Triptans for migraine therapy: a comparison based on number needed to treat and doses needed to treat.

OBJECTIVE: Managed care and other decision makers need sound comparative information to support the formulary selection process and reimbursement decisions for the treatment of migraine. The objective of this study was to compare currently marketed triptan therapies using number-needed-to-treat (NNT) and doses-needed-to-treat (DNT) measures. DNT was further used to derive triptan treatment cost to achieve 100 successfully treated patients such that the cost-effectiveness of each treatment regime could be compared from the payer perspective. METHODS: Using published meta-analysis data to categorize patients as treatment success or failure, an NNT and a DNT were derived for each triptan. Treatment success was defined as achieving a 2-hour pain response, sustained through 24 hours postdose. Costs were derived by multiplying DNT by the average wholesale price (AWP) minus 15% for each triptan. RESULTS: Eletriptan 40 mg had the lowest NNT, with 361 patients needing to be treated in order to have 100 patients achieve clinical benefit; rizatriptan 5 mg had the highest NNT (597 patients). Eletriptan 40 mg required 388 doses to successfully treat 100 patients.the lowest number of doses of the triptans considered; rizatriptan 5 mg required the highest number (662 doses). Eletriptan 40 mg had the lowest total triptan cost of USD 5,630 to successfully treat 100 patients. The highest total triptan cost of treatment was USD 11,136 for naratriptan 2.5 mg. CONCLUSIONS: Eletriptan 40 mg provides the best value in terms of the lowest DNT, assuming an approximately equal AWP discount for each triptan. Eletriptan 40 mg also was found to have the lowest total triptan cost to successfully treat 100 patients. Future research should further explore the utility of DNT in managed care decision making.

Functional Assessment in Migraine (FAIM) questionnaire: development of an instrument based upon the WHO's International Classification of Functioning, Disability, and Health.

OBJECTIVE: The goal of this project was to develop a migraine functional measurement instrument, derived from the World Health Organization International Classification of Impairments, Disabilities, and Handicaps version 2 classification system, which focuses on functional outcomes, and is both reliable and valid. METHODS: The Functional Assessment in Migraine (FAIM) questionnaire was developed using a multistep approach to ensure the brevity, relevance, reliability, and validity of items. A test set of 71 Mental Functioning and 50 Activity and Participation items was generated and administered to migraineurs in the United States and Germany. A subset of 22 Mental Functioning and 28 Activity and Participation items that rated highly on frequency-weighted importance and showed strong psychometric properties was piloted to determine a final item set and to test reliability and validity. RESULTS: The final version of the FAIM included nine Mental Functioning items measuring the dimensions of Attention/Thought (5 items) and Perception (4 items), and a list of 28 Activity and Participation items from which respondents chose the five items most relevant to their lifestyle. Construct validity analysis of FAIM dimensions found significant positive correlations with self-reported symptom severity, moderately significant positive correlations with dimensions of the Migraine-Specific Quality of Life questionnaire and no significant correlation with Short Form Health Survey (SF-12) component scores. CONCLUSION: The FAIM offers physicians a brief and valid method of measuring the impact of migraine on mental functioning and activity and participation as defined by the WHO International Classification of Functioning, Disability, and Health. Additional testing is underway to assess its responsiveness to change.

Economic and patient-reported outcomes of oral triptans in the treatment of migraine.

Migraine places a tremendous burden on patients, employers, the healthcare system and society. Triptans often effectively reduce pain and suffering caused by migraine and return patients to their typical routine. Seven triptans are marketed in the USA, and prescribers and payers need information to compare their effectiveness and value. However, studies that compare the treatment and economic impact between the seven triptans are limited. Meta-analyses are a useful source of information to make comparisons between the triptans and provide essential information for clinical and formulary decision makers. Future research should assess and expand upon the use of composite outcome measures that capture the desired response to treatment, consider the placebo effect in migraine, and make comparisons among the available triptans.

An economic evaluation of triptan products for migraine.

OBJECTIVE: A composite outcome measure in migraine treatment assessment is useful to clinical decision-makers and payers as it can provide a more accurate reflection of effectiveness and allows for more complete modeling of economic value. The objective of this study was to compare the total triptan cost to treat 100 migraine patient attacks and the cost per successfully treated patient (CPSTP) for six marketed triptans using a composite measure of effectiveness, the "successfully treated" migraine (defined as requiring only one triptan dose to treat one migraine attack during a 24-h period). METHODS: This analysis was conducted from the perspective of the payer. Clinical data were abstracted from a rigorous, published meta-analysis. Two-hour response and pain-free response were used in conjunction with the recurrence rate reported in the meta-analysis to calculate the number of doses used by treatment successes and failures. The average wholesale price per dose was then used to calculate total triptan cost. RESULTS: Of the nine oral triptan doses compared, eletriptan 40 mg was associated with both the lowest total triptan cost for treating 100 migraine attacks ($1560) and with the lowest CPSTP ($56.39). CONCLUSIONS: The relative CPSTP rankings for migraine therapies are dependent on the definition of treatment success and relative pricing. The results of this study support the use of eletriptan for the treatment of acute migraine based on the model assumptions. This study can be used to assist in formulary considerations and offers a model that can be adapted by health-care decision-makers.

Induction of mucosal protection against primary, heterologous simian immunodeficiency virus by a DNA vaccine.

An effective vaccine against human immunodeficiency virus (HIV) should protect against mucosal transmission of genetically divergent isolates. As a safe alternative to live attenuated vaccines, the immunogenicity and protective efficacy of a DNA vaccine containing simian immunodeficiency virus (SIV) strain 17E-Fr (SIV/17E-Fr) gag-pol-env was analyzed in rhesus macaques. Significant levels of cytotoxic T lymphocytes (CTL), but low to undetectable serum antibody responses, were observed following multiple immunizations. SIV-specific mucosal antibodies and CTL were also detected in rectal washes and gut-associated lymphoid tissues, respectively. Vaccinated and naive control monkeys were challenged intrarectally with SIV strain DeltaB670 (SIV/DeltaB670), a primary isolate whose env is 15% dissimilar to that of the vaccine strain. Four of seven vaccinees were protected from infection as determined by the inability to identify viral RNA or DNA sequences in the peripheral blood and the absence of anamnestic antibody responses postchallenge. This is the first report of mucosal protection against a primary pathogenic, heterologous isolate of SIV by using a commercially viable vaccine approach. These results support further development of a DNA vaccine for protection against HIV.