New York City, USA: Insurers cannot discriminate when underwriting insurance for New Yorkers who use pre-exposure prophylaxis (PrEP), a combination of prescription drugs used to reduce the risk of contracting human immunodeficiency virus (HIV), the New York Department of Financial Services (DFS) said in it’s guidance issued today, Financial Services Superintendent Maria T. Vullo announced.
The guidance issued today follows news reports that some insurers may be denying coverage or taking other adverse underwriting actions for life insurance, disability income insurance or long-term care insurance if an applicant uses PrEP. DFS previously issued guidance to health insurers to ensure that insurance coverage for PrEP is available to all New Yorkers and that insurance companies do not discriminate against those requesting PrEP based on lifestyle or behavior.
“DFS will not tolerate discrimination in the underwriting of insurance for any New Yorker, nor will we tolerate any denial of insurance that is not based on sound actuarial principles,” said Superintendent Vullo. “Today’s action will ensure that consumers who are taking prudent steps to protect their health by reducing the risk of contracting HIV will be able to purchase life insurance, disability income insurance and long-term care insurance at fair and reasonable prices and without fear of unfair denials.”
DFS began an investigation of underwriting guidelines and practices following reports that some issuers may be denying coverage or taking other adverse underwriting actions for life insurance, disability income insurance, or long-term care insurance if an applicant uses PrEP. Under New York Insurance Law, the Superintendent may examine issuers to confirm that their underwriting of such policies, where HIV prevention strategies are relevant, is based on underwriting and actuarial principles reasonably related to actual or anticipated experience.
In the guidance issued today, DFS noted that underwriting practices in which adverse decisions are based on an applicant’s use of PrEP violate New York Insurance Law because these practices result in unfair discrimination between individuals with the same level of potential exposure to HIV. These practices result in adverse underwriting decisions for individuals who are taking steps to mitigate the risk of contracting HIV infection but no adverse underwriting decisions for individuals with the same level of potential exposure to HIV who are not taking steps to mitigate the risk. Indeed, evidence suggests that the use of PrEP can significantly reduce the risk of contracting HIV infection.
In addition, Insurance Law prohibits issuers of life insurance, disability income insurance, and long-term care insurance from refusing to insure or continue to insure, limiting the amount, extent or kind of coverage, or charging a different rate for the same coverage solely because of the physical or mental disability, impairment or disease, or prior history of the disability or disease of an insured or potential insured, except where the refusal, limitation or rate differential is permitted by law or regulation and is based on sound actuarial principles or is related to actual or reasonably anticipated experience.
What Is Pre-exposure Prophylaxis (PrEP)?
Pre-exposure prophylaxis (PrEP) is a course of HIV drugs taken by HIV-negative people to reduce their risk of HIV infection.
Truvada is currently the only drug approved for use as PrEP. Truvada is a single pill that is a combination of two anti-HIV drugs, tenofovir and emtricitabine.
The anti-HIV drugs in PrEP stop the virus replicating in your body. If you are exposed to HIV but have been taking PrEP correctly, there will be high enough levels of the drugs to prevent you from getting HIV.
If used consistently and correctly, PrEP can virtually eliminate the risk of you becoming infected with HIV.
A number of large, high profile trials undertaken across the world have continued to prove PrEP’s effectiveness.
PrEP will protect you from HIV, but it doesn’t give you any protection against sexually transmitted infections (STIs). Using a condom is the best way to prevent other STIs such as gonorrhoea, chlamydia and hepatitis C.
Truvada is FDA approved.
FDA approves first drug for reducing the risk of sexually acquired HIV infection
The U.S. Food and Drug Administration has approved Truvada (emtricitabine/tenofovir disoproxil fumarate), the first drug approved to reduce the risk of HIV infection in uninfected individuals who are at high risk of HIV infection and who may engage in sexual activity with HIV-infected partners. Truvada, taken daily, is to be used for pre-exposure prophylaxis (PrEP) in combination with safer sex practices to reduce the risk of sexually-acquired HIV infection in adults at high risk.
