Biosimilar Panel
On Tuesday, June 13, 2017, the Canadian Association for Healthcare Reimbursement (CAHR) held the Market Access 201 conference in Toronto. The theme for this conference was “Parallel or Intersecting Paths, the Future of Public and Private Reimbursement in Canada” which consisted of five fascinating panels focusing on key topics of interest to the Canadian pharmaceutical stakeholders. Over the coming weeks, MORSE will be releasing summaries for each panel to share key learnings from this conference. This issue will focus on the biosimilar panel discussion.
Session Topic: Biosimilars
Description: Given the upcoming launch of multiple biosimilars for the same agent and the ongoing pCPA Biologic/Biosimilar Consultation, this discussion panel focused on the recent developments surrounding biosimilars from the pCPA and public payer perspective and contrasted those with developments in the private payer market.
Speakers:
Imran Ali, Senior Manager, pan-Canadian Pharmaceutical Alliance Office
Judy McPhee, Former Executive Director of Pharmaceutical Services and Extended Health Benefits with the Nova Scotia Department of Health and Wellness
Ned Pojskic, Pharmacy Strategy Leader, Green Shield Canada
Dr. Judith Glennie, President, J.L. Glennie Consulting Inc. (MODERATOR)
Summary:
Policy issues related to biosimilars have been simmering in the Canadian environment and made a big splash over the past year and a half. They are about to become a very active and aggressively addressed area. These panelists are on the cutting edge of this area and we want to know what has their sector done with regards to biosimilars?
Ned Pojskic, Pharmacy Strategy Leader, Green Shield Canada
Green Shield has been at the centre of biosimilar policy in Canada and have been listing biosimilars preferentially since mid 2016, with the first listing in January 2015. They took on a leadership role within the biosimilar space and addressed three underlining principles with their policy.
Principles
- Clinical safety and efficacy data
- There is no difference for biosimilars compared to originators
- Since they’re new and we don’t understand completely it creates fear
- Identical in every aspect
- Ten years of European experience
- The products have the same efficacy and safety
- Being a payer in Canada and understanding other jurisdictions we felt a responsibility to foster the biosimilar market
- Necessary to support them differently than other types of products
- Clinicians are going to tend to go with the originator since they have experience with it
- With regards to deals with originator products; Green Shield does not engage because it would affect the biosimilar market
- Transparency in pricing is important
- Have that with biosimilars and not with originators
- Not opposed to all PLAs, but if they have transparent prices should try to take advantage through the pCPA
Imran Ali, Senior Manager, pCPA
The pCPA is a collective of fourteen different jurisdictions and their respective public drug plans and in April 2016 they released the First Principles on biosimilars. At the time, there was one biosimilar negotiation conducted by pCPA and it was prudent to set up a guide for future negotiations. A formal consultation was not conducted at the time, however the pCPA heard a lot from industry regarding the First Principles. Feedback was received around topics such as: appropriate timeline for biosimilars negotiations, stability of supply, impact on other payers, transparent pricing, switching and interchangeability and interactions of pCPA, biosimilar manufacturer and innovator manufacturer. Under the guidance of the First Principles, the pCPA conducted 5 product negotiations on biosimilars. In March 2017 recognizing that there was a need for further clarification on the mechanics of negotiations, pCPA undertook a consultation specifically with industry.
This consultation considered how the pCPA negotiates, what are options around pricing, listing status and garnering viewpoints on therapeutic equivalence. pCPA received very rich feedback which will be helpful in providing more clarity on potential approaches going forward. It is one thing to reach these deals but the uptake of the biosimilar is also important.
Judy McPhee, Former Executive Director of Pharmaceutical Services and Extended Health Benefits with the Nova Scotia Department of Health and Wellness
Judy McPhee is not speaking on behalf of the drug plans, Nova Scotia or the pCPA.
Drug plans would have loved to take the Green Shield approach however, they are working in a political environment where that’s not possible. There is some angst and concern surrounding these products.
Despite this, drug plans see biosimilars as a huge opportunity to use biosimilars to benefit tax payers, patients, clinicians etc. Right now, the plans have shrinking budgets and are under immense pressure to fund more and more drugs. Seeing a 4 – 6 % increase in budgets just to cover the same as they had the year before and often only getting a 1% or roll-back in budget. There are shrinking budgets and huge drug costs so the uptake of biosimilars will create headroom.
There is a lot of experience to draw on from Europe and drug plans are going to have to be bold and put these things into play otherwise they will not be able to cover new drugs.
QUESTIONS
Ned, you mentioned the European experience and how we see other jurisdictions being much more aggressive, Australia for example. Imran can you give us an idea on how international experiences affect Canadian policy?
- IA: Canada is in a different place; Europe has 10 plus years and a lot of experience.
