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Exceptional Access Program criteria on record (ministry list dated 2025-01-01, not exhaustive): Ministry criteria list dated January 1, 2025; the program's current criteria may differ; SADIE shows the current version. https://www.ontario.ca/page/sadie-special-authorization-digital-information-exchange Sapropterin Brand(s): Kuvan DOSAGE FORM/ STRENGTH: 100 mg tablet Effective date: February 20, 2013; Updated December 2, 2020 Ongoing funding of sapropterin (Kuvan) will be considered through the EAP for non-pregnant patients and patients actively planning pregnancy who have a diagnosis of Phenylketonuria(PKU) and who have demonstrated a response to the initial 6 month trial of sapropterin [generally reimbursed through the Biomarin, the manufacturer of Kuvan]. Initial Criteria for the Trial Period ( First 6 months) For the management of patients with the diagnosis of hyperphenylalaninemia (HPA) due to tetrahydrobiopterin (BH4)-responsive phenylketonuria (PKU) who meet ALL of the following criteria: 1. Diagnosis of PKU confirmed through an approved test. 2. Compliance with low protein diet and formulas. 3. Documented baseline blood phenylalanine (Phe) levels, which have been measured at least twice during a 3 to 6 month period, are greater than 360 μmol/L despite compliance with a low protein diet; 4. Baseline protein intake assessment by a dietitian. Ability to comply with their medication regimen 5. Managed by a prescriber specialized in metabolic/ biochemical diseases. 6. the Patient’s blood Phe tolerance levels will be documented at months 1 to 2 and 4 to 6 during the Trial Period. Modified Criteria for Pregnant Patients during the 6 month trial period: 1. Patient has a diagnosis of PKU confirmed through an approved test 2. Patient’s treatment is being managed by a prescriber specialized in metabolic/biochemical diseases; and 3. Patient’s baseline blood Phe level is greater than 360 μmol/L despite compliance with all recommendations for dietary intervention and monitoring or compliance with a low protein diet. In the case of Patients who are eligible for but do not utilize the Patient support program for a 185-day or 6-month trial. Executive Officer will approve a request to reimburse claims for Kuvan at a dosage of up to 20mg/kg per day for the trial period of up to 6 months provided that the above conditions are met. 193 Sapropterin Brand(s): Kuvan DOSAGE FORM/ STRENGTH: 100 mg tablet Approval Duration: 6 months Funding Criteria for Kuvan in the Post Trial Period: Patients must have demonstrated the response as per the trial criteria to be funded following the 6 month trial period. Initial Criteria Post Trial: For the management of patients with the diagnosis of hyperphenylalaninemia (HPA) due to tetrahydrobiopterin (BH4)-responsive phenylketonuria (PKU) who meet ALL of the following criteria: 1. Compliance with low protein diet, formulas, and Kuvan; AND 2. During the 6 month trial period under EAP or PSP patient has achieved one of more of the following: i) a demonstrated response to the Kuvan responsiveness test or PKU clinical protocol, based on the following information: ii) the clinic’s definition for response; and iii) all relevant laboratory results used to determine that the Patient was a responder to Kuvan 3. Patient meets one of the following: i) normal sustained Blood Phe levels [ > 120 μmol/L and < 360 μmol/L] (At least 2 levels measured at least 1 month apart); OR ii) sustained blood Phe reduction of at least 30% (At least 2 levels measured at least 1 month apart)compared to baseline if the Phe baseline level is < 1200 μmol/L; OR iii) sustained blood Phe reduction of at least 50% (At least 2 levels measured at least 1 month apart) compared to baseline if the Phe baseline level is > 1200 μmol/L; 4. Demonstrated an increase in dietary protein tolerance based on targets set between the clinician and patient 5. Managed by a prescriber specialized in metabolic/ biochemical diseases. Dosage: Up to a maximum of 20 mg/kg per day Approval Duration: 1 year 194 Sapropterin Brand(s): Kuvan DOSAGE FORM/ STRENGTH: 100 mg tablet Renewal Criteria: Renewals will be considered for patients meeting the following criteria: 1. Demonstrates ongoing response to treatment; AND 2. Complies with and will continue to comply with a low protein diet, formulas, and treatment with Kuvan; AND 3. the request for extended coverage includes a recent follow-up from a prescriber specialized in metabolic/biochemical diseases. Exclusion Criteria for both Initial (Trial and Post Trial period) and Renewal criteria: (Patients meeting any of the following criteria will not be funded) • the Patient is not on a low protein diet or is not compliant with their low protein diet; or • the Patient has a baseline blood PHe level less than 360 μmol/L prior to initiating therapy with Kuvan. Dosage: Up to a maximum of 20 mg/kg per day Approval Duration: 1 year 195  EAP source: eap-frequently-requested-drugs-2025-01-01.txt, page 193, record 111, corpus 2025-01-01; name match only, not an eligibility decision

