Sam Tarantino:   0:02
Welcome to The Pharma Podcast. Conversations with industry experts and business leaders about important and current topics in Canadian Pharma, Biotech and MedTech. I'm your host, Sam Tarantino. Today I'm speaking with Jane Farnham, Vice president, strategic partnerships and external relations at Bio Script Solutions and co chair of the board of the Canadian Organization for Rare Disorders. Jane Farnham is a recognized thought leader in streamlining the complex processes for patients receiving specialty medications. She has both professional and personal interest in the rare disease space. In this episode, Jane will provide insights on the evolving role of specialty pharmacy in supporting patients with increasing complex new therapies in a changing regulatory and reimbursement environment. Welcome to the podcast Jane. 

Jane Farnham:   0:56
Sam. It's really great to have an opportunity to be here with you

Sam Tarantino:   0:59
Jane, can you tell us briefly about yourself and the professional journey that led you to where you are today?

Jane Farnham:   1:06
I'm a pharmacist with a business degree, and I've often say I've worked on all sides of the industry. With the exception of government. I started my career as a practicing hospital pharmacist. I spent some time in community pharmacy. I worked in the public sector at the University Health Network. That was my first business job, and I moved from there over into the business sector. I worked in the biotech  space, spent a good degree of time in the generic industry and also worked in negotiated buying programs for the largest network of community pharmacy banners in Canada.  

Sam Tarantino:   1:50
Let's start with a specialty drug. What is a specialty drug? 

Jane Farnham:   1:54
There isn't really a clear definition for specialty drug, but generally we think of a specialty drug as a drug that cost more than $10,000 per year per course of therapy. It often involves special dispensing and distribution procedures such as cold chain. More intensive clinical care is required with these therapies, typically more monitoring and more adherence management. And many of these therapies air administered via infusion or injection, and many of them are biologics.

Sam Tarantino:   2:26
So what does a specialty pharmacy in Canada do? 

Jane Farnham:   2:32
A specialty pharmacy typically works with hundreds of drugs versus the thousands of drugs that a typical community pharmacy he works with. The pharmacists, who are working in specialty pharmacies, have in depth training on all of the medications that they're working with. Typically, there's more time required to start a patient on a specialty therapy, and there's a tremendous amount of support and follow up required. So when a patient begins their journey with a specialty pharmacy, they would typically become involved with an on boarding call where the pharmacists would learn not only about their medication history but also about their entire medical background. They'd be given an opportunity to understand about the therapy there Side effects, how it might interact with their disease conditions. It's a very complex process, for many of these patients are seeing many health care professionals and have many appointments and other therapies and specialty pharmacies are there  to support the patient through that journey.

Sam Tarantino:   3:36
So how does a specialty pharmacy support patients that require specialty drugs?

Jane Farnham:   3:44
A specialty pharmacist will spend whatever time is required with the patient to make sure that they understand the needs related to their therapy, all the potential side effects and outcomes. There's also something called reimbursement navigation, which is often required when a patient is receiving a specialty therapy. Even if patients have drug coverage, many if not most of drug plans don't provide 100% coverage. So if you're prescribed a medication that costs a $100,000 a year and your plan pays 20 or 80% of the cost, you're still left with a $20,000 per year expense. And that's really something that could be quite overwhelming for most Canadians.

Sam Tarantino:   4:32
So relative to the the traditional pharmacy Space Retail Pharmacy. What is the size of specialty pharmacy market in Canada?

Jane Farnham:   4:44
So the drug market in Canada is approximately $35 billion today. We're just at the beginning of the reporting season. And so the numbers I'm speaking about came out in 2019 at that time and continuing to today about 1/3 of the total drugs spend  in Canada is specialty, and, interestingly enough, only 2% of the claims are actually for specialty products.

Sam Tarantino:   5:13
And so what are the trends? Are there any trends in the specialty pharmacy? 

Jane Farnham:   5:18
Some of the trends that I'm observing is a really focus on growth of specialty products in the oncology pipeline. There are a lot of new products, a lot of new indications. There's been double digit growth in that space over the last five years, the late stage oncology pipeline is up 77%. That's where we're seeing a lot of evolution and development in terms of targeted therapies in next generation biotherapeutic agent. So cell and gene therapy. The other interesting trend that we started to see over the last year or so is new evolution in biologic treatments for patients with migraine. The first treatment hit the Canadian market in late 2018. And, another trend that we've been observing over the last couple years is the levelling out or the normalizing of the hepatitis C therapy, which really spiked in 2015 and has been normalizing since then.

Sam Tarantino:   6:25
Let's move to the patient experience, Jane. So how, how can a specialty pharmacy also help patients with reimbursement? 

