A Hard Pill to Swallow - Pharmaceutical Executive


A Hard Pill to Swallow

Pharmaceutical Executive

Entering the Success Zone

The hardest drugs to keep patients compliant on are those for diseases (or conditions) with symptoms that are largely unapparent. These include statins and other cardiovascular drugs; patients can't feel the drug working—they just don't have a heart attack.

To help patients better understand how their medication is working, Novartis established patient adherence and education program called the BP Success Zone (BPSZ). The program helps patients monitor their blood pressure and track their improvement online, while providing educational information, diet plans, and exercise programs to help patients enhance their overall health.

Patients placed on one of Novartis' of hypertension treatments are encouraged by their physician to sign up for BPSZ. When they join, they receive a membership card with a coupon for $10 off their next prescription. In addition, members can purchase a blood pressure monitoring system to track their progress at home. Novartis provides each patient $40 to help cover the cost of the unit.

"Literature has shown that monitoring helps improve patient adherence over time," says Sherry Pudloski, executive director, strategic planning, Novartis. "Taking a medication is very much like losing weight. It's something everyone knows they should do, but there are all kinds of barriers—psychological, physical, and behavioral—to losing weight. It's the same with medication adherence.

To date, most prescription adherence programs have focused on giving reminders to patients. Pudloski explains that many people who forget to take their medication are actually committed to taking their treatment. "They're just human," she says. "To err is human, but to adhere is divine. What we do with the BP Success Zone is get to some of the beliefs and knowledge areas of the 25 percent of patients who don't even fill their prescription in the first place. We need to convince them that it's worth filling. It's time to get past reminders and address the cognitive issues around drug adherence."

"[BP Success Zone] has been a very good program as a DTC marketing effort, but it's also had a significant impact on adherence," says Rob Nauman, principal, BioPharma Advisors. "The content in that program makes patients come back and interact with it. And the patients who participate in the program are more adherent to their antihypertensive therapy than the patients who don't."

A big part of the program's success lies in finding messages that resonate with patients, and framing hypertension within a relevant conscious framework. The educational material focuses less on what will happen down the line, and focuses instead on what patients can do to improve their health today.

"The key is ongoing engagement—patients have [hypertension] for life," Pudloski explains. "That's what the tracking, diet plans, and personalization are all about."

Novartis won't give particulars about return on investment beyond that the program currently has half a million patients enrolled. The next step is to install a goal and possibly a rewards system to the BP Success Zone. Right now the "goal" is defined as the specific blood pressure level the patient needs to reach, but Novartis wants to make the reward more tangible.

Peer to Peer

Talecris, a manufacturer with products derived from human plasma proteins, speculated that peer-to-peer education might work best for its patients—and its Apha-1 Antitrypsin (ATT) Deficiency Health Management Program put that proposition to the test. Big Pharma companies might not be able to have one patient call hundreds of other patients every month to see how they are doing, but for smaller, specialty companies this might be a practical solution.

Talecris' main product is purified Alpha-1 protein that patients infuse on a weekly basis, for life, to provide a protective level of Alpha-1 Antitrypsin they don't get naturally because of genetic deficiency. (Alpha-1 Antitrypsin Deficiency is a genetic disease and the leading cause of chronic obstructive pulmonary disease.) For half an hour each week, the patient is hooked up to an IV and infused with plasma.

"While not the longest infusion in the world, it can be burdensome," explains Charlie Gayer, director, Pulmonary, US Product Management, Talecris. "Getting the protein doesn't cure the disease, it just prevents progression of the disease."

Talecris provides the product through a single specialty pharmacy that handles enrollment, works with insurance companies, and provides home nursing. The company also provides a comprehensive health management program designed specifically for patients with Alpha-1 deficiency. AlphaNet, founded by the Alpha-1 Foundation, handles the health management of the program, including a comprehensive education component and a patient advisor. With about 5,000 people currently on therapy nationwide, Talecris has two-thirds of the market cornered, so the ability to manage an adherence program is far easier than a drug with a hundreds of thousands of users.

"All the patients that are referred for a Prolastin prescription get enrolled in this program," Gayer says. "But 99 percent of them choose to participate. If you exclude uncontrollable attrition, such as death and people getting lung transplants, we keep 96 percent of our patients on therapy, year over year. Those patients take greater than 95 percent of their prescribed dosage."

Gayer acknowledges that one of the reasons why Prolastin users stay on their treatment is because of the threat level the disease poses—ATT deficiency can lead to liver disease, cirrhosis, and liver cancer But he's quick to counter that just a few years back the compliance level on one HIV treatment he worked with (for another company) was only 70 percent.

"Everything about our program is a little bit different," says Gayer. "I think our model works because it's 'high touch'—there's a lot of personal contact. This isn't an e-mail reminder program. Patients are getting information from peer educators who have the disease. These are people who lived the first half of their lives normally, and then started having severe respiratory problems. They now have a career helping others understand and manage these life changes."

