Monday, 25 April 2016

Transparent Public Pricing for Biosimilars: pCPA Releases First Principles for SEBs

Guest Blog By Arvind Mani
Director of Market Access and Policy Research
PDCI Market Access

The pan-Canadian Pharmaceutical Alliance (pCPA) recently issued a communiqué outlining their initial perspective on subsequent entry biologics (SEBs) and innovative/reference biologics as it aims to establish a SEB policy framework.

 Key Takeaways


It appears that the pCPA’s first principles for SEBs are targeted at ensuring that manufacturers of both SEB and innovative/reference products must negotiate with the pCPA – i.e. not approach individual jurisdictions to seek product listing agreements once the SEB is poised to enter the market.  Further, SEB manufacturers must be prepared for the pCPA to consider evidence beyond regulatory evaluations and health technology assessments (HTA) – perhaps this may involve reviewing international evidence.  Although this may create some uncertainty for SEB manufacturers, it appears that the pCPA balances this with a plan to ensure a competitive market – which may mean some form of preferential listing similar to what was negotiated for Inflectra. 

For manufacturers of innovative/reference biologics, these principles have clarified the pCPA’s expectations by insisting if these manufacturers put forward proposals in response to the entry of an SEB, these proposals provide national value with no incremental costs to any jurisdictions
Finally, the pCPA is clearly moving towards transparent prices for both SEB manufacturers and innovative/reference manufacturers who aim to renegotiate their agreements with the pCPA in anticipation of an SEB entry.  Although confidential product listing agreements are well entrenched and growing in importance for innovative products, it seems that when it comes to the SEB market, public payers are keenly focused on establishing a framework that ensures a greater level of price transparency. 

The table below summarizes pCPA’s negotiation expectations for the respective manufacturers in the SEB marketplace.

SEB Manufacturers
    Innovative/Reference Drug       Manufacturer

National Negotiation –must not approach an 
individual jurisdiction and should focus its negotiation efforts nationally with the pCPA.

National Negotiation –must not approach an individual jurisdiction and focus its negotiation nationally with the pCPA.

Broader Evidence –must be prepared for the pCPA to look at other evidence beyond the Health Canada and HTA information available.
National Value –must seek negotiations focusing on national value – i.e. no incremental costs to any individual province.

Competitive Environment –may benefit from the pCPA ensuring the creation of a competitive environment.

Transparent Price –must be prepared to not only provide a similar value to the SEB, but must include a similar or better transparent price.


Transparent Price –must provide a reduced transparent price.



pCPA First Principles for SEBs (actual communiqué)

The emergence of SEBs in the Canadian market has led the pan-Canadian Pharmaceutical Alliance (pCPA) to begin developing principles to guide more consistent negotiations for these products and related reference biologics, as the pCPA works towards establishment of a SEB policy framework.
The following first principles will guide the pCPA approach to negotiations on SEBs and reference biologics:

·         All SEB and reference biologic manufacturer proposals will only be considered through the national pCPA negotiation process rather than individual or selected jurisdictions. Determination of whether or not to proceed with negotiations with the requesting manufacturer will be made at the discretion of the pCPA.
·         Products under consideration by the pCPA will be informed by Health Canada's regulatory determinations (that the SEB products are safe and efficacious with no clinically meaningful differences with the comparator reference drugs), Health Technology Assessment recommendations, and/or other evidence or considerations as available.
·         Consistent with its mandate that includes increasing patient access to clinically and cost-effective drug treatment options, the pCPA will encourage a competitive environment that includes SEB market growth and is conducive to long-term cost reductions and sustainability for public drug plans.
·         The introduction of an SEB must provide a reduction in the drug’stransparent price to benefit all Canadians.
·         Proposals from reference biologic manufacturers will only be considered if they:
·         Provide overall national value to public drug plans and do not result inincremental costs to individual jurisdictions; and
·         Provide at least similar overall value compared to the SEB, and must include similar or better transparent price reductions if equivalent listing status is sought.
·         These first principles are a starting point and are expected to evolve through the pCPA’s engagement with stakeholders, including the pharmaceutical industry, to develop a more comprehensive SEB policy framework.



