DarshanTalks Podcast

How Can Health Literacy Be Improved?

The health care system can be difficult for patients to navigate, particularly for those who lack sufficient health literacy skills. Health literacy is the ability to understand basic health information and services, and it is a skill that many adults across the United States struggle with. Despite the challenges that come with navigating the health care system, patients can become adept if given the right resources. By communicating health information clearly with patients, providers can help remove a few of the barriers that patients may face when seeking treatment.

What Problems Do Patients Encounter?

Patients may encounter the disconnect between health care providers and insurance companies. There is often little communication between providers and insurers, and the responsibility of ensuring that medications are compatible with insurance plans often falls to patients. For instance, if a doctor prescribes a specific medication to her patient, this does not mean that the patient’s health insurance will cover the medication. The doctor’s advice to take the medication may mean that the patient has to take a medication that is not on the formulary. This can make receiving care costly for patients by leaving them with unexpected bills. By not being fully transparent with patients, providers and insurers may end up discouraging patients from seeking future treatment. To improve conditions for consumers, health care providers should focus on revising information and services so that they meet the health literacy levels of their patients.

Two Steps for Increasing Health Literacy

Plain Language

Plain language is a strategy for making information easier to understand—improving overall health literacy among patients. Materials written in plain language will avoid technical terminology, use simple language, and break down complex information into understandable chunks.

Providing Information in Different Formats

Health information provided in different formats allows patients to process the information given to them more fully. These formats can include video, text, or audio--depending on whichever format the patient is most comfortable receiving.

Conclusion

Although many patients struggle with health literacy, health care providers can address this problem by communicating health information more clearly through the use of training and better materials. Companies in the health care industry should consider consulting with a legal expert to ensure that they are being transparent and engaging with their patients.

If you have any other questions about how to communicate with the FDA or how your past and/or current FDA communications affect you and your business goals, reach out to me on Twitter, LinkedIn, or send me a message here.

I also host a podcast called DarshanTalks, a show that discusses newsworthy FDA issues and how they apply to bringing a product to market – and keeping it there. From patient centricity in clinical trials to the government shutdown to CRISPR and bioethics to why big data is doomed to fail in healthcare, we’ve got quite the list of topics to review!

 

 

What is Health Literacy?

Health literacy enables patients to find and use health information and services to better protect their health.

 

Entering the market with a new drug can be a competitive experience for pharmaceutical companies—particularly if they lack established connections with major companies in the industry. Although there can be many barriers to entry, it is possible for emerging companies to navigate the financial market successfully and pitch their products. By reaching out to brokers and analyzing their leverage points, pharmaceutical companies can remain on an equal footing with their competitors and push their products to market.

Establishing Relationships with Major PBMs

Creating ongoing relationships with the top pharmacy benefit managers (PBM) is crucial for pharmaceutical companies looking to put new drugs on the market. PBMs are companies that provide prescription drug programs to end payers. Of the existing PBMs in the healthcare industry, there are three primary companies controlling roughly 80% of the market share: CVS Health, Express Scripts, and OptumRx. Because these PBMs handle almost all prescription claims, it is necessary for pharmaceutical companies to build a relationship with these key players to get their drugs out to patients. If an emerging company cannot develop a relationship with a PBM, they risk being pushed out by competitors with better rates.

To establish a relationship with a major PBM, pharmaceutical companies should consider hiring consultants or brokers with a background in PBM relationships to guide them through reaching out. Once a relationship is in place, pharmaceutical companies can use their connection with the PBM to negotiate rates, rebates, and additional discounts for their drugs. This is a considerable advantage for an emerging pharmaceutical company because it allows them to break into the financial market and compete with more established companies.

Accounting for Rebates

Another point of consideration for emerging pharmaceutical companies is the effect that rebates have on the net cost of drugs. For instance, if a pharmaceutical company develops a new drug that is cheaper than the drugs of their competitors, they may still end up breaking even with their competitors because they did not account for competitive rebates. This is because rebates provide PBMs with an incentive to supply the drug with the highest rebate. It is therefore important for emerging pharmaceutical companies to maximize their rebates to remain competitive within the financial market. 

Leverage Points for New Drug Companies

There are three primary leverage points that emerging pharmaceutical companies should consider when negotiating rates and discounts for their drug products:

Incidence of Disease

Incidence of disease is the rate of new cases of the disease. If there are many patients with the disease that the drug targets, a pharmaceutical company may use this to their advantage to negotiate a favorable rate with the PBM.

Options in Therapeutics Class

We can find another leverage point in the therapeutics class. If there are a lot of competing drug companies occupying the same market, or if a key player dominates the market,

Pharmaceutical drugs can be costly, posing an issue for both the patient and the payer. Pharmaceutical companies can manage these high drug costs by implementing risk management programs. These programs allow companies to reduce their own spending while lowering drug costs for patients. Adopting a risk management program can be highly rewarding for pharmaceutical companies—particularly as it allows them to reduce health costs and gives customers a financial incentive to choose their products.

