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Province of British Columbia
NEWS RELEASE
For Immediate Release
2021HLTH0067-000653
April 7, 2021
Ministry of Health
B.C.’s biosimilars program expands

VICTORIA – As British Columbia continues to lead the way in Canada and adds another biosimilar for provincial coverage, savings continue to be reinvested to make prescription medications more affordable.

On April 7, 2021, almost 6,000 patients on the biologic drug Humira will be transitioned over a six-month period to one of five adalimumab biosimilars. Coverage for the etanercept biosimilars Brenzys and Erelzi will also be expanded allowing new and existing plaque psoriasis patients currently being treated with Enbrel to transition over the same six-month period.

Humira, and its biosimilars Amgevita, Hadlima, Hulio, Hyrimoz and Idacio, are used to treat: rheumatoid arthritis, polyarticular juvenile idiopathic arthritis, ankylosing spondylitis, Crohn’s disease, ulcerative colitis, hidradenitis suppurativa, moderate to severe plaque psoriasis, and psoriatic arthritis.

“Biosimilars are highly similar versions of their biologic drugs, meaning they are just as safe and effective, but are a fraction of the cost,” said Adrian Dix, Minister of Health. “As thousands more patients transition to the next biosimilar (adalimumab), B.C. will save over $100 million over three years. This is in addition to savings from earlier phases of the program that are being reinvested in our health-care system. These savings have allowed us to expand coverage of treatments and add more drugs to our formulary to offer more affordable medications for British Columbians.”

Bioengineered drugs, known as biologics, are collectively the single biggest expense for public drug plans, and their costs continue to climb. For example, from Dec. 1, 2019, to Nov. 30, 2020, PharmaCare spent almost $94 million to provide Humira coverage. The biosimilars are at least 40% less expensive.

Biosimilars cost anywhere from 15% to 50% less than biologics. Canada has an approximately 8% use rate, compared to other nations that have upwards of a 50%  to 95% use rate.

Health Canada confirms that patients and health-care providers can be confident that biosimilars are as effective and safe as their biologic reference drug. Other federal organizations also support the use of biosimilars.

Coverage decisions are informed by evidence from international jurisdictions that have more than 10 years’ experience with these innovative drugs.

After the initial biosimilars program announcement in May 2019, over 90% of PharmaCare patients are on biosimilar drugs for infliximab, etanercept and insulin glargine. Exceptions may be granted for patients whose physicians determine they are medically unable to transition to a biosimilar. Exceptional coverage requests are reviewed by PharmaCare’s Special Authority branch on a case-by-case basis in consultation with physician-led advisory committees, as needed.

Patients or health-care providers with questions about transitioning to a biosimilar can access support by emailing: Biosimilars.Initiative@gov.bc.ca
Or they can call 1 844 915-5005 from Monday to Friday, from 8:30 a.m. to 4:30 p.m.

This announcement is about improving access to prescription drugs for British Columbians. A list of drugs recently added to the PharmaCare formulary can be found in a backgrounder.

In January 2019, B.C. made a $105-million investment, over three years, to reduce and/or eliminate deductibles and co-payments for lower-income British Columbians. B.C. also held a leading role in the national Generics 2.0 agreement to lower costs of the most commonly prescribed drugs and actively participates in the pan-Canadian Pharmaceutical Alliance to negotiate for lower drug costs for all Canadians.

British Columbia will continue to work to make sure everyone can afford and receive the medication they need. 

Learn More:

For more information about biosimilars, visit: https://www2.gov.bc.ca/gov/content/health/health-drug-coverage/pharmacare-for-bc-residents/what-we-cover/drug-coverage/biosimilars-initiative-patients

Four backgrounders follow.

