HIV patients might face limited access to Gilead´s Quad pill

[Common_ground]

AHF asks state health departments & AIDS directors, private insurers to place Gilead´s new Quad pill on "Prior Authorization" status
   
Gilead’s once-daily ‘Quad’ pill—expected to get FDA approval within the next two weeks—is expected to be priced thousands of dollars higher than current drugs purchased by state programs without representing a significant clinical and safety improvement over existing medications

In response, advocates from AHF call on state government programs and private insurers to place cost-prohibitive AIDS drug on ‘Prior Authorization’ status in order, “… ensure the Quad is only prescribed to patients when there is a documented need for it, and also will help ensure access for people with HIV/AIDS to these safety net programs.”

WASHINGTON (August 17, 2012) – In what may be an unprecedented move on drug pricing and access, advocates from AIDS Healthcare Foundation, are calling on state AIDS and Medicaid directors as well as a number of private medical insurers nationwide asking them to place Gilead Science’s new ‘Quad’ pill—a four-in-one, once-daily HIV/AIDS combination tablet—on ‘Prior Authorization’ status on their respective drug formularies. In general, ‘Prior Authorization’ requires that a particular prescription must be reviewed by a second medical provider for assessment of medical necessity before being filled for a particular drug, and the process may add a day to the timeline of a filling a prescription.

It is widely expected that Gilead will get FDA approval for the ‘Quad’ sometime within the next two weeks—and also expected that it will likely then price the combination therapy at thousands of dollars more than drugs that state AIDS Drug Assistance Programs (ADAP) currently purchase.

In response, AHF this week began sending letters asking leaders of state government programs and private insurers to place the potentially cost-prohibitive AIDS drug on prior authorization status once it has been FDA-approved and comes to market in order,  “…ensure access for people with HIV/AIDS to these safety net programs.”

“We request that your state place the Quad on Prior Authorization in your ADAP and Medicaid programs. This will ensure the Quad is only prescribed to patients when there is a documented need for it, and also will help ensure access for people with HIV/AIDS to these safety net programs.”

Later in the letter, AHF wrote:

“…clinical studies have shown that the Quad does not provide a substantial medical improvement over existing HIV drugs. For example, a recent study found the Quad only to be medically “non-inferior” to (i.e., it was not worse than) Atripla (the most popular HIV treatment on the market), in terms of controlling the virus and keeping patients healthy.”

The letter adds:

“…the use of prior authorization is warranted to control unnecessary cost while not unduly restricting access.  In situations where there is not a documented need for the Quad to be prescribed, patients will still have access to numerous other effective treatment options. In addition, patients can already access the same medication classes available in the Quad by taking its components in separate tablets. Taken separately, these medications are equally effective, and safer. “

Over the past months, AIDS advocates from AHF and other groups have spearheaded a campaign urging John C. Martin, CEO of Gilead not to decimate ADAP and other drug programs by pricing its latest HIV/AIDS drug combination, the ‘Quad,’ higher than Gilead’s Atripla, currently the most prescribed HIV/AIDS medication. Earlier this week, a group of U.S. Congress members wrote to Mr. Martin telling him that they are “troubled” by media reports indicating Gilead may charge may charge thousands more than existing AIDS drugs for the ‘Quad.’ In the letter, the Congress members also urged Gilead “…to consider sustainable pricing strategies for its products that would help allow ADAP to provide treatment to as many individuals as possible.”

“Gilead’s excessive pricing of it AIDS drugs has generated record profits for it, and $53 million in annual pay for its CEO, John Martin (making him the 10th highest paid executive in the nation),” wrote AHF’s President, Michael Weinstein. “However, this has come at the expense of state ADAP and Medicaid programs, the largest purchasers of Gilead’s products, and the people living with HIV/AIDS that rely on these programs but cannot access them due to funding constraints. To save lives, curb the spread of HIV, and lower long-term care expenses, it is imperative to get more patients tested and into antiretroviral treatment. This will be impossible if we continue to introduce new HIV drugs, like the Quad, at prices higher than the drugs they replace.”

Previous ‘Prior Authorization’ Requests

In California, advocates from AHF previously—and successfully—asked for ‘Prior Authorization’ status for Serono’s drug, Serostim (somatropin), a drug used to combat AIDS wasting and weight loss in HIV/AIDS patients. AHF sought ‘Prior Authorization’ status for Serostim because many doctors and providers believed it was medically unnecessary if patients faithfully followed their antiretroviral (ARV) drug regimens—and because the drug has a price tag of over $7,000 per month. It is widely believed that AHF’s requests to have Gilead’s ‘Quad’ placed on ‘Prior Authorization’ status is the first such request for any antiretroviral therapy used to treat HIV/AIDS.

