Renewed education efforts on the part of employers are slowly helping them regain control of coverage decisions in their dealings with pharma. Will it translate to cost savings for employees along the healthcare value chain?

	Pharma’s relationship with employers over the years has had an on-again, off-again dynamic. Seen as key decision-makers, employers once drew the attention of pharma in the way of direct sales teams that would call on companies to keep plan creators informed.

	Over the past 10 or so years, however, a number of factors have pulled pharma away from engaging employers in a meaningful way. As a result, the lack of employer education has become a barrier to market access, and the industry is now recognizing a need to revisit its old way of doing business.

	Though pharmacy benefit managers (PBMs) existed long before this retreat, it is fair to say they helped shift pharma’s focus away from employers. As PBMs grew more powerful, pharma turned its attention to creating strategic accounts with them. They were convinced their organizations needed strong relationships with PBMs, because these entities ultimately controlled the employers.

	“Employers gave responsibility to payers and PBMs to make coverage decisions, but I think it was also partially pharma trying to streamline their field presence across all sales teams,” says David Dierk, co-president of Aventria Health Group.

	The loss of direct influence and manpower needed to address the sheer number of companies ultimately pushed pharma to reallocate resources and exit the employer space.

	As pharma shifted its resources toward PBM engagement, a downside that emerged was that employers’ information became mainly sourced by PBMs and consultants, which often have PBMs’ interests at heart.

	“Many employers are completely reliant on their consultants and PBMs to direct their employee health benefits,” says Kimberly Westrich, vice president for health services research at the National Pharmaceutical Council (NPC). “The result is that employers don’t always know if their plan design is aligned to their own 

priorities and goals for their employees.”

	Many employers don’t even realize how consultants make their money. They aren’t aware that there’s often a per-claim catch to PBMs.

	As one industry insider explained, oftentimes, consultants will tell an employer that they will take its business out to bid to the PBMs at no cost to them. What they fail to explain, the insider claims, is how they plan on getting their money. While the employer may assume the cost is absorbed in some sort of service fee they will pay, what really happens is that the consultant approaches the major PBMs with an offer to give them the large employer client. However, to qualify for the request for proposal (RFP), the PBM is asked to agree to pay a certain amount-maybe 50 cents-for every claim that goes through on that employer client over a specific period of time. As a result, some of the consultants’ revenue model is from the PBM side, versus from their clients.

	This lack of transparency is concerning, experts contend. Without fiduciary obligations, the loyalty of both PBMs and brokers is in question, and employers’ best interests become suspect. This limited knowledge can affect a company’s decisions, which ultimately can be detrimental to patients.

	“There is a lack of understanding and education regarding where the true costs lie with specialty medicines,” says Kollet Koulianos, senior director of payer relations at the National Hemophilia Foundation (NHF). “Most PBMs don’t share data showing how cost-shifting strategies lead to non-adherence, when those strategies are used to direct exclusive business to their wholly owned specialty pharmacies. [When someone] is giving advice, or directing benefit design while being conflicted, there is a real risk for a much higher total cost of care.”

	As employers express their dissatisfaction in the value of their current healthcare investment, the market seems to be shifting once again, however. “[Employers] are assuming more and more direct responsibilities in select areas of high cost to make decisions relative to access rather than leaving it in the hands of payers and PBMs,” says Dierk. “You’re starting to see pharma, once again, increase its field team presence calling on employers, because the employers are beginning to take back control.”

	Innovative employers are looking to foster new relationships as they begin to regain decision-making over their healthcare spend. To meet that need, about half a dozen large pharma companies have newly dedicated employer sales forces. As pharma makes a move back into the employer space, its focus is also being renewed,


	with those companies undergoing the shift more focused today on supporting high-cost specialty product segments.

	“Whether it’s hemophilia, or multiple sclerosis, or oncology, those are some areas that are more likely for pharma to put employer field forces in place,” says Dierk.

	Other ways pharma can educate employers is by:

		Working with employer coalitions (see sidebar) as a way to reach smaller companies.

		Providing white papers and other information that might help employers ask questions.

		Helping medium and smaller companies adopt best practices.

		Generating data that’s relevant to employers/work site.

	As employers look for ways to take things on themselves, there are several ways they can help grow their knowledge, even without the help of pharma.

	Some companies are hiring experts whose business model is to review PBM contract and spend.

		A number of transparent and fiduciary PBMs are beginning to emerge.

		Larger employers might demand a direct contract for rebates, versus allowing PBMs to do that.

		Jumbo employers are hiring pharmacists and medical directors to start tackling access decisions in-house.

	Some employers also are becoming more active in directly engaging with PBMs. “Employers need tools to more proactively engage and partner with their PBMs and consultants for benefits that serve the needs of their employees,” says Westrich.

	NPC seeks to educate them by offering a number of resources to evaluate the approach taken by their PBMs and consultants. The organization also offers research highlighting perspectives on the employer/PBM relationship and ideas on how employers can play a more active role in driving value in benefit design.

	As employers look to save money, they should become better informed about their specific disease cost drivers. According to Koulianos, 1.2% of the population accounts for approximately 31% of all healthcare spend. Meeting with specific disease organizations can provide companies with a better understanding of their cost drivers and help them develop strategies to manage their total cost of care with optimal outcomes.

	“[Every year,] Sun Life puts out a catastrophic claims report identifying the highest-cost claimants,” she says. “If you couple that with data shared by the National Business Group on Health saying 78% of employers plan to focus their efforts on high-cost claimants, then that’s where the connection will really be valuable.”

	NHF is working with pharma to improve communication. In 2014, it started the Comprehensive Care Sustainability Collaborative, which brings together payers and providers to help drive value-based dialogue and help mitigate risk when it comes to high-cost claimants.

	For conditions that are considered cost-drivers, employers could help patients connect with rare disease organizations or hold lunch-and-learns, for example.

“If you have an unhealthy workforce, and you can’t deliver the labor that you need to produce the product, then the cost truly skyrockets,” says Dierk. “The whole idea is to have aligned objectives so that the right decisions are being made that positively affect that employer’s business model.”

	 “It has been said that employers are one of the only stakeholders that have a vested interest in the whole person,” adds Stacey Richter, co-president of Aventria Health Group and QC-Health. Richter is also host of the podcast Relentless Health Value.

	Which employers will be the ones to lead this healthcare reform effort? Our industry insider believes tech companies could help pave the road, with their large number of employees, technological know-how to disrupt traditional models, and appetite to infiltrate a new space to create change. Manufacturing might also play a big role. Due to a population of older workers and the physical nature of the business, drivers such as musculoskeletal spend could force them to the forefront of change.

