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B.C. Pharmacare Drug Information Sheet for Safinamide (Onstryv)

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B.C. Pharmacare Drug Information Sheet for Safinamide (Onstryv) The drug below is being considered for possible coverage under the B.C. PharmaCare program. PharmaCare is a government-funded drug plan that helps British Columbians with the cost of eligible prescription drugs and specific medical supplies. For more information on PharmaCare, visit Ministry of Health - PharmaCare. PharmaCare reviews each drug for treating a specific illness or medical condition (known as an “indication”). If a decision is made to cover the drug, it will be only for that illness or condition. In some cases, PharmaCare may cover a drug only for people who have the illness or condition and have not responded to other drugs used to treat that illness or condition. For more information on PharmaCare’s drug coverage review process, see the last page of this information sheet. Information about the drug Generic name (scientific name) safinamide Brand name Onstryv® Manufacturer Valeo Pharma Inc. Indication Onstryv® is used to treat Parkinson’s Disease. Has the drug been reviewed by Yes the Common Drug For more information about the CDR’s review of safinamide (Onstryv®), you can Review (CDR)? Search the CDR Reports. (see the note below this table.) Public input start date Wednesday, September 18, 2019 Public input closing date Wednesday, October 16, 2019 AT MIDNIGHT How is the drug taken? Onstryv® is taken orally with water. How often is the drug taken? Onstryv® is taken once a day at a starting dose of 50 mg. After two weeks, dosing may be increased to 100 mg a day based on patient need and tolerability. Ministry of Health Pharmaceutical Services Division Page 1 of 4 BC PharmaCare Drug Information — safinamide (Onstryv®) continued… Information about the drug General drug and/or drug Parkinson’s disease is a long-term degenerative disorder of the central nervous system study information that mainly affects the motor system. Patients with Parkinson’s disease are thought to have insufficient amounts of dopamine, a chemical produced by the brain that allows nerve impulses to travel smoothly from one nerve to another. Patients with Parkinson’s disease suffer from characteristic resting tremor, rigidity, bradykinesia (slowness of movement) and postural instability, leading to loss of control of voluntary movement. Onstryv® belongs to a group of drugs called Monoamine Oxidase Type B (MAO-B) inhibitors. Onstryv® contains the active ingredient safinamide, which works to block the breakdown of dopamine and increase the amount of it in the brain. It is an add-on therapy to a treatment regimen that already includes levodopa. Studies looked at the following to determine if Onstryv® is safe and effective for the treatment of Parkinson’s disease: • Assessment of Parkinson’s symptoms using standard measurement scales • Assessment of ON or OFF states (i.e., a period of time where medication was providing benefit with regard to mobility, stiffness and slowness and where a patient felt he/she could perform normal daily activities) • Cognitive function • Mood (depression) • Health-related quality of life • Mortality • Bad reactions • Serious bad reactions • Patients leaving the trial due to bad reactions • Bad reactions of special interest (constipation, loss of control of voluntary movement, hallucinations, impulsive behaviour, insomnia, skin cancer, nausea, low blood pressure when standing quickly, serotonin syndrome, vomiting) Other considerations None Note: The Common Drug Review (CDR) is a national organization that reviews drugs on behalf of Canadian public sector plans when manufacturers want to have the jurisdictions provide coverage for the drugs. For detailed information on B.C. PharmaCare’s drug review process, including the role of the CDR in that process, see The Drug Review Process in B.C. - Overview. Ministry of Health Pharmaceutical Services Division Page 2 of 4 BC PharmaCare Drug Information — safinamide (Onstryv®) continued… Cost of the drug under review compared to other drugs used to treat the same indication generic name PharmaCare Status Usual Dose Annual Cost of Therapy (Brand Name) of (if and how the drug is Drug Comparator already covered) Once daily by mouth, with Safinamide (Onstryv®) Under Review potential to double the dose $2,520a after two weeks Dopamine Agonists Two to three doses by Bromocriptine (generics) Regular Benefit $372 to $4,453 mouth daily Pramipexole (generics) Limited Coverage Three doses by mouth daily $427 Ropinirole (generics) Limited Coverage Three doses by mouth daily $311 to $1,367 Rotigotine (Neupro®) Limited Coverage Apply patch once daily $1,292 to $5,307 Oral Levodopa/Decarboxylase Inhibitor Combinations Levodopa-benserazide Five to six doses by mouth Regular Benefit $1,614 to $1,937 (Prolopa®) daily Levodopa-carbidopa Three to four doses by Regular Benefit $242 to $540 (generics) mouth daily Levodopa-carbidopa Two to four doses by mouth (generics) Regular Benefit $260 to $2,078 daily controlled-release COMT Inhibitors Multiple doses by mouth Entacapone (generics) Limited Coverage $146 to $1,171 daily Levodopa-carbidopa- Multiple doses by mouth Limited Coverage $1,913 to $5,102 entacapone (Stalevo®) daily MAO-B Inhibitors Rasagiline (generics) Non-Benefit Once daily by mouth $2,237 Selegiline (generics) Regular Benefit Twice daily by mouth $367 Other Once or twice daily by Amatadine (generics) Regular Benefit $192 to $383 mouth All prices are as per the CADTH Common Drug Review Pharmacoeconomic Review Report for safinamide. a Manufacturer’s submitted price. Ministry of Health Pharmaceutical Services Division Page 3 of 4 BC PharmaCare Drug Information — safinamide (Onstryv®) continued… The Drug Review Process in B.C. A manufacturer submits a request to the Ministry of Health (Ministry). An independent group called the Drug Benefit Council (DBC) gives advice to the Ministry. The DBC looks at: • whether the drug is safe and effective • advice from a national group called the Common Drug Review (CDR) • what the drug costs and whether it is a good value for the people of B.C. • ethical considerations involved with covering or not covering the drug • input from physicians, patients, caregivers, patient groups and drug submission sponsors The Ministry makes PharmaCare coverage decisions by taking into account: • the existing PharmaCare policies, programs and resources • the evidence-informed advice of the DBC • the drugs already covered by PharmaCare that are used to treat similar medical conditions • the overall cost of covering the drug For more information about the B.C. Drug Review Process, visit: The Drug Review Process in B.C. - Overview. This document is intended for information only. It does not take the place of advice from a physician or other qualified health care provider. Ministry of Health Pharmaceutical Services Division Page 4 of 4 .
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