Tag Archives: CADTH

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.

Epclusa Recommended by CADTH Canadian Drug Expert Committee If

Epclusa Recommended by CADTH Canadian Drug Expert Committee IfEpclusa (generic name: sofosbuvir/velpatasvir), developed by Gilead Sciences Canada, Inc., just passed its Common Drug Review with the release of the Canadian Drug Expert Committee (CDEC) Final Recommendation for it.

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) compares the drug’s clinical and cost-effectiveness to those of other treatments. This recommendations report is then sent to the provinces and territories to help them decide on coverage.

The Canadian Drug Expert Committee’s Final Recommendation Advocates for Epclusa to be Reimbursed as a Treatment for Chronic Hepatitis C if the Following Conditions are Met:
Criterion:
  • Treatment should be started by physicians experienced managing patients w chronic hep C.
Conditions:
  • Reduced price.
The Canadian Drug Expert Committee’s Reasons for their Epclusa Recommendations
  1. Very good SVR/cure rates seen for all genotypes and among treatment-naive and patients who have already, unsuccessfully, tried treatment. The ASTRAL-1, ASTRAL-2, ASTRAL-3, and ASTRAL-4 clinical trials showed that treatment with Epclusa achieved high rates of SVR12 (cure at 12 weeks) for all types of hep C patients, including those who have been considered hard to treat.
  2. “There is insufficient evidence that the new treatment is superior
    to the least costly alternative.”
  3. “The true incremental cost-effectiveness of SOF/VEL versus other interferon (IFN)-free regimens is uncertain in the various patient populations considered.”
Other Noted Discussion Points
  • “The drug plan cost of treatment with the drug under review should not exceed the drug plan cost of treatment with the least costly alternative interferon-free option.”
Reported Research Gaps

Research should look into the following as a high priority:

  • Patients who were activity using drugs and co-infected with HIV or hepatitis B were excluded from the trials submitted to this review.
  • Resistance-associated variants (RAVs) should be examined more as they may influence future coverage criteria.

Epclusa

Epclusa (generic name sofosbuvir / velpatasvir) is the first pan-genotypic hepatitis C treatment, treatment for all 6 hep C virus types, to be approved for use in Canada against all 6 hep C virus types.

Epclusa is made up of 2 direct-acting antivirals, sofosbuvir and velpatasvir. Sofosbuvir is a nucleotide NS5B polymerase inhibitor that directly targets the hep C virus to stop it from making copies of itself in the liver. They attach themselves onto the genetic information, called RNA, to block the virus from multiplying.  Velpatasvir is a NS5A inhibitor that blocks a virus protein, NS5A, that the virus needs for reproducing and various stages of infection.

For more information about Epclusa, CADTH, or any other new and emerging hep C drug, please visit PHCN’s Hepatitis C Treatment Information Project or email.

“We can now cure the majority of HCV-infected patients with a simple, safe and effective 12-week treatment, regardless of genotype or treatment history.” ~Dr. Jordan Feld

Requesting Feedback for Patient Input Report Template Changes

Requesting Feedback for Patient Input Report Template ChangesProposed Changes to CADTH’s Template for Patient Group Input to CADTH Common Drug Review and pan-Canadian Oncology Drug Review (Word document from CADTH)

Between September 12th and October 25th, CADTH is collected feedback from patient groups on proposed revisions to their patient input template. To submit feedback, please use the feedback form and email it to feedback@cadth.ca. All feedback will be considered and used to help create the final CADTH template, targeted for use in December 2016.

Noticed Changes to the Patient Input Report Template

  • Word limits for answers;
  • Clear table to report how the patient input was gathered;
  • More directly worded questions wanting concise answers;
  • New questions about patient experiences with the treatment in question;
  • 2 pages of questions about patient group conflicts of interest and funding.

More information about these proposed changes and this request for feedback can be found at Feedback on Proposed Revisions to Patient Input Template for CDR and pCODR.

