Begin main content
CADTH Document Viewer

HIV Pre-Exposure Prophylaxis with Emtricitabine/Tenofovir Disoproxil Fumarate — Regulatory and Reimbursement Policies

August 2017

Context

Infection with the HIV continues to be a public health concern in Canada. Despite the wide availability and effectiveness of condoms in reducing sexual transmission, new HIV infections occur annually. The Public Health Agency of Canada estimated that 2,570 new infections (range: 1,940 to 3,200) occurred in Canada in 2014;1 of these, 54.3% were in sexually active men who have sex with other men (MSMs).2

HIV infection can be effectively treated with a range of antiretroviral drugs as part of antiretroviral therapy (ART) to suppress the virus and halt its progression. ART also reduces the transmission of the virus.3 However, at this time a permanent cure remains elusive and much focus is given to prevention. Until recently, the main approaches to HIV infection prevention consisted of promoting the use of physical barriers during sex (condoms) or behavioural changes such as needle exchange when injecting drugs and avoidance of high-risk sexual encounters — precautions that may not be accepted by some individuals. This situation changed in 2012 with the FDA approval and availability of the fixed-dose antiviral combination emtricitabine and tenofovir disoproxil fumarate (FTC/TDF) Truvada, manufactured by Gilead, for HIV pre-exposure prophylaxis (PrEP) in the US. Taking the antivirals once daily lowers the likelihood of HIV establishing a productive infection in the human host.4 Clinical trials have shown this treatment could allow a 44% to 75% relative risk reduction in sexually transmitted HIV infections in individuals at risk overall, and up to 86% in individuals at high risk of infection.5,6 This regimen for the indication of PrEP was approved by the FDA in 2012,7 and in early 2016 by Health Canada.8

In August 2016, the CADTH Canadian Drug Expert Committee (CDEC) recommended reimbursement of FTC/TDF for use as PrEP of HIV type 1 (HIV-1) in combination with safer sex practices to reduce the risk of sexually acquired HIV-1 infection in adults at high risk of infection.1 FTC/TDF was previously recommended for reimbursement by CDEC for treatment of HIV in combination with another antiretroviral9 and is listed in all Canadian public drug plan formularies. However, while use of FTC/TDF for PrEP has shown clinical efficacy in the indicated populations, the cost of preventive treatment may have a significant impact on public drug budgets and is likely cost-effective only in certain high-risk groups.5,10,11 Hence, the need for further understanding of national and international established criteria or policies to promote the optimal use of the drug in selected high-risk groups as well as national and international provision models for HIV PrEP is warranted to support decision-making.

Objectives

The objectives of the Environmental Scan are to:

  • describe national and international regulations, policies and patient selection criteria for the public provision of HIV PrEP with FTC/TDF
  • identify patient eligibility criteria for the public funding of HIV PrEP with FTC/TDF

The Environmental Scan provides an overview of such policies and criteria in Canada and six reference countries (the US, UK, Australia, France, Ireland, and New Zealand). It neither provides a comprehensive review or appraisal of the effectiveness of these criteria or policies nor does it recommend one policy option over another.

Methods

A limited literature search was conducted on key resources including PubMed, MEDLINE, Embase, the Cochrane Library, Canadian and major international health technology agencies, as well as a focused Internet search. No methodological filters were applied to limit retrieval by study type. Grey literature (literature that is not commercially published) was identified by searching relevant sections of the Grey Matters checklist (www.cadth.ca/grey-matters). Where possible, retrieval was limited to the human population. The search was also limited to English language documents published between January 1, 2011, and December 16, 2016.

The review of the grey literature was performed by consulting websites of national and international Health Technology Assessment agencies, drug and device regulatory agencies, health economics repositories, clinical guideline repositories, systematic review repositories, professional associations, and other relevant public repositories. Google and other Internet search engines were used to search for additional Web-based materials, including government resources. These searches were supplemented by reviewing the bibliographies of key papers and by information obtained from consultation with Canadian clinicians and researchers in HIV PrEP.

Findings

A summary of the international regulatory approval and public payer coverage status of FTC/TDF for PrEP in countries included in the scan is provided in the Table 1. Country-specific details on patient selection criteria set by regulators and public payers is subsequently outlined in Appendix 1.

Table 1: Regulatory Approval and Public Coverage of FTC/TDF for PrEP

Country Regulatory Approval of FTC/TDF for PrEP Year of Regulatory Approval Open Benefit Public Drug Plan Coveragea for FTC/TDF Public Payer Reimbursement of FTC/TDF for PrEP Indication Public Distribution of FTC/TDF for PrEPb
Canada Yes (Health Canada) 2016 In some provinces — see Appendix 2 Yes (Quebec) No
US Yes (FDA) 2012 Yes (US Medicaid/Medicare) Yes (US Veterans Affairs) Yes (the State of New York, the State of Washington, and the City of Philadelphia)
UK Yes (EMA) 2016 No Yes (NHS Scotland) No
France Yes (EMA) 2016 No Yes (French Social Security) No
Ireland Yes (EMA) 2016 No No No
Australia Yes (TGA) 2016 No No No
New Zealand No NA No No No

EMA = European Medicines Agency; FDA = US Food and Drug Administration; NA = not applicable; NHS = National Health Service; TGA = Therapeutic Goods Administration.
a Public drug plan coverage is independent of the indication of use (treatment or prevention) and without criteria.
b Public HIV care programs that are not administered as general drug benefit programs.

Canada

In February 2016, FTC/TDF received approval from Health Canada for the indication of HIV PrEP in combination with safer sex practices. The Health Canada authorized product monograph8 for Truvada (FTC/TDF) describes the high-risk population for HIV infection as follows:

  • has partner(s) known to be HIV-1 infected
  • engages in sexual activity within a high-prevalence area or social network and one or more of the following:
    • inconsistent or no condom use
    • diagnosis of sexually transmitted infections (STIs)
    • exchange of sex for commodities (such as money, food, shelter, or drugs)
    • use of illicit drugs or alcohol dependence
    • incarceration
    • partner(s) of unknown HIV-1 status with any of the factors listed above

In August 2016, CDEC recommended reimbursement of FTC/TDF for use as PrEP of human HIV-1 in combination with safer sex practices to reduce the risk of sexually acquired HIV-1 infection in adults at high risk for infection if the following conditions are met:

  • provided in the context of a sexual health program by a prescriber experienced in the treatment and prevention of HIV-1 infection
  • reduced price for Truvada

CDEC discussed the definition of “high risk,” noting that the risk of HIV-1 infection in adults is dependent on both individual factors and the prevalence of HIV-1 infection in a given setting.1

Currently in Canada, public drug plans reimburse FTC/TDF for the treatment of HIV (see Appendix 2) and a number of jurisdictions including Nova Scotia, Ontario, Quebec, Veterans Affairs, and the federal Non-Insured Health Benefits Program list the drug combination as a general benefit (i.e., its reimbursement not being tied to specific criteria or indications).12-15 In Alberta, British Columbia, and Prince Edward Island, FTC/TDF is provided without specified restrictions through special drug programs. Of note, these programs are focused on HIV treatment and do not consider antiviral use for PrEP.16-18 Other provincial drug plans impose eligibility criteria for reimbursing FTC/TDF for HIV treatment (see Appendix 2).

