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November 20, 2018

Patient Support Programs - Trending or Transformative?

Their Place Today and Tomorrow — a sold out event!

Gaps in our healthcare system and other landscape complexities make a Patient Support Program (PSP) an avenue to marketing pharmaceutical products and creating equity for brands. This sold out meeting covered an overview of the evolution of PSPs in the Canadian healthcare landscape and the direction they are going; the different models, structure and stakeholders involved; the opportunities and costs associated to PSPs; and best practices for running a PSP.

Opening Remarks and Housekeeping -   Santiago Molano, PMCQ Director

• Membership perks: Did you take advantage of the 5% discount for the annual PAAB Workshop this month? This is just one of the many perks that come with being a member of the PMCQ!
• The next PMCQ event: The Future of Cannabis in the Pharmaceutical Industry. Don’t miss this event, which is a BREAKFAST meeting, on January 22, 2019.
• Holiday Soirée: Mark December 12^th in your calendar if you like delicious food and guaranteed fun. This event will be hosted at 40 Westt Steakhouse & Raw Bar.
• Thank you to McCann Health for doing the creative for this event and Novartis for their sponsorship of our association.

Introduction of Panelists -   Catherine Dickinson

The meeting was moderated by Catherine Dickinson, Director Health Management, Novartis Pharmaceuticals, and featured a panel of industry experts:

• Guy Payette, President, Innomar Strategies
• Ravi Deshpande, Senior Vice President, McKesson Specialty Health
• Alison Shore, Director Patient Engagement, AbbVie
• Linda Lin, Director Clinical Services & Pharmaceutical Strategies, ClaimSecure Inc.

The History and Evolution of PSPs -   Guy Payette

The past:

• PSPs emerged in the late 90s and early 2000s when biologics entered the market and the market wasn’t prepared for the barriers to access and reimbursement.
• PSPs used a one-size-fits-all approach with multiple vendors, which was hard to manage.

The present:

• The current state of access is still fragmented across the country, especially for rare orphan disease products.
• The healthcare system is facing issues including the cost increase in specialty medicines and the aging population.
• Private payers are looking more into disease management solutions, so collecting data from the program is an important factor for the manufacturer to consider when tailoring the PSP to change the payer framework landscape.
• Single vendors are now offering an integrated approach — one in which everything is available in one database — providing helpful business insights from the collected data to better understand the brand and improve the patient journey.
• PSPs have become a standard requirement, especially for specialty products.
• Programs are now customizable to the stakeholder and molecule needs and feature services that are as unique as the product.
• There is more focus on education — there are now field case managers to educate on the value of the PSP and help physicians navigate reimbursement.

The future:

• Key challenges include the emergence of biosimilars, personalized medicine, and gene therapy, but these are still too new to discuss in depth.
• There is also a tremendous amount of changes happening rapidly around payer outcome requirements linked to access, Pharmacy Provider Networks (PPNs), and technology customization.
• Emerging trends:
  • The biggest change will be in technology and providing a more digital solution.
  • Data will be increasingly important for business insights and access.
  • More integration of the PSP with payers, physicians, EMRs, etc.
  • Consolidation of programs into central hubs.
  • The changing regulatory environment is causing more audits.

How do you see us applying technology to AE reporting and compliance (and other things done manually in the past) in the future? Technology will play a big role. There are systems now and they are starting to be adopted by vendors but the barrier is cost. There are also excellent quality management systems that make it possible to provide transparent and traceable records.

Are PSPs trending or transformative? Absolutely transformative. We’re about to see the greatest changes in the next couple years just because of the digital aspect of it.

