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Reason for Use code 571 For those unable to swallow or tolerate solid oral dosage form AND For the treatment of Cytomegalovirus (CMV) retinitis in patients with HIV/AIDS. Coverage limit: LU Authorization Period: 1 year Reason for Use code 572 For those unable to swallow or tolerate solid oral dosage form AND For the prevention of Cytomegalovirus (CMV) in solid organ transplant patients (not lung or heart-lung). Coverage limit: LU Authorization Period: Up to 6 months Reason for Use code 573 For those unable to swallow or tolerate solid oral dosage form AND For the prevention of Cytomegalovirus (CMV) in lung or heart-lung transplant patients. Coverage limit: LU Authorization Period: Up to 12 months Exceptional Access criteria on record are for Brand(s): Valcyte; DOSAGE FORM/ STRENGTH: 450 mg tablet, 50 mg/mL oral solution — 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 Valganciclovir Brand(s): Valcyte DOSAGE FORM/ STRENGTH: 450 mg tablet, 50 mg/mL oral solution For the treatment of cytomegalovirus (CMV) disease following solid organ and/or bone marrow transplant in patients who meet the following criteria: 1. Objective evidence of active CMV infection determined by any one of the following methods: • CMV antigenemia assay;OR • CMV polymerase chain reaction (PCR); OR • bDNA assay; OR • Tissue biopsy with pathological changes showing intra-nuclear inclusion bodies compatible with CMV infection (i.e. Owl’s eye) • Primary Infection - positive CMV IgM antibodies; OR • Reactivation - Positive CMV IgM antibodies with four-fold or greater increase in CMV IgG antibodies 2. Consolidation phase of treatment (maintenance phase post-induction with IV ganciclovir) Standard Approval Duration: 3 to 6 months Renewals will be considered for patients who continue to have active CMV infection. Renewal requests not meeting the criteria will be considered on a case-by-case basis but the physician must submit a rationale of why ongoing treatment is necessary. Standard Approval Duration: 3 months For prophylaxis (prevention) of Epstein-Barr Virus (EBV) infection in EBV D+/R- transplant recipients. Standard Approval Duration: 6 months 476 Valganciclovir Brand(s): Valcyte DOSAGE FORM/ STRENGTH: 450 mg tablet, 50 mg/mL oral solution For treatment of Epstein-Barr Virus (EBV) infection in transplant patients according to the following criteria: 1. Confirmed via biopsy (rare EBV positive cells present); OR 2. Objective evidence of active EBV infection (Patient must have one of the three below): • Newly positive or rising EBV PCR; OR • Reactivation: Positive anti-VCA IgM antibodies with a four-fold or greater increase in anti-VCA IgG antibodies; OR • Presence of EBV DNA or protein in pathologic tissue Standard Approval Duration: 3 months Notes: Valganciclovir oral solution is considered for patients who meet the above requirements but who cannot swallow tablets or cannot use the tablets to achieve the planned dosing regimen. Renewals for patients showing continued active infection with EBV PCR may be considered on a case-by-case basis by submitting the request to the EAP. Requests for valganciclovir not meeting the above criteria or the Limited Use criteria on the formulary will be considered on a case-by-case basis but the prescriber must submit the request to the EAP. 477 Valganciclovir Brand(s): Valcyte DOSAGE FORM/ STRENGTH: 450 mg tablet, 50 mg/mL oral solution Approvals will be provided for the treatment of moderate to severe symptomatic congenital CMV (cCMV) in newborns who meet the following criteria: • Prescribed by or in consultation with a pediatric ID specialist (from one of the 5 treatment centres in Ontario: London, Hamilton, Toronto, Kingston, Ottawa; or Winnipeg for the NorthWestern region of Ontario) • Confirmed diagnosis of cCMV within the first 3 weeks¹ of birth by: o PCR (urine, saliva or quantitative serum CMV); OR o Positive culture results (urine or saliva) • Treatment to start within one month of birth² • Evidence of one or more of the following symptoms: o CNS disease (e.g., seizures, microcephaly, imaging abnormalities associated with CMV) o Eye disease (e.g., chorioretinitis) o Severe life-threatening organ dysfunction (must be described)³ • Regular monitoring of labs for toxicity while on therapy Approval Duration: maximum 6 months at 16mg/kg/dose BID (with dose adjustments in renal dysfunction, < 32 weeks gestational age, etc.) Renewals: No extensions will be provided unless extenuating circumstances for severely affected infants. Case-by-case review with rationale for continued treatment (must include pediatric ID specialist consult note) Valganciclovir oral liquid will be approved for newborns. All other requests not meeting the above criteria will be reviewed on a case-by-case basis including: • Initiation of treatment after one month of age² • Evidence of sensorineural hearing loss (SNHL) only (i.e., no other symptom described above) • Isolated/multiple findings of mild symptoms such as: intrauterine growth retardation (IUGR), thrombocytopenia, elevated liver enzymes, jaundice, hepatitis Sufficient rationale including consult from pediatric ID specialist must be provided before sending for external review. 478 Renewals of HIV Drugs EAP source: eap-frequently-requested-drugs-2025-01-01.txt, page 476, record 318, corpus 2025-01-01; name match only, not an eligibility decision 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 Valganciclovir Brand(s): Valcyte and Generics DOSAGE FORM/ STRENGTH: 450 mg tablet, 50mg/mL pd for oral solution For the treatment of moderate to severe symptomatic congenital CMV (cCMV) in newborns who meet the following criteria: • Prescribed by or in consultation with a pediatric ID specialist (from one of the 5 treatment centres in Ontario: London, Hamilton, Toronto, Kingston, Ottawa; or Winnipeg for the North Western region of Ontario1) • Confirmed diagnosis of cCMV within the first 3 weeks of birth by: o PCR (urine, saliva or quantitative serum CMV); OR o Positive culture results (urine or saliva) • Treatment to start within one month of birth • Evidence of one or more of the following symptoms: o CNS disease (e.g., seizures, microcephaly, imaging abnormalities associated with CMV) o Eye disease (e.g., chorioretinitis) o Severe life-threatening organ dysfunction (specify/describe) • Regular monitoring of labs for toxicity while on therapy 51 Valganciclovir Brand(s): Valcyte and Generics DOSAGE FORM/ STRENGTH: 450 mg tablet, 50 mg/mL pd for oral solutions Approval Duration: maximum 6 months at 16mg/kg/dose BID (with dose adjustments in renal dysfunction, < 32 weeks gestational age, etc.) Renewals: No extensions will be provided unless extenuating circumstances for severely affected infants. Case-by-case review with rationale for continued treatment (must include pediatric ID specialist consult note) All other requests not meeting the above criteria will be reviewed on a case-by-case basis including: • Initiation of treatment after one month of age • Evidence of sensorineural hearing loss (SNHL) only (i.e., no other symptom described above) • Isolated/multiple findings of mild symptoms such as: intrauterine growth retardation (IUGR), thrombocytopenia, elevated liver enzymes, jaundice, hepatitis 1List of treatment centres and addresses: • Children’s Hospital of Eastern Ontario, 401 Smyth Road, Ottawa ON K1H 8L1 • Kingston General Hospital, 76 Stuart Street, Kingston ON K7L 2V7 • The Hospital for Sick Children, 555 University Avenue, Toronto ON M5G 1X8 • McMaster Children’s Hospital, 1200 Main Street West, Hamilton ON L8N 3Z5 • London Health Sciences Center, 339 Windermere Road, London ON N6A 5A5 EAP source: eap-frequently-requested-drugs-2025-01-01.txt, page 51, record 29, 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 ↗)