Excluding the guidance in the Truvada (FTC/TDF) product monograph, there are currently no pan‑Canadian policies or guidelines addressing the selection of candidates at high risk for PrEP. In addition, no pan-Canadian initiative or program incorporating FTC/TDF for HIV prevention was identified.

While FTC/TDF for PrEP is currently not routinely covered in British Columbia, the British Columbia Centre for Excellence in HIV/AIDS provides general practice guidelines on HIV PrEP.19 These guidelines give information to physicians who may choose to prescribe these medications for patients covered by private insurance or willing to cover the drug costs.

Guidance on the use of FTC/TDF for PrEP was developed by the Quebec Ministry of Health before the product receiving marketing approval in Canada for that indication. In 2013, the Ministère de la santé et des services sociaux released a temporary notice on HIV PrEP addressing the lack of clear directives regarding prescribing FTC/TDF for this indication.20 The notice recognized the potential use of FTC/TDF in individuals at high risk of acquiring HIV, while advising against its widespread and unselected use. FTC/TDF is listed as an unrestricted benefit in the régime public d’assurance médicaments formulary.13 Thus, Quebec is currently the only Canadian public administration to both acknowledge and fund pharmacologic HIV PrEP. The Quebec Ministry of Health’s notice recommended the use of FTC/TDF for PrEP as follows:

  • Use of FTC/TDF for PrEP is acceptable by MSMs who are HIV-negative and exhibiting high-risk behaviours (unprotected anal sex with individuals of positive or unknown HIV status), or serodiscordant couples with one partner showing detectable HIV loads.
  • Physicians should follow patients and screen for HIV and other STIs every three months.
  • Counselling should be provided to support compliance and address potential health issues, such as FTC/TDF side effects, and prevention and treatment of STIs.

United States

The FDA became the first regulatory agency to approve the use of FTC/TDF for PrEP in 2012. The considerations for suitable selection of patients in the FDA-approved monograph7 are the same as in the Health Canada–approved monograph.8 In 2013, the US Centers for Disease Control and Prevention (CDC) and US Public Health Service produced joint HIV PrEP clinical practice guidelines to help patient selection, care, and follow-up.21 These guidelines recommend that FTC/TDF for PrEP be considered for individuals who engage in behaviours that lead to increased risk of HIV-1 transmission, including:

  • MSMs who are at substantial risk of HIV acquisition
  • heterosexually active men and women who at substantial risk of HIV acquisition
  • adult injection drug users who are at substantial risk of HIV acquisition
  • heterosexually active men and women whose partners are known to have HIV infection

Behaviours or conditions that place an individual at substantial risk of HIV acquisition include:

  • commercial sex work
  • having a sexual partner who is HIV-positive
  • STI diagnosed or reported in the last six months
  • high number of sex partners
  • history of inconsistent condom use
  • injecting partner who is HIV-positive

These guidelines have been adopted by a number of national and local organizations.22-26 Notably, the US Department of Veterans Affairs covers FTC/TDF for PrEP, albeit with restrictions (see Appendix 1).26,27 The department recommends clinicians use CDC guidelines for selecting patients for PrEP.26

While federal guidelines are in place, FTC/TDF is not covered by the US government for the general population. The US Medicare and Medicaid programs provide FTC/TDF with no restrictions only to their target populations, namely people with disabilities, people with low income, and the elderly (65 and above).28 A majority of US PrEP beneficiaries pay for FTC/TDF out of pocket or with some assistance from private insurance.29 For people without access to health coverage, a medication assistance program is available from the Truvada (FTC/TDF) manufacturer.30 Some local and regional public health programs in the US do support HIV PrEP access for individuals who do not benefit from coverage by private or federal plans. For example, the city of Philadelphia provides PrEP free of charge to all of its residents regardless of insurance status and without explicit restrictions.31 The State of Washington covers drug costs only for HIV-negative individuals enrolled in a health insurance plan.32 Candidates must meet the following risk factors:

  • is male or transgender, has sex with men, and has one or more of the following risks:
    • diagnosis of rectal or urethral gonorrhea, rectal chlamydia, or early syphilis in the prior 12 months
    • methamphetamine or popper use in the prior 12 months
    • history of providing sex for money, drugs, food, shelter, or transportation in the prior 12 months
    • unprotected anal sex outside of a long-term, mutually monogamous relationship
  • is in an ongoing sexual relationship with an HIV-infected person who:
    • is not on ART
    • is on ART but is not virologically suppressed
    • is within six months of initiating ART
    • is on ART and is virologically suppressed
  • is in an ongoing sexual relationship in which the female partner is trying to get pregnant
  • is a woman who provides sex for money, drugs, food, shelter, or transportation
  • injects drugs that are not prescribed by a medical provider

In the State of New York, a special PrEP assistance program provides reimbursement for necessary primary care services (including drugs) for patients under the care of clinicians experienced in providing services to patients who are HIV-negative and at high risk,25 in accordance with the guidelines by the Medical Care Criteria Committee.33 These guidelines recommend that clinicians should discuss PrEP with the following individuals who are not infected with HIV and who have substantial and ongoing risk:

  • MSMs who engage in unprotected anal intercourse
  • individuals who are in a serodiscordant sexual relationship with a known HIV-infected partner
  • male-to-female and female-to male transgender individuals engaging in high-risk sexual behaviours
  • individuals engaging in transactional sex, such as sex for money, drugs, or housing
  • individuals who use injection drugs and who report any of the following behaviours:
    • sharing injection equipment (including to inject hormones among transgender individuals)
    • injecting one or more times per day
    • injecting cocaine or methamphetamine
    • engaging in high-risk sexual behaviours
  • individuals who use stimulant drugs associated with high-risk behaviours, such as methamphetamine
  • individuals diagnosed with at least one anogenital STI in the last year
  • individuals who have been prescribed non-occupational post-exposure prophylaxis (nPEP) who demonstrate continued high-risk behaviour or have used multiple courses of nPEP

In summary, there is no single program or set of criteria for providing HIV PrEP in the US. All US programs identified in this report mention serodiscordant couples, MSMs, transgender individuals, sex workers and injection drug users as eligible HIV PrEP beneficiaries. Parameters defining high-risk sexual behaviour are provided by the CDC and the State of Washington but not by the State of New York or the City of Philadelphia. The State of New York program is the only public payer that recommends HIV PrEP for prior nPEP users.