Turnaround times The Exceptional Access Program receives between 250 and 500 requests a day. Requests are categorized in order of priority based on how quickly a drug is needed, the type of drug, and the condition for which the drug is being used. Turnaround times begin on the business day on which the EAP receives a complete request from a physician or nurse practitioner. You may have to wait longer if the request is missing information or supporting documents required by the EAP criteria, if a request requires external review, or if documents are sent by fax or mail instead of submitted via SADIE. EAP Weekly Progress Report Date: September 15, 2026 Processing categories and examples | Target | Current | Priority 1 — for drugs such as antibiotics, cancer medications, and initial requests for pain medications | 3 business days | 2 business day | Priority 2 — for antiviral drugs to treat HIV, drugs for multiple sclerosis, and pulmonary hypertension | 5 business days | 3 business days | Biologics — for biologic drugs to treat rheumatoid arthritis, psoriatic arthritis, ulcerative colitis and Crohn’s disease | 10 business days | 4 business days | Chronic — for drugs used for chronic conditions such as migraines, chronic pain, Ménière's disease and symptoms of Parkinson’s disease. | 4 to 6 weeks | 11 business days | (ontario.ca, Updated September 15, 2026 ↗) For selected drugs, the Telephone Request Service is available to authorized prescribers or their delegates. In most cases, the funding decision is provided by the end of the call and processed within one business day. (ontario.ca, Updated September 15, 2026 ↗)

Kuvan · DIN 02482207 Manufacturer: BioMarin International Ltd.; listing date 2024-01-31 Health Canada: Marketed since 2019-12-05 · brand KUVAN · ATC A16AX07 SAPROPTERIN · form Powder · route Oral · ingredients SAPROPTERIN DIHYDROCHLORIDE 100 MG/SACHET · company Biomarin international limited · schedule Prescription

DIN 02482207: Kuvan Raw flags: notABenefit=Y, sec3=Y, sec3b=Y Item: 920000778; group id 954; item number 2267; lccId None; manufacturer id BIM Source form: Pd for Sol (Sachet Pk); strength: 100mg Recorded listing: Off-Formulary Interchangeable, not an ODB benefit Source prices (unrounded): not recorded; ministry not recorded Source: ODB odb-formulary-ed43-extract-2026-08-26.xml extract_date=2026-08-26 DIN=02482207 Health Canada DPD extract of Sep 2, 2026 (Open Government Licence – Canada) · https://health-products.canada.ca/dpd-bdpp/info?lang=eng&code=97268

Interchangeable products

Reddy-Sapropterin · DIN 02534533 · not recorded

Shortage status: no shortage or discontinuation reported (checked 2026-09-13T08:10:21.292534+00:00); reports as of 2026-09-13T08:10:21.292534+00:00 (Health Product Shortages Canada) Source: https://healthproductshortages.ca/search?term=02482207

