Canada: Canadian Provincial Governments Actively Redirecting Patients To Biosimilar Drugs To Save Money

Biologics are drugs which contain an active medicinal ingredient that is derived from living cells. They are generally proteins, which are larger and more complex than the chemically synthesized small molecule pharmaceuticals (acetaminophen etc.) that have for decades made up the bulk of drugs on the market. Biosimilars are competitor versions that attempt to "copy" the originally approved biologic drug. Biosimilars are approved for marketing by the short-cut of showing to regulators they are sufficiently similar to a biologic reference drug that is already approved for sale. This biosimilarity standard is less strict than the bioequivalence standard which applies to conventional generic pharmaceutical drugs. Showing biosimilarity allows biosimilar manufacturers to rely largely on the innovator drug's clinical data, thereby dramatically reducing the time and expense otherwise required to obtain market authorization.

We have previously reported on biosimilar drug approvals increasing in Canada. Despite the lower cost of biosimilars, patient uptake has not been as significant as some provincial governments would like. For conventional, small molecule pharmaceutical drugs, provincial governments have typically required substitution of the more expensive brand name drug with a less expensive (bioequivalent) generic drug. This practice of mandatory substitution was not initially extended to biosimilars. Biosimilars were relatively new, so there were lingering safety and efficacy concerns, particularly with respect to switching patients already accustomed to the brand name biologic drug. Since the biosimilar is similar, not bioequivalent, the government formularies took a wait and see approach. In the meantime, provincial drug expenditures increased annually, for a variety of reasons, which created a cost pressure on the government.

Health care providers and patients tend to be cautious, and are not highly motivated to switch from the brand biologic drug to the biosimilar on their own. Most patients would prefer, and in some cases need, to have their choice of drug, the cost of which may be largely paid for by the government or private insurance. For certain drugs, governments have tried to require new patients to start on the biosimilar for at least certain indications, to avoid the switching issue. The rheumatoid-arthritis drug, Remicade (common name: infliximab), is one example where most provinces stopped paying for the drug for new patients for certain indications. The new patients had to accept the biosimilar version of infliximab from the start, or pay out-of-pocket for the brand name drug (very few patients on a government insurance plan are likely to self-fund medications). In 2017, the Quebec provincial government also stopped funding the brand name Remicade for new patients for certain indications. Patients already using Remicade could continue on. Earlier this year, the Quebec Court of Appeal struck down this arrangemen t, on the basis that the government decision lacked procedural fairness. The government may still eventually move to stop paying, but it is required to first give the drugmaker, Janssen, notice and an opportunity to respond. The Quebec government has, at least temporarily, reinstated coverage for Remicade.

The British Columbia provincial government is now effectively requiring dispensing of certain biosimilar drugs to both new and existing patients, for certain indications. The government will no longer pay for the brand name drug for those indications after November 2019. These drugs include entanercept, infliximab and glargine, for certain indications. Patients that do not switch will have to pay for the drug entirely out-of-pocket, or apply for a discretionary exemption for medical reasons. This change applies to patients with government drug coverage, not other patients that get coverage from private insurance plans.

Using Remicade/infliximab as an example, there have been recent, promising clinical studies where patients switch to biosimilars. However, it is also not difficult to find literature that recommends caution and patient-specific consideration. Brand name companies and biosimilar companies are both spreading their own messages. The brands focus on safety of established treatment and risks of switching. The biosimilar manufacturers emphasize safety of their products, and are pushing for interchangeability.

The British Columbia government is arguably conducting a bit of a science experiment by requiring all patients to switch to biosimilar drugs this year. The government emphasized the cost savings it plans to achieve through requiring the use of biosimilars. To the extent there are patient risks, the government message is essentially requiring patients to plead their case one-by-one or else accept the risks. The success or failure of this approach will have significant implications for other biosimilar drugs.

The content of this article is intended to provide a general guide to the subject matter. Specialist advice should be sought about your specific circumstances.

To print this article, all you need is to be registered on Mondaq.com.