Can an RDUR Reduce Spending? 

One method for drastically reducing spending is by using a retrospective drug utilization review program (RDUR). This program is an interventional program that goes over the claims data to identify instances of fraud, overuse, or medically unnecessary care. By investigating patterns in the claims data, an RDUR program offers prescribers lower-cost options and reduces the amount of money being lost by medically unnecessary care or overuse. This decreases overall costs for prescribers because it allows them to reduce unnecessary spending and choose lower cost plans. 

Choosing Alternative Products

Another way of reducing drug spending is by choosing alternative, lower-cost products. Pharmaceutical companies can do this by consulting with a clinical pharmacy organization and choosing the cheaper options on their formulary. For instance, a company may purchase products not preferred on their formulary and consequently end up paying a premium. Being knowledgeable about which products are preferred on their formulary enables companies to save up to 30% by finding lower cost alternative products and avoiding costly premiums. 

Encouraging Patient Adherence to Medications

It may seem like patient compliance with medications does not affect the overall cost of the medications, but this is wrong. In fact, patient adherence with medications is a huge issue in the healthcare industry, costing the US healthcare system an estimated $100 billion and $289 billion annually. This is because if patients do not follow their treatment plans, they often end up exacerbating their health conditions and accrue debt by spending time in the emergency room. To encourage patients to adhere to their medications, some companies have set up specialized call centers. These centers intend to help start a conversation with patients—discussing with patients the necessity of staying compliant with their treatment plans and investigating reasons patients may fall out of compliance. By serving as an educational resource for patients, and providing patients with reasons to stay compliant with their medications, call centers can lower drug costs for healthcare companies. 

Although drug costs are often very high for pharmaceutical companies, it is possible to be proactive and set up interventional programs or call centers to reduce health spending. By taking a cost-effective approach, pharmaceutical companies can not only lower their own health costs but also those of their customers.

If you have any other questions about how to communicate with the FDA or how your past and/or current FDA communications affect you and your business goals, reach out to me on Twitter, LinkedIn, or send me a message here.

I also host a podcast called DarshanTalks,

What Is the Value of Different Patient Perspectives?

Patient advocates play a crucial, if sometimes overlooked, role in advocating for patients and ensuring that pharmaceutical companies consider issues affecting patient communities in their development process. Despite the critical role that patient advocates play, some argue that patient advocates are so enmeshed in the healthcare industry that they carry over implicit biases—ruining their credibility as patients. However, this ignores the value that patient advocates can provide, which may not be possible for the average patient. There are also different roles that patients can fill when advising pharmaceutical companies—while patient advocates offer a more expertise perspective, the average patient’s insight is just as valuable. 

Do Patient Insights Differ?

Pharmaceutical companies often turn to patient advocates to gain insight on how patients are navigating various health policies, however, this may neglect the broader group of patients who lack such expertise. Most patients lack research and patient expertise, and may only be knowledgeable about their own experiences living with their health conditions. Despite being less knowledgeable, this group of patients can still provide value to pharmaceutical companies in the form of showing what daily life is like with their condition. This group of patients can also show what it is like for a “non-expert” to navigate the healthcare industry and try to decipher the information being presented to them. 

Patient advocates make up the more informed sector of the patient population. This group is highly knowledgeable about issues affecting patient communities and the policies that make up the healthcare industry. Although this group of patients is effectively smaller than the former group, they offer valuable insights for designing protocols and increasing patient engagement. 

How Should Companies Engage with Patients?

Life Science companies should ultimately recognize that there are different patients and ensure that they are engaging with the correct group. This means pulling in patient advocates for advice on developing protocols and regulations that may fall beyond the average patient. Patient advocates will have a more thorough understanding of existing healthcare policies and protocols, and will therefore be more valuable to companies looking at these matters. Patient experience could be imminently helpful for investigating how the average patient deals with their conditions daily, however, “patients by experience” may be more helpful to look at. “Patients by Experience” represent the wider demographic of patients and provides life science companies with a good idea of how the average patient understands the information being presented to them.

Takeaways

Companies must learn to identify what type of patients they want to engage with. This means not only going to qualify patient experts but also considering what insights the average patient can offer. By making these distinctions, companies can develop policies that are more inclusive and reach a broader base of patients.

If you have any other questions about how to communicate with the FDA or how your past and/or current FDA communications affect you and your business goals, reach out to me on Twitter, LinkedIn, or send me a message here.

