Biosimilars Initiative for Health Professionals

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Background

The Biosimilars Initiative (“the Initiative”) transitions PharmaCare-covered patients taking originator drugs to equally safe and effective biosimilar versions. The Biosimilars Initiative optimizes B.C.’s public resources to get the best value for new treatments and services, and to improve patient access to medicines.

A “switch period” of six months gives a patient time to meet with their prescriber and discuss their biosimilar options. If a patient wants continued PharmaCare coverage of their medication, their prescriber writes a new prescription for an approved biosimilar. Following the switch period, PharmaCare covers only the biosimilar (unless there is a medical reason for exceptional coverage of the originator).

Since the evidence-based Biosimilars Initiative was launched in May 2019, many PharmaCare-covered patients have successfully switched from an originator to an approved biosimilar:

  • Phase One - 73 percent of patients transitioned
  • Phase Two - 78 percent of patients transitioned
  • Over 90 percent of PharmaCare patients taking infliximab, etanercept and insulin glargine are now taking biosimilars

All switches are planned in consultation with prescribers and stakeholders.

Current switch period

Switching adalimumab (Humira®) and etanercept (Enbrel®): April 7, 2021 to October 6, 2021
Drug Originator Biosimilar Conditions include
adalimumab Humira® Amgevita®
Hadlima®*
Hulio®
Hyrimoz®
Idacio®
ankylosing spondylitis
Crohn’s disease
hidradenitis suppurativa (for adults)
plaque psoriasis (for adults)
polyarticular juvenile idiopathic arthritis
psoriatic arthritis
rheumatoid arthritis
ulcerative colitis
etanercept Enbrel® Brenzys®
Erelzi®
plaque psoriasis (for adults)

*Hadlima is not indicated for pediatric Crohn’s disease.
The Initiative is currently switching PharmaCare patients covered for adalimumab (Humira®), and patients taking etanercept (Enbrel®) to treat plaque psoriasis (PsO), to approved biosimilar options, between April 7, 2021 and October 6, 2021.

During this six-month period, patients with PharmaCare coverage for Humira® or Enbrel® will be switched to an appropriate biosimilar option, listed above, if they wish to receive continued coverage. Humira, Enbrel, and all listed biosimilars will be covered during the switch period. After the switch period, PharmaCare will only cover approved biosimilars for the affected indications.


How do I support the patient?

  1. Identify a patient who will lose PharmaCare coverage if they don't switch. You can request a list of covered patients using HLTH 5843 - Patient List Request (PDF, 533KB) form. PharmaCare will send a list within 2 weeks, of patients who filled a prescription for the originator drug within the past 6 months.
  2. Discuss switching to a biosimilar with the patient.
  3. Write your patient a new prescription, clearly indicating a specific biosimilar.
  4. Initiate enrolment in the patient support program for the biosimilar (if applicable).
  5. Submit the Biosimilar Patient Support Fee code with your MSP billing.
  6. For any patients unable to switch due to a medical reason, submit a new Special Authority request for exceptional coverage of the respective biologic, with clear rationale.

What if I can't see patients before the end of the switch period?

If you can't write a new biosimilar prescription for a patient by the final day of a switch period, their coverage for the originator drug will expire at the end of that day, unless exceptional coverage is in place (see below). For a patient to get PharmaCare coverage for a regular benefit biosimilar following a switch period, write the biosimilar prescription as soon as possible; coverage will be activated when the prescription is filled. If the biosimilar requires Special Authority, submit a new request as soon as you can.

PharmaCare coverage extensions may be considered on a case-by-case basis in situations where despite best efforts, a prescriber is unable to initiate a switch for a patient within the six-month transition window. Prescribers can use the PharmaCare prescriber line to request an extension.

What about patients who can't switch?

Sometimes medical reasons prevent a patient from switching to a biosimilar. In such cases, the patient’s prescriber may submit an exceptional request for Special Authority (SA) coverage of the originator drug. In the request, the prescriber must clearly identify why the patient is unable to switch. Forms are listed on the SA eForms platform or a drug’s criteria page.

