Pharmaceutical Executive

Pharmaceutical companies continue to find it challenging to deliver critical treatments to underserved patients in unlicensed or non-commercial markets. Historically, these companies distributed via their international subsidiaries or out-license partners for commercialization in secondary commercial markets, but little was done to reach tertiary or unlicensed markets. Named Patient Programs, including “compassionate use” programs, have emerged to enable individual patient access to medicines in countries where they are not commercially available. For these programs to be a success, country-specific regulations, complicated supply chains, and healthcare provider communication must all be handled flawlessly.   	 	

 spoke with Banks Bourne, Founder and Chairman of Tanner Pharma Group-which provides commercialization, named patient, and specialized procurement solutions to patients and partners in more than 120 countries around the world-about his role in delivering access initiatives for products not commercially available in many parts of the world.	 

	PharmExec: What inspired you to establish Tanner Pharma Group? 

 Through my investment in the late 90s in King Pharmaceuticals, now owned by Pfizer, I saw their pioneering concept of purchasing mature brands from big pharma that needed attention and/or life cycle capital. My experience with King showed me the potential of licensing or acquiring pharmaceuticals for commercialization in markets outside the US, and how this could change the lives of patients who don’t have access to much-needed medications.	 	Though Tanner began by providing outsourced solutions to pharma companies enabling them to enter new markets commercially, we have expanded to deliver access initiatives for products not commercially available in many parts of the world. Since 2005 we’ve been leveraging named patient supply channels to enable patients to obtain access to pharmaceutical products that would otherwise not be available in their country. Part of our overall strategy has also focused on global expansion of our footprint including Brazil in 2012, the UK in 2015, Switzerland in 2016 and Ireland in 2019. We will likely be looking at expansion into Asia in the coming years.  	 	We have structured our programs to offer a comprehensive global commercial strategy, knowing that some countries meet a threshold for marketing authorization and full commercialization, while other countries would benefit from named patient access – including either proactive awareness building or, at the very least, urgent fulfillment of on-demand inquiries. 	 

	To what extent are you providing access programs for patients in emerging countries?

	Some of our access solutions target emerging economies, where products will likely never be available commercially, and where we can use the named patient supply channels to import medicines into those markets on a donation basis. We partner with ministries of health, hospitals, key opinion leaders, local importers, and non-profit organizations to deliver products to those markets. With emerging markets, and even for more developed markets, we are seeing a significant spike in demand for new innovative medicines. Patients, especially in the rare disease space, know what is in development for their disease, and are asking their physicians for access to medicines that may never be available commercially where they live or that may be unaffordable. Most of our access solutions require providing controlled access, and that means clinicians are provided with adequate education and only patients meeting eligibility criteria determined by the pharma company get access to the medicine. We can also provide approved medical information as requested by healthcare providers, build awareness of the availability of the product, and distribute the product to hospitals for immediate treatment.  	 

	Can you share some examples of these programs?

