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Ampyra (dalfampridine) Prior Authorization with Quantity Limit Program Summary
Policy Number: PH-1023
This program applies to Blue Partner, Commercial, NetResults A series, SourceRx, and Health Insurance Marketplace formularies.
POLICY REVIEW CYCLE
Effective Date |
Date of Origin |
04-01-2024 |
06-01-2010 |
FDA APPROVED INDICATIONS AND DOSAGE
Agent(s) |
FDA Indication(s) |
Notes |
Ref# |
Ampyra® (dalfampridine)* Tablet |
To improve walking in adult patients with multiple sclerosis (MS). This was demonstrated by an increase in walking speed |
*generic equivalent available |
1 |
See package insert for FDA prescribing information: https://dailymed.nlm.nih.gov/dailymed/index.cfm
CLINICAL RATIONALE
Multiple Sclerosis |
Multiple sclerosis (MS) is a disorder of the central nervous system (CNS) characterized by demyelization, inflammation, and degenerative changes. Most people with MS experience relapses and remissions of neurological symptoms, particularly early in the disease, and clinical events are usually associated with areas of CNS inflammation. Gradual worsening or progression, with or without subsequent acute attacks of inflammation or radiological activity, may take place early, but usually becomes more prominent over time. While traditionally viewed as a disease solely of CNS white matter, more advanced imaging techniques have demonstrated significant early and ongoing CNS gray matter damage as well.(2) Those diagnosed with MS may have many fluctuating and disabling symptoms (including, but not limited to, fatigue, pain, bladder and bowel issues, sexual dysfunction, movement and coordination problems, visual disturbances, and cognition and emotional changes.(8) There are currently four major types of MS: clinically isolated syndrome (CIS), relapsing-remitting MS (RRMS), primary progressive MS (PPMS), and secondary progressive MS (SPMS).(2) Many patients with MS develop gait impairment, and some eventually require a cane or wheelchair. Gait impairment in MS can result from a multitude of issues such as spasticity, weakness, fatigue, sensory loss, visual loss, and vestibular dysfunction. Leg weakness and spasticity can result from MS lesions in the descending motor tracts of the brain and spinal cord. Ambulatory imbalance can be caused by lesions involving the cerebellar pathways. The International Symposium on Gait and balance in Multiple Sclerosis states that the causes of gait and balance dysfunction in patients with MS are multifactorial and therefore may benefit from a wide range of interventions. Evidence based recommendations from the 2nd International Symposium included balance rehabilitation, self-management, medications, functional electrical stimulation, robotics, sensory augmentation, gait training with error feedback, and fall prevention.(7) There is ample evidence to support the benefits of ongoing treatment for the majority of people with multiple sclerosis, there may be some situations in which clinicians and their patients might consider stopping treatment. Although freedom from subsequent relapse is impossible to guarantee, treatment cessation may be considered in patients who:(2)
Earlier discontinuation, particularly in patients with active disease, may lead to increased disease activity. Clinical and MRI monitoring for recurrent disease activity is clearly warranted in those patients.(2) |
Efficacy |
The effectiveness of Ampyra (dalfampridine) was studied in two adequate and well controlled trials involving 540 patients. Patients in these two clinical trials had a mean Kurtzke Expanded Disability Status Scale (EDSS) score of 6. Patient inclusion criteria in both trials included the ability to walk 25 feet in 8 to 45 seconds at baseline. Both trials used a responder analysis as the primary endpoint. Responders were defined as patients who achieved faster walking speeds (measured by a timed 25-foot walk in seconds) in at least three of four visits during the study period compared to their fastest speed during the off-treatment period.(1) A retrospective analysis of a previous trial indicated that treatment responders experienced a 25% improvement in walking speed compared to baseline.