Auro-Valganciclovir · DIN 02535483 Manufacturer: Auro Pharma Inc.; listing date 2023-12-29 Health Canada: Marketed since 2023-09-13 · brand AURO-VALGANCICLOVIR · ATC J05AB14 VALGANCICLOVIR · form Powder for solution · route Oral · ingredients VALGANCICLOVIR (VALGANCICLOVIR HYDROCHLORIDE) 50 MG/ML · company Auro pharma inc · schedule Prescription

DIN 02535483: Auro-Valganciclovir Raw flags: sec12=Y, sec3=Y Item: 081800108; group id 115; item number 0198; lccId 00328; manufacturer id AUR Source form: Pd for Oral Sol-100mL Pk; strength: 50mg/mL Recorded listing: Limited Use: paid only with a Reason for Use code and the criteria below Source prices (unrounded): $150.9900; ministry $150.9900 Source: ODB odb-formulary-ed43-extract-2026-08-26.xml extract_date=2026-08-26 DIN=02535483 Health Canada DPD extract of Sep 2, 2026 (Open Government Licence – Canada) · https://health-products.canada.ca/dpd-bdpp/info?lang=eng&code=102433

Interchangeable products

Valcyte · DIN 02306085 · $150.9900

Shortage status: active shortage (reported 2025-10-03, estimated to end 2027-02-28, last updated 2026-06-24); reports as of 2026-09-13T08:10:21.292534+00:00 (Health Product Shortages Canada) Source: https://healthproductshortages.ca/search?term=02535483

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

Reason for Use code 571 For those unable to swallow or tolerate solid oral dosage form AND For the treatment of Cytomegalovirus (CMV) retinitis in patients with HIV/AIDS. Coverage limit: LU Authorization Period: 1 year Reason for Use code 572 For those unable to swallow or tolerate solid oral dosage form AND For the prevention of Cytomegalovirus (CMV) in solid organ transplant patients (not lung or heart-lung). Coverage limit: LU Authorization Period: Up to 6 months Reason for Use code 573 For those unable to swallow or tolerate solid oral dosage form AND For the prevention of Cytomegalovirus (CMV) in lung or heart-lung transplant patients. Coverage limit: LU Authorization Period: Up to 12 months 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 Valganciclovir Brand(s): Valcyte and Generics DOSAGE FORM/ STRENGTH: 450 mg tablet, 50mg/mL pd for oral solution For the treatment of moderate to severe symptomatic congenital CMV (cCMV) in newborns who meet the following criteria: • Prescribed by or in consultation with a pediatric ID specialist (from one of the 5 treatment centres in Ontario: London, Hamilton, Toronto, Kingston, Ottawa; or Winnipeg for the North Western region of Ontario1) • Confirmed diagnosis of cCMV within the first 3 weeks of birth by: o PCR (urine, saliva or quantitative serum CMV); OR o Positive culture results (urine or saliva) • Treatment to start within one month of birth • Evidence of one or more of the following symptoms: o CNS disease (e.g., seizures, microcephaly, imaging abnormalities associated with CMV) o Eye disease (e.g., chorioretinitis) o Severe life-threatening organ dysfunction (specify/describe) • Regular monitoring of labs for toxicity while on therapy 51 Valganciclovir Brand(s): Valcyte and Generics DOSAGE FORM/ STRENGTH: 450 mg tablet, 50 mg/mL pd for oral solutions Approval Duration: maximum 6 months at 16mg/kg/dose BID (with dose adjustments in renal dysfunction, < 32 weeks gestational age, etc.) Renewals: No extensions will be provided unless extenuating circumstances for severely affected infants. Case-by-case review with rationale for continued treatment (must include pediatric ID specialist consult note) All other requests not meeting the above criteria will be reviewed on a case-by-case basis including: • Initiation of treatment after one month of age • Evidence of sensorineural hearing loss (SNHL) only (i.e., no other symptom described above) • Isolated/multiple findings of mild symptoms such as: intrauterine growth retardation (IUGR), thrombocytopenia, elevated liver enzymes, jaundice, hepatitis 1List of treatment centres and addresses: • Children’s Hospital of Eastern Ontario, 401 Smyth Road, Ottawa ON K1H 8L1 • Kingston General Hospital, 76 Stuart Street, Kingston ON K7L 2V7 • The Hospital for Sick Children, 555 University Avenue, Toronto ON M5G 1X8 • McMaster Children’s Hospital, 1200 Main Street West, Hamilton ON L8N 3Z5 • London Health Sciences Center, 339 Windermere Road, London ON N6A 5A5 EAP source: eap-frequently-requested-drugs-2025-01-01.txt, page 51, record 29, corpus 2025-01-01; name match only, not an eligibility decision 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 Valganciclovir Brand(s): Valcyte DOSAGE FORM/ STRENGTH: 450 mg tablet, 50 mg/mL oral solution For the treatment of cytomegalovirus (CMV) disease following solid organ and/or bone marrow transplant in patients who meet the following criteria: 1. Objective evidence of active CMV infection determined by any one of the following methods: • CMV antigenemia assay;OR • CMV polymerase chain reaction (PCR); OR • bDNA assay; OR • Tissue biopsy with pathological changes showing intra-nuclear inclusion bodies compatible with CMV infection (i.e. Owl’s eye) • Primary Infection - positive CMV IgM antibodies; OR • Reactivation - Positive CMV IgM antibodies with four-fold or greater increase in CMV IgG antibodies 2. Consolidation phase of treatment (maintenance phase post-induction with IV ganciclovir) Standard Approval Duration: 3 to 6 months Renewals will be considered for patients who continue to have active CMV infection. Renewal requests not meeting the criteria will be considered on a case-by-case basis but the physician must submit a rationale of why ongoing treatment is necessary. Standard Approval Duration: 3 months For prophylaxis (prevention) of Epstein-Barr Virus (EBV) infection in EBV D+/R- transplant recipients. Standard Approval Duration: 6 months 476 Valganciclovir Brand(s): Valcyte DOSAGE FORM/ STRENGTH: 450 mg tablet, 50 mg/mL oral solution For treatment of Epstein-Barr Virus (EBV) infection in transplant patients according to the following criteria: 1. Confirmed via biopsy (rare EBV positive cells present); OR 2. Objective evidence of active EBV infection (Patient must have one of the three below): • Newly positive or rising EBV PCR; OR • Reactivation: Positive anti-VCA IgM antibodies with a four-fold or greater increase in anti-VCA IgG antibodies; OR • Presence of EBV DNA or protein in pathologic tissue Standard Approval Duration: 3 months Notes: Valganciclovir oral solution is considered for patients who meet the above requirements but who cannot swallow tablets or cannot use the tablets to achieve the planned dosing regimen. Renewals for patients showing continued active infection with EBV PCR may be considered on a case-by-case basis by submitting the request to the EAP. Requests for valganciclovir not meeting the above criteria or the Limited Use criteria on the formulary will be considered on a case-by-case basis but the prescriber must submit the request to the EAP. 477 Valganciclovir Brand(s): Valcyte DOSAGE FORM/ STRENGTH: 450 mg tablet, 50 mg/mL oral solution Approvals will be provided for the treatment of moderate to severe symptomatic congenital CMV (cCMV) in newborns who meet the following criteria: • Prescribed by or in consultation with a pediatric ID specialist (from one of the 5 treatment centres in Ontario: London, Hamilton, Toronto, Kingston, Ottawa; or Winnipeg for the NorthWestern region of Ontario) • Confirmed diagnosis of cCMV within the first 3 weeks¹ of birth by: o PCR (urine, saliva or quantitative serum CMV); OR o Positive culture results (urine or saliva) • Treatment to start within one month of birth² • Evidence of one or more of the following symptoms: o CNS disease (e.g., seizures, microcephaly, imaging abnormalities associated with CMV) o Eye disease (e.g., chorioretinitis) o Severe life-threatening organ dysfunction (must be described)³ • Regular monitoring of labs for toxicity while on therapy Approval Duration: maximum 6 months at 16mg/kg/dose BID (with dose adjustments in renal dysfunction, < 32 weeks gestational age, etc.) Renewals: No extensions will be provided unless extenuating circumstances for severely affected infants. Case-by-case review with rationale for continued treatment (must include pediatric ID specialist consult note) Valganciclovir oral liquid will be approved for newborns. All other requests not meeting the above criteria will be reviewed on a case-by-case basis including: • Initiation of treatment after one month of age² • Evidence of sensorineural hearing loss (SNHL) only (i.e., no other symptom described above) • Isolated/multiple findings of mild symptoms such as: intrauterine growth retardation (IUGR), thrombocytopenia, elevated liver enzymes, jaundice, hepatitis Sufficient rationale including consult from pediatric ID specialist must be provided before sending for external review. 478 Renewals of HIV Drugs EAP source: eap-frequently-requested-drugs-2025-01-01.txt, page 476, record 318, 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 ↗)

