HIV Early Treatment Workshop Planning for removal of the CD4 <500 requirement for prescribing ART

1. HIV Early Treatment WorkshopPlanning for removal of theCD4 <500 requirement for prescribing ART A partnership between

2. Support for this meeting • Queensland Government • Queensland HIV Foundation • Australasian Society for HIV Medicine • Participant travel support • ACT, NSW, SA, TAS, VIC, WA governments • Confirmed - ViiV Healthcare, Gilead Sciences • Note additional support is pending/may have been received in the past few days

3. Support for the PBAC Submission • ASHM, AFAO, NAPWA, Kirby - Submission • Commonwealth Government – Fee waiver • ViiV Healthcare, Janssen – Financial support • NSW, NT, QLD, TAS, VIC – Financial support

4. Declarations of Interest • Participants in the workshop may have been supported to attend CROI and or may have other relationships with the pharmaceutical industry. • Participants are asked to disclose interests in their presentations and in the proceedings. • Industry partners are not involved in the development, delivery or reporting of this workshop.

5. Objectives • To develop a shared understanding of: • recent PBAC changes • features of an individual patient assessment • current attitudes of clinicians to early treatment • the status of bio medical prevention, treatment as prevention and PREP • To identify key issues which would: • recommend early treatment initiation • recommend delaying treatment initiation and • barriers to early treatment uptake and how to address these. • To identify key messages, examples and case studies which can be used to illustrate the clinical issues raised in the above items • To generate a set of agreed answers to questions which might be raised by clinicians and patients in subsequent educational activities

6. PBAC Decision • Initial treatment of HIV infection in combination with other antiretroviral agents, in a patient who is antiretroviral treatment naïve following diagnosed HIV infection. • Continuing treatment of HIV infection in combination with other antiretroviral agents where the patient has previously received PBS-subsidised therapy for HIV infection. • The PBAC noted that the requested restriction would allow the initiation of ART at a CD4+ count >500 cells/mm3 for patients with HIV, irrespective of the presence of symptomatic disease.

7. Request • To remove the CD4+ cell count restriction for initiation of first line anti-retroviral therapy (ART) in asymptomatic, ART naïve HIV positive patients. • Anti-retroviral therapy for HIV infection is currently available on the PBS via the Section 100 (Highly Specialised Drugs Program). Highly Specialised Drugs are medicines for the treatment of chronic conditions, which, because of their clinical use or other special features, are restricted to supply to public and private hospitals having access to appropriate specialist facilities.

8. Economic Analysis • The PBAC considered that although the economic model had limitations, it was as accurate a depiction of the cost effectiveness as could be generated with the clinical data available.

9. Usage and Financial Implications • The PBAC considered that not all patients diagnosed with HIV infection would automatically start ART. Factors including age, adherence, preparedness and awareness of the lifelong commitment to therapy will all impact on the patient and physician decision to initiate treatment. • The PBAC agreed with the statement in the Pre-Sub-Committee Response (PSCR) that the decision to initiate treatment is individualised and that people living with HIV in Australia are managed by a relatively small number of clinicians who are specifically trained to become Section 100 Highly Specialised Drug prescribers of ART. This promotes a relatively standardised approach to initiating and monitoring ART.

10. Rationale for Decision • The PBAC noted that the potential benefits of removing the CD4+ count restriction include: • Reduced transmission of HIV infection • Individualisation of patient therapy • Empowering patients to be able to choose when to commence therapy • The PBAC considered there to be an advantage to patients associated with being able to have greater choice, together with their prescribers, of when to initiate therapy with ART. The PBAC considered this greater choice to represent good Quality Use of Medicines.

11. Implementation • The PBAC released the Public Summary Document on 7 March 2014, which is available at http://www.pbs.gov.au/info/industry/listing/elements/pbac-meetings/psd • Provided the PBAC decision is accepted by the Australian Government the change should come into effect with the release of the 1 April 2014 PBS Schedule of Pharmaceutical Benefits “Yellow Book” and be effective from that date.

12. New ART S100 prescribing criteria • Initial treatment of HIV infection in combination with other antiretroviral agents, in a patient who is antiretroviral treatment naïve following diagnosed HIV infection. • Continuing treatment of HIV infection in combination with other antiretroviral agents where the patient has previously received PBS-subsidised therapy for HIV infection.