# # #

AIDS Healthcare Foundation (AHF), the largest global AIDS organization, currently provides medical care and services to more than 176,000 individuals in 27 countries worldwide in the US, Africa, Latin America/Caribbean the Asia/Pacific region and Eastern Europe. To learn more about AHF, please visit our website: www.aidshealth.org, find us on Facebook: www.facebook.com/aidshealth and follow us on Twitter: @aidshealthcare.

http://www.aidshealth.org/archives/14385/

[Newguy]

This pill makes no sense. It simply is Truvada plus an integrase inhibitor and a booster. You are probably paying extra for the booster but Truavada and Issentress does the same thing with less med in your body. I understand the pill burden argument but for the extra cost is it really worth it? Wait for dolutegravir to be approved, once a day no booster integrase inhibitor (maybe twice for people with resistance issues).

[Ann]

My hiv doctor and I talked about this yesterday. For those of you who don't know, my doc is also an hiv pharmacologist/research scientist (his actual title is Professor) and he's also one of the researchers behind Liverpool University's hiv-druginteraction.org website. He's got well over 20 years of experience, has published more studies on hiv and hiv meds than you could shake a stick at and he's a great guy all-round. I call him The Wizard of Poz.

He thinks the fuss about the Quad pill is much ado about nothing and that the proposed pricing is just nuts. He believes it to actually be an inferior med to many for several reasons, side-effects being one of them. (Quad was hoped to have fewer side-effects than Norvir-boosted combos.) He very much doubts he will be prescribing it, even if the price comes down.

The new med he's REALLY excited about is Dolutegravir. He mentioned this the last time I saw him as well, but he rattled off its experimental-stage, alpha-numeric name (S/GSK 1249572) and I neglected to write it down so I could look it up later. (I was more interested in talking about my current combo choice.) 

He says it's going to be a very powerful, effective and well-tolerated med that most people will be able to take once a day with Truvada or Epzicom/Kivexa. Only people who have developed resistance to one of the other integrase inhibitors will have to take it twice a day - but at least they'll still be able to use it.

He was actually hoping I'd wait until dolutegravir came out, but I went with Prezista, Norvir and Truvada and I'm happy with that for now. He said I could probably change to dolutegravir at a later date if I want.

[Newguy]

Also, there is a once day pill containing dolutegravir and kivexa in phase 3 from ViiV which should be very exciting should you be able to take it. This should be approved soon.

Best

[buginme2]

He thinks the fuss about Complera is much ado about nothing

Complera? Or Quad?

[Ann]

Complera? Or Quad?

Sorry, good catch. I did indeed mean Quad. I've corrected it - thanks for pointing it out.

[Ann]

Also, there is a once day pill containing dolutegravir and kivexa in phase 3 from ViiV which should be very exciting should you be able to take it. This should be approved soon.

Best

Yes, he mentioned that too, but I forgot to say so earlier. It's out for me though, because he won't prescribe abacavir for me - not because of the sensitivity issue, but because it's not recommended for people who smoke and have a history of heart disease in their family. He said even if I quit smoking tomorrow, he would not be comfortable with me being on abacavir (aka Ziagen).

[Newguy]

Hi Ann

I am hoping I can go on Kivexa which I find out next week. I quit smoking four years ago and have no family history with heart disease. Barring any sensitivity issues, I think Kivexa looks like a good drug. I prefer it over Truvada because it has a higher brain penetration rating than Truvada and less bone and kidney risks.  Ideally I would like to wait for Dolutegravir but all of this is pure speculation because it depends on what my numbers say.

[Common_ground]

It strange since analysts predicts Quad to be Gilead´s cash cow but still the HIV community with doctors and patients seems reluctant to its benefits. I can for the love of god not understand why Gilead didnt wait and pushed through the development of the tenofovir pro drug and incorporated it in the Quad, then it would/could at least have an edge on the other regimens out there.

I can only see a few reasons for why people would change regimen:
Resistance
Pill burden
Price
Side effects

Quad doesnt seem superior in any of these categories. Whats the business strategy of Quad? Was it cheap to develop? Gilead is already involved in both the two once-a-day pills out