Valcyte · DIN 02306085 Manufacturer: Cheplapharm Arzneimittel GmbH; listing date 2020-02-28 Health Canada: Marketed since 2022-07-19 · brand VALCYTE · ATC J05AB14 VALGANCICLOVIR · form Powder for solution · route Oral · ingredients VALGANCICLOVIR (VALGANCICLOVIR HYDROCHLORIDE) 50 MG/ML · company Cheplapharm arzneimittel gmbh · schedule Prescription

DIN 02306085: Valcyte Raw flags: sec12=Y, sec3=Y Item: 081800108; group id 115; item number 0198; lccId 00328; manufacturer id CHE Source form: Pd for Oral Sol-100mL Pk; strength: 50mg/mL Recorded listing: Limited Use: paid only with a Reason for Use code and the criteria below Source prices (unrounded): $321.8454; ministry $150.9900 Source: ODB odb-formulary-ed43-extract-2026-08-26.xml extract_date=2026-08-26 DIN=02306085 Health Canada DPD extract of Sep 2, 2026 (Open Government Licence – Canada) · https://health-products.canada.ca/dpd-bdpp/info?lang=eng&code=79164

Interchangeable products

Auro-Valganciclovir · DIN 02535483 · $150.9900

Shortage status: resolved shortage (ended 2023-11-02); reports as of 2026-09-13T08:10:21.292534+00:00 (Health Product Shortages Canada) Source: https://healthproductshortages.ca/search?term=02306085

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

Reason for Use code 374 For the treatment of CMV retinitis in patients with HIV/AIDS. Coverage limit: LU Authorization Period: 1 year Reason for Use code 568 For the prevention of Cytomegalovirus (CMV) in solid organ transplant patients (not lung or heart-lung). Coverage limit: LU Authorization Period: Up to 6 months Reason for Use code 569 For the prevention of Cytomegalovirus (CMV) in lung or heart-lung transplant patients. Coverage limit: LU Authorization Period: Up to 12 months Exceptional Access criteria on record are for Brand(s): Valcyte; DOSAGE FORM/ STRENGTH: 450 mg tablet, 50 mg/mL oral solution — 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 Valganciclovir Brand(s): Valcyte DOSAGE FORM/ STRENGTH: 450 mg tablet, 50 mg/mL oral solution For the treatment of cytomegalovirus (CMV) disease following solid organ and/or bone marrow transplant in patients who meet the following criteria: 1. Objective evidence of active CMV infection determined by any one of the following methods: • CMV antigenemia assay;OR • CMV polymerase chain reaction (PCR); OR • bDNA assay; OR • Tissue biopsy with pathological changes showing intra-nuclear inclusion bodies compatible with CMV infection (i.e. Owl’s eye) • Primary Infection - positive CMV IgM antibodies; OR • Reactivation - Positive CMV IgM antibodies with four-fold or greater increase in CMV IgG antibodies 2. Consolidation phase of treatment (maintenance phase post-induction with IV ganciclovir) Standard Approval Duration: 3 to 6 months Renewals will be considered for patients who continue to have active CMV infection. Renewal requests not meeting the criteria will be considered on a case-by-case basis but the physician must submit a rationale of why ongoing treatment is necessary. Standard Approval Duration: 3 months For prophylaxis (prevention) of Epstein-Barr Virus (EBV) infection in EBV D+/R- transplant recipients. Standard Approval Duration: 6 months 476 Valganciclovir Brand(s): Valcyte DOSAGE FORM/ STRENGTH: 450 mg tablet, 50 mg/mL oral solution For treatment of Epstein-Barr Virus (EBV) infection in transplant patients according to the following criteria: 1. Confirmed via biopsy (rare EBV positive cells present); OR 2. Objective evidence of active EBV infection (Patient must have one of the three below): • Newly positive or rising EBV PCR; OR • Reactivation: Positive anti-VCA IgM antibodies with a four-fold or greater increase in anti-VCA IgG antibodies; OR • Presence of EBV DNA or protein in pathologic tissue Standard Approval Duration: 3 months Notes: Valganciclovir oral solution is considered for patients who meet the above requirements but who cannot swallow tablets or cannot use the tablets to achieve the planned dosing regimen. Renewals for patients showing continued active infection with EBV PCR may be considered on a case-by-case basis by submitting the request to the EAP. Requests for valganciclovir not meeting the above criteria or the Limited Use criteria on the formulary will be considered on a case-by-case basis but the prescriber must submit the request to the EAP. 477 Valganciclovir Brand(s): Valcyte DOSAGE FORM/ STRENGTH: 450 mg tablet, 50 mg/mL oral solution Approvals will be provided for the treatment of moderate to severe symptomatic congenital CMV (cCMV) in newborns who meet the following criteria: • Prescribed by or in consultation with a pediatric ID specialist (from one of the 5 treatment centres in Ontario: London, Hamilton, Toronto, Kingston, Ottawa; or Winnipeg for the NorthWestern region of Ontario) • Confirmed diagnosis of cCMV within the first 3 weeks¹ of birth by: o PCR (urine, saliva or quantitative serum CMV); OR o Positive culture results (urine or saliva) • Treatment to start within one month of birth² • Evidence of one or more of the following symptoms: o CNS disease (e.g., seizures, microcephaly, imaging abnormalities associated with CMV) o Eye disease (e.g., chorioretinitis) o Severe life-threatening organ dysfunction (must be described)³ • Regular monitoring of labs for toxicity while on therapy Approval Duration: maximum 6 months at 16mg/kg/dose BID (with dose adjustments in renal dysfunction, < 32 weeks gestational age, etc.) Renewals: No extensions will be provided unless extenuating circumstances for severely affected infants. Case-by-case review with rationale for continued treatment (must include pediatric ID specialist consult note) Valganciclovir oral liquid will be approved for newborns. All other requests not meeting the above criteria will be reviewed on a case-by-case basis including: • Initiation of treatment after one month of age² • Evidence of sensorineural hearing loss (SNHL) only (i.e., no other symptom described above) • Isolated/multiple findings of mild symptoms such as: intrauterine growth retardation (IUGR), thrombocytopenia, elevated liver enzymes, jaundice, hepatitis Sufficient rationale including consult from pediatric ID specialist must be provided before sending for external review. 478 Renewals of HIV Drugs EAP source: eap-frequently-requested-drugs-2025-01-01.txt, page 476, record 318, corpus 2025-01-01; name match only, not an eligibility decision 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 Valganciclovir Brand(s): Valcyte and Generics DOSAGE FORM/ STRENGTH: 450 mg tablet, 50mg/mL pd for oral solution For the treatment of moderate to severe symptomatic congenital CMV (cCMV) in newborns who meet the following criteria: • Prescribed by or in consultation with a pediatric ID specialist (from one of the 5 treatment centres in Ontario: London, Hamilton, Toronto, Kingston, Ottawa; or Winnipeg for the North Western region of Ontario1) • Confirmed diagnosis of cCMV within the first 3 weeks of birth by: o PCR (urine, saliva or quantitative serum CMV); OR o Positive culture results (urine or saliva) • Treatment to start within one month of birth • Evidence of one or more of the following symptoms: o CNS disease (e.g., seizures, microcephaly, imaging abnormalities associated with CMV) o Eye disease (e.g., chorioretinitis) o Severe life-threatening organ dysfunction (specify/describe) • Regular monitoring of labs for toxicity while on therapy 51 Valganciclovir Brand(s): Valcyte and Generics DOSAGE FORM/ STRENGTH: 450 mg tablet, 50 mg/mL pd for oral solutions Approval Duration: maximum 6 months at 16mg/kg/dose BID (with dose adjustments in renal dysfunction, < 32 weeks gestational age, etc.) Renewals: No extensions will be provided unless extenuating circumstances for severely affected infants. Case-by-case review with rationale for continued treatment (must include pediatric ID specialist consult note) All other requests not meeting the above criteria will be reviewed on a case-by-case basis including: • Initiation of treatment after one month of age • Evidence of sensorineural hearing loss (SNHL) only (i.e., no other symptom described above) • Isolated/multiple findings of mild symptoms such as: intrauterine growth retardation (IUGR), thrombocytopenia, elevated liver enzymes, jaundice, hepatitis 1List of treatment centres and addresses: • Children’s Hospital of Eastern Ontario, 401 Smyth Road, Ottawa ON K1H 8L1 • Kingston General Hospital, 76 Stuart Street, Kingston ON K7L 2V7 • The Hospital for Sick Children, 555 University Avenue, Toronto ON M5G 1X8 • McMaster Children’s Hospital, 1200 Main Street West, Hamilton ON L8N 3Z5 • London Health Sciences Center, 339 Windermere Road, London ON N6A 5A5 EAP source: eap-frequently-requested-drugs-2025-01-01.txt, page 51, record 29, corpus 2025-01-01; name match only, not an eligibility decision

