Where to turn:  Convincing arguments not enough for drug plan adjudicators

In May of this year my doctor gave me samples of a new drug called Lyrica because my current medications were not controlling the symptoms of my Fibromyalgia (FMS). I was fortunate: Lyrica worked for me; it worked so well that after three days on the medication I felt better than I had in years. Unfortunately it is not listed in the Saskatchewan formulary and I cannot afford to pay for it out of my own pocket. This is when my incredibly frustrating dealings with Canada’s drug system began.

My doctor asked administrators of the Saskatchewan drug plan to grant me coverage under the Exceptional Drug Status (EDS) portion of the drug plan. The request was denied on the basis that Lyrica is not listed on the formulary and EDS drugs must be listed.

I began advocating on my own behalf by speaking to the pharmacist responsible for EDS requests. I asked if there was a process through which I could appeal the refusal to cover this drug for me. I even asked if I needed to make a direct appeal to the Saskatchewan Minister of Health. I was told to have my doctor write a letter to another representative within the Saskatchewan drug plan detailing my drug history and the reason I needed this new drug.

My doctor did not give them my detailed drug history. Rather than informing me that she had not received the drug history letter, she submitted the letter of appeal without it. The second official also rejected the request. In fact she sent the exact same form letter the first official had, the only difference being that she included a transcript of the decision by the Common Drug Review (CDR) that recommended that Lyrica not be covered by the provincial drug plans.

The next step was to take this matter to my MLA. His assistant listened to my case and forwarded my documents to an official in the Saskatchewan Health Ministry. I was promised that my case would be considered on its merits and that a decision would be made on those merits. However, on October 26th I received a letter from the office of the Deputy Minister of Health rejecting my request on the same basis as the first two officials: Lyrica is not listed on the provincial formulary. Blame was placed on the CDR and I was given the number of a CDR official that I could call at my own expense.

I had, however, been in contact with Health Canada and the agency that oversees the CDR, the Canadian Agency for Drugs and Technologies in Health (CADTH). I was told by both agencies that, “Members of the general public are not allowed any input into the decision-making process and are only given information when a final decision is made. This is the case for both the decision by Health Canada to license a drug for use in Canada, including the condition(s) for which the drug may officially be prescribed, and the CDR's recommendation to the provinces regarding coverage for the drug under the provincial drug plans.” In short, contacting this official would be a waste of both my time and money.

Interestingly, during this process I discovered that because Health Canada did not approve Lyrica, as a treatment for FMS the officials at the CDR and within the provincial drug plans cannot consider the clinical evidence regarding the effectiveness of the drug in treating the symptoms of this disease. This is due to the legal liabilities that would arise out of recommending a drug for treating a condition that is not on the Health Canada approved list for that drug. Lyrica received its NOC in September 2007 and is approved in Canada for the management of neuropathic pain associated with diabetic peripheral neuropathy or post-herpetic neuralgia. The conclusion to the main study done regarding the effectiveness of Lyrica on FMS said it best: “Pregabalin (the drug’s generic name) was well tolerated and improved global measures and health-related quality of life”. So while the drug has been shown to be very effective for some FMS sufferers, it does not matter to the bureaucrats administering the drug plan program. Nor does it matter to them that while the medications currently on the market only treat the pain of FMS, Lyrica has been clinically proven to treat the pain and the disturbed sleep and fatigue that many FMS patients suffer with.

The only avenue open to me now is to make a direct appeal to the new Saskatchewan Minister of Health. As the facts have not swayed any of the bureaucrats that work in the Canadian drug plan system, I don’tknow if a direct appeal will have any effect. Perhaps the fact that Lyrica was approved in the United States as a treatment for FMS and Pfizer has begun advertising it on American television will create enough demand to force the drug plan to do the right thing. I guess for FMS sufferers like me, we can only hope that something does.