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 Disadvantages
Systemic Oral
therapy
Advantages
Disadvantages
-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
Intra-ocular (IO)
therapy
-Efficacious
-Ideal option for treatment
of immediate eye-sight
threatening lesions
-Requires an IV line
(hospitalization)
-Trained staff
–Systemic side effects
(pancytopenia, renal
dysfunction and GI side
effects)
-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 Valganciclovir
Offer
Price per tablet
in USD
12 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 clinic
4 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
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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
Thank You
Questions and Comments?
Arax.Bozadjian@geneva.msf.org
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