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New Treatment Opportunity: Valganciclovir
Arax Bozadjian, PharmD
International AIDS Conference
Kuala Lumpur, Malaysia
June 2013
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Outline–Current Treatment Options–Advantages and Disadvantages of
existing forms of treatment–Price Analysis Assumptions–Price Analysis-Oral Valganciclovir–Price Analysis-Intraocular Ganciclovir–Barriers to scaling up treatment of
CMV retinitis with oral therapy–Overcoming barriers to enable access
to oral therapy
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Current Treatment Options• Ganciclovir
– Systemic Injection– Intravitreal Injection– Intraocular Injection – Intraocular Implant
• Valganciclovir– Oral tablet
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Advantages and DisadvantagesAdvantages Disadvantages
Systemic Oral therapy -Easy to administer-Systemic efficacy-No training of staff-Benefit contra-lateral eye-IDSA/CDC/NIH recommended
-Systemic side effects (pancytopenia, hypertension, diarrhea/nausea/vomiting) -Price
Injectable (IV) therapy -Systemic efficacy -Benefit contra-lateral eye-IDSA/CDC/NIH recommended
-Requires an IV line (hospitalization)-Trained staff –Systemic side effects (pancytopenia, renal dysfunction and GI side effects)
Intra-ocular (IO) therapy
-Efficacious-Ideal option for treatment of immediate eye-sight threatening lesions
-Trained staff to administer-Discomfort for both patient and provider-Higher level of risk
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Price Analysis Assumptions• For the oral therapy we used two scenarios for the
time frames:– Induction phase: 3 weeks (Dose: 2 tablets twice daily)– Maintenance phase: 9 weeks and 24 weeks (Dose: 2
tablets daily)• For the intraocular injection we used the following
time frames:– Induction phase: 6 weeks (Dose: 0.05ml or 2.5 mg
daily)– Maintenance phase: 22 weeks (Dose: 0.05ml or 2.5
mg daily)• The sources of our pricing is procurement reported
prices, as well as private market prices
CDC,IDSA Guidelines for Prevention and Treatment of Opportunistic Infections in HIV-Infected adults and adolescents 2009
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Price analysis-Oral Valganciclovir
The dosing for oral Valganciclovir 450 mg for the treatment of CMV retinitis is as follows:
• Induction Phase: 3 weeks = 84 tablets
• Maintenance Phase Scenario 1: 9 weeks = 126 tablets
• Maintenance Phase Scenario 2: 24 weeks = 336 tablets
• Total Number of tablets = 210 (Scenario 1) or 420 (Scenario 2)
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Price analysis-Oral ValganciclovirOffer Price per tablet
in USD12 weeks Treatment
regimen cost (USD/pp)
27 weeks Treatment
regimen cost (USD/pp)
Roche’s Valcyte® price from a procurement agency based in Europe (2012)
10.50 2,206 4,412
Roche’s Valcyte® price in Indian domestic market (2012)
12.03 2,527 5,053
Cipla’s generic Valganciclovir in Indian domestic market (2012)
3.53 741 1,482
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Price analysis-Intraocular Ganciclovir
Induction (6 weeks)
Maintenance (22 weeks)
Total treatment (28 weeks)
1/5th patients (20 patients)
4/5th patients (80 patients)
Total 100 patients
20 pts x 6 injections x 2.5 mg per dose = 300 mg
80 pts x 8 injections x 2.5 mg per dose = 1600 mg
Total = 1600 mg + 300 mg = 1900 mg
• Assuming 100 patients are in our clinic, and the single dose is 0.05 ml (2.5 mg)
• The cost of 1 vial of Ganciclovir from a procurement agent in Europe is $ 35 USD
• The need based upon above scenario is approximately 4 vials (1900mg ÷ 500 mg)
• Approximately 4 vials are needed to treat 100 patients at our clinic4 vials x 35 USD per vial = 140 USD to treat 100 patients
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Barriers to Scaling Up Treatment of CMV retinitis with Oral Therapy• Currently, there is insufficient demand for
Valganciclovir due to:– Patients under-diagnosed for CMV retinitis– Lack of normative clinical guidance on CMV
retinitis (for screening and treatment)– Lack of donor interest in opportunistic
infections– Current high costs of oral therapy as
compared to the intraocular injection– No demand, hence no supply
Overcoming Barriers to enable Access to Oral Therapy
• Global Level:– WHO to rapidly issue evidence-based
treatment guidelines– Enabling generic competition for additional
quality-assured and affordable sources of Valganciclovir
– Negotiation with the originator company to reduce the price of Valganciclovir
– Donors to include diagnosis and treatment of CMVr as a component of basic HIV package of care
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