologics treatment. It is an unfair comparison to look at just one part without considering all of the other aspects involved.

In addition, in contrast to the BC policy, the vast majority of European countries leave the decision of what biologic medicine to use with the treating physician in consultation with their patient. This is a model that the Gastrointestinal Society supports completely.

So why is the BC government making patients switch?

 

Similar but Not Equivalent

Biosimilars, unlike generic medications, are not interchangeable with the innovator biologic medication. Consider that even identical twins have significant differences as they grow – they are biologic and therefore do not always stay identical, even with identical genetic material. Can we substitute one twin for the other and still get the same person – no, of course not.6 Think of innovator biologics and biosimilars this way. They are not interchangeable. Even if the biosimilar manufacturer gets a very close result to the innovator, there are variances as they develop, just like in human twins.

Health Canada 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.4 Bureaucrats, plan administrations, and employers need to heed this directive.

When designing real care for real individuals – which drug benefit packages should do – please consider that physicians train in school for many years to learn how to care for patients. Each individual patient is unique and requires special handling. How can a non-physician decide who will get a medication when they are in a vacuum, unaware of the unique nuances of the person who is the patient? Physicians in consultation with a patient, not government, not private payers, not employers, not your neighbour, should have the final decision-making authority on what is best for any individual patient.

 

Increasing Options Benefits Patients

Competition is important in our culture and usually benefits payers, plan sponsors, and patients. Although some biosimilar industry stakeholders are suggesting the “need for new policies in Canada to support implementation and uptake of biosimilars”,7 we believe that biosimilars and innovator biologic medicines should co-exist and compete for the benefit of patients and the sustainability of the Canadian healthcare system. We don’t want patients to suffer from hastily designed policy. There are other options, such as asking the innovator manufacturers to match the biosimilar cost so that patients don’t have to switch medication, and to do so confidentially. Most government deals are confidential, yet the BC government is hanging its hat on transparency. We know that in a global marketplace, transparent prices are unusual, so why force this just for biosimilars? It does not make sense. Policies should aim to encourage competition between manufacturers to produce better products at lower prices. We know that the panCanadian Pharmaceutical Alliance has set guidelines for provincial and territorial governments that suggests transparency for pricing of originator biologics and their biosimilars, but there is no law or regulation that mandates this. It is a jurisdictional choice that only applies to biologic medications and puts those patients who need these medications in the middle.

Any new policies need to support a competitive environment that does not restrict the ability of either biosimilar or innovator manufacturers from providing value to the system while maintaining or improving patient health outcomes and quality of life. This value is a combination of safety, efficacy, price, medication administration services, patient education, and patient support. None of this should be at the cost of patient health outcomes and quality of life.

 

Best for Canadians or Best for Payers?

We welcome the addition of new biologic treatment options for Canadian patients. Recognizing that biosimilars are not generic biologics, their integration to the market must be done responsibly. It is shameful that some “professionals” are using misinformation in the public domain. 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 approval of new treatment options, including biosimilars, is a positive development for patients. Everyone benefits in an environment that supports co-existence of biosimilars and innovator biologic medicines for the benefit of patients and the Canadian healthcare system. Physician and patient choice is integral to a healthy system. Evidence-based, inclusive payer policies will serve to support the highest level of patient care and safety. Meaningful dialogue between manufacturers and payers is needed to ensure patients continue to maintain access to safe and effective medications deemed most appropriate for them in consultation with their specialist.

Keep the individual patient in mind when developing policy. Look to the person sitting across from you or beside you. Are you the same? Do you have the same likes and interests; are you based on the same genetic information? If you are different in any way, you will need different things in life, from your spouse, to your breakfast, to your medications. Identify your therapeutic options and consequences. Be cautious, be careful, be thoughtful.


1. Health Canada Health Products and Food Branch Guidance Document: Information and Submission Requirements for Biosimilar Biologic Drugs www.canada.ca/en/health-canada/services/drugs-health-products/biologics-radiopharmaceuticals-genetic-therapies/applications-submissions/guidance-documents/information-submission-requirements-biosimilar-biologic-drugs.html Accessed 2018-09-25
2. Biosimilar Focus Group Project Report 2017. The Arthritis Society et al. Available at: https://www.arthritis.ca/AS/media/pdf/About%20Arthritis/TAS_FocusGroupReport_Final_ENG_V5.pdf Accessed 2018-09-04
3. Survey Results: Subsequent Entry Biologics (Biosimilars) 2015. Gastrointestinal Society. Available at: https://www.badgut.org/survey-results-biosimilars/. Accessed 2018-09-04.
4. Canadian Prescriber Survey. 2017 Alliance for Safe Biologic Medicines. Available at:  https://safebiologics.org/surveys/canada2017/ Accessed 2018-09-04
5.  Fact Sheet: Biosimilar Substitution. British Columbia Policy vs European Policy. Alliance for Safe Biologic Medicines. Available at:  https://safebiologics.org/2019/08/asbm-releases-fact-sheet-on-british-columbia-vs-eu-substitution-policies/
6. Fraga MF et al. Epigenetic differences arise during the lifetime of monozygotic twins. Proc Natl Acad Sci U S A. 2005;102(30):10604-9.
7. Health Canada’s 2017 Biosimilars Workshop: Summary Report www.canada.ca/en/health-canada/services/drugs-health-products/biologics-radiopharmaceuticals-genetic-therapies/applications-submissions/guidance-documents/biosimilars-workshop.html Session II; Paragraph 4. Accessed 2018-09-25.