AIDS DRUGS POLICY – MINISTRY OF HEALTH/BRAZIL

One of the primary missions of Brazil´s National STD/AIDS Program (NSAP) is to make HIV medications available free of charge to all citizens who need them though the country´s public health care system.  This effort was initiated in the early 1990´s with limited distribution of the AZT capsule, and was strengthened with a 1996 presidential decree that guaranteed that all HIV-infected citizens would have free access to essential medication to combat HIV.  The distribution of protease inhibitors began between December 1996 and January 1997.  The same presidential decree stipulated that the criteria for dispensing HIV treatment would be established by The Ministry of Health, which has two task forces working the problem, one focusing on HIV therapy for adults and adolescents and one for children.  The two task forces come together at least once a year to review the criteria and to discuss new medical breakthroughs and the availability of new treatments.

Together with its policy of drug distribution, the Brazilian Government’s National STD/Aids Programme has worked hard to reinforce the public laboratories throughout the country so as to establish the National Network of laboratories for T CD4+ lymphocyte counting and for quantifying HIV viral load, making available the tests required for indication of anti-retroviral therapy and chemo-prophylaxis of opportunistic infections, as well as for the suitable monitoring of patients receiving treatment. Over the last two years, over 150,000 viral load tests and more than 235,000 tests for TCD4+  counting have been carried out,  at a cost of around  $US 16 million ( unit cost of $US15 per CD4 test and $US 29 for a viral load test).

A survey undertaken in 1998 by the countries participating in the Horizontal Technical Co-operation Programme in Latin America showed that of all the patients undergoing treatment in 10 countries, Brazil accounted for 73.33%, followed by Mexico with 12.64%, Argentina with 11.38% and the remaining countries (Chile, Panama, Costa Rica, Cuba, Uruguay, Ecuador and Peru) with fewer than 3% of the patients.

Approximately 90,000 patients received ARV through the public health system (95% adults and adolescents and 5% children).  In 1997, when protease inhibitors were initially made available, the program experienced its greatest increase in the number of patients, an increase of about 26,000.  In 1998, the increase was about 14,000 and in 1999 it was about 19,500.

Currently, the range of antiretroviral medications made available by the Ministry of Health, include 12 drugs (5 analog reverse transcriptase inhibitors, 3 non-analog reverse transcriptase inhibitors, and 4 protease inhibitors).  These 12 HIV inhibitors are made available in a total of 25 pharmaceutical versions.

It is important to note that the acquisition and distribution of medications for treating opportunistic infections in Brazil is decentralized and is the responsibility of States and Municipalities, not the federal government.

The Brazilian Programme’s needs for ARV drugs are estimated in accordance with the following data:

• Cumulative data on the total of patients undergoing anti-retroviral treatment

• Cumulative data on the number and percentage of patients using each anti-retroviral drug

• New recommendations for ARV therapy an adults and adolescents

• New recommendations for ARV therapy an children

Federal expenditures for purchasing antiretroviral medications were approximately US$34 million in 1996, US$224 million in 1997, US$305 million in 1998, US$335 million in 1999, and US$332 million (estimated) in 2000.  The increase in expenditures is mostly due to increased the number of patients, increased use of complex therapies, and overall refinement of therapies and treatment.  With regard to the budget at the  Ministry of Health, the expenditures represent 24% of the budget 1996, 1.18% in 1997, 1.82% in 1998, 3.18% in 1999, and 3% in 2000 (estimated).

The prices of antiretroviral medications acquired by the Ministry of Health have in general been going down over the last few years.  This is due, in large part, to the Ministry of Health investments in establishing national laboratories along with effective negotiation of prices with pharmaceutical companies that are exclusive producers. The most dramatic reduction in prices relates to medications currently being manufactured within Brazil, both by private companies and by national laboratories.  In fact, prices of drugs produced within Brazil, fell on average 72.5 between 1996 and 2000.  The prices of imported drugs went down on average 9.6% during the same period.  The drug that went down in price the most was Zalcitabine, which went down 95%.

National Production of ARV and First Year of Production: zidovudine (1993); stavudine (1997); zalcitabine (1997); didanosine (1998); zidovudine plus lamivudine (1999); lamivudine (1999); indinavir (2000) and nevirapine (2000).

In 1999, 47% of antiretroviral medications, which corresponds to 19% of total expenditures, were produced inside Brazil (92% from national laboratories and 7% from private companies) and 53% of anti-viral medications, which corresponds to 81% of total expenditures, were purchased from multinational pharmaceutical companies. It is interesting to note that in 1999, the Ministry of Health had planned to produce several drugs internally under license but ended up not doing so because the multinational pharmaceutical companies lowered their prices sufficiently to make it economical to continue importing the drugs.