Tuesday, 5 April 2016

Why medical marijuana should be exempt from sales tax

The authors are members of the Canadian Medical Cannabis Council patient advisory committee: Lynne Belle-Isle (Canadian AIDS Society), Joanne Simons (Arthritis Society), Cody Lindsay (The Wellness Soldier), Jonathan Zaid (Canadians for Fair Access to Medical Marijuana), Sharon Baxter (Canadian Hospice Palliative Care Association), Sandy Smeenk (Improving the Lives of Children) and Jackie Manthorne (Canadian Cancer Survivor Network).
While Canada engages in complex dialogue about how best to regulate the sale of cannabis for adult use, tens of thousands of Canadians are currently authorized to use cannabis to treat a variety of symptoms and medical conditions. They have obtained this authorization from a physician or nurse practitioner, the only way they can use it legally under current regulations.
Research funded by the University of British Columbia’s Institute for Healthy Living and Chronic Disease Prevention has shown that for many Canadians with chronic medical conditions, a lack of affordability can be a barrier to using cannabis for medical purposes. Sales tax on medical cannabis only adds to the financial burden.
Among research participants who reported buying cannabis for medical purposes, the median amount spent was $200 a month. Likewise, more than half of respondents who currently use cannabis for medical purposes report that they can never or only sometimes afford to buy enough cannabis to relieve their symptoms. The proportion was higher – approximately two-thirds – among those who reported fair to poor general health. Perhaps more importantly, a third of respondents stated that they often or always have to choose between medical cannabis and other necessities, such as food, rent and other medicines.
Health Canada has reiterated that cannabis should be treated like other prescription drugs. Canada’s Excise Tax Act specifies that drugs prescribed by a health-care practitioner that are not available over the counter are zero-rated and not subject to federal and provincial tax. Under the Marihuana for Medical Purposes Regulations, medical cannabis can only be purchased with a medical document obtained from a health-care practitioner. This medical document has been acknowledged as being akin to a prescription by the Colleges of Physicians and Surgeons in Ontario, British Columbia, New Brunswick, Nova Scotia, Quebec and Saskatchewan.
While Canada will likely benefit greatly from the sales tax revenue from the legal adult recreational cannabis market, this should not come at the expense of people who need it for medical purposes. With sales tax unfairly applied and few cost-coverage options available, patients who cannot afford their medicine are suffering.
The removal of sales tax from medical cannabis is a simple and effective first step to increase affordability.
The Canadian Medical Cannabis Council has taken an active leadership role in advocating for this straightforward but critical change. Interim executive director Philippe Lucas has already met with the Ministry of Finance, making the case that removing this financial barrier for those who rely on legal medical cannabis is a low cost, non-controversial investment in the well-being of Canadian patients with a high level of public support, as demonstrated by the 8,000-plus signatures gathered so far in a petition to that end.
As members of CMCC’s patient advisory committee, we represent the interests of people who use cannabis for medical purposes. Together, we join the growing number of voices calling for the minister to treat medical cannabis like other medical necessities and exempt it from sales tax.
Medical cannabis is not just another commodity. For many people, it’s a medical necessity. It should receive the same zero-rating as other prescription medications.

Tuesday, 2 February 2016

Feds Take a Seat at the pCPA Table

Reposted with permission from the author, 
On January 20-21, 2016, the provincial Ministers of Health met in British Columbia to discuss health care priorities and were joined for their second day of meetings by Canada’s new federal Minister of Health, Jane Philpott.  At the conclusion of their meetings, it was announced that the federal government will be joining:
  1.  The pan-Canadian Pharmaceutical Alliance (pCPA)
  2. Federal/Provincial/Territorial (F/P/T) Working Group on Pharmaceuticals  

Implications

Pharmaceutical Manufacturer
  • Steeper Rebates: Although the federal Non-Insured Health Benefit (NIHB) program has been negotiating product listing agreement with manufacturers for the past several years, this formal inclusion will likely increase the level of rebates offered to the federal plans.
  • Reduced Administrative Burden: There will be less administrative burden for manufacturers as they no longer need to separate negotiations between the pCPA and the federal plans.
The pan-Canadian Pharmaceutical Alliance 
  • Capacity: The pCPA will now have another jurisdiction that can take the lead on pCPA negotiations.
  • Funding: Although no formal funding mechanism has yet to be established for the new pCPA office, including the federal government provides another source of potential funding for the office lead initiative.
Health System Reform
  • Intergovernmental Collaboration: The pCPA will now be a well-integrated F/P/T collaboration that will directly impact the reimbursement of prescription medications and could lay the groundwork for more bold initiatives surrounding a national formulary or catastrophic drug coverage program.