The FDA previously approved Truvada to be used in combination with other antiretroviral agents for the treatment of HIV-infected adults and children 12 years or older.
As part of PrEP, HIV-uninfected individuals who are at high risk will take Truvada daily to lower their chances of becoming infected with HIV should they be exposed to the virus. A PrEP indication means Truvada is approved for use as part of a comprehensive HIV prevention strategy that includes other prevention methods, such as safe sex practices, risk reduction counseling, and regular HIV testing.
“Today’s approval marks an important milestone in our fight against HIV,” said FDA Commissioner Margaret A. Hamburg, M.D. “Every year, about 50,000 U.S. adults and adolescents are diagnosed with HIV infection, despite the availability of prevention methods and strategies to educate, test, and care for people living with the disease. New treatments as well as prevention methods are needed to fight the HIV epidemic in this country.”
As a part of this action, the FDA is strengthening Truvada’s Boxed Warning to alert health care professionals and uninfected individuals that Truvada for PrEP must only be used by individuals who are confirmed to be HIV-negative prior to prescribing the drug and at least every three months during use. The drug is contraindicated for PrEP in individuals with unknown or positive HIV status. The FDA strongly recommends against such use.
Truvada for PrEP is being approved with a Risk Evaluation and Mitigation Strategy (REMS) to minimize the risk to uninfected individuals of acquiring HIV infection and to reduce the risk of development of resistant HIV-1 variants. The central component of this REMS is a training and education program to assist prescribers in counseling individuals who are taking or considering Truvada for PrEP. The training and education program will not restrict distribution of Truvada but will provide information about the importance of adhering to the recommended dosing regimen and understanding the serious risks of becoming infected with HIV while taking Truvada for the PrEP indication.
“The REMS for Truvada for the PrEP indication is aimed at educating health care professionals and uninfected individuals to help ensure its safe use for this indication without placing an unnecessary burden on health care professionals and patients,” said Janet Woodcock, M.D., director of the FDA’s Center for Drug Evaluation and Research.
Truvada’s safety and efficacy for PrEP were demonstrated in two large, randomized, double-blind, placebo-controlled clinical trials. The iPrEx trial evaluated Truvada in 2,499 HIV-negative men or transgender women who have sex with men and with evidence of high risk behavior for HIV infection, such as inconsistent or no condom use during sex with a partner of positive or unknown HIV status, a high number of sex partners, and exchange of sex for commodities. Results showed Truvada was effective in reducing the risk of HIV infection by 42 percent compared with placebo in this population. Efficacy was strongly correlated with drug adherence in this trial.
The Partners PrEP trial was conducted in 4,758 heterosexual couples where one partner was HIV-infected and the other was not (serodiscordant couples). The trial evaluated the efficacy and safety of Truvada and tenofovir versus placebo in preventing HIV infection in the uninfected male or female partner. Results showed Truvada reduced the risk of becoming infected by 75 percent compared with placebo.
No new side effects were identified in the clinical trials evaluating Truvada for the PrEP indication. The most common side effects reported with Truvada included diarrhea, nausea, abdominal pain, headache, and weight loss. Serious adverse events in general, as well as those specifically related to kidney or bone toxicity, were uncommon.
As a condition of approval, Truvada’s manufacturer, Gilead Sciences, Inc., is required to collect viral isolates from individuals who acquire HIV while taking Truvada and to evaluate these isolates for the presence of resistance. Additionally, the company is required to collect data on pregnancy outcomes for women who become pregnant while taking Truvada for PrEP and to conduct a trial to evaluate drug adherence and its relationship to adverse events, risk of seroconversion, and resistance development in seroconverters. Gilead has committed to provide national drug utilization data in order to better characterize individuals who utilize Truvada for a PrEP indication and to develop an adherence questionnaire that will assist prescribers in identifying individuals at risk for low compliance.
Gilead Sciences, Inc. is based in Foster City, California.