A publication for understanding how to navigate the American health care system

Pre-exposure Prophylaxis

How to get PrEP

your life matters

APRIL 2014

Check out our four videos on PrEP as well!

• • • •

an overview of PrEP how PrEP fits into your life making decisions with your doctor PrEP and mixed status couples

Go to www.projectinform.org/prep.

Table of contents Using this booklet ...

2

A little background

3–4

First, a few health care terms

5–6

Your patient/doctor relationship

7–9

Finding a health care provider Local clinical studies Types of insurance coverage Online resources

10–11 12 13–15 16

How to get PrEP: things to consider before starting the process

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Using this booklet ... We’ve written this booklet to help you manage the process for getting a prescription for PrEP. You’ve probably already read a good deal about how PrEP works and how it could help you stay free of HIV. Unfortunately, some aspects of the American medical system can make getting PrEP more difficult or at least take more time than what you had thought it would. It is very possible you won’t encounter many if any hiccups along the way. But we want you to be aware of what could hamper the process and not get discouraged from pursuing this biomedical prevention tool. Generally speaking, this booklet describes the following: • You should be able to get PrEP if you have decided it’s an appropriate option to protect yourself from getting HIV. • Truvada for PrEP is FDA-approved and can be prescribed by any doctor who is able to write prescriptions. • You’re entitled to having a health provider who supports your decision to use PrEP. • Insurance companies and Medicaid programs are covering the cost of PrEP. • Your out-of-pocket costs may end up being higher than what you expected, so ask about co-pays and other costs. • If you’re under- or uninsured, there are ways to help with the cost of the prescription.

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How to get PrEP: things to consider before starting the process

A little background Taking daily Truvada for PrEP is a new way to prevent HIV, approved by the FDA in July 2012. Although it requires getting a prescription from a medical provider, some doctors do not yet know about it while others may not want to prescribe it. In the months since its approval, we’ve heard from some people about their experiences with getting PrEP. Some men and women have had problems getting the prescription. However, we also know that some doctors, nurses and office staff have not been helpful. The newness of prescribing this pill in our health care system has presented its own set of problems. Some doctors may not be comfortable with asking their patients about sexual activity. (And maybe you’re anxious about that too.) Doctors may be unwilling to incorporate the increased number of visits that PrEP requires into their practices. Some may even refuse it altogether, pointing to condom use as the only acceptable means of protecting yourself against HIV. continued ...

How to get PrEP: things to consider before starting the process

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A little background What can also make it harder is that extra paperwork may sometimes be needed, which can strain medical staff time and resources. Insurance companies can also throw complications into the mix. Hopefully this isn’t the case for you because, frankly, it shouldn’t be. But we want to let you know about ways to work within the medical system in case you encounter these problems. This way you have a better chance of advocating for yourself. In the end, you may actually help to change our health care system for the better. If you run into barriers that you can’t resolve, please contact one of these organizations for help: Project Inform (415-558-8669, [email protected]), My PrEP Experience ([email protected], myprepexperi ence.blogspot.com), and PrEP Facts (https://www.facebook. com/groups/PrEPFacts/).

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How to get PrEP: things to consider before starting the process

First, a few health care terms Prior authorization Insurance companies place some drugs (like Truvada for PrEP) on a prior authorization (PA) list. This means they want more info from your doctor’s office before they’ll approve the prescription. For PrEP, it’s normally because they’re making sure you’re HIV-negative. Some people don’t find out about a PA until their pharmacists tell them they can’t fill the scrip. If this happens to you, it doesn’t mean you’re being denied coverage. Go back to your doctor’s office and ask them to complete the proper forms, which should be covered by your care with them. If the office discourages you from pursuing this, let us know about that. So far, PAs do not appear to be a major obstacle in getting a scrip for PrEP. (You can read more about PAs at www. consumer-health.com/services/cons_take51.php.) Higher cost tiers Each insurance company publishes a list of drugs that they cover, called a formulary. Within the formulary they place a range of drugs on lower cost levels or tiers up through higher cost tiers: generics, preferred brands, non-preferred brands, new drugs and specialty drugs. Some companies are putting Truvada on a higher cost tier, likely because it’s a recently approved drug for preventing HIV. (A year’s supply of Truvada retails about $14,000, but insurance company and continued ...

How to get PrEP: things to consider before starting the process

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First, a few health care terms public program negotiate a lower price.) This may mean that you’ll have larger co-pays for this scrip than what you may pay for other meds. There’s not much you can do about what tier Truvada for PrEP is on, but the maker of Truvada (Gilead) offers help with co-pays up to $200/month (www. truvada.com). Prescription denial Sometimes insurance companies will deny covering the cost of a prescription that your doctor writes for you. If this happens to you, first check to make sure Truvada for PrEP is on the formulary. Next, check to make sure your doctor’s office filled out paperwork correctly. If necessary, ask them to re-submit. If you’re still denied, then you have a right to appeal the denial. It may be a simple administrative mistake and easy to clear up. However, appeal until you’re satisfied with the result. Again, your doctor’s office should help you out with this.