 
Contact:
 
Ministry of Health
Communications
250 952-1887 (media line)
 

 
Province of British Columbia
BACKGROUNDER 1
For Immediate Release
2021HLTH0067-000653
April 7, 2021
Ministry of Health
What are biosimilars?
  • Biosimilars are highly similar versions of bioengineered drugs, known as biologics.
  • Biologics are expensive, injectable drugs made from living organisms (e.g., bacteria or yeast) and are used to treat a growing number of diseases from cancer to chronic conditions including arthritis, diabetes, and Crohn’s and ulcerative colitis.
  • Once patents for biologic drugs expire (20 years after patent was filed), other manufacturers can bring biosimilars onto the Canadian market, in a similar way to generic drug manufacturers.
  • Since biosimilars are based on work done to develop the original biologic drug, they require less research and development.
  • This means the biosimilar can be priced lower than the biologic – anywhere from 25% to 50% less– providing the same health benefits, for better value.
  • Biosimilars are approved for sale just like any other drug. In fact, Health Canada will not approve a biosimilar for sale unless it is proven to have no clinically meaningful difference to the patient compared to the original biologic drug.
  • Similarity between biologics and biosimilars is demonstrated using a step-wise approach beginning with structural and functional studies and continuing with human clinical trials and are evaluated to confirm that there are no clinically meaningful differences in safety and efficacy between them. 
 
Contact:
 
Ministry of Health
Communications
250 952-1887 (media line)
 

 
Province of British Columbia
BACKGROUNDER 2
For Immediate Release
2021HLTH0067-000653
April 7, 2021
Ministry of Health
What other countries are doing with biosimilars

The Patented Medicines Price Review Board has provided the following data on 2018 infliximab biosimilar use rates for Organisation for Economic Co-operation and Development countries. Infliximab treats rheumatoid arthritis, psoriatic arthritis, plaque psoriasis, and Crohn’s disease and ulcerative colitis. The legacy or reference biologic is called Remicade and the two biosimilars currently available in Canada are called Inflectra and Renflexis.

  • Norway                        98%
  • Poland                         96%
  • UK                                92% 
  • Austria                         89%
  • Italy                             79%
  • Sweden                       78%
  • Slovenia                       64%
  • Portugal                      63%
  • France                         60%
  • Czech Republic            59%
  • Spain                           56%
  • Germany                     53%
  • Ireland                         40%
  • Korea                           37%
  • Slovakia                       36%
  • Belgium                       30%
  • Turkey                         23%
  • Switzerland                 22%
  • Mexico                        17%
  • Finland                        17%
  • Australia                      16%
  • Japan                           9%
  • Canada                        8%
  • USA                              7%
  • Chile                            0%
  • Hungary                       0%
  • New Zealand               0%

Data source: MIDAS Database, prescription retail and hospital markets, Q4-2018, IQVIA.

 
Contact:
 
Ministry of Health
Communications
250 952-1887 (media line)
 

 
Province of British Columbia
BACKGROUNDER 3
For Immediate Release
2021HLTH0067-000653
April 7, 2021
Ministry of Health
Rising cost of biologics
  • According to the Patented Medicines Price Review Board, seven of the top 10 selling drugs in Canada in 2016 were biologics. In addition, there are 13 biologics that have expired patents or patents that will expire. This will allow manufacturers to submit biosimilars for market authorization. Since there is a much higher use of biologics in Canada, it means that Canadians have the most to gain from biosimilar savings. (source: https://www.cadth.ca/sites/default/files/symp-2017/presentations/april24-2017/Concurrent-Session-B4-Gary-Warwick.pdf
  • According to 2018 data from the Canadian Institute for Health Information, $14.4 billion of prescribed drug spending (42.7%) was financed by the public sector. Biologics used to treat conditions like rheumatoid arthritis and Crohn’s disease accounted for the highest proportion of public drug spending (8.2%) for the sixth consecutive year. Canadians with drug costs of $10,000 or more represented 2% of beneficiaries but accounted for more than one-third of public drug spending in 2017. (source: https://www.cihi.ca/en/health-spending/2018/prescribed-drug-spending-in-canada)
  • In addition, as of September 2018, there are seven biosimilars available in Canada. Their uptake has been modest. For example, infliximab and etanercept biosimilars accounted for 2.4% of claims and 1.4% of spending in 2017: (https://www.cihi.ca/sites/default/files/document/pdex-report-2018-en-web.pdf)
  • According to the Canadian Agency for Drugs and Technologies in Health, many of the top selling biologic drugs already have or are expected to have biosimilars enter the market within the next few years. The European experience shows that increased biosimilar competition has not only affected the prices of the directly comparable biosimilars and their reference product, but also of the whole product class. (source: https://cadth.ca/sites/default/files/pdf/ES0317_biosimilars.pdf)
 