(3) An FDA analysis using the entire study group (not just responders) found that neither trial demonstrated statistically significant differences in change in walking speed at visit 6 compared to baseline or average walking speed during the treatment phase of the trial. The FDA calculated that changes in walking speed would improve the 25 foot walk time for dalfampridine patients compared to placebo by 0.88 seconds and 0.5 seconds in trials MS-F203 and MS-F204, respectively. FDA analyses found that there was no significant difference between groups in either trial for the SGI score.(4) SGI is a measurement of patient perceived improvement of disease. The FDA analysis did not compare differences in walking endpoints or SGI for the responder group compared to placebo. Evidence is lacking on how to identify patients that are likely to respond to dalfampridine without a trial of the drug. Dalfampridine is approved to improve walking speed in patients with MS and has not been shown to be effective in improving strength in other neurologic conditions (spinal cord injury, etc.). Evidence supports criteria similar to that used in Phase 3 clinical trials which includes patients diagnosed with MS who have difficulty walking as defined by a timed 25 foot walk between 8 and 45 seconds.(5) The Kurtzke Expanded Disability Status Scale (EDSS) quantifies the level of functioning that is used by health care providers diagnosing MS. The EDSS provides a total score on a scale that ranges from 0 to 10. EDSS 1.0 to 4.5 refer to patients with a high degree of ambulatory ability and subsequent levels 5.0 to 9.5 refer to the loss of ambulatory ability. An EDSS score of 7 indicates the patient is unable to walk beyond 5 meters even with aid, essentially restricted to wheelchair.(6) |
Safety |
Ampyra is contraindicated in:(1)
|
REFERENCES
Number |
Reference |
1 |
Ampyra prescribing information. Acorda Therapeutics, Inc. November 2021. |
2 |
Multiple Sclerosis Coalition. The Use of Disease Modifying Therapies in Multiple Sclerosis: Principles and Current Evidence. A Consensus Paper by the Multiple Sclerosis Coalition. June 2019. |
3 |
Goodman AD, Brown TR, Cohen JA, et al. Dose comparison trial of sustained release fampridine in multiple sclerosis. Neurology 2008;71:1134-1141. |
4 |
FDA. Medical review of fampridine. Available at: http://www.accessdata.fda.gov/drugsatfda_docs/nda/2010/022250s000_MedR.pdf. |
5 |
Pikoulas TE and Fuller MA. Dalfampridine: A Medication to Improve Walking in Patients with Multiple Sclerosis. The Annals of Pharmacotherapy 2012;46:1010-15. |
6 |
U.S. Department of Veterans Affair. Kurtzke Expanded Disability Status Scale. Available at: https://www.va.gov/MS/Professionals/diagnosis/Kurtzke_Expanded_Disability_Status_Scale.asp. Accessed November 2018. |
7 |
Zackowdki KM, Cameron M, Wagner JM. Perspectives in Rehabilitation. 2nd International Symposium on Gait and Balance in Multiple Sclerosis: interventions for gait and balance in MS. Journal of Disability and Rehabilitation. Volume 36,2014 – Issue 13. Pages 1128-1132. |
8 |
MS international federation. About MS - Symptoms. Accessed at MS Symptoms | Multiple Sclerosis (msif.org) |
POLICY AGENT SUMMARY PRIOR AUTHORIZATION
Target Brand Agent(s) |
Target Generic Agent(s) |
Strength |
Targeted MSC |
Available MSC |
Final Age Limit |
Preferred Status |
|
||||||
Ampyra |
Dalfampridine Tab ER 12HR 10 MG |
10 MG |
M ; N ; O |
O ; Y |
|
|
POLICY AGENT SUMMARY QUANTITY LIMIT
Target Brand Agent Name(s) |
Target Generic Agent Name(s) |
Strength |
QL Amount |
Dose Form |
Day Supply |
Duration |
Addtl QL Info |
Allowed Exceptions |
Targeted NDCs When Exclusions Exist |
|
|||||||||
Ampyra |
dalfampridine tab er |
10 MG |
60 |
Tablets |
30 |
DAYS |
|
|
|
CLIENT SUMMARY – PRIOR AUTHORIZATION
Target Brand Agent Name(s) |
Target Generic Agent Name(s) |
Strength |
Client Formulary |
Ampyra |
Dalfampridine Tab ER 12HR 10 MG |
10 MG |
Blue Partner ; Commercial ; Health Insurance Marketplace ; NetResults A Series ; SourceRx |
CLIENT SUMMARY – QUANTITY LIMITS
Target Brand Agent Name(s) |
Target Generic Agent Name(s) |
Strength |
Client Formulary |
Ampyra |
dalfampridine tab er |
10 MG |
Blue Partner ; Commercial ; Health Insurance Marketplace ; NetResults A Series ; SourceRx |
PRIOR AUTHORIZATION CLINICAL CRITERIA FOR APPROVAL
Module |
Clinical Criteria for Approval |
||||||||
|
Initial Evaluation Target Agent(s) will be approved when ALL of the following are met:
Length of Approval: 6 months for MS and 12 months for another FDA approved diagnosis NOTE: If Quantity Limit applies, please refer to Quantity Limit Criteria. *Step therapy requirement may not apply if a prior health plan paid for the medication - documentation of a paid claim may be required.
