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The Pulse of the Pharmaceutical Industry

Agenda 2019: Choose your own adventure

Written by: | | Dated: Wednesday, February 13th, 2019


Med Ad News asked its sources what key questions for 2019 we’d left out. This is what they told us.


1. What can pharma marketers do to ensure data security and privacy in the face of public concern and ever-stricter regulations and requirements?

– Wendy Blackburn, Executive VP, Intouch Group

Wendy Blackburn

In 2018, we watched the Cambridge Analytica fiasco unfold, the European Union’s General Data Protection Regulation go into effect, and the announcement of the California Consumer Privacy Act, which goes into effect in January 2020. This is only the beginning. Privacy concerns about data collection and targeting will be a big influence on pharma marketing and advertising for the next 5-10 years. Security and compliance aren’t add-ons; they’re foundational, and we, as an industry, have a responsibility to ensure we collect, handle and use customer data in the right ways.

“Personal data” can be anything from a name, address, photo, email address, medical information, to an IP address. One way pharma marketers can continue to use personal data to an extent is to anonymize or pseudonymize the data.

Conducting a thorough inventory can help identify distinct types of data, where they reside, and how they should be managed and accessed to minimize security risk. For example, if you’re storing PHI or PII (personally identifiable information), follow industry best practices ensuring that information is encrypted both at rest (in the database) and in transit (in that file export to be shared with a trusted partner). From there, you can layer additional security measures, but data encryption is the key.

International privacy regulations are varied and ever-changing. To ensure that a project will be acceptable in all regions, pharma marketers should know which countries to take into account, understand their policies, and only start building once that understanding is in place.

Marketers should state clearly on their websites what data they’re collecting, how they’ll use it and how users can opt out in the future. This opt-in process should shape best practices for UX moving forward.

The healthcare industry is uniquely positioned to adapt to the new rules and regulations surrounding data security and privacy. In general, these rules will keep you safe: Respect patient privacy; follow data security best practices; know the laws; know the tech; know the limits; be transparent regarding the potential use of the data; and only work with partners who understand and follow these guidelines.


2. How can vendors prevent “EHR burnout” among healthcare providers?

Angelo Campano

– Angelo Campano, VP, point of care practice (EHR/ABM), Ogilvy Health

Software solutions that have significance and want to be innovative are flooding the healthcare world, but often become more of a challenge than the ones they set out to solve. A recent report detailed how venture capitalists, engineers and tech teams need to pair with physicians to gain better insight into the type of problems they aim to solve.

For example, it points to the Electronic Health Record and software giant Epic sending technology leads and focused engineers to open heart surgeries across various health systems as a model of the standard that medical software developers should be trying to work toward. Many EHR platforms and vendors don’t have that degree of connection to the HCP or health system, however, and the result is burnout – the HCP spending hours on data entry, and a general dissatisfaction toward health software solutions that are supposed to help, but really just mean more work and another hard-to-navigate system.

What is on the way: Recognizing this, the American Medical Association has recently paired with many EHR developers and focused clinicians to develop the Digital Health Implementation Book, which helps physicians better adopt Health Information Technology (HIT) in their practices – and suggests what EHR software companies can do to make their products more useful and user-friendly.

Since practices vary and one piece of software can be used in different ways depending on the provider, developers need to be responsive to requests for information and support.

Additionally, AMA recommends that developers need to listen to physician feedback and focus on hearing how doctors actually use their software so that they can continuously improve their solutions.

What we have seen so far: Physicians trying to cope with technology annoyances are hardly a new thing for 2019. Burnout is a major problem that many EHR platforms, health systems, and technology experts are desperately trying to find a solve for and eventually to correct. Similarly, others in the healthcare space are seeing how responsivity and feedback-gathering can lead to better care for a patient. It follows, then, that this technique works backwards for developers. Spending more time with actual physicians and watching them at work will help vendors make products that will fit into a physician workflow – not just be added on top of it.

If your marketing in the EHR still relies exclusively on one-way channels like display advertisements, you’re missing opportunities to grow a stronger relationship with your customers. Display advertisements flow in one direction. With EHRs, you can both talk and listen via the feedback-gathering mentioned above. One-way communication just isn’t as effective. When you know what your customers want, you can offer discounts, inform of special events, and deliver relevant information in your EHR campaigns that resonates, is more likely to convert, and generates more excitement. EHR “feedback-gathering” marketing is a channel especially well suited where trust is paramount and strong relationships already exist.

Personalized information collected through feedback-gathering also enables the manufacturer to remain above the customer marketing noise. When fighting for customer mindshare, it’s easy for messages to get lost in the shuffle. A key to breaking through the clutter is with personalization and relevance.

Everyone has communication preferences, so you’ll reach the most targets at the most opportune times when you’re not dependent on a single channel.


3. How is the rise of personalized medicine going to play out?

– Michael Golub, M.D., medical and scientific director, DiD Agency

Doctors have always strived to prescribe the best medication based clinical assessment: the diagnosis, patient characteristics such as weight, age, sex, and comorbidities, and treatment variables, such as dose, route of administration, tolerability and side effects. Based on the sheer number of variables involved in human biology, we have been willing to accept the reality of drug therapy as a “best guess.” In some fields of medicine, 50 percent efficacy is acceptable; in case of hard-to-treat cancers, 50 percent response rates is phenomenal. But which patient will be lucky enough to be in that 50 percent? Doctors would have to prescribe a treatment, then wait and see.