Europe

In July 2016, the European Medicines Agency Committee for Medicinal Products for Human Use recommended granting Truvada (FTC/TDF) a marketing authorization in the European Union for PrEP.34 The committee recommended educational material be prepared for prescribers and patients, but did not provide criteria or definitions for identifying individuals at high risk.

In England, FTC/TDF is not covered by NHS England for the prevention of HIV infection. In early 2016, NHS England contended that it did not have the legal authority to commission a service providing access to drugs for HIV PrEP and that local public health authorities were responsible for this type of care. After assessing the case, the court of justice reaffirmed the NHS England authority on the matter.35 NHS England is appealing on the judgment, but will also consider PrEP coverage in its prioritization process for new interventions and may use the opportunity to negotiate a lower medication price with the manufacturer.36

More recently, the National Health Service and Public Health England have announced their plan to provide FTC/TDF for PrEP to 10,000 users in 2017, and to continue providing it over three years. This will be conducted in the context of a clinical trial aiming to answer outstanding questions concerning implementation and sustainability before a wider availability of the program in England.37 The selection criteria for enrolling in this trial are currently unknown.

To support program and policy development, consultations and clinical reviews were conducted38 and an impact assessment report was produced.39 A draft policy proposition outlining a proposed patient care pathway and funding model is available for consultation.40 According to this proposal, PrEP is projected to be made available by NHS England for individuals meeting any of the following three criteria:40

  • MSMs, trans women or trans men who are currently HIV-negative and who are clinically assessed to be at high risk of HIV acquisition through fulfilling the following criteria:
    • have a documented confirmed HIV-negative test during an earlier episode of care in the preceding year (i.e., 42 days ago to 365 days ago)
    • report condomless intercourse in the previous three months, and this is documented in the clinical notes
    • affirm their likelihood of repeated condomless intercourse in the next three months, and this is documented in the clinical notes
  • The partner who is HIV-negative (confirmed by a current documented HIV-negative test) of a person diagnosed with HIV who is not known to be virally suppressed and with whom condomless intercourse is anticipated and so is clinically assessed and considered to be at high risk of HIV acquisition. PrEP should be recommended where the treating clinician recommends and monitors treatment as part of an active risk-reduction intervention including health education, safer sex promotion, and exploration of treatment as prevention for the HIV-positive partner.
  • heterosexual men and women who are HIV-negative, clinically assessed and known to have had condomless sex with a person with HIV (who is not known to be virally suppressed) within the past three months and for whom it is anticipated that this will occur again, either with the same person or another person with similar status, and so is clinically assessed and considered to be at high risk of HIV acquisition. PrEP should be recommended where the treating clinician recommends and monitors as part of an active risk-reduction intervention including health education and safer sex promotion.

The NHS England draft policy also mentions the following exclusions:

  • individuals in monogamous relationships with a partner who is known to be diagnosed with HIV and whose viral load is undetectable
  • individuals without a current confirmed negative HIV test result (to minimize the risk of patients with undiagnosed HIV starting PrEP and developing a drug-resistant virus)
  • individuals who do not or no longer meet the criteria for high risk of HIV acquisition
  • individuals whose only risk of HIV acquisition is due to injecting drug use (as the current HIV incidence in this group in the UK is too low for PrEP to be cost-effective)
  • people known to be diagnosed with HIV
  • individuals under 16 years of age
  • treatment outside of Level 3 genitourinary medicine services.

To mitigate financial risks of commissioning HIV PrEP, the impact assessment proposed “ensuring eligibility criteria are enforced so only those at demonstrably high risk of HIV acquisition have access to PrEP, in line with the evidence for clinical and cost-effectiveness. If those not at risk have access to PrEP, cost-effectiveness is undermined.”41

In Scotland, reimbursement of FTC/TDF for PrEP was recommended by the Scottish Medicines Consortium in March 2017.42 NHS Scotland endorsed this recommendation and accepted providing FTC/TDF for PrEP to eligible individuals.43,44 The recommendation mentions that, “PrEP should be available to people with greatest risk of acquiring HIV if aged 16 or over, tested HIV-negative, able to attend the clinic for regular three monthly review including for monitoring, sexual health care and support, and to collect prescriptions, willing to stop NHS-funded PrEP if the eligibility criteria no longer apply and resident in Scotland.”42 In addition, one of the following criteria should be met before offering HIV PrEP:42

  • current sexual partners, irrespective of gender, of people who are HIV-positive with a detectable viral load
  • MSMs and transgender women with a documented bacterial rectal STI in the last 12 months
  • MSMs and transgender women reporting condomless penetrative anal sex with two or more partners in the last 12 months and likely to do so again in the next three months
  • individuals, irrespective of gender, at an equivalent highest risk of HIV acquisition, as agreed with another specialist clinician.

In France, evaluations were undertaken in 2015 (before the European Medicines Agency’s review of FTC/TDF for PrEP) to assess the value of HIV PrEP, its implementation and its associated public health benefits. An expert panel led by Professor Philippe Morlat produced a series of recommendations as the basis of national guidelines on HIV PrEP.45 As a result, the Haute Autorité de Santé provided positive advice for the exceptional use of FTC/TDF for PrEP in the context of a temporary use recommendation (recommandation temporaire d’utilisation) that approved the “off-label” use of FTC/TDF for PrEP in France for a period of three years, beginning in January 2016.46

The recommendation targets the use of FTC/TDF for PrEP in the following populations:46

  • MSMs or transgender persons at high risk of acquiring HIV who:
    • report unprotected anal relations with at least two partners over a period of six months
    • have experienced several STI episodes in the past year
    • have used post-exposure prophylaxis in the past year
    • usually consume psychoactive substances during sex.
  • on a case-by-case basis for:
    • IV drug users who share syringes
    • sex workers exposed to unprotected sex
    • vulnerable individuals exposed to unprotected sex with a high risk of HIV transmission (with partners from a high-prevalence group, or with physical characteristics increasing the risk of HIV transmission such as ulcerations, bleeding or concomitant STI).