Lowest DBP recovery rule under medically necessary no-substitution claims: 6.2 Medically Necessary "No Substitution" Claims The Side Effect Reporting Form will not have to be renewed. However, the pharmacy must maintain a copy of the prescription that contains a direction that there be no substitution and the required Health Canada Side Effect Reporting Form (completed and signed by the prescriber). The prescriber must write “No Substitution” or “No Sub” on renewal or subsequent new written prescriptions, and indicate “No Substitution” on subsequent new oral prescriptions. The dispenser will be reimbursed the DBP plus a mark-up and the lesser of the posted usual and customary fee or the ODB dispensing fee minus the applicable ODB co-payment amount. Where a completed Side Effect Reporting Form is not available at the pharmacy during an inspection, the difference between the cost of the higher-cost product and the lowest DBP listed for the interchangeable category will be recovered. (ontario.ca, Revision #17; 2026-08-03 ↗) 6.2 Medically Necessary "No Substitution" Claims The Ministry will provide reimbursement of a higher-cost interchangeable product in medically necessary circumstances where a patient has experienced a significant adverse reaction with two (2) lower-cost interchangeable drug products, where available. When a prescriber identifies a patient for which it is medically necessary that a higher cost interchangeable product be provided, the prescriber must: • Complete, sign and forward to the pharmacist a copy of the Health Canada side effect reporting form for each lower-cost interchangeable drug product trialed (Side Effect Reporting Form[s]); and • Write “No Substitution” or “No Sub” on a written prescription or indicate “No Substitution” to the pharmacist in the case of a verbal prescription. The prescriber should keep a copy of the completed form in the patient’s record for future use and reference. In the case of a written prescription, when the pharmacist or dispensing physician receives a prescription with the written notation “No Substitution” or “No Sub”, reimbursement will be provided for the higher-cost interchangeable product only if the prescription is accompanied by a completed Health Canada Side Effect Reporting Form for each of the lower-cost interchangeable drug products trialed. This form must be completely filled out noting the details of the adverse reaction and signed by the prescriber. In the case of a verbal prescription, the prescriber must satisfy the operator of the pharmacy or dispensing physician that a completed Health Canada Side Effect Reporting Form for each of the lower-cost interchangeable drug products trialed has been completed and signed by the prescriber. A written record of this verbal prescription and the completed Health Canada Side Effect Reporting Form must be received by the pharmacy prior to claim submission. Upon receipt, the pharmacist must: • Fax, submit online or mail the completed and signed form to Health Canada’s Canada Vigilance Program; and • Retain his or her copy of the completed and signed Side Effect Reporting Form. (ontario.ca, Revision #17; 2026-08-03 ↗)

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 ↗)

Auro-Valganciclovir · DIN 02435179 Manufacturer: Auro Pharma Inc.; listing date 2015-11-26 Health Canada: Marketed since 2015-04-10 · brand AURO-VALGANCICLOVIR · ATC J05AB14 VALGANCICLOVIR · form Tablet · route Oral · ingredients VALGANCICLOVIR (VALGANCICLOVIR HYDROCHLORIDE) 450 MG · company Auro pharma inc · schedule Prescription

DIN 02435179: Auro-Valganciclovir Raw flags: sec12=Y, sec3=Y Item: 081800066; group id 116; item number 0199; lccId 00145; manufacturer id AUR Source form: Tab; strength: 450mg Recorded listing: Limited Use: paid only with a Reason for Use code and the criteria below Source prices (unrounded): $5.8553; ministry $5.8553 Source: ODB odb-formulary-ed43-extract-2026-08-26.xml extract_date=2026-08-26 DIN=02435179 Health Canada DPD extract of Sep 2, 2026 (Open Government Licence – Canada) · https://health-products.canada.ca/dpd-bdpp/info?lang=eng&code=91945

Interchangeable products

Mint-Valganciclovir · DIN 02495457 · $5.8553 Teva-Valganciclovir · DIN 02413825 · $5.8553 Valcyte · DIN 02245777 · $5.8553

Shortage status: resolved shortage (ended 2024-03-15); reports as of 2026-09-13T08:10:21.292534+00:00 (Health Product Shortages Canada) Source: https://healthproductshortages.ca/search?term=02435179