Note that patients are expected to trial a biosimilar (unless there is a medical exception). If a trial has been attempted and stopped, the rationale for stopping the trial must be documented in the request for exceptional coverage. The complications must be unlikely to recur or intensify if the patient resumes taking the originator.

SA reviews exceptional requests on a case-by-case basis. The request may also be reviewed by the appropriate Drug Benefit and Adjudication Advisory Committee, if needed. Exceptional requests should be submitted as soon as possible to avoid uninterrupted coverage.

A biosimilar patient support fee is offered in recognition of the effort involved in contacting patients and supporting their switch to a biosimilar. The $50 fee is billable to MSP in addition to other services billed on the same date of service, using the Teleplan claims system.

The fee can be claimed once per qualifying patient during the switch period, regardless of whether the patient switches to a biosimilar.

See the table below for fee codes, which are active during their respective phase periods. Note fee codes are restricted by prescriber type.

Biosimilar Switch:
 Apr. 7, 2021 to Oct. 6, 2021
Prescriber  Fee Code
Humira® gastroenterologists, rheumatologists, dermatologists, internal medicine specialists (includes pediatric gastroenterology and rheumatology specialists) 97014
Enbrel® dermatologists, internal medicine specialists 97010

During interactions with a patient (e.g. patient inquiry, prescription dispense or medication review), if you notice that a patient’s medication record indicates current use of Humalog® or NovoRapid®:

  1. Confirm the patient will be affected.
    • Initiate a conversation to confirm they are using the drug for the listed condition
    • Check whether they have active PharmaCare coverage or Special Authority for that drug
    • Ask if another pharmacy has provided support for the switch
  2. Provide the patient with the Ministry of Health patient information sheet for their drug.
  3. Inform the patient that they may be affected by the biosimilar switch. Encourage them to see their prescriber for a new prescription before the switch period ends to maintain PharmaCare coverage.
  4. Submit a claim in PharmaNet for the appropriate biosimilar patient support fee for pharmacists.

See How to talk to patients for tips on how to approach biosimilar discussions with a patient.

Pharmacists may claim the biosimilar patient support fee for identifying patients and providing information to assist their switch to a biosimilar. This $15 fee can be claimed once for each affected PHN, even if the patient uses more than one drug involved. Fee claims will only be paid during the active switch period.

Biosimilar patient support fees are entered as a PIN in PharmaNet and paid monthly to pharmacies, in accordance with the usual monthly payment schedule.

Switch Period Effective Dates PIN
adalimumab and etanercept (for PsO) April 7, 2021 to October 6, 2021 66127318

Patients with existing SA approval for an originator drug do not require new SA approvals for their biosimilar medication. The existing SA approval for the originator drug (e.g. Humira®, or Enbrel® for plaque psoriasis) remains in effect until its renewal date or the end of a switch period (e.g. October 6, 2021), whichever comes first. When renewed, coverage will be provided only for a biosimilar version. The patient must meet with their prescriber for a new biosimilar prescription if they wish to maintain uninterrupted PharmaCare coverage.

New SA requests and renewals for adalimumab or etanercept will only be granted for the approved biosimilars.

For patients with a clinical requirement that prevents switching, their prescriber can submit a new SA request for exceptional coverage of the originator. A clear medical reason must be provided in the request. Exceptional requests are reviewed by SA on a case-by-case basis.

Note that patients are expected to trial a biosimilar (unless there is a medical exception). If the trial has been attempted and halted, the trial must be well documented and a rationale for halting must be included in the request for exceptional coverage.

Criteria changes

At this time, there are no changes in coverage criteria for adalimumab or etanercept for any indications. Patients approved for exceptional coverage of Enbrel from Phase One of the Biosimilar Initiative will maintain their coverage (only patients taking Enbrel for plaque psoriasis will be affected by the current switch).

For a list of updated forms, see the adalimumab criteria page or the etanercept criteria page.

Prescribers and pharmacists are a trusted source of information, expertise, and experience. As a trusted expert, you may set the tone of the discussion, facilitate continuity of care, and empower the patient to understand and realize their best outcomes.

