Tag Archives: ZEPATIER

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

Grazoprevir and Elbasvir at the Liver Meeting 2016

Grazoprevir and Elbasvir at the Liver Meeting 2016As we begin to look back on 2016, this post highlights some of the presentations that took place at the Liver Meeting 2016 about the hep C treatments grazoprevir and elbasvir.

Grazoprevir and Elbasvir

  • #74C-ISLE: Grazoprevir/Elbasvir plus Sofosbuvir in Treatment- naïve and Treatment-experienced HCV GT3 Cirrhotic Patients Treated for 8, 12 or 16 weeks
Treatment Naive Treatment Experienced
Arm 1, 8 weeks + RBV Arm 2, 12 weeks without RBV Arm 3, 12 weeks without RBV Arm 4, 12 weeks with RBV Arm 5, 16 weeks without RBV
Treatment Week 4 87% 74% 71% 88% 71%
Treatment Week 8 100% 100% 100% 100% 100%
  • #76Efficacy and Safety of Elbasvir/Grazoprevir in Treatment-Naive Subjects with Chronic HCV GT 1, GT 4 and GT 6 Infection (C-CORAL): A Phase III Randomized Multinational Clinical Trial

Summary: Hepatitis C contributes significantly to the overall liver disease burden in the Asia Pacific region and Russia where the seroprevalence rates vary from 1-5% and genotype (GT) 1b accounts for about half of infections. Conclusion: A 12-week regimen of EBR/GZR is effective and well-tolerated in GT1 and GT4-infected, treatment-naive patients in the Asia Pacific/Russia region.

Genotype SVR12 Rate
Overall (232/250) 92.8%
GT1a (23/26) 88.5%
GT1b (185/187) 98.9%
GT4 (2/2) 100%
GT6 (22/35) 62.9%
  • #110Safety and Efficacy of the Fixed-Dose Combination Regimen of MK-3682/Grazoprevir/MK-8408 With or Without Ribavirin in Non-cirrhotic or Cirrhotic Patients with Chronic HCV GT1, 2 or 3 Infection (Part B of C-CREST-1 & 2)

Summary: Treatment was generally well tolerated, with no cardiac or renal safety signals seen. One GT1-infected patient died due to a study drug-unrelated bacterial sepsis The most common side effects, in >5% of all patients, were fatigue, headache, and nausea.

Patients SVR8/12 Rate
126 GT1-infected patients who recieved 8 or 12 weeks of treatment 100%
85 patients (46 GT1a/39 GT1b) who received 12 weeks of therapy 100%
  • #112High Sustained Virologic Response (SVR) Rates in Patients with Chronic HCV GT1, 2 or 3 Infection Following 16 Weeks of MK-3682/Grazoprevir/MK-8408 Plus Ribavirin After Failure of 8 Weeks of Therapy (Part C of C-CREST-1 & 2)

Summary: To evaluate a retreatment regimen for patients who had failed therapy with a 3-drug direct-acting antiviral (DAA) combination: MK-3682, an NS5B polymerase inhibitor, grazoprevir, an NS3/4A protease inhibitor, and either elbasvir or MK-8408, which are NS5A inhibitors. All of the patients achieved SVR. The most common (>10%) side effects were headache, fatigue, nausea, rash, pruritus, insomnia, decreased hemoglobin, and cough.

  • #193Safety and Efficacy of the Fixed-Dose Combination Regimen of MK-3682/Grazoprevir/MK-8408 in Cirrhotic or Non-cirrhotic Patients with Chronic HCV GT1 Infection who Previously Failed a Direct-acting Antiviral Regimen (C-SURGE)

Summary: Patients who have failed an NS5A-containing DAA treatment regimen (Harvoni or Zepatier) are an unmet medical need because there isn’t enough data to guide physicians in their management. This study found that the treatment MK-3682/Grazoprevir/MK-8408 did well.

Arm Proportion of Patients with HCV RNA <15 IU/mL
Treatment Week 4 Treatment Week 8
16 weeks + RBV 39/42 (93%) 35/35 (100%)
24 weeks without RBV 44/49 (90%) 38/38 (100%)

More information about the Liver Meeting 2016 or these and other studies can be found in our blog post The Liver Meeting 2016 Hep C Abstract Highlights (Part2) or on the American Association for the Study of Liver Diseases (AASLD)’s website.

Sunvepra, Technivie, Zepatier, and Drug Approval Negotiations

Sunvepra, Technivie, Zepatier, and drug approval negotiationsWhile the last step of the drug development and approval process in Canada and BC, the pan-Canadian Pharmaceutical Alliance (pCPA) negotiations, is taking place for three new hepatitis C treatments (SunvepraTechnivie,  and Zepatier), there is still a larger discussion going on that is “…exploring the need for a national formulary…”. (CMAJ, May 16, 2016)^

A formulary is a health insurance provider’s official list of pharmaceutical drugs that they have approved for coverage. (Merriam-Webster Dictionary)

The Pan-Canadian Pharmaceutical Alliance (pCPA) and the Current System of Individual Provincial / Territorial Drug Formularies

Steps Towards Listing a Treatment

Currently, within the Canadian drug approval process, Health Canada first evaluates a drug’s safety, effectiveness, and how it’s made.