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

Reason for Use code 374 For the treatment of CMV retinitis in patients with HIV/AIDS. Coverage limit: LU Authorization Period: 1 year Reason for Use code 568 For the prevention of Cytomegalovirus (CMV) in solid organ transplant patients (not lung or heart-lung). Coverage limit: LU Authorization Period: Up to 6 months Reason for Use code 569 For the prevention of Cytomegalovirus (CMV) in lung or heart-lung transplant patients. Coverage limit: LU Authorization Period: Up to 12 months Exceptional Access criteria on record are for Brand(s): Valcyte; DOSAGE FORM/ STRENGTH: 450 mg tablet, 50 mg/mL oral solution — 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 Valganciclovir Brand(s): Valcyte DOSAGE FORM/ STRENGTH: 450 mg tablet, 50 mg/mL oral solution For the treatment of cytomegalovirus (CMV) disease following solid organ and/or bone marrow transplant in patients who meet the following criteria: 1. Objective evidence of active CMV infection determined by any one of the following methods: • CMV antigenemia assay;OR • CMV polymerase chain reaction (PCR); OR • bDNA assay; OR • Tissue biopsy with pathological changes showing intra-nuclear inclusion bodies compatible with CMV infection (i.e. Owl’s eye) • Primary Infection - positive CMV IgM antibodies; OR • Reactivation - Positive CMV IgM antibodies with four-fold or greater increase in CMV IgG antibodies 2. Consolidation phase of treatment (maintenance phase post-induction with IV ganciclovir) Standard Approval Duration: 3 to 6 months Renewals will be considered for patients who continue to have active CMV infection. Renewal requests not meeting the criteria will be considered on a case-by-case basis but the physician must submit a rationale of why ongoing treatment is necessary. Standard Approval Duration: 3 months For prophylaxis (prevention) of Epstein-Barr Virus (EBV) infection in EBV D+/R- transplant recipients. Standard Approval Duration: 6 months 476 Valganciclovir Brand(s): Valcyte DOSAGE FORM/ STRENGTH: 450 mg tablet, 50 mg/mL oral solution For treatment of Epstein-Barr Virus (EBV) infection in transplant patients according to the following criteria: 1. Confirmed via biopsy (rare EBV positive cells present); OR 2. Objective evidence of active EBV infection (Patient must have one of the three below): • Newly positive or rising EBV PCR; OR • Reactivation: Positive anti-VCA IgM antibodies with a four-fold or greater increase in anti-VCA IgG antibodies; OR • Presence of EBV DNA or protein in pathologic tissue Standard Approval Duration: 3 months Notes: Valganciclovir oral solution is considered for patients who meet the above requirements but who cannot swallow tablets or cannot use the tablets to achieve the planned dosing regimen. Renewals for patients showing continued active infection with EBV PCR may be considered on a case-by-case basis by submitting the request to the EAP. Requests for valganciclovir not meeting the above criteria or the Limited Use criteria on the formulary will be considered on a case-by-case basis but the prescriber must submit the request to the EAP. 477 Valganciclovir Brand(s): Valcyte DOSAGE FORM/ STRENGTH: 450 mg tablet, 50 mg/mL oral solution Approvals will be provided for the treatment of moderate to severe symptomatic congenital CMV (cCMV) in newborns who meet the following criteria: • Prescribed by or in consultation with a pediatric ID specialist (from one of the 5 treatment centres in Ontario: London, Hamilton, Toronto, Kingston, Ottawa; or Winnipeg for the NorthWestern region of Ontario) • Confirmed diagnosis of cCMV within the first 3 weeks¹ of birth by: o PCR (urine, saliva or quantitative serum CMV); OR o Positive culture results (urine or saliva) • Treatment to start within one month of birth² • Evidence of one or more of the following symptoms: o CNS disease (e.g., seizures, microcephaly, imaging abnormalities associated with CMV) o Eye disease (e.g., chorioretinitis) o Severe life-threatening organ dysfunction (must be described)³ • Regular monitoring of labs for toxicity while on therapy Approval Duration: maximum 6 months at 16mg/kg/dose BID (with dose adjustments in renal dysfunction, < 32 weeks gestational age, etc.) Renewals: No extensions will be provided unless extenuating circumstances for severely affected infants. Case-by-case review with rationale for continued treatment (must include pediatric ID specialist consult note) Valganciclovir oral liquid will be approved for newborns. All other requests not meeting the above criteria will be reviewed on a case-by-case basis including: • Initiation of treatment after one month of age² • Evidence of sensorineural hearing loss (SNHL) only (i.e., no other symptom described above) • Isolated/multiple findings of mild symptoms such as: intrauterine growth retardation (IUGR), thrombocytopenia, elevated liver enzymes, jaundice, hepatitis Sufficient rationale including consult from pediatric ID specialist must be provided before sending for external review. 478 Renewals of HIV Drugs EAP source: eap-frequently-requested-drugs-2025-01-01.txt, page 476, record 318, corpus 2025-01-01; name match only, not an eligibility decision 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 Valganciclovir Brand(s): Valcyte and Generics DOSAGE FORM/ STRENGTH: 450 mg tablet, 50mg/mL pd for oral solution For the treatment of moderate to severe symptomatic congenital CMV (cCMV) in newborns who meet the following criteria: • Prescribed by or in consultation with a pediatric ID specialist (from one of the 5 treatment centres in Ontario: London, Hamilton, Toronto, Kingston, Ottawa; or Winnipeg for the North Western region of Ontario1) • Confirmed diagnosis of cCMV within the first 3 weeks of birth by: o PCR (urine, saliva or quantitative serum CMV); OR o Positive culture results (urine or saliva) • Treatment to start within one month of birth • Evidence of one or more of the following symptoms: o CNS disease (e.g., seizures, microcephaly, imaging abnormalities associated with CMV) o Eye disease (e.g., chorioretinitis) o Severe life-threatening organ dysfunction (specify/describe) • Regular monitoring of labs for toxicity while on therapy 51 Valganciclovir Brand(s): Valcyte and Generics DOSAGE FORM/ STRENGTH: 450 mg tablet, 50 mg/mL pd for oral solutions Approval Duration: maximum 6 months at 16mg/kg/dose BID (with dose adjustments in renal dysfunction, < 32 weeks gestational age, etc.) Renewals: No extensions will be provided unless extenuating circumstances for severely affected infants. Case-by-case review with rationale for continued treatment (must include pediatric ID specialist consult note) All other requests not meeting the above criteria will be reviewed on a case-by-case basis including: • Initiation of treatment after one month of age • Evidence of sensorineural hearing loss (SNHL) only (i.e., no other symptom described above) • Isolated/multiple findings of mild symptoms such as: intrauterine growth retardation (IUGR), thrombocytopenia, elevated liver enzymes, jaundice, hepatitis 1List of treatment centres and addresses: • Children’s Hospital of Eastern Ontario, 401 Smyth Road, Ottawa ON K1H 8L1 • Kingston General Hospital, 76 Stuart Street, Kingston ON K7L 2V7 • The Hospital for Sick Children, 555 University Avenue, Toronto ON M5G 1X8 • McMaster Children’s Hospital, 1200 Main Street West, Hamilton ON L8N 3Z5 • London Health Sciences Center, 339 Windermere Road, London ON N6A 5A5 EAP source: eap-frequently-requested-drugs-2025-01-01.txt, page 51, record 29, corpus 2025-01-01; name match only, not an eligibility decision

Lowest DBP recovery rule under medically necessary no-substitution claims: 6.2 Medically Necessary "No Substitution" Claims The Side Effect Reporting Form will not have to be renewed. However, the pharmacy must maintain a copy of the prescription that contains a direction that there be no substitution and the required Health Canada Side Effect Reporting Form (completed and signed by the prescriber). The prescriber must write “No Substitution” or “No Sub” on renewal or subsequent new written prescriptions, and indicate “No Substitution” on subsequent new oral prescriptions. The dispenser will be reimbursed the DBP plus a mark-up and the lesser of the posted usual and customary fee or the ODB dispensing fee minus the applicable ODB co-payment amount. Where a completed Side Effect Reporting Form is not available at the pharmacy during an inspection, the difference between the cost of the higher-cost product and the lowest DBP listed for the interchangeable category will be recovered. (ontario.ca, Revision #17; 2026-08-03 ↗) 6.2 Medically Necessary "No Substitution" Claims The Ministry will provide reimbursement of a higher-cost interchangeable product in medically necessary circumstances where a patient has experienced a significant adverse reaction with two (2) lower-cost interchangeable drug products, where available. When a prescriber identifies a patient for which it is medically necessary that a higher cost interchangeable product be provided, the prescriber must: • Complete, sign and forward to the pharmacist a copy of the Health Canada side effect reporting form for each lower-cost interchangeable drug product trialed (Side Effect Reporting Form[s]); and • Write “No Substitution” or “No Sub” on a written prescription or indicate “No Substitution” to the pharmacist in the case of a verbal prescription. The prescriber should keep a copy of the completed form in the patient’s record for future use and reference. In the case of a written prescription, when the pharmacist or dispensing physician receives a prescription with the written notation “No Substitution” or “No Sub”, reimbursement will be provided for the higher-cost interchangeable product only if the prescription is accompanied by a completed Health Canada Side Effect Reporting Form for each of the lower-cost interchangeable drug products trialed. This form must be completely filled out noting the details of the adverse reaction and signed by the prescriber. In the case of a verbal prescription, the prescriber must satisfy the operator of the pharmacy or dispensing physician that a completed Health Canada Side Effect Reporting Form for each of the lower-cost interchangeable drug products trialed has been completed and signed by the prescriber. A written record of this verbal prescription and the completed Health Canada Side Effect Reporting Form must be received by the pharmacy prior to claim submission. Upon receipt, the pharmacist must: • Fax, submit online or mail the completed and signed form to Health Canada’s Canada Vigilance Program; and • Retain his or her copy of the completed and signed Side Effect Reporting Form. (ontario.ca, Revision #17; 2026-08-03 ↗)