Strategic Reasons for Starting a PSP -   Ravi Deshpande

Strategic reasons for starting a PSP:

1. Access: Make sure patients start on therapy.
2. Adherence and differentiation: There are many treatment choices (including biosimilars), and sometimes the program is the differentiator.
3. Support for HCPs: Physicians now have several (up to 8–10) different specialty products to prescribe, which is time-consuming because there is a lot do (i.e. paperwork, arranging infusions, etc.) In Canada, we face a shortage of specialists and patient throughput is decreasing because of the large number of specialty drugs available. HCPs need help with supporting the patients so that they can see other patients. In ophthalmology, PSPs increased patient throughput 2X.
4. Demonstrating the value (and cost) of therapy:  If you can’t demonstrate the value of the drug, payers won’t want to pay in the future. We are moving towards value-based medicine where payment may be tied to outcomes. PSPs may be necessary to get coverage for the product.

Outlook on the Future:

• Patients receiving specialty products tend to be younger; as a result, they are more interested in digital products and self-serve services. Integration will help them get care when and where they want. They are comfortable with Artificial Intelligence (AI) applications and they expect a level of customization and speed.
• HCPs don’t want to use multiple systems, so integration into the existing workflow is very important and will result in better care for patients because of the ease of access.
• Pharma companies are getting directly involved in the management of the PSPs.
• Focus is increasing on data collection (value-based outcomes) and safety, especially with oncology products because they are entering the market after phase IIb studies, instead of after phase III studies.

Big pharma is trending towards internalization, so how will third-party PSP vendors adjust? What will new vendor relationships look like? More companies are seeing that the data are important. As big pharma becomes more specialty focused, it is inevitable that they will want to be closer to patients and data. It doesn’t mean the role of vendors will disappear, because they are the ones in the physicians’ offices, but it will change.

Are PSPs trending or transformative? Both. Transformative for those innovative products, but trending in the biosimilar world, we are seeing them as being necessary commodities. I’ve had more than one pharma CEO ask me if PSPs are going to become commoditized and I said, no, they’re going to become differentiating for the most part. With new biosimilars coming in and group programs, I think they are seeing them as trending and not transformative in those cases.

What Sets AbbVie’s Patient Engagement Team Apart -   Alison Shore

What is AbbVie’s special recipe for success?

1. Commitment to putting patients first

• AbbVie manages to be patient focused because the patient engagement team is a completely separate and distinct team.
• The Companion Study:
  • An observational cohort study with ~11,000 patients to determine to what extent the services AbbVie provides have an impact on patient outcomes.
  • Metrics included script abandonment (do-not-start rate), persistence, adherence, and overall clinical outcome.
  • The study successfully demonstrated that there is a high value to the PSP services; for example, the do-not-start rate was 46% lower in patients who had received an initial care call and there was a 31% increase in the number of patients who remained on therapy beyond one year when they received ongoing care calls.
• A customer satisfaction survey done once a year by a third-party organization asked patients specifically about the services in an array of programs and found that patients rated AbbVie Care #1.

2. Connection and making sure the services are truly tailored to patient needs

• Understanding the patient journey is an ongoing process that requires constant learning and adjustment.
• Understanding that different patients have different needs; small things, like how you communicate with patients, are important to truly respect their preferences.
• To gather insights, go beyond the business intelligence person. This is a multi-stakeholder affair.

3. The right balance between technology and human touch

• A new chatbot named Cara is being piloted to give patients with Crohn’s disease instant, 24/7 access to the program.
• This allows the people in the field looking after the patients, to focus on answering the tougher questions that need more human support.

What made AbbVie decide to take the leap with Cara? We have an enterprising team. It was also insights we gathered from patients. Frequent communication is important for them.

Are PSPs trending or transformative? Definitely transformative, but there’s an element of trending stability we want to maintain, but direction is transformative.

Overview of Market Access and Private Payer Landscape -   Linda Lin

The private payer landscape:

• Employers are the private payers, but they don’t know the differences between the medications, so they work with advisors or consultants, such as Mercer, Towers, and Normandin Beaudry, which advise at a high-level what kind of plan makes sense for an employer to choose an insurance company that meets their needs.
• 70% of the Canadian private payer market is controlled by three major companies: Sunlife, Great-West Life and Manulife.
• Not all large insurance companies don’t own their own adjudication systems, so market access teams in pharma companies have to not only work with insurance companies, but also their adjudicators (namely Telus and ESC, but also Medavie Blue Cross, Greenshield and ClaimSecure), as well as the consulting companies, so there are many stakeholders involved — much more than the public system.
• Whether drugs are covered on a plan is complicated because specialty drugs are expensive, so they require prior authorization and a PPN.

