New opportunities for the management and therapy of hepatitis C in correctional settings.

Hepatitis C in prison populations is now a major public health problem, and large numbers of correctional facilities have no comprehensive management program, often because of formidable projected costs and tightening budget constraints. The North Dakota Department of Corrections and Rehabilitation has operated a management and therapy program since 2002 using consensus interferon and ribavirin with 45% cost savings. The program has provided excellent sustained viral responses: 54.2% for genotype 1 hepatitis C, 75% for genotypes 2 and 3, and 63.6% overall.

Cost-effectiveness study comparing imatinib with interferon-alpha for patients with newly diagnosed chronic-phase (CP) chronic myeloid leukemia (CML) from the Chinese public health-care system perspective (CPHSP).

OBJECTIVE: Imatinib, a breakthrough oral molecular-targeted therapy, has demonstrated durable responses and significant survival advantage compared with interferon-based treatment. This study compares imatinib with interferon in newly diagnosed chronic-phase chronic myeloid leukemia (CML-CP) patients from the Chinese public health-care system perspective (CPHSP). METHODS: One-year cost responder and lifetime cost-utility analyses were conducted, respectively. Complete cytogenetic response was used to define a responder. Direct medical costs were included. Response rates as well as survival estimates were obtained from published literature. RESULTS: The cost per responder for interferon was close to 20 times higher than that for imatinib. The cost per additional responder was RMB36,545. The incremental cost-effectiveness ratio (ICER) comparing imatinib with interferon was RMB73,674 (95% confidence interval RMB67,712-RMB79,637) per quality-adjusted life-year. CONCLUSION: In newly diagnosed CML-CP, the cost per responder for patients treated with imatinib is much lower than that for patients treated with interferon. In the cost-utility analysis, the ICER is below the cost-effectiveness threshold recommended by the World Health Organization for developing countries. Therefore, imatinib is more cost-effective than interferon from the CPHSP.

Utilization, cost trends, and member cost-share for self-injectable multiple sclerosis drugs--pharmacy and medical benefit spending from 2004 through 2007.

BACKGROUND: In 1993, interferon beta-1b became the first of 4 self-injectable multiple sclerosis (MS) drugs to be approved by the U.S. Food and Drug Administration. Initially covered as a medical expense, self-injectable MS drugs are increasingly considered specialty pharmaceuticals and are often covered under the pharmacy benefit. Self-injectable MS drugs are expensive, costing approximately $2,000 per month per patient in 2007. OBJECTIVES: To (1) determine the trends for price and utilization of self-injectable MS drugs, (2) meld medical and pharmacy claims data to capture total health care spending on self-injectable MS drugs, and (3) calculate the out-of-pocket cost-share for members with pharmacy benefits. METHODS: A pharmacy benefits manager with integrated medical claims for approximately 1.8 million commercial members, about 20% of its total of 9 million commercial members, analyzed self-injectable MS pharmacy claims for a 45-month period beginning in January 2004 and ending in September 2007 and integrated medical and pharmacy claims for a 42-month period beginning in January 2004 and ending in June 2007. The 9 million members are beneficiaries of 10 Blue Cross Blue Shield (BCBS) health plans distributed throughout the United States, and the subset of 1.8 million members are enrolled in 1 BCBS health plan in the Northern Plains states. Self-injectable MS drugs were identified using Generic Product Identifier (GPI) codes for the National Drug Code (NDC) numbers on pharmacy claims. Mail order pharmacy claims with up to a 90-day supply were counted as 3 claims, and community pharmacy claims dispensed with up to a 34-day supply were counted as 1 claim. Self-injectable MS drugs were identified from medical claims using Healthcare Common Procedure Coding System (HCPCS) codes: J1595 for glatiramer, J1830 for subcutaneous interferon beta-1b, Q3026 for subcutaneous interferon beta-1a, and Q3025 and J1825 for intramuscular interferon beta-1a. RESULTS: For the approximately 9 million members with data from pharmacy claims only, these 4 self-injectable MS drugs accounted for approximately 1.8% of total pharmacy benefit spending in 2004, 1.9% in 2005, 2.3% in 2006, and 2.4% in 2007. The mean average wholesale price (AWP) per member per month (PMPM) increased by 56.8%, from $1.11 PMPM in the first quarter of 2004 to $1.74 PMPM in the third quarter of 2007. Utilization was flat at about 82-83 claims per 100,000 members per month during the 45-month measurement period. The average annual price increase per unit ranged from 8.9% for interferon beta-1a to 13.3% per year for interferon beta-1b. Members paid a median out-of-pocket cost per pharmacy claim of $15 in 2004, $20 in 2005 and 2006, and $25 in the first 9 months of 2007. For the 1.8 million members with both pharmacy and medical benefit claims, the medical benefit accounted for 2.5% of total spending on MS self-injectables in 2004, 2.0% in 2005 and 2006, and 1.2% in 2007. CONCLUSION: The percentage of all pharmacy expenditures that was attributable to self-injectable MS drugs increased from 1.8% in 2004 to 2.5% in 2007. Nearly all of the increase in spending on self-injectable MS drugs over the nearly 4-year period was attributable to drug price increases because PMPM utilization was essentially unchanged. The median member cost-share was approximately 1% of the total cost of self-injectable MS drugs.