Shortage record checked 2026-09-13T08:10:21.292534+00:00

Exceptional Access criteria on record are for Brand(s): Kuvan; DOSAGE FORM/ STRENGTH: 100 mg tablet — not this product; no criteria on record for this product in this block. Exceptional Access Program criteria on record (ministry list dated 2025-01-01, not exhaustive): Ministry criteria list dated January 1, 2025; the program's current criteria may differ; SADIE shows the current version. https://www.ontario.ca/page/sadie-special-authorization-digital-information-exchange Sapropterin Brand(s): Kuvan DOSAGE FORM/ STRENGTH: 100 mg tablet Effective date: February 20, 2013; Updated December 2, 2020 Ongoing funding of sapropterin (Kuvan) will be considered through the EAP for non-pregnant patients and patients actively planning pregnancy who have a diagnosis of Phenylketonuria(PKU) and who have demonstrated a response to the initial 6 month trial of sapropterin [generally reimbursed through the Biomarin, the manufacturer of Kuvan]. Initial Criteria for the Trial Period ( First 6 months) For the management of patients with the diagnosis of hyperphenylalaninemia (HPA) due to tetrahydrobiopterin (BH4)-responsive phenylketonuria (PKU) who meet ALL of the following criteria: 1. Diagnosis of PKU confirmed through an approved test. 2. Compliance with low protein diet and formulas. 3. Documented baseline blood phenylalanine (Phe) levels, which have been measured at least twice during a 3 to 6 month period, are greater than 360 μmol/L despite compliance with a low protein diet; 4. Baseline protein intake assessment by a dietitian. Ability to comply with their medication regimen 5. Managed by a prescriber specialized in metabolic/ biochemical diseases. 6. the Patient’s blood Phe tolerance levels will be documented at months 1 to 2 and 4 to 6 during the Trial Period. Modified Criteria for Pregnant Patients during the 6 month trial period: 1. Patient has a diagnosis of PKU confirmed through an approved test 2. Patient’s treatment is being managed by a prescriber specialized in metabolic/biochemical diseases; and 3. Patient’s baseline blood Phe level is greater than 360 μmol/L despite compliance with all recommendations for dietary intervention and monitoring or compliance with a low protein diet. In the case of Patients who are eligible for but do not utilize the Patient support program for a 185-day or 6-month trial. Executive Officer will approve a request to reimburse claims for Kuvan at a dosage of up to 20mg/kg per day for the trial period of up to 6 months provided that the above conditions are met. 193 Sapropterin Brand(s): Kuvan DOSAGE FORM/ STRENGTH: 100 mg tablet Approval Duration: 6 months Funding Criteria for Kuvan in the Post Trial Period: Patients must have demonstrated the response as per the trial criteria to be funded following the 6 month trial period. Initial Criteria Post Trial: For the management of patients with the diagnosis of hyperphenylalaninemia (HPA) due to tetrahydrobiopterin (BH4)-responsive phenylketonuria (PKU) who meet ALL of the following criteria: 1. Compliance with low protein diet, formulas, and Kuvan; AND 2. During the 6 month trial period under EAP or PSP patient has achieved one of more of the following: i) a demonstrated response to the Kuvan responsiveness test or PKU clinical protocol, based on the following information: ii) the clinic’s definition for response; and iii) all relevant laboratory results used to determine that the Patient was a responder to Kuvan 3. Patient meets one of the following: i) normal sustained Blood Phe levels [ > 120 μmol/L and < 360 μmol/L] (At least 2 levels measured at least 1 month apart); OR ii) sustained blood Phe reduction of at least 30% (At least 2 levels measured at least 1 month apart)compared to baseline if the Phe baseline level is < 1200 μmol/L; OR iii) sustained blood Phe reduction of at least 50% (At least 2 levels measured at least 1 month apart) compared to baseline if the Phe baseline level is > 1200 μmol/L; 4. Demonstrated an increase in dietary protein tolerance based on targets set between the clinician and patient 5. Managed by a prescriber specialized in metabolic/ biochemical diseases. Dosage: Up to a maximum of 20 mg/kg per day Approval Duration: 1 year 194 Sapropterin Brand(s): Kuvan DOSAGE FORM/ STRENGTH: 100 mg tablet Renewal Criteria: Renewals will be considered for patients meeting the following criteria: 1. Demonstrates ongoing response to treatment; AND 2. Complies with and will continue to comply with a low protein diet, formulas, and treatment with Kuvan; AND 3. the request for extended coverage includes a recent follow-up from a prescriber specialized in metabolic/biochemical diseases. Exclusion Criteria for both Initial (Trial and Post Trial period) and Renewal criteria: (Patients meeting any of the following criteria will not be funded) • the Patient is not on a low protein diet or is not compliant with their low protein diet; or • the Patient has a baseline blood PHe level less than 360 μmol/L prior to initiating therapy with Kuvan. Dosage: Up to a maximum of 20 mg/kg per day Approval Duration: 1 year 195  EAP source: eap-frequently-requested-drugs-2025-01-01.txt, page 193, record 111, corpus 2025-01-01; name match only, not an eligibility decision

