Tag Archives: daklinza

The PHCN’s News in Review Newsletter (06/04/17)

The PHCN's News in Review Newsletter (07/04/17)Welcome to the Pacific Hepatitis C Network (PHCN)‘s Hepatitis C News in Review Newsletter. This is where we review all of the major current issues and events around hepatitis C and hep C treatments. It is an email that includes links to our recent blog posts—including links to a blog post about the importance of eliminating hepatitis C.

Hepatitis C Elimination is Possible and Essential

The group most impacted by hepatitis C, some 60,000 in B.C., are baby boomers, those who were born between 1945 and 1965. Many have lived with the infection for years but have never been tested or treated because they have never believed themselves to be at risk.  This is the time that everyone, including baby boomers, should be tested and treated for hepatitis C.

Relapse, Recurrence, Null & Partial Response/rs

In hepatitis C and hep C treatment there are three ‘R’s that are big, sad, and scary. They are the bringers of sadness that if doctors, friends, and communities could protect someone from, they would. Click the above link for more information.

Epclusa, Zepatier, Daklinza, and Sunvepra Expanded Coverage

Coverage for four hepatitis C treatments has changed. The four new hepatitis C treatments (Epclusa, Zepatier, Daklinza, and Sunvepra) are being or have been added to various provincial formularies across Canada.

Technivie and BC PharmaCare

Technivie, the hepatitis C treatment, was approved for use in Canada in October 2015 and then later went on to pursue approval for BC PharmaCare coverage in January 2016. However, negotiations that may have led to BC PharmaCare coverage being granted in the near future were closed as an agreement couldn’t be reached between AbbVie and pCPA at this time.

Holkira Pak and BC PharmaCare

The hepatitis C treatment Holkira Pak was approved for use in Canada in March 2015 and then was later approved for BC PharmaCare coverage in July  2015. Although Holkira Pak is still approved for use in Canada and has an amazingly high cure rate, as of March 23, 2017, BC PharmaCare wont cover it.

Blog Posts by PHCN’s President Daryl Luster

Coming this Spring

Eh, starting this spring, Help-4-Hep helpline will be in Canada.  Help-4-Hep is a non-profit, peer-to-peer helpline where counselors work with patients to meet the challenges of hepatitis C head-on. Look for more details to come or call the American Help-4-Hep helpline all free of charge.

For more information about hepatitis C and its cures, please email or visit the Hepatitis C Treatment Information Project.

Epclusa, Zepatier, Daklinza, and Sunvepra Expanded Coverage

Epclusa, Zepatier, Daklinza, and Sunvepra Expanded CoverageCoverage for four hepatitis C treatments is changing. The four new hepatitis C treatments (Epclusa, Zepatier, Daklinza, and Sunvepra) are being added to provincial formularies across Canada.

Treatment Coverage Across Canada

Treatment coverage across Canada is decided upon by each province and territory. This means that not only can treatments vary, and be compared to each other, but treatment coverage may vary from location to location as well.

For more information about what treatment is covered in your province, we have created an easy to understand webpage with links to more information.

This page is a quick summary of what hepatitis C treatments are covered, in some form or another, by the different provinces and territories across Canada. The links within the table will take you to information about the treatments and to information about treatment coverage.

Lastly, towards the bottom of the webpage, there are links to information about Canadian clinics and additional resources about hepatitis C treatment coverage outside of BC.

However, please note that one of the most important things to know when looking into hepatitis C and its treatment, far beyond what treatments are covered by your province now, is that being in contact with a healthcare practitioner, who is regularly monitoring your health, is essential.

PHCN’s Statement about the Successful Negotiations for 3 New Hepatitis C Treatments

PHCN's Statement about the Successful Negotiations for 3 New Hepatitis C Treatments‘No One Left Behind!’

Pacific Hepatitis C Network (PHCN) is very happy to learn that effective March 21, an extensive list of hepatitis C treatments will be available through BC PharmaCare – at far better prices than they previously had been. The high cost of hepatitis C treatment has effectively restricted the numbers of people living with hepatitis C who could access treatment.