[Cost-utility analisys of multiple sclerosis treatment with glatiramer acetate or interferon beta in Spain]. / Análisis coste utilidad del tratamiento de la esclerosis múltiple remitente-recidivante con acetato de glatiramero o interferón beta en España.

OBJECTIVE: To carry out a cost-utility analysis of the treatment of relapsing-remitting multiple sclerosis (RRMS) with glatiramer acetate (copaxone) or interferon beta (all, avonex, rebif and betaferon). METHODS: A pharmacoeconomic Markov model was used to compare treatment options by simulating the life of a hypothetical cohort of women aged 30, from the societal perspective. The transition probabilities, utilities, resource utilisation and costs (direct and indirect) were obtained from Spanish sources and from bibliography. Univariant sensitivity analyses of the base case were performed. RESULTS: In the base case analysis, the average cost per patient (euro in 2001) for a lifetime treatment, considering a life expectancy of 53 years, would be 1,243,906 euros (euro), 1,818,149 euros, 1,763,263 euros, 1,987,153 euros and 1,704,031 euros with copaxone, all interferons, avonex, rebif and betaferon, respectively. Therefore, the saving with copaxone would range between 460,000 and 737,000 euros approximately. The quality-adjusted life years (QALY) obtained with copaxone or interferons would be 10.977 and 6.917, respectively, with an average gain of 4.060 QALY patient with copaxone. The sensitivity analyses confirmed the robustness of the base case. The interferons would only be superior to copaxone in the unlikely hypothetical case that they delay the progression of the illness by 20% more than that actually observed in clinical trials. CONCLUSIONS: For a typical patient with RRMS, treatment with copaxone would be more efficient than interferons and would dominate (would be more efficacious with lower costs) interferon beta.

Early intervention in multiple sclerosis : better outcomes for patients and society?

Multiple sclerosis (MS) is thought to be a chronic inflammatory disorder of the CNS. The past decade has seen the introduction of the new immunomodulatory drugs, interferon (IFN)-beta and glatiramer acetate, that have considerably improved the therapeutic options for this often disabling disease. The efficacy of these treatments in terms of reducing relapse rate and slowing progression has been proven in several large, multicentre, randomised, controlled trials. Similarly, early IFNbeta treatment of patients with clinically isolated syndromes suggestive of MS has been shown to lengthen time to conversion into definite MS. Cost-effectiveness has been questioned with the increasing use of these innovative and, therefore, costly therapies; however, modern studies with appropriate economic modelling suggest that treatment with IFNbeta may indeed be cost-effective. Since increasing disability is associated with increasing costs, stabilisation of the disease at low functional grades of disability should aim at not only improving quality of life for the individual patient, but provide for prospective cost-benefit analysis focussing on the socioeconomic aspects of MS.

[Comparative results of therapy with amizon and reaferon of patients with chronic viral hepatitis B and C and kidney complications]. / Porivnial'ni rezul'taty likuvannia amizonom i reaferonom khvorykh na khronichnyi virusnyi hepatit B i C z urazhenniam nyrok.

A comparative clinical-and-laboratory investigation was undertaken designed to study efficiency of employment of reaferon and amison in 30 patients with viral hepatitis B and 30 patients with viral hepatitis C and renal lesions. Amison has been shown to significantly reduce or dispel dispeptic events in the above patient populations, with no serious ill effects noted. Amison has proved to be endowed with the ability to exert apparent antiinflammatory, interferonogenic, immunomodulating, and hepatoprotecting effects, and it is much cheaper compared to reaferon.

Cost-effectiveness of interferon-alpha2 as adjuvant therapy in malignant melanoma.

An extensive literature review on clinical trials and economic studies published on the use of IFN-alpha as adjuvant therapy in stage II - III (AJCC 1992) malignant melanoma was performed. Large clinical trials with sufficient follow-up were selected to assess the efficacy. Medico-economic studies, based on the results of several of these trials, were analysed to estimate the cost-effectiveness ratios of IFN in this disease. IFN-alpha demonstrated efficacy as adjuvant therapy in malignant melanoma with high-dose regimens in patients with overt regional nodal disease (so-called high-risk patients) and with low-dose regimens in stage IIA and -B patients without clinically detectable nodes (so-called intermediate risk patients). This efficacy was associated with high rates of severe side effects using a high-dose regimen. Based on these assumptions, economic analyses performed in different settings and using several methods to extrapolate clinical results are producing similar results of extra costs for IFN associated with a medical benefit. Incremental cost-effectiveness ratios provided are (< US dollars 50,000 per life year gained) in the range of current and widely used medical strategies in different diseases and settings. This should allow the recommendation of the use of IFN-alpha therapy in malignant melanoma, using high doses in high-risk patients and low doses in intermediate-risk patients. In the final decision of whether or not to treat, however, the patient has to be informed that IFN will probably only delay events, with the possibility of any curative effect being uncertain. This limited effect has to be balanced with the severe impact on quality of life of high-dose regimen and with the fact that many patients in whom low doses are indicated would not recur in the absence of treatment. It is also clear that patients with only a positive sentinel node are to be considered with the intermediate risk group in which they were evaluated.