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 ↗)

Mint-Valganciclovir · DIN 02495457 Manufacturer: Mint Pharmaceuticals Inc.; listing date 2020-07-31 Health Canada: Marketed since 2020-05-27 · brand MINT-VALGANCICLOVIR · ATC J05AB14 VALGANCICLOVIR · form Tablet · route Oral · ingredients VALGANCICLOVIR (VALGANCICLOVIR HYDROCHLORIDE) 450 MG · company Mint pharmaceuticals inc · schedule Prescription

DIN 02495457: Mint-Valganciclovir Raw flags: sec12=Y, sec3=Y Item: 081800066; group id 116; item number 0199; lccId 00145; manufacturer id MIN Source form: Tab; strength: 450mg Recorded listing: Limited Use: paid only with a Reason for Use code and the criteria below Source prices (unrounded): $5.8553; ministry $5.8553 Source: ODB odb-formulary-ed43-extract-2026-08-26.xml extract_date=2026-08-26 DIN=02495457 Health Canada DPD extract of Sep 2, 2026 (Open Government Licence – Canada) · https://health-products.canada.ca/dpd-bdpp/info?lang=eng&code=98537

Interchangeable products

Auro-Valganciclovir · DIN 02435179 · $5.8553 Teva-Valganciclovir · DIN 02413825 · $5.8553 Valcyte · DIN 02245777 · $5.8553

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=02495457

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

Reason for Use code 374 For the treatment of CMV retinitis in patients with HIV/AIDS. Coverage limit: LU Authorization Period: 1 year Reason for Use code 568 For the prevention of Cytomegalovirus (CMV) in solid organ transplant patients (not lung or heart-lung). Coverage limit: LU Authorization Period: Up to 6 months Reason for Use code 569 For the prevention of Cytomegalovirus (CMV) in lung or heart-lung transplant patients. Coverage limit: LU Authorization Period: Up to 12 months Exceptional Access criteria on record are for Brand(s): Valcyte; DOSAGE FORM/ STRENGTH: 450 mg tablet, 50 mg/mL oral solution — 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 Valganciclovir Brand(s): Valcyte DOSAGE FORM/ STRENGTH: 450 mg tablet, 50 mg/mL oral solution For the treatment of cytomegalovirus (CMV) disease following solid organ and/or bone marrow transplant in patients who meet the following criteria: 1. Objective evidence of active CMV infection determined by any one of the following methods: • CMV antigenemia assay;OR • CMV polymerase chain reaction (PCR); OR • bDNA assay; OR • Tissue biopsy with pathological changes showing intra-nuclear inclusion bodies compatible with CMV infection (i.e. Owl’s eye) • Primary Infection - positive CMV IgM antibodies; OR • Reactivation - Positive CMV IgM antibodies with four-fold or greater increase in CMV IgG antibodies 2. Consolidation phase of treatment (maintenance phase post-induction with IV ganciclovir) Standard Approval Duration: 3 to 6 months Renewals will be considered for patients who continue to have active CMV infection. Renewal requests not meeting the criteria will be considered on a case-by-case basis but the physician must submit a rationale of why ongoing treatment is necessary. Standard Approval Duration: 3 months For prophylaxis (prevention) of Epstein-Barr Virus (EBV) infection in EBV D+/R- transplant recipients. Standard Approval Duration: 6 months 476 Valganciclovir Brand(s): Valcyte DOSAGE FORM/ STRENGTH: 450 mg tablet, 50 mg/mL oral solution For treatment of Epstein-Barr Virus (EBV) infection in transplant patients according to the following criteria: 1. Confirmed via biopsy (rare EBV positive cells present); OR 2. Objective evidence of active EBV infection (Patient must have one of the three below): • Newly positive or rising EBV PCR; OR • Reactivation: Positive anti-VCA IgM antibodies with a four-fold or greater increase in anti-VCA IgG antibodies; OR • Presence of EBV DNA or protein in pathologic tissue Standard Approval Duration: 3 months Notes: Valganciclovir oral solution is considered for patients who meet the above requirements but who cannot swallow tablets or cannot use the tablets to achieve the planned dosing regimen. Renewals for patients showing continued active infection with EBV PCR may be considered on a case-by-case basis by submitting the request to the EAP. Requests for valganciclovir not meeting the above criteria or the Limited Use criteria on the formulary will be considered on a case-by-case basis but the prescriber must submit the request to the EAP. 477 Valganciclovir Brand(s): Valcyte DOSAGE FORM/ STRENGTH: 450 mg tablet, 50 mg/mL oral solution Approvals will be provided for the treatment of moderate to severe symptomatic congenital CMV (cCMV) in newborns who meet the following criteria: • Prescribed by or in consultation with a pediatric ID specialist (from one of the 5 treatment centres in Ontario: London, Hamilton, Toronto, Kingston, Ottawa; or Winnipeg for the NorthWestern region of Ontario) • Confirmed diagnosis of cCMV within the first 3 weeks¹ of birth by: o PCR (urine, saliva or quantitative serum CMV); OR o Positive culture results (urine or saliva) • Treatment to start within one month of birth² • Evidence of one or more of the following symptoms: o CNS disease (e.g., seizures, microcephaly, imaging abnormalities associated with CMV) o Eye disease (e.g., chorioretinitis) o Severe life-threatening organ dysfunction (must be described)³ • Regular monitoring of labs for toxicity while on therapy Approval Duration: maximum 6 months at 16mg/kg/dose BID (with dose adjustments in renal dysfunction, < 32 weeks gestational age, etc.) Renewals: No extensions will be provided unless extenuating circumstances for severely affected infants. Case-by-case review with rationale for continued treatment (must include pediatric ID specialist consult note) Valganciclovir oral liquid will be approved for newborns. All other requests not meeting the above criteria will be reviewed on a case-by-case basis including: • Initiation of treatment after one month of age² • Evidence of sensorineural hearing loss (SNHL) only (i.e., no other symptom described above) • Isolated/multiple findings of mild symptoms such as: intrauterine growth retardation (IUGR), thrombocytopenia, elevated liver enzymes, jaundice, hepatitis Sufficient rationale including consult from pediatric ID specialist must be provided before sending for external review. 478 Renewals of HIV Drugs EAP source: eap-frequently-requested-drugs-2025-01-01.txt, page 476, record 318, corpus 2025-01-01; name match only, not an eligibility decision 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 Valganciclovir Brand(s): Valcyte and Generics DOSAGE FORM/ STRENGTH: 450 mg tablet, 50mg/mL pd for oral solution For the treatment of moderate to severe symptomatic congenital CMV (cCMV) in newborns who meet the following criteria: • Prescribed by or in consultation with a pediatric ID specialist (from one of the 5 treatment centres in Ontario: London, Hamilton, Toronto, Kingston, Ottawa; or Winnipeg for the North Western region of Ontario1) • Confirmed diagnosis of cCMV within the first 3 weeks of birth by: o PCR (urine, saliva or quantitative serum CMV); OR o Positive culture results (urine or saliva) • Treatment to start within one month of birth • Evidence of one or more of the following symptoms: o CNS disease (e.g., seizures, microcephaly, imaging abnormalities associated with CMV) o Eye disease (e.g., chorioretinitis) o Severe life-threatening organ dysfunction (specify/describe) • Regular monitoring of labs for toxicity while on therapy 51 Valganciclovir Brand(s): Valcyte and Generics DOSAGE FORM/ STRENGTH: 450 mg tablet, 50 mg/mL pd for oral solutions Approval Duration: maximum 6 months at 16mg/kg/dose BID (with dose adjustments in renal dysfunction, < 32 weeks gestational age, etc.) Renewals: No extensions will be provided unless extenuating circumstances for severely affected infants. Case-by-case review with rationale for continued treatment (must include pediatric ID specialist consult note) All other requests not meeting the above criteria will be reviewed on a case-by-case basis including: • Initiation of treatment after one month of age • Evidence of sensorineural hearing loss (SNHL) only (i.e., no other symptom described above) • Isolated/multiple findings of mild symptoms such as: intrauterine growth retardation (IUGR), thrombocytopenia, elevated liver enzymes, jaundice, hepatitis 1List of treatment centres and addresses: • Children’s Hospital of Eastern Ontario, 401 Smyth Road, Ottawa ON K1H 8L1 • Kingston General Hospital, 76 Stuart Street, Kingston ON K7L 2V7 • The Hospital for Sick Children, 555 University Avenue, Toronto ON M5G 1X8 • McMaster Children’s Hospital, 1200 Main Street West, Hamilton ON L8N 3Z5 • London Health Sciences Center, 339 Windermere Road, London ON N6A 5A5 EAP source: eap-frequently-requested-drugs-2025-01-01.txt, page 51, record 29, corpus 2025-01-01; name match only, not an eligibility decision