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

CADTH is an independent, not-for-profit organization responsible for providing health care decision-makers with objective evidence and recommendations to reimbursement programs, such as BC PharmaCare. Their input helps these programs decide whether or not, or how, to provide reimbursement for health technologies, such as drugs, tests, and surgical devices and procedures. Their reviews are Step 4 in the drug approval process for resources, such as hep C treatments, working towards PharmaCare coverage.

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.

 

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.

Patient Group Input sent for Sofosbuvir / Velpatasvir

Patient Group Input sent for Sofosbuvir / VelpatasvirPatient group input was just sent in for the hep C treatment sofosbuvir / velpatasvir. Thank you to all of you who completed PHCN’s sofosbuvir / velpatasvir survey and shared it with others. It was truly an honour to read your responses and to use them to write the patient group input report for the Canadian Agency for Drugs and Technologies in Health (CADTH) on your behalf.

The patient group input reports requested by CADTH are an important step towards getting new treatments for hep C more widely available in Canada and BC.

The sofosbuvir / velpatasvir report was sent in last night. We now wait to hear the outcome of the treatment’s submission. The Hepatitis C Treatment Information Project will keep you apprised of any news.

Sofosbuvir / Velpatasvir

Sofosbuvir / velpatasvir is an all-pill, short-course (possibly only 8 weeks), interferon-free treatment that can be taken with or without ribavirin. In Phase 3 clinical trials, sofosbuvir/velpatasvir (with or without ribavirin) cured an overall 99% of those with genotype 1, 2, 4, 5, or 6 hep C and was found to be well tolerated by patients.

“This drug regimen changes the standard of care in treating patients with HCV. We can now cure almost everyone with a very simple treatment,” said Dr. Jordan Feld, a liver specialist at Toronto Western Hospital.

Hepatitis C Treatment Information Project

PHCN’s Hepatitis C Treatment Information Project is a source of information that doesn’t post a ‘site last modified date’ because it is truly forever changing. Pay it a visit for more information about currently approved hep C treatments, new and emerging drugs, or resources to help in getting ready for treatment. You can also email us your questions about hep C treatments.

Thank you for taking the time to voice your opinion and help advocate for a better tomorrow.

Sofosbuvir/Velpatasvir CTAC Webinar

Sofosbuvir/Velpatasvir CTAC Patient Group Input WebinarThis Monday, May 2nd, from 11 AM to 12 PM (PDT/in BC) / 2 PM to 3 PM (EDT/in Ontario), the Canadian Treatment Action Council (CTAC) will be hosting a webinar about the exciting new hep C treatment sofosbuvir/velpatasvir.

Following the webinar, there will be a survey to collect information that will help them write a patient input report for sofosbuvir/velpatasvir’s Common Drug Review. CTAC’s sofosbuvir/velpatasvir survey is different from PHCN’s patient input survey or PHCN’s loved ones/caregivers survey. Please consider filling out the still available PHCN survey that was created for you as well as CTAC’s survey.

Registration for the CTAC webinar is required to attend
. Click here to register and for more information about the webinar.

The Canadian Treatment Action Council (CTAC)

CTAC is a Canadian non-governmental organization led by and for people living with HIV and HIV/HCV co-infection. Since 1996, they have been working to secure and ensure equitable, affordable, and timely access to treatment and care and support for people in Canada living with HIV and HIV/HCV co-infection.

Patient Group Input Reports Requested by CADTH’s Common Drug Reviews

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.

 Sofosbuvir/Velpatasvir

Sofosbuvir/velpatasvir is an all-pill, short-course (sometimes only 8 weeks), interferon-free treatment that can be taken with or without ribavirin. In Phase 3 clinical trials, sofosbuvir/velpatasvir (with or without ribavirin) cured an overall 99% of those with genotype 1, 2, 4, 5, or 6 hep C and was found to be well tolerated by patients.

