Patient Assistance Programs Taking Some of the Burden Off Oncology Nurses, PhysiciansMarch 4, 2009
Web posted by Rosemary Frei
Oncology Nursing News
March 04 2009
Cancer-drug manufacturers help patients and nurses untangle cost, reimbursement, and side-effect management issues
The development and marketing of popular but very expensive cancer medications such as bevacizumab (Avastin, Genentech) and imatinib (Gleevec, Novartis) has led to an increased need for assistance programs for patients who are prescribed these drugs. This is because many patients are ill-equipped to find the money for the multithousand-dollar monthly price tags of some of the agents.
The programs are free of charge and help patients in a variety of ways. Most include assistance in maximizing reimbursement from insurance companies, and many also refer patients to foundations that provide a portion of the copays that insurance companies will not cover or to the overall cost if coverage is denied. Some differences exist among programs, including the maximum income level required for eligibility. Each is similar, however, in the rationale for its creation and the features it offers patients in need.
Bayer Programs Relieve Some of the Time Squeeze for Nurses, Other Clinicians
Take, for example, the REACH (Resources for Expert Assistance and Care Helpline) and NexConnect programs jointly from Bayer HealthCare Pharmaceuticals and Onyx Pharmaceuticals. (See sidebars for details on these and other programs.) REACH was created in December 2005 and NexConnect in June 2007 for patients prescribed sorafenib (Nexavar) tablets for unresectable hepatocellular carcinoma or advanced renal cell carcinoma. Sorafenib was introduced in December 2005.
Patients, nurses, or physicians can register patients in the NexConnect program any time after the patient has been prescribed sorafenib. Patients can also enroll by calling a toll-free number, mailing in a registration card, or filling out a form online. The program was created because sorafenib is an oral medication that the patient takes at home, rather than an intravenous medication that is administered in a clinic.
Approximately 600 patients are enrolled in NexConnect each month, comprising 70% to 80% of all patients who are on sorafenib. Within 3 days of enrolling, patients receive a call from an oncology nurse and a “welcome kit” in the mail. The kit contains samples of skin cream, a pill-box, and patient education materials. Within another 4 days they get a patient care package that includes, among other items, a brochure that describes all the adverse events that can occur with sorafenib and how to mitigate their effects. Two more packages arrive within the next 3 weeks. Additional calls from nurses to the patients are made throughout the first 30 days. Patients can also call the toll-free number to speak to a NexConnect nurse at any time.
This is all designed to “set expectations for the first 30 days on Nexavar,” explains James E. Christie, associate director of US Marketing, Oncology, for Bayer HealthCare Pharmaceuticals, Wayne, NJ, “because adverse events with Nexavar generally start between the second and fourth weeks. And our studies, and some of the data within NexConnect, show that if you get patients past those first 30 to 45 days, the adverse events begin to lessen, and the patient is much more likely to stay on therapy and achieve the full benefits of Nexavar, potentially.”
“It is a positive program for patients who use it,” affirms Cyndy Simonson, MS, CRNP, AOCN, an adult nurse practitioner at Duke University Medical Center, Durham, NC, who works with physicians specializing in the treatment of hepatocellular carcinoma. “I think the NexConnect nurses [who staff the program] have a great deal of experience with oncology and the medication. And I think the patients who have used it have found it valuable. But it doesn't relieve any kind of patient management burden from me. Because I follow my patients, I want to hear about every side effect, want to let them know how to manage those side effects, et cetera.” Ms Simonson says, however, that the other Bayer/Onyx patient assistance program, REACH, which is focused on helping patients who cannot afford their medication, does save her a significant amount of time and hassle when ordering and refilling medication.
Patients, their caregivers, or members of their healthcare team who contact REACH can receive free medication from Bayer/Onyx if the patient does not have health insurance and meets Bayer's eligibility criteria; have their questions answered regarding insurance coverage, including the Medicare Part D drug benefit; receive assistance with contacting the patient's insurance company about covering sorafenib; and get help in identifying, and applying to third-party foundations for payment for Nexavar if the patient is denied coverage by the insurance company.
The staff of REACH provide benefit verifications, prior authorizations, denial and appeals strategies, and medical necessity support; research alternative coverage options for patients such as the National Organization for Rare Diseases, the Patient Advocate Foundation, and the Patient Access Network Foundation; and offer information on and assistance with applying for the Social Security low-income subsidy.
