I know its been a while since I've had a chance to post. Ok, fine, its been well over six months! However, I coming bearing tepidly good news. As promised, I did some more digging into The Alzheimer's Disease Therapy Initiative (ADTI) which according to previous Ministry releases was supposed to be wrapped up this year, but was given an extra breath of life. My timing is indeed impeccable!
ADTI will continue until 2012, during which time those diagnosed with moderate Alzheimer's Disease (AD) and whose doctor's prescribe cholinesterase inhibitors are eligible for coverage. Emphasis on moderate AD and cholinesterase inhibitors. Looking through the eligibility criteria bring up some caveats which I was not aware of at first glance:
So what are the implications of all these caveats? Well, firstly, ADTI is at its heart, a research project. To be honest, this was my 'aha' moment. Or perhaps it was more of a Homer Simpson 'duh' moment. Not sure which yet. All this time, I had assumed ADTI was a pilot project designed by the Ministry to determine how many BC residents need coverage, what the cost implications are etc. But a research project brings a completely different lens to the initiative. It also means that, at the end of the day, all the stringent criteria makes more sense when grounded in the context that it is meant to help recruit a very specific study population. Finally, a tenuous flicker of light has infiltrated the oblivion that is Saskia's knowledge of ADTI!
But wait a minute, any basic search on PubMed (a database of biomedical literature that any grad student worth their salt would check) demonstrates that reams upon reams of research has been devoted to evaluating the effectiveness of cholinesterase inhibitors. So, why are we doing it all again? Well, the folks at the Ministry feel, and I quote, that ADTI is needed "to address the lack of clinical evidence to support PharmaCare coverage of cholinesterase inhibitors and allow individuals affected by Alzheimer’s disease to access these medications without the restrictive cost." (http://www.health.gov.bc.ca/pharmacare/adti/index.html accessed 26/12/2010). It appears the current clinical trials provide insufficient evidence that cholinesterase inhibitors are beneficial for functional outcomes (ie. activities of daily living). Curiouser and curiouser. My next post will delve more into understanding what the research questions being framed by the ADTI are and why BC, of all provinces, felt it needed to undertake a research initiative to examine this before covering any of the drugs used in the treatment of AD.
Before I sign off, a few cautions about the criteria used to recruit patients to the study:
I leave you with some food for though. The New York Times recently published a very interesting article, 'Tests Detect Alzheimer's Risks, but Should Patients Be Told?' Would you want to know?
ADTI will continue until 2012, during which time those diagnosed with moderate Alzheimer's Disease (AD) and whose doctor's prescribe cholinesterase inhibitors are eligible for coverage. Emphasis on moderate AD and cholinesterase inhibitors. Looking through the eligibility criteria bring up some caveats which I was not aware of at first glance:
- The primary dementia diagnosis must be AD
- Coverage is only for patients with a score of 10 - 26 on the MMSE (Mini Mental State Examination. Designed to track the level of cognitive decline)
- ADTI will only cover cholinesterase inhibitors. Ebixa (aka. Memantine Hydrochloride) which functions via a different mechanism and is used for moderate to severe AD, is not covered
- Patients need to be evaluated every six months via an MMSE
- Unless a doctor recommends patients for the coverage, they won't be covered
- Coverage is not retroactive
So what are the implications of all these caveats? Well, firstly, ADTI is at its heart, a research project. To be honest, this was my 'aha' moment. Or perhaps it was more of a Homer Simpson 'duh' moment. Not sure which yet. All this time, I had assumed ADTI was a pilot project designed by the Ministry to determine how many BC residents need coverage, what the cost implications are etc. But a research project brings a completely different lens to the initiative. It also means that, at the end of the day, all the stringent criteria makes more sense when grounded in the context that it is meant to help recruit a very specific study population. Finally, a tenuous flicker of light has infiltrated the oblivion that is Saskia's knowledge of ADTI!
But wait a minute, any basic search on PubMed (a database of biomedical literature that any grad student worth their salt would check) demonstrates that reams upon reams of research has been devoted to evaluating the effectiveness of cholinesterase inhibitors. So, why are we doing it all again? Well, the folks at the Ministry feel, and I quote, that ADTI is needed "to address the lack of clinical evidence to support PharmaCare coverage of cholinesterase inhibitors and allow individuals affected by Alzheimer’s disease to access these medications without the restrictive cost." (http://www.health.gov.bc.ca/pharmacare/adti/index.html accessed 26/12/2010). It appears the current clinical trials provide insufficient evidence that cholinesterase inhibitors are beneficial for functional outcomes (ie. activities of daily living). Curiouser and curiouser. My next post will delve more into understanding what the research questions being framed by the ADTI are and why BC, of all provinces, felt it needed to undertake a research initiative to examine this before covering any of the drugs used in the treatment of AD.
Before I sign off, a few cautions about the criteria used to recruit patients to the study:
- A primary dementia diagnosis of AD means that, if a patient is diagnosed with vascular dementia as the primary diagnosis, they are ineligible for coverage
- A MMSE score of 10-26 seems to eliminate all patients with severe or mild AD. However, a score of 24 (out of 30) and above is actually considered 'normal' so in fact, those with potentially mild AD or Mild Cognitive Impairment (MCI) are being included. This makes sense to me since a large percentage of patients with MCI later convert to AD
- Coverage of only cholinesterase inhibitors effectively means primarily patients with moderate AD are included in the study. Ebixa has been approved for treatment of moderate to severe dementia and has a completely different mechanism of action. But if the ADTI is truly examining efficacy of all drugs used in the treatment of AD and their cost, shouldn't Ebixa be included?
- Being evaluated every six months in order to have continued coverage can be quite difficult for patients with AD and their caregivers, I would imagine. Getting to a clinic can be quite hard, particularly if you don't have a caregiver and makes me wonder about patients in long-term care facilities? Then there's the task of doing another MMSE which in itself can be stressful for a patient, but is doubly so if your drug coverage rests on the score. And how do the clinicians feel about all of this? From a researcher's point of view, having the frequent cognitive function results are useful to understanding long term effects of the drug, I'm not sure about the practicality of it though
- What if a doctor doesn't want to recommend a patient? Most clinicians already have enough paperwork to fill, doing Special Authority forms and frequent evaluations might discourage them. Where does that leave the patient, particularly if they don't even know about the ADTI?
I leave you with some food for though. The New York Times recently published a very interesting article, 'Tests Detect Alzheimer's Risks, but Should Patients Be Told?' Would you want to know?
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