Background

  1.  Federal government Joins the pCPA  
The Canadian federal government joins Alberta, British Columbia, Manitoba, New Brunswick, Newfoundland and Labrador, Northwest Territories, Nova Scotia, Ontario, Quebec, Prince Edward Island, Saskatchewan, and the Yukon as a participating member of the Alliance.  Through various programs described below, the federal governments spends approximately $630 million in drug-related spending on an annual basis. 
The Government of Canada federal drug plans provides drug benefits to:
First Nations and Inuit: The Non-Insured Health Benefits (NIHB) Program of Health Canada provides supplementary health benefits, including prescription and non-prescription drugs, to approximately 808,686 registered First Nations and recognized Inuit to meet medical or dental needs not covered by provincial, territorial or other third-party health insurance.
Veterans: The Health Care Program of Veterans Affairs Canada (VAC) provides veterans and other eligible clients with health-related products and services. VAC's Prescription Drug Program is the second largest of the federal programs, serving eligible veterans and former members of the Canadian Forces. Each year 83,000 clients of 132,000 eligible members access VAC prescription drug benefits.
Canadian Forces: The Canadian Forces Health Services (CFHS) is the designated health care provider for Canada's military personnel, delivering medical and dental services at military installations across Canada and overseas. The Canadian Forces Health Services (CFHS) provides health care and services to95,000 Regular and Reserve Forces personnel in two distinct contexts: at home, which is referred to as in-garrison, and on deployment.
Federal Inmates: Correctional Service Canada (CSC) is the federal government agency responsible for administering correctional sentences for terms of two years or more, as imposed by a court. On any given day CSC is responsible for approximately 23,000 offenders, approximately 15,140 of whom are incarcerated (receiving direct health services in CSC institutions) and 7,750 of whom are on conditional release in the community (receiving health services in the community).
  1. Federal-Provincial-Territorial (F/P/T) Working Group on Pharmaceuticals
The federal government has been invited by Ontario to join an F/P/T working group on pharmaceuticals which aims to consider “a range of other measures to reduce pharmaceutical prices and improve prescribing and appropriate use of drugs, while striving to improve health outcomes.” The working group will also “explore approaches to improving coverage and access to prescription drugs for Canadians.”
In June 2015, a meeting of the provincial health ministers resulted in a call to have some form of national pharmacare by several provincial and territorial health ministers.  While the Minister of Health for Ontario appeared to be strongly supporting some form of pharmacare and has initiated provincial consultation sessions on this subject, it is unclear how committed other provinces are to this notion. In fact, some of the other health ministers at the June meeting said federal leadership is crucial to efforts to create a universal pharmacare system
The topic of a national pharmacare program was not on the agenda of the Health Ministers meeting but it appears that the creation of this working group is aimed at addressing some of the key issues associated with prescription drugs – namely improving coverage and access for all Canadians.
Written by 

Wednesday, 16 December 2015

New cervical cancer portal provides essential information for Canadian women

Ottawa, December 10, 2015: The Canadian Cancer Survivor Network is pleased to announce the launch of its newest website portal on cervical cancer.

Approximately 1,050 Canadian women are diagnosed with cervical cancer annually, and this number increases every year.  For those dealing with this type of cancer, the journey from diagnosis to treatment and management of the disease is rarely a road travelled alone. Spouses, partners, children, extended family, friends and even colleagues may share in the burden of this life-changing disease.
The Canadian Cancer Survivor Network (CCSN) recognizes the heavy burden a diagnosis of cervical cancer places not only on women who are diagnosed with it, but on their families and extended support networks. In response, CCSN has created an online portal recognizing and addressing the experience of cervical cancer, whether in its early or more advanced stages.

