Access to High-Cost Medications: A Balancing Act

UKBlogImageSmallAs continuing innovation moves us further toward personalized healthcare and the development of targeted treatments, how can patients across Europe ensure they have fair access to high-cost medications?

Securing reimbursement remains one of the biggest challenges to delivering market access for new treatments. The debate around balancing tight health budgets with fair access for patients is shaping the way governments and payers respond to these advancements. Cancer treatments are a specific concern, especially those designed to target rare and aggressive cancers, and as such have a particularly high development cost per patient.

So what’s the way forward?

This was the question posed by the Ogilvy Healthworld UK Market Access team earlier this summer when we brought together a panel of leading experts in front of an audience of industry figures, academics and patient representatives.

The panelists discussed the issue from the viewpoint of each of the 4P’s of healthcare—payers, prescribers, policymakers and patients—to chart out the future course of reimbursement.

What was the outcome?

After a far-ranging debate, five key ideas stood out as important for taking the conversation on the introduction of high-cost medicine ahead:

1. While schemes like the UK Cancer Drugs Fund have been a success, they may prove unsustainable in the long term. New systems to assess and support the uptake of new treatments must be a national priority.

2. Three key areas that will affect the cost of medication over the next decade are:

– Technological development; as new innovations make treatments more expensive, not cheaper

– How care is delivered; and potential cost-savings that can be made in reforming healthcare systems

– Whether health systems can reform the way that healthcare is funded to support uptake of new technology

3. New treatments will not necessarily lead to cost-efficiencies, but rather higher costs for payers. This means that demand and pricing must be controlled to maintain a healthy balance between supporting innovation and ensuring access to new medicines for patients.

4. Current value assessments are too narrow and need to be reformed to better reflect their full value. As newer medicines that raise costs are developed, a more complex assessment model will be necessary to ensure that their total cost/ benefit to the healthcare system can be successfully mapped.

5. If payers are to be able to afford new high-cost medicines, cost-efficiencies must be found in the delivery of services. Although healthcare systems should remain a center of healthcare delivery across Europe, it was agreed that the way they operate must fundamentally change to provide care in the most effective way possible. This should be focused on reducing hospital visits and supporting “community-based care” systems.


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The Great Migration

Wildebeest Migration
Physicians: Owners to Employees

In the animal kingdom migration is natural and instinctual, a relatively long-distance movement of individuals as a group, as defined in the dictionary. It is found in all major animal species. The trigger for the migration may be climate, availability of food, the season of the year, or a major habitat change or disruption. Whatever it is, migration means survival!

So if birds, fish, butterflies, and elk do it, just to name a few, why are physicians doing it? The answer is adaptation for survival due to environmental shifts.

The Facts

There are approximately 100,000 (or 1/3) fewer doctors in an ownership private practice setting today than in 2000.

Accenture researchers analyzed data from the American Medical Association and MGMA-ACMPE to determine trends in physician independence and practice ownership. Physicians were defined as independent if they owned at least part of a practice.












Source: “Clinical Transformation: New Business Models for a New Era in Healthcare,” Accenture accessed 11/25/2013.

The Why

Top concerns prompting physicians to consider employment

Several issues are persuading doctors to think seriously about leaving independent practice. Accenture researchers surveyed 204 specialty and primary care physicians in May to identify the most pressing concerns.

87% cited business expenses.

61% named the prevalence of managed care.

53% were concerned about EHR requirements.

53% mentioned maintaining and managing staff.

39% cited the number of patients required to break even.

Source: “Clinical Transformation: New Business Models for a New Era in Healthcare,” Accenture, accessed 11/25/2013.

More and more physicians are facing excessive business costs as employers in private practice and decide the price of autonomy just isn’t worth it anymore.