Identification of candidates and decisions regarding PrEP must be performed in the context of a confidential and non-judgmental conversation between the potential candidate and the physician to identify high-risk circumstances in the most objective manner.45

FTC/TDF for PrEP is now funded under the French social security umbrella (with 100% coverage) and can be dispensed at hospitals or local pharmacies. FTC/TDF for PrEP can only be prescribed by physicians in hospitals or infectious disease clinics experienced in the management of HIV infection.46 Two HIV PrEP schemes are approved: continuous PrEP (one pill per day) and “on-demand” PrEP, with drug intake during the period surrounding a high-risk sexual encounter.45

In summary, Europe, France and Scotland have moved forward with national programs for the provision of HIV PrEP to their eligible populations. The UK is planning public provision of HIV PrEP and has proposed some criteria. These are shared in this report with the caveat that they may change along the development process. HIV PrEP is recommended for MSMs or transgender persons at high risk of acquiring HIV by all three jurisdictions. IV drug users, sex workers and other individuals at high risk of acquiring HIV are not formally recommended, but eligibility may be granted on a case-by-case basis. Partners of individuals with detectable HIV are deemed eligible in the UK but not in France, although interpretations may vary.

Australia

FTC/TDF was approved by the Therapeutic Goods Administration for the indication of PrEP in May 2016.47 The Therapeutic Goods Administration–approved product information document for Truvada (FTC/TDF) mentions that the product “is indicated in combination with safer sex practices for PrEP to reduce the risk of sexually acquired HIV-1 in adults at high risk.”48 Proposed considerations for identifying suitable candidates are individuals:

  • with partner(s) known to have HIV-1
  • engaging in high-risk sexual behaviour or sexual activity within a high-prevalence area or social network or who have partners from high-prevalence areas

In July 2016, Australia’s Pharmaceutical Benefits Advisory Committee did not recommend the reimbursement of FTC/TDF for HIV PrEP on the basis of unacceptable and uncertain cost-effectiveness in the proposed population (defined according to the Therapeutic Goods Administration’s indication) and at the proposed price.49 Without public reimbursement of FTC/TDF, PrEP as a publicly provided service in Australia is uncertain; alternative approaches such as state-sponsored public health programs and large‑scale demonstration projects are being considered.50-52

Other Jurisdictions

Based on the conducted scan, FTC/TDF for HIV PrEP is approved but not publicly reimbursed in Ireland.53 The drug is not available in New Zealand.41

Limitations

The findings of this review are not intended to provide a comprehensive review of the topic, but rather present current policy examples in Canada and comparable countries based on a limited literature review. Additionally, this report does not depict the full context of HIV care; rather, the findings presented reflect the perspective of public payers. Hence, it does not capture information about general practice guidelines, sexual health programs, demonstration projects or clinical trials. Guidelines were not searched in a systematic manner, but were identified and summarized when a public provider referred to selection criteria mentioned therein. Due to the unique context of each jurisdiction in regards to health system infrastructure, population composition, and societal values, it may be that provision models, programs, or policies are not directly transferable to other jurisdictions.

Conclusions

The objective of this Environmental Scan was to gain an understanding of the characteristics of candidates that are linked to public provision of HIV PrEP with FTC/TDF in Canada and internationally. There is a patchwork of funding schemes for PrEP in Canada due to the recent approval and recommendations from national bodies. While PrEP has been used in the US for five years at the time of the publication of this report, there are no broad national programs for public provision of the therapy. Public support is limited to local initiatives or reimbursement by national programs covering people who are elderly, on a low income, have a disability, or are a veteran. In Europe, France has taken the lead with a nationwide provision of drugs for PrEP, and Scotland has recently followed suit. England has been more conservative and is now assessing the implementation and potential impact of such a program.

Overall, eligibility criteria do not vary significantly between jurisdictions. Most jurisdictions identify potential PrEP users as MSMs with recent STIs, multiple sex partners, use of drugs during sex, and inconsistent condom use. Sex workers, injection drug users, and users of nPEP are also prioritized by some jurisdictions. HIV-negative individuals in a serodiscordant sexual relationship are also generally identified as good PrEP candidates, but the level of HIV suppression in the positive partner is not always a consideration. Product monographs approved by regulators7,8,34 suggest identification of high-risk candidates based on local HIV prevalence in the population or the candidate’s social network; this consideration is not found in any public provider criteria or guidelines identified in the current report. In addition to selection criteria, guidelines from regulators mention the importance of clinician and patient education to maximize the effectiveness of PrEP and to mitigate any risks.