	Each of our programs is unique as we solve problems for both our biopharma industry partners as well as physicians and patients. For example, we have a global Named Patient Program where the company has a specialty oncology product with marketing authorization only in the US. Tanner provides access to their medication in all ex-US markets around the world on a charge-for basis. We respond to requests coming from these countries and are able to fulfill the need of our pharma partner by helping them better control their supply chain, and ultimately the need of patients who would otherwise not have this type of access.   	 	In terms of donation programs, we are incredibly proud of our work with The Max Foundation, a non-governmental organization (NGO) with a full range of programs serving people living with cancer around the world. Before we knew about The Max Foundation and what they did, we had received requests from them to purchase and donate product that they could not get donated from pharmaceutical companies. Every time they called, we said yes.   	 	Eventually we said, “Hey, we need to learn more about The Max Foundation.” We found out that we had a lot in common – we are both “mission driven” and we share a passion for delivering medicine to patients in need. Upon seeing this alignment, the first thing we did was offer to donate our services for quality, regulatory and logistics for some of the programs they run. After we donated our services to The Max Foundation, they told us they were interested in partnering with us for a very large program they were working on with a major pharmaceutical company. They needed a turn-key solution to accept donations of medications and deliver them directly to the patient’s healthcare provider. The programs we run with The Max Foundation now deliver donated medicines to more than 30,000 patients, most with a chronic form of leukemia, in 75 emerging economies.	 	In 2018, Rob Keel, Director of Tanner’s Managed Access Programs, and I made the journey to Uganda  to help bridge the “last mile” of treatment access for cancer patients. The last mile refers to the unseen efforts of patients and caregivers to make treatment truly accessible. The fundraising and trip were meant to echo the journey cancer survivors take, sometimes walking many miles, to get the treatment, care, and support they need. While in Uganda, we had the opportunity to meet with patients, partners, and doctors to discuss local needs, advocacy techniques, and the future of treatment access.  Seeing hundreds of people camped outside the oncology centers while family members were inside receiving chemo treatment was hard to take, but patients were thrilled to even have the opportunity to get treated. While touring one of the oncology facilities with an oncologist, who could have easily stayed in the U.S. to earn significantly more money and use state-of-the-art treatment protocols, I asked him why he came back. He said it was his duty to the country – that comment, and his dedication, have stuck with me ever since we left Uganda. We believe everyone should be able to receive life-saving medicines regardless of their location, financial means, or the country where they were born.	 	Another program that comes to mind is one focused on rare diseases. We work with a pharma company that intends to sponsor a donation program in low-income countries for a very expensive treatment for pediatric cancer that requires specialized physician training and administration in an advanced hospital setting. Tanner has been helping the company with the design of the program that includes identifying and certifying hospital facilities capable of administering the treatment, training treating physicians, and delivering the medicine to the hospital.	 

	What are some of the challenges presented by emerging markets?  

	Many patients, physicians, hospitals and pharmacies don’t even know the pathways they can leverage to get access to medicines from other markets. Another challenge can be supply chain control and delivery through to the last mile; this challenge is amplified for patients in remote locations and with cold-chain products. We have detailed quality procedures to closely monitor product integrity throughout the supply chain and we have the means to be able to deliver to just about any country in the world. To minimize risk and ensure supply chain control, we deliver every product using current EU good distribution practice (GDP) guidelines, which describe the minimum standards that a distributor must meet to ensure the quality and integrity of medicines is maintained throughout the supply chain. We look at the entire supply chain, from manufacturing through to the patient. These programs don’t work if delivery ends at a customs warehouse or the port in the destination country. We work with local partners in every market to ensure that, even after our product passes through customs, it is still delivered with the same quality and care that it received on the manufacturing line. We’ve developed a global network of partners to help with this logistics piece and we audit the entire supply chain in the countries we serve.  	 

	Your company runs a program called TannerCares. What is that?

	I am proud to say that philanthropy is part of our DNA – it is how we are wired as an organization.  TannerCares is the philanthropic commitment of our company. We allocate a percentage of every revenue dollar that we make to philanthropic giving. We support worthy charities within the healthcare space, the causes of our partners, and local events that mean something to our team members. We have done everything from sponsoring the 20th Anniversary Gala of The Max Foundation to a 5k run in our community that raised money to support gastric health because it had a personal impact on some of our US-based team members.  	 	A critical part of our success is that the mission and culture of Tanner Pharma is embodied in each person we have hired over the years. Whether it is through the global programs we develop and manage for our clients or fundraising we do close to home, we all want to play a part in creating a world where patients around the world have access to medication they need. 	 	

Articles

Banks Bourne of Tanner Pharma Group talks about the organization's role in delivering access initiatives for products not commercially available in many parts of the world.

A Passion for Access: Banks Bourne, Tanner Pharma Group

	Expanded access programs provide the opportunity for patients with unmet medical needs, who are unable to participate in a clinical trial, to get access to drugs prior to their approval. Many countries have regulatory programs in place for expanded access-type programs, sometimes referred to as “compassionate use”or “named-patient” programs. 

