Holkira Pak and BC PharmaCare

Holkira Pak and BC PharmaCareThe 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 has decided not to approve new requests for coverage.

For patients whose coverage was approved before March 23, 2017, BC PharmaCare will continue coverage until their current Special Authority expires. For more information about this change, please contact your doctor, nurse, or call the AbbVie Care program at: 1-844-471-2273.

From all of the BC residents who were able to access Holkira Pak and, therefore, may have been cured of the hepatitis C virus, we would like to thank all of the people who work within the hepatitis C approval pipeline who made their recovery possible.

Holkira Pak

Treatment Description: Holkira Pak is a treatment for patients with chronic genotype 1 hep C, including those with cirrhosis. It is an all-pill, short-course, interferon-free treatment that can be taken with or without ribavirin.

  • Ombitasvir / Paritaprevir / Ritonavir +/-
  • Ribavirin

Daily Dose: 4 pills +/- ribavirin pills

Sustained Viral Response (SVR)/”Cure Rate”: 95 – 100% with ribavirin

Usage Warning: Holkira Pak should not be taken with/by the following:

  • Those with moderate to severe liver impairment (Child-Pughs B and C);
  • Ethinyl estradiol-containing medicines (such as some birth control products);
  • Drugs that are sensitive cytochrome P450 (CYP) 3A substrates and for which elevated plasma concentrations;
  • Strong CYP2C8 inhibitors and inducers;
  • Moderate or strong inducers of CYP3A;
  • Recreational drugs.

Length of Treatment:

Genotype Previously Treated Cirrhosis Treatment # of Weeks
1a Yes or No No 2 pills once daily + 1 pill twice daily + 1 pill twice daily of RBV* 12
1b Yes or No No 2 pills once daily + 1 pill twice daily 12
1a/1b No Yes 2 pills once daily + 1 pill twice daily + 1 pill twice daily of RBV 12
1a Yes Yes 2 pills once daily + 1 pill twice daily + 1 pill twice daily of RBV 24**
*RBV stands for ribavirin. Holkira Pak with ribavirin is recommended for patients with an unknown genotype 1 subtype or with mixed genotype.
**24 weeks of Holkira Pak + ribavirin is recommended for patients with genotype 1a infection with cirrhosis who previously didn’t respond to pegylated interferon and ribavirin (PR).

Common Side Effects Reported in Clinical Trials:

  • Can’t sleep (insomnia)
  • Diarrhea
  • Headache
  • Itchiness
  • Nausea
  • Tiredness

Access to Hep C Treatment in Federal Institutions Webinar

Access to Hep C Treatment in Federal Institutions WebinarThursday, March 23rd at 11am PST,  join CTAC Policy Researcher Amanda Fletcher’s webinar to learn more about the prevalence of hepatitis C in Canada’s federal institutions.*

Hepatitis C impacts between 250,000-300,000 Canadians, among whom at least 44% are undiagnosed and untreated. While the national hep C burden among Canadians is approximately 1%, the prevalence of hep C in correctional institutions is estimated to be between 20 and 40%.

March 23rd CTAC Webinar

This CTAC webinar will focus on issues and recommendations around access to hep C treatment in federal institutions and address questions like: How has treatment, traditionally, been administered? What are the factors behind such a high hep C prevalence rate? What kind of preventative measures can be taken? How have Correctional Service Canada’s drug eligibility restrictions changed, and what does this mean for hep C treatment within the institutional setting?

Learn more about screening; treatment; harm reduction; social determinanents of health (gender, mental health/substance abuse); Correctional Service Canada’s new and less restrictive eligibility requirements around fibrosis scores; and, finally, CTAC’s recommendations for increasing treatment access.

Don’t delay. Register now!

On the day of the event, you will need to log on to the webinar at http://ctac.adobeconnect.com/hepCprison and dial in for the audio toll-free at 877-473-4906 with conference code 4564615148

CTAC

CTAC is an organization that focuses on access to treatment for people living with HIV and HIV/HCV co-infection. Since 1996, they have worked to secure and ensure equitable, affordable and timely access to treatment, care and support for people in Canada living with HIV and HIV/HCV co-infection.
*Content by CTAC

The PHCN’s News in Review Newsletter (13/03/17)

The PHCN's News in Review Newsletter (13/03/17)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 blog posts about the BC Ministry of Health announcing that they are now covering additional 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…

BC MINISTRY OF HEALTH COVERS ADDITIONAL HEPATITIS C TREATMENTS

Agreements between the pCPA and Gilead Sciences Canada, Merck Canada, and Bristol-Myers Squibb Canada were reached 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

BC MINISTRY OF HEALTH ANNOUNCES END OF LIVER FIBROSIS F1> TREATMENT REQUIREMENT

PharmaCare announced that starting in 2018-19, they will provide coverage for any British Columbian living with chronic hepatitis C, regardless of the type or severity of their disease.