References

  1. The epidemiology of HIV in Canada [Internet]. Toronto (ON): CATIE; 2017. [cited 2017 Mar 15]. Available from: http://www.catie.ca/sites/default/files/epi%20hiv%20EN%202017%2003%2009.pdf
  2. Summary: estimates of HIV incidence, prevalence and proportion undiagnosed in Canada, 2014 [Internet]. Ottawa (ON): Public Health Agency of Canada; 2015 Nov. [cited 2017 Mar 15]. Available from: http://www.catie.ca/sites/default/files/2014-HIV-Estimates-in-Canada-EN.pdf
  3. Guidelines for the Use of Antiretroviral Agents in HIV-1-Infected Adults and Adolescents [Internet]. Rockville (MD): AIDS Info; 2017. [cited 2017 Jun 19]. Available from: https://aidsinfo.nih.gov/guidelines/html/1/adult-and-adolescent-arv-guidelines/10/initiation-of-antiretroviral-therapy
  4. Plosker GL. Emtricitabine/tenofovir disoproxil fumarate: a review of its use in HIV-1 pre-exposure prophylaxis. Drugs. 2013 Mar;73(3):279-91.
  5. Common Drug Review. CADTH Canadian Drug Expert Committee final recommendation. Emtricitabine/tenofovir disoproxil fumarate (Truvada - Gilead Sciences Canada, Inc.). Indication: pre-exposure prophylaxis of HIV-1 infection [Internet]. Ottawa (ON): CADTH; 2016 Aug 24. [cited 2017 Mar 15]. Available from: https://www.cadth.ca/sites/default/files/cdr/complete/SR0479_complete_Truvada_Aug-26-16.pdf
  6. McCormack S, Dunn DT, Desai M, Dolling DI, Gafos M, Gilson R, et al. Pre-exposure prophylaxis to prevent the acquisition of HIV-1 infection (PROUD): effectiveness results from the pilot phase of a pragmatic open-label randomised trial. Lancet [Internet]. 2016 Jan 2 [cited 2017 Mar 27];387(10013):53-60. Available from: http://www.ncbi.nlm.nih.gov/pmc/articles/PMC4700047
  7. Gilead Sciences. Prescribing information: Truvada (emtricitabine/tenofovir disoproxil fumarate) tablets, for oral use. Silver Spring (MD): U.S. Food and Drug Administration; 2016 Apr.
  8. PrTruvada® (emtricitabine/tenofovir disoproxil fumarate) tablets: (200 mg/300 mg) antiretroviral agent [product monograph]. Foster City (CA): Gilead Sciences Canada, Inc.; 2016 Mar 24.
  9. Common Drug Review. CEDAC final recommendation and reasons for recommendation. Emtricitabine/tenofovir disoproxil fumarate (Truvada - Gilead Sciences Canada, Inc.). Indication: treatment of HIV-1 infection [Internet]. Ottawa (ON): CADTH; 2006 Oct 25. [cited 2017 Mar 15]. Available from: https://www.cadth.ca/sites/default/files/cdr/complete/cdr_complete_Truvada_oct25-06.pdf
  10. Gomez GB, Borquez A, Case KK, Wheelock A, Vassall A, Hankins C. The cost and impact of scaling up pre-exposure prophylaxis for HIV prevention: a systematic review of cost-effectiveness modelling studies. PLoS Med [Internet]. 2013 [cited 2017 Mar 15];10(3):e1001401. Available from: http://www.ncbi.nlm.nih.gov/pmc/articles/PMC3595225
  11. Cambiano V, Miners A, Phillips A. What do we know about the cost-effectiveness of HIV preexposure prophylaxis, and is it affordable? Curr Opin HIV AIDS. 2016 Jan;11(1):56-66.
  12. e-Formulary: Ontario drug benefit formulary/comparative drug index: electronic version [Internet]. Version 2.4. Toronto (ON): Ontario Ministry of Health and Long-Term Care; 2007 - [cited 2017 Apr 13]. Available from: https://www.formulary.health.gov.on.ca/formulary/
  13. Liste des médicaments [Internet]. Québec (QC): Régie de l'assurance maladie; 2016. [cited 2016 Dec 8]. Available from: http://www.ramq.gouv.qc.ca/fr/regie/publications-legales/Pages/liste-medicaments.aspx French.
  14. Non-insured health benefits - drug benefit list 2016 [Internet]. Ottawa: Health Canada; 2016 Jul 21. [cited 2017 Apr 13]. Available from: http://www.healthycanadians.gc.ca/publications/health-system-systeme-sante/nihb-drug-list-2016-liste-medicaments-ssna/index-eng.php
  15. Prescription drug program (POC 10). Drug formulary search [Internet]. Ottawa (ON): Veterans Affairs Canada; 1999 -. Drug 02274906. Truvada tab 300/200 mg; 2017 [cited 2017 Jul 28]. Available from: http://www.veterans.gc.ca/eng/services/health/treatment-benefits/poc/poc10/search/form_detail/02274906
  16. HIV/AIDS drugs available through the BC-CfE [Internet]. Vancouver: British Columbia Centre for Excellence in HIV/AIDS; 2016. [cited 2017 Jan 13]. Available from: http://www.cfenet.ubc.ca/sites/default/files/uploads/drugs-available/HIV-AIDS-Drugs-available-through-the-BC-CfE_v2017_12_04.pdf
  17. Specialized High Cost Drug Program [Internet]. Edmonton: Alberta Health; 2016. [cited 2017 Jan 13]. Available from: http://www.health.alberta.ca/services/drugs-high-cost.html
  18. Health PEI. AIDS/HIV drug program [Internet]. Charlottetown (PEI): Government of Prince Edward Island; 2017. [cited 2017 Jul 20]. Available from: https://www.princeedwardisland.ca/en/information/health-pei/aidshiv-drug-program
  19. Guidance for the use of re-exposure prophylaxis (PrEP) for the prevention of HIV acquisition in British Columbia [Internet]. Vancouver: British Columbia Centre for excellence in HIV/AIDS; 2016. [cited 2017 Jan 13]. Available from: http://www.cfenet.ubc.ca/sites/default/files/uploads/publications/centredocs/guidance-for-the-use-of-pre-exposure-prophylaxis11-oct-2016.pdf
  20. Avis intérimaire sur la prophylaxie préexposition au virus de l'immunodéficience humaine [Internet]. Québec (QC): Ministère de la Santé et des Services sociaux; 2013. [cited 2016 Dec 9]. Available from: http://publications.msss.gouv.qc.ca/msss/fichiers/2013/13-308-03W.pdf
  21. US Public Health Service. Preexposure prophylaxis for the prevention of HIV infection in the United States - 2014 [Internet]. Atlanta (Georgia): Centres for Disease Control; 2014. [cited 2016 Dec 20]. Available from: https://www.cdc.gov/hiv/pdf/PrEPguidelines2014.pdf
  22. Commonwealth of Massachusetts. Frequently Asked Questions: Pre-exposure prophylaxis (PrEP) for HIV infection [Internet]. Boston (MA): Massachusetts Department of Public Health; 2013. [cited 2016 Dec 20]. Available from: http://www.mass.gov/eohhs/docs/dph/aids/prep-faq-providers.pdf
  23. Denver Health [Internet]. Denver (CO). Pre-Exposure Prophylaxis (PrEP) for HIV; 2016 [cited 2016 Dec 20]. Available from: http://www.denverhealth.org/public-health-and-wellness/public-health/clinics-and-services/hiv-care-and-prevention/prevention-and-education/prep-for-hiv
  24. CT Pre-exposure Prophylaxis (PrEP) Local Medical Services [Internet]. Hartford (Connecticut): Connecticut Department of Public Health; 2016 Oct. [cited 2016 Dec 21]. Available from: http://www.ct.gov/dph/lib/dph/aids_and_chronic/prevention/pdf/prep_services.pdf
  25. Pre-Exposure Prophylaxis Assistance Program (PrEP-AP) [Internet]. Albany (NY): New York State Department of Public Health; 2016. [cited 2016 Dec 22]. Available from: https://www.health.ny.gov/diseases/aids/general/resources/adap/prep.htm
  26. Exposure prophylaxis (PrEP) to prevent to HIV infection: clinical considerations from the Department of Veterans Affairs National HIV Program, in the HIV, Hepatitis and Public Health Pathogens Program, Office of Patient Care Services [Internet]. Washington (DC): U.S. Department of Veterans Affairs; 2016 Sep. [cited 2017 Mar 15]. Available from: http://www.hiv.va.gov/pdf/PrEP-considerations.pdf
  27. Veterans Affairs national formulary [Internet]. Bethesda (MD): U.S. Department of Veterans Affairs; 2017. [cited 2017 Mar 16]. Available from: http://www.pbm.va.gov/PBM/NationalFormulary.asp
  28. Which prescription drugs are covered under the Medicare part D plans? [Internet].Q1Medicare.com; 2017. [cited 2017 Mar 15]. Available from: https://q1medicare.com/PartD-Which-Drugs-Will-Be-CoveredPartD.php
  29. HRC policy paper on pre-exposure prophylaxis (PrEP) [Internet]. Washington (DC): Human Rights Campaign; 2015. [cited 2017 Apr 13]. Available from: http://www.theaidsinstitute.org/sites/default/files/attachments/HRC-PrEP_Document.pdf
  30. Truvada. Support and resources [Internet]. Foster City (CA): Gilead Sciences, Inc.; 2016. [cited 2016 Dec 8]. Available from: http://www.truvada.com/truvada-patient-assistance