Click to Login as an existing user or Register so you can print this article.

Authors
 
In association with
Related Topics
 
Related Articles
 
Related Video
Up-coming Events Search
Tools
Print
Font Size:
Translation
Channels
Mondaq on Twitter
 
Mondaq Free Registration
Gain access to Mondaq global archive of over 375,000 articles covering 200 countries with a personalised News Alert and automatic login on this device.
Mondaq News Alert (some suggested topics and region)
Select Topics
Registration (please scroll down to set your data preferences)

Mondaq Ltd requires you to register and provide information that personally identifies you, including your content preferences, for three primary purposes (full details of Mondaq’s use of your personal data can be found in our Privacy and Cookies Notice):

  • To allow you to personalize the Mondaq websites you are visiting to show content ("Content") relevant to your interests.
  • To enable features such as password reminder, news alerts, email a colleague, and linking from Mondaq (and its affiliate sites) to your website.
  • To produce demographic feedback for our content providers ("Contributors") who contribute Content for free for your use.

Mondaq hopes that our registered users will support us in maintaining our free to view business model by consenting to our use of your personal data as described below.

Mondaq has a "free to view" business model. Our services are paid for by Contributors in exchange for Mondaq providing them with access to information about who accesses their content. Once personal data is transferred to our Contributors they become a data controller of this personal data. They use it to measure the response that their articles are receiving, as a form of market research. They may also use it to provide Mondaq users with information about their products and services.

Details of each Contributor to which your personal data will be transferred is clearly stated within the Content that you access. For full details of how this Contributor will use your personal data, you should review the Contributor’s own Privacy Notice.

Please indicate your preference below:

Yes, I am happy to support Mondaq in maintaining its free to view business model by agreeing to allow Mondaq to share my personal data with Contributors whose Content I access
No, I do not want Mondaq to share my personal data with Contributors

Also please let us know whether you are happy to receive communications promoting products and services offered by Mondaq:

Yes, I am happy to received promotional communications from Mondaq
No, please do not send me promotional communications from Mondaq
Terms & Conditions

Mondaq.com (the Website) is owned and managed by Mondaq Ltd (Mondaq). Mondaq grants you a non-exclusive, revocable licence to access the Website and associated services, such as the Mondaq News Alerts (Services), subject to and in consideration of your compliance with the following terms and conditions of use (Terms). Your use of the Website and/or Services constitutes your agreement to the Terms. Mondaq may terminate your use of the Website and Services if you are in breach of these Terms or if Mondaq decides to terminate the licence granted hereunder for any reason whatsoever.

Use of www.mondaq.com

To Use Mondaq.com you must be: eighteen (18) years old or over; legally capable of entering into binding contracts; and not in any way prohibited by the applicable law to enter into these Terms in the jurisdiction which you are currently located.

You may use the Website as an unregistered user, however, you are required to register as a user if you wish to read the full text of the Content or to receive the Services.

You may not modify, publish, transmit, transfer or sell, reproduce, create derivative works from, distribute, perform, link, display, or in any way exploit any of the Content, in whole or in part, except as expressly permitted in these Terms or with the prior written consent of Mondaq. You may not use electronic or other means to extract details or information from the Content. Nor shall you extract information about users or Contributors in order to offer them any services or products.

In your use of the Website and/or Services you shall: comply with all applicable laws, regulations, directives and legislations which apply to your Use of the Website and/or Services in whatever country you are physically located including without limitation any and all consumer law, export control laws and regulations; provide to us true, correct and accurate information and promptly inform us in the event that any information that you have provided to us changes or becomes inaccurate; notify Mondaq immediately of any circumstances where you have reason to believe that any Intellectual Property Rights or any other rights of any third party may have been infringed; co-operate with reasonable security or other checks or requests for information made by Mondaq from time to time; and at all times be fully liable for the breach of any of these Terms by a third party using your login details to access the Website and/or Services

however, you shall not: do anything likely to impair, interfere with or damage or cause harm or distress to any persons, or the network; do anything that will infringe any Intellectual Property Rights or other rights of Mondaq or any third party; or use the Website, Services and/or Content otherwise than in accordance with these Terms; use any trade marks or service marks of Mondaq or the Contributors, or do anything which may be seen to take unfair advantage of the reputation and goodwill of Mondaq or the Contributors, or the Website, Services and/or Content.

