Drug access navigators are a lifeline for cancer patients. But are they also a sign of a broken system?
When Glenn and Kathy heard that Glenn’s chemotherapy drug would cost $100,000 a year, they were astounded. “We said, ‘How would we ever afford that?’” recalls Kathy, an Owen Sound resident. They both had private insurance, but, even when combined, their plans covered drugs up to a max of $5,000 a year.
The oncologist had the couple make an appointment with Amy Pilon, a drug access navigator at Grey-Bruce Health Services. They were asked to bring in their insurance information and tax documents.
“She sat down with us and she explained everything to us and got us to sign some forms so that she could deal with directly with the [insurers],” Kathy says. “Without her, I’m sure there would be a lot of distress.”
While various private and public programs will pay for most cancer drugs, accessing these funds can be an incredibly bureaucratic process. With the growing number of new drugs on the market that haven’t yet been publicly approved for funding, and the growing trend of “personalized medicine,” patients have to provide more and more information to justify why they should get access to a drug, says Mary Lou Robertson, a former Ontario drug access navigator turned consultant.
Enter the drug access navigator—someone paid by the hospital who will “work like hell” to get patients the cancer medications they need, as Deb Maskens, co-chair of CanCertainty, an advocacy group for cancer patients, puts it.
There is no question that drug access navigators help patients immensely. They deal with multiple levels of approval processes and help patients reeling from a life-course-altering diagnosis fill out the complicated paperwork. Without them, patients might have their treatment delayed further, or they may not get the treatment at all. Some see drug access navigators as a Band-Aid for a broken and antiquated system of cancer drug funding. But others point out they’re a sign of the times, as the increasingly specific and expensive drugs on the market mean that, more and more, patients to have to prove their cases for funding on individual bases.
What is a drug access navigator and what do they do?
Hospitals have begun employing drug access navigators in response to patients’ demands for help accessing cancer drug funding. They’re not regulated, and there is no official training or certification process. Many have backgrounds as pharmacists, pharmacy technicians, social workers, or nurses. Almost unheard of a decade ago, there are now around 50 drug access navigators in Ontario; most cancer centres have one and large hospitals employ multiple navigators. There are more than 10 drug access navigators in B.C., two in Alberta and a few in Quebec and the Atlantic provinces, according to Alan Birch, the administrator of Oncology Drug Access Navigators of Ontario (ODANO), a growing and informal network for navigators.
Pilon, the drug access navigator in Owen Sound, has a business administration degree and had worked for years coordinating and booking surgeries before she was hired as the drug navigator. She is stationed on the oncology floor, so she has easy access to the oncologist to get information about the patient’s condition and to get help filling out the approval forms. And there are many forms.
Pilon often starts with asking patients how old they are. In Ontario, if they’re younger than 25 or older than 65, they’re eligible for access through the Ontario Drug Benefit Program. She’ll need to enrol them in that program, if they’re not already enrolled. And she’ll need to apply as well to the provincial government’s Exceptional Access Program (EAP). Because they’re so expensive, oral chemotherapy drugs aren’t automatically approved; patients have to show they meet the eligibility criteria.
If a patient is between 25 and 64, Pilon finds out if they have private insurance, because public funds can often only be used after private insurance has been maxed. In many cases, even when both the patient’s and the spouse’s insurance has been utilized, “there still isn’t enough coverage to even pay for the drug for one month,” says Pilon.
From there, Pilon often applies to the provincial government’s Trillium Drug Program, available for patients who spend three or more percent of their after-tax income on drug costs. As with the Ontario Drug Benefit Program, she’ll also need to file a separate EAP application.
In the meantime, Pilon might work with the pharmaceutical company to see if they can provide “bridging” cancer drugs to the patient. Companies will provide a short-term supply of drugs both as a compassionate move, so patients don’t have to wait for funding to start treatment, as well as a profit-motivated one, as companies want to make the sale, and they know an insurer will eventually start paying for the drug.
Pharma companies don’t simply hand over drugs, however. They require financial means tests. And many of the companies’ “patient support” or “patient assistance” programs, as they’re commonly known, have caps on how much they will give. In many cases, the caps have been reached, and a patient won’t get access to the program until another patient no longer needs the financial support from the company. “I may have to call the program every day, sometimes two or three times a day. You have to call at the exact moment the funding is available because it’s first come, first served,” explains Pilon.
To illustrate just how complicated patient cases can get, Pilon tells the story of an elderly patient, a 77-year-old person with multiple myeloma. She has been prescribed an IV chemotherapy drug that isn’t covered by the Ontario government because it hasn’t yet been assessed in the province for effectiveness and cost-effectiveness. But, says Pilon, the doctor thinks the drug is the best treatment chance she’s got. She has “really good” private insurance which will pay 80 percent of the cost of her $12,000-per-month IV drug, but that leaves her with a $2,400 bill every month. The pharmaceutical patient support program has agreed to pay the 20 percent, but is requiring her to use a private infusion clinic the company has partnered with, and the closest one is three hours away. Pilon now has to petition the company so she can get the infusion done at the local hospital. “We can’t start giving her the drug because she doesn’t drive, and anyway, she’s too sick to be on the road for six hours,” says Pilon. “She has the funding approval, and yet we’re having to delay her therapy.”
According to Birch, all drug access navigators are paid for by the hospital. Though a cost analysis hasn’t been done, Birch points out that navigators free up the time of doctors and nurses, who have traditionally tried to help patients access drugs.