  31. City of Philadelphia Public Health. HIV pre-exposure prophylaxis (PrEP) [Internet]. Philadelphia (PA): City of Philadelphia; 2016? [cited 2016 Dec 8]. Available from: http://www.phila.gov/health/ambulatoryhealth/prep.html
  32. Pre-Exposure Prophylaxis Drug Assistance Program (PrEP DAP) [Internet]. Spokane (WA): Washington State Department of Health; 2016. [cited 2016 Dec 22]. Available from: http://www.doh.wa.gov/YouandYourFamily/IllnessandDisease/HIVAIDS/HIVCareClientServices/PrEPDAP
  33. Guidance for the use of pre-exposure prophylaxis (PrEP) to prevent HIV transmission [Internet]. Albany (NY): New York State Department of Health AIDS Institute; 2015 Oct. [cited 2016 Dec 22]. Available from: http://www.hivguidelines.org/clinical-guidelines/pre-exposure-prophylaxis/guidance-for-the-use-of-pre-exposure-prophylaxis-prep-to-prevent-hiv-transmission/
  34. Committee for Medicinal Products for Human Use. Truvada: assessment report [Internet]. London, United Kingdom: European Medicines Agency; 2017. [cited 2017 Mar 16]. Available from: http://www.ema.europa.eu/docs/en_GB/document_library/EPAR_-_Assessment_Report_-_Variation/human/000594/WC500212857.pdf
  35. McKee S. Court rules that NHS England can fund HIV PReP. PharmaTimes [Internet]. 2016 Nov 11 [cited 2016 Dec 8]. Available from: http://www.pharmatimes.com/news/court_rules_that_nhs_england_can_fund_hiv_prep_1176349?utm_source=PT+Daily+Newsletter&utm_medium=email&utm_campaign=pt+daily+news+alert
  36. August update on the commissioning and provision of Pre Exposure Prophylaxis (PREP) for HIV prevention [Internet]. Redditch (GB): NHS England; 2016 Aug 2; 2016? [cited 2016 Dec 8]. Available from: https://www.england.nhs.uk/2016/08/august-update-on-the-commissioning-and-provision-of-pre-exposure-prophylaxis-prep-for-hiv-prevention/
  37. McKee S. NHS England to fund HIV prevention programme. PharmaTimes [Internet]. 2016 Dec 5 [cited 2016 Dec 8]. Available from: http://www.pharmatimes.com/news/nhs_england_to_fund_hiv_prevention_programme_1180013?utm_source=PT+Daily+Newsletter&utm_medium=email&utm_campaign=pt+daily+news+alert
  38. NHS England. Consultation on Specialised Services clinical commissioning policies and service specifications [Internet]. London (GB): NHS England; 2016. [cited 2016 Dec 21]. Available from: https://www.engage.england.nhs.uk/consultation/specialised-services/
  39. NHS England. Impact Assessment: Consultation on Specialised Services clinical commissioning policies and service specifications [Internet]. London (GB): NHS England; 2016. [cited 2016 Dec 21]. Available from: https://www.engage.england.nhs.uk/consultation/specialised-services/user_uploads/f03x06-impact-assessment.pdf
  40. NHS England. Policy Proposition: Consultation on Specialised Services clinical commissioning policies and service specifications [Internet]. London (GB): NHS England; 2016. [cited 2016 Dec 21]. Available from: https://www.engage.england.nhs.uk/consultation/specialised-services/user_uploads/f03x06-policy-proposition.pdf
  41. Pre-exposure prophylaxis (PrEP) [Internet]. Auckland (NZ): New Zealand AIDS Foundation; 2016. [cited 2016 Dec 8]. Available from: https://www.nzaf.org.nz/hiv-aids-stis/hiv-prevention/prep/
  42. Emtricitabine/tenofovir disoproxil 200mg/245mg film-coated tablets (Truvada®) [Internet]. Glasgow (Scotland): Scottish Medicines Consortium; 2017 Mar 10. [cited 2017 Apr 11]. (SMC advice; no. 1225/17). Available from: http://www.scottishmedicines.org.uk/files/advice/emtricitabine_tenofovir_disoproxil_Truvada_FINAL_March_2017_for_website.pdf
  43. NHS Scotland to fund 'game-changer' Prep HIV drug [Internet]. Edinburgh (GB): BBC News; 2017 Apr 10. [cited 2017 Apr 11]. Available from: http://www.bbc.com/news/uk-scotland-39552641
  44. Scotland first UK nation to routinely offer HIV PrEP [Internet]. London (GB): PharmaTimes; 2017 Apr 11. [cited 2017 Apr 11]. Available from: http://www.pharmatimes.com/news/scotland_first_uk_nation_to_routinely_offer_hiv_prep_1191181?utm_source=PT+Daily+Newsletter&utm_medium=email&utm_campaign=pt+daily+news+alert
  45. Prise en charge médicale des personnes vivant avec le VIH - Actualisation 2015 : Prophylaxie pré-exposition [Internet]. Paris (FR): Conseil national du sida et des hépatites virales; 2015. [cited 2016 Dec 8; updated 2016 Jun 10]. Available from: http://cns.sante.fr/wp-content/uploads/2015/10/experts-vih_prep2015.pdf French.
  46. Guide de l'accompagnement communautaire lors de consultations PrEP [Internet]. Pantin (FR): AIDES; 2016 Apr 27. [cited 2016 Dec 8; updated 2016 Jun 10]. Available from: http://www.prepwatch.org/wp-content/uploads/2016/09/IPERGAY-guide-PrEP.pdf French.
  47. Shaw A. TGA approves Truvada for PrEP - next: put it on the PBS say HIV advocates [Internet]. East Sydney (AU): Gay News Network (GNN); 2016 May 6. [cited 2016 Dec 8]. Available from: http://gaynewsnetwork.com.au/checkup/tga-approves-truvada-for-prep-next-put-it-on-the-pbs-says-hiv-advocate-21090.html
  48. Gilead Sciences. Product information: Truvada (tenofovir disoproxil fumarate and emtricitabine) tablets. Canberra (AU): Australian Government, Therapeutic Goods Administration; 2016 May 2. [cited 2017 Apr 13].
  49. July 2016 PBAC outcomes - 1st time decisions not to recommend [Internet]. Canberra (AU): Australian Government Pharmaceutical Benefits Scheme (PBS); 2016. [cited 2016 Dec 8]. Available from: http://www.pbs.gov.au/industry/listing/elements/pbac-meetings/pbac-outcomes/2016-07/first-time-decisions-not-to-recommend-2016-07.pdf
  50. Cairns G. Australia adopts ambitious plan to use PrEP to 'virtually eliminate' HIV by 2020 [Internet]. London (GB): NAM; 2016 Jul 21. [cited 2016 Dec 8]. Available from: http://www.aidsmap.com/Australia-adopts-ambitious-plan-to-use-PrEP-to-virtually-eliminate-HIV-by-2020/page/3073611/
  51. Zablotska I. Expanded implementation of PrEP across Australia [slide deck on the Internet]. Geneva (CH): International AIDS Society; 2016 Jul 20. [cited 2016 Dec 8]. Available from: http://programme.aids2016.org/PAGMaterial/PPT/5840_3900/Zablotska%20AIDS2016%20WORKSHOP%20-%20PrEP%20implementation%20in%20Australia.pptx (presented at AIDS 2016; 2016 Jul 18-22; Durban, South Africa).
  52. EPIC-NSW [Internet]. Sydney (AU): ACON. 2016 [cited 2016 Dec 8]. Available from: https://epic-nswstudy.org.au/
  53. Pre-exposure prophylaxis (PREP) [Internet]. Dublin (IE): HIV Ireland; 2016. [cited 2016 Dec 8]. Available from: http://www.hivireland.ie/living-with-hiv/hiv-and-you/prep/
  54. The Prescription Drugs Cost Assistance Act (C.C.S.M. c.P115) [Internet]. Winnipeg: Government of Manitoba; 2017. [cited 2017 Jun 19]. Available from: http://www.gov.mb.ca/health/mdbif/docs/sdr.pdf
  55. New Brunswick drug plans formulary [Internet]. Fredericton (NB): Department of Health; 2017. [cited 2017 Jun 19]. Available from: http://www2.gnb.ca/content/dam/gnb/Departments/h-s/pdf/en/NBDrugPlan/NewBrunswickDrugPlansFormulary.pdf
  56. The Newfoundland and Labrador Prescription Drug Program. Criteria for the coverage of special authorization drugs [Internet]. St. John's (NL): Newfoundland and Labrador Department of Health and Community Services; 2017. [cited 2017 Jun 19]. Available from: http://www.health.gov.nl.ca/health/nlpdp/criteria.pdf
  57. Nova Scotia formulary [Internet]. Halifax: Nova Scotia Department of Health; 2017. [cited 2017 Jun 19]. Available from: http://novascotia.ca/dhw/pharmacare/documents/formulary.pdf
  58. P.E.I. Pharmacare Formulary [Internet]. Charlottetown (PE): PEI Pharmacare; 2017 Mar. [cited 2017 Apr 13]. Available from: http://www.gov.pe.ca/photos/original/hpei_formulary.pdf
  59. Drug Plan and Extended Benefits Branch. Saskatchewan online formulary database [Internet]. Regina: Government of Saskatchewan; 2017 [cited 2017 Jun 19]. Available from: http://formulary.drugplan.ehealthsask.ca/
  60. Exception Drug Status [Internet]. Whitehorse (YK): Yukon Health and Social Services; 2013. [cited 2017 Jun 19]. Available from: http://www.hss.gov.yk.ca/pdf/yukon_drug_programs_formulary-exceptiondrugstatus.pdf

