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Oral medication. --- Oral mucosa.

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eebo-0021

Oral medication --- Pharmacy

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Sapropterin (SAP) (Kuvan) is indicated in conjunction with a phenylalanine (Phe)-restricted diet to reduce blood Phe levels in patients with hyperphenylalaninemia (HPA) due to tetrahydrobiopterin (BH4)-responsive phenylketonuria (PKU). The initial dosage is 20 mg/kg/day administered orally for a period of up to 1 month. Once responsiveness to sapropterin (SAP) has been established, the dosage may be adjusted within the range of 5 to 20 mg/kg/day according to response to therapy. The confidential price per 100 mg tablet is 33.00 dollar. Based on representative body weight values obtained from trials of SAP, and depending upon dosage, annual costs for an 11 kg patient were estimated at 12,000 dollar to 36,000 dollar; for a 29 kg patient, 24,000 to 72,000 dollar; and for a 68 kg patient, 48,000 dollar to 169,000 dollar. SAP was originally submitted to the CADTH Common Drug Review (CDR) in 2010, and in January 2011, the Canadian Expert Drug Advisory Committee (CEDAC) issued a Final Recommendation that Kuvan not be listed. The key reason for the recommendation was that patient details were insufficient to identify a subpopulation for whom SAP may provide a significant clinical benefit that is cost-effective. A Request for Advice regarding SAP was submitted to CDR by CDR-participating drug plans in October 2011, which did not result in any changes to the recommendation. The basis for the current resubmission is the availability of new clinical evidence. Following the 2011 CEDAC recommendation, provincial reimbursement of Kuvan has occurred in Ontario (as of February 2013) and Saskatchewan (as of September 2013). The manufacturer states that reimbursement criteria in these provinces were developed with the understanding that new data would be forthcoming about the effectiveness and appropriate use of SAP to treat patients with PKU. The submitted price for SAP is the same as in the 2010 submission; however, a revised cost-effectiveness model was provided as part of the resubmission.

Oral medication. --- Cost effectiveness.

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This report addresses the following question: Is there a difference in efficacy between oral and intravenous antibiotic treatment of infectious diseases for large and important groups of patients. The report does not answer the question of when (how soon) you can change from intravenous to oral treatment. Methods We based this systematic review of a search for other systematic reviews in relevant bibliographic databases. For pneumonia and urinary tract infections, we also searched for randomized controlled trials. We compiled, analysed and graded the quality of the documentation. We summarized the results for six main outcomes: Total mortality, cure rates, treatment failure, re-admissions, length of stay in hospital and serious side effects. Results We included six systematic reviews which evaluated the effect of oral versus intravenous administration of antibiotics for pneumonia, urinary tract infection, osteomyelitis, spontaneous bacterial peritonitis, and febrile neutropenia in cancer patients. In addition, we included 10 randomized controlled trials. On the whole, we did not find significant differences between oral and intravenous administration of antibiotics. The quality of this documentation is low and the estimates are therefore uncertain. Conclusion The documentation provides no basis for determining whether there is difference in efficacy and side effects of oral versus intravenous administration of antibiotics. This does not mean that there are no differences in the administration route, but the results are too uncertain for us to draw conclusions about this.

Oral medication. --- Pneumonia --- Treatment --- Cost effectiveness.

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Oral medication. --- Type 2 diabetes --- Treatment.