Tag Archives: Canadian Agency for Drugs and Technologies in Health

Drug Pipeline

Zepatier Approved in Canada

ZepatierZepatier (grazoprevir / elbasvir) is now an approved hepatitis C treatment in Canada! Health Canada has granted the treatment a Notice of Compliance (NOC) for the treatment of chronic hepatitis C (genotype 1, 3, or 4) in adult patients who have or don’t have liver cirrhosis (liver scarring).

When Zepatier will be prescribed to patients, the treatment’s regimen will depend on the genotype/type of hepatitis C virus one has, whether or not one has liver cirrhosis, and one’s treatment history (whether or not treatment has already been tried without success).

See Zepatier (grazoprevir / elbasvir) Facts for more information about Zepatier.

What a Notice of Compliance (NOC) Means for Zepatier

Receiving a Notice of Compliance allows a treatment to be sold in Canada with official approval. If a drug has a Notice of Compliance, a doctor may prescribe it – but at this stage the new drug is still not available on public drug plans, like BC PharmaCare, just private insurers. Private insurers each decide company coverage of the new drug (i.e. what percentage of the drug costs they will cover).

For more information about Zepatier (grazoprevir / elbasvir), or any other new and emerging hep C treatments, please visit PHCN’s Hepatitis C Treatment Information Project or email.

Drug Pipeline

Zepatier (grazoprevir / elbasvir) Facts

*This Zepatier (grazoprevir / elbasvir) treatment facts sheet was updated January 21, 2016. It was originally put together in October 2015, while CADTH was seeking input for it from patient groups. This sheet is made up of Canadian treatment details. We will keep you updated as the treatment proceeds through the Canadian drug approval process.

Zepatier (grazoprevir / elbasvir)

Targeted Genotypes: 1, 3, 4

Treatment Description: Zepatier (grazoprevir / elbasvir) is made up of two direct-acting antivirals. Grazoprevir is a NS3/4A protease inhibitor. It works by blocking a viral enzyme (protease) that enables the hep C virus to survive and replicate in host cells. Elbasvir is a NS5A inhibitor. It blocks a virus protein, NS5A, that the virus needs to reproduce and for various stages of infection.

The treatment has been studied with ribavirin and Sovaldi (sofosbuvir) for multiple hep C genotypes and in patients with difficult-to-treat conditions, such as HIV/HCV co-infection and advanced chronic kidney disease.

Approximate Sustained Viral Response (SVR)/”Cure Rate”: 90% – 98%

Daily Dose: 1 pill of Zepatier at the same time every day +/- Sovaldi +/- ribavirin
Zepatier can be taken with or without food.

Possible Length of Treatment:  8 – 16 weeks

Without Ribavirin:

Patients Weeks
With hep C genotype 1 or 4 who have never tried treatment or have tried treatment with peginterferon and ribavirin (PR) but relapsed 12
With hep C genotype 1 who has tried treatment with a protease inhibitor but relapsed 12
With hep C genotype 1b who has never tried treatment and doesn’t have liver cirrhosis 8
With hep C genotype 1b who has tried treatment with peginterferon or PR but experienced on-treatment virologic failures 12

With Ribavirin:

Patients Weeks
With hep C genotype 1a who has tried treatment with peginterferon (PI) or with peginterferon and ribavirin (PR) but experienced on-treatment virologic failures 16
With hep C genotype 4 who have tried treatment with PR but experienced on-treatment virologic failures 16

With Sovaldi:

Patients Weeks
With hep C genotype 3 who have never tried treatment 12

Availability:  Zepatier is approved for use in Canada

Common Side Effects Reported During Clinical Trials:

  • Diarrhea
  • Headache
  • Nausea
  • Tiredness (fatigue)
  • Trouble sleeping

If you experience any side effects listed or not listed here, contact your healthcare professional.

Usage Warning: Do not take Zepatier if you have moderate or severe liver problems (Child-Pugh B or C). Tell your doctor about any medication (over the counter, prescribed, or recreational) you are taking before taking Zepatier.

See our Sovaldi and ribavirin pages for more information about their possible side effects and usage warnings.

Co-infected with HIV:  Same dose and length of treatment required. Tell your doctor about any medication (over the counter or prescribed) you are taking before taking Zepatier.

More Information:

  • Health Canada’s Summary Basis of Decision (SBD) documents that provide information related to the original authorization of a product.