While there is a significant crossover between patients and patient advocacy groups, one might see Patient advocates from a special lens because they often have a broader perspective of issues facing the patient community at large. We may contrast this with the average patient who may only be knowledgeable about their own health condition.  As a result, the patient advocate may view the healthcare industry differently than the average patient, and can therefore offer a more cohesive perspective to life science companies regarding their patient engagement strategies.

Three Types of Patients

1) The Patient As Their Own Expert

We can describe this first category of patients as having knowledge solely based on his or her own experience living with a health condition.  This category of patient has knowledge by personal experience and may be informed enough to manage their condition daily but lacks knowledge beyond that.

2) The Expert Patient

We can describe the second category of patients as an “expert patient.” The expert patient is not only knowledgeable about his or her own experience living with the condition, but also knows about the experiences and issues affecting other patients with their condition.  This group of patients may share information with their peers, and engage in dialogue centered around their condition.

3) Patient Advocates

We can categorize the third group as a patient advocate.  This group of patients have looked beyond their disease area and are highly knowledgeable about issues affecting other patient communities.  The patient advocate is well-informed about the challenges facing patients at large including lack of health literacy, use of technology within healthcare, and patient engagement with difficult-to-reach patient communities.  Patients who engage with the healthcare industry to this degree may even have knowledge about policy making and clinical trial design--making them highly informed about the overall structure of the healthcare industry.

Do Patient Advocates Lose Credibility?

One of the potential issues facing patient advocates who are campaigning for policies to protect patients is becoming part of the healthcare industry.  It may seem, to an outsider’s perspective, that a patient advocate becomes so enmeshed with the industry that they lose their credibility as patients. Patient advocates assert that while this is a potential concern, it does not appear to be legitimate.  This is because patient advocates can provide unique insights to pharmaceutical companies regarding issues affecting the patient community.  The patient advocate can provide these companies with new information about issues affecting the patient—and not just the patient sharing their disease area.

Conclusion

Patient advocates play a crucial role in the pharmaceutical industry by offering companies their unique insights into patient engagement and relaying the issues affecting the patient community at large.  This group of patients is vital for companies to reach out to, particularly as they can offer suggestions about how to better reach out and engage with patients.

 

If you have any other questions about how to communicate with the FDA or how your past and/or current FDA communications affect you and your business goals, reach out to me on Twitter,

​How Is Technology Changing the Role of the Patient?

As patient engagement becomes increasingly important in healthcare, various communities have sprung up to encourage patient participation. Emerging technologies have facilitated these communities—allowing patient advocates from across the country to connect with one another and allow for a more global discussion of the patient’s role in healthcare. This discussion has led to many insights, including the idea that pharmaceutical companies can build patient centricity into their development process.

The Globalization of Patient Advocacy

The emergence of various social media platforms has allowed patient advocates to connect on a more global basis. There are many online communities organized around patient health in which patient advocates can share their experiences with one another. These communities often run various courses promoting patient centricity, including the European Patient Advocacy Group (ePAG) which offers members the opportunity to gain a patient advocacy qualification in research and development. Other organizations such as Patient Focused Medicines Development work across patient communities and investigate issues affecting drug development. The work these groups are undertaking is to put patient needs at the forefront of healthcare and empower patients to decide about their own health. These groups are becoming more organized because of emerging technologies, and patient advocacy efforts have only strengthened.

Emerging Technology and Patient Advocacy

New technology and social media platforms enable patient engagement. Because of social media, organizations can now reach a much larger base of patients to connect with. This allows patients and patient advocates to collaborate with one another and organize in a way that they could not previously. It is now possible to talk with patient advocates from across the globe to share information about new patient-centered initiatives. This kind of engagement with other patient advocates is valuable, particularly as it connects those within the pharmaceutical industry who are trying to facilitate change. With more conversation occurring between patient advocates, it may be easier to coordinate patient advocacy efforts.

How Do You Engage with Patients?

Pharmaceutical companies are now beginning to build patient engagement into the development process. In development, there are many ways for health organizations to ensure that patient needs are being met in various stages. For instance, companies can encourage patient participation in study designs and protocols. Patients can weigh in on these protocols to ensure that their needs are being adequately met. Companies can also develop research questions and outcome measures relevant to patients. This may mean that companies must determine which patient populations it should include in the study design and make study participation easier for patients.

Patient advocacy promises to change the patient-clinician relationship—emphasizing the importance of the patient’s needs in healthcare and engaging patients in shared decision making about their treatment plans. Companies should include patient engagement in their development process. To facilitate this, it may be helpful to consult with an

 

 

Has the Patient Become More Important in Healthcare?

Patient centricity may still be in its early stages, but it has the potential to change the role of the patient in healthcare.

 

Has the Patient Become More Important in Healthcare?

