Pharmacoeconomic review report: Nitisinone (Nitisinone tablets) (Cycle Pharmaceuticals Ltd.) indication : for the treatment of patients with hereditary tyrosinemia type 1 in combination with dietary restriction of tyrosine and phenylalanine

Nitisinone (Nitisinone Tablets) is indicated for the treatment of hereditary tyrosinemia type 1 (HT-1) in combination with dietary restriction of tyrosine and phenylalanine. Nitisinone Tablets are available in 2 mg, 5 mg, and 10 mg strengths. The submitted price of nitisinone is based on dose: 2 mg...

Full description

Bibliographic Details
Corporate Author: Canadian Agency for Drugs and Technologies in Health
Format: eBook
Language:English
Published: Ottawa (ON) Canadian Agency for Drugs and Technologies in Health 2018, August 2018
Series:CADTH common drug review
Subjects:
Online Access:
Collection: National Center for Biotechnology Information - Collection details see MPG.ReNa
LEADER 03126nam a2200313 u 4500
001 EB001872276
003 EBX01000000000000001035647
005 00000000000000.0
007 tu|||||||||||||||||||||
008 190824 r ||| eng
245 0 0 |a Pharmacoeconomic review report: Nitisinone (Nitisinone tablets) (Cycle Pharmaceuticals Ltd.)  |h Elektronische Ressource  |b indication : for the treatment of patients with hereditary tyrosinemia type 1 in combination with dietary restriction of tyrosine and phenylalanine 
246 3 1 |a Pharmacoeconomic review report for nitisinone tablets 
246 3 1 |a Nitisinone (Nitisinone tablets) (Cycle Pharmaceuticals Ltd.) 
260 |a Ottawa (ON)  |b Canadian Agency for Drugs and Technologies in Health  |c 2018, August 2018 
300 |a 1 PDF file (27 pages)  |b illustrations 
505 0 |a Includes bibliographical references 
653 |a Enzyme Inhibitors / therapeutic use 
653 |a Canada 
653 |a Tyrosinemias / drug therapy 
653 |a Enzyme Inhibitors / economics 
653 |a Cost-Benefit Analysis 
710 2 |a Canadian Agency for Drugs and Technologies in Health 
041 0 7 |a eng  |2 ISO 639-2 
989 |b NCBI  |a National Center for Biotechnology Information 
490 0 |a CADTH common drug review 
500 |a "Version: Final." 
856 4 0 |u https://www.ncbi.nlm.nih.gov/books/NBK539410  |3 Volltext  |n NLM Bookshelf Books  |3 Volltext 
082 0 |a 330 
520 |a Nitisinone (Nitisinone Tablets) is indicated for the treatment of hereditary tyrosinemia type 1 (HT-1) in combination with dietary restriction of tyrosine and phenylalanine. Nitisinone Tablets are available in 2 mg, 5 mg, and 10 mg strengths. The submitted price of nitisinone is based on dose: 2 mg ($12.95), 5 mg ($25.06), and 10 mg ($47.40). The recommended initial dose is 1 mg/kg body weight daily divided into two doses, administered orally. Patients whose plasma and urine succinylacetone are still detectable one month after starting treatment should be increased to 1.5 mg/kg/day, with a maximum of 2 mg/kg/day, based on the evaluation of all clinical parameters. If biochemical response is satisfactory, dosage should only be adjusted according to body weight. The CADTH Common Drug Review (CDR) previously reviewed another brand of nitisinone (Orfadin) for the treatment of HT-1; the CADTH Canadian Drug Expert Committee (CDEC) recommended that nitisinone (Orfadin) be reimbursed for the treatment of adult and pediatric patients with an established diagnosis of HT-1 in combination with dietary restriction of tyrosine and phenylalanine if the following conditions are met: the drug is prescribed by a physician with experience in the diagnosis and management of HT-1, and the price is reduced by at least 74%. CDR recently reviewed a third nitisinone product (MDKNitisinone), with a similar recommendation, noting that the cost of MDK-Nitisinone should not exceed the cost of other nitisinone products. The manufacturer submitted a Markov state-transition model comparing Nitisinone Tablets with diet restriction to diet restriction alone for newborn patients newly diagnosed with HT-1