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.”
The comments section is closed.
Canada is a great country to live in,but not when it comes to healthcare where the government would rather let people die than to give them access to drugs that can give them a better quality of life and extend their life expectancy .The drugs I’m referring to are the drugs for the treatment of pulmonary fibrosis .
Could you please tell me how I can gain access to the drug, Neupogen. My husband is undergoing chemotherapy treatment at London Regional Cancer Care. Because his cancer is considered non curative, he does not qualify for this drug. Further more if he becomes neutropenic , he will be dose reduced with his next treatment. It’s like being kicked once for being non curative and then again when you become sick with the treatment. IT IS MORALLY WRONG TO WITHHOLD THIS DRUG!
I’m sure that the cost to treat a patient with neutropenia in hospital far outweighs the cost of preventing hospital admission as well as giving the patient better quality of life with each cancer treatment
If you are independent of government, I would love to tell you our occuring story. What I have found is a very secretive health ministr, actually I have recently opened a “Pandora’s Box”. We have been trying to access a drug for my mother and have been denied. She wii die without this medication. I have found out that there are very unfavourable and what I consider unethical and conflict of interest connections to these processes.
Durhane Wong-Rieger’s suggestion to collect information about patients’ experiences with drugs approved through the Exceptional Access Program in Ontario is an interesting one. If we are to do this, we should do this well, which would require considerable extra resources. Would this be worthwhile?
Knowledge about how long patients take the drugs prescribed can be obtained from administrative data, and would not require a special reporting mechanism. On the other hand, information about patients’ clinical course and quality of life on the drugs would require considerable extra data collection and would only be useful if most patients who are prescribed the drugs submit the required information, and their physicians complete the required forms. Even then, knowing how these patients would have done without the drug will be difficult. My gut tells me that collecting this kind of information will not be as useful as one might initially think.
I note that a study similar to the one proposed by Durhane was started in 2007 by the Canadian Fabry Research Consortium. (http://clinicaltrials.gov/show/NCT00455104). Apologies if I have missed it, but I haven’t seen a report or publication from this group yet.
Finally, I note that Cancer Care Ontario has an Evidence Building Program for some cancer drugs, which is intended to allow “…CCO to to fund the drug on a time-limited basis to collect real-world data on its clinical and cost-effectiveness.”. Trastuzumab (Herceptin) for certain women with small breast cancers was the first drug funded under this program in May 2011. (https://www.cancercare.on.ca/cms/one.aspx?portalId=1377&pageId=96671). It would be interesting to hear when the first reports from the EBP will be forthcoming.
Absolutely not! We submitted an EAP request over two months ago. My mother, a senior has IPF which is an aggressive fatal disease that fills your lungs with scar tissue, eventual death by suffocation. A brand new drug called Esbriet was approved by health canada in October 2012, the first and only drug in the world proven of benefit for sufferers. My mother was denied access, it was also suggested by EAP that she consult with her physician, and he may prescribe a different drug covered under ODP. It was clearly stated on the EAP request that this was the only drug and there were no alternatives, hence “exceptional”. My mothers left lung was completely destroyed in a timeframe of 3 months. It is noe over two months that I have been communicating with our minister of health to please approve this drug for my mother. she is not hearing our most critical need for this. our ministry have ignored us and are allowing my mother this horrendous suffering!
I’m sorry that your mother has IPF. It is indeed a terrible disease.
We mostly focused on wait times for drugs that are funded under EAP in our article. But of course the question you raise – what drugs will be funded by EAP, and what drugs won’t? – is in many ways even more important.
You probably know this already, but patients in the UK will receive Esbriet free of charge, with the manufacturer selling the drug to the National Health Service at a discount from the list price. (See http://www.nice.org.uk/nicemedia/live/13039/63134/63134.pdf for details.)
Hopefully a similar discount will result in the drug being made available in Ontario too.
Thank you for tour reply. We have received notice this drug will not be funded, certainly not on criteria I would agree with. Also, the initial rejection form received from EAP clearly shows a standard template that was given no consideration or review whatsoever. We have a government document stating that after review, CDR had made a recommendation not to fund and the executive officer had made “her” decision not to cover, the drug was listed, following this, the next paragraph read the drug had not been reviewed and a decision had not been made.
This shows blatantly that we have a problem with our Ministry of Health. When speaking with a clerk at the EAP office, my mother a senior was told “we’ll if you need the drug you will just have to find the money somewhere”. Very disgusting treAtment of a 77 year old woman who worked from the age of 15-67, and contributed dearly to this country over those years.