Sampling of Phase II/III Clinical Trials for Zepatier:

Clinical Trial Patients Treatment Regimen Duration in Weeks
 SVR12*
C-EDGE (looked at treatment-naive, treatment experienced and HIV co-infected patients) GT 1, 4, 6 treatment naive with (C) or without cirrhosis (NC) ZEPATIER 12 95% (total) NC 94%, C 97%, GT1a 92%, GT1b 99%, GT4 100%, GT6 80%
GT 1, 4, 6 HIV/HCV co-infected with (C) or without cirrhosis (NC) ZEPATIER 12 95% (total) NC 94%, C 100%, GT1a 94%, GT1b 96%, GT4 96%, GT6 100%
GT 1, 4, 6 treatment- experienced with or without cirrhosis ZEPATIER +/- Ribavirin (RBV) 16 92% (- RBV total), GT1a 94%, GT1b 96%, GT4 60%, GT6 75%
97% (+ RBV total), GT1a 95%, GT1b 100%, GT4 100%, GT6 100%
C-SALVAGE (looked at retreat duration)
 GT 1, previously failed with PR + a DAA**, with or without cirrhosis ZEPATIER + RBV 12 96% (total)
94% (cirrhosis)
C-SURFER (still ongoing) GT 1, treatment-naïve and patients who failed pegylated interferon, with or without cirrhosis, chronic kidney disease stages 4 or 5 ZEPATIER 12 99%
*In clinical trials for hepatitis C virus (HCV) infection treatments, the goal is to cure/achieve SVR (sustained viral response)/reduce the virus so that it can’t be detected in the blood and liver disease from hep C is stopped.

**The direct antiviral agents listed were Incivek (telaprevir), Victrelis (boceprevir), and Galexos (simeprevir).
Drug Pipeline

Grazoprevir/Elbasvir Announcement

Grazoprevir/elbasvirYesterday the Canadian Agency for Drugs and Technologies in Health (CADTH) sent out notice that they are currently seeking patient group input for the hep C treatment grazoprevir/elbasvir, developed by Merck.

About Grazoprevir/Elbasvir

Grazoprevir/elbasvir is a once-daily, single-pill hep C treatment made up of grazoprevir, a NS3/4A protease inhibitor, and elbasvir, a NS5A inhibitor. It is being tested on patients with difficult-to-treat conditions such as HIV/HCV co-infection, advanced chronic kidney disease, or advanced liver cirrhosis or inherited blood disorder.

In April, the Food and Drug Administration (FDA) in America gave the treatment Breakthrough Therapy designation to treat patients with hep C genotype 1 with end stage renal disease on hemodialysis, and patients with hep C genotype 4 or 6. The Breakthrough Therapy designation helps fast-track treatments through the American drug approval process when they treat serious diseases and their clinical trial results show that the drug may be a large improvement over existing therapies.

In Canada, Health Canada is currently reviewing the treatment. It has not been approved for use yet.

Additional grazoprevir/elbasvir information can be found on the Hepatitis C Treatment Information Project’s Hep C Drug Pipeline Treatments and Clinical Trial Results pages.

About Patient Group Input Reports Requested by CADTH

Within the Canadian drug approval process, Health Canada evaluates a drug’s safety, clinical effectiveness, and its manufacturing process. The Common Drug Review (CDR) by CADTH assesses the treatment’s clinical and cost-effectiveness as it compares to other treatments.

During Common Drug Reviews, CADTH requests patient input reports. These patient input reports help ensure that health outcomes and issues important to patients are incorporated into the Common Drug Review process in a formal and meaningful way.

They help ensure that patients and their loved ones can be a part of the drug review process!

Drug Pipeline

Ombitasvir/ paritaprevir/ ritonavir Announcement

Ombitasvir/ paritaprevir/ ritonavirThis morning the Canadian Agency for Drugs and Technologies in Health (CADTH) sent out notice that they are currently seeking patient group input for Technivie (ombitasvir/ paritaprevir/ ritonavir). Technivie is an interferon-free treatment for hepatitis C genotype 4 infections.

Please keep your eyes open for a blog post with more information about Technivie (ombitasvir/ paritaprevir/ ritonavir) and a link to PHCN’s patient input survey. They will be finalized and sent out in the next few weeks.

About Patient Group Input Reports Requested by CADTH

Within the Canadian drug approval process, Health Canada first evaluates a drug’s safety, clinical effectiveness, and its manufacturing process. The Common Drug Review (CDR) by CADTH then assesses the treatment’s clinical and cost-effectiveness as it compares to other treatments.

During Common Drug Reviews, CADTH requests patient input reports. These patient input reports help ensure that health outcomes and issues important to patients are incorporated into the Common Drug Review process in a formal and meaningful way.

They help ensure that patients and their loved ones can be a part of the drug review process!

Please email or visit the Hepatitis C Treatment Information Project for more information about Technivie (ombitasvir/ paritaprevir/ ritonavir) or any other hep C treatment.

Drug Pipeline

Holkira Pak, CADTH, and the pCPA

Holkira PakHolkira Pak (generic name: ombitasvir / paritaprevir / ritonavir and dasabuvir) has been listed on the pan-Canadian Pharmaceutical Alliance‘s most recent table of active drug product negotiations. Negotiations between the pan-Canadian Pharmaceutical Alliance (pCPA), a negotiations team from different provinces and territories that works to get the best value for brand name and generic drugs for publicly funded drug programs, and Holkira Pak’s manufacturer, AbbVie, are currently underway.