ONTARIO DRUG BENEFIT PROGRAM FUNDING HEPATITIS C DRUGS

Effective February 28, 2017, the following hepatitis C drug products will be funded under the Ontario Drug Benefit (ODB) Program for eligible ODB recipients for the treatment of hepatitis C.

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

CROI 2017

The Conference on Retroviruses and Opportunistic Infections (CROI), an annual preeminent HIV research meeting, was held in Seattle, Washington, February 13-16 this year. CROI gathers scientists researching epidemiology and biology of human retroviruses and associated diseases to discuss their findings. The following blog posts highlight HIV/HCV information that was at the conference.

REFLECTIONS BY PHCN’S PRESIDENT DARYL LUSTER

For more information about the topics in this newsletter, please click on the links, visit PHCN’s Hepatitis C Treatment Information Project, or email us.

CROI 2017 by Lucinda K. Porter, RN

CROI 2017 by Lucinda K. Porter, RNLucinda K. Porter

This is a collection of blog posts written by Lucinda K. Porter, RN, a hepatitis C writer who attended this year’s Conference on Retroviruses and Opportunistic Infections (CROI). The blog posts below highlight hepatitis C studies presented at the conference that stood out to her.

Please scroll down and click on the blog tittles that interest you.

Sampling of CROI 2017 Meeting Highlights Written by Lucinda K. Porter, RN

CROI 2017

The Conference on Retroviruses and Opportunistic Infections (CROI), an annual preeminent HIV research meeting, was held in Seattle, Washington, February 13-16 this year. CROI gathers scientists researching epidemiology and biology of human retroviruses and associated diseases to discuss their findings.

More information about the CROI and the studies that were presented there can also be found in our blog post CROI 2017 Hep C Highlights Part I.

“Creating a world free from hepatitis C one step at a time” -Lucinda Porter

CROI 2017 Hep C Highlights Part II

CROI 2017 Hep C (HCV) HighlightsCROI 2017

The Conference on Retroviruses and Opportunistic Infections (CROI), an annual preeminent HIV research meeting, was held in Seattle, Washington, February 13-16 this year. CROI gathers scientists researching epidemiology and biology of human retroviruses and associated diseases to discuss their findings.

This blog post is a collection of HIV/HCV highlights that were presented at CROI 2017. Please scroll down and click on the subjects that interest you.

More Interesting CROI 2017 Abstracts about HIV/HCV Coinfection

More information about The Conference on Retroviruses and Opportunistic Infections (CROI), or these and other studies can be found in our blog post CROI 2017 Hep C Highlights Part I or on the conference’s website.

CROI 2017 Hep C Highlights Part I

CROI 2017 Hep C Highlights Part ICROI 2017

The Conference on Retroviruses and Opportunistic Infections (CROI), an annual preeminent HIV research meeting, was held in Seattle, Washington, February 13-16 this year. CROI gathers scientists researching epidemiology and biology of human retroviruses and associated diseases to discuss their findings.

This blog post is a collection of HIV/HCV highlights that were presented. Please scroll down and click on the subjects that interest you.

Interesting Meeting Abstracts about HIV/HCV Coinfection

More information about The Conference on Retroviruses and Opportunistic Infections (CROI), or these and other studies can be found in our blog post CROI 2017 Hep C Highlights Part II or on the conference’s website.

Ontario Drug Benefit Program Funding Hepatitis C Drugs

Ontario Drug Benefit Program Funding Hepatitis C Drugs“The criteria for coverage of hepatitis C treatments is being expanded in a phased approach. Coverage will be further extended to all patients regardless of severity of disease or genotype within the next 12 months.” –Ontario Public Drug Programs

“We look forward to the day that all criteria are lifted and all people living with hep C can access treatment, regardless of disease and genotype.” -Pacific Hepatitis C Network

Reposted from Ontario Public Drug Program Dated February 21, 2017

Effective February 28, 2017, the following hepatitis C drug products will be funded under the Ontario Drug Benefit (ODB) Program for eligible ODB recipients for the treatment of hepatitis C.

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

The above drugs will be listed on the ODB Formulary/Comparative Drug Index (Formulary) as Limited Use (LU) benefits.

Health care providers are advised to refer to the Formulary for information about the specific reimbursement criteria applicable to each of the funded hepatitis C drugs.

The range of funded hepatitis C drug products will enable funding consideration for patients with most of the common or mixed genotypes in Ontario when the specified criteria are met.

The full details of the LU criteria will be also be posted in the February 2017 monthly Formulary update at:

www.health.gov.on.ca/en/pro/programs/drugs/odbf_eformulary.aspx

For more information, refer to the Frequently Asked Questions (FAQs) for healthcare providers and patients.

Additional Information:
For pharmacies:
Please call ODB Pharmacy Help Desk at: 1-800-668-6641

For all other Health Care Providers and the Public:
Please call ServiceOntario, Infoline at 1-866- 532- 3161 TTY 1-800-387 -5559. In Toronto, TTY 416- 327 -4282

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