Eliminate the EAP backlog and denials of coverage for patients already on biologics

Denying coverage of biologic medications for patients already on those medications is very harmful!

Thousands of Canadians are on biologic therapies (designer antibodies) for life-threatening diseases. These drugs are much more complicated molecules than most other medicines, and cost much more, generally $20,000-$50,000 per year per patient. Many patients on biologics do not have adequate insurance coverage through group plans to cover these costs, and the very fact of being on biologics excludes them from purchasing individual health plans. The Exceptional Access Program (EAP) is the entity in Ontario responsible for securing treatment for these patients, many of whom would be unable to work, function, or even live without these specialized treatments. Two thousand patients in Ontario relied on the EAP for the biologic Remicade alone in 2009 (see page 1495) and the current number of patients is even larger.

Unfortunately for these patients and their families, however, the EAP routinely delays and/or denies coverage to patients for whom it previously approved these medications. Patients who had been given approval to use biologics after all other medications had failed, and who are able to stay in good health on biologics for years at a time, often have their coverage cut off without warning. Sometimes this is due to a processing backlog (like the backlog of 10,000 applications in 2010), and sometimes it is for specious reasons. Much of the time, it is because patients’ situations change so that they no longer fit within the EAP’s guidelines for patients who merit biologic coverage — guidelines that are much more restrictive than the guidelines put out by medical societies (see this post for details). Patients must then either pay thousands of dollars out of pocket for each dose of life-saving medicine, or get publicity through newspapers and/or beg their MPs or the Ontario Ombudsman to bring their cases forward in order to get the treatments they need, or become seriously ill.

Appealing these denials of coverage takes months, may require the patient to endure months of illness at a reduced dose in order to prove eligibility (like I was forced to), and does not necessarily result in refunds. Delaying treatment with biologics can also cause patients to develop serum sickness, a serious immune reaction when re-exposed to a biologic after a long time, preventing those patients from ever being able to resume using the biologics they were on. Delays in the reapproval of coverage for biologics therefore put patient lives at risk and increase visits to physicians, hospitalizations and patient sick days, and causes undue emotional and financial hardship to disabled people’s families.

The EAP is currently disorganized and underfunded; in 2011 (!) it was still struggling to digitize its records of how many patients are on which medications [I obtained this information through a Freedom of Information Request]. Biologics accounted for almost 12% of drug expenditures in Canada in 2009-2010, and this value is also growing around 12% per year; considering how ill-equipped the EAP is to help the patients under its control stay healthy now, the picture in 2014 and beyond looks dire.

We need action NOW to reform the EAP so that patients in need of biologic treatment in order to stay healthy and active can receive their medicine in a consistent and timely manner — and stay in the workforce and out of the hospital!