Jane Farnham:   6:39
Specialty pharmacies play a really important role in patients requiring reimbursement for their therapies, so I like to call it heavy lifting. The pharmacist is doing the heavy lifting for the patient.  A lot of these programs exceptional access programs and special authorization programs require a lot of coordination of paperwork. The physician has to fill out a component of the paperwork. The patient has to complete a section. The pharmacist has a role to play. And so, typically a specialty pharmacy will coordinate all of that for the patient. It can be very challenging and very complex, and so a good specialty pharmacy will coordinate all of that. Make sure it's since submitted to the insurance organization and follow up to ensure that reimbursement is received.

Sam Tarantino:   7:30
Can you achieve this through a centralized dispensary or doesn't have to be regional based on the the jurisdiction you're in?

Jane Farnham:   7:38
There are some regional differences, So in Canada, each of our provinces have a different provincial drug program, with different formularies and different rules to follow. So typically you will work with a specialty pharmacy in the province in which you're located. And it's important because that pharmacy will then understand all of the nuances of your drug program in your particular circumstances.

Sam Tarantino:   8:04
And do you integrate with the patient's health care professional team toe provide, you know, become part of an integrated health management team.

Jane Farnham:   8:11
We absolutely do. And that's what I consider part of the heavy lifting that a specialty pharmacist will do on behalf of the patient. Navigating the health care system can be incredibly overwhelming for a patient newly prescribed a specialty medication. And so we are coordinating with the physician's offices were also coordinating with the Patient Support Program, which is typically associated with one of these medications. We coordinate with clinics for injected and infused medications, and we can also be involved in coordinating lab testing that may be required for biologics blood work. All of those things that can become really challenging for patients to navigate on their own.

Sam Tarantino:   9:01
I Imagine this is all part of not just a specialty pharmacy, but a patient support program as well as part of a larger program. So when we're talking about specialty Pharmacy, we also have to talk about a P S p r patient support program. So how does how does a P S P help and support the patient's journey?

Jane Farnham:   9:21
Sam, There are as many different types of patient support programs, I think, almost as there are therapies, so there are some programs that provide very intensive support. They will take on the role of the reimbursement navigation so they'll coordinate with the patient the understand what drug coverage they have if they have a spokes with drug coverage, and they also work to coordinate with the pharma company who's supporting the program if there's a gap in coverage. So if he used the example we spoke about earlier, if the patient is going to be out of pocket $20,000 per year, and that makes that product unaffordable for them than the patient support program will work in coordination with the manufacturer to look for sources of funding for that product. The  patient support program can also have a role in coordinating with physician's offices. They're often involved in connecting a patient to a clinic in a community nearest them if they're receiving and infused or an injected medication. They also play a role in coordinating lab testing and blood work at point of care wherever possible.

Sam Tarantino:   10:31
Where do you see, the future of Specialty Pharmacy. Where do you think it's going? 

Jane Farnham:   10:42
It's a really interesting question. The payer landscape in Canada is changing in A lot of meaningful ways. Payers are implementing a lot of new cost containment strategies, and so specialty pharmacies are needing to be able to figure out how to be able to provide The service is they traditionally been providing as margins are becoming compressed, and so that's a really important challenge. Technology is playing an increasingly important role in specialty pharmacy. Meaningful data insights are really key and understanding and recognizing that the specialty pharmacy can be a really important partner in generating real world evidence. And I think the holy Grail of all of this is being able to link the outcomes of specialty therapy to things that really matter to employers and the people who are funding drug plans. So if we can actually marry the utilization of a specialty product with reductions and things like disability and absenteeism and improvements in present-teeism is, um then we can really make a meaningful impact in the space. Also, I think patient reported outcomes are becoming increasingly important. I think over the years they've been under recognized and specialty pharmacies are really important collection point for patient reported insights and another trend that I see that I hope is going to happen is that pharma companies start to incorporate specialty pharmacy planning much earlier on in the product lifecycle so that by the time they're actually presenting to public and prior private payers for access, they are actually incorporating the specialty pharmacy. As a provider of data and evidence and a trusted partner in the process.

Sam Tarantino:   12:41
Okay. Do you see a future role for specialty pharmacy supporting outcomes based reimbursement?

Jane Farnham:   12:51
I absolutely do. I know we've been talking about it for a number of years. I know there are a lot of challenges in the space in terms of being able to implement these programs. I see Specialty Pharmacy is being a really important partner in being able to implement, execute and report on outcomes.

