I for one will certainly admit to being confused.
Post# of 15624
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Posted On: 03/31/2017 2:59:10 PM
I for one will certainly admit to being confused. On reading the information on efficacy testing for psoriasis, it appeared to have been done with human material, but not with patients, but was done IAW with an est,ablished protocol. On seeing how effective this was, a decision to do further double blind trials with other skin diseases was announced to be planned in the next 60 to 90 days.
If I understand what's being said, the psoriasis cream should be available for sale in the second or third quarter with safety trials completed in healthy patients, but no efficacy testing on live patients. Meanwhile, testing will be initiated with live patients in other skin diseases, and these trials will be double blinded.
I'm fine with what's being stated, but wondering why live patients with psoriasis won't require similar testing.
I understand that the intent is to bring out the cream as a cosmetic, and as such perhaps additional testing isn't necessary. However, if double blind trials are successful in other various indications, I'll use acne as an example, will that mean that acne sufferers will get the drug by prescription as a drug, while psoriasis patients can buy it over the counter, or in Green Cross stores.
If the intent of the strategy is to move the cream from cosmetic to drug, shouldn't it be done for psoriasis patients as well.
I know that their are many drugs which are available over the counter as well as by prescription. The advantage of prescription is, they become covered by insurance, and therefore are far cheaper for the patient, and encourage the patient to stay on the drug. Clearly this is more expensive to the insurance companies, and I'm unclear if they pay more, or less than the over the counter price for the prescribed version of the drug.
I believe that if the intent is to move from cosmetic to drug status in the future, they will be spending very substantial money and time in gaining efficacy trial approvals. I would suspect the price by prescription would be dramatically higher than over the counter, but insured patients would probably pay less.
I believe at some point psoriasis patients will also be able to get the product as a drug, covered by insurance. The question may be, will it happen because of overwhelming anecdotal evidence of efficacy, or will a double blind Pivotal Trial be necessary.
Finally, if all this occurs, once available as a drug for all uses, does the over the counter product get removed from the shelves, or do they co-exist as both prescription drug, and OTC cosmetic.
Gary
If I understand what's being said, the psoriasis cream should be available for sale in the second or third quarter with safety trials completed in healthy patients, but no efficacy testing on live patients. Meanwhile, testing will be initiated with live patients in other skin diseases, and these trials will be double blinded.
I'm fine with what's being stated, but wondering why live patients with psoriasis won't require similar testing.
I understand that the intent is to bring out the cream as a cosmetic, and as such perhaps additional testing isn't necessary. However, if double blind trials are successful in other various indications, I'll use acne as an example, will that mean that acne sufferers will get the drug by prescription as a drug, while psoriasis patients can buy it over the counter, or in Green Cross stores.
If the intent of the strategy is to move the cream from cosmetic to drug, shouldn't it be done for psoriasis patients as well.
I know that their are many drugs which are available over the counter as well as by prescription. The advantage of prescription is, they become covered by insurance, and therefore are far cheaper for the patient, and encourage the patient to stay on the drug. Clearly this is more expensive to the insurance companies, and I'm unclear if they pay more, or less than the over the counter price for the prescribed version of the drug.
I believe that if the intent is to move from cosmetic to drug status in the future, they will be spending very substantial money and time in gaining efficacy trial approvals. I would suspect the price by prescription would be dramatically higher than over the counter, but insured patients would probably pay less.
I believe at some point psoriasis patients will also be able to get the product as a drug, covered by insurance. The question may be, will it happen because of overwhelming anecdotal evidence of efficacy, or will a double blind Pivotal Trial be necessary.
Finally, if all this occurs, once available as a drug for all uses, does the over the counter product get removed from the shelves, or do they co-exist as both prescription drug, and OTC cosmetic.
Gary
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