Patient centricity and patient engagement are terms often used by healthcare providers to signify that they personalize their treatments for patients, however, these terms can often be abstract and difficult to quantify. The distinctions between patient centricity and engagement are subtle, but they may allow those within healthcare to better understand how to support patients through every step of the healthcare journey. This new focus being placed on patients represents a shift away from traditional models of thinking about the patient—instead allowing patients to gain more autonomy and voice in their treatment.

Patient Centricity versus Patient Engagement

Although patient centricity and patient engagement are often used interchangeably, there is a notable difference between the two phrases. We can define patient centricity as putting the patient’s needs at the center, as opposed to the patient herself.

This differs from how people typically conceptualize patient centricity as putting the patient at the center. The patient’s needs highlights the importance of the stakeholders involved in the healthcare journey. To achieve this kind of centricity, you must first engage with patients. This is where the two terms depart from one another: We can define patient engagement as any time a healthcare provider engages with an individual with a health condition, whereas patient centricity focuses on the patient’s needs. A project which engages patients may not meet standards of patient centricity because it does not address the patient’s needs. This underlines the importance of being patient centric and considering the needs of the patients, rather than interacting with patients on a surface level.

Traditional Way of Thinking About Patients

The recent upsurge in patient centricity reflects a new way of thinking about patients. The traditional way of thinking about the patient was as a separate entity from the healthcare industry who was not involved. This way of viewing the patient neglects the patient’s perspective and shuts them out of having conversations with healthcare providers. The newer patient model changes this dynamic and allows the patient to become more involved in the healthcare process. Instead of being the sole source of expertise, the physician now becomes the interpreter of the information, and can coordinate the patient’s interaction with the rest of the healthcare delivery ecosystem.

The attempts that healthcare providers are making to include patients in conversations about their treatment plans represents a drastic shift in healthcare. As patients become a more integral part of the healthcare industry, there are more chances for them to voice their concerns. Patient centricity and patient engagement may still be in their early stages, however they have the potential to drastically alter the patient-sponsor relationship--allowing patients to become far more involved in healthcare.

If you have any other questions about how to communicate with the FDA or how your past and/or current FDA communications affect you and your business goals, reach out to me on Twitter, LinkedIn, or send me a message here.

I also host a podcast called

Pharmacogenomics: Post-Drug Development

Pharmacogenomics is the study of genes and how they impact drug response in certain individuals. This information allows physicians to customize treatment plans for their patients by taking into account a patient’s genetic unique background. The emerging technologies that have resulted from pharmacogenomics have changed the structure of drug development and FDA regulatory law. Pharmaceutical companies should stay informed about these changing regulations to ensure that their drug products can successfully stay on the market and meet new legal guidelines.

Will the FDA Use Pharmacogenomic Data?

As pharmacogenomics changes the drug development process, the FDA must adapt its approval process to reflect these changes. Pharmacogenomic testing allows companies to determine which patient populations will respond adversely to a drug and therefore avoid potential harm. This is valuable information for the FDA, particularly when protecting patient health. According to Kate Merton, Head of Commercial Development at Navigate BioPharma, the FDA will approve drugs based on the best data available to them, which includes pharmacogenomic testing. They may investigate whether companies have done studies into pharmacogenomics and if the right patient populations were being targeted. For example, if a pharmaceutical company targeted a population that should not be receiving a drug, the FDA may step in and enforce a black box warning. The FDA may issue a warning that highlights adverse drug reactions when patient safety is at risk. Pharmacogenomics allows the FDA to implement even better guidelines to protect patient safety and ensure that drugs do not harm patients.

How Will the Drug Approval Process Change?

As pharmacogenomics becomes more widely used, the FDA may require companies that have already gone through the approval process to re-examine their drugs. This may involve going back and performing more pharmacogenomic testing to ensure that they are targeting the correct patient populations. Companies may also have to undergo a “sifting process,” according to Ms. Merton, and examine retrospective data to identify drugs that may cause adverse reactions in patients. For potentially harmful drugs, it is helpful to go back and ensure that patients are not at risk for health problems such as cardiovascular events. To provide evidence that a drug is safe, companies should perform a pharmacogenomic test and show that patients at risk are not being exposed to the drug. This sifting process may end up saving companies money, particularly because pharmacogenomic tests prove far cheaper than running clinical studies. 

Weighing the Costs of Clinical Studies

Determining whether to run a clinical study is yet another consideration facing pharmaceutical companies. Companies should ideally perform pharmacogenomic testing to ensure that their drugs do not have the potential to harm patients. These tests would reveal the subset of patients who should not be taking the drug and potentially guard the company against class action lawsuits. If there is no testing, however, companies risk exposing themselves to lawsuits from patients harmed by their drugs. A lawyer representing a plaintiff may say that the drug contained a “design defect,” and that the company did not adequately protect patients taking its drug. If there is substantial evidence suggesting that a drug may harm a certain group of patients, pharmaceutical companies should conduct a clinical trial to ensure patients are being protected.