I feel like I am banging my head against a brick-wall when it comes to off-label prescribing. #PoliticalSpeak #ClinicSpeak #OffLabel
"We have been promoting the Barts-MS essential off-label list of DMTs for several years with little uptake across the world. Why? We simply don't have the marketing and PR budgets big pharma has at getting the message out; our only medium is social media (free) and some rare platforms at international meetings (not free). When I originally put the list together I was really only targeting resource poor settings, i.e. low to middle income countries without socialist healthcare, and to cover people such as illegal immigrants and refugees with MS in high-income countries. However, the study from the USA below has made me change my perspective. I think off-label prescribing should also apply to the uninsured in high-income countries who do not have adequate health insurance coverage."
"In the survey below of pwMS in the USA not taking DMTs, a large number cited insurance/financial concerns as the sole reason. Amazingly, a quarter of respondents taking DMTs partially or completely relied on support from free/discounted drug access programs. This figure tells you what a problem high drug prices are causing in the USA and that the rich, or well-insured, are essentially subsidising the poor or uninsured. Is this a type of capitalist socialism? I also note the problem of insurance denial and problems with co-payments, something that doesn't happen in the UK."
"There are arguments, and then there are arguments, to support the high-cost of innovative therapies, but when pwMS can't afford to be on these treatments we need some pragmatic solutions. Surely, the use of off-label therapies that have an evidence-base to support their use in MS is one solution? How do we get the world of MS to adopt off-label prescribing as a solution to the problem of under treating, or not treating, MS? Are we fighting a losing battle?"
OBJECTIVE: To evaluate the association between health insurance coverage and disease-modifying therapy (DMT) use for multiple sclerosis (MS).
METHODS: In 2014, we surveyed participants in the North American Research Committee on MS registry regarding health insurance coverage. We investigated associations between negative insurance change and (1) the type of insurance, (2) DMT use, (3) use of free/discounted drug programs, and (4) insurance challenges using multivariable logistic regressions.
RESULTS: Of 6,662 respondents included in the analysis, 6,562 (98.5%) had health insurance, but 1,472 (22.1%) reported negative insurance change compared with 12 months earlier. Respondents with private insurance were more likely to report negative insurance change than any other insurance. Among respondents not taking DMTs, 6.1% cited insurance/financial concerns as the sole reason. Of respondents taking DMTs, 24.7% partially or completely relied on support from free/discounted drug programs. Of respondents obtaining DMTs through insurance, 3.3% experienced initial insurance denial of DMT use, 2.3% encountered insurance denial of DMT switches, and 1.6% skipped or split doses because of increased copay. For respondents with relapsing-remitting MS, negative insurance change increased their odds of not taking DMTs (odds ratio [OR] 1.50; 1.16-1.93), using free/discounted drug programs for DMTs (OR 1.89; 1.40-2.57), and encountering insurance challenges (OR 2.48; 1.64-3.76).
CONCLUSIONS: Insurance coverage affects DMT use for persons with MS, and use of free/discounted drug programs is substantial and makes economic analysis that ignores these supplements potentially inaccurate. The rising costs of drugs and changing insurance coverage adversely affect access to treatment for persons with MS.