There's also an obvious cost issue. Therapy for Prolastin costs $80,000 to $100,000 a year, so all stakeholders involved are keen to make sure patients follow through on treatment.

Beyond the Usual Outreach

AstraZeneca Canada is going a step beyond reminder ads, reaching out directly to patients to educate them about their disease state and encourage them to stay on their medications. The program, Harmony Health, provides patients with targeted information at every point in their treatment.

The innovative part of the Harmony Health program is that AZ is working directly with pharmacies through RxCanada. Having a pharmacist ask patients directly if they would like to participate in the program makes patients more likely to sign up. "RxCanada allows us to identify patients who are currently taking the medication, and send the newsletters directly to them," says Alana Pentney, marketing manager, patients, AstraZeneca. "So we're enrolling patients who volunteer to be part of the program, but we're also involving patients who may not have proactively signed up."

All newsletters are sent through traditional mail, and patients get different material depending on how far along in the treatment they are.

"We're creating programs for all of our products because the adherence rate—even for breast cancer drugs—is not optimal," says Jeff Sleep, senior marketing manager, patients, allied health, AstraZeneca. "In deciding whether or not to create a program for a product, the determining factor really is the current usage of the product as opposed to what should it be. "

For example, AZ determined that some patients weren't taking its cancer therapy Arimidex as it was prescribed by physicians. This created an opportunity to launch a program that would reach patients at times when they are most likely to discontinue usage. Sleep says that since direct-to-consumer advertising is forbidden in Canada, it would be easier to create a US version of the program; however, to date AZ has not conceived a US counterpart.

"Because we're doing the program through our supplier, we are able to see specifically whether or not our patients have been taking their medication regularly," Pentney says. "With the Arimidex program, data shows that on average patients enrolled take an additional 28 days of therapy versus the control group over a six month period."

"The biggest challenge is understanding the psychology of the patient," Sleep says. "What we're really trying to do is change behavior. You need to get down to what is making patients not want to take their medication. The next step will be to figure out what are the drivers of non-adherence, so that we can deliver an even more compelling message in the mailings."

Asking the Right Questions

Rather than continue to sink money into adherence programs that might or might not work, Merck established a socio-psychological analysis of patients to help doctors ask better questions about adherence. The Adherence Estimator offers a brief, proximal screener for patient propensity to adhere to prescription medications for chronic disease

"We know that patients are asked about their medication-taking behavior. But no matter who asks them, they always say they are more adherent than they really are," explains Colleen McHorney. "So instead of asking them directly about medication taking, we decided to get at it indirectly by asking questions about the beliefs and barriers and facilitators that are most proximal to medication taking."

Indirect questions answered with level of agreement include: "I worry that my prescription medication will do more harm than good to me"; "I am convinced of the importance of my medication"; and "I feel financially burdened by my out-of-pocket expenses for my prescription medication."

Merck conducted two years of research to identify what the most proximal drivers were. What they discovered was not unusual: Patients are concerned about side effects, the need for the medication, and the cost of the treatment. The company then scanned the literature to see what the most effective approach to adherence is.

"The fact is there's a lot of mixed data out there, and there is no clear guidance from clinical literature," says Jeff Simmons, strategist, customer solutions group, Merck.

"A fair amount of past research has been incomplete because it focuses on a single issue and does not gather information on other competing drivers and facilitators that might make the investigators first idea evaporate," McHorney says.

That research led to the creation of the Adherence Estimator, a segmentation survey that can be used with multiple patient types. The purpose of the survey is to help doctors determine the fundamental reason why a patient does not take their treatment. After the survey is completed, the physician can tally up the answers and compare them to a point system to determine the patient's risk for non-adherence.

In clinical trials, Merck's Adherence Estimator was found to be 86 percent accurate in identifying potential non-adherent patients. According to a report from the study, even false positives are a good thing, because additional communication through educational material or physician contact is not going to harm the patient.

"This allows the healthcare provider to focus their conversation specifically on issues that the patient has reported," Simmons says. "One thing that we learned is that patients can have different adherence patterns to different medications. Specifically, their beliefs about a certain medication could predict their adherence to each medication."

The surveys and directions are being distributed to healthcare providers and pharmacists who have expressed interest in improving adherence for chronic-disease medication. The company has plans to expand the program in the future.

While none of these tools or programs are a silver bullet for pharma's adherence bęte noire, they show that industry is hunting for a solution. Whether these measures can help patients and at the same time recoup billions in lost scrips remains to be seen.

"Adherence programs are a long-term investment that requires more of a customer-centric viewpoint," Nauman says. "[Pharma] must get relevant medical information to the patient at the time they're looking for it to really hit the home run and create the desired behavior change."


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