Even with lower prices, those restrictions will remain in place until next year. Come March 2018, those restrictions (requiring a liver fibrosis stage of F2 or greater) will be lifted and hepatitis C treatment will be available to any person living with hepatitis C in BC, “regardless of the type and severity of their disease”.

The Province, via the Ministry of Health, co-led the negotiations for new, affordable prices and we at PHCN are both proud of that fact and sincerely grateful. We hope the same for new, hep C drugs that are currently in development and that improve even more on cure rates, tolerability, length of treatment, and treating more than one HCV genotype.

And with these new developments, our work continues! Now is the time to identify and address the barriers still in place that keep those living with hep C from accessing care and treatment: low levels of primary care provider awareness of hep C and treatments; believes about who deserves treatment and who doesn’t; patient education and outreach to those who were diagnosed years ago but are not engaged in care for their hep C. Stigma can and does underlay many of those barriers and must be addressed.

PHCN applauds the ushering in of the first critical step by BC’s Ministry of Health and we urge continued vigilance and collective planning and action to ensure ’No One Left Behind!’ when it comes to hepatitis C care and treatment in BC.

More information can be found here.

BC Ministry of Health Press Release: More Patients to Benefit from Hepatitis C Treatments

BC Ministry of Health Press Release: More Patients to Benefit from Hepatitis C TreatmentsCopied and Pasted from BC Ministry of Health on February 21, 2017.

Thousands of British Columbians living with hepatitis C will have better access to treatment as a result of successful negotiations brokered by the pan-Canadian Pharmaceutical Alliance (pCPA).

“This agreement changes the landscape for hepatitis C patients living in B.C.,” said Health Minister Terry Lake. “Not only are there four new treatment options for what is now a curable virus, but the savings that were negotiated will allow us to cover treatment options for all hepatitis C patients – rather than just those in more advanced stages of the disease.”

British Columbia and Ontario co-led the negotiations with the drug manufacturers on behalf of the pCPA. The alliance helps provinces and territories leverage their collective buying power and negotiate better prices for new drugs.

The collaborative effort resulted in a significant cost savings to drug plans for participating provinces and territories. The agreement also allows access to treatment for all eligible patients in a fiscally sustainable manner. Prices and terms for this negotiation are confidential.

The list cost to the health system for hepatitis C treatment has ranged from $45,000 to over $100,000 per patient, depending on the drug and disease progression.

Agreements with the pCPA were reached with Gilead Sciences Canada, Merck Canada, and Bristol-Myers Squibb Canada to provide several hepatitis C drugs at an improved cost:

  • Daklinza (daclatasvir) – new
  • Epclusa (sofosbuvir/velpatasvir) – new
  • Harvoni (ledipasvir/sofosbuvir)
  • Sovaldi (sofosbuvir)
  • Sunvepra (asunaprevir) – new
  • Zepatier (elbasvir/grazoprevir) – new

PharmaCare is expanding the criteria in March 2017 to provide coverage to more patients living with hepatitis C. Physicians can apply for coverage of the new drugs on behalf of their patients on or around March 21, 2017. Starting in 2018-19, PharmaCare will provide coverage for any British Columbian living with chronic hepatitis C, regardless of the type or severity of their disease.

Up to 75,000 British Columbians are estimated to be living with hepatitis C. Approximately 24% of those exposed to the virus are able to clear it on their own. However, when left untreated, it can cause serious complications such as liver failure and liver cancer. The new modern hepatitis C therapies are highly effective, with the ability to clear the virus at rates over 95%.

If untreated, hepatitis C virus infection can be a life-threatening communicable disease. Risk and harm reduction practices are strongly encouraged for those who may be at higher risk for re-acquiring the virus after successful treatment, including people who inject drugs, men who have sex with men, and commercial sex workers.

Hepatitis C is the most-frequent cause of premature death among reportable infectious diseases in North America, and has become the most-frequent cause of premature death among people living with both hepatitis C and HIV.