	“If you look at jumbo employers-Boeings and Caterpillars and Disney and those types-they have much greater masses, and in some cases they have much greater healthcare spend,” says Dierk. “So while I say, yes, tech could be an opportunity if you’re trying to be innovative and an engaged patient, if you’re trying to hit large, high-cost, high-need, chronic patients, that might not be the first place to go.”

	Employers are slowly but surely recognizing the need for change, and pharma’s support is imperative. The industry can start by helping to reform the supply chain, including how PBMs contract with employers, in order to push the savings farther downstream. If pharma can stop the value from being eaten up in the middle and

 pass it on to employers directly, employers then could lower the amount of cost-sharing that their employees
	have to bear.

	According to our insider, there was a time when pharma might say it would like to distance itself from PBMs quietly but not publicly. However, that has changed in the past 18 months. The industry has started to shame aspects of the PBM business model, and pharma has a growing interest in pushing their concession down to the patient.

	As drug manufacturers embark on this journey, they face the major hurdle of earning back employers’ trust.

	“There are a lot of opportunities for pharma to collaborate that can be win-win, but it needs to be authentic, 

with a real understanding of the needs and opportunities and options from the employer standpoint,” says Richter. “Pharma is probably in the best position ever to really start to work with employers to improve the clinical journey, improve patient outcomes, and at the same time make good on their promise to lower long-term cost.”

	Pharma can also build trust through example. “When you bring something out to employers, be prepared to have a discussion from the perspective of the pharma manufacturer as an employer itself,” says Dierk. “If you can speak from their point of view, even experientially, to say we’ve educated our employees, we’ve created support services to get better patient outcomes in this particular area, that goes a long way.”

’s Senior Editor. She can be reached at 

Articles

Features

Renewed education efforts by employers, however, are slowly helping them take back decision-making reins in their engagements with pharma.

Market Access: Employers as Barriers to Value

Pharm Exec sits down with Lundbeck’s Taj Bhardwaj, who shares insights on the big-picture vs. short-term focus mindset of leading local and global-level market access strategy in pharma-and how his current company is committed to stay in the fight to advance  new treatments and break down stigmas in mental health

	Tajinder (Taj) Bhardwaj gained a Master of Science in Laboratory Medicine and Pathobiology at the University of Toronto, Canada, before going on to McMasters University (Hamilton, Ontario) to complete an MBA. After majoring in finance and serving an internship at Wyeth, Bhardwaj found that his skill set was 

suited to the market access discipline. Beginning his pharma career as a health economics analyst at Bayer Inc. in Canada in 2006, over the next nine years Bhardwaj rose to the position of head of access strategy at Bayer Pharmaceuticals. After moving to Danish drugmaker Lundbeck in 2014 as senior director and head of global pricing, he was appointed the company’s vice president, global pricing and market access in January 2018.

sat down with Bhardwaj to gather his thoughts on how the market access function has evolved during his career, how he made the shift from a country-specific to a global role, and the challenges and opportunities he faces leading the market access efforts of a company focused on brain disorders in a changing mental health space.

How did your early experience in Canada prepare you for current position?

I started off at an affiliate level with Bayer and worked on several assets when I was at a local level. Canada happens to be a great breeding ground for market access. You can really develop your skill set and competencies because there is a plethora of different systems all rolled into one country. Each of the regions can make decisions independently, but there’s also a national health technology assessment (HTA) agency. So it was a great opportunity to really understand what market access and pricing are all about and how to manage the different dynamics.

	Canada happened to be one of the front runners in HTA reform, back in 2004. So, when countries such as Germany had their HTA reform in 2011, and other countries started to adopt different practices, it became very easy to transfer my skill set to the European setting; there was a lot of overlap. Also, the healthcare systems in Canada and Europe are quite similar.

How did you navigate that transition from a country-specific to global role?

On a country level, you tend to be very operational. You’re very much focused on filing the submissions, on speaking with the stakeholders. You do speak with stakeholders at a global level but it’s more on a strategic basis. You’re trying to identify the global positioning of the product and also allow for the flexibility that might be needed for local adaptation. You’re focused on providing a primary foundation, a starting point for everybody to work from.

	Moving to a global level requires more big-picture thinking. You have to ensure that you’re able to position a product and produce a strategy that will allow the highest number of patients to benefit from it. At an affiliate level, you tend to have a more short-term focus, whereas at a global level, you’re not only thinking about the product in front of you, you’re also thinking about the future and how you shape the pipeline, how you shape the market understanding.

What do you think have been the key changes in the market access field over the course of your career?

Very early on, there was a huge push and need for people to be competent with regard to healthcare systems, the technology assessment process, and how to move through the system. It was more administrative and technical. Once those competencies were developed, we got to the point of filing a submission, filing a written request for reimbursement. What I feel has been a slowly moving shift is in knowing how to ensure we are producing the right evidence that will meet the needs of our stakeholders,

 and how that changes the complexities and the demand on the competencies that are needed.

	Market access colleagues now need to be clinical trial specialists, talking about endpoints and statistical tests and managing expectations in terms of the magnitude of benefit. There are still those that want to pursue the “idealistic path” in terms of what an HTA or a payer is looking for, but that needs to balanced with commercial pragmatism, one that reflects on the risks of conducting certain studies. We need to know not only the limitations of our technologies, but also the limitations of how clinical trials are designed or of the instruments that are used to capture the value of our products. Working in market access has become a much more comprehensive, encompassing effort than it was before.

How can those new market access competencies be fostered and sustained?

It has a lot to do with the dialogue that you have internally, cross-functionally. I can tell you first-hand, when I went from a country to a global level, I was following that idealistic path. But then I quickly saw the challenges and the limitations of pursuing that path. When individuals appreciate that, you can then start to collaborate more effectively with your colleagues on how to find alternative solutions.

	On the external level, you need to constantly engage with the right stakeholders to talk about the value of products and how that value can be shared. It’s about engaging with medical associations, patient associations, HTA, payers; we’re all in this together. If we can have a very robust, transparent dialogue with each other, then we are on the right path toward a solution.

Looking forward, what would you say are some of the market access barriers and opportunities you are facing?

I see the barriers and opportunities as linked. One of the heaviest challenges that we face, especially with Lundbeck being a company fully dedicated to mental health, is in elucidating and translating the value of our products. If we have a scenario where our products are improving cognition or allowing patients to get back to work, showcasing that value in a manner that is appreciated by our stakeholders is a challenge. And when we are able to produce that information, having our stakeholders appreciate it is also a challenge.