Reddy-Sapropterin · DIN 02534533 Manufacturer: Dr. Reddy's Laboratories Inc.; listing date 2024-01-31 Health Canada: Marketed since 2023-12-11 · brand REDDY-SAPROPTERIN · ATC A16AX07 SAPROPTERIN · form Powder for solution · route Oral · ingredients SAPROPTERIN DIHYDROCHLORIDE 100 MG/SACHET · company Dr reddy's laboratories ltd · schedule Prescription

DIN 02534533: Reddy-Sapropterin Raw flags: notABenefit=Y, sec3=Y, sec3b=Y Item: 920000778; group id 954; item number 2267; lccId None; manufacturer id DRR Source form: Pd for Sol (Sachet Pk); strength: 100mg Recorded listing: Off-Formulary Interchangeable, not an ODB benefit Source prices (unrounded): $24.7500; ministry not recorded Source: ODB odb-formulary-ed43-extract-2026-08-26.xml extract_date=2026-08-26 DIN=02534533 Health Canada DPD extract of Sep 2, 2026 (Open Government Licence – Canada) · https://health-products.canada.ca/dpd-bdpp/info?lang=eng&code=102345

Interchangeable products

Kuvan · DIN 02482207 · not recorded

Shortage status: no shortage or discontinuation reported (checked 2026-09-13T08:10:21.292534+00:00); reports as of 2026-09-13T08:10:21.292534+00:00 (Health Product Shortages Canada) Source: https://healthproductshortages.ca/search?term=02534533

