21st Expert Committee on Selection and Use of Essential Medicines
Peer Review Report
[Antiretroviral deletion]
(1)
Does the application adequately address the issue of the public health need
for the medicine?
Yes
No

Please provide brief details:
(2)
Have all important studies/evidence of which you are aware been included
in the application?
Yes
No

Please provide brief comments on any relevant studies that have not been included:
(3)
Does the application provide adequate evidence of efficacy/effectiveness of
the medicine for the proposed use?
Yes
No

(a) Briefly summarise the reported benefits (e.g. clinical versus surrogate) and
comment, where possible, on the actual magnitude of benefit associated with use
of the medicine:
(b)
Is there evidence of efficacy in diverse settings and/or populations? Please
provide brief details:
(4)
Has the application adequately considered the safety and adverse effects of
the medicine? Are there any adverse effects of concern, or that may require
special monitoring?
Yes
No

Please provide brief details:
(5)
Please comment on the overall benefit to risk ratio of the medicine (e.g.,
favourable, uncertain etc).
ADDITIONAL CONSIDERATIONS:
(6)
Are there special requirements or training needed for the safe, effective
and/or appropriate use of the medicine?
Yes
No
Please provide brief details:
(7)
Are there any issues regarding the registration of the medicine by
regulatory authorities? (e.g., recent registration, new indications, off-label
use)
Yes

No
Please provide brief details:
(8)
Is the medicine recommended for use in a current WHO GRC-approved
Guideline (i.e., post 2008)?
Yes

No
Please provide brief details:
(9)
Please comment briefly on issues regarding cost and affordability of this
medicine.
(10)
Any additional comments?
(11)
Please frame the decisions and recommendations that the Expert
Committee could make.
From the memorandum with no additional evidence to support the decision, we
can comment as below:
1. Exclusion of the drug as a therapeutic option in current guidelines
ARV
Stavudine / lamivudine /
nevirapine
Tab 30+150+200 mg
Tab 30+50+6 mg
Saquinavir solid oral
dosage form 200, 500 mg
Rationale for exclusion
- Long term cumulative
toxicity
- New drugs are better
profile
- High toxicity
- High pill burden
- No availability in FDC
Comments
Delist according to the
given rationale.
Delist according to the
given rationale.. (please
see detail in the separate
with booster
- New drugs are better
profile
peer review report of the
other application for
delisting saquinavir )
2. Exclusion of the formulation as a therapeutic option in current
guidelines
ARV
Zidovudine
IV infusion 200 mg / 20 mL
Rationale for exclusion
- No clinical evidence
- Not better than oral form
- Complex administration
- Additional cost
Comments
Delist Zidovudine
IV infusion 200 mg / 20 mL
according to the given
rationale.
3. Provide alignment with the optimal IATT formulary
ARV
Nevirapine
Tab 200 mg
Rationale for exclusion
- EMLc deletion
- Replaced by more proper
formulation as dispersible
tablet 50 mg.
Atazanavir
Solid oral dosage form
150 mg
- EMLc deletion
- Replaced by more proper
formulation as tablet 100
mg.
Comments
Delist Nevirapine tablet
200 mg from EMLc since
more proper formulation
50 mg dispersible tablet is
listed.
Atazanavir solid oral
dosage form 150 mg
should be retained in the
list since recommended
dose for pediatric patients
covers the dose range 150,
200, 300, 400 mg(1,2).
References:
1. Truven Health Analytics. Micromedex solutions [online]. Ann Arbor, MI. 2017
[cited 2017 Mar 11]: Available at URL:
http://www.micromedexsolutions.com/home/dispatch.
2. Datapharm Communications. The electronic Medicines Compendium (eMC):
Reyataz 150 mg, 200 mg and 300mg hard capsules [online]. 2016 Dec 15 [cited
2017 Mar 11]: Available at URL:
http://www.medicines.org.uk/emc/medicine/14145.
4. Exclusion proposed by 2015 EML expert committee
(No application or justification to support the retention)
ARV
Abacavir
Oral liquid 100 mg/5mL
Rationale for
exclusion
- No support for
retention
Comments
Delist abacavir oral liquid in EML and
EMLc since there are available
suitable dosage form and strength
available.
The proposed text in EML
1. abacavir (ABC)
Oral liquid: 100 mg (as sulfate)/5 mL.
Tablet: 300 mg (as sulfate).
2. abacavir + lamivudine Tablet
(dispersible, scored): 60 mg (as
sulfate) + 30 mg
In WHO HIV and Thai HIV
guidelines (3,4), for children, ABC is
always recommended with 3TC. So
that, the single ABC is not necessary.
There is not enough reason in the
application to delist efavirenz 200 mg
capsule and keep only tablet 200 mg
(scored) & 600 mg. Efavirenz 50, 100,
200 mg is necessary for dose
adjustment for pediatric use.
ABC+3TC+ EFV is a preferred regimen
in pediatric patient (3,4). There is no
fixed combination of these 3 drugs.
The availability is (fixed ABC+3TC) +
EFV. EFV in different strength is
necessary to be used in children
varied by weight (5).
This drug should be deleted due to
toxicity profile and can be replaced by
other drugs.
Efavirenz
Capsule 50, 100, 200 mg
Stavudine
Capsule 15, 20, 30 mg
Powder for oral liquid 5
mg/5mL
Zidovudine
Capsule 100 mg
Lamivudine
Oral liquid 50 mg/5mL
References:
- Delete from
EML
- But retains in
EMLc
Delist Zidovudine Capsule 100 mg in
EML and EMLc since there are other
suitable strengths of AZT for adult
use and oral liquid for pediatric use
The proposed text in EML
Capsule: 100 mg; 250 mg.
Oral liquid: 50 mg/5 mL.
Solution for IV infusion injection: 10
mg/ mL in 20- mL vial.
Tablet: 300 mg .
Capsule 100 mg is not necessary in
adult patient due to the dosing 500 or
600 mg/day can be covered by
capsule 250 mg and tablet 300 mg.
Capsule 100 mg may be not necessary
in pediatric patient due to the dosing
360-480 mg/m 2 (3 or 4 divided dose)(6)
can be covered by oral liquid 50/5mg
or other fixed combination
(3TC+NVP+AZT 30+50+60 mg &
3TC+AZT 30+60 mg).
Delist from EML but retain in EMLc
Proposed text in EML
lamivudine (3TC)
Oral liquid: 50 mg/5 mL.
Tablet: 150 mg .
3.
4.
5.
6.
(12)
World Health Organization. Consolidated guidelines on the use of antiretroviral
drugs for treating and preventing HIV infection: Recommendations for a public
health approach. 2nd ed. France: World Health Organization; 2016.
Bureau of AIDS, TB and STIs, Department of Disease Control, Ministry of Public
Health. Thailand national guidelines on HIV/AIDS treatment and prevention
2017. Bangkok: The Agricultural Co-operative Federation of Thailand; 2017.
Datapharm Communications. The electronic Medicines Compendium (eMC):
Sustiva 50 mg, 100 mg and 200 mg Hard Capsules [online]. 2016 Oct [cited 2017
Mar 14]: Available at URL: http://www.medicines.org.uk/emc/medicine/9877.
Datapharm Communications. The electronic Medicines Compendium (eMC):
Zidovudine 100mg capsules [online]. 2008 Aug 1 [cited 2017 Mar 14]: Available at
URL: http://www.medicines.org.uk/emc/medicine/24327.
References (if required)