Designing adherence programs: Local is better than global
Kenneth Youngstein, CEO of Biocom, on the regulatory, strategic, and tactical challenges of cross-border compliance programs.
By on Aug 23, 2010Kenneth Youngstein, CEO of Biocom, on the regulatory, strategic, and tactical challenges of cross-border compliance programs.
Non-adherence of patients to medication regimes continues to baffle pharmaceutical companies.
In the 2008 study Disease Management and Drug Adherence: Strategies To Support Patients and Enhance Treatment Persistence, DataMonitor noted that adherence typically drops by 50% after six months of treatment.
Compliance rates are extremely variable in chronic diseases, even for life-threatening conditions.
Non-adherence costs pharmaceutical companies some $25 billion per year worldwide, while patients pay for non-adherence with illness, death, and lost productivity.
The cost to insurers for events related to non-adherence is as high as $100 billion a year.
And growing populations of chronically ill and elderly patients will only make the situation worse.
But companies fond of global or regional marketing campaigns quickly learn that compliance programs must be designed at the local level.
You can drive the first prescription through multi-national or global campaigns, says Kenneth Youngstein, CEO of Zurich-based Biocom, which designs international drug adherence programs.
But there is no such thing as a global compliance program.
Is non-compliance really irrational?
Side effects are a major driver of non-compliance, followed by a perception that the drug is no longer needed or isnt working.
Experts view such attitudes as irrational, but Youngstein believes they contain a grain of truth.
One can debate whether non-compliance really is irrational for some, he says. Drug dosing tends to be arbitrary, and assumes that one dose fits all patients.
Skipping doses or stopping entirely may, for some, be a legitimate way to avoid dangerous side effects.
Since physicians are generally ambivalent about titrating doses individually, they tend simply to prescribe another drug.
Youngstein also doubts the mantra that non-adherence is costly to insurers.
Most chronic diseases worsen despite strict adherence.
End-stage disease is rarely completely prevented, even in patients who take their medicine strictly.
And in the United States, which lacks a single-payer system, the question of which insurer pays depends on who insures the patient at what stage of the disease.
Depending on where you are in the disease, it may be either more or less expensive for the insurer, Youngstein says.
Its very hard to tell if the compliance models were working under, and the concepts behind them, are really true.
Flexible from the outset
A company can design a perfectly effective core adherence program that works out of the box in its home country, but chances are the program will require significant adaptation to be of value somewhere else.
The most significant barriers reside within the local affiliates, which may lack the staff or money first to adapt the program to their markets and then to execute it, Youngstein observes.
These projects do not run themselves. Although the mother company paid for the development, local adaptation is nevertheless expensive.
Youngstein: You cant just translate it and send it out.
Differences in national health systemsinterrelationships among stakeholders and how they are reimbursed, the roles of physicians and pharmacies, cultural differences, and patient marketing regulationsare additional barriers.
Cultural and demographic differences come into play particularly when adherence programs go high-tech, with computer pop-up or email reminders or text messages, for example.
Older patients tend to be less Internet-savvy and, at least in the US, use text messaging infrequently, so adherence programs based on those technologies would probably not work in that age group.
So programs intended to cross borders must incorporate flexibility from the outset.
Such programs must be database-driven, be capable of utilizing translation and adaptation tools, and support Unicode for easy porting into non-Roman alphabets, according to Youngstein.
Biocoms programs utilize content generators and translation generators, which facilitate adoption in multiple countries and languages through a single platform.
Strengthen the patient-physician relationship
Regulations differ among countries, particularly in how drug companies may communicate with consumers.
One work-around is to operate through third-party organizations, such as patient groups, professional societies, or hospitals.
These have much greater leeway than companies in how they may interact with patients, Youngstein says.
Disease-specific versus drug-specific information programs is another issue.
The more non-branded you are, the more you can say, explains Yongstein.
But then marketing people will ask, legitimately, why they should undertake a disease awareness campaign that benefits their competitors.
One strategy to avoid, according to Youngstein, is implementing plans that cut doctors out of the loop.
Its an outrageous concept, bordering on arrogance, that you can bypass the doctor and improve compliance, he says.
Patients experiencing events contributing to non-adherence call or visit their doctors, Youngstein argues, not a drug company hotline.
Since the physician ultimately directs the course of therapy, the best adherence programs are therefore ones that provide tools that strengthen, rather than weaken, the patient-physician relationship.
For more on patient groups, see How patient advocacy groups can boost patient compliance.
For more on pharmacies and adherence, see The pharmacist as an ally in patient adherence and How pharmacists can help improve patient compliance.