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How to get PrEP: things to consider before starting the process

Your patient/doctor relationship Getting a PrEP prescription may be relatively easy for you. Unfortunately, we’ve heard that some providers don’t know about PrEP or refuse to provide it. (Many say, “Just use condoms.”) You may feel you can’t even bring up the topic with your current provider, and the discussion about sexual health and HIV risk may make you both apprehensive. The initial process for getting a scrip may also take a few weeks … which includes making your appointment, seeing your doc, getting blood tests done and reviewing results, getting approval from your insurer, and getting the scrip filled and in your hands. That can leave room for some slipups along the way. That’s a lot to think about, but here are some tips. • If you’re in a relationship with someone living with HIV, then your doc may be more receptive to talking with you about PrEP. However, as some doctors and individuals mistakenly believe, having a positive partner is not a requirement to get PrEP. continued ...

How to get PrEP: things to consider before starting the process

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Your patient/doctor relationship • Don’t assume your provider won’t write the scrip. Test the water. Be prepared to describe why PrEP is important to you and why you want his/her help with this. (Read a helpful brochure at www.cdc.gov/hiv/pdf/risk_ PrEP_TalkingtoDr_FINALcleared.pdf.) • LGBT-friendly docs or family physicians or other providers who are experienced in sexual health care may be good resources, though this is no guarantee. • Many primary care physicians (PCPs) are referring PrEP patients to infectious disease (ID) and other docs. We don’t think this is necessary because you don’t have an infectious disease. Taking PrEP is about prevention, so it’s similar to screening and monitoring for other conditions, like diabetes or cardiovascular issues. If PCPs are engaged in these areas of preventive health with their patients, then PrEP shouldn’t be a stretch for them to include in their practice. • Providers with exclusively or primarily HIV-based practices may not be the best resource for PrEP. However, it shouldn’t keep you from asking. • You may find that you know more about PrEP than your doctor. That’s very possible since it’s a newly approved use for Truvada. You can share these medical resources: INTERIM GUIDANCE (full guidance coming soon): www.cdc.gov/mmwr/preview/mmwrhtml/mm6003a1.htm (for MSM); continued ... 8

How to get PrEP: things to consider before starting the process

Your patient/doctor relationship www.cdc.gov/mmwr/preview/mmwrhtml/mm6131a2.htm (for heterosexual men and women); and www.cdc.gov/mmwr/preview/mmwrhtml/mm6223a2.htm (for people who inject drugs). OTHER RESOUCES: Clinician Consultation Center (800-933-3413), which can help answer questions from your doctor on PrEP. (They don’t answer questions from patients.) Insurance codes. Your provider may also need help with coding the prescription. A list of possible codes will soon be published at www.prepfacts.org. • Some doctors don’t have any experience prescribing an HIV medication. This should not be a reason to deny you a prescription or send you to an ID doc. There are clear guidelines on how to monitor someone on Truvada for PrEP, and it’s no more difficult than monitoring other aspects of your health. (Check previous bullet.) • If your provider won’t write a scrip, then you may need to find a new doc who’s invested in your sexual health (see next page). • Contact a local clinical study if one’s available. (See page 12, or go to www.clinicaltrials.gov.)

How to get PrEP: things to consider before starting the process

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Finding a health care provider If you need to find a doctor, there are many ways to go about that, although it may take some effort on your part. • Start with your current doctor. Be prepared to broach the topic and discuss why PrEP is important to you. If there’s some apprehension at first, that doesn’t mean to just move on. Doctors have to learn new things over time, and it can take some time and effort to get used to this. However, you’ll probably know when to give up and move on to Plan B. (This CDC brochure may help you prepare to have that first talk: www.cdc.gov/ hiv/pdf/risk_PrEP_TalkingtoDr_FINALcleared.pdf.) • Check the physicians directory in your health plan materials. If your current doc isn’t providing PrEP, then look for doctors in your health network who state that they’re sensitive to sexual health or LGBT issues. If your partner is HIV-positive, then his/her provider may be in your health network and may be willing to prescribe PrEP for a mixed status couple. This may be true for private practices as well as public clinics, especially ones that receive Ryan White funding. continued ... 10

How to get PrEP: things to consider before starting the process

Finding a health care provider • Public health clinics. If you get your care at a public clinic, the same issues we see in private practices can still apply. Additionally, some public clinics won’t provide PrEP because they don’t have a funding source in place to prescribe it. • Contact a local clinical study. If there’s one near you, they may have identified providers for people who can’t get into the study. Call Project Inform for contact info on demo projects or search for “HIV PrEP clinical studies” on www.clinicaltrials.gov. • Contact your local health department. The best bet may be to speak with someone in the STD or HIV program. Since they deal with sexual health, PrEP may be a part of their services. However, many departments have not yet developed referral lists and may not be able to guide you. • Emergency rooms. It’s highly unlikely you could get a PrEP scrip at an ER or urgent care facility. Because you need follow-up doctor visits, an ER is not the place to go. • Check online. These websites have physician finders that could help you locate someone, although we can’t promise who will/ won’t prescribe PrEP: glma.org, aahivm.org and hivma.org. (Some HIV docs who have general practices may provide PrEP.) How to get PrEP: things to consider before starting the process

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Local clinical studies Many clinical studies are being conducted in major cities around the country. These studies look at different ways to support patients around taking PrEP in various communities, so certain ones may be the right fit for you while others are not. Some are demonstration projects and others are implementation projects. These studies will likely provide PrEP, routine blood work and condoms to participants. Most last about a year or less. So if you get into one, think ahead about how you’ll continue on PrEP before leaving the project. If you can’t get into a study because you’re not eligible or it’s closed to enrollment, then it never hurts to ask the staff for referrals to doctors who are prescribing PrEP in your area.