	Not so long ago, these programs weren’t widely understood by the pharmaceutical industry, patients or healthcare professionals. A sea change has happened in recent years, however. The industry has grown increasingly comfortable with offering pre-approval access. The voices of patients and advocacy groups have been amplified in part due to social media channels. And new laws have been enacted; as part of the 

 which went into effect in the United States in 2017, companies developing new medicines are required to publish their policies for expanded access on their websites. In 2018, the Right to Try Act created a second route to access to investigational drugs. 

 recently spoke with Natalie Douglas, co-founder of RareiTi, a global managed access platform focused on rare diseases. She is the former CEO of Idis, one of the first companies to provide expanded access services and a leading voice in the field. 

	PharmExec: You’ve counseled many pharma and biotech companies on the development and management of expanded access programs. Can you tell us how you first learned about these programs?

 I became aware of expanded access and compassionate use through my job at Janssen Pharmaceuticals in the 1990s. I was a sales rep working at many of the large London teaching hospitals and saw some really interesting and innovative new medicines coming through. I was responsible for a medication that was used to treat severe opportunistic infection and many of the patients had late-stage AIDS. Janssen’s parent was J&J and they had a solution formulation of this drug called itraconazole in clinical trials and the doctors were anxious to be able to offer this to patients in need. There was a compelling unmet need and the importance of compassionate use became obvious. 

	You joined Idis when expanded access was a relatively unknown term. How did you help advance the understanding and acceptance of these programs?

	A: I joined Idis when the company was very small and focused on sourcing and supplying medicines for hospital pharmacies. It was clear to me, however, that we could build a model that supported pharmaceutical companies in making provisions for ethical access to medicines in this way. It was a true greenfield opportunity, a complete unknown. My experience at Janssen/J&J enabled me to go to big pharma and talk about this to chief medical officers and senior members of the regulatory and operations teams. That was in 2000 and there was a lack of awareness and understanding of these programs. Within five years or so and from truly a standing start, however, Idis was working with many of the world’s top pharmaceutical companies in implementing and managing their expanded access programs. 

	Apart from persistence, the keys to success were maintaining a patient focus and providing education about something that was, to most of these companies, brand new. 

	What’s your perception of where we are today with expanded access? What’s working and what’s not?

	If I contrast the early days with what I’m seeing now, the driving force for implementation of these programs has shifted. It used to be that companies with interesting drugs in the pipeline would start to get calls from patients and physicians asking about access. At times, they were inundated with requests. Unfortunately, there wasn’t always someone at the pharma company responsible for taking those calls and most of time, no programs in place to properly handle the requests. I’d hear from companies saying that they were focused on approval or launch – and appropriately so – rather than providing access outside the confines of their ongoing trials. Understandably, patients would use whatever channels of communication they could leverage and sometimes their appeal would wind up on the evening news; this was only further amplified with the advent of social media. 

 Century Cures Act the US are positive steps. I love the attention these initiatives have brought to the topic; people should remember, however, that the decision to provide this type of access remains with the drug developer. In the UK, there is support for expanded access under a refined mechanism, where there wasn’t a process in place 20 years ago. In 2014, the Early Access to Medicines scheme was introduced and is overseen by the Medicines and Healthcare Products Regulatory Agency (MHRA). I was happy to see this as I’ve always been a major advocate in pushing the MHRA to provide a much clearer protocol-led approach. Initiatives to update and/or establish expanded access regulations are happening around the world. And while these are all important steps, the process can still be perceived as complicated, costly and time-consuming.

	I work very closely with the rare disease community and collectively, it has had to push boundaries when there is unmet need. That still continues, which is a good thing. There is still a need for more education on expanded access for all stakeholders – companies, patients and physicians. This will help overcome the fear associated with these programs, how the programs work and for whom. There are still operational, organizational and logistical factors to consider when it comes to expanded access, all happening at the same time the company is focused on successful completion of their clinical trials and commercialization – which ultimately provides access to the greatest number of patients. 

	At the end of the day, we need to be looking at how we can make provision possible while ensuring that such provision is the best possible choice for the patient under the circumstances in which they find themselves. I’m happy that the frameworks for these programs are in place, or being put in place, as we enter a whole new realm of therapeutic options with cell and gene therapy. The cost of these drugs, their limited patient population and possibility of a one-dose cure bring a whole different dimension to expanded access. I hope the conversation continues and stakeholders continue to work together to find the best way forward for patients in need and overcome the impediments to access which remain. 