In Brazil, the reduction in the prices of anti-viral medications pushed down prices considerably for chemoprophylaxis with Zidovudine for controlling the vertical transmission of HIV (per patient) from US$ 661.94 in 1996 to US$ 207.56 in 2000 (a decrease of 68.6%).  The  mean cost of double therapy of NRTI (per patient) went from US$3,812.06 in 1996 to US$763.22 in 2000 (a decrease of 80%).  Thanks to a reduction in the mean cost of nucleoside analogs, the cost for triple therapies with PI fell from US$ 7,341.87 in 1997 to US$4,716.84 in 2000 and the mean cost of triple therapies of NRTIN went from US$4,583.74 in 1998 to US$3,008.70 in 2000. It varied from 35.7% to 34.4% and it may be due, specially, to costs decrease of NRTI. The mean cost for patient/year in antiretroviral therapy from 1996 to 1997 showed a significant increase,  due to the start of distribution of PI. Nevertheless, it has been declining from 1997 to 2000 in approximately 15% ( US$ 4,858.14 in 1997 to US$ 4,137.20 in 2000), besides the proportional increase of patients using more expensive and complex therapeutic schemes.

Considering the daily costs of treatment, the NRTI drugs have presented lower costs, that varied from US$ 0.24 (ddC) to US$ 2.04 (ddI), followed by the NNRTI, that varied from US$ 5.36 (NVP) to US$ 6.97 (EFZ), and finally, the PI that varied from 6.75 (SQV) to US$ 12.24 (NFV).

Aids drugs logistical system

Anti-retroviral drugs are purchased centrally by the Ministry of Health. As you will see on the slide, the brown arrows represent the flow of the acquisition of Aids drugs in the Ministry of Health, beginning in the National STD/Aids Programme with the scheduling of needs; the green arrows show the scheduling of distribution at the various levels of the system; the blue arrows indicate the different flows of drugs from their initial delivery by the laboratories and all the way through to the patients; finally, the red arrows show the flow of information from the patient back to the National Programme: information which is essential for Aids drugs distribution and the purchasing programme.   

The National STD/AIDS Programme has developed a computerized system for the Logistical Control of Anti-Retroviral Drugs known as SICLOM. The main features of this are:

·         A National Patient Register

·         A Register which is linked to the Aids Drugs Dispensing Units

·         Checks made on the register and on drugs dispensing according to criteria laid down by the Ministry of Health

·         Computerization of the Drugs Dispensing Units

·         The authentication of requests for ARV drugs by means of magnetic cards

·         Information given to patients regarding how to take and store the drugs correctly

·         Updating of the data by telephone to the National STD/AIDS Programme

At present there are 424 Drugs Dispensing Units in Brazil. The SICLOM has already been set up in 26 of the country’s largest units and accounts for 30% of the total number of patients.  It is currently being expanded  by 85 more units, making a total of 111 units to cater for 65% of the patients.

Impact of the Antiretroviral Therapy

 The program of universal access to the antiretroviral therapy, together with other actions, such as the use of chemoprophylaxis for the most important opportunistic infections, and the availability of care modalities that aim the reduction of hospitalizations, as the Specialized Ambulatory Care, Day-Hospital and Home Care, have an impact compared to the ones verified in developed countries. In relation to the reduction of deaths, in the last few years it was observed an expressive reduction in the number of deaths by AIDS. This reduction is of about 38%, between 97/95 and of about 54% in the city of Sao Paulo, between 99/95, which concentrates 22% of AIDS cases in the country. It also reduced in 60-80%, the most common opportunistic processes related to severe immune deficiency in HIV+ patients, such as cryptococcosis, citomegalovirus, Kaposi´s Sarcoma and tuberculosis.

In relation to the costs, some studies show that the expenses with antiretroviral therapy is, in a great extent, compensated by the savings with medications for the treatment of opportunistic diseases, and with hospitalizations due to these diseases. In the data analysis available in the Ministry of Health, it was verified a significant reduction in the number of hospitalizations /patients. There is an estimation that approximately 146.000 hospitalizations were avoided in the period of 1997-1999, allowing the country an economy of resources for the Ministry of Health of about US$ 422 million. In relation, for example, to the disease by citomegalovirus, a disease that strikes individuals in the advanced stage of the HIV infection and may lead to blindness, the registered data about the use of gancyclovir, medication used for its treatment, indicate a reduction in the use of 69%, in the period of 1997-1999. This reduction in the use of gancyclovir, in the last two years,  represented an economy of about US$ 34 million. The total estimated economy with the reduction of hospitalizations and treatment of opportunistic diseases (CMV, PCP, Cryptococcosis e MAC) was of US$ 472 million.