Treatment-naïve patients started on a biosimilar tend to accept biosimilars without issues. Treatment-experienced, stable patients using an originator biologic may need more support.

The most critical information patients need to know is that biosimilars:

  • Are safe and effective
  • Work similarly to their current medication
  • Add no increased risk of adverse reactions
  • Don’t involve major changes to their routines or dosing
  • Are accompanied by patient support programs, if applicable
  • Are available at nearby infusions centres (if applicable), though it may be a different infusion centre than they currently attend
  • Are well studied; switch programs have been successful around the world

The nocebo effect

The nocebo effect is when a patient’s negative expectations affect their treatment outcomes. A patient’s mindset can impact their symptoms and their sense of well-being. The nocebo effect can be arise due to one’s mental health state, language barriers, use of online media as an information source, the setting in which they receive information, and other factors that are out of the control of healthcare professionals.

To guard against a potential nocebo effect:

  • Acknowledge the nocebo effect
  • Speak face-to-face (or via video conferencing) when possible
  • Get informed about biosimilars 
  • Be attentive and empathetic
  • Promote a neutral or positive outlook
  • Give balanced information about desired effects and adverse effects
  • Suggest a plan for follow-up
  • Direct them to PharmaCare's patient information sheets, which summarize coverage changes 

Biosimilar manufacturers provide patient support programs (PSP), as well as access to infusion centres similar to those for originator drugs. Prescribers can help patients enrol in a PSP, if applicable.

adalimumab

Amgevita®

The Enliven® patient support program is for patients prescribed AMGEVITA®. The program gives patients access to services such as reimbursement navigation, financial assistance, adherence assistance, injection training and nurse support. Enliven® can also help patients with Crohn's disease and ulcerative colitis access laboratory testing.

Contact the Enliven® patient support program at:

Phone 1-877-936-2735
Fax 1-833-423-0252
Email AMGEVITA@oneenliven.ca
Hours Monday to Friday, 8 am to 8 pm EST

Hadlima®

The Harmony™ by Organon patient support program is for patients prescribed Hadlima®. The program gives patients access to services such as cost reimbursement navigation, financial assistance, self-injection training and coordination of laboratory testing.

To enrol, both the prescriber and patient must sign a completed Harmony™ by Organon support group enrolment form.

Contact the Harmony™ by Organon patient support program at:

Phone 1-866-556-5663
Fax 1-866-240-4076
Email info@harmonybyorganon.ca
Hours Monday to Friday, 8 am to 8 pm EST

Hulio®

The Viatris advocate program is for individuals prescribed a Viatris immunology product. The program gives patients access to services such as cost reimbursement assistance, nurses for adherence support, and therapy administration assistance.

Contact the Viatris advocate program at:

Phone 1-844-485-4677
Fax 1-844-554-8546
Email hulio@assistprogram.com
Hours Monday to Friday, 8 am to 8 pm EST

Hyrimoz®

The XPOSE® by Sandoz patient support program is for patients prescribed HYRIMOZ® . The program gives patients access to services such as a nurse case manager, cost reimbursement assistance, injection services, clinical support services such as TB testing, fecal calprotectin, and therapeutic drug monitoring.

Contact the XPOSE® by Sandoz patient support program at:

Phone 1-888-449-7673
Fax 1-844-449-7673
Email xpose@sandozprogramsupport.ca
Hours Monday to Friday, 9 am to 9 pm Pacific time

Idacio®

The KabiCare program by Fresenius Kabi supports patients prescribed Idacio® (adalimumab injection) and their health care team. KabiCare gives patients access to services such as reimbursement navigation, financial assistance, and patient education.

Contact KabiCare at:

Phone 1-888-304-2034
Fax 1-844-304-2014
Email info@kabicare.ca
Hours Monday to Friday, 9 am to 5 pm Pacific time

etanercept

Brenzys®

The Harmony™ by Organon Patient Support Program provides support services, including coordination with private payers for patients taking Brenzys®. To enroll a patient, contact the Harmony™ by Organon central number, and you will be directed to an assigned coordinator.

