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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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Thank You

Questions and Comments?

Arax.Bozadjian@geneva.msf.org