Please answer the following questions and fax this form to the number listed above. Patients taking dalfampridine ampyra should be reevaluated periodically to assess the clinical benefit and potential adverse effects of treatment. Patient is not restricted to using a wheelchair if edss is not measured 4. Patient is not restricted to using a wheelchair if edss is not measured authorization will be issued for 12 months. Ampyra can cause a seizure convulsions, even if you have never had one before. Edss kurtzke expanded disability status score download pdf 16,008 kb definition. Dec 20, 2019 the effectiveness of ampyra in improving walking in patients with multiple sclerosis was evaluated in two adequate and well controlled trials involving 540 patients. Each tablet contains 10 mg dalfampridine, formulated as an extendedrelease tablet for twicedaily oral administration.
In the clinical studies, the efficacy of ampyra was shown by an increase in walking speed, as measured by the t25fw using a responder analysis see results and. The expanded disability status scale edss is a method of quantifying disability in multiple sclerosis and monitoring changes in the level of disability over time. The edss score did not deteriorate in any of the patients. Y n if the answer to this question is yes, go to question. Criteria reauthorization documentation of disease stability or lack of disease progression e.
Is the patient restricted to utilizing a wheelchair if edss is not measured. The extended disability status scale edss as a predictor of impairments of. If i do not wish to receive information related to ampyra or any related products or services or to be contacted occasionally for market research purposes, i understand that i may call the ampyra patient support services centers tollfree number, 8888811918 at any time. The member has worsening disability sustained worsening of expanded disability status scale edss score or neurological examination findings intolerance is defined as intolerable side effects despite optimized management strategies. Guidebook kurtzke expanded disability status scale edss. It is not known if ampyra is safe or effective in children less than 18 years old.
An aid to walking in patients with multiple sclerosis find, read and. It is available as prolongedrelease tablets 10 mg in europe. Patient inclusion criteria in both trials included the ability to walk 25 feet in 8 to 45 seconds at baseline. Safety and immunological effects of mesenchymal stem cell. Three months after initiating dalfampridine ampyra, the timed 25foot walk test may be readministered. The following information is not intended to endorse any particular medication.
Policy requirements for a trial of an injectable drug therapy may be waived for persons who. Maximum 20mg per day 10mg every 12 hours approve for 6 months. Yes no is ampyra prescribed by or in consultation with a neurologist. The recipient d oes n ot have mod e rate to severe renal d ysfuncti o n. Nice has published guidance on the use of fampridine within the document multiple sclerosis.
Patient has an edss score less than or equal to 7 patient is not restricted to using a wheelchair if edss is not measured. Specialty pharmacy clinical policy bulletins aetna non. Ampyra is a prescription medicine used to improve walking in adults with multiple sclerosis ms. Edss expanded disability status score acronymattic. Patients in these two clinical trials had a mean kurtzke expanded disability status scale edss score of 6. Ampyra dalfampridine extended release tablets, for oral use. Ampyra is being requested to improve walk ing fdaapproved indication. Patients in these two clinical trials had a mean disease duration of years and a mean kurtzke expanded disability status scale edss score of 6. Aug 08, 2018 ampyra dalfampridine is a potassium channel blocker. Is the patient ambulatory with an expanded disability status scale edss score between 2. Is there physician confirmation the patients walking has improved with ampyra therapy.
Ampyra patient support services center phone 8888811918. Pdf on dec 1, 2010, raymond lamore and others published dalfampridine ampyra. Does the patient have an expanded disability status scale edss score less than or equal to 7. Ms is known as the expanded disability status scale edss. The recipient d oes n ot have mod e rate to severe renal d ysfuncti o n creatinine clearance jan, 2020 ampyra dalfampridine extendedrelease tablets are available in a 10 mg strength and are white to offwhite, biconvex, oval shaped, filmcoated, nonscored tablets with flat edge, debossed with a10 on one side, containing 10 mg of dalfampridine. The scale was renamed the kurtzke expanded disability status scale edss. The legally binding text is the original french version.
The edss assigns a severity score to the patients clinical status that ranges from 010 in increments of 0. The purpose of this s cale was to quantify the level of disability that could be used by health care providers diagnosing ms and monitor changes of disability. Does the patient have an expanded disability status scale edss score than or equal to 7. More specifically, at the end of the 6 months of followup, the edss score remained unchanged in 4 patients and was reduced by 0. The edss assesses the disability status of ms patients on a scale from 0 to 10. Is there physician confirmation that the patient has improved walking with ampyra therapy. Backgroundoverview dalfampridine ampyra is a potassium channel blocker indicated to improve walking in patients with multiple sclerosis ms. We may cover ampyra when the above criteria is met and with previous use of dalfampridine. A 20% or greater improvement in walking speed is a desired response.