Personalized medicine expands the clinical purview. For a growing number of medications (e.g. warfarin, antidepressants) we can now assay genetic polymorphisms involved in drug metabolism. This pharmacokinetic “insight” removes some of the guesswork in prescribing. In immuno-oncology, determination of whether cancer cells express the PD-L1 ligand (programmed death-ligand 1) helps guide therapy.

The trend is clear. Advanced diagnostics are enhancing our ability to predict treatment success. Visible manifestations of disease are only a first step, as invisible (i.e. sub-microscopic) patient factors and disease manifestations guide treatment. The possibilities are limitless.

Here is what’s not clear. Who will cover the costs of additional, expensive diagnostic tests? Will such tests routinely be incorporated into Phase III drug trials? What if a test reveals that a life-saving, $300,000 treatment only has a 15 percent chance of success based on a genetic polymorphism or molecular signature? What role will the pharma industry play as human intelligence and artificial intelligence intertwine in medical decision-making? These questions may seem more philosophical than practical. But the pace of progress is accelerating, and complicated issues are emerging. The pharmaceutical industry is a major stakeholder in this arena, and needs to be prepared to address these exciting and challenging questions.


4. Are the days of “us” versus “them” going away?

Karl Kraft

– Karl Kraft, VP, marketing operations and med/reg/legal, TGaS Advisors

A potentially major shift is starting to unfold in how commercial/promotional assets are being approved. Multiple pharmaceutical companies have implemented or are piloting having the Marketer, rather than the Medical/Legal/Regulatory (MRL) review team, make the final approval decision. How does it work? Each of the subject matter experts, Medical, Regulatory and Legal, review the asset, interpret the appropriate guidelines and regulations and advise the Marketing team on their evaluation of any potential risk. Based on that evaluation, the Senior Marketer makes the final decision to approve or not approve. Has this led to more potentially high-risk materials being approved? No, just the opposite. TGaS research and experience with companies who have implemented this change suggests that given the increased responsibility and accountability on Marketing, the level of scrutiny on the materials and the decision has increased. This change is something to watch closely, as it could evolve the “us” versus “them” mentality to “we’re all in this together.” Stay tuned.


5. What will be the impact on manufacturers as payers more closely scrutinize the costs of orphan/rare disease medications?

– Michael Zilligen, market access practice lead, Ogilvy Health

Michael Zilligen

The National Organization for Rare Disorders (NORD) currently estimates that there are as many as 7,000 rare diseases and that up to 30 million Americans suffer from a rare disease. While providers and payers (and even patients) agree that unmet needs exist for those who suffer from a rare disease, both public and private payers are now scrutinizing the clinical AND economic evidence to a new level. Gone are the days where P&T committees are “rubber stamping” approval for an FDA product with orphan drug designation. Payers (and organizations such as ICER) are assessing the “value” of rare disease products given the premium costs and international price disparities. With the intense pressure to control healthcare costs, and the release of the international pricing index (IPI) model, public and private payers have reassessed their reimbursement strategies. In fact, there is a move toward managing rare disease medications as a category rather than class by class.

One important implication for manufacturers is the demand by payers for real world evidence. Clinical trial data alone may not be enough to satisfy the needs for evidence. Additional information sources like claims data, electronic health records, and patient registries, and more recently biometric data from wearables, provide rich insights on the patient population for these high-cost therapies. Assessing disparate datasets may yield meaningful insights regarding patient outcomes that payers demand. These additional data allow for more in-depth risk assessment and targeted benefit design. Not to mention greater justification of the product’s price tag!

A second implication is an increased acceptance of outcomes-based contracts. These agreements tie payment terms for medication(s) or other healthcare technologies to agreed-upon clinical outcomes or measures. The premise is improved clinical outcomes will reduce costs and offset the use of pharmaceutical products. This approach aligns with pay-for-performance and risk-sharing strategies with providers and will continue to gain traction. While numerous variations of value-based contracts exist, including risk sharing, shared accountability, coverage with evidence generation, etc., these will continue to grow in acceptance by payers and manufacturers alike.

Finally, there is an even greater emphasis on comprehensive (and streamlined) patient assistance programs (PAPs). As increased costs continue to shift to the patient, and high coinsurance directly impacts affordability, a comprehensive PAP (or foundation for those who qualify) provides essential information and services to both patients and providers. Today, these programs are the cost of entry, and manufacturers must increase investment in technology to streamline and automate these services, thereby shortening the time from prescription to fulfillment and reducing abandonment rates, which is especially important for rare disease. Yes, payers will continue to push back with co-pay accumulators, where the manufacturer’s payments no longer count toward a patient’s deductible or out-of-pocket maximum, but more innovative patient assistance solutions could positively impact a brand’s commercial success.


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June 2019 Focus: Payer access, biotech/biopharma, DTC, rare diseases, and more!


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