Contact Harmony™ by Organon at:

Phone 1-866-556-5663
Fax 1-866-240-4076
Email info@harmonybyorganon.ca
Hours Monday to Friday, 8 am to 8 pm EST

Erelzi®

The Erelzi XPOSE® program provides support services, including self-injection training, for patients taking Erelzi®. Both the prescriber and patient must complete and sign an enrolment form to enroll in the program.

Contact Erelzi XPOSE® at:

Phone 1-844-279-7673
Fax 1-866-872-5771
Hours Monday to Friday, 5 am to 5 pm Pacific time
 

Previous switch periods

Switch Period Drug (Originator) Biosimilar(s) Conditions
Phase One
(May 27, 2019 to November 25, 2019)
etanercept (Enbrel®) Brenzys®
Erelzi®
ankylosing spondylitis
psoriatic arthritis (PsA)*
rheumatoid arthritis
*only Brenzys was indicated for PsA at this time
infliximab (Remicade®) Inflectra®
Renflexis®
ankylosing spondylitis
plaque psoriasis
psoriatic arthritis
rheumatoid arthritis
insulin glargine (Lantus®) Basaglar® diabetes (type 1 and 2)
Phase Two
(September 5, 2019 to March 5, 2020)
infliximab (Remicade®) Inflectra®
Renflexis®
Crohn's disease
ulcerative colitis
rituximab phase
(August 20, 2020 to February 18, 2021)
rituximab (Rituxan®) Truxima® granulomatosis with polyangiitis (GPA)
microscopic polyangiitis (MPA)
relapsing-remitting multiple sclerosis
rheumatoid arthritis
Riximyo®*
*Riximyo is not yet approved to treat GPA or MPA
Ruxience™

Note: On February 18, 2021, the PharmaCare formulary added Brenzys for the treatment of psoriatic arthritis, and the biosimilar infliximab Avsola™ for the treatment of ankylosing spondylitis, plaque psoriasis, psoriatic arthritis, and rheumatoid arthritis.

Originator drugs are made from organic cells, which have natural variability. They are often large and complex in structure. Biosimilar drugs are highly similar, but not identical, to the originators. Biosimilars usually enter the market following the expiry of originator patents. Manufacturers can produce biosimilar versions at a much lower cost.

For approved use in Canada, biosimilars undergo thorough testing. Evaluations must find no clinically meaningful differences in efficacy and safety compared to their originators.

Originator drugs are Canada’s largest drug expense, with costs increasing at an unsustainable rate. The Initiative’s targeted originators historically represent some of the largest drug expenditures in B.C. Since biosimilars are more affordable than originators, PharmaCare can invest savings in more treatment options. Until the Initiative, biosimilar medications went largely underused in B.C.

The safety and efficacy of switching to biosimilars is supported by a large body of international evidence. Many European nations have switched patients under their publicly-funded coverage plans.  More than 75 research studies on biosimilars in rheumatology, gastroenterology, dermatology and other neurological disorders collectively show little to no clinical differences between biosimilars and their biologic originators, either when used with treatment-naïve patients, or for patients switching to a biosimilar. Most switching studies have also found that efficacy loss associated with switching to biosimilars was the same as is expected for patients who remain on the originator drug.

Patient perspectives are also valuable. In B.C., the Ministry of Health carefully monitors biosimilar drug usage, patient outcomes, and feedback from patients and healthcare practitioners.

>> Search Canada’s Regulatory Decision Summary Search to find when and why certain biosimilar drugs have been approved in accordance with the Food and Drug Regulations.

>> Search the PharmaCare Formulary to see which biosimilars are available for PharmaCare coverage.

Health Canada approves biosimilars for use in Canada after evaluating functional, structural, and clinical studies comparing them to their originators. Health Canada expects no meaningful differences in switching from routine use of an originator drug to a biosimilar for an approved indication. See Biosimilar biologic drugs in Canada: Fact Sheet.

Drug Decision Summaries


Other resources


Additional reading

rituximab

 

Contact

If you have further questions or feedback, please contact PharmaCare by

Phone: 1-844-915-5005 (Monday to Friday, 8:30 am to 4:30 pm Pacific time)
Email: Biosimilars.Initiative@gov.bc.ca