Quick Facts:

  • Hepatitis C is a serious, communicable disease that is spread through direct contact with the blood of a person living with the virus. Symptoms may include fatigue, jaundice, abdominal pain and joint pain. In some people, it can cause liver damage (cirrhosis) or liver cancer.
  • Up to 75,000 people are estimated to be living with hepatitis C in British Columbia. However, many people with the virus have no symptoms. About one-quarter of people living with hepatitis C do not know they have it.
  • About one-quarter of people with hepatitis C do not need treatment, as their body fights off the infection.
  • Once someone is successfully treated and cured of hepatitis C infection, they are no longer able to pass the disease on to others.
  • Currently, there is no vaccine to prevent hepatitis C infection.
  • From March 2015 to December 2016, PharmaCare coverage was provided to about 3,800 people in B.C. for medication used to treat chronic hepatitis C.

Learn More:

For more information on the pan-Canadian Pharmaceutical Alliance:
http://www.pmprovincesterritoires.ca/en/initiatives/358-pan-canadian-pharmaceutical-alliance

For more information about B.C.’s PharmaCare program:
http://www2.gov.bc.ca/gov/content/health/health-drug-coverage/pharmacare-for-bc-residents

Successful Negotiations for Three New Hepatitis C Treatments

Successful Negotiations for Three New Hepatitis C TreatmentsDirectly copied statement from the pan-Canadian Pharmaceutical Alliance

TORONTO, Feb. 21, 2017 /CNW/ – On behalf of participating federal, provincial and territorial public drug plans, the pan-Canadian Pharmaceutical Alliance (pCPA) has concluded successful negotiations with three drug manufacturers to help jurisdictions expand access to publicly funded medications for the treatment of chronic hepatitis C.

Hepatitis C is a communicable liver disease that is caused by an infection with the hepatitis C virus. Seventy-five per cent of people who have contracted hepatitis C cannot spontaneously clear the virus. This leads to chronic hepatitis C infection. Although many of the estimated 250,000 infected Canadians may have no symptoms for decades, if left untreated, chronic hepatitis C can lead to serious complications such as liver failure and liver cancer.

Just a few years ago, hepatitis C patients took a combination of pills and injections for almost a year and these earlier drugs had lower rates of treatment success. Today’s newer therapies are more effective, available in oral form and require substantially shorter durations of treatment.

These benefits, however, come at a substantial cost. Depending on the drug and disease progression, the list cost for hepatitis C treatments ranged from $45,000 to over $100,000 per patient. Although these costs were made more affordable with previous agreements, the funding of hepatitis C treatments has resulted in significant cost pressures.

Recently, multiple products have become available, creating a more competitive environment for hepatitis C treatment price negotiations.

The pCPA’s approach to hepatitis C treatment negotiations was guided by the following:

  • goal of providing treatment for patients regardless of genotype and disease severity
  • financial affordability and sustainability
  • a fair approach in negotiating value among multiple drugs and manufacturers.

Gilead Sciences Canada, Merck Canada, and Bristol-Myers Squibb Canada were able to reach an agreement through the pCPA to provide hepatitis C drugs at an improved cost. These agreements will help increase publicly funded access for most patients with hepatitis C.

As with all pCPA drug negotiations, individual participating jurisdictions will be responsible for implementing changes under their respective public drug plans.

SOURCE Pan Canadian Pharmaceutical Alliance (pCPA)

For further information: For more information (media): David Jensen, Ministry of Health and Long-Term Care, 416-314-6197

Month by Month 2016 Hepatitis C Drug Pipeline Highlights

2016 Hepatitis C Drug Pipeline HighlightsA lot happened in 2016 within the hepatitis C drug pipeline. Some treatments sought approval to be used in Canada and other treatments sought to be listed on PharmaCare’s formulary. The following highlights just some of their 2016 milestones:

2016 Hepatitis C Drug Pipeline Highlights

January
February
March
April
May
June
July
August

October

December

Have we missed any events in our list of 2016 hepatitis C drug pipeline highlights that you feel should be included? Send us an email and we may update this post.

Treatments in the Final Steps of the Canadian Drug Approval Pipeline

In the Final Steps of the Canadian Drug Approval PipelineThere are a couple of hepatitis C treatments making their way through the final steps of the Canadian drug approval pipeline. The following table was created to highlight these treatments and highlight the ways that you may be able to include your voice in their approval process.