The type of practice setting doctors choose is a decision affecting everything from their salary, practice relationships, and the hours they work. What’s more, given the changes taking place in the healthcare arena, selecting a practice model is no longer a simple decision made in one’s final year of residency. Managed care reimbursement for services and formulary protocols and practices restrictions have increasingly changed the healthcare delivery landscape, financial pressures, government regulation, and technological as well as administrative demands from payers— i.e., commercial health plans, GPOs, hospitals, Medicare, and Medicaid are influencing physicians of all ages and stages in their careers to reevaluate their practice decisions just to make a living. “Where is the doctor-patient relationship in all this?” many doctors have asked me over the past few years.

Many physicians after paying all their monthly expenses and staff salaries have little or nothing to pay themselves and turn to market research and advisory opportunities to supplement their income. Many physicians find this increasingly frustrating and start looking for other options like migration.

Migration takes many forms: just walking away and becoming a chief, retiring, teaching/academia, and physician concierge. One doctor I know walked away and just opened a bar. The answer for many physicians is migration to more of an employee type setting.

Let’s just focus on institutional practice and what that means to manufactures and marketers. The physician has moved from employer to employee—a big communications game changer.

Being part of a hospital or institutional setting relieves physicians of many of the financial and administrative burdens of owning/running a practice. It gives them retirement plans and also support services they may not have had before, and enables them to offer their staff better benefits. Doctors I have interviewed have followed colleagues in this migration of selling their practices, and liked the results.

The Implications

Autonomy is compromised in the new payer-centric environment for survival, and the opportunity for manufactures to have the traditional access to communicate, educate and cultivate relationships is now forever changed.

The implications are profound and we need to adapt traditional forms of communications, and find new and meaningful ways to communicate. We need to take a more critical view of some of the more recent options we tend to look toward, like websites. “No, not another website! We are already pulling down ones that are doing nothing for us!” many manufacturers say. I have heard that more times over the past few years than I can count. Today, a new website or iPad detail aid will not do it. We need to fully understand how physicians today want and need to be communicated to in their new environment; it is not one size fits all anymore.  We need to look at institutional barriers to access and develop business-to-business value propositions to gain access. And it doesn’t stop there. We need to look at multiple or customized  value propositions by HCP specialties, gender, age, cultural diversity, as well as regional differences to optimize brand opportunities for growth in the brief moments in time we have to communicate. Think of it this way: a 29-year-old female internist in Texas most likely looks through a different lens for communications, information, and decision-making than a 62-year-old male internist in Vermont. What do they have in common? Most likely today they are in an institutional setting, they want to help keep or get their patients well, and they have no time to talk to you in their growing payer-centric institutional environment.

The Way to Adapt

The answer for manufacturers and marketers is that we need to change. Look to nature and migrate how we think and constantly adapt what we do to survive.

The question is, how are you going to activate your migration?

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Is it time to be more balanced about fair balance?

A recent New York Times editorial asserts that the PDUFA act, which allows the FDA to collect industry-paid user fees to expedite the drug-approval process, has resulted in a “cozy” fiscal relationship that may undermine objectivity and weaken the FDA’s resolve to put public safety first.

There is no arguing that the safety of drugs and devices should be rigorously and objectively monitored in the interest of public safety. To that end, robust systems have been put in place over the last two decades to facilitate the tracking and publicizing of emerging risks associated with prescription drugs, such as compulsory reporting of side effects to the FDA, well-publicized channels encouraging patients to report side effects on their own, and Risk Evaluation and Mitigation Strategies (REMS). At the same time, the FDA has steadily increased the scope of requirements for maintaining a fair balance of efficacy and safety in all communications that fall under the broad umbrella of product promotion.

Yet, as two physicians pointed out in a letter of response to the Times editorial, the ever-growing emphasis on safety and risks required in marketing communications has, in some cases, crossed a line that is no longer fair or balanced and may in fact be undermining the well-being of the patients they are trying to protect. Indeed, with today’s fair balance requirements, the amount and prominence of safety information in a journal ad, brochure, website, or TV ad can be so predominant that important drug benefits become eclipsed. Add to that the stringent limitations on efficacy or benefit claims, and a product ad may become little more than a drug risk manifesto intended to scare patients away from starting or staying on treatment.