 

Appendix 1: Public Payer Eligibility Criteria for HIV PrEP

Public Payer or Public Health Program Criteria or Considerations for Identification of Individuals at High Risk

Quebec Ministère de la santé et des services sociaux20

HIV-negative MSMs exhibiting high-risk behaviours (unprotected anal sex with individuals of positive or unknown HIV status), or serodiscordant couples with one partner showing detectable HIV loads

US Veterans Affairs26

Populations for which PrEP should be considered include:

  • Sexually active MSMs at substantial risk of HIV acquisition
  • heterosexually active men and women at substantial risk of HIV acquisition
  • adult injection drug users at substantial risk of HIV acquisition
  • heterosexually active men and women whose partners are known to have HIV infection

Behaviours or conditions that place an individual at substantial risk of HIV acquisition include:

  • commercial sex work
  • having a sexual partner who is HIV-positive
  • STI diagnosed or reported in the last six months
  • high number of sex partners
  • history of inconsistent condom use
  • injecting partner who is HIV-positive

Washington State32

Individuals considered to be at substantial risk of HIV acquisition include those who are:

  • male or transgender, have sex with men, and have one or more of the following risks:
    • diagnosis of rectal or urethral gonorrhea, rectal chlamydia or early syphilis in the prior 12 months
    • methamphetamine or popper use in the prior 12 months
    • history of providing sex for money, drugs, food, shelter or transportation in the prior 12 months
    • unprotected anal sex outside of a long-term, mutually monogamous relationship
  • in an ongoing sexual relationship with a person who is infected with HIV and who:
    • is not on ART
    • is on ART but is not virologically suppressed
    • is within six months of initiating ART
    • is on ART and is virologically suppressed
  • in an ongoing sexual relationship in which the female partner is trying to get pregnant
  • a woman who provides sex for money, drugs, food, shelter or transportation
  • users of injection drugs who use drugs that are not prescribed by a medical provider

New York State33

Individuals considered to be at substantial risk of HIV acquisition include those who are:

  • MSMs who engage in unprotected anal intercourse
  • in a serodiscordant sexual relationship with a partner who is known to be infected with HIV
  • male-to-female and female-to male transgender individuals engaging in high‑risk sexual behaviours
  • engaging in transactional sex, such as sex for money, drugs, or housing
  • users of injection drugs who report any of the following behaviours:
    • sharing injection equipment (including to inject hormones among transgender individuals)
    • injecting one or more times per day
    • injecting cocaine or methamphetamine
    • engaging in high-risk sexual behaviours
  • individuals who use stimulant drugs associated with high-risk behaviours, such as methamphetamine
  • diagnosed with at least one anogenital STI in the last year
  • prescribed nPEP and who demonstrate continued high‑risk behaviour or have used multiple courses of nPEP

England (draft)40

Individuals considered to be at substantial risk of HIV acquisition include those who are:

  • MSMs or transgender persons who are currently HIV-negative and who are clinically assessed to be at high risk of HIV acquisition through fulfilling the following criteria:
    • have a documented confirmed HIV-negative test during an earlier episode of care in the preceding year (i.e., 42 days to 365 days ago)
    • report condomless intercourse in the previous three months, and this is documented in the clinical notes
    • affirm their likelihood of repeated condomless intercourse in the next three months, and this is documented in the clinical notes
  • HIV-negative (confirmed by a current documented negative HIV test) and the partner of a diagnosed person with HIV who is not known to be virally suppressed and with whom condomless intercourse is anticipated and so is clinically assessed and considered to be at high risk of HIV acquisition
  • heterosexual men and women who are HIV-negative and clinically assessed and known to have had condomless sex with a person with HIV (who is not known to be virally suppressed) within the past three months and for whom it is anticipated that this will occur again, either with the same person or another person with similar status, and so is clinically assessed and considered to be at high risk of HIV acquisition

