Worldwide Issues
South Africa: Hefty Price Tag On Two New Cervical Cancer Vaccines
14 March 2008- Johannesburg-Cape Town, South Africa--
Two costly new vaccines that protect women from cervical cancer have been registered with the Medicines Control Council, paving the way for the products to be launched on the South African market.
That should be good news as cervical cancer is among the most common cancers affecting women and often goes undetected until it is too advanced to treat.
However, the hefty price tags on GlaxoSmithKline's Cervarix and Gardasil from Merck Sharpe & Dohme (MSD) ask tough questions about whether SA can afford to provide the shots.
Part of the problem is that the benefit of the vaccines will not be immediate. Unlike vaccinations in childhood -- which protect infants right away against killer infections they encounter -- the cervical cancer jabs offer protection against a disease which might only strike 20 or 30 years down the line.
As with the new vaccines against rotavirus and pneumococcal diseases, the debate on whether to provide Human Papilloma Virus (HPV ) vaccines goes to the heart of how medical providers ration limited resources. Both Glaxo and MSD's vaccines help the body fight infections with strains 16 and 18 of HPV , which cause cervical cancer. Gardasil also offers protection against HPV 6 and 11, which cause genital warts.
At least half of all sexually active men and women get infected with HPV at some point, and 80% of women will get infected by the time they are 50.
Often the virus will go away on its own, but in other cases it causes cancer. If trea ted early, the prognosis is good. However, in countries such as SA, with patchy screening programmes, many women will die from the disease.
The vaccines could prevent up to four-fifths of cases of cervical cancer, which killed about 3424 South African women in 2000, according to the Medical Research Council. Since the cervical cancer-causing HPV strains are spread by skin-to-skin contact during sex, the vaccine needs to be given to young adolescents before they start having sex.
"Like all vaccinations they coul d have a major effect on public health, and in this case, prevent a lethal and devastating cancer that kills women in the prime of their lives," says Prof Lynette Denny, a cervical cancer expert at the University of Cape Town.
"However, there are a lot of issues that need to be resolved before recommending implementation of the vaccine into the public health sector, the most important being cost," she says.
Cost is likely to hamper private sector patients' access to the HPV vaccine too.
The shots are to be launched in SA next month. Glaxo plans to sell Cervarix to its private sector customers at about R2100 for a course of three shots administered over six months, on a par with prices in Europe.
By the time mark ups and GP consultations are factored in, a parent can expect to pay about R3000 for each child.
There are no laws compelling medical schemes to pay for vaccinations, and so most private sector patients can ex pect to foot the bill themselves.
SA's biggest medical scheme Discovery Health, for example, requires members to use their savings accounts for immunisations. Discovery has yet to consider the new HPV vaccines, but for now will apply the standard rules, says the company's head of strategy Jonathan Broomberg.
Gardasil has yet to be priced for the South African market, but is likely to be set below the international benchmark of $120 a shot, says MSD SA's medical director Beverley Cowper.
The jabs will not replace screening programmes for cervical cancer, she says.
"With the newer vaccines, the cost (of development) has increased tremendously," says Glaxo director of clinical research and development Alain Brecx, explaining why the shots are so expensive.
A new vaccine takes 8-12 yea rs to develop, at a cost of between $500m and $800m, he says, declining to provide specifics on Cervarix. Developing vaccines has become more expensive in recent years because companies no longer just assess whether a vaccine provokes an immune response from the body and is safe, but now also try to prove the vaccine actually works in the field.
These large-scale efficacy trials can involve tens of thousands of volunteers.
Both Glaxo and MSD say the government will benefit from their tiered pricing policies, which see rich countries subsidising poor ones. Since talks with government officials have yet to get seriously under way, the firms are loathe to talk prices.
"Yet price is not the only issue," says Brecx. "One of the key questions is whether it is feasible to successfully vaccinate a cohort of adolescent girls", he says.
Public health experts will have to figure out whether a school-based immunisation programme will work in countries with a high drop-out rate among girls, he says.
There are also unanswered questions about how effective the vaccine will be for women who later become infected with HIV, a key issue in countries such as SA with a high incidence of the AIDS-causing virus, says Prof Helen Rees, head of the Reproductive Health Research Unit at the University of the Witwatersrand.
"We think there might be other strains of HPV that play a role in cervical cancer for women infected with HIV, and that cervical cancer strikes women with HIV at a younger age," she says. Scientists are researching these iss ues, she says.
Questions aside, experts are keen to get the HPV vaccine out to as many young women as possible. "To have a safe and effective vaccine against the two HPV strains responsible for cervical cancer is a major breakthrough. It could save the lives of hundreds of thousands of women worldwide," Rees says.