“This drug regimen changes the standard of care in treating patients with HCV. We can now cure almost everyone with a very simple treatment,” said Dr. Jordan Feld, a liver specialist at Toronto Western Hospital.

Take this survey. Sofosbuvir / Velpatasvir Input Requested.

The above survey links will only remain open until April 27th, 2016, so please complete a survey and share the survey links with others ASAP.

The Drug Approval Process is Seeking Patient and Caregiver Input

The Canadian Agency for Drugs and Technologies in Health (CADTH) wants to hear from you! They are currently reviewing the hep C treatment sofosbuvir / velpatasvir. As part of their review, they are seeking patient and caregiver input about hep C and hep C treatments from Canadian patient groups. Therefore, we, the Pacific Hep C Network (PHCN), are seeking your thoughts, opinions, and experiences for our patient group input report.

More information about CADTH and patient group reports is below.

PHCN’s Sofosbuvir / Velpatasvir Patient Input Surveys

There are two PHCN Input Surveys

The first survey was written for those with hep C or those who have had hep C. It includes 14 questions, some multiple choice, and is divided into 4 sections. The most important of these sections are ‘Section 2 of 4: Your Expectations of Sofosbuvir / Velpatasvir’ and Take this survey. Sofosbuvir / Velpatasvir Input Requested.‘Section 3 of 4: Your Experience with Sofosbuvir / Velpatasvir’, if you have been treated with sofosbuvir / velpatasvir. If you haven’t taken sofosbuvir / velpatasvir, the survey lets you skip this section.

The second survey was written for loved ones or caregivers of those living with hep C/have had hep C. It includes 7 questions divided into 2 sections.

If the surveys don’t focus on something you would like to add, please use a textbox and include it as one of your answers. Some of the questions require answers but others were written to, hopefully, help you share your experiences and voice your opinion.

Survey responses are anonymous (we don’t know your name or other information about you). The information gathered will be used as part of the sofosbuvir / velpatasvir patient group input report for CADTH.

By completing the survey you accept that PHCN can use the information gathered by it in our patient group input report for CADTH.

The survey links will only remain open until April 27th, so please complete a survey and share the survey links with others ASAP.

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 are a part of the drug review process!

Email the Hepatitis C Treatment Information Project for more information about the surveys or for more information about sofosbuvir / velpatasvir.

Thank you for taking the time to voice your opinion and help advocate for a better tomorrow.

Sofosbuvir / Velpatasvir is up for Review

Sofosbuvir / Velpatasvir is up for ReviewSofosbuvir / velpatasvir is up for review. This morning the Canadian Agency for Drugs and Technologies in Health (CADTH) sent out notice that they are currently seeking patient group input for sofosbuvir / velpatasvir. Sofosbuvir / velpatasvir is an all-pill, short-course, interferon-free treatment for those with chronic hepatitis C, genotype 1, 2, 4, 5, or 6.

Please keep your eyes open for a blog post with more information about sofosbuvir / velpatasvir and a link to PHCN’s patient input survey. They will be finalized and sent out in the next few days.

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 are a part of the drug review process!

Please email or visit the Hepatitis C Treatment Information Project for more information about sofosbuvir / velpatasvir or any other hep C treatment.

Canadian Public Drug Plans Request Answers

Canadian Public Drug Plans Request AnswersSubmit Your Answers to the Following 2 Questions BY EMAIL

OR

Submit Your Answers to the Following 2 Questions BY ONLINE QUESTIONNAIRE

Only submit your answers once. Submit your answers before February 12, 2016.

Our Request

We are asking that you take a moment to send us your answers to the two questions below and any other information that may help us with this request for patient input.

CADTH’s Request for Patient Input

The public drug plans that seek advice from CADTH’s Canadian Drug Expert Committee (CDEC), such as BC PharmaCare, have requested guidance about aligning two sets of recommendations for four hepatitis C treatments (Daklinza, Harvoni, Holkira Pak, and Sovaldi). The two sets of recommendations that the drug plans want aligned are CADTH’s therapeutic review on drugs for hepatitis C and CDEC Final Recommendation for the four hepatitis C treatments. (More information about the four CDEC final recommendations is below.)

