Product Details

Valcyte

Valganciclovir
50 mg/mL
Powder for Oral Solution
100-mL Pack

DIN/PIN/NPN

02306085

Manufacturer

Cheplapharm Arzneimittel GmbH

Formulary Listing Date

2020-02-28  

Unit Price

308.1394

Amount MOH Pays

150.9900

Coverage Status

Limited Use Product

ODB Formulary Therapeutic Classification

Therapeutic Note

NO

ATC Code

J05AB14

Interchangeable Products

DIN/ PIN/ NPN Brand name Unit Price Amount MOH pays
02306085 Valcyte 308.1394 150.9900
02535483 Auro-Valganciclovir 150.9900 150.9900
 

LU Clinical Criteria

LU Code Auth. Period Clinical Criteria
571 1 year

For those unable to swallow or tolerate solid oral dosage form AND

For the treatment of Cytomegalovirus (CMV) retinitis in patients with HIV/AIDS.
572 Up to 6 months

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).
573 Up to 12 months

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.
 

EAP Criteria

Therapeutic Class Reimbursement Criteria
Anti-Infectives

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:

  1. 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)

  2. Confirmed diagnosis of cCMV within the first 3 weeks of birth by:
    • PCR (urine, saliva or quantitative serum CMV);
    OR
    • Positive culture results (urine or saliva)

  3. Treatment to start within one month of birth

  4. Evidence of one or more of the following symptoms:
    • CNS disease (e.g., seizures, microcephaly, imaging abnormalities associated with CMV)
    • Eye disease (e.g., chorioretinitis)
    •Severe life-threatening organ dysfunction (specify/describe)

  5. 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, less than 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:

  1. Children’s Hospital of Eastern Ontario, 401 Smyth Road, Ottawa ON K1H 8L1

  2. Kingston General Hospital, 76 Stuart Street, Kingston ON K7L 2V7

  3. The Hospital for Sick Children, 555 University Avenue, Toronto ON M5G 1X8

  4. McMaster Children’s Hospital, 1200 Main Street West, Hamilton ON L8N 3Z5

  5. London Health Sciences Center, 339 Windermere Road, London ON N6A 5A5

EAP Drug Request Form:

Standard Form for EAP Drug Requests
Post-transplant Drugs – Telephone Request Service (TRS) Drugs

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 

  1. 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

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

  1. 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.

Approvals will be provided for the treatment of moderate to severe symptomatic congenital CMV (cCMV) in newborns who meet the following criteria: 

  1. 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) 

  2. Confirmed diagnosis of cCMV within the first 3 weeks1 of birth by:
    •     PCR (urine, saliva or quantitative serum CMV);
    OR
    •     Positive culture results (urine or saliva)

  3. Treatment to start within one month of birth2

  4. Evidence of one or more of the following symptoms:
    •     CNS disease (e.g., seizures, microcephaly, imaging abnormalities associated with CMV)
    •     Eye disease (e.g., chorioretinitis)
    •     Severe life-threatening organ dysfunction (must be described)3

  5. 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, less than 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.

Product Monograph

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