Calls for formalizing the drug navigator role
Even in Ontario, which has the highest number of oncology drug access navigators, not every cancer patient is benefiting. The drug access navigators “are not getting everybody,” says Maskens. Her organization has heard from patients who left the hospital without ever being told about the navigator service, and had to try to figure out how they would pay for thousands of dollars a month for their drug.
The other issue is that “there’s no consistency” with drug access navigators, says Maskens. In a very small centre, the navigator may be a nurse or pharmacist who helps patient on the side. And some centres have better access to patient assistance programs due to partnerships between community pharmacies and the pharmaceutical companies.
According to Robertson, the former drug access navigator, the patchwork access is due to the fact that, in Canada’s health care system “it remains the patient’s individual responsibility to navigate through drug coverage in our system. Nothing is mandated to say there’s a government or hospital responsibility to do that.”
Robertson is working with the ODANO network on the development of training and standards for the profession, including policies on how navigators work with pharma companies’ patient assistance programs.
Why is it so difficult to access cancer drugs in Ontario and the Atlantic provinces?
In Canada, approved IV cancer therapies are paid for under the provincial health care system because they are a hospital-based treatment, covered by the Health Act. In Ontario, the IV chemotherapy is paid for by Cancer Care Ontario (CCO), which has been mandated by the Ministry of Health to prevent and treat cancer. There is an electronic ordering system that makes it simple for physicians to provide the clinical information to show the patient is eligible for the drug. Patients don’t have to wait for funding approval.
But the newer oral chemotherapy drugs are treated differently in many provinces, as they don’t have to be administered in the hospital and are taken at home. (Today, most new cancer therapies are oral drugs, rather than IV.) In Ontario, patients take their prescriptions to community pharmacies, and try to access funding for them through the patchwork of various public and private funders.
In other provinces, including B.C., Alberta, Manitoba and Saskatchewan, IV and oral chemotherapy drugs are funded under the same streamlined system. In B.C., whether the cancer drugs are taken by mouth or by IV, patients can “march down the hall” and pick up the drug at the hospital pharmacy, at no cost, Maskens explains.
In Ontario, it takes numerous forms and a long waiting period to get funding approval for an oral cancer drug. The 2015 Auditor General report found it takes an average of about one month for the Trillium program to approve funding, and about two weeks for the Exceptional Access Program. (These programs can be applied for simultaneously.) Cancer drug funding is only rejected by the EAP in five percent of cases, so patients are often waiting for the go-ahead for medications that everyone knows will be greenlit.
When it comes to cancer treatment, delays of days or weeks can affect survival. And delays for drugs to treat life-threatening side effects of chemotherapy can also be deadly.
It would be expensive for the government of Ontario to fund oral chemotherapy drugs without having patients first exhaust their private insurance and prove financial need. A cost analysis commissioned by CanCertainty found it would require a $42-million investment each year in Ontario. But the province would save much of the money it’s spending to have community pharmacists dispense oral chemotherapy drugs, which in 2015, was estimated at $26 million.
Bringing both oral and IV chemotherapy under the cancer drug funding system—something that the CanCertainty coalition has been demanding for years—would drastically reduce the need for drug access navigators in Ontario and the Atlantic provinces. That’s because oncologists could order oral chemotherapy drugs electronically, uploading the patient’s health information, and the system would provide funding approval immediately. As Maskens explains, “If they put in a drug for Mrs. Jones and she’s not eligible, it comes right up on the screen.” With the Exceptional Access Program, in contrast, the navigator fills out forms manually and faxes them. The Auditor General report found 20 percent of applications are sent back with requests for further information.
The future of drug access navigators
Even if Ontario merged the funding for oral and IV chemotherapy, some think the need for drug access navigators will continue to grow. Indeed, B.C., which has the ideal cancer drug funding system, according to Birch, still has about a dozen drug access navigators, mostly to help with cancer drugs that aren’t on the government’s approved list.
They have to show they meet the criteria to access a certain drug, and that the lower-cost alternative drugs will not be sufficient. “In multiple sclerosis, in Crohn’s disease, in cancer, in HIV, drugs have become so specialized, you can’t just say ‘Oh they have lung cancer, check the box they can get the drug,’” says Robertson. “The person has to pass a number of conditions, because the drug has been designed for a certain type of lung cancer, and for a certain type of mutation.”
Birch points out that drug access navigators are being looked at beyond just cancer. “I’ve talked to patient groups who said we could totally use this in mental health, in rare disease, in cystic fibrosis,” he says. He spoke to health providers at the Centre for Addiction and Mental Health in Toronto about how psychiatric patients will get admitted to the hospital and discharged with a week’s worth of medication. And then they’ll be back a week later in crisis, because “no one was holding their hand to make sure they’re put on to the proper government program to get access to the drug.”
Steve Morgan, a health services and policy professor at the University of British Columbia, worries, however about the larger trend of extremely expensive drugs—which necessitate special funding approvals. In his view, pharmaceutical companies are charging hundreds of thousands for a drug a year “because they can,” he says. He thinks public payers need to work together, on a global basis, to push pharmaceutical companies to price drugs fairly.
CanCertainty will continue to press the Ontario’s new Conservative government to bring oral and IV cancer drug funding under Cancer Care Ontario. Until that happens, says Maskens, the province’s oncology drug access navigators will be struggling to send off forms to multiple private and public insurance programs, while also appealing to pharmaceutical companies for compassionate access in the meantime.
“I have the utmost respect for the [drug access navigators] who are working with patients who are in crisis. I can’t imagine doing that job. They’re working in the coal face, patching holes, filling cracks. But the mine is crumbling all around them,” says Maskens.