This can have serious implications for patients with any chronic condition that, left untreated, significantly increases the risk of disease-related morbidity and mortality. In the realm of serious diseases like cancer or HCV, this is particularly troubling. Because of the complex and cagey nature of these diseases, they have proven very difficult to treat. In fact, AIDS and many types of cancer were considered untreatable until the relatively recent discovery of therapies that could rise to the challenge and make a difference. Sure, many of these treatments are associated with some potentially serious toxicities that require vigilant monitoring and proactive management, but they also have the potential to save or significantly extend lives—otherwise they would not have been approved in the first place. However, both the amount and prominence of safety information required in promotion tends to be foreboding and overwhelming. Many of the warnings are detailed only enough to sound ominous, but are too vague for patients to understand what this really means relative to their chances of developing a serious side effect, and whether or not it can be predicted, avoided, or managed. Permissible information about efficacy and potential benefits is often scant, buried in a thicket of safety, and confusingly ambiguous.

Take, for example, a patient website for an oral oncology product that I reviewed recently. On the landing page, aside from the drug indication and a photo of a smiling patient, the only information about the drug is its safety, risks, and warnings. Many of the potentially serious side effects listed in the warnings occurred in only a small percentage of patients, and were severe in an even smaller percentage of the treated population. Yet there is no mention of this, nor is there any information about how often and in whom they are likely to become serious, and what steps can be taken to reduce or mitigate the risk of certain side effects.  Missing, too, is any reference to managing less serious but unpleasant side effects that may discourage a patient from staying on therapy. Yet effective interventions do exist for many of them. Drug benefit is only briefly mentioned on two pages within the entire site, pointing out that mean survival in patients who took the drug was a couple of months longer than in those who took standard treatment only. A definition of “mean” is provided, but it probably does not mean much to the average non-statistician, leaving the impression that the drug’s benefits are minimal while the side effects and risks are substantial. Recommending that patients consult with their physicians regarding the relevance of the efficacy data would be helpful—after all, don’t patients have the right to thoroughly understand how a drug may benefit them? Nonetheless, this type of recommendation is generally not permitted in prescription drug advertising.

Many of these pitfalls spilled over onto the professional website—pages are crowded with broad and vague safety statements that are elucidated only in the adverse events section of the site, and while there is information about monitoring for certain side effects, information about interventions is missing entirely. These omissions and gaps in information are by no means intentional on the part of the drug companies—they are mandated by regulatory in the name of “fair balance.”

This is only one example of many. By and large, branded ads, brochures, and websites, and patient education booklets representing drugs for serious conditions are crowded with safety, obscuring or completely displacing other important information—not just about the rationale for and benefits of the treatment, but also information about side effect management and patient support programs that can encourage recognition and reporting of potentially serious, but manageable, side effects. Focusing on management rather than just laundry-listing risks would likely reduce risks while encouraging, rather than discouraging, adherence. This, in turn, would likely improve treatment results and outcomes, which is the point of prescribing a drug in the first place.

So what is the solution to the increasingly imbalanced way in which safety information is presented in drug promotion? Disclosure about side effects and risks should, of course, always remain a priority; every doctor and patient deserves to know the risks or side effects that may occur with any given treatment. But is there a way to disclose this information so that it does not threaten to nullify the drug’s therapeutic benefits? Is it time to rethink how and when safety is presented and in what context? Rather than barraging doctors and patients with an ever-expanding litany of possible risks in a venue that does not allow for full disclosure about what those risks really mean, wouldn’t it be better to streamline and shift the weight of the safety discussion so that it focuses more on recognition, reporting, and intervention? Is it possible that the industry and the FDA partner and negotiate a middle ground that more effectively and fairly communicates the ways in which treatment may help, rather than just harm, patients?


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