	Many healthcare systems are not really focused on what worker productivity looks like. Say you have a patient suffering from anhedonia, they are not really costing the system any money because they’re sitting at home, they’re detached, they’re withdrawn from society. How do we provide benefits to such a patient where this spend might not necessarily be seen, where it is not appreciated by stakeholders who are focused on a drug or healthcare budget? I think that is a barrier, but at the same time it’s an opportunity.

What has always motivated me in this space is the challenge. When you look at mental health and you look at Lundbeck specifically, we are one of the last remaining players in the space. Many companies have abandoned the space altogether, which is truly a shame because, more so than ever, you need a focus within mental health. Not only do you have the inherent challenges of market access, but you also have this a challenge of staying relevant on political agendas and making sure that mental health is not forgotten.

	It’s almost as if there’s a view now that what we have is good enough. I can’t support that notion, because there’s so much more that needs to be done. I think that’s where my drive has always come from, to work for organizations that have that focus in mind, that have that desire to constantly innovate and add benefits to all stakeholders involved. That was one of the main things that attracted me to Lundbeck. I hadn’t worked in mental health up until then and I saw that many were abandoning it. That gave me more of a reason to want to join the fight and the challenge to keep it relevant and alive.

People are talking about mental health more than they were 10 or 15 years ago.

You’re right, we are seeing more of a dialogue taking place. That has a lot to do with the stigma around mental health being lifted. But, let’s make no mistake, there is still a stigma. In certain markets, mental health is not discussed at all. And if it is, it’s portrayed in a different light altogether. The number of treated patients for depression in western countries, for example, is up to 40 times higher per capita than in China. That speaks volumes; in China there is a very large population, but the dialogue around mental health is still growing. So, you can imagine the energy and the resources that are needed to educate and to ensure that appropriate use of our products is taking place there.

	More importantly, patients need to know that there are options for them and that they don’t need to suffer in silence or suffer alone.

	I think that we are having very healthy conversations around mental health now and I continue to support them. I wouldn’t say that there’s one solution that will solve everything; I still think that we’re on that journey to find a way to bring all these different dimensions together.

	Lundbeck is not only about one solution for a patient, it’s about being part of an ecosystem that ensures that individuals get the help that they need.

’s Online and European Editor. He can be reached at 

Lundbeck executive Taj Bhardwaj talks about the differing mindsets necessary to lead local and global-level market access strategy in pharma-and how his current company is committed to stay in the fight to advance new treatments and break down stigmas in mental health.

Lundbeck's Taj Bhardwaj: Market Access and Mental Health

Key considerations for emerging biopharmas seeking to tap region

	After the US, Europe is the world’s biggest pharma market, but the region is “significantly more challenging than the US in terms of entering the market and accessing patients,” according to a new report. 

Seven Secret Ingredients for Successfully Launching and Commercializing a Biopharma’s First Drug in Europe

, by Christian Schuler, senior partner, and Lukas Hirn, senior consultant, respectively, at Simon-Kucher & Partners, notes that while “transitioning from an R&D-focused biopharma company to a commercially viable operation is already a challenging endeavor, the prospect of having to master complex European launch requirements while also steering US business makes this shift even more daunting.” This is particularly the case for companies without any regional presence or experience.

	Faced with the complexities of navigating the pricing and market access landscapes of 28 different European Union member states, most emerging biopharma companies take the “easier” option and out-license or partner with other companies, primarily big pharma. But this strategy, the authors warn, “may leave significant shareholder value, learning, and scaling opportunities on the table.”

	In highlighting that many emerging US-based, R&D-focused biopharma companies are failing to grasp the importance of the factors needed for successful access to the European markets, the report-which is drawn from research covering “more than 20 company analog cases, 4,500 data points, and 18 industry expert 

discussions”-raises a number of pertinent questions. 

 caught up with Schuler to address those questions and to distill the report’s findings and recommendations for preparing and executing a successful launch in Europe.

	“If we want to boil things down to the key mistake that companies make, it’s not having the right product with the necessary clinical evidence to really substantiate the clinical value of the product,” explains Schuler. “This means there’s a mismatch between the company’s opinion of the value of a drug and what is perceived by the European payers.” In a lot of therapeutic areas in the US, prices can be twice, three times, even four times the price of those drugs in Europe. This leads companies to be “over-aspirational,” he adds. “They think they can achieve a similar price in Europe. But then the product does not live up to its promises.” The wrong pricing strategy leads to lower revenues than originally planned for, and for a one-product company this negatively impacts the organizational setup.

	Another mistake is that a company often fails to engage with the key medical and payer stakeholders early on. “Executives need to broaden their outlook regarding the commercial attractiveness of their drug in worldwide markets, ideally at the very beginning of the process or, at the latest, prior to setting up pivotal clinical trials,” Schuler told 

. “There needs to be some payer-rationalized clinical trial design research, where you ask, ‘How should we set up this trial in order to optimally meet your needs and deliver the value that you want to see?’” Best practice is to break up silos and identify assumptions to engage early on with regional regulatory bodies (e.g., EMA) and country-specific payer authorities (such as NICE in the UK, the Transparency Commission in France, and the Federal Joint Committee [G-BA] in Germany) to understand key requirements for the ideal clinical trial design and successful approaches to pricing and market access.

	All of this takes time, of course. For Schuler, companies should start their planning well ahead of their European launch. This involves setting in place the general manager, the CEO of the European organization, and “a small core team around” the European CEO (covering clinical, medical, pricing and market access, and commercial), all of whom should be hired “ideally two years before the launch,” says Schuler. “The quality of the people that you are selecting here is key. They must be very open and prepared to communicate

 interactively, and to cooperate very closely with the other functions.”

	Just thinking that a company can transfer what it has done in the US to Europe is “definitely not the right way to go,” explains Schuler. “The secret ingredient is to hire the right talent and to empower them in the best possible way. You need European experts. There should be a constant information exchange between the US and Europe, but you really need to give the European team the freedom to succeed and do what they think is best given the product, its merits, and the knowledge of the European healthcare market.”

	With the initial core talent in place, companies should then plan how they will approach the individual markets in Europe. Germany and the UK are “normally markets where products can be launched first,” says Schuler. In France, Italy, and Spain, affiliate offices should be established about a year before launch. “In those countries, it very much depends on how good you are at bringing the product to market fast, and on your negotiation skills with the respective health authorities,” he says. “But you will need to be a little flexible. In Italy or Spain, for example, time to market can take longer than expected-sometimes two, three, even four years. So, you won’t need to hire the full affiliate team right from the start, maybe just the general manager and a pricing and market access expert for that market. You can start hiring the rest of the commercial team about six months before launch.”