Lowest DBP recovery rule under medically necessary no-substitution claims: 6.2 Medically Necessary "No Substitution" Claims The Side Effect Reporting Form will not have to be renewed. However, the pharmacy must maintain a copy of the prescription that contains a direction that there be no substitution and the required Health Canada Side Effect Reporting Form (completed and signed by the prescriber). The prescriber must write “No Substitution” or “No Sub” on renewal or subsequent new written prescriptions, and indicate “No Substitution” on subsequent new oral prescriptions. The dispenser will be reimbursed the DBP plus a mark-up and the lesser of the posted usual and customary fee or the ODB dispensing fee minus the applicable ODB co-payment amount. Where a completed Side Effect Reporting Form is not available at the pharmacy during an inspection, the difference between the cost of the higher-cost product and the lowest DBP listed for the interchangeable category will be recovered. (ontario.ca, Revision #17; 2026-08-03 ↗) 6.2 Medically Necessary "No Substitution" Claims The Ministry will provide reimbursement of a higher-cost interchangeable product in medically necessary circumstances where a patient has experienced a significant adverse reaction with two (2) lower-cost interchangeable drug products, where available. When a prescriber identifies a patient for which it is medically necessary that a higher cost interchangeable product be provided, the prescriber must: • Complete, sign and forward to the pharmacist a copy of the Health Canada side effect reporting form for each lower-cost interchangeable drug product trialed (Side Effect Reporting Form[s]); and • Write “No Substitution” or “No Sub” on a written prescription or indicate “No Substitution” to the pharmacist in the case of a verbal prescription. The prescriber should keep a copy of the completed form in the patient’s record for future use and reference. In the case of a written prescription, when the pharmacist or dispensing physician receives a prescription with the written notation “No Substitution” or “No Sub”, reimbursement will be provided for the higher-cost interchangeable product only if the prescription is accompanied by a completed Health Canada Side Effect Reporting Form for each of the lower-cost interchangeable drug products trialed. This form must be completely filled out noting the details of the adverse reaction and signed by the prescriber. In the case of a verbal prescription, the prescriber must satisfy the operator of the pharmacy or dispensing physician that a completed Health Canada Side Effect Reporting Form for each of the lower-cost interchangeable drug products trialed has been completed and signed by the prescriber. A written record of this verbal prescription and the completed Health Canada Side Effect Reporting Form must be received by the pharmacy prior to claim submission. Upon receipt, the pharmacist must: • Fax, submit online or mail the completed and signed form to Health Canada’s Canada Vigilance Program; and • Retain his or her copy of the completed and signed Side Effect Reporting Form. (ontario.ca, Revision #17; 2026-08-03 ↗)

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 ↗)

Teva-Valganciclovir · DIN 02413825 Manufacturer: Teva Canada Limited; listing date 2015-01-28 Health Canada: Marketed since 2014-11-27 · brand TEVA-VALGANCICLOVIR · ATC J05AB14 VALGANCICLOVIR · form Tablet · route Oral · ingredients VALGANCICLOVIR (VALGANCICLOVIR HYDROCHLORIDE) 450 MG · company Teva canada limited · schedule Prescription

DIN 02413825: Teva-Valganciclovir Raw flags: sec12=Y, sec3=Y Item: 081800066; group id 116; item number 0199; lccId 00145; manufacturer id TEV Source form: Tab; strength: 450mg Recorded listing: Limited Use: paid only with a Reason for Use code and the criteria below Source prices (unrounded): $5.8553; ministry $5.8553 Source: ODB odb-formulary-ed43-extract-2026-08-26.xml extract_date=2026-08-26 DIN=02413825 Health Canada DPD extract of Sep 2, 2026 (Open Government Licence – Canada) · https://health-products.canada.ca/dpd-bdpp/info?lang=eng&code=89847

Interchangeable products

Auro-Valganciclovir · DIN 02435179 · $5.8553 Mint-Valganciclovir · DIN 02495457 · $5.8553 Valcyte · DIN 02245777 · $5.8553

Shortage status: Reversed (report reversed by the reporter); reports as of 2026-09-13T08:10:21.292534+00:00 (Health Product Shortages Canada) Source: https://healthproductshortages.ca/search?term=02413825