"It is critically important to address the information needs and concerns of women diagnosed with cervical cancer and their families,” said Jackie Manthorne, President and CEO of the Canadian Cancer Survivor Network. "Each woman will have her own experience of cervical cancer. Aside from purely medical considerations, the journey includes many practical decisions and adjustments. Each of these changes has the potential to impact those closest to them. Providing families and other caregivers a place to find reliable information they can relate to, and a place to connect, can help alleviate some of the anxiety associated with a cervical cancer diagnosis.”

About the Portal

The Cervical Cancer Portal provides a trusted and accurate source of information and resources. Like the spokes of a wheel, sections on the portal centralize information on the diagnosis and treatment of cervical cancer, provide information and resources on financial planning and address the issues that caregivers face. It also provides detailed information that the HPV test for cervical cancer is more accurate than the Pap test in that it detects cancer risk earlier and prevents more deaths than the Pap test.

The Cervical Cancer Portal includes the following sections:
  • Cervical Cancer Screening: the HPV and Pap test
  • HPV and cervical cancer risk factors
  • Diagnosis of cervical cancer
  • Cervical cancer treatment
  • Living well with cervical cancer
  • Caregiving and cervical cancer 
  • Financial information and resources
Social media platforms including a cervical cancer Twitter account, @cervicalcanca, as well as the Canadian Cancer Survivor Network’s general Twitter account, @survivornetca.

About the Canadian Cancer Survivor Network

The Canadian Cancer Survivor Network (CCSN) works to connect patients, survivors and other stakeholder groups with decision makers and the wider community to engage in discussion and to act on evidence-based best practices to alleviate the medical, emotional, financial and social costs of cancer. CCSN encourages and conducts research on ways to overcome barriers to optimal cancer care and follow-up for survivors in Canada.

This website portal was made possible by the generous support of Qaigen.

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For additional information or interviews:
Jackie Manthorne, President & CEO
Canadian Cancer Survivor Network
1-613-898-1871
jmanthorne@survivornet.ca

Thursday, 5 November 2015

Increased melanoma diagnoses basis for new Melanoma Portal

Ottawa, November 3, 2015: The Canadian Cancer Survivor Network is pleased to announce the launch of its newest website portal on melanoma at http://survivornet.ca/en/cancer_basics/melanoma_portal.

Approximately 6,500 Canadians are diagnosed with melanoma annually, and this number increases every year.  For those dealing with this type of cancer, the journey from diagnosis to treatment and management of the disease is rarely a road travelled alone. Spouses, partners, children, extended family, friends and even colleagues may share in the burden of this life-changing disease.

The Canadian Cancer Survivor Network (CCSN) recognized the heavy burden a diagnosis melanoma places not only on those who are diagnosed with it, but on their families and extended support networks. In response, CCSN has created an online portal recognizing and addressing the experience of melanoma, whether in its early or more advanced stages.

"It is critically important to address the information needs and concerns of melanoma patients and their families,” said Jackie Manthorne, President and CEO of the Canadian Cancer Survivor Network. "Each patient will have his or her own experience of melanoma. Aside from purely medical considerations, the journey includes many practical decisions and adjustments. Each of these changes has the potential to impact those closest to them. Providing families and other caregivers a place to find reliable information they can relate to, and a place to connect, can help alleviate some of the anxiety associated with a melanoma diagnosis.”

About the Portal

The Melanoma Portal provides a trusted and accurate source of melanoma information – and connection. Like the spokes of a wheel, sections on the portal centralize information on the diagnosis and treatment of melanoma, provide information and resources on financial planning and address the issues that caregivers face.
The portal includes the following sections: 
  •         About Melanoma
  •          Prevention
  •          Risk factors, Signs and Symptoms
  •          Diagnosis
  •          Treatment of Melanoma
  •          Living Well with Melanoma
  •          The Side-Effects of Treatment and Melanoma
  •          Mental Wellness
  •          Caregiving
  •          Financial Information and Resources

 Social media platforms including a melanoma Twitter account, @melanomacan as well as the Canadian Cancer Survivor Network’s general Twitter account, @survivornetca .

