Patient assistance programs keep growing and changing to meet demand

The rise of a complex and lucrative specialty drug market in the U.S. has created not only new opportunities for drugmakers, but also new challenges. With a significant portion of care shifting from in-patient to out-patient settings and insurers tightening the reins on specialty drug coverage, drugmakers have turned to patient assistance programs (PAPs) to help them succeed.

Moving from simple administration of copay assistance and other programs to deeper involvement in almost every chapter of a patient's time on therapy, industry service providers have taken on new weight in drugmakers' quests for success.

Companies such as Amerisourcebergen Corp.'s Lash Group, Cardinal Health Inc.'s Sonexus and Trialcard Inc. are leading the charge on benefit investigations, copay assistance, side effect management and even how to keep up with critical therapies during disasters such as hurricanes and tornadoes. Patients come into contact with the service providers, often without knowing they've reached a third party rather than a drugmaker itself, after dialing 800 numbers on copay cards, following advice from their doctors about support services tied to a course of therapy, advice from patient advocacy groups and via other channels, such as web search.

Honora Gabriel, vice president of not-for-profit operations at Lash Group, has watched the industry develop for more than 15 years, starting on the front lines as a patient case coordinator and eventually moving into management. Over time, she moved into commercial operations, dealing with reimbursement support programs, intended to help insured patients understand their coverage and gain access to drugs sold by Lash's clients. Looking for a challenge, about three years ago, she took the opportunity to shift her focus to Lash's work with nonprofit patient assistance foundations – programs that generally provide free medication to qualifying patients – and independent copay charities, groups that focus on copay assistance grants to "underinsured" patients, those who have insurance but still shoulder high drug costs and need assistance with affording their drug copays.

The patient assistance programs Lash runs are generally manufacturer-titled programs. Pharma companies make donations of chosen drugs to foundations that are then provided to qualifying patients. As a program administrator, Lash basically adopts the identity of the drugmaker, right down to answering the phone in its name.

Copay foundations, such as Good Days from CDF, on the other hand, are charities that operate independently of manufacturers under regulations set out by the Department of Health and Human Services' Office of Inspector General (OIG). Pharmaceutical companies make donations to the programs, but they aren't supposed to have any influence over which drugs are supported or how the foundation's funding is allocated. When the OIG suspects programs might run afoul of anti-kickback statutes or other rules, it makes recommendations regarding how to bring the programs into compliance.

A third important type of assistance comes from manufacturer-sponsored copay programs, which can only help private commercially insured patients, such as those with employer-sponsored insurance plans. There can be no Medicare or Medicaid insured patients enrolled in them.

The eligibility criteria for the three types of programs has remained pretty consistent over time, mostly focusing on some type of financial qualification (usually earning a certain percentage of the Federal Poverty Level) and whether or not a patient has insurance. Other qualifiers can include whether or not a patient is a U.S. resident and a patient's age.

CHANGE AFOOT

Prior to 2006, Gabriel told BioWorld Today, a lot of the focus in the industry was on helping uninsured and qualifying patients access therapies. What changed is that in January of that year, as part of the Medicare Modernization Act, Medicare began to implement its Part D prescription drug benefit for Medicare-eligible patients. Prior to 2006, Medicare patients didn't necessarily have prescription drug coverage if they didn't purchase supplementary coverage. Afterward, they did, but with the flaw of the now well-known "donut hole" leaving them paying out of pocket for coverage between the time they surpass their maximum coverage and have not yet hit their catastrophic care benefits. It's at that point that independent copay charities began to grow in number, because unlike patient-assistance programs, copay charities can help Medicare patients with their copay requirements.

Another big shift Gabriel has seen is movement from "a disease-centric approach where we're very much focused on the type of disease to a more patient-centric approach." she said. Lash's approach to patient-centric care is called "Thumbprint." Using predictive analysis and condition-related health risk information, it helps Lash "empower patients to really be an active participant in their own care," said Gabriel.

It has three main components: First is "Mycommitment," a program that uses patient-directed communication, education and outreach to convince patients to participate in and engage with their treatment. Benefits pitched to drugmakers for the program include real-time collection of patient insights on the impact of initial therapy starts, increases in the number of initial therapy starts, increases in length of therapy and increases in refill rates.

Second is "Mytransitions," a program focused on ensuring continuity of treatment, despite transitions in care. Some of the goals of the program include giving Lash's clients better insight into patients' health outcomes, reducing hospital readmissions and other in-patient charges and reducing the time from which a therapy is prescribed to when it is filled.

Last, with "Myconnection," Lash works to avoid patients dropping off therapy with targeted outreach campaigns that anticipate patients' needs related to their disease progression or the onset of side effects.

"When patients are adherent, on their treatment, and following their treatment plan they're going to experience improved outcomes and that is going to help reduce overall health care costs," said Gabriel.

NEW DRUGS, NEW TREATMENT SETTINGS

Jan Nielsen, vice president for Access & Patient Support, Sonexus at Cardinal Health, has also seen significant shifts in the type of services offered to assist patients. "Ten years ago, chemotherapy was an induction within a hospital setting. Now, with the oral oncolytics, you're sitting in your own home," she toldBioWorld Today. That shift in setting has created a need for services such as weekly transportation to labs for blood draws when patients are too sick to drive or don't have a spouse who can take them because they're working.

Service providers like Sonexus have also become better at ensuring that everyone involved in a patient assistance program, including client drugmakers, physicians and patients, are all aware of what services are provided as treatment progresses, both to prevent unintended confusion and fraud. New changes are also afoot in helping patients secure and understand the outcomes of genetic testing where appropriate, she said. "As drugs become more sophisticated, are targeted at different intervals, and our life expands under the treatments, you're going to see changes occurring."

Nielsen is also seeing changes in the way manufacturers are supplying drugs to patients in need. In response to OIG concerns that some manufacturers might use PAPs to subsidize the purchase of their own products or improperly steer patient selection of drugs, some have simply decided to forgo involvement with patient assistance foundations altogether, instead choosing to give free medicines directly to patients through nonprofit pharmacies to better control which patients they reach and to avoid potential pitfalls associated with foundations misspending funds on costs and fees.

AN EXPANDING BUSINESS

Growing opportunities in the market access space have also led its various players to extend their businesses. For instance, in September Morrisville, N.C.-based Trialcard, which originally built its business primarily around copay programs, launched a new division called TC Market Access, of which Scott Dulitz will be vice president. During the better part of the last 18 years, Dulitz has seen new technologies transform the pharmaceutical services industry. Core services such as benefit investigations and prior authorization assistance have gone from being handled largely by call center associates working the phones to reach pharmacy benefit managers and payers to understand a patient's benefits for any given product to a process more reliant on online tools.

"During the last few years, we've started to see technology be able to expedite the ability to pull though that kind of information, with electronic benefit verifications and electronic prior authorization," Dulitz toldBioWorld Today. "It has really brought a lot of these services into the 21st century."

That said, there remains a lot of room for improvement. While the adoption of technology has helped streamline processes in the PAP field, interoperability issues between computer systems remains a barrier. "The next evolution will be to embed some of these processes inside of provider workflows in such a way that they don't have to leave that workflow to log into a manufacturer's brand-level portal to initiate some of these services, but instead to initiate them right within the EMR workflow," said Dulitz. "You've started to see some progress here in the marketplace, but there is still a ways to go before a new standard will emerge."

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