Mondaq reserves the right, in its sole discretion, to take any action that it deems necessary and appropriate in the event it considers that there is a breach or threatened breach of the Terms.

Mondaq’s Rights and Obligations

Unless otherwise expressly set out to the contrary, nothing in these Terms shall serve to transfer from Mondaq to you, any Intellectual Property Rights owned by and/or licensed to Mondaq and all rights, title and interest in and to such Intellectual Property Rights will remain exclusively with Mondaq and/or its licensors.

Mondaq shall use its reasonable endeavours to make the Website and Services available to you at all times, but we cannot guarantee an uninterrupted and fault free service.

Mondaq reserves the right to make changes to the services and/or the Website or part thereof, from time to time, and we may add, remove, modify and/or vary any elements of features and functionalities of the Website or the services.

Mondaq also reserves the right from time to time to monitor your Use of the Website and/or services.

Disclaimer

The Content is general information only. It is not intended to constitute legal advice or seek to be the complete and comprehensive statement of the law, nor is it intended to address your specific requirements or provide advice on which reliance should be placed. Mondaq and/or its Contributors and other suppliers make no representations about the suitability of the information contained in the Content for any purpose. All Content provided "as is" without warranty of any kind. Mondaq and/or its Contributors and other suppliers hereby exclude and disclaim all representations, warranties or guarantees with regard to the Content, including all implied warranties and conditions of merchantability, fitness for a particular purpose, title and non-infringement. To the maximum extent permitted by law, Mondaq expressly excludes all representations, warranties, obligations, and liabilities arising out of or in connection with all Content. In no event shall Mondaq and/or its respective suppliers be liable for any special, indirect or consequential damages or any damages whatsoever resulting from loss of use, data or profits, whether in an action of contract, negligence or other tortious action, arising out of or in connection with the use of the Content or performance of Mondaq’s Services.

General

Mondaq may alter or amend these Terms by amending them on the Website. By continuing to Use the Services and/or the Website after such amendment, you will be deemed to have accepted any amendment to these Terms.

These Terms shall be governed by and construed in accordance with the laws of England and Wales and you irrevocably submit to the exclusive jurisdiction of the courts of England and Wales to settle any dispute which may arise out of or in connection with these Terms. If you live outside the United Kingdom, English law shall apply only to the extent that English law shall not deprive you of any legal protection accorded in accordance with the law of the place where you are habitually resident ("Local Law"). In the event English law deprives you of any legal protection which is accorded to you under Local Law, then these terms shall be governed by Local Law and any dispute or claim arising out of or in connection with these Terms shall be subject to the non-exclusive jurisdiction of the courts where you are habitually resident.

You may print and keep a copy of these Terms, which form the entire agreement between you and Mondaq and supersede any other communications or advertising in respect of the Service and/or the Website.

No delay in exercising or non-exercise by you and/or Mondaq of any of its rights under or in connection with these Terms shall operate as a waiver or release of each of your or Mondaq’s right. Rather, any such waiver or release must be specifically granted in writing signed by the party granting it.

If any part of these Terms is held unenforceable, that part shall be enforced to the maximum extent permissible so as to give effect to the intent of the parties, and the Terms shall continue in full force and effect.

Mondaq shall not incur any liability to you on account of any loss or damage resulting from any delay or failure to perform all or any part of these Terms if such delay or failure is caused, in whole or in part, by events, occurrences, or causes beyond the control of Mondaq. Such events, occurrences or causes will include, without limitation, acts of God, strikes, lockouts, server and network failure, riots, acts of war, earthquakes, fire and explosions.

By clicking Register you state you have read and agree to our Terms and Conditions