Hepatitis C Treatments in the Final Steps of the Canadian Drug Approval Pipeline

Sunvepra (asunaprevir) + Daklinza (daclatasvir) +/- Pegylated Interferon with Ribavirin (PR) Technivie (ombitasvir, paritaprevir, ritonavir) +/- Ribavirin (RBV) Epclusa (sofosbuvir / velpatasvir +/- RBV Zepatier (elbasvir / grazoprevir) +/- RBV Zepatier (elbasvir / grazoprevir) + Sovaldi (sofosbuvir)
Treatment Drug Classes NS3/4A Protease Inhibitor, NS5A Inhibitor NS5A Inhibitor, NS3/4A Protease Inhibitor, and Ritonavir, a booster for paritaprevir Nucleotide NS5B Polymerase Inhibitor, NS5A Inhibitor NS5A Inhibitor, NS3/4A Protease Inhibitor NS5A Inhibitor, NS3/4A Protease Inhibitor, Nucleotide NS5B Polymerase Inhibitor
Step Within Canadian Drug Approval Pipeline Step 5 – Provincial Review
Currently Seeking Patient / Caretaker Input Has already been collected Has already been collected Has already been collected Has already been collected Has already been collected
Genotype (GT) Health Canada has Approved it for 1, 4 4 1 – 6 1, 4 3
Under BC PharmaCare Review for Genotype 1, 4 4 1 – 6 1, 4 3
Approximate SVR (Approx Rate of Cure) 93 – 100% 90% without RBV, 100% with RBV 94 – 100% 93 – 100% 91 – 100%
May Require PR* Yes No
May Not Require PR or RBV
Yes
Daily Pills 3 +/- PR 1 +/- twice daily RBV 1 +/- twice daily RBV 1 +/- twice daily RBV 2 once daily
Possible Weeks of Treatment 24 12 8, 12, or 24 8, 12, or 16 12
Most Common Side Effects** (Ribavirin can affect side effects)
  • Headache
  • Tiredness (fatigue)
  • Headache
  • Insomnia
  • Nausea
  • Tiredness
  • Weakness (asthenia)
  • Headache
  • Nausea
  • Tiredness (fatigue)
  • Anemia
  • Headache
  • Nausea
  • Tiredness (fatigue)
  • Headache
  • Nausea
  • Tiredness (fatigue)
Drug Warnings (Healthcare providers, patient assistance programs, and/or online product monographs, links below, have more information) Sunvepra is not for patients with moderate to severe liver impairment (Child-Pughs B and C). Do not take Sunvepra without combining it with other hep C treatments. Please see Bristol-Myers Squibb Canada’s Sunvepra information page for more information.

Technivie is not for patients with moderate to severe liver impairment (Child-Pughs B and C). Technivie should not be taken while taking: ethinyl estradiol-containing medicines, drugs that are sensitive cytochrome P450 (CYP) 3A substrates and for which elevated plasma concentrations are associated with serious adverse reactions, strong CYP2C8 inhibitors and inducers, moderate or strong inducers of CYP3A.

Patients taking amiodarone should not take Sovaldi (sofosbuvir) in any combination.

Zepatier is not for patients with moderate to severe liver impairment (Child-Pughs B and C). Zepatier is contraindicated with organic anion transporting polypeptide 1B (OATP1B) inhibitors, strong inducers of cytochrome P450 3A (CYP3A), and efavirenz.

Zepatier is not for patients with moderate to severe liver impairment (Child-Pughs B and C). Zepatier is contraindicated with organic anion transporting polypeptide 1B (OATP1B) inhibitors, strong inducers of cytochrome P450 3A (CYP3A), and efavirenz.

Patients taking amiodarone should not take Sovaldi (sofosbuvir) in any combination.