Contact:
 
Ministry of Health
Communications
250 952-1887 (media line)
 

 
Province of British Columbia
BACKGROUNDER 4
For Immediate Release
2021HLTH0067-000653
April 7, 2021
Ministry of Health
New additions to PharmaCare formulary

This Biosimilars initiative is allowing government to add new drugs to the PharmaCare formulary, meaning more people get affordable access to the medications they need. By using biosimilars in B.C., government will put savings back into health care over the next three years to help fund coverage for more medications.

Recent additions have been made to the PharmaCare formulary under limited coverage.

To be eligible for coverage of these drugs, the patient must meet criteria pre-defined by PharmaCare. Actual coverage depends on rules of the patient's PharmaCare plan, including any annual deductible requirement.

Recent additions to the formulary since May 2020 include:

  • Mepolizumab line extension for the treatment of asthma. Asthma is a common long-term inflammatory disease of the airways of the lungs. It is characterized by variable and recurring symptoms, reversible airflow obstruction and easily triggered breathing spasms. Symptoms include episodes of wheezing, coughing, chest tightness and shortness of breath.
  • Glecaprevir+pibrentasvir (Maviret) criteria change for the treatment of Hepatitis C. Hepatitis C is a viral infection that causes liver inflammation, sometimes leading to serious liver damage.
  • Sarilumab (Kevzara) for the treatment of rheumatoid arthritis. Rheumatoid arthritis is a chronic inflammatory condition that primarily impacts a person’s joints. In some people, the condition can damage a wide variety of body systems, including the skin, eyes, lungs, heart and blood vessels.
  • Inhaler coverage changes including addition of Trelegy Ellipta for the treatment of chronic obstructive pulmonary disease (COPD). COPD is a type of obstructive lung disease characterized by long-term breathing problems. The main symptoms include shortness of breath and cough. COPD is a progressive disease, meaning it typically worsens over time. Many people have unrecognized COPD and remain undiagnosed.
  • Edaravone (Radicava) for the treatment of amyotrophic lateral sclerosis, a relentless progressive, incurable neurogenerative disorder.
  • Ocrelizumab (Ocrevus) for the treatment of primary progressive multiple sclerosis. A relatively rare form of multiple sclerosis characterized by disease progression from the onset of diagnosis.
  • Perampanel (Fycompa) as an adjuvant therapy for the management of primary generalized tonic-clonic seizures in adult patients.
  • Latanoprostene bunod (Vyzulta) for the treatment of open-angle glaucoma or ocular hypertension.
  • Tofacitinib (Xeljanz) for the treatment of rheumatoid arthritis.
  • Tocilizumab (Actemra) for the treatment of rheumatoid arthritis, systemic juvenile idiopathic arthritis and polyarticular juvenile idiopathic arthritis.
  • Levodopa-carbidopa (Duodopa) for the treatment of Parkinson’s disease.
  • Semaglutide (Ozempic) for the treatment of type 2 diabetes.
  • Epinephrine (Allerject Emerade) as another option for the emergency treatment of anaphylactic reactions.
  • Ciprofloxacin-dexamethasone (Ciprodex and generics) coverage change from limited coverage to a regular benefit for the treatment of acute otitis externa and acute otitis media with tympanostomy tubes.
  • Isavuconazole (Cresemba) for the treatment of invasive mucormycosis, a relatively rare, and potentially life-threatening fungal infection.
 
Contact:
 
Ministry of Health
Communications
250 952-1887 (media line)
 

 
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