The response to this request may result in changes to the current CDEC recommendations or new CDEC Records of Advice for these treatments.

Therefore, the CDEC has asked for patient input about the four hep C treatments, specifically answers to the following two questions:

  • Question 1: “Is there anything the CADTH review team should be aware or reminded of, when updating individual recommendations for Harvoni, Holkira Pak, Sovaldi and/or Daklinza?”
  • Question 2: “How do patients or how do you view hep C treatments that require ribavirin?”

Question 2 has been asked due to mixed feelings regarding ribavirin that have been expressed by hep C organizations. Some groups have reported that patients regard ribavirin as an intolerable treatment that is just as bad as interferon, whereas others see it as “tolerable and acceptable, if only barely and temporarily.”

Therefore, how do you feel about ribavirin? Would ribavirin as part of a hepatitis C treatment make you hesitant about that treatment? Would you take ribavirin if it increased your chances of a hep C cure? What information would influence whether you would take ribavirin or not?

Summaries of the CDEC Final Recommendations for Daklinza, Harvoni, Holkira Pak, and Solvaldi

Treatment Targeted Genotypes Recommended Criteria Suggested Conditions for Coverage
Daklinza in combination with Sovaldi*

(CDEC Final Recom-mendation Published Sept 21, 2015)

1, 2, 3
  • Treatment
    experienced patients
    without cirrhosis who have not responded to
    pegylated
    -interferon plus ribavirin (PR).
  • Prescribing restricted to hepatologists and physicians with experience treating patients with hepatitis C
  • Drug plan cost of a treatment course with daclatasvir plus sofosbuvir should not exceed the drug plan cost of a treatment course with sofosbuvir plus ribavirin.
Harvoni*

(CDEC Final Recom-mendation Published Feb 18, 2015)

1
  • A fibrosis stage of F2 or higher
  • Prescribing restricted to hepatologists and physicians with experience treating patients with hepatitis C
  • Substantially reduced price
Holkira Pak*

(CDEC Final Recom-mendation Published May 21, 2015 and updated July 22, 2015)

1
  • A fibrosis stage of F2 or higher
  • Pescribing restricted to hepatologists and physicians with experience treating patients with hepatitis C
  • Price should not exceed the drug plan costs of other interferon-free hep C treatments
Sovaldi + Pegylated Interferon with Ribavirin (PR)

(CDEC Final Recom-mendation Published Aug 18, 2014)

1
  • A fibrosis stage of F2, F3, or F4
  • Have never been treated
  • Funding should not exceed a duration of 12 weeks for the treatment of patients with
    genotype 1 or 2 hep C and 24 weeks for the treatment of patients with genotype 3 hep C
  • Reduced price
Sovaldi + Ribavirin (RBV)*

(CDEC Final Recom-mendation Published Aug 18, 2014)

2
  • A fibrosis stage of F2, F3, or F4
  • Previous treatment experience with PR or a medical contraindication to PR
3
  • A fibrosis stage of F2, F3, or F4
  • Previous treatment experience with PR or a medical contraindication to PR
*These treatments have possible pegylated interferon and/or ribavirin free options. Click their links for more information about the treatments. Our Basic Hep C Treatment Terms page also has more information about terms some may not be familiar with. Our Comparing Hep C Treatments page has additional information about the treatments except for Daklinza in combination with Sovaldi.

About CADTH

Within the Canadian drug approval process, Health Canada evaluates a drug’s safety, clinical effectiveness, and its manufacturing process. CADTH then assesses the treatment’s clinical and cost-effectiveness as it compares to other treatments.

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.

Please email hepctip@pacifichepc.org for more information about this CDEC request.

Thank you for taking the time to voice your opinion and help advocate for a better tomorrow.