Within the Canadian drug approval process, Health Canada first evaluates a drug’s safety, clinical effectiveness, and its manufacturing process. After which, a Common Drug Review (CDR) by the Canadian Agency for Drugs and Technologies in Health (CADTH) assesses the drug’s clinical and cost-effectiveness as it compares to other treatments.

For Holkira Pak, CADTH started this step on November 3rd, 2014, when it called for patient input. Although, Holkira Pak’s submission for a Common Drug Review is listed as only being accepted on December 3rd, 2014, one month later.

According to the pan-Canadian Pharmaceutical Alliance (pCPA)’s website, once a CDR is complete, the pCPA may then step in after deciding that joint pan-Canadian negotiations for the drug will occur. A province/territory then assumes the lead in negotiations, contacts the manufacturer, and negotiations get underway. If an agreement is reached about treatment prices, the lead province, the manufacturer, and the other jurisdictions all sign a Letter of Intent. The Letter of Intent ends the pCPA’s involvement in the drug’s approval process.

Provinces/territories then make their own final decisions about funding the drug or not through their healthcare plans. If they choose to do so, they then sign a product listing agreement with the manufacturer.

This is where it gets a bit more interesting. Currently, Holkira Pak is listed by CADTH as still undergoing a CADTH Common Drug Review (CDR). The last step listed as completed on the CDR’s Submission Status sheet for Holkira Pak is dated May 28th, 2015. On May 28th, the CDR reports and the recommendation by the Canadian Drug Expert Committee (CDEC), the committee of experts who review all of the data and analyses involved, were sent to the provincial/territorial drug plans and the drug’s manufacturer. A target date for the final CDEC recommendations being sent to drug plans and manufacturer is tentatively listed as 15 business days after that, June 18th.

The pan-Canadian Pharmaceutical Alliance’s most recent table of active drug product negotiations, the one that lists Holkira Pak as a new drug product undergoing negotiations, was dated April 30th, 2015.

And so, we wait. We wait for news from all three parties currently involved, AbbVie (Holkira Pak’s manufacturer), CADTH, and the pan-Canadian Pharmaceutical Alliance.

Holkira Pak

Holkira Pak (ombitasvir/paritaprevir/ritonavir and dasabuvir) is a treatment for patients with chronic genotype 1 hep C, including those with cirrhosis. It is an all-oral, short-course, interferon-free treatment that can be taken with or without ribavirin.

In Phase 3 clinical trials, Holkira Pak (with or without ribavirin) cured an overall 97% of genotype 1 hep C patients, and 98% of patients completed treatment. In Phase 2 and 3 clinical trials, the overall rates of treatment discontinuation due to adverse reactions were low (0.2%).

For more information about Holkira Pak, CADTH, the pan-Canadian Pharmaceutical Alliance, or any other new and emerging hep C drug, please visit PHCN’s Hepatitis C Treatment Information Project or email.

Advocacy

Acknowledged by CADTH

CADTH NewsThe Canadian Agency for Drugs and Technologies in Health (CADTH) acknowledged and thanked the Pacific Hepatitis C Network for being one of 17 patient groups who have contributed five or more patient input submissions to their Common Drug Reviews (CDR).

CADTH Common Drug Reviews, and the patient group input reports that are part of them, are important steps towards getting new treatments more widely available in Canada and BC. They allow patients to have their voices heard in the Canadian drug approval process. They allow patients to explain what it’s like to live with their diseases day-to-day. They allow patients to explain what nobody else can explain.

CADTH’s first Call for Patient Input was issued in May 2010. Three patient groups responded to it. That first review was for Actemra, a treatment for rheumatoid arthritis. It was said that, “The groups provided insight and their unique perspectives into the CADTH Common Drug Review’s (CDR) assessment of Actemra.” Over the years, the insight has continued to be sent in by patient groups and used by CADTH.

Since 2010, CADTH has received 297 patient input submissions from 114 groups for Common Drug Reviews. This patient input has contributed to 142 final recommendations for treatments to be reimbursed, or not, by our publicly funded drug plans.

Thank you to all of you who have contributed to patient input reports submitted by the Pacific Hepatitis C Network. We couldn’t have written the reports without you!

The Canadian Agency for Drugs and Technologies in Health (CADTH)

The Canadian Agency for Drugs and Technologies in Health (CADTH) is an independent, not-for-profit organization responsible for providing health care decision-makers with objective evidence and recommendations to help make informed decisions about the use of health technologies, such as drugs, tests, and surgical devices and procedures.

CADTH has brief but interesting videos about itself and patient input submissions posted on YouTube.

The above is a snapshot of CADTH’s list of the 17 patient groups that have contributed five or more patient group input submissions to Common Drug Reviews over the past five years. The complete article, Five Years of Patient Engagement, can be found online.