Private payer concerns:

• Before 2010, specialty drugs represented less than 10% of a private plan’s drug budget. Today, that number keeps going up. Depending on the geographic location, it ranges between 20-25%. Nationally, it is 22%. But these drugs only represent 1% of the claims.
• Private payers are thus concerned that specialty drugs are becoming more expensive. Newspaper articles are scaring private payers about their budgets and HR managers are putting spending caps on plans. Formularies are now tiered. The question is not whether a drug is covered, but on what tier it is. Different tiers have different levels of reimbursement and authorizing criteria. This is not necessarily in best interest of patients, but it manages the cost. PPNs help control dispensing costs.

How Pharma can help private payers:

1. Reimbursement: Fill out the prior authorization form correctly. When the drug is covered by the government, working with physicians to move the cost from the private payer to the government would be greatly appreciated.
2. Financial assistance: In provinces other than Quebec, patients have to pay out of pocket. Looking to PSPs to help support listing condition decisions.
3. Distribution and dispensing: Keep in mind the top three insurers and ClaimsSecure have their own PPN, which adds complexity to the delivery, but would like to work together to lower costs.
4. Education and case management: Data collection is important because private payers want to know if treatment helped improve patient outcomes — did the person come to work and be more productive? What is the ROI?

Are PSPs trending or transformative? I think there’s opportunity to work together as partners, that’s transformative.

Questions and Closing Remarks

There’s so much talk about Bill 92. What do we really need to understand to prepare for the future?

• Linda: Each province will have their own rules. My understanding is that the bill is only applicable in Quebec and only applicable to drugs listed on RAMQ. When it comes to co-pay assistance, if a product is not listed on RAMQ, the private payer can only pay as per plan design, so I see a role for the PSPs. Once it gets listed on RAMQ, as a private payer, we have the responsibility, the minimum rule requirement to adjudicate to pay equal if not better than RAMQ, so once there is a patient maximum contribution, 100% will be covered. So, we’re not talking about the same magnitude of out of pocket costs for the patient. The need for co-pay assistance may not be the same once the product is listed on RAMQ.
• Guy: Obviously there are changes with controlled distribution programs. One thing we have to be careful about is differentiating what the bill is and what it isn’t. There is a lot of talk about it and people are starting to think it regulates everything but you have to go back to what the legislation is really about. There are a lot of things it isn’t about, so be careful when someone tells you something can’t be done because of Bill 92. Get informed advice.

There is a lot of scrutiny about the interactions PSPs have with HCPs. What are the most important considerations for these models to be compliant within this context?

• Alison: I think transparency is extremely important. Voluntarily disclose information. For program design, think about the role of the PSP and how it complements but not replaces the HCP’s role.
• Guy: Programs have become complex. Work with physicians to understand the regulations and how we can optimize their practices.

How do you think the proposal of PMPRB reforms could impact the industry’s ability to support PSPs in the future?

• Linda:  At the end of the day, PMPRB is trying to control the price. The price drops and the budget for PSPs will undergo scrutiny by your bosses at the top. But PSPs are here to stay in Canada. Physicians are very bad at filling forms and want that headache removed. If there is more access, then more patients, so more budget.
• Ravi: A change like this will cause transformative change. We’ll have to become more efficient in what we are delivering, while still keeping the patient in the middle of it. It probably won’t be as extreme as we think, though, and these programs still offer tremendous support for patients.

How do you internalize a PSP from a privacy and compliance perspective? When internalized, are they housed in different divisions? What are the challenges when moving a program internally?