In patients with ms, the mean edss score declined gradually indicating functional improvement from 6. Ampyra dalfampridine was evaluated in 2 randomized, placebocontrolled studies including a total of 540 patients with disease durations ranging from 0. Ampyra dalfampridine prior authorization with quantity. The renewal dose of ampyra will have the same restrictions as initial criteria. Functional impairment resolved as a result of increased speed of ambulation resulting in the member being able to complete instrumental activities of daily living such as meal preparation, household chores, etc. Documentation that the patients walking has improved with ampyra therapy such as improvement in 25 foot walk test and 2. Patients in the two clinical trials had a mean disease duration of years and a mean expanded disability status scale edss score of 6. Lechelle edss expanded disability status scale edmus. It is widely used in clinical trials and in the assessment of people with ms.
We may cover dalfampridine when all of the following criteria are met. Pdf reallife experience with fampridine fampyra for. In february 1994 a meeting titled outcomes assessment in multiple sclerosis clinical trials was held in charleston, sc. Multiple sclerosis ms is a demyelinating disease, causing axonal damage and disability. The member has worsening disability sustained worsening of expanded disability status scale edss score or neurological examination findings. Patient has an expanded disability status scale edss score score. It is primarily used in clinical trials to determine who should participate in a given study and to assess the. The expanded disability status scale edss is a standardized system used to classify the severity and progression of multiple sclerosis msin other words, to provide a measure of how much disability the disease has caused. Ampyra dalfampridine is a potassium channel blocker. Target drugs and program quantity limit brand generic gpi multisource code quantity per day limit ampyra dalfampridine 10 mg tablet 62406030007420 m, n, o, or y 2 tablets prior authorization and quantity limit criteria for approval.
Is the baseline timed 25foot walk test t25fw establishing a baseline walking speed between 8 and y n 45 seconds. Patients in the two clinical trials had a mean disease duration of years and a mean expanded disability status scale edss score. Baseline walking speed timed 25 foot walk t25w or expanded disability status scale edss 7. Yes no is the patient restricted to using a wheelchair if edss score is not measured. Examen neurologique normal tous systemes fonctionnels sf a 0. Which neurologic systems are evaluated in the kurtzke. The patient has a kurtzke expanded disability status score edss of 4. The recipient is ambulatory and has an expanded disability status scale edss score between 2. The patient is directed to walk 25 feet quickly and safely as possible from one marked end to the other.
Expanded disability status scale edss functional systems. Dalfampridine dal is an extendedrelease formulation of 4aminopyridine 4ap and broad. Multiple sclerosis medical clinical policy bulletins aetna. This was demonstrated by an increase in walking speed. Does not require the use of a wheelchair bilateral assistance is acceptable, such as a brace, cane, or crutch, as long as the patient can walk 20 meters without resting the expanded disability status score edss. Ampyra dalfampridine extendedrelease tablets, for oral use.
The effectiveness of ampyra in improving walking in patients with multiple sclerosis was evaluated in two adequate and well controlled trials involving 540 patients. Medication is prescribed by or in consultation with a neurologist reauthorization criteria. The scale was developed by a neurologist called john kurtzke in 1983 as an advance from his previous 10. Ampyra the effectiveness of ampyra dalfampridine was studied in two adequate and well controlled trials involving 540 patients. Ampyra dalfampridine is a potassium channel blocker, available in a 10 mg tablet strength. Scoring for the timed 25foot walk is the average of two trials. Rating neurologic impairment in multiple sclerosis. These highlights do not include all the information needed to use ampyra safely and effectively. The time is calculated from the initiation of the patient instructed. Patient has an expanded disability status scale edss score less than or equal to 7 b. Member is ambulatory and has an expanded disability status scale edss score between.
The effectiveness of ampyra in improving walking in patients with ms was evaluated in two pivotal, wellcontrolled trials involving 540 patients. In the clinical studies, the efficacy of ampyra was shown by an increase in walking speed, as measured by the t25fw using a responder analysis see results and description of studies in. For eligibility requirements go to i request that acorda provide two 60 count bottles of ampyra extended release tablets. Kurtzke expanded disability status scale multiple sclerosis. The expanded disability status scale edss and the functional systems score fss together describe severity of disability in patients with ms. It is the dedication of healthcare workers that will lead us through this crisis. The expanded disability status score edss quantifies disability in eight functional life expectancy in patients attending multiple sclerosis clinics. Ampyra dalfampridine is a potassium channel blocker indicated to improve walking in adult. Ampyra patient support services center free 60 day trial. In study 2, time to progression in edss was longer in the betaseron treatment group p0.
Yes no does the patient have an expanded disability status scale edss score less than or equal to 7. Intolerance is defined as intolerable side effects despite optimized management strategies. Key eligibility criteria were an age of 18 to 55 years, a diagnosis of primary progressive multiple sclerosis according to the 2005 revised mcdonald criteria, a score on the expanded disability status scale edss of 3. The expanded disability status score edss quantifies disability in eight functional systems. The primary outcome measure was progression of disability, defined as a 1. Ampyra will be limited to the fdalabeled dosage of 10 mg twice daily. Physician confirmation that the patients walking improved with ampyra therapy. The edss provides a total score on a scale that ranges from 0 to 10. Renewal criteria include documentation of at least a 20% improvement from baseline in timed walking speed or an edss score of less than 7. These patients have an expanded disability status score edss of 7 or higher.
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