General Hep C Treatment Usage Warning Do not take treatments while taking recreational drugs or over-the-counter drugs, such as St. John’s wort, without first talking with your healthcare provider as they may interact with each other. If you have any side effects not listed here, contact your healthcare provider. Tell your healthcare provider if you may be or may become pregnant. The safety and efficacy of most of these treatments in children less than 18 years of age has not been established.
Patient Assistance Program Contact Information Bristol-Myers Squibb Canada’s CLAIRE Program 1-844-HCV-2559 AbbVie Care 1-844-471-2273
Gilead’s Momentum Patient Assistance Program 1-855-447- 7977 Merck Care Program 1-866-872-5773
Information by Health Canada Sunvepra Technivie Epclusa Zepatier
Information about HCV / HIV Co-infection Sunvepra (by Bristol-Myers Squibb Canada) Technivie (by CATIE)

Epclusa (by hepmag)

Zepatier (by CATIE)
*PR stands for pegylated interferon with ribavirin. It may be combined with other drugs for the treatment of hep C. RBV stands for ribavirin. **If patients experience treatment side effects, they are usually not severe enough to stop treatment.

Canadian drug approval pipeline and treatment information was gathered last week from Health Canada’s Drug and Health Products sheets, BC PharmaCare Drug Information sheets, CATIE, hepmag, product monographs, and the Hepatitis C Treatment Information Project.

Sunvepra (Asunaprevir) Final Recommendation Sent to PharmaCare Plans

Sunvepra (asunaprevir) Final RecommendationSunvepra (generic name asunaprevir), developed by Bristol-Myers Sqibb, passed its Common Drug Review with the release of the Canadian Drug Expert Committee (CDEC) Final Recommendation for it.

The Canadian Drug Expert Committee Final Recommendation is important within the Canadian drug approval process as it’s sent to the provinces and territories to help them decide on how they want to cover the treatment through their PharmaCare plans.

The CDEC Final Recommendation for Sunvepra (asunaprevir) when combined with Daklinza (daclatasvir)

The CDEC advocates that Sunvepra, in combination with Daklinza (daclatasvir), be listed by drug plans as a treatment for adults with chronic hepatitis C genotype 1b and with Daklinza, pegylated interferon, and ribavirin, for patients with hep C genotype 1 or 4, if the following criteria/conditions are met:

Recommended Clinical Criteria
  • None listed. This is the first CDEC report for a hep C treatment to not recommend that the treatment only be covered for patients who have a liver fibrosis stage of F2 or higher–this is a great omission.
Recommended Conditions
  • Drug plans should save money when comparing this treatment’s cost to the cheapest hep C treatment alternative.
  • Treatment should be started by hepatologists or physicians experienced with treating chronic hepatitis C.

Reasons for the Above Sunvepra Recommendations
  1. A review of clinical trial results suggests that Sunvepra’s treatment response rates are comparable to success/cure rates of other interferon-free hep C treatments. However, it was noted that there are no trial results with direct comparisons to other treatments already covered by public drug programs. This has also been noted in CDEC recommendations for other hep C treatments.

  2. “There is uncertainty regarding the cost-effectiveness of ASV [Sunvepra] combination regimens…” when they are compared with other hepatitis C treatments.(CDEC)
Noted Discussion Points
  • Efficacy of these Sunvepra-based treatment combinations for patients with decompensated liver disease, hepatitis B, or HIV coinfection, malignancy, or recent drug use, remains uncertain. However, the current data indicates that Daklinza + Sunvepra is effective and safe for all of these patients.
  • The CDEC believes that there will be “limited use” of pegylated interferon with ribavirin-based treatments when there are interferon-free treatments available.
  • Further research into patients infected with hepatitis C with L31 or Y93 HCV NS5A-resistant variant at baseline is needed. (CDEC)

The Canadian Drug Expert Committee’s Final Recommendation for Sunvepra can be found here.

Sunvepra (asunaprevir)

Sunvepra (asunaprevir) is prescribed with other hepatitis C treatments/direct-acting antivirals (DAAs). It is a treatment for patients with chronic hepatitis C genotype 1 or 4.

Sunvepra, in combination with Daklinza, peginterferon, and ribavirin, has been tested on those with hep C genotype 1 or 4 who were non-responders (patients who tried treatment but it failed to achieve SVR/a cure) with great results. The cure rate when treating patients with hep C genotype 1 is 93.2%. The cure rate when treating patients with hep C genotype 4 is 100%. (Health Canada)

Lastly, doctors are able to prescribe Sunvepra to patients, but the hepatitis C treatment isn’t covered by PharmaCare yet.