	The UK and German markets are not without their own challenges, of course. Traditionally, these markets were free pricing markets. But in the UK, a lot of patient access schemes require significant discounts in order to make a product “cost effective.” Germany offers free pricing for the first year, but since the introduction of the AMNOG law in 2011, this has required a benefit assessment of every new drug by the G-BA, which looks at the value of a product based on its clinical merits for six months. Based on these issues, the benefit assessment follows a rating scale from “no added benefit” to “major clinical benefit.” Subsequent price negotiations between the pharma company and the National Association of Statutory Health Insurance Funds (GKV-SV) then take another six months, until a negotiated price between both parties finally is agreed on. If no agreement on the price is reached after this process, an arbitration board issues a verdict on the final price three months later (i.e., 15 months after a product’s launch).

	Formulating the strategy for the UK, Germany, France, Spain, and Italy is one thing, but it potentially leaves another 23 countries to think about. How does a company tailor its model when expanding farther into Europe? For Schuler, “it definitely depends on the product that you have, and often on the prevalence of the disease. Where are the patients? Where are the buckets of patients? For diseases related to genetic defects, you may find ‘hot spots’ for patients in parts of the Nordics or Portugal, for example.”

	For access to Eastern Europe, Schuler found that companies either establish a hub in Austria or Poland or out-license or partner with other companies for those markets. While it “normally takes much longer to get access to those markets, the opportunity might not be that large to justify the setup of one’s own commercialization infrastructure,” he adds.

	Faced with the variables and the complexities of the European markets, an emerging biopharma company could be forgiven for thinking that it is better to take the out-licensing or partnering route. Indeed, Schuler says the experts canvassed for the report agree that it is “probably not worth” going it alone for just one product. In that situation, a company should think about out-licensing or partnering unless there are additional indications for the product being launched, or the company has other promising products in its R&D pipeline.

	But Schuler notes that “quite a number of successful companies have done it on their own.” He explains: “There are significant financial upsides if you have the right drug, which offers a high degree of therapeutic improvement in an area of very high unmet medical need, or you have a smaller patient population (e.g., orphan or ultra-orphan disease areas) that does not require you to have a significant organizational setup.” If the value of a product is acknowledged by the payers “because there is nothing else out there,” and the company is able to achieve a good or high price for it, then they are on the road to success.

	It is then a case of building the commercial organization or the commercial setup around the drug that fits the needs of the drug, “so it’s not just copy-and-pasting what others might have done,” says Schuler. With that in mind, a product “can easily make $200 million or $400 million, or even well beyond that,” he adds, and the company is in “a good position to become the next Celgene, Biogen, or BioMarin.” 

’s Online and European Editor. He can be reached at 

Exploring the roadmap for US-based, R&D-focused biopharma companies seeking to successfully penetrate product markets and reach patients in Europe.

The Route to Market Access in Europe

	After decades of decline, the industry pipeline of approved products has rebounded

over the last five years and in 2018, 59 new drugs were approved by FDA, the highest number in history. This includes 19 (32%) novel drugs approved as first in class. More than half of the new drugs (34 out of 59) were approved to treat rare or orphan disease.

 These innovative drugs enter into constrained healthcare systems that struggle to cope with demographic change and complex incentive and payment systems. While patients demand fast access to these new treatment options, payers are forced to make trade-offs in allocating their constrained budgets.

	There is broad consensus that a focus on “value” is the appropriate approach for optimizing spend of constrained healthcare resources. By focusing on value, payers aim to optimally and equitably allocate constrained resources to areas of greatest need and to treatments with greatest impact on patients and healthcare systems. However, value assessments are not only about the equitable allocation of resources and funding, but also need to cover the creation of appropriate rewards to spur innovation.

	Today, every pharmaceutical product at the time of its introduction into the market is assessed based on the value it offers in the majority of countries. Although pharmaceutical products only represent about 15% of total healthcare expenditures, they are still the only category subject to rigorous assessment of value and there are considerable differences in the perspectives and frameworks used to assess this value.

	Multiple value frameworks have been put forward, and each approach embeds-quite naturally-the perspective of its issuing entity or stakeholder. Providers, payers, academics, and health economists have each seen the same treatment through their individual lens, assigning different emphasis to different aspects of a treatment, leading to variation in perceived value. Further, the multiple frameworks do not share a common set of value characteristics or language, leading to even further variation in the value assigned to a drug treatment.

	In this report, we first present observations about current value assessment frameworks, and outline the unintended implications of many current value assessment approaches. We then identify and define value characteristics that might, collectively, become part of a higher-level, shared approach to valuing pharmaceutical treatments. We do not intend to propose yet another value assessment framework. Rather, we offer a more holistic approach to bridge across different frameworks and stakeholder perspectives and provide common language to describe value.

	The Boston Consulting Group (BCG) Market Access Roundtable is a forum that brings together senior market access leaders and serves as a platform for interactive discussion on industry-level topics. Roundtable members 

collectively select critical topics that are relevant but not handled in other forums, and which can have either near- or long-term relevance. Members work in smaller working groups on specific topics to develop thought pieces, relevant frameworks, or policy-related publications, which are collectively ratified by the Roundtable on a bi-annual basis. As of summer 2019, 20 companies are full-time members of the BCG Market Access Roundtable. The opinions expressed in this report are solely those of the authors and do not represent the positions of the organizations they are a part of.

A Look at current value assessment frameworks

	Beauty is said to lie in the eye of the beholder. This is true also for the value of a pharmaceutical product, even though we expect it to be objectively assessed. In theory, value assessments should provide an unbiased, objective, and transparent evaluation of a wide range of clinical and economic benefits of a new therapy relative to what is already available for patients. In practice, all valuation approaches make certain choices to keep assessments manageable and practical. Thus, value assessments incorporate inherent trade-offs and perspectives. By setting a focus or emphasis on some value elements over others, the perspective of the assessing entity or stakeholder naturally influences the outcome of value assessments.

	For this reason, no value assessment is fully objective or perfect. Yet, given the increasing importance of fair and transparent pharmaceutical evaluation, it is important to note and understand their limitations. Payers make formulary and reimbursement decisions based on assessment of pharmaceutical value. Since these assessments also guide where drug manufacturers invest, all healthcare stakeholders should have an interest in further improving the current value frameworks. Looking across the different value assessment models in use today, we make four observations.

