MABs: Costs & Availability in S Africa

[Guest guest]

Hello Prof Vijay Thawani & Fellow Members,

It is good to be in touch. Those remembering me from the RDU course

I did in Jaipur, India, will know that I work for the state

provincial sector in KwaZulu-Natal, S Africa.

Whilst the MABs are very useful and promising agents, the costs are

so prohibitive and the products are not registered by the

manufacturing companies with our regulation authority in S Africa.

A presentation to the provincial Pharmacy & Therapeutics committee

(PTC) on a MAB for the off-labelled use for intravireal bevacizumab

for macular degeneration, diabetic retinopathy and retinal vein

occlusion proved that the manufacturing company was unwilling to

register the product simply because they had another more costly

product to treat the same. The morality of such a practice is dumb

founding.

The supportive facts to the above statement are: -

• Ranibizumab (Lucentis): Costs a whopping R11 000 (+Rs66 000)

per treatment.

• Bevacizumab: Costs are R3197 per 100mg in 4ml vial and can

be used to treat four patients if the product is divided using an

aseptic technique reducing the costs to R800 (+Rs 4 800) per

treatment.

Data to support use: " Statistically significant improvements in

visual acuity, as well as decreases in retinal thickness and the

extent of choroidal neovascularization, were noted. Intravitreal

bevacizumab was well tolerated over the short term. In a registry

compiling adverse experiences of 7113 intravitreal injections, rates

of adverse events were less than or equal to 0.21% " (Lynch SS, Cheng

CM Bevacizumab for neovascular ocular diseases. Ann Pharmacother.

2007 Apr; 41(4):614-25).

Yoganathan et al. (Visual improvement following intravitreal

Bevacizumab in exudative age-related macular degeneration. Retina

2006; 26: 995-998) followed up 24-50 weeks, after an average 3.5

injections per eye found that there was no severe visual loss or

adverse event and that the average visual improvement was 6.5

letters (ETDRS)

Avaialbilility:

• Ranibizumab (Lucentis), is FDA approved, but not available

in S Africa and is sourced via an import via a special permit

• Bevacizumab is registered for Ca Colon in S Africa but is

needed to prevent blindness and to support the dignity and self-help

of individuals.

Change is needed internationally for the registration and use of

medicines. Is there any hope of inter-collaborative efforts via the

WHO and WHA?

Best wishes

m Cassimjee