Each weekday, staff at the Exceptional Access Program (EAP) of the Ontario Ministry of Health and Long-Term Care receive between 250 and 300 requests for special prescription medications.

These prescription drugs—typically expensive medications that are felt to be cost effective only when used to treat selected patients with specific problems—are not on the province’s regular drug formulary.

It’s the job of the EAP staff at the Ministry of Health and Long-Term Care to determine that individual patients meet the relevant criteria before they approve public funding for the specific drug being requested.

Across the country, provincial governments have programs like the EAP for patients who need to take these specialized drugs.

The provincial programs are all a bit different—in terms of what drugs are covered and other details—which can be challenging for patients who move within the country and must navigate different systems, notes Durhane Wong-Rieger, president of both the Canadian Organization for Rare Disorders and the Institute for Optimizing Health Outcomes.

Criteria for funding and specialized forms are now posted online

But Wong-Rieger notes that provinces have made the application process simpler in the past five or six years, because they now provide much more information about the criteria that must be met in order for funding to be approved. In the past, the process of applying for specialized high cost drugs used to be “ad hoc and hit and miss,” she says.

For example, both Ontario and Alberta now provide detailed information online about the criteria that must be met and, for many drugs, they provide specific forms that must be completed.

Demand for these expensive drugs has been steadily increasing. Close to 65,000 requests were made in 2010 (and 42,506 were approved), according to the 2012 Ontario Public Drug Plan annual report, and by 2012, the total requests had increased to about 77,000, according to EAP staff.

Of course, only those eligible for publicly funded prescription drugs in Ontario can apply to the Exceptional Access Program. Others must rely on private health insurance plans or pay for their prescription drugs out of pocket.

About 850 different drugs are available under the Exceptional Access Program; in contrast, the province’s formulary lists approximately 3,800 drug products.

An example of a drug available under the Exceptional Access Program is filgrastim, which is sold under the brand name Neupogen. Filgrastim stimulates white blood cell growth to help fight infection and will be approved by EAP staff for patients with cancer who are being treated with specific chemotherapy regimens. It will also be approved for patients who have had a fever and a low white blood cell count during a previous round of chemotherapy.

About 25% of requests for filgrastim are rejected each year. But when request forms are filled out properly, the average time to approval is less than 5 days.

Some requests can be made by telephone, most by fax

While most EAP requests are sent by fax, some 40 EAP drugs—many needed urgently, such as medication to treat Clostridium difficile infections—can be requested over the telephone. Approval for these drugs is often provided instantaneously.

The EAP also posts the names of drugs that it will not fund, and explains the reasons.

“It would make both our lives easier” if physicians checked the information available on the EAP website, says Margaret Wong, the EAP’s operations manager.

While physicians and patients often complain about the EAP process—both because of delays in approving applications and because some drugs aren’t covered—restricting access makes sense from a health policy point of view if the drug is expensive, if its benefit is restricted to a subset of patients, or if the drug poses a substantial risk of harm.

At the EAP, drugs are sorted into four categories. The categories determine approval times, which range from a few days to weeks. For example, although the average turnaround time for a properly submitted request for filgastrim is 4.7 days, the turnaround time for sumatriptan, a drug used to treat migraine headaches, is 18.8 days.

Incomplete forms and the need for more vetting by experts can lead to delays

Longer delays in response time most commonly arise when request forms are incomplete, or when EAP staff determine that they need additional medical expertise to review the request. For these reasons, in 2010/11 it took on average more than a month from the time a physician initially submitted a request to the time a final decision is rendered.

At the end of this process, many requests are refused—38% in 2009.

Wong-Rieger says that from her conversations with physicians and patients, it appears that refusals are sometimes inconsistent—there may be no significant difference between the medical condition of a patient who has funding approved, compared to one for whom it is refused.

To that end, she says some medical specialists who frequently request drugs from Ontario’s EAP keep track of their applications and the outcome in order to build their own data base. That way, if a patient is refused, but whose condition is very similar to that of a patient who was approved for the drug, they can draw this to the attention of EAP staff.

While Ministry of Health and Long-Term Care staff handle EAP requests in Ontario, Alberta Blue Cross administers “special authorization” requests on a contract basis in Alberta.

Renewals and some requests handled at the pharmacy level in Alberta

In that province, “step based” requests—for example, a second line drug that cannot be prescribed until a patient tries a first line drug—are handled at the pharmacy by Alberta Blue Cross as their computers, linked to every pharmacy, have the prescribing history for every patient, notes Glenn Monteith, chief delivery officer for Alberta Health. (There are 97 medications listed through the step therapy route.)

Another 469 medications can be accessed through special authorization. Most requests are paper based, although the Alberta Blue Cross system allows for auto-renewals at the pharmacy level. Both Alberta and Ontario are aiming to facilitate electronic applications as more physicians incorporate prescription information into their electronic medical records.

Increasing numbers of specialized and expensive medications are approved by Health Canada and funded by provinces and territories, as well as private health insurers, so governments and, increasingly, private insurers are taking steps to ensure that the drugs are prescribed in a cost effective manner.

Challenge is to improve follow up and analysis of patient experience with drugs, Wong-Rieger says

While Wong-Rieger applauds the transparency about the criteria for applying for special, expensive drugs, she notes that patients’ subsequent experiences with the drugs is not monitored.

“There is no feedback or evaluation process… for example, patients may be given a six month supply of a drug, but quit taking it after a month. That they quit, and why they quit, is not tracked.”

She says a lot of time is spent putting in “gates” to ensure appropriate access to certain specialized and expensive drugs, but very little is done in the way of  follow up, of data collection, assessment or analysis about patient experiences with the drugs. “This is our challenge.”