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

Reason for Use code 374 For the treatment of CMV retinitis in patients with HIV/AIDS. Coverage limit: LU Authorization Period: 1 year Reason for Use code 568 For the prevention of Cytomegalovirus (CMV) in solid organ transplant patients (not lung or heart-lung). Coverage limit: LU Authorization Period: Up to 6 months Reason for Use code 569 For the prevention of Cytomegalovirus (CMV) in lung or heart-lung transplant patients. Coverage limit: LU Authorization Period: Up to 12 months 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 Valganciclovir Brand(s): Valcyte and Generics DOSAGE FORM/ STRENGTH: 450 mg tablet, 50mg/mL pd for oral solution For the treatment of moderate to severe symptomatic congenital CMV (cCMV) in newborns who meet the following criteria: • Prescribed by or in consultation with a pediatric ID specialist (from one of the 5 treatment centres in Ontario: London, Hamilton, Toronto, Kingston, Ottawa; or Winnipeg for the North Western region of Ontario1) • Confirmed diagnosis of cCMV within the first 3 weeks of birth by: o PCR (urine, saliva or quantitative serum CMV); OR o Positive culture results (urine or saliva) • Treatment to start within one month of birth • Evidence of one or more of the following symptoms: o CNS disease (e.g., seizures, microcephaly, imaging abnormalities associated with CMV) o Eye disease (e.g., chorioretinitis) o Severe life-threatening organ dysfunction (specify/describe) • Regular monitoring of labs for toxicity while on therapy 51 Valganciclovir Brand(s): Valcyte and Generics DOSAGE FORM/ STRENGTH: 450 mg tablet, 50 mg/mL pd for oral solutions Approval Duration: maximum 6 months at 16mg/kg/dose BID (with dose adjustments in renal dysfunction, < 32 weeks gestational age, etc.) Renewals: No extensions will be provided unless extenuating circumstances for severely affected infants. Case-by-case review with rationale for continued treatment (must include pediatric ID specialist consult note) All other requests not meeting the above criteria will be reviewed on a case-by-case basis including: • Initiation of treatment after one month of age • Evidence of sensorineural hearing loss (SNHL) only (i.e., no other symptom described above) • Isolated/multiple findings of mild symptoms such as: intrauterine growth retardation (IUGR), thrombocytopenia, elevated liver enzymes, jaundice, hepatitis 1List of treatment centres and addresses: • Children’s Hospital of Eastern Ontario, 401 Smyth Road, Ottawa ON K1H 8L1 • Kingston General Hospital, 76 Stuart Street, Kingston ON K7L 2V7 • The Hospital for Sick Children, 555 University Avenue, Toronto ON M5G 1X8 • McMaster Children’s Hospital, 1200 Main Street West, Hamilton ON L8N 3Z5 • London Health Sciences Center, 339 Windermere Road, London ON N6A 5A5 EAP source: eap-frequently-requested-drugs-2025-01-01.txt, page 51, record 29, corpus 2025-01-01; name match only, not an eligibility decision 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 Valganciclovir Brand(s): Valcyte DOSAGE FORM/ STRENGTH: 450 mg tablet, 50 mg/mL oral solution For the treatment of cytomegalovirus (CMV) disease following solid organ and/or bone marrow transplant in patients who meet the following criteria: 1. Objective evidence of active CMV infection determined by any one of the following methods: • CMV antigenemia assay;OR • CMV polymerase chain reaction (PCR); OR • bDNA assay; OR • Tissue biopsy with pathological changes showing intra-nuclear inclusion bodies compatible with CMV infection (i.e. Owl’s eye) • Primary Infection - positive CMV IgM antibodies; OR • Reactivation - Positive CMV IgM antibodies with four-fold or greater increase in CMV IgG antibodies 2. Consolidation phase of treatment (maintenance phase post-induction with IV ganciclovir) Standard Approval Duration: 3 to 6 months Renewals will be considered for patients who continue to have active CMV infection. Renewal requests not meeting the criteria will be considered on a case-by-case basis but the physician must submit a rationale of why ongoing treatment is necessary. Standard Approval Duration: 3 months For prophylaxis (prevention) of Epstein-Barr Virus (EBV) infection in EBV D+/R- transplant recipients. Standard Approval Duration: 6 months 476 Valganciclovir Brand(s): Valcyte DOSAGE FORM/ STRENGTH: 450 mg tablet, 50 mg/mL oral solution For treatment of Epstein-Barr Virus (EBV) infection in transplant patients according to the following criteria: 1. Confirmed via biopsy (rare EBV positive cells present); OR 2. Objective evidence of active EBV infection (Patient must have one of the three below): • Newly positive or rising EBV PCR; OR • Reactivation: Positive anti-VCA IgM antibodies with a four-fold or greater increase in anti-VCA IgG antibodies; OR • Presence of EBV DNA or protein in pathologic tissue Standard Approval Duration: 3 months Notes: Valganciclovir oral solution is considered for patients who meet the above requirements but who cannot swallow tablets or cannot use the tablets to achieve the planned dosing regimen. Renewals for patients showing continued active infection with EBV PCR may be considered on a case-by-case basis by submitting the request to the EAP. Requests for valganciclovir not meeting the above criteria or the Limited Use criteria on the formulary will be considered on a case-by-case basis but the prescriber must submit the request to the EAP. 477 Valganciclovir Brand(s): Valcyte DOSAGE FORM/ STRENGTH: 450 mg tablet, 50 mg/mL oral solution Approvals will be provided for the treatment of moderate to severe symptomatic congenital CMV (cCMV) in newborns who meet the following criteria: • Prescribed by or in consultation with a pediatric ID specialist (from one of the 5 treatment centres in Ontario: London, Hamilton, Toronto, Kingston, Ottawa; or Winnipeg for the NorthWestern region of Ontario) • Confirmed diagnosis of cCMV within the first 3 weeks¹ of birth by: o PCR (urine, saliva or quantitative serum CMV); OR o Positive culture results (urine or saliva) • Treatment to start within one month of birth² • Evidence of one or more of the following symptoms: o CNS disease (e.g., seizures, microcephaly, imaging abnormalities associated with CMV) o Eye disease (e.g., chorioretinitis) o Severe life-threatening organ dysfunction (must be described)³ • Regular monitoring of labs for toxicity while on therapy Approval Duration: maximum 6 months at 16mg/kg/dose BID (with dose adjustments in renal dysfunction, < 32 weeks gestational age, etc.) Renewals: No extensions will be provided unless extenuating circumstances for severely affected infants. Case-by-case review with rationale for continued treatment (must include pediatric ID specialist consult note) Valganciclovir oral liquid will be approved for newborns. All other requests not meeting the above criteria will be reviewed on a case-by-case basis including: • Initiation of treatment after one month of age² • Evidence of sensorineural hearing loss (SNHL) only (i.e., no other symptom described above) • Isolated/multiple findings of mild symptoms such as: intrauterine growth retardation (IUGR), thrombocytopenia, elevated liver enzymes, jaundice, hepatitis Sufficient rationale including consult from pediatric ID specialist must be provided before sending for external review. 478 Renewals of HIV Drugs EAP source: eap-frequently-requested-drugs-2025-01-01.txt, page 476, record 318, 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 ↗)

Valcyte · DIN 02245777 Manufacturer: Cheplapharm Arzneimittel GmbH; listing date 2003-04-16 Health Canada: Marketed since 2022-07-19 · brand VALCYTE · ATC J05AB14 VALGANCICLOVIR · form Tablet · route Oral · ingredients VALGANCICLOVIR (VALGANCICLOVIR HYDROCHLORIDE) 450 MG · company Cheplapharm arzneimittel gmbh · schedule Prescription

DIN 02245777: Valcyte Raw flags: sec12=Y, sec3=Y Item: 081800066; group id 116; item number 0199; lccId 00145; manufacturer id CHE Source form: Tab; strength: 450mg Recorded listing: Limited Use: paid only with a Reason for Use code and the criteria below Source prices (unrounded): $28.9683; ministry $5.8553 Source: ODB odb-formulary-ed43-extract-2026-08-26.xml extract_date=2026-08-26 DIN=02245777 Health Canada DPD extract of Sep 2, 2026 (Open Government Licence – Canada) · https://health-products.canada.ca/dpd-bdpp/info?lang=eng&code=69890

Interchangeable products

Auro-Valganciclovir · DIN 02435179 · $5.8553 Mint-Valganciclovir · DIN 02495457 · $5.8553 Teva-Valganciclovir · DIN 02413825 · $5.8553

Shortage status: resolved shortage (ended 2024-01-31); reports as of 2026-09-13T08:10:21.292534+00:00 (Health Product Shortages Canada) Source: https://healthproductshortages.ca/search?term=02245777

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