The latest BEERS criteria have listed doxepin ≤6mg/day is comparable to placebo. Hence even though it is considered a tricyclic antidepressant which is usually discouraged in the elderly, the use of doxepin at ≤6mg/day may be recommended for insomnia, instead of benzodiazepines or other tricycle antidepressants or anticholinergics which are considered much more harmful in this population.

However if you look at our current Formulary from Ontario Drug Benefits Program, doxepin is not covered at this dose, but is listed for coverage at much higher doses (10mg – 100mg). So when patients cannot afford to pay for doxepin 6mg/day which costs about $50/month, they will be forced to use a higher strength of doxepin and be exposed to the many  anti-cholinergic side effects because our system does not pay for the safer and lower strength.

How does all this make sense?  

If you look at how a drug is listed in the Ontario Drug Benefit Formulary, it relies on the manufacturer to send in a drug submission with a number of required information.

Of course once a submission is made, the Ontario Drug Benefit Program will review the information and decide whether to list a drug, whether to put additional restrictions in place for prescribing (e.g. LU code, EAP status) as well as negotiating the cost of coverage with the manufacturer.

So the key is we rely on the manufacturers to decide what they want to add to the formulary and then we decide if the clinical information is worthy enough to pay for the drug.

Other examples include Fentanyl Patch where the lowest strength of 12mcg/hr is not reimbursed by our government plan but higher strengths are and premipixole where 0.5mg tablet is not reimbursed but the lower strengths are.

What if the manufacturer never makes a submission in the first place? The drug is just never considered for listing in the formulary despite any subsequent established benefits. Hence, the majority of the public would be forced to pay for the drug out of pocket, reimbursed if they have private insurance coverage or change to an alternative that is covered by the government drug plan.

Should our drug access program takes a more proactive approach to determine what drugs should be listed for coverage, instead of relying on the manufacturers to make their first steps? It seems we have to jump through many loopholes just to be able to prescribe and have access to a safer medication these days!