About the Canadian Cancer Survivor Network

The Canadian Cancer Survivor Network (CCSN) works to connect patients, survivors and other stakeholder groups with decision makers and the wider community to engage in discussion and to act on evidence-based best practices to alleviate the medical, emotional, financial and social costs of cancer. CCSN encourages and conducts research on ways to overcome barriers to optimal cancer care and follow-up for survivors in Canada.


This website portal was made possible by the generous funding of Merck. 

Tuesday, 13 October 2015

October 13th is Metastatic Breast Cancer Awareness Day!

This October 13th, during breast cancer awareness month, CCSN recognizes the unique experience of metastatic breast cancer patients. Approximately 30 percent of women and men diagnosed with breast cancer will at some point be diagnosed with metastatic breast cancer, and while metastatic breast cancer can be treated, it currently cannot be cured.

This does not mean that those living with metastatic breast cancer cannot enjoy good quality of life! However, the needs and issues facing metastatic breast cancer patients are vastly different.

  • Breast cancer support groups are mostly composed of newly or recently diagnosed patients and those who have metastatic breast cancer often do not have much in common with them. Unfortunately, metastatic breast cancer support groups are few and far between. 
  • Women and men living with metastatic breast cancer are in and out of treatment, hoping that their cancer will stop its progression so they have a decent quality of life. 
  • They need ongoing help both accessing and navigating the healthcare and cancer care system. Metastatic breast cancer patients and their families need ease of connection to accurate, updated clinical information, improved access to clinical trials, and readily available psychosocial support. 

During this month of October, when there is so much awareness raising of and fund raising for breast cancer research, we must not forget the 30 percent whose breast cancer has metastasized.

"It is critically important to address the information needs and concerns of those living with metastatic breast cancer,” says Jackie Manthorne, President and CEO of the Canadian Cancer Survivor Network. "Aside from purely medical considerations, the metastatic journey includes many practical decisions and adjustments. Each of these changes has the potential to impact those closest to the patient. As well, metastatic breast cancer patients often feel isolated and ignored, especially during October when they often feel that they do not have a voice in most breast cancer awareness and fundraising campaigns. We hope that our website section on metastatic breast cancer provides them a place to learn, to find resources and to share their experiences.”

This website section can be accessed here.

It includes information on:
  • What makes metastatic breast cancer different?
  • Statistics and research in metastatic breast cancer
  • Metastatic breast cancer blogs
  • Bone health in metastatic breast cancer patients
  • Think before you pink campaign
  • Resources for metastatic breast cancer patients

Tuesday, 9 June 2015

Ottawa Mayor Jim Watson proclaims National Cancer Survivors Day

This morning, Ottawa Mayor Jim Watson proclaimed National Cancer Survivors Day in recognition of the nearly one million cancer survivors living in Canada today. This annual celebration of life took place at City Hall in the presence of representatives of the Canadian Cancer Survivor Network and Prostate Cancer Canada Network Ottawa.
On National Cancer Survivors Day and the days following, thousands of cancer survivors and their families and supporters gather across the globe to honour cancer survivors and to show the world that life after a cancer diagnosis can be fruitful, rewarding and even inspiring. It is also a time to draw attention to the ongoing challenges of cancer survivorship in order to promote more resources, research, and survivor-friendly legislation to improve cancer survivors’ quality of life.
Mayor Watson stated that “a cancer survivor is defined as anyone living with a history of cancer – from the moment of diagnosis through the remainder of their life; there are nearly one million cancer survivors living in Canada today.”
While early diagnosis and improvements in treatment have resulted in cancer patients living longer, much remains to be done to ameliorate the physical, emotional, and financial effects of cancer on survivors as well as including cancer survivors in decision-making on issues which affect them within Canada’s cancer care and healthcare system.
The Canadian Cancer Survivor Network (CCSN) works to connect patients, survivors and other stakeholder groups with decision makers and the wider community to engage in discussion and to act on evidence-based best practices to alleviate the medical, emotional, financial and social costs of cancer and encourage research on ways to overcome barriers to optimal cancer care and follow-up for survivors in Canada.
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For information or an interview please contact:
Jackie Manthorne
President & CEO
Canadian Cancer Survivor Network
613-898-1871
613-710-3636 (cell)
jmanthorne@survivornet.ca
Photos attached.