Shortage record checked 2026-09-13T08:10:21.292534+00:00

Exceptional Access criteria on record are for Brand(s): Kuvan; DOSAGE FORM/ STRENGTH: 100 mg tablet — not this product; no criteria on record for this product in this block. Exceptional Access Program criteria on record (ministry list dated 2025-01-01, not exhaustive): Ministry criteria list dated January 1, 2025; the program's current criteria may differ; SADIE shows the current version. https://www.ontario.ca/page/sadie-special-authorization-digital-information-exchange Sapropterin Brand(s): Kuvan DOSAGE FORM/ STRENGTH: 100 mg tablet Effective date: February 20, 2013; Updated December 2, 2020 Ongoing funding of sapropterin (Kuvan) will be considered through the EAP for non-pregnant patients and patients actively planning pregnancy who have a diagnosis of Phenylketonuria(PKU) and who have demonstrated a response to the initial 6 month trial of sapropterin [generally reimbursed through the Biomarin, the manufacturer of Kuvan]. Initial Criteria for the Trial Period ( First 6 months) For the management of patients with the diagnosis of hyperphenylalaninemia (HPA) due to tetrahydrobiopterin (BH4)-responsive phenylketonuria (PKU) who meet ALL of the following criteria: 1. Diagnosis of PKU confirmed through an approved test. 2. Compliance with low protein diet and formulas. 3. Documented baseline blood phenylalanine (Phe) levels, which have been measured at least twice during a 3 to 6 month period, are greater than 360 μmol/L despite compliance with a low protein diet; 4. Baseline protein intake assessment by a dietitian. Ability to comply with their medication regimen 5. Managed by a prescriber specialized in metabolic/ biochemical diseases. 6. the Patient’s blood Phe tolerance levels will be documented at months 1 to 2 and 4 to 6 during the Trial Period. Modified Criteria for Pregnant Patients during the 6 month trial period: 1. Patient has a diagnosis of PKU confirmed through an approved test 2. Patient’s treatment is being managed by a prescriber specialized in metabolic/biochemical diseases; and 3. Patient’s baseline blood Phe level is greater than 360 μmol/L despite compliance with all recommendations for dietary intervention and monitoring or compliance with a low protein diet. In the case of Patients who are eligible for but do not utilize the Patient support program for a 185-day or 6-month trial. Executive Officer will approve a request to reimburse claims for Kuvan at a dosage of up to 20mg/kg per day for the trial period of up to 6 months provided that the above conditions are met. 193 Sapropterin Brand(s): Kuvan DOSAGE FORM/ STRENGTH: 100 mg tablet Approval Duration: 6 months Funding Criteria for Kuvan in the Post Trial Period: Patients must have demonstrated the response as per the trial criteria to be funded following the 6 month trial period. Initial Criteria Post Trial: For the management of patients with the diagnosis of hyperphenylalaninemia (HPA) due to tetrahydrobiopterin (BH4)-responsive phenylketonuria (PKU) who meet ALL of the following criteria: 1. Compliance with low protein diet, formulas, and Kuvan; AND 2. During the 6 month trial period under EAP or PSP patient has achieved one of more of the following: i) a demonstrated response to the Kuvan responsiveness test or PKU clinical protocol, based on the following information: ii) the clinic’s definition for response; and iii) all relevant laboratory results used to determine that the Patient was a responder to Kuvan 3. Patient meets one of the following: i) normal sustained Blood Phe levels [ > 120 μmol/L and < 360 μmol/L] (At least 2 levels measured at least 1 month apart); OR ii) sustained blood Phe reduction of at least 30% (At least 2 levels measured at least 1 month apart)compared to baseline if the Phe baseline level is < 1200 μmol/L; OR iii) sustained blood Phe reduction of at least 50% (At least 2 levels measured at least 1 month apart) compared to baseline if the Phe baseline level is > 1200 μmol/L; 4. Demonstrated an increase in dietary protein tolerance based on targets set between the clinician and patient 5. Managed by a prescriber specialized in metabolic/ biochemical diseases. Dosage: Up to a maximum of 20 mg/kg per day Approval Duration: 1 year 194 Sapropterin Brand(s): Kuvan DOSAGE FORM/ STRENGTH: 100 mg tablet Renewal Criteria: Renewals will be considered for patients meeting the following criteria: 1. Demonstrates ongoing response to treatment; AND 2. Complies with and will continue to comply with a low protein diet, formulas, and treatment with Kuvan; AND 3. the request for extended coverage includes a recent follow-up from a prescriber specialized in metabolic/biochemical diseases. Exclusion Criteria for both Initial (Trial and Post Trial period) and Renewal criteria: (Patients meeting any of the following criteria will not be funded) • the Patient is not on a low protein diet or is not compliant with their low protein diet; or • the Patient has a baseline blood PHe level less than 360 μmol/L prior to initiating therapy with Kuvan. Dosage: Up to a maximum of 20 mg/kg per day Approval Duration: 1 year 195  EAP source: eap-frequently-requested-drugs-2025-01-01.txt, page 193, record 111, corpus 2025-01-01; name match only, not an eligibility decision

Reddy-Sapropterin · DIN 02535610 Manufacturer: Dr. Reddy's Laboratories Inc.; listing date 2024-01-31 Health Canada: Marketed since 2023-12-19 · brand REDDY-SAPROPTERIN · ATC A16AX07 SAPROPTERIN · form Powder for solution · route Oral · ingredients SAPROPTERIN DIHYDROCHLORIDE 500 MG/SACHET · company Dr reddy's laboratories ltd · schedule Prescription

DIN 02535610: Reddy-Sapropterin Raw flags: notABenefit=Y, sec3=Y, sec3b=Y Item: 920000779; group id 954; item number 2268; lccId None; manufacturer id DRR Source form: Pd for Sol (Sachet Pk); strength: 500mg Recorded listing: Off-Formulary Interchangeable, not an ODB benefit Source prices (unrounded): $123.7500; ministry not recorded Source: ODB odb-formulary-ed43-extract-2026-08-26.xml extract_date=2026-08-26 DIN=02535610 Health Canada DPD extract of Sep 2, 2026 (Open Government Licence – Canada) · https://health-products.canada.ca/dpd-bdpp/info?lang=eng&code=102445

Interchangeable products

Kuvan · DIN 02482215 · not recorded

Shortage status: no shortage or discontinuation reported (checked 2026-09-13T08:10:21.292534+00:00); reports as of 2026-09-13T08:10:21.292534+00:00 (Health Product Shortages Canada) Source: https://healthproductshortages.ca/search?term=02535610

Shortage record checked 2026-09-13T08:10:21.292534+00:00