Updated Recommendations

Updated Recommendations“All patients with CHC [a chronic hepatitis C] infection should be considered for treatment, regardless of fibrosis score. Given the potential impact on health system sustainability of treating all patients with CHC infection on a first-come basis, priority for treatment should be given to patients with more severe disease.” (CADTH Canadian Drug Expert Committee, page 2, May 18, 2016)

Updated CADTH Canadian Drug Expert Committee Recommendations

The Canadian Drug Expert Committee (CDEC) updated their recommendations for the hep C treatments: Harvoni, Holkira Pak, Sovaldi, and Daklinza. They now recommend that the liver fibrosis stage F2 or greater requirement for treatment through PharmaCare should be removed. Where once their clinical criteria for treatment with Harvoni, for example, read, “Patients must have a liver fibrosis stage of F2 or greater before they are eligible for PharmaCare coverage“, the same report sections for Harvoni now read:

Recommendation:

CDEC recommends that ledipasvir/sofosbuvir (LDV/SOF) be reimbursed for the treatment of chronic hepatitis C virus (CHC) genotype 1 infection in adults, if the following conditions are met.

Conditions:
  • Treatment should be initiated by physicians with experience in the management of CHC patients.
  • Drug plan costs for LDV/SOF should not exceed the drug plan costs of other interferon (IFN)-free regimens for the treatment of CHC. (CDEC, May 2016)

Additional Noteworthy Updates

The CDEC also recommended/stated that:

  • Disease symptoms and other health concerns be considered when deciding to treat or not treat, or as it is written in the report, “Extrahepatic manifestations are additional considerations in defining disease severity.”
  • The more sever patients be treated first.
  • Treatment is likely cost-effective across all METAVIR scores. Detailed explanations of this are included in the recommendation reports (links below).

A Possible Next Step for Hep C Advocates

A possible next step for hep C advocates may be to highlight these changes and to ask governments, who follow the CDEC recommendations, to follow suit.

The Links to the Updated CADTH Canadian Drug Expert Committee Recommendations and Summary Reports on Drugs for Chronic Hepatitis C Infection

About CADTH’s Canadian Drug Expert Committee (CDEC)

CADTH’s CDEC is an advisory board made up of experts and public members (for a lay perspective) that makes recommendations to the publicly funded drug plans about what and what not to cover and how to cover it.

 

Daklinza for historically difficult to treat patients

Daklinza (daclatasvir) for historically difficult to treat patientsMay 24, 2016 – Daklinza (daclatasvir), taken for 12 weeks (in combination with Sovaldi and with or without ribavirin), has been approved by Health Canada for the treatment of patients with chronic hepatitis C (genotype 1, 2, or 3) and with HIV co-infection, advanced liver cirrhosis, or post-liver transplant hep C recurrence.

This approval is good news as due to potential drug interactions between hep C treatments and HIV treatments or anti-rejection drugs for post-transplant, patients who are co-infected or have had  liver transplants have been historically difficult to treat. This difficulty hasn’t been good news as, for example, approximately 20% of Canadians with HIV also have hep C (HCV). When patients have both infections, hep C progresses much faster than it does in those infected with just HCV–progresses much faster to the point where HCV related liver disease is the leading cause of death for those who are co-infected. (BMS Canada)

These new Health Canada approvals, or treatment indications, were based on data from the clinical trials ALLY-1 and ALLY-2.

Click here to read the news release by Bristol-Myers Squibb Canada.

Daklinza (daclatasvir) with Sovaldi (sofosbuvir)

Daklinza taken in combination with other hep C antivirals, such as Sovaldi, was approved for Canadian use in August 2015.

Daklinza with Sovaldi and with or without ribavirin is a treatment for those with chronic hep C genotype 1, 2, or 3, including those with cirrhosis, and now with HIV co-infection, advanced cirrhosis, or post-liver transplant hep C recurrence. It is an all-oral, short-course (12 or 24 weeks), interferon-free, possibly ribavirin-free, treatment.

“With this expanded label for Daklinza, we are proud to provide an option that helps bridge what has been a challenging treatment gap for these patients.” –Dr. Nawal Peacock, President and General Manager, Bristol-Myers Squibb Canada.