FDA approves new combination treatment for hepatitis C. Food and Drug Administration.

AIDS: The Food and Drug Administration (FDA) approved ribavirin (Rebetol) plus interferon-alpha for the treatment of hepatitis C, a liver infection that can progress from liver deterioration to death. The new combination treatment is more effective than interferon-alpha alone; however it is costly and may cause significant side effects. The treatment involves receiving interferon-alpha injections and ribavirin capsules over six months. The new combination was approved in response to the number of patients who relapse or do not respond to the standard interferon-alpha treatment.^ieng

Interferon-alpha for viral hepatitis.

IFN-alpha has emerged as a promising treatment of chronic viral hepatitis. Although therapeutic response to IFN is far from universal, efficacy has been demonstrated; and studies combining IFN-alpha with other agents, as well as trials with new preparations of IFN-alpha, are under way. Children do not represent a large part of the identified population with chronic viral hepatitis. Yet children, by simple virtue of age, are more recently infected. In addition, longer life expectancies can be expected to be associated with greater morbidity from chronic viral hepatitis. Children seem to tolerate therapy with IFN-alpha well. Treatment of children with chronic viral hepatitis should be strongly considered, with protocols designed to ascertain specific pediatric safety and efficacy.

Low doses of interferon-alpha are as effective as higher doses in inducing remissions and prolonging survival in chronic myeloid leukemia.

OBJECTIVE: To determine the toxicity and efficacy of low-dose interferon-alpha therapy in inducing remissions and prolonging survival in patients with chronic myeloid leukemia. DESIGN: Phase II evaluation and comparison with historical control patients and other series in which the investigators used higher interferon-alpha doses. SETTING: Tertiary care leukemia research clinic. PATIENTS: 41 patients with newly diagnosed or previously treated chronic-phase, Philadelphia chromosome-positive chronic myeloid leukemia received interferon-alpha at a dose of 2 x 10(6) U/m2 body surface area daily for 28 days and then three times weekly. MEASUREMENTS: Complete blood counts and physical examinations were done monthly to determine hematologic remission and toxicity. To determine karyotypic response, bone marrow cytogenetic analyses were done at 6 monthly intervals in patients who achieved a complete hematologic remission. In addition, Kaplan-Meier survival curves and median survival values were generated from diagnosis and the start of therapy with interferon-alpha. RESULTS: 70% of patients treated with low-dose interferon-alpha within 1 year of diagnosis achieved a complete hematologic remission, and 22% of these patients had a major or complete karyotypic response. Investigators who used higher interferon-alpha doses in similar patient populations have reported complete hematologic remission rates of 59% to 70% and major and complete cytogenetic response rates of 16% to 29%. The Kaplan-Meier estimated 5-year survival rate of minimally pretreated patients in our study is 73% (95% CI, 51% to 95%), which compares favorably with survivals reported by investigators who used higher doses. The estimated yearly cost of the interferon-alpha used in our study is $5953 compared with a median of $24,375 for the higher doses used by other investigators. Less toxicity was also observed. CONCLUSION: Low-dose interferon-alpha is as effective as higher-dose interferon-alpha in inducing remissions and prolonging survival in patients with chronic myeloid leukemia but is considerably less expensive and toxic.

Intralesional alpha interferon. Cost-effective therapy for vulvar vestibulitis syndrome.

The cost-effectiveness of two treatment strategies for vulvar vestibulitis syndrome (VVS) was compared. Our prospective study consisted of 55 patients with human papillomavirus (HPV)- and non-HPV-associated VVS of at least 6 months' duration treated with intralesional recombinant alpha interferon injections, followed by surgery for nonresponders and responders compared with a hypothetical model of surgery alone. The setting was a private-practice multispecialty center for vulvovaginal disorders. Improvement was defined by patients' subjective evaluation of change in the level of introital dyspareunia and the ability to have sexual relations and objective evidence of change in the degree of erythema and tenderness to touch within the vestibule. Statistical analyses of the overall probability of improvement, overall costs and the cost per patient treated were done. Twenty-seven (49%) of 55 patients treated with alpha interferon had substantial or partial improvement. Of the 28 (51%) who did not improve following alpha interferon, 19 elected to have surgery. Surgery resulted in substantial improvement in 84% of the patients and partial improvement in 11%. Statistical analysis comparing the group treated with alpha interferon (some of whom went to surgery with the hypothetical model of surgical treatment alone) showed significant cost-saving in the group first treated with alpha interferon. At the level of effectiveness achieved in this study, intralesional alpha interferon as a first choice in the treatment of VVS is cost-effective.