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How to get PrEP: things to consider before starting the process

Types of insurance coverage If you have insurance ... If you have a doctor and insurance, you “should” be able to get PrEP through him/her. It appears that most large insurance companies will cover Truvada for PrEP, although there may be some exceptions. Some people have had no problem getting PrEP, while others have had their share of problems. Most of these include what has been stated before: requiring a PA, higher co-pay, scrip denial, and doctor refusal to prescribe. If you’re on Medicaid ... State Medicaid programs must cover Truvada for PrEP, however, your state can make different requirements about what you need to do to get it. Each program is different, so don’t expect to get what you hear someone else may be getting in another state. Many states currently require a PA. However, your Medicaid plan may also limit how many of your medications it will cover each month, so a PrEP scrip may be denied due to prescription limitations. If you don’t have insurance ... If you don’t have insurance or get your health care in a public clinic, you may be able to get the PrEP scrip covered by Gilead, the maker of Truvada. Gilead’s Patient Assistance Program (855-330-5479) will help pay the cost of Truvada for individuals with low enough income (about $23,000/ year or less). Your doctor’s office should be able to help you continued ... How to get PrEP: things to consider before starting the process

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Types of insurance coverage fill out the proper application for this. Gilead will also help with paying for HIV tests while you’re on Truvada for PrEP as well as provide free condoms. However, you will need to find ways to pay for the required lab work and office visits. If you’re purchasing insurance through state health marketplaces ... As new health coverage gets implemented under the Affordable Care Act, it’s been difficult to know how Truvada for PrEP is being covered by plans. It can be difficult to find the right formulary for your new plan. If Truvada is covered, the amount you pay can vary widely from plan to plan. For example, bronze plans may have the least expensive premiums, but they also have more out-of-pocket costs and much higher deductibles than others. That means you have to pay much more before the insurance starts covering PrEP. Many if not most plans will require a PA for the scrip. Some plans may not list Truvada as a combo pill on their formularies; instead, they may list the pill’s two drugs separately: tenofovir/Viread and emtricitabine/Emtriva. continued ...

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How to get PrEP: things to consider before starting the process

Types of insurance coverage Use your employer’s HSA … Your employer may offer a health savings account (HSA) to you as way to set aside pre-tax dollars to pay for out-of-pocket medical costs. You may already be using one which you could increase your pre-tax contribution for PrEP costs. If you’re not, check in to see if an HSA is offered. Using it could help offset some of the costs of taking PrEP.

How to get PrEP: things to consider before starting the process

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Online resources Information on PrEP

Articles

Pre-Exposure Prophylaxis www.projectinform.org/prep

Talking to your doctor about PrEP http://www.cdc.gov/hiv/pdf/ risk_PrEP_TalkingtoDr_FINALcleared.pdf

My PrEP Experience http://myprepexperience. blogspot.com/ PrEP Facts http://prepfacts.org/ What is PrEP? www.whatisprep.org PrEP Watch www.prepwatch.org Positively Aware PrEP issue http://positivelyaware. com/2013/13-05/ PrEP Facts Facebook www.facebook.com/groups/ PrEPFacts/ Truvada for PrEP (company website) http://start.truvada.com/# Truvada for PrEP (REMS) https://www.truvadapreprems. com/# APPLICATION FORM Medication Assistance Program (for uninsured people to cover the cost of Truvada, work with doctor to fill it out) https://start.truvada.com/ Content/pdf/Medication_Assistance_Program.pdf

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Is PrEP right for me? A primer for women considering PrEP http://hiv.ucsf.edu/care/ perinatal/forpatients/prep_ right_2012.pdf Thinking about having a baby? http://hiv.ucsf.edu/care/perinatal/forpatients/neg_female_ pos_male_2012.pdf Websites for clinicians Truvada for a PrEP Indication https://start.truvada.com/ CDC Fact Sheet (PrEP: A New Tool for HIV Prevention) www.cdc.gov/hiv/prep/pdf/ PrEPfactsheet.pdf CDC Guidance on HIV PrEP for Various Populations www.cdc.gov/hiv/prevention/ research/prep/ Clinician Consultation Center 800-933-3413 http://nccc.ucsf.edu/ Clinical Studies Resources www.avac.org/ht/d/sp/i/262/ pid/262

How to get PrEP: things to consider before starting the process

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