After this, a Common Drug Review (CDR) by the Canadian Agency for Drugs and Technologies in Health (CADTH) then assesses the drug’s clinical and cost-effectiveness as it compares to other treatments.

Thirdly, according to the pan-Canadian Pharmaceutical Alliance (pCPA)’s website, once a CDR is complete, individual provinces/territories may then negotiate with the manufacturer without pCPA or, if the pCPA steps in after deciding that joint pan-Canadian negotiations for the drug will occur, provinces/territories may negotiate collectively.* This happens about 80% of the time. (CMAJ, May 16, 2016)

A province/territory then assumes the lead in the pCPA negotiations, contacts the manufacturer, and starts negotiations. If an agreement about treatment prices is reached, the lead province, the manufacturer, and the other provinces/territories negotiating sign a Letter of Intent. The Letter of Intent ends the pCPA’s involvement in the drug’s approval process.

After a Letter of Intent is signed, the participating jurisdictions will work with the manufacturer on their individual Product Listing Agreement (PLA), or work on a translation of the terms agreed to in the Letter of Intent. This translation is not a second negotiation. After this, the treatment is then listed.

When Negotiations Fail to Reach an Agreement

However, if negotiations are closed without reaching an agreement, as recently happened with Daklinza (daclatasvir), a treatment for those infected with hep C genotype 1, 2, or 3, provinces/territories involved in the pCPA negotiations can not restart negotiations with the manufacturer on their own.

Once pCPA negotiations are closed, future requests by the provinces/territories for re-consideration start with the treatment’s file being resubmitted to pCPA for further review through their office. In the future, if a manufacture believes that it is “able to provide the value needed by the jurisdictions”**, the manufacturer can also submit an unsolicited offer to the pCPA office and possibly restart negotiations that way. When this happens, provinces/territories are not bound to re-enter pCPA negotiations for the treatment.**

The Current Discussion about Changing the System of Provincial / Territorial Drug Formularies to a National Formulary

Currently, there is talk about changing the system of provincial/territorial drug formularies into a more national pharmacare system. The below are recent articles and videos about this discussion:

*The pCPA also negotiates for military and RCMP employees, First Nations and Inuit people. It is estimated that the pCPA has saved $490 million since 2010. (CMAJ, May 16, 2016)

**The source of this information was a requested email from the Pan-Canadian Pharmaceutical Alliance and the links within this post.

^Some of this post was originally published in May 2016. As there are now three hepatitis C treatments being examined by pCPA, instead of two, we believed that the subject matter was important and current enough to publish it again.

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.

Technivie, Zepatier, pCPA, and the Drug Approval Process

Technivie, Zepatier, and the pCPAWhile pan-Canadian Pharmaceutical Alliance (pCPA) negotiations are taking place for two new hepatitis C treatments, Technivie (ombitasvir / paritaprevir / ritonavir) and Zepatier (elbasvir / grazoprevir), there is a bigger discussion going on in Canada that is “…exploring the need for a national formulary…” (CMAJ, May 16, 2016)

A formulary is a health insurance provider’s official list of pharmaceutical drugs that they have approved for coverage. (Merriam-Webster Dictionary)

The Pan-Canadian Pharmaceutical Alliance (pCPA) and the Current System of Individual Provincial / Territorial Drug Formularies

Steps Towards Listing a Treatment

Currently, within the Canadian drug approval process, Health Canada first evaluates a drug’s safety, effectiveness, and how it’s made.

Secondly, a Common Drug Review (CDR) by the Canadian Agency for Drugs and Technologies in Health (CADTH) then assesses the drug’s clinical and cost-effectiveness as it compares to other treatments.

Thirdly, according to the pan-Canadian Pharmaceutical Alliance (pCPA)’s website, once a CDR is complete, individual provinces/territories may then negotiate with the manufacturer without pCPA or, if the pCPA steps in after deciding that joint pan-Canadian negotiations for the drug will occur, provinces/territories may negotiate collectively.* This happens about 80% of the time. (CMAJ, May 16, 2016)

A province/territory then assumes the lead in the pCPA negotiations, contacts the manufacturer, and starts negotiations. If an agreement about treatment prices is reached, the lead province, the manufacturer, and the other provinces/territories negotiating sign a Letter of Intent. The Letter of Intent ends the pCPA’s involvement in the drug’s approval process.