	My co-founder Wendy White and I have launched RareiTi, a global managed access and medicines management model, specifically for the rare disease community. Through our combined experiences in healthcare and our work as board members of Global Genes, we saw there was a gap in the market for rare diseases and we had to respond. We help rare patients gain access to medicines and help manage their care and deliver invaluable insights about their disease. Our advisory practice is designed to help the biopharmaceutical industry develop innovative and effective rare disease strategies. This might include conducting gap analyses, identifying opportunities for engagement in the rare disease community, adopting best in class internal practices and policies and improving outcomes in rare disease from clinical trial design through to international commercialization. At the end of the day, our goal is to help extraordinary patients gain access to the care they need.

Natalie Douglas talks about her experience in the area of managed and expanded access and her new venture, RareiTi.

Managed Access to Rare Disease Medicines

Pharmaceutical Executive talks to industry innovation luminary Rick Krohn, M.A., M.B.A., President of HealthSense, Inc., to assess the pharma applications of one of tech’s hottest solutions – blockchain.

	Pharm Exec: For many people, blockchain is an obscure technology – can you explain it in simple terms?

: Blockchains are peer-to-peer systems of 3 components: a globally distributed network of computers; a secure, shared transaction ledger; and digital transactions. A distributed network of computers stores an identical database - a ledger, and approved network members can add or review transactions to each ledgers’ block. The central feature of this capacity - the distributed ledger guarantees data integrity while creating a secure data sharing environment that is both scalable and adaptive to healthcare’s trends towards collaboration and personalization. The vision for blockchain in healthcare is to create a trusted, common database of health information that all stakeholders can securely share across information platforms.

	How can blockchain impact the pharma industry?

	For pharma, particularly Big Pharma, the benefits of blockchain technology include reducing or eliminating fraud, establishing a foundation of trust, data integrity and secure data sharing, improving asset management and supply chain, and streamlining complex clinical and financial transactions.

	Blockchain can mitigate the risks of a compromised supply chain - associated with counterfeit, unapproved and fake drugs. A Blockchain-enabled chain of custody model reveals where the drug was manufactured, where it has been since, and when it has been disbursed to patients. And in the U.S. With the opioid epidemic raging, blockchain could offer an innovative way to ensure that abuse-prone medications are better controlled. The impact could be huge - it’s estimated that the pharmaceutical industry could achieve savings of $200 billion by introducing a blockchain-of-custody for the supply chain.

	Clinical trials are another rich opportunity

 blockchain technology can address issues ranging from the tracking and sharing of data to the need for transparency and privacy for patients. The technology can directly increase the quantity and quality of patients recruited for clinical trials - the distributed ledger could allow individual patients to store their medical data by anonymous methods, making it visible to trial recruiters. It can overcome the problems of fraudulent results and removal of data and streamline communication between doctors and patients.

	Blockchain can create a data sharing environment that keeps health data private and secure while embracing the ever-expanding nodes of data and catalog of connected medical devices. With a centralized ledger and clean data repositories, medical research, clinical trials, treatment protocols and personalized medicine can all become vastly more effective. Applied to population health, by connecting stakeholders with more timely, complete patient data, researchers could develop 

	Where else is blockchain likely to have an impact?

	The holy grail is a truly integrated EMR. A blockchain-enabled EMR model can empower trusted parties across the spectrum of healthcare venues - hospitals, practices, clinics, payers and patients to view and populate records from multiple databases on a shared ledger. The flow of securely encrypted data can be shared among an unlimited number of non-integrated, approved stakeholders. But there are many other intriguing applications - Medical Research, Medical Tourism, AI, and Peer-to-Peer Insurance illustrate the scope of potential applications.  

	Always. Integration with existing systems will be 

, and regulatory concerns alone will likely slow implementation. Any Blockchain solution that handles large amounts of patient data in real time will need to be faster than is currently available in most enterprise systems. Equally challenging is the need to address privacy and data protection considerations unique to the healthcare industry. And because blockchain as a class of technology is still in its’ youth, the full dimension of these obstacles has yet to be revealed. 

	Looking ahead, what can we expect from blockchain in pharma?