	A multitude of factors help evaluate and determine the total value of a treatment or therapy. Clearly, clinical efficacy/efficiency, typically measured in terms of mortality, morbidity, and patient quality of life, and safety/tolerability are core aspects of value. These aspects, despite being quantifiable and thus easily comparable across different products, do not match real-life effectiveness measures and do not necessarily represent a healthcare patient-centered context.

	We would suggest that other significant aspects of value also need to be considered. For example, most stakeholders would agree that the ease of treatment (e.g., whether a patient has to spend several hours on an IV infusion or can, instead, take a pill) constitutes an important aspect of value, both from a patient perspective but in particular also from the perspective of health systems with limited capacity to administer complex treatments. Further, whether a treatment allows a patient to live a near unimpaired life or alternatively, needs to undergo stationary care, would certainly influence the value a patient ascribes to a pharmaceutical product. From a healthcare system or societal perspective, the disease burden addressed and the related productivity impact would contribute additional value.

	To manage the complexity of value assessments, current frameworks focus on only a few aspects of value. More specifically, all assessment approaches evaluate clinical efficacy/efficiency and safety/tolerability. On the flip side, assessment approaches vary widely for other aspects for value. For example, quality-of-life aspects such as functional and behavioral outcomes as well as ease of treatment, or the quality of evidence, are often not covered. While understandable from a practical perspective, stakeholders must recognize that applying a specific focus inevitably biases the valuation outcome. The inclusion of one value aspect but not another may, inadvertently, put preference on one product over another or favor one disease over another.

	Another common approach to simplify value assessments is the use of point-in-time or static assessments. While a point-in-time assessment method may seem practical, the full-treatment value may often unfold over time. For example, the availability of real-world utilization and outcomes data reduces the uncertainty regarding a product’s clinical benefits in day-to-day practice. However, relying on only a point-in-time assessment (typically before launch) renders it impossible to incorporate the new information and adjust the value of a pharmaceutical accordingly.

	In addition, many value assessments only consider summary measures of outcome, such as median overall survival or average number of complications. There may be significant variations in treatment outcomes across patients and it is clearly important for patients to know whether a new treatment offers a significant proportion of patients the chance of long-term benefit or even cure. So, ideally, value assessments should consider the distribution of treatment outcomes across patients.

Embedded stakeholder and patient perspectives not always clear

	By emphasizing specific aspects of value, a stakeholder makes conscious choices and trade-offs. While these choices are based on rational deliberation, assessment nuances are, of course, shaped by the perspective of the entity performing the valuation. For instance, a provider may value one aspect of a treatment that is important from a healthcare cost perspective but less relevant to a patient. Given their different perspectives, the value assessment of a patient may emphasize different aspects of value than the payer or provider.

	In current value assessment frameworks, it is not always clear which perspective is incorporated and for which audience it is intended. Further, we find that the perspective of the patient is often underrepresented. For example, few valuation approaches give adequate weight to quality-of-life aspects, and many do not consider the full distribution of treatment outcomes. Indeed, there is ongoing research into the value of certainty, where a treatment is very precise and has a highly predictable treatment outcome, as well as the “value of hope,” when outcomes are variable but a meaningful proportion of patients have durable benefits and may even be cured.

	Importantly, we would add that because of the varying focus of each framework, outcomes will differ and comparability will be difficult.

The conflation of value, price, and access 

	Many frameworks assess value and price simultaneously. Others simply make price a component of value. Indeed, it may seem difficult or even impractical to decouple value from price from access. In the discussion around value-based healthcare, Michael Porter defines value as “outcomes over cost.” This is mathematically equivalent to the approach taken in cost-utility analyses like in the UK or Canada, where value is quantified in terms of incremental cost-effectiveness ratios. In this report, we propose to consider value more in the sense of incremental benefit to patients, healthcare systems and society, and independent of the price of the intervention that is required to achieve these benefits. We believe such decoupling is central to the discussion since price can be adjusted and is “context-specific” while value is more universal and largely equivalent to “benefit.”

	The ability and/or willingness to fund certain medicines will vary across different healthcare systems. A health system’s affordability or ability to pay is connected to the country’s GDP per capita and its political decisions on how to prioritize healthcare against other needs like education or defense. The willingness to pay for a certain intervention is ultimately driven by the importance the health system places on a certain disease and/or treatment option. As such, they are context-specific, and the ability/willingness to fund a medicine, therefore, varies in different health care systems and geographies. But from the standpoint of the patient, pharmaceutical value is not impacted by the context of the wealth of a country or the funding priorities of a given healthcare system. Hence, it is important to untangle the value and the price discussions.

	As a more tangible example, a consumer’s relative ability to afford a given product (e.g., an iPhone) does not alter the value that he or she assigns to the product. The value is defined by the utility of the iPhone to the consumer (e.g., ease of use, calling features, or the subjective benefit of its design). The price defines the other side of the cost vs. benefit assessment in the consumer calculus, and it ultimately informs whether or not a consumer will buy the iPhone. Similarly, whether or not a payer elects (or is able) to fund a certain medicine does not alter its clinical value to the patient at a given time.

	Healthcare systems and care delivery are often fragmented and funded out of separate siloed budgets. Assessments of value and decisions around priorities for access are often particular to a specific sector of healthcare, and value is considered only within these constraints rather than across the whole system.

	Fragmentation of healthcare delivery systems often do not allow an estimation of the resources that are saved/no longer allocated to a particular therapeutic area or pathway as a consequence of the advent of the new pharmaceutical product. The value framework should assess the value of a medicine on the healthcare system overall, rather than only the segment in which value is assessed.

	In addition to the patients’ perspective, all stakeholder perspectives should be embedded in the value framework definition. Better treatment options for Alzheimer’s patients, for example, will provide a significant benefit for the caregiver/family, who are often providing the bulk of care and also suffer the consequences of the disease. Benefits to the healthcare system should be quantified and incorporated in the value definition.

Three principles for value assessments/value characteristics frameworks

	With the shift toward value-based healthcare, value assessments are becoming increasingly important. Value assessments impact treatment decisions, funding allocations, and research focus, to name just a few. But crucially, value assessments determine patient access. It is, therefore, paramount that healthcare stakeholders agree on pragmatic, transparent, and equitable approaches for assigning value to medicines.

	Stakeholder perspectives on where to focus value assessment will naturally continue to differ. But the healthcare community could begin by using a common language and agreeing on an overarching set of value characteristics. In this spirit, the BCG Market Access Roundtable proposes a set of overarching value characteristics.

	Our proposal is driven by three guiding principles (see Figure 1 below):

	1. We try to account for the different perspectives of all healthcare stakeholders to identify and define a  holistic set of value characteristics. Since we are not suggesting specific weighting of different characteristics, we believe it is possible to generate a common language on the proposed value-determining elements.