Sam Tarantino:   13:14
I read a recent article that 70% of the drugs in development, our specialty drugs that have an identified biomarker. So the future is personalized medicine. What is the role of specialty pharmacy? Given the growth of of personalized medicine targeted and more targeted therapies,

Jane Farnham:   13:38
it absolutely is the future of drug development globally. And I think the role of the specialty pharmacy is really evolving in the space. So some of the new products that we're seeing hit the market that our gene therapy products have a requirement that they really need to be administered in an institutional setting. I see that were going to be evolving to products that can have a really application in a community setting, and I think specialty pharmacies a re really poised in position to be able to provide that level of support I've seen over the years. That and I'd like to see institutions and hospitals looking at specialty pharmacies as community partners where they can have reassurance that there is a pharmacy in the community who can adhere to the same standards and processes and procedures that can be implemented in the institutional sector.

Sam Tarantino:   14:41
And do you see the trend,, away from small molecules to specialize, biologics continuing? 

Jane Farnham:   14:49
don't see it changing. I think you've said it quite well. I think the future is in personalized medicine. I think it's important, though, that we never forget that small molecules really formed the basis of the foundation of the drug development that we have existing today, and obviously there's going to be continued development in that space. If you look at diseases like cancer, the ability to be able to have a targeted therapy and potentially avoid chemotherapy that may not provide any benefit to you is huge. So I think the future is precision and targeted therapies,

Sam Tarantino:   15:28
And do you see any of these targeted therapies moving out of a hospital setting in Canada into private clinics.

Jane Farnham:   15:34
I think the future is to be determined, but like we have seen in the past, A lot of infused and injected therapies that once were only administered in hospitals now moved out into the community with the advent of biologics, I think, well, we are not unlikely to see a very similar trend once we get more experience with some of these therapies. And we also have to remember that the hospital system is quite overburdened and very challenged. And so they are continuing, looking for ways to innovate and find other ways to provide the therapies to a greater cross section of people.

Sam Tarantino:   16:15
I'd like to talk about a little more about specialty generics. There is increasing investment in the specialty generic space, Um, and more's expected over the coming years. How can specialty Pharmacy play a role in specialty generics?

Sam Tarantino:   0:00
Uh, so Jane, There are a number of health reforms on the horizon, all of which are topics for a future podcast. So in light of the health reforms that are on the rise, and do you see any of them impacting specialty pharmacy? I think  Uh, so Jane, There are a number of health reforms on the horizon, all of which are topics for a future podcast. So in light of the health reforms that are on the rise, and do you see any of them impacting specialty pharmacy?  

Sam Tarantino:   16:33
Uh, so Jane, There are a number of health reforms on the horizon, all of which are topics for a future podcast. So in light of the health reforms that are on the rise, and do you see any of them impacting specialty pharmacy? I think

Sam Tarantino:   0:00
There are a number of health reforms on the horizon, all of which are topics for a future podcast. So in light of the health reforms that are on the rise, and do you see any of them impacting specialty pharmacy? 

Jane Farnham:   17:26


Jane Farnham:   17:27
Sam, that I see almost all of them impacting specialty pharmacy and most impacting pharmacy in general. One of the biggest areas of under discussion in Canada right now are the reforms to our patented medicines Regulations, which are were finalized on August of 2019 and  the consultation period on the guidelines for the regulations just closed on Valentine's Day. And the implementation is meant to be July 1st of this year, and they will have, I believe, a significant impact across all aspects of the farm a sector and will absolutely impact specialty pharmacy.

Sam Tarantino:   18:17
Can you elaborate? In what ways do you think availability of drug is it price is it not being a top tier launch country?

Jane Farnham:   18:27
All of the above, there are some third party experts that are predicting upwards of 80 plus percent price reductions for rare disease medications, in particular around 60% price reductions for oncology medications as a result of these regulations. And so I've worked in the in the pharma industry, and I understand how launch decisions are made in consideration is obviously going to be made to the impact on global pricing considerations. So we're really concerned that products won't be launched in Canada or they will be launched much later than other countries, such as the U. S., We're concerned that the reductions in price points also will result in the reduction in the level of clinical trials that are being conducted in Canada. Just before coming to meet with you this morning, I heard a very interesting and, I think hot off the press statistic that in 2019 there was a 40% reduction in the number of clinical trials being conducted in Canada. So I think there's significant cause for concern. I'm very actively involved, as you know, in the rare disease community, and we are incredibly concerned about the impact on the launch and availability of trials and drugs for rare disease therapy in Canada as a result of these regulations,

Sam Tarantino:   20:03
what about reimbursement? And, um, do any of these health reforms do you think have an impact on reimbursement rates? My understanding and correct me if I'm wrong is that reimbursement rates over the last decade have in fact, have been declining. Is that true? And do you see that trend continuing?