	A blockchain solution for pharma must meet 3 benchmarks: scalability, access security and data privacy. As healthcare data continues to pile up, a blockchain solution must absorb ever -growing transactions and throughput. Security and privacy (in compliance with regs. like HITECH and HIPAA) must also be baked into any Blockchain solution. Its’ ability to impact healthcare will depend in the industry’s willingness to invest in technical infrastructure – blockchain is costly, and there are some concerns regarding its integration with existing technology. Most likely, adoption and implementation of Blockchain in healthcare will be incremental and evolutionary, as business models gravitate towards clinical collaboration and data normalization.

Rick Krohn (rkrohn@healthsen.com) is the author of more than 100 articles on a wide range of health technology topics and 2 HIMSS books detailing Connected Health Innovation. His latest book is 

Connected Health: Improving Care, Safety, and Efficiency with Wearables and IoT solutions.

Rick Krohn talks to Pharm Exec about the pharma applications of one of tech’s hottest solutions – blockchain.


Looking Ahead at Blockchain in Healthcare

 	Earlier this year, leaders at Lash Group and Xcenda, two AmerisourceBergen companies, Lash Group and Xcenda, were among the featured speakers at PAP 2018, CBI’s 19th Annual Patient Assistance & Access Programs conference where industry experts were invited to discuss today’s dynamic landscape of healthcare coverage, access and the next forefront of patient services and innovation. 	 	In the following Q&A, Tommy Bramley, Ph.D, president of Lash Group, and Kristine Flemister, PharmD, president of Xcenda, examine today’s increasingly complex healthcare environment, and share insights into how stakeholders - including patient support companies – should be evolving to better help patients and providers navigate barriers around access and affordability. 	 

	How have regulations and legislation affected access to health insurance and the demand for patient assistance program support?

 Recent regulatory and legislative changes could exacerbate patient access and affordability challenges, likely resulting in a heightened demand for patient support services. For example, the repeal of the ACA individual mandate has the potential to leave as many as three million more Americans uninsured by 2019, according to estimates from the Congressional Budget Office. 	 	What’s more, the repeal of the individual mandate, coupled with additional regulatory changes - such as decreases in cost-sharing subsidies - actually poses a significant risk in the health insurance exchange market, as younger, healthier individuals may decide to forego coverage altogether, particularly in the exchanges. As a result, health insurance carriers participating in the exchange will likely be forced to raise premiums and continue to pass high out-of-pocket costs on to those remaining participating patients, many of whom are already at high health risk. Eventually, we may even start to see carriers withdraw from select counties and states, leaving prospective enrollees with limited options, limited access to prescribed therapies, or possibly without any insurance options at all. 	 	

 As patients face mounting financial and access barriers and the number of uninsured and underinsured individuals increases, the demand for patient support services will continue to grow. To help patients start and stay on therapy, manufacturers will, in many cases, need to provide increased patient-focused support that addresses challenges related to patient access, affordability and adherence.  Patient assistance and foundation programs play a critical role throughout the treatment journey. Whether it is providing free product to patients in need or offering services that ease the financial burden for uninsured and underinsured patients, patient support services help patients navigate and overcome the barriers they face. 	 

	What types of “new” burdens are patients bearing? Which ones should patients be most concerned about? 

 Rising copays and high-deductible insurance plans shift more of the cost burden to patients, compounding existing affordability challenges, especially among lower-income individuals. Further, we are seeing escalating use and complexity of tactics such as prior authorization and step therapies by payers as methods of cost management, creating additional barriers for patients. The evolving market pressures exacerbate current pain points throughout the patient journey, creating greater uncertainty around patient access. 	 	

 Affordability and access, of course, remain top of mind for patients. However, another burden that patients face is delayed therapy initiation. Prior authorization requirements and benefit verification processes can delay a patient’s access to treatment by days or even weeks. While benefit verification is an important process that summarizes a patient’s healthcare coverage and out-of-pocket costs for his or her medication, it can serve as a barrier – particularly for the millions of patients whose benefits are still verified manually through phone calls and paperwork exchanged among healthcare provider offices, payers and third-party hub support service providers. As a result, more patient service providers – including Lash Group – are introducing innovative technology solutions to improve turnaround time. In fact, we just launched an electronic benefit verification solution that leverages artificial intelligence and machine learning to drive faster speed to therapy and incorporates real-time payer and plan changes, updating algorithms and producing the highest quality benefit summaries.	 