	2. We differentiate value, price, and access. As previously outlined, it is important to review value independent of price and access, as value can be objectively assessed while price and access are dependent on context.

	3. We expand on the concept of context modifiers. Rather than being elements of value, context modifiers modulate the perspective on a number of elements of value. For example, the uncertainty or quality of evidence modulates the value of all value elements, as low quality of evidence puts into doubt all outlined benefits. Similarly, budget impact will modulate the price debate. Generally, payers are able to pay higher unit prices for products treating indications with fewer patients as the total budget implications remain manageable.

	We acknowledge that payers will prioritize technologies that demonstrate avoidance of otherwise not-avoidable costs in absence of that specific treatment, and these cost savings will be a critical component of price setting and negotiations. But we also realize that such win-win situations where patients get better benefit at reduced cost are the exceptions and, often, new drugs will increase costs for payers overall-at least until products lose their exclusivity, after which they will be available at significantly lower cost.

Proposed overarching framework of value characteristics and context modifiers

	In our proposed meta-framework, we identify two context modifiers and four layers of value characteristics (see Figure 2 below). 

, as determined relative to the current standard of care, and 

, expressed by the quality of evidence, are the two principal context modifiers.

	The four value characteristics comprehensively cover all aspects of value. First, clinical benefit, which is unequivocally core to the value proposition of a pharmaceutical product. It is followed by additional benefits derived by patients and caregivers. From a healthcare system perspective, the drug’s broader impact is critical, including the clinical and economic benefits, and among these, especially, any cost savings that are conferred both on healthcare systems and on society more broadly.

	This is the anchor component of value, describing the most profound impact on a patient’s health and life, including but not limited to mortality, disease- and treatment-related morbidity, and quality of life. Current value assessments consistently cover drug efficacy/efficiency, and the majority also cover safety/tolerability. While this risk/benefit balance is also considered by regulators in their approval decisions, value is always relative to the current standard of care; in this sense, value frameworks should address “incremental” risk/benefit (N.B. The ICER framework

 is the most notable exception not covering safety/tolerability). Clinical benefit can be objectively measured with well-established variables, and pharmaceutical companies can normally present robust data from clinical trials.

	From a patient’s perspective, there are additional benefits of a pharmaceutical product that can have a profound impact on their well-being. Take the mode of administration as an example. The difference between spending half a day in an infusion room each week for months at a time versus being able to receive the same drug through a quick, subcutaneous injection can make a world of difference to a patient. Faster administration also confers value to the provider, who does not need to provide costly IV infusion infrastructure. Yet, if one were to limit consideration to the clinical benefit, both drug formulations would seem to offer the same value.

	In addition, value assessments sometimes need to consider the concepts of option value, value of certainty, and value of hope. Option value is created when a therapy allows a patient to survive until new or existing therapies may become available. A typical situation is for patients with blood tumors, where bone marrow transplantation is a curative treatment but it takes time to find a suitable donor, so that extended survival creates the option for such a curative treatment. Value of certainty and value of hope are relevant in situations where two therapies with the same “average” outcome may have very different consequences for patients; certainty reduces the hit and miss approach that is still the case for many therapies, where the biology of the disease and the mechanism of action of the drug are not fully understood. On the other hand, this uncertainty may also have the positive aspect that a proportion of patients may have a much better outcome and potentially even experience a cure.

	The value delivered by a pharmaceutical product often goes beyond clinical and patient benefit. More pointedly, the impact on the broader healthcare system differs from drug to drug. Value assessments need to take this additional factor into account to assign adequate value. Let us examine two hypothetical products that are comparable in all aspects of value with a single exception: one product addresses a condition with a large disease burden, while the second product addresses a condition with a lower disease burden. In this situation, the first product clearly offers greater value to the health system, a fact that needs to be represented in value assessment methodologies.

	Now consider the same two hypothetical products. One product addresses a condition that consumes significantly more healthcare resources than the other condition. Clearly, the product that addresses the resource-heavy condition and thus frees up the time of a healthcare professional or lowers the cost to treat provides greater value. From the perspectives of the provider (and some payers), the healthcare cost-avoidance benefit that a pharmaceutical product can offer is a substantial part of the value offered. Hence, an adequate and comparable value assessment needs to account for the impact on other healthcare resources.

	Finally, pharmaceutical products can deliver value to society as a whole. If a drug therapy enables a patient to return to the workplace during treatment, or resume work earlier than with an alternate treatment, the incremental productivity benefits both the economy and society overall.

	Pharmaceutical innovation often comes in increments rather than in big jumps. The first drugs that improved outcomes for HIV/AIDS patients did not have impressive benefits, but they paved the way to better understand the disease and develop better treatments so that today’s patients can expect good control of the disease, enabling them to live normal lives. We can expect a similar stepwise innovation as we address difficult diseases like Alzheimer´s. The development of a truly new mechanism of action (MOA) in one product can lead to further downstream innovation by applying this MOA to other conditions. Consequently, a product that uses a novel MOA provides more value than one leveraging an established one (all else being equal).

	It is important to note that how we value pharmaceutical products also influences the R&D decisions of drug developers. While all stakeholders benefit from the discovery of a new MOA, on average, it is far riskier to develop a product using a novel approach. It is, therefore, sensible to reward innovation and also to assign value based on the degree of innovation within a product.

	Ultimately, pharmaceutical innovation has an impact on broader societal issues. Advances in the treatment of certain conditions can further efforts to fight poverty and hunger. Healthy individuals are likely-and perhaps even predisposed-to both take care of themselves and to positively impact their children and elders. Since this more obscure pharmaceutical benefit is predominantly important for emerging market diseases, it is often overlooked in current value frameworks, which tend to focus on oncology, cardiology, and other diseases of established markets.

	Regulators have provided special regulatory pathways for products of potentially significant patient benefit in areas of high unmet need. Unmet need is not very well-defined, but typically includes absence of effective treatments and a significant gap between the health experienced by patients with this condition compared to otherwise healthy patients despite standard of care. We believe that unmet need equally should be considered in the determination of value. We would posit that there are very few disease areas of unmet need, where inventors have not tried to develop treatment options. The fact that unmet need remains, for example, in pancreatic cancer or Alzheimer´s disease is testament to the fact that these are complex diseases that do not have simple solutions. The benefits delivered to patients with these conditions by new therapies should potentially be rewarded beyond proportion, in the end “a QALY is not a QALY” but depends on the underlying disease severity and unmet need.