Renewal Evaluation Target Agent(s) will be approved when ALL of the following are met:
Length of Approval: 12 months NOTE: If Quantity Limit applies, please refer to Quantity Limit Criteria |
QUANTITY LIMIT CLINICAL CRITERIA FOR APPROVAL
Module |
Clinical Criteria for Approval |
QL with PA |
Quantity Limit for the Target Agent(s) will be approved when ONE of the following is met:
Length of Approval: Initial: 6 months for MS and 12 months for another FDA approved diagnosis. Renewal: 12 months |
CLASS AGENTS
Class |
Class Drug Agents |
MS Disease Modifying Agents drug class: CD20 monoclonal antibody |
|
MS Disease Modifying Agents drug class: CD20 monoclonal antibody |
BRIUMVI*ublituximab-xiiy soln for iv infusion |
MS Disease Modifying Agents drug classes: CD20 monoclonal antibody |
|
MS Disease Modifying Agents drug classes: CD20 monoclonal antibody |
KESIMPTA*Ofatumumab Soln Auto-Injector |
MS Disease Modifying Agents drug classes: CD20 monoclonal antibody |
OCREVUS*Ocrelizumab Soln For IV Infusion |
MS Disease Modifying Agents drug classes: CD52 monoclonal antibody |
|
MS Disease Modifying Agents drug classes: CD52 monoclonal antibody |
LEMTRADA*Alemtuzumab IV Inj |
MS Disease Modifying Agents drug classes: Fumarates |
|
MS Disease Modifying Agents drug classes: Fumarates |
BAFIERTAM*Monomethyl Fumarate Capsule Delayed Release |
MS Disease Modifying Agents drug classes: Fumarates |
TECFIDERA*Dimethyl Fumarate Capsule Delayed Release |
MS Disease Modifying Agents drug classes: Fumarates |
VUMERITY*Diroximel Fumarate Capsule Delayed Release |
MS Disease Modifying Agents drug classes: Glatiramer |
|
MS Disease Modifying Agents drug classes: Glatiramer |
COPAXONE*Glatiramer Acetate Soln Prefilled Syringe |
MS Disease Modifying Agents drug classes: Glatiramer |
GLATOPA*Glatiramer Acetate Soln Prefilled Syringe |
MS Disease Modifying Agents drug classes: IgG4k monoclonal antibody |
|
MS Disease Modifying Agents drug classes: IgG4k monoclonal antibody |
TYSABRI*Natalizumab for IV Inj Conc |
MS Disease Modifying Agents drug classes: Interferons |
|
MS Disease Modifying Agents drug classes: Interferons |
AVONEX*Interferon Beta- |
MS Disease Modifying Agents drug classes: Interferons |
BETASERON*Interferon Beta- |
MS Disease Modifying Agents drug classes: Interferons |
EXTAVIA*Interferon Beta- |
MS Disease Modifying Agents drug classes: Interferons |
PLEGRIDY*Peginterferon Beta- |
MS Disease Modifying Agents drug classes: Interferons |
REBIF*Interferon Beta- |
MS Disease Modifying Agents drug classes: Purine antimetabolite |
|
MS Disease Modifying Agents drug classes: Purine antimetabolite |
MAVENCLAD*Cladribine Tab Therapy Pack |
MS Disease Modifying Agents drug classes: Pyrimidine synthesis inhibitor |
|
MS Disease Modifying Agents drug classes: Pyrimidine synthesis inhibitor |
AUBAGIO*Teriflunomide Tab |
MS Disease Modifying Agents drug classes: Sphingosine 1-phosphate (SIP) receptor modulator |
|
MS Disease Modifying Agents drug classes: Sphingosine 1-phosphate (SIP) receptor modulator |
|
MS Disease Modifying Agents drug classes: Sphingosine 1-phosphate (SIP) receptor modulator |
GILENYA*Fingolimod HCl Cap |
MS Disease Modifying Agents drug classes: Sphingosine 1-phosphate (SIP) receptor modulator |
MAYZENT*Siponimod Fumarate Tab |
MS Disease Modifying Agents drug classes: Sphingosine 1-phosphate (SIP) receptor modulator |
PONVORY*Ponesimod Tab |
MS Disease Modifying Agents drug classes: Sphingosine 1-phosphate (SIP) receptor modulator |
TASCENSO*fingolimod lauryl sulfate tablet disintegrating |
MS Disease Modifying Agents drug classes: Sphingosine 1-phosphate (SIP) receptor modulator |
ZEPOSIA*Ozanimod Cap Pack |
This pharmacy policy is not an authorization, certification, explanation of benefits or a contract. Eligibility and benefits are determined on a case-by-case basis according to the terms of the member’s plan in effect as of the date services are rendered. All pharmacy policies are based on (i) information in FDA approved package inserts (and black box warning, alerts, or other information disseminated by the FDA as applicable); (ii) research of current medical and pharmacy literature; and/or (iii) review of common medical practices in the treatment and diagnosis of disease as of the date hereof. Physicians and other providers are solely responsible for all aspects of medical care and treatment, including the type, quality, and levels of care and treatment.
The purpose of Blue Cross and Blue Shield of Alabama’s pharmacy policies are to provide a guide to coverage. Pharmacy policies are not intended to dictate to physicians how to practice medicine. Physicians should exercise their medical judgment in providing the care they feel is most appropriate for their patients.
Neither this policy, nor the successful adjudication of a pharmacy claim, is guarantee of payment.
ALBP _ Commercial _ CSReg _ Ampyra_(dalfampridine)_PAQL _ProgSum_ 04-01-2024 _
© Copyright Prime Therapeutics LLC. January 2024 All Rights Reserved