“It's tremendously helpful,” says Ms Simonson. “I would never be able to track through the financial piece of it for the patients the way REACH does. I wouldn't have as many people able to take the drug, because in this day and age you simply don't have the time to track down all the funding sources for each patient.”
The other part of the REACH program is getting the drug to the patients.
“After verifying insurance coverage [or that the patient is eligible for free medication], the REACH program counselor will send the patient's prescription to a specialty pharmacy provider,” explains Fanny Martinez-Schultz, reimbursement manager at Bayer. “The provider will fill the patient's prescription and arrange for delivery of Nexavar. Then, before each refill is due, the patient will receive a call to arrange the next delivery.”
Programs Available for Patients on Every Expensive Cancer Medication
You name the drug, there's a program to go with it. Genetech's program, Access Solutions, is for users of bevacizumab, erlotinib, and 2 other agents. Like REACH and the other patient assistance programs, this is a 1-stop shop for assistance with reimbursement challenges. The program was actually created well before bevacizumab came on the scene, beginning in 1985 after the approval of the growth hormone product Protropin (somatrem).
Patients can enroll in Access Solutions, or their healthcare providers can do so on their behalf. Access Solutions staff conduct benefit investigations, obtain prior authorizations when necessary, help with appeals when prior authorization or reimbursement is denied, refer patients to independent, nonprofit organizations for copay assistance, and refer uninsured and under-insured individuals to the Genentech Access to Care Foundation to determine if they are eligible to receive free medication.
“We have 350 people in Access Solutions,” notes the program's vice president, Alexander Hardy. “I think that speaks to how central the program is to Genentech. As of the end of 2008 we've given away approximately $1.3 billion in free medication since 1985. And in terms of donations we've made to third-party foundations that provide copay assistance, we've donated approximately $250 million since the end of 2005.”
When asked specifically about whether fewer physicians have been enrolling patients in Access Solutions since the November 2008 federal government policy change that makes it more likely that off-label indications for cancer medications will be approved—such as bevacizumab for ovarian, brain and kidney cancers—Genentech's Senior manager of public affairs, Edward Lang, Jr, says no.
“As compendia change and coverage improves for different tumor types, we do see a change in the requests in those specific tumors—however, from a macro level, with the worsening US economy, rising unemployment and the loss of value in retirement plans, we are seeing an overall increase in the number of patients who are working with Access Solutions,” he notes.
One program that perhaps stands out somewhat from the others is Novartis's Patient Assistance Now. It was created in 2000 and includes approximately 6000 users enrolled, imatinib users as well as several thousand people taking other Novartis cancer products.
Based on an explanation of Patient Assistance Now's offerings by Julie Jones, a client service supervisor for the program, there appears to be more assistance available from this initiative than from most others. The reason for this is not readily apparent, but likely has to do with previous patient pressure.
Ms Jones noted, for example, that patients are eligible to receive free imatinib if they earn less than 500% of the federal poverty level—a generous level matched only by the sanofi-aventis PACT+ (Providing Access to Cancer Therapy) and the Genentech Access Solutions programs. Program staff also help patients apply for the federal government's low-income subsidy. In addition, if a patient is unhappy with his or her current plan for Part D benefits, the Access Solutions staff will look for alternative plans.
They also help individuals who are about to hit the Part D ‘donut hole.'
“If the patient can't afford the copay even before they hit the donut hole, we put them on a 90-day gratis supply of Gleevec,” clarifies Ms Jones. “We then ask [these patients] for a list of all the drugs that they're on, and we verify that they, indeed, do not have the income to pay for them. They are then allowed to stay on the free-medication program until they are through the donut hole.”
Bottom Line: Programs Help Nurses, Patients
Each of the programs has strengths and weaknesses, but the high percentages of enrollees attests to their overall positive impact on patient care and satisfaction. And oncology nurses provide an invaluable bridge between patients and pharmaceutical and insurance companies, by talking to patients about the adverse events and costs associated with cancer treatments, and enrolling patients in assistance programs when appropriate.
“Sometimes patients who have financial difficulties have enormous difficulty talking about these issues,” notes Mr. Hardy of Genentech's Access Solutions. “And there's a great deal of trust between the patients and the oncology nurses. The oncology nurses supply valuable information to patients on the assistance programs. Everybody in the physicians' offices wants to ensure that the patients get the best possible treatment. And we're here to support them in that process, by trying to deal with the reimbursement/ financial issues as best we can.”