	Ultimately, all stakeholders prefer proof of value over mere promise. To this end, well-controlled randomized clinical trials in the appropriate patient population demonstrating improvements on final outcomes like mortality, morbidity, and patient quality of life against the current standard of care remain the hallmark of clinical development. However, we also need to balance timely access for patients to new treatment options against our expectations for certainty. In particular as we address diseases at an earlier stage, it will take longer to observe these final outcomes and we may have to resort to intermediate outcomes and biomarkers. Also, with increasing personalization of healthcare, we are addressing smaller and smaller patient populations, in which randomized trials may not be feasible. It is important to have flexible standards that align practicality of evidence-generation with evidence expectations with time, while, simultaneously, appreciating that less certainty of value will likely require adaptation of price expectations and adjustment of price with time.

	This is an area where the increasing availability and usage of real-world data will allow for a “conditional” assessment of value based on initial, perhaps less mature clinical trial data with clear requirements for the manufacturer (and health system) to collect additional evidence in the real world; this data can then be used to update the value of the medicine at a later stage. We believe this enables a balanced approach where risk is shared between manufacturers and healthcare systems for the benefit of patients in need. Roundtable members recognize this is an area that is still evolving and could benefit from greater solidarity amongst all stakeholders. Towards this objective, the Roundtable is launching additional working groups to tackle specific themes within real-world evidence.

	Each stakeholder will, quite naturally, have a different perspective on how to weigh the various elements that determine value. Most likely, different vantage points will prevent finding a consensus on valuation weight factors. However, we believe that all stakeholders can come to agreement on an overarching set of value characteristics and common language to describe them. Thus, we are not advocating the weightings and methodology that should be applied for each element, but rather a framework that enables informed dialogue on whether society is paying for the right things, and incentivizing the right behaviors. We further believe that such a holistic approach will, in fact, lay the groundwork for more structured dialogue and debate.

	We see our framework of overarching value characteristics as a first step toward a more unified debate on the value of pharmaceuticals. While we made every effort of accounting for the perspectives of multiple stakeholders, the framework can certainly be further fine-tuned through multi-stakeholder debate. To fully account for all stakeholder perspectives and gain consensus on value calculation, we encourage and welcome follow-on debate and structured multi-stakeholder discussion.

	1. The Endless Frontier? The Recent Upsurge of R&D Productivity in Pharmaceuticals, Fabio Pammolli et al, bioRxiv 670471; doi: 

	2. Advancing health through innovation: 2018 new drug therapy approvals, Center for Drug Evaluation and Research, U.S. Food & Drug Administration

https://icer-review.org/methodology/icers-methods/icer-value-assessment-framework/

Industry working group identifies the value characteristics that may, collectively, become part of a shared approach to valuing pharmaceutical treatments.

A Multi-Stakeholder Perspective On Assessing Drug Value

	This issue’s focus topic is Market Access-a very large topic with many nuances. Price and value are now the major determinants of access, and clearly each of those is a multi-pronged discussion unto itself. Our coverage points to an online report in

 from the Boston Consulting Group (BCG) Market Access Roundtable, a forum that brings together senior market access leaders and serves as a platform for interactive discussion on

 industry-level topics, which tackled the value proposition of therapies in-depth. Outside of European Editor Julian Upton’s report on access in the EU, the other editors focused on employee/employer-related access issues, with topics connected more to how patients pay for their therapies. Those include the trend of under-education among employers on the net effect of their chosen benefit plan designs; the very in-the-weeds subject of co-pay accumulators; and potential disruptors employer coalitions and cash-based pharmacies.

	One topic we didn’t focus on is value-based contracts (VBCs), which are often offered as a way for pharma and payers to agree on the terms of payment based on value. However, this year hasn’t seen too much dialogue on the topic. According to PhRMA’s mid-year 2019 report, only one new value-based agreement had been added this year to its ongoing tracking since 2009.

	Deloitte noted that barriers to VBCs continue to prevent widespread adoption of these arrangements. In a 

 published in March, based on stakeholder input from health plans, health systems, pharmaceutical manufacturers, and patient organizations, agreement as to overcoming those barriers would be “for industry players to share the successes and failures of these arrangements more widely.” Another hurdle is the lack of “necessary infrastructure and resources to efficiently collect, link, and analyze the necessary patient data to support VBCs.” Both are not insignificant in time and resources needed to make VBCs a scalable reality.

	Two recently reported events point to the access elephant in the room: how are patients going to pay for their needed drugs and healthcare? These reports focus on physicians going to bat for their patients.

, which reported in September that the University of Virginia Health System sued 36,000 patients over six years for more than $100 million, and used aggressive tactics, including seizing wages and savings, which resulted in bankrupting some families. The health system even blocked a UVA undergrad’s enrollment because of an outstanding medical bill, as well as suing 100 of its own employees each year for billing issues. In the intervening months, UVA Health System first said it was well within in rights under the law to collect debt, but now says it will scale back on the reach of its collection activities. However, this may be a little too late as the health system’s own doctors and UVA faculty are 

. As stated in the article, “the system’s practices undermined their efforts to improve care for middle- and lower-income families and was not in keeping with an ethos of putting patients first.”

	Meanwhile, the patient’s ability to pay came to a head at a recent Heart Failure Society of America meeting, where one of the lead physician authors on a pivotal, Pfizer-funded study of tafamidis publicly decried the drugmaker for the $651-a-day cost of the treatment. In an 

, Dr. Mathew Maurer said: “[The drug] is equal to a patient’s food budget for a month. Drugs don’t work if people can’t afford to take them…and the pharmaceutical company’s $225,000-a-year price was well out of bounds.”

	In the article, Pfizer explains its rationale for the pricing, as well as saying it does offer patient assistance for accessing the drug. However, the 

piece cites the debate around whether the drug is actually treating a rare disease-Pfizer’s justification for the high cost-or if the true market for the product is much larger than what rare is defined as.

	What all of these developments, in different areas, mean for the Market Access function remains to be seen. Clearly, this function will be tackling much more in the coming years.

From the Editor

With so many different rationales for drug pricing and “value” continuing to feed the debate, the market access function in healthcare must clearly tackle these issues-but at what cost to the patient?  

When the Patient Loses in Market Access

A look at how the industry is getting a handle on the cost-shift implications of copay accumulator programs, including their impact on patient access to specialty drugs and the downstream risks for pharma’s bottom line

	A group of industry experts presented at CBI’s Coupon and Copay Forum in October, which devoted the first half of the two-day conference to the topic of copay accumulators. While the audience largely comprised pharma leaders and service providers charged with patient access, many were new to the conference and the effect of copay accumulator programs. Patients and pharma have been caught unaware of the copay accumulator trend, which CBI first heard about at its annual Patient Access and Assistance Programs (PAP) conference in March 2018. Since then, CBI has included the topic at its related events.