- There are differences but we do recognize the opportunities and lessons learned.
- There are many different approaches employed internationally including for example:
- Mandatory price cuts on originator
- 35% + lower
- Major discount is expected
- Minimum price reduction
- Tendering (naïve, interchangeable)
- Tenders with multiple or single
- Direct utilization to least costly option
- Commitment to renegotiate with innovator
- Gain sharing
- Mandatory reduction with a product that has lost exclusivity
- Some things have worked well and others have not. It impacts Canada and is a formal part of the work the drug plans look at.
- JM: All of those things should and I expect will be looked at by the drug plans.
- I expect we will eventually see a framework similar to that of generics especially with multiple drugs in the same therapeutic space
- The EU experience is key to moving that along
- NP: We need to delve into international experience
- What is different between Canada and Europe? In reality there isn’t one.
- The European experience supplements the clinical trial data
- That is the missing piece and we continue to say we don’t have the real-world data but it exists in Europe.
- JG: Industry cannot, on the one hand, say that it wants RWE for HTA submissions and then tell payers not use it for assessing biosimilars.
We know that there are biosimilars coming in the oncology space. A JAMA article indicated that clinicians see them as an opportunity to treat a broader group of patients. Do you think we need a more nuanced policy for oncology?
- IA: How much of the policies we are putting in place are fixed and how much is variable?
- It is always different in oncology
- From a public plan perspective, we have cancer agencies that are involved who are well positioned to contribute to policy development
- JM: I see no reason why you would need a different policy for a cancer drug. I think it easier with oncology.
- Not chronic therapies and much easier for the short-term treatment space.
- The oncology community have recognized that they have a sustainability issue going forward and have been using generic products.
- NP: I couldn’t agree more – there should be no difference.
- If the evidence says they are equally efficacious why should they be treated any differently.
- Relying on Health Canada and their approval process.
How do the clinicians figure into this? If they are the rate-limiting step in terms of uptake of biosimilars, is there a way for payers or review agencies to work with them so they are more likely to prescribe them?
- NP: There is a lot of dialogue required. We don’t want to support irrational prescribing. If there is a reason to prescribe them then they are going to be covered.
- It is a different experience where they can choose vs. when they don’t
- They may start shifting to other drugs to avoid the biosimilar
- JM: In some provinces, it is easier to work with clinicians, where they are smaller communities.
- The EU put out an information guide by healthcare professionals which was a thoughtfully laid out document
- If you can have the dialogue with clinicians and show them you can treat more patients they do get that
- Drug plans are looking to save money in order to treat more patients
Will we see the same pricing framework for biosimilars as generic? And how do you think CAPCA will address?
- NP: I think the market forces are there. That has been achieved in the Scandanivian countries but they have been more aggressive. Are we ever going to hit 25%? I don’t know.
- IA: Have to consider non-price factors as well. CAPCA will continue doing what they are set up to do – to help with implementation issues. I don’t see their involvement in biosimilars being any different.
- JM: CAPCA is a group that have recognized the sustainability issue and will likely support the use of biosimilars.
- JG: CAPCA is a clinician linkage as well to get that clinician input. There is a built-in relationship there that may not exist in other therapeutic areas.
While the uptake is low, what constraints does that place on negotiation in terms of the value that pCPA can look to? 2 brands of the same biosimilar behaving very much as brands. Does pCPA tolerate a higher price while those companies are left to drive their own uptake?
- IA: It’s a good question. If uptake is high would pCPA try for a higher discount, I don’t think so. It probably is something that could be considered. It is not formally done but does figure in some ways.
- JM: it doesn’t have that much bearing but you are looking at that there will be uptake. The drug plans have policy levers to force that uptake which to date have not been used. I think that will change. Uptake is more of a factor for chronic illnesses, switching needs to be used and need to make sure they are not being switched to other products.
Can you provide an update on the pCPA consultation timeline?
- IA: We did just finish the biosimilar consultation and invited the associations to correct the document or provide additional feedback. The associations and individual manufacturers have provided feedback. We are absorbing and synthesizing that information right now.
- In terms of a timeline the pCPA has recognized there is a natural break in the wave of biosimilars. The first wave we used the first principles and a second set is a little way out. There is a window which is good. Probably 2 – 3 months.
- On the brand process guidelines in general we are working on that as well and having conducted the consultation we have some space to go do the general guideline as well.
MORSE thanks our Reimbursement Strategist, Avery Hughes, for diligently preparing these summary notes during the conference. This summary is not an official transcript of the presentations/ discussions – as such, it may contain some errors/omissions/misinterpretations. Please contact the pCPA Office, Judy McPhee, Green Shield or Judith Glennie if you would like additional information or clarification on this topic.
Summary of Biosimilar Panel presentations/discussions from the June 13th CAHR 201 conference. Share on X
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