Excluding individuals who are:

  • in monogamous relationships with a partner who is known to be diagnosed with HIV and whose viral load is undetectable
  • without a current confirmed negative HIV test result (to minimize the risk of patients with undiagnosed HIV starting PrEP and developing a drug-resistant virus)
  • no longer considered at high risk of HIV acquisition, as they no longer meet the criteria
  • only at risk of HIV acquisition due to injecting drug use (as the current HIV incidence in this group in the UK is too low for PrEP to be cost-effective)
  • known to be diagnosed with HIV
  • under 16 years of age
  • in a treatment outside of level 3 genitourinary medicine services

Scotland42

Individuals considered to be at substantial risk of HIV acquisition include those who are:

  • current sexual partners, irrespective of gender, of people who are HIV-positive and with a detectable viral load
  • MSMs and transgender women with a documented bacterial rectal STI in the last 12 months
  • MSMs and transgender women reporting condomless penetrative anal sex with two or more partners in the last 12 months and likely to do so again in the next three months
  • individuals, irrespective of gender, at an equivalent highest risk of HIV acquisition, as agreed with another specialist clinician

France46

The use of FTC/TDF for PrEP has been recommended in the following populations

  • MSMs or transgender persons at high risk of acquiring HIV and who:
    • report unprotected anal relations with at least two partners over a period of six months
    • have experienced several STI episodes in the past year
    • have used post-exposure prophylaxis in the past year
    • usually consume psychoactive substances during sex
  • on a case-by-case basis for:
    • IV drug users who share syringes
    • sex workers exposed to unprotected sex
    • vulnerable individuals exposed to unprotected sex with a high risk of HIV transmission (with partners from a high-prevalence group, or with physical characteristics increasing the risk of HIV transmission such as ulcerations, bleeding or concomitant STI)

 

ART = antiretroviral therapy; MSMs = sexually active men who have sex with other men; nPEP = non-occupational post-exposure prophylaxis; PrEP = pre-exposure prophylaxis; STI = sexually transmitted infection.

Appendix 2: Canadian Public Drug Plan Benefit Status for FTC/TDF

Jurisdiction Full Benefit Restricted Benefit Restrictions or Other Notes
Alberta17   Alberta Specialized High Cost Drug Program covers drugs (100% of costs) for the treatment of patients with HIV infection that are dispensed through the Southern and Northern Alberta clinics
British Columbia16   Provided by the British Columbia Centre for Excellence in HIV/AIDS
Federal Non-Insured Health Benefits14    
Manitoba54   Exceptional Drug Status Program
New Brunswick55   For treatment of HIV infection in patients requiring a dual nucleoside/nucleotide option and for whom efavirenz is not indicated Special authorization required if the prescriber is not an infectious disease specialist or medical microbiologist
Newfoundland and Labrador56   Special authorization required Reserved for the treatment of patients with HIV where the virus is susceptible to both agents and efavirenz is not indicated due to adverse effects or antiretroviral resistance
Nova Scotia57   Prescriber must be a medical doctor and pharmacist in HIV clinic only
Ontario12    
Prince Edward Island58   The Prince Edward Island AIDS/HIV drug program18 is available to residents of the province who:
  • test positive for HIV
  • are diagnosed with AIDS
  • have a needle-stick injury that is not work related and do not have private medical insurance
Quebec13   Ministère de la santé et des services sociaux guidance for use in HIV PrEP20
Saskatchewan59   Exceptional Drug Status For treatment of patients with HIV where:
  • the virus is susceptible to tenofovir and emtricitabine
  • efavirenz is not indicated due to adverse effects or antiretroviral resistance
When prescribed by, or on the advice of an infectious disease specialist familiar with HIV post-exposure prophylaxis (PEP); please refer to the HIV PEP treatment document on the formulary website Possible to perform online Exceptional Drug Status adjudication using a list of approved prescribers; antivirals for the treatment of HIV should be used under the direction of an infectious disease specialist
Veterans Affairs Canada15    
Yukon60   Exceptional Drug Status Covered by the Chronic Disease Program on a case-by-case basis on recommendation of specialist

 

About this Document

Authors: Louis de Léséleuc, Philippe Laramée, Sarah Jones

Cite As: HIV pre-exposure prophylaxis with emtricitabine/tenofovir disoproxil fumarate — regulatory and reimbursement policies. Ottawa: CADTH; 2017 Aug. (Environmental scan; no.64).

Contributors: Kirsten Chelak

Disclaimer: The Canadian Agency for Drugs and Technologies in Health (CADTH) takes sole responsibility for the final form and content of this environmental scan. The statements and conclusions in this environmental scan are those of CADTH. The Environmental Scanning Service is an information service for those involved in planning and providing health care in Canada. Environmental Scanning Service responses are based on a limited literature search and are not comprehensive, systematic reviews. The intent is to provide information on a topic that CADTH could identify using all reasonable efforts within the time allowed. Environmental Scanning Service responses should be considered along with other types of information and health care considerations. The information included in this response is not intended to replace professional medical advice nor should it be construed as a recommendation for or against the use of a particular health technology. Readers are also cautioned that a lack of good quality evidence does not necessarily mean a lack of effectiveness, particularly in the case of new and emerging health technologies for which little information can be found but that may in future prove to be effective. While CADTH has taken care in the preparation of the report to ensure that its contents are accurate, complete, and up to date, CADTH does not make any guarantee to that effect. CADTH is not liable for any loss or damages resulting from use of the information in the report. Links: This report may contain links to other information available on the websites of third parties on the Internet. CADTH does not have control over the content of such sites. Use of third party sites is governed by the owners’ own terms and conditions.

Copyright ©CADTH 2017. You are permitted to make copies of this document for non-commercial purposes provided it is not modified when reproduced and appropriate credit is given to CADTH.

About CADTH: CADTH is an independent, not-for-profit organization responsible for providing Canada’s health care decision-makers with objective evidence to help make informed decisions about the optimal use of drugs, medical devices, diagnostics, and procedures in our health care system.

Funding: CADTH receives funding from Canada’s federal, provincial, and territorial governments, with the exception of Quebec.

Views: The views expressed herein are those of CADTH and do not necessarily reflect the views of our funders.

Contact requests@cadth.ca with inquiries about this notice or legal matters relating to CADTH services.

Cite As: HIV pre-exposure prophylaxis with emtricitabine/tenofovir disoproxil fumarate — regulatory and reimbursement policies. Ottawa: CADTH; 2017 Aug. (Environmental scan; no.64).