• Catherine: at Novartis, we’ve had a mixture of both. What’s key is the patient knows where their data will be kept.

How can vendors be more proactive in supporting manufacturers in developing pay-for-outcomes models seen in the payer landscape?

• Ravi: We’re starting to see those programs already. In fact, we’re setting up structures to help adjudicate against payment. How can we be more proactive? It has to be a mutual thing because you guys are the ones who will be negotiating these things with payers. It’s important when doing those negotiations that you go in with an understanding of what can and cannot be done in terms of measurement. It has to be a mutual effort because there is risk on both sides.
• Guy: I agree. Perhaps where we could add more value is on the business planning side, identifying those products with opportunities and work on them earlier.

What is the role of the PSP service provider when working with large oncology institutions like PMH, Sunnybrook, etc.?

• Ravi: Oncology is largely delivered by centres of excellence and publicly funded institutions. The biggest challenge has been the introduction of a large number of oral oncology products. What we’ve been hearing from these centres is when patients leave the hospital and take oral therapy, they completely fall into a black hole in which the HCPs have no idea what is going on with these patients. The biggest opportunity is not to compete with these centres but to work with them and use technology to extend the care of patients beyond the clinics. When patients move from setting to setting, that’s when things fall apart. The other thing is that the publicly funded oncology world has a dim view of all other oncology specialists out there, so you’ve got to prove your credibility and show that the quality of care is equal to what the patient would get at the centre.
• Guy: I think it’s evolving. It’s building trust and credibility. There are also small pockets of opportunity to partner and do some pilots.

Are PPNS really needed or could private payers simply put a dispensing mark-up cap?

• Linda: Yes and no. Of course, technology will allow us to do a mark-up cap, but the question then is will the patient get a surcharge if they choose to go to a pharmacy down the street. An adjudicator will not be able to negotiate the mark up and get accepted at 9,000 pharmacies across Canada.

How can PSP vendors and insurers work together to mitigate the increasing cost of healthcare in the Canadian market?

• Ravi: In Canada, two-thirds of what we spend on healthcare is spent in hospitals. To me, specialty drugs allow us to move patients from hospitals to the community. The more we do to make that journey and the quality of care in the community better, the more we’re going to save. Community care is cheaper.

How do third party PSP vendors feel about managing a segment as opposed to the entire program?

• Guy: It’s a change that has occurred over time. It’s not so much the model, it’s the partnership. If you have a strong partnership, the model really doesn’t matter.
• Ravi: We know you can do it and you have experienced people who used to work for us, but I 100% agree it is about the partnership.

These programs cover a lot of gaps in the healthcare system, but the Globe and Mail article has put a negative spin on this. Is there anything we can do to manage the reputations of these programs?

• Guy: We view all of our associates as ambassadors for PSPs. Immediately following the publication of the article, our communication team sent out a Q & A so that people are aware of it and can respond to it in an appropriate manner. We also view it as our responsibility to be engaging with stakeholders, whether it be key opinion leaders or government. We have a stakeholder relation division, so we are actively involved in talking to the government, which is a change from the past. As we engaged, we found out they knew very little about what we did. Now we talk about the value we bring and they are listening. It changes the conversation.
• Alison: I think one of the biggest gifts we can give ourselves is transparency. We stand behind how we operate and have a stringent code of ethics.
• Ravi: This article may have been a blessing in disguise because people know about PSPs now. There may be a benefit or opportunity there. The articles weren’t about PSPs; they were about infusions conducted in physician offices. I think the story that Kelly Grant wanted to write was that drug companies are paying doctors to write their prescriptions and the facts were twisted to match that story. If there is one learning out of this, it is that if you pay a single dollar to a physician, make sure you think about it every which way before you do that. That’s the greatest reputational risk you run as a pharmaceutical company.

Download the presentation.

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Justine Garner
Freelance Medical Writer
Cell: (514) 605-5109
Courriel: jgarnerwriting@gmail.com
www.jgarnerwriting.com