Sustiva price

The report on new patented medicines - Sustiva
Sustiva price
Brands (total): SUSTIVA (efavirenz)

DIN: 02239886 50 mg capsules
02239887 100mg capsule
02239888 200 mg capsules

Patent: Bristol-Myers Squibb Pharmaceutical Group (formerly DuPont Pharma)

Indication (per product monograph): For the treatment of HIV-1 infection in combination with other antiretroviral drugs. This indication is based on analyses of plasma HIV-RNA levels of CD4 cells, and counts in controlled studies of up to 24 weeks.

Notification of Compliance: March 19,1999

Date of first sale: March 1999
In most cases, the patents issued to the drug to come to market. In this case, the first patent on Sustiva has been published August 28, 2001, and was under the PMPRB jurisdiction at the time.

ATC class: J05AG03
Antiretrovirals for systemic use:
non-nucleoside reverse transcriptase inhibitors (NNRTI)

Application Guidelines
Sustiva price
Summary:

Introductory price of Sustiva at the date of the first sale, were within the guidelines, because the cost of treatment is not greater than the cost of treating existing drugs for therapeutic class comparison, and the price does not exceed the price range in other comparator countries Sustiva, which was sold. These prices are still within the guidelines in 2001, when Sustiva came under the jurisdiction PMPRB.

Scientific review:

In PMPRB Rights Drug Advisory Panel (HDAP), recommended that Sustiva be considered as a category 3 new drugs (provide moderate, little or no therapeutic advantage over comparable medicines).
Sustiva price
In comparison therapeutic class (TCC) to test the guidelines stipulate that the price of a category 3 new drug product may not exceed the price of other drugs that treat the same disease or condition. Comparators are generally selected from among the existing drug products in the same level of the Anatomical 4th, therapeutic, chemical (ATC) systems, which are clinically equivalent in the decision approved indication. The guidelines stipulate that she may, however, be appropriate to include products from other classes ATC if they are clinically equivalent for the indication of drug product under consideration. See PMPRB in the compilation of guidelines, policies and procedures to better describe the guidelines and policies on troops.

Members of the same level ATC 4th grade include Sustiva as Rescriptor (delavirdine) and Viramune (nevirapine).

Like other drugs for HIV-infected people, Sustiva is usually used in combination with other drugs. Guidance on the use of antiretroviral drugs in HIV-infected adults and adolescents supported HIV / AIDS Treatment Information Service (ATIS), the United States (available on the Internet: # http://www.hivatis.org/trtgdlns.html adults) include Sustiva, in combination with other drugs to the list "strongly recommended" drugs, including non-nucleoside reverse transcriptase inhibitors (NNRTIs) and protease inhibitors (PIs). British HIV Association (BHIVA) guidelines for the treatment of HIV-infected adults receiving antiretroviral therapy (July 2001) to identify Sustiva, PX and NNRTIs, which will be used in conjunction with dual nucleoside reverse transcriptase inhibitors (NRTIs) background therapy.

In light of the evidence that Sustiva is used in combination with two NRTIs as an alternative to the PI-based treatment, the other scheme or NNRTI-based treatment Ziagen in patients with HIV HDAP recommended NNRTIs and PV if necessary troops comparators for Sustiva.

In PMPRB Guidelines provide that the dose recommended for comparison purposes, as a rule, should not exceed the maximum of the usual recommended dosage. Maintaining adult daily dose identified in the individual product monographs and supported by clinical literature was recommended for comparison purposes. See table below prices test section.

Price Review:

The Guidelines, the introductory price of the new drug product category 3 will be deemed excessive if it exceeds the cost of comparable drug products based on the test of troops, and if it exceeds the price of the same drugs in the seven countries listed in the Patented Medicine Rules , 1994.
Sustiva price
Next troops has been set up to Sustiva 200 mg capsule. It should be noted that, although Rescriptor and Agenerase would be appropriate comparators troops from a scientific point of view, they were not included, as these products were drugs in the field of view during Sustiva review. The exclusion of these products does not affect the outcome of the price review.