ampyra

[gigi]

Is anyone considering how they plan to cover ampyra? any criteria? appears that the cost/benefit ration could be problematic.

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[chantell.reagan]

In January 2010, Acorda received FDA approval for a new oral treatment, Ampyra (dalfampridine) to improve walking in patients with multiple sclerosis (MS). This is the first symptomatic treatment approved for MS, which can be used in combination with disease-modifying therapies. Plans may want to take the following considerations into account with regards to formulary management and development of policies:

• What is the proportion of MS patients affected by walking impairment? In a patient survey facilitated by Acorda, approximately 64% of MS patients experience trouble walking, which they defined as the inability to walk or loss of balance at least twice each week.

•How is walking impairment assessed objectively in MS patients in the clinical practice setting? There are a number of scales and questionnaires used to measure walking speed in MS, including the MS Walking Scale 12 (MSWS-12), Timed 25-foot Walk (T25FW), and Walking Improvement Questionnaire (WIQ). Additionally as mentioned above, it can also be as simply defined as "the inability to walk or loss of balance at least 2 times/week. It is unknown whether any of these are used as a "standard" in clinical practice.

•What options are used to treat walking impairment in MS patients? Besides physical therapy, dalfampridine is the first pharmacological treatment approved for improving walking impairment in MS.

•What is the clinical data supporting the use of Ampyra in MS patients with walking impairment? The product was approved on the basis of 2 studies, involving 540 patients (with average EDSS score of 6). In a study published in Lancet in 2009, 35% of patients showed improvement in walking speed (vs 8% of placebo group). A later abstract from 6/09, demonstrated that 42.9% of patients found improvement in walking speed (vs. 9.3% for placebo).

•What patient subgroups are more likely to respond to Ampyra? How long should treatment continue in terms of response vs. nonresponse? In clinical trials, up to 43% of patients with all types of MS (from new-onset to relapsing-remitting) showed response to dalfampridine. Response was defined as faster walking speeds for most visits during treatment than the fastest speed at baseline. In both trials there no differences in baseline characteristics between responders and non-responders were noted. As mentioned in one of the study publications, “the selectivity of responsiveness might be related to the proposed mechanism of action—the improvement of conduction in demyelinated pathways via blockade of voltage-dependent potassium channels. Only some patients would be expected to have axons susceptible to the drug effects at any given time.” Unfortunately, differences in individual neuropathologies cannot be easily discerned and objectively assessed in clinical practice. In clinical trials, response was evaluated during a 14-week treatment period.

In terms of continuation, in the same clinical trials, a responder was defined as a patient who showed faster walking speed for a least 3 out of a possible 4 visits. Long-term treatment might be required for responders after the initial 14-week trial. In clinical trials, treatment discontinuation was associated with declines in mobility improvements.

•What are some of the safety considerations with Ampyra? From a safety perspective, the prescribing information notes that Ampyra should not be used in doses > 10mg bid, as higher doses can increase the risk of seizures and is contraindicated in those patients with seizure history.

•What is the cost of monthly Ampyra treatment? From a cost perspective, Acorda reports the wholesale cost to be $1056/per 30 day supply. Also of note, the product will be commercially available starting in March 2010.

•Which specialty pharmacies are participating in the limited distribution program? According to Ampyra Patient Support Services, the following network of specialty pharmacies will exclusively distribute Ampyra: Accredo, Aetna, BioScrip, Caremark/Curascript, Diplomat, Precision Rx, Prescription Solution, Specialty Care, Tel-Drug/Cigna, US Bioservices and Walgreens.

A policy comparison of Ampyra prior authorization criteria will be forthcoming, as policies become publically available.

Sources:
Ampyra (dalfampridine) website
Acorda press release 2/10
National MS Society news article 2/10
National MS Society news article 3/08
Acorda press release 6/08

[stockrabbit]

We looked at this drug and plan to come back once we gather more feedback from the community. Just by looking at the clinical studies, it is not robust...
Our P&T members mentioned 4-AP compound...it is being used in europe, but not expecting that to get acceptance from the physician to try...

[diana.papshev]

Anonymous member feedback:

"We cover canes, walkers and wheelchairs"

[diana.papshev]

Anonymous response:

"Covered initially without restriction"

[docscarlett]

since the compound has been used in a variety of products for the past 50 years - why the justification behind the high cost?

[diana.papshev]

Anonymous response:

"suggesting a prior authorization guideline restricting to neurologist prescriber and FDA approved indication to prevent off-label usage"

[diana.papshev]

Anonymous member feedback:

"We have an open formulary so it is covered under tier 3 with PA. Our PA criteria includes:

1) Prescriber by Neurologist
2) Diagnosis of MS
3) EDSS score between 2.5-6.5
4) No renal impairment (moderate to severe)
5) No history of seizures
6) Dosed 10mg BID

We also have renewal criteria after 4 months:
1) Improvement in timed walking speed
2) Dosed 10mg BID"

[diana.papshev]

Anonymous member feedback:

"We have developed criteria recommending a prior authorization as well as a quantity limit. The prior auth would require prescribing by a neurologist, diagnosis of MS, currently on disease-modifying therapy for MS, and limited to quantity of 60 for 30/days. Increasing dose beyond 10mg twice a day did not achieve any additional clinical benefit but did increase risk for side effects including seizures"

[chantell.reagan]

Ampyra (dalfampridine) was approved by the FDA in January 2010 and indicated to improve walking in patients with multiple sclerosis (MS). In response to a member inquiry, we analyzed 7 local and national plans for their Ampyra coverage criteria and the following are our key findings:

•7/7 plans have a diagnosis requirement with 3/7 plans requiring concurrent treatment with a disease-modifying drug
•5/7 plans use the timed 25-foot walk (T25FW) as the measure of walking impairment (between 8-46s)
•2/7 plans require significant limitations in instrumental activities of daily living
•6/7 plans institute specific reauthorization criteria (ranging from 10-50% improvement in T25FW scores from baseline)

The following figure provides a comparative summary of the selected policies (click on the image to enlarge it).


Additional sources:

Ampyra prescribing information

BlueCross Blue Shield of Alabama. Ampyra policy

BlueCross BlueShield of Florida. Medical Policy

BlueCross BlueShield of Michigan. Clinical Formulary Step Therapy

Excellus BlueCross Blue Shield. Clinical Review Prior Authorization

The Regence Group. Ampyra policy

MVP Healthcare. Prior Authorization update 7/10

Aetna. Clinical Policy Bulletin: Multiple Sclerosis