After a Letter of Intent is signed, the participating jurisdictions will work with the manufacturer on their individual Product Listing Agreement (PLA), or work on a translation of the terms agreed to in the Letter of Intent. This translation is not a second negotiation. After this, the treatment is then listed.

When an Agreement isn’t Reached

However, if negotiations are closed without reaching an agreement, as recently happened with Daklinza (daclatasvir), a treatment for those infected with hep C genotype 1, 2, or 3, provinces/territories involved in the pCPA negotiations can not restart negotiations with the manufacturer on their own.

Once pCPA negotiations are closed, future requests by the provinces/territories for re-consideration start with the treatment’s file being resubmitted to pCPA for further review through their office. In the future, if a manufacture believes that it is “able to provide the value needed by the jurisdictions”**, the manufacturer can also submit an unsolicited offer to the pCPA office and possibly restart negotiations that way. When this happens, provinces/territories are not bound to re-enter pCPA negotiations for the treatment.**

The Current Discussion about Changing the System of Provincial / Territorial Drug Formularies to a National Formulary

Currently, there is talk about changing the system of provincial/territorial drug formularies into a more national pharmacare system. The below are recent articles and videos about this discussion:

*The pCPA also negotiates for military and RCMP employees, First Nations and Inuit people. It is estimated that the pCPA has saved $490 million since 2010.  (CMAJ, May 16, 2016)

**The source of this information was a requested email from the Pan-Canadian Pharmaceutical Alliance and the links within this post.

In the Final Steps of the Canadian Drug Approval Pipeline

In the Final Steps of the Canadian Drug Approval PipelineCurrently, there 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

Technivie (ombitasvir, paritaprevir, ritonavir) +/- Ribavirin (RBV) Sovaldi (sofosbuvir) + Daklinza (daclatasvir) +/- RBV Sofosbuvir / Velpatasvir +/- RBV Zepatier (elbasvir / grazoprevir) +/- RBV Zepatier (elbasvir / grazoprevir) + Sovaldi (sofosbuvir)
Treatment Drug Classes NS5A Inhibitor, NS3/4A Protease Inhibitor, and Ritonavir, a booster for paritaprevir Nucleotide NS5B Polymerase Inhibitor, NS5A Inhibitor Nucleotide NS5B Polymerase Inhibitor, NS5A Inhibitor NS5A Inhibitor, NS3/4A Protease Inhibitor NS5A Inhibitor, NS3/4A Protease Inhibitor, Nucleotide NS5B Polymerase Inhibitor
Steps in Canadian Drug Approval Pipeline Step 5 – Provincial Review Step 5 – Provincial Review Step 4 – Common Drug Review by CADTH Step 4 – Common Drug Review by CADTH / Step 5 – Provincial Review Step 4 – Common Drug Review by CADTH / Step 5 – Provincial Review
Currently Seeking Patient Input No, not anymore. No, not anymore. No, not anymore. No, not anymore. No, not anymore.
Genotype (GT) Health Canada has Approved it for 4 1, 2, 3 This treatment has just begun the Canadian review process. Clinical trials have examined it on hep C genotypes 1-6. 1, 3, 4 3
Under BC PharmaCare Review for Genotype 4 Genotype 1, 2 or 3 without RBV, Genotype 2 or 3 with RBV Genotype 1, 3, 4 with or without RBV 3
Approximate SVR (Approx Rate of Cure) 90% without RBV, 100% with RBV 90 – 100% 94 – 100% 93 – 100% 91 – 100%
May Require PR* No
May Not Require RBV
Yes
Daily Pills 1 +/- twice daily RBV 2 +/- twice daily RBV 1 +/- twice daily RBV 1 +/- twice daily RBV 2 once daily
Possible Weeks of Treatment 12 12 or 24 8, 12, or 24 8, 12, or 16 12
Limited Most Common Side Effects**  (Ribavirin can affect side effects)
  • Headache
  • Insomnia
  • Nausea
  • Tiredness
  • Weakness (asthenia)
  • Diarrhea
  • Headache
  • Nausea
  • Tiredness (fatigue)
  • 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)

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.

Sovaldi is not for patients taking amiodarone. Tell your doctor if you are taking CYP3A inhibitors or P-gp, OATP 1B1, 1B3, BCRP, phenytoin, carbamazepine, rifampin, or St. John’s wort (Hypericum perforatum) as they limit Daklinza’s effectiveness. 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. Tell your doctor 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 AbbVie Care 1-844-471-2273
Bristol-Myers Squibb Canada’s CLAIRE Program 1-844-HCV-2559 Gilead’s Momentum Patient Assistance Program 1-855-447- 7977 Merck Care Program 1-866-872-5773
Information by Health Canada Technivie Daklinza Zepatier
Information about HCV / HIV Co-infection Technivie (by CATIE) Daklinza (by CATIE)

Sovaldi / Velpatasvir (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. 

Information was gathered 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 within the past week.