	Christopher Dowd, chairperson of the October forum and executive vice president, market and product development, with ConnectiveRx, defined the mechanics behind accumulators in benefit plan schemes: Copay assistance and coupons are counted toward a patient’s deductible. Instead of the coupons helping patients with their out-of-pocket expenses, pharmacy benefit managers (PBMs) found a way to count their use against patient deductibles. Dowd said data showed between 5% to 15% of patients are affected by accumulators because of the resulting higher out-of-pocket costs. Other data from a National Business Group on Health survey found that 50 million lives are affected by copay accumulators; these are included in benefit plans for 17% of approximately 140 employers in companies that have less than 5,000 workers.

	As noted at the conference, copay assistance and copay coupons from pharmaceutical manufacturers are a highly resourced and integral part of a pharma brand’s affordability budget and market access strategy. In reality, copay assistance has become an extension of a safety net provided by manufacturers that doesn’t exist in the current economic and healthcare model in the US. The problem in that current system of what was called “compounding dysfunction” is the emergence of counter-schemes by PBMs and payers that leave pharma-and patients, advocacy groups, and physicians-scrambling to ensure that out-of-pocket costs don’t overburden patients, lead to unfilled prescriptions, and are followed by higher-cost medical outcomes and an unhealthy or severely compromised quality of life by individuals.

	The trend in private insurance is moving increasingly toward high-deductible plans, a mechanism for employers to shift the financial burden of healthcare to their employees. Seeking to limit costs further, employers asked for more discounts from their plans. That’s when the copay accumulator plans began to emerge.

	When benefit plans started implementing the new copay accumulators, language was buried deep within the particular benefit plan. In fact, as reported in 

 the AIDS Institute became concerned by the impact copay accumulators would have on those accessing HIV and hepatitis C drugs. Based in Tampa, Fla., the Institute began searching the state’s qualified health plans online to determine how an individual would be able to find out if a plan had a copay accumulator or coupon limitation policy. Even with the benefit of knowledge-the Institute knew what terms to search for-it still took it “seven steps to find a reference to copay accumulators for Florida Blue, the largest private insurer in Florida. The copay accumulator language was finally discovered on page 47 in a section called “Pharmacy Limitations and Exclusions” within a 144-page “Schedule of Benefits” document that is part of the plan contract.

	The AIDS Institute isn’t the only organization interested in how copay accumulators disproportionately affect patients who are on specialty drugs with limited-to-no generic or therapeutic alternatives. The Patient Access Network (PAN) Foundation, The Arthritis Foundation, the National Hemophilia Foundation, and Aimed Alliance, a not-for-profit health policy organization, have all had representatives speaking on this topic at recent CBI conferences. Presenting at an event in August, Kollet Koulianos, senior director of payer relations at the National Hemophilia Foundation, told the story of one 27-year-old hemophilia patient who 

reached out because of financial concerns around accessing his needed medicine. Prior to the implementation of his plan’s accumulator program, the patient was able to afford the $38,000 for his maintenance drugs with the assistance of manufacturer copay coupons. After the accumulator, he was unable to afford the $6,350 deductible. While it took Koulianos 40 days to help the patient get his medications, he was left with untreated bleeds, which resulted in internal bleeding with additional surgeries to correct. The patient has been in and out of the hospital, is currently in a wheelchair, and is not working, all at a cost of $3.5 million.

	Many of these patient-focused organizations want to place their focus on the employer education component (see more 

). Collectively, the advocates believe employers don’t objectively understand the net effect of the copay accumulators. And they contend that short-sighted transactional decisions to include an accumulator can lead to longer-term health problems for employees.

	Anecdotally related at the conference is when a copay accumulator is instituted in an employer’s health plan, and the spouse of the CEO or executive team is unable to get their or their family’s medications at the prices they were previously paying. That changes the benefit plan for the company very quickly.

	After employer education, much of the attention is on legislation. Because of the opaque language and burying in the plans’ benefits documents, states have taken notice based on both deceptive practices and negative impact on the individual. Bans of copay accumulator programs have been enacted in Arizona, Illinois, Virginia, and West Virginia, with similar bills pending in Connecticut, Indiana, Kentucky, and North Carolina. Confusion reigns on the federal level, as the Centers for Medicare and Medicaid Services (CMS) changed its direction on copay accumulators for 2020, deferring the addressment of conflicts and stakeholder concerns until 2021.

	Meanwhile, pharma isn’t pleased, but there is as yet no recorded data of downstream effects to its plans or budgets. In this 

 published last December, the author stated “copay offset programs are utilized to offset patient out-of-pocket costs, on average, 38% of the time for specialty brand prescriptions and 15% of the time across retail brands. Thus, brand teams have allocated budget to fund these programs accordingly.”

	Pharma has the potential for revenue loss due to accumulators, as well as the allocations for servicing the coupon programs. What was recommended at the October conference was careful and consistent documentation from service providers. If spikes in unfilled prescriptions, increased call volumes from patients, or decreased copay card usage, an accumulator problem could be pinpointed and brand teams can get ahead of the problem.

	Where will the copay accumulators story end? Legislation continues, but there are no illegalities of the arrangements as yet determined by the Office of the Inspector General (OIG) or Department of Justice (DOJ). However, the court of public opinion could weigh in as patient education and awareness also ramps up. NeedyMeds, a public-facing website, holds insurers accountable in its Copay Cards FAQ

: “With these programs, the insurance companies collect your deductible twice-once from the pharma company that supports the copay card and then again from the patient who has to meet the deductible.” 

’s Editor-in-Chief. She can be reached at 

https://www.drugchannels.net/2018/06/hidden-policies-search-for-copay.html

The industry’s quest to get a handle on the cost-shift implications of these new programs and the risks for patient access and pharma’s bottom line.

Pharmaceutical Executive-12-01-2019

Market Access: Employers as Barriers to Value

Lundbeck's Taj Bhardwaj: Market Access and Mental Health

The Route to Market Access in Europe

A Multi-Stakeholder Perspective On Assessing Drug Value

When the Patient Loses in Market Access

Making Sense of Copay Accumulators

Year in Review: R&D, Regulatory, and Reimbursement Hurdles

Who’s Going to Choose Where to Launch a Drug?

Back to the Basics?

Pharmaceutical Executive, December 2019 Issue (PDF)

Focus Report: Puerto Rico