Jane Farnham:   20:24
If you're talking about employer sponsored drug plans in reimbursement rates, I see that we are over the last decade or so seeing reductions. I remember when I started my career, the first couple of jobs I had I had 100% reimbursement for my drug plan. I don't think you see that very more. I think we're seeing reductions to, you know, increase the copay required by the Plan member. We're also seeing trends, troubling trends occurring in the space where we're seeing employers and plan, um, and administrators, placing caps on coverage. So where in the past we would have had an employer sponsored drug plan where there would be no limit to the amount of coverage that employees had Today, we're seeing caps put in place, sometimes on an annual level and sometimes on a lifetime level. So even if you, for example, have a $50,000 lifetime cap and your prescribed, um, an immunotherapy that cost $75,000 per year, your drug coverage isn't worth a whole lot to you. So there's some really troubling trends and a real need for new thinking around reimbursement for high cost drugs and drugs for rare diseases.

Sam Tarantino:   21:54
A new model, any ideas, but that new model should entail.

Jane Farnham:   21:58
I think there are some much smarter people than me working on some of this modeling, but I've had the opportunity to be involved in some discussions. There's some, I think, really good thinking coming out of Harvard and MIT. These days. I think if we think about some of these now what I would call ultra high costs therapy. So, for example, some of the therapies for babies born with rare metabolic disorders or rare cancers where a treatment administered in the first year or two of life can provide that child with a normal lifespan, and the treatment, perhaps could cost $750,000 a year, or a 1,000,000 or or more. I think questions have to be asked around, particularly in the kind of work environment that exist today. So if that child is born to a 30 year old parent who you know, maybe changing jobs every 3 to 5 years, is it reasonable to expect that that employer would bear the entire, say, $1,000,000 cost of that therapy when the downstream benefits would be realized by the public system or potentially future employers? So there's some really, really good questions being asked, and I think in the next couple of years we're going to start to see some really good proposals and thinking coming out of this.

Sam Tarantino:   23:30
Where do you see, the future of specialty pharmacies and preferred pharmacy networks? PPN's. You see the current infrastructure, the current um continuing. It's good question.

Jane Farnham:   23:47
I think the PPN infrastructure is really well established in Canada. I think the reason for the bringing to Canada of a P P N model was probably quite different in I think it was around 2012 that we saw the first P P N in Canada. I think today the reasons are less economic because market forces have really taken care of a lot of the conditions and have placed caps and reductions on margins that were the really essential first purpose of a PPNs And I think we're starting to see PPNs morph into being providers of incremental value to the payer. So an assurance of a particular standard or level of service. And I think what's becoming increasingly important to payers, both public and private, is some of the data that can be produced coming out of the programs. So I think that they are here probably to stay. But I think we're going to see them take on different shapes and forms and rolls and provide incremental value versus what they were originally envisioned to provide.

Sam Tarantino:   25:05
Finally, can specialty pharmacy and traditional pharmacy live symbiotically

Jane Farnham:   25:12
Emphatically? Yes, I am really passionate about this issue. I often use the analogy when speaking about Specialty pharmacy of a GP family doctor and a specialist physician. I think there is a role for both. I've spent a great deal of my career working in and advocating on behalf of traditional community pharmacy, and I have the utmost respect for all of my friends and, um network within the traditional community pharmacy space. I think there are some therapies that require a great deal more intense handling and monitoring, and I really like I would love to see us evolve to a much more collaborative model where the community pharmacy would feel comfortable handing off that part of the patient's therapy for that part of the treatment journey. And we're both specialty and community pharmacy, our partners in care for their shared patient. And when the patient has finished their specialty journey, if it's a ah, short term journey than the patient, goes back to their home traditional community pharmacy and continues to be cared for. It does upset me when I see a lot of the, um, competition, if you will arising between the two sectors, and I would like to see a lot more collaboration and coordination.

Sam Tarantino:   26:40
Jane, thank you for your advice. How can the audience connect with you?

Jane Farnham:   26:45
Thanks, Sam. It's really been my pleasure to speak with you. I can be reached by  LinkedIn page and also via my email, which is JaneFarnham8888@ gmail .com

Sam Tarantino:   26:56
Thanks, Jane. Contact details for Jane are also available on our website at Thepharmapodcast.ca . Thank you for listening. Please subscribe and follow me on LinkedIn to stay up to date on future podcast. This podcast, along with a transcript of the show, can be found on our website at Thepharmapodcast.ca.  Thank you to our sound engineer, Errol Francis and the town of Oakville for providing studio. If you'd like to be a guest on this podcast or if there's a topic we should cover in  future episodes, please connect with me via LinkedIn.