	Given this increasing patient burden, how do patient support services and field-based teams continue to evolve in order to help alleviate those pain points and ensure patients start and stay on therapy?

 There is a lot of uncertainty and complexity in today’s evolving healthcare landscape. Helping patients navigate this landscape successfully and gain access to their medications requires the ability to aggregate and connect the right people and the right information at the right time. With Fusion, Lash Group’s CRM, we’re making significant investments in technology and data analytics to enable manufacturers to take a faster, more strategic approach when designing and executing patient support programs. The patient insights gathered will further enhance patient outcomes and improve the patient and provider experience. With increased visibility through reporting and analytics, manufacturers can anticipate potential barriers for each patient – based, in part, on individual characteristics and predictive therapeutic-related risks – and optimize their strategy to ensure they engage patients at critical points throughout the treatment journey. 	 	

Coordination is a core component of a successful approach. Field-based teams and reimbursement hubs offer a variety of services, from prior authorization and denial assistance to provider education and access to financial assistance options, which help providers navigate potential barriers. For example, the teams can educate patient care coordinators on benefit verification services, which will provide clarity into the patient’s insurance coverage, cost-sharing or PA requirements. Field reimbursement teams can not only guide staff on how to complete a PA form, but they can also educate them about payer requirements and address patient access barriers. Once product coverage is confirmed, field-based teams and reimbursement hubs can educate providers on reimbursement and access support services, such as affordability options and processes, to ensure necessary financial assistance is available for prospective patients.	 

	Are there other emerging market trends that could impact what patient services are offered or how they are delivered? If so, how can companies stay abreast of these emerging trends to assist in optimal access for patients? 

 One area, in particular, we remain focused on is the emergence of copay accumulator programs. Introduced by pharmacy benefit managers (PBMs) and health plans, the programs do not allow a manufacturer’s payments-through manufacturer-sponsored copay programs-to count toward the patient’s deductible and out-of-pocket maximum obligations. As a result, patients will be left to bear more of the upfront financial burden. For patients who struggle to access their medications without copay assistance, these programs can lead to decreased medication adherence rates, patient frustration and confusion, and increased demand for and utilization of patient assistance programs to bridge the gap. This trend continues to evolve, which is why we’ve created a Copay Accumulator Learning Center to provide the latest insights to pharmaceutical manufacturers. 	 	

 Xcenda recently conducted a survey of representatives from 46 national and regional commercial plans, which revealed that about 40 percent of plans currently limit the use of commercial copay assistance. This research further revealed that in the next two years, that percentage could skyrocket to more than 80 percent, significantly limiting the assistance these programs bring to patients. Right now, the vast majority of the plans that restrict copay assistance use the accumulator model, while less than 10 percent just use the maximum allowable model – a program that adjusts the plan’s benefit design so that the cost-sharing amount required is set to the maximum financial amount allowed by the manufacturer.	 	Amid today’s fast-changing landscape, companies should monitor regulatory efforts and key developments, particularly those that impact patient access and support services. Subscribing to relevant publications and industry newsletters like Xcenda’s Health Policy Weekly, a weekly newsletter that offers analysis of legislative and regulatory developments and news that affects the healthcare industry, is an easy start. Companies should also be aware of their patient populations, know whether they will be affected by these growing practices, and adjust programs accordingly. By remaining updated on industry trends, companies can plan for and adapt to changes, and ensure they have the necessary offerings and robust financial resources to meet patient needs.  	 	 	 	 	 

Tommy Bramley and Kristine Flemister discuss today’s increasingly complex healthcare environment, and share insights into how stakeholders should be evolving to better help patients and providers navigate barriers around access and affordability. 

Author | Pharmaceutical Executive

Articles

A Passion for Access: Banks Bourne, Tanner Pharma Group

Managed Access to Rare Disease Medicines

Looking Ahead at Blockchain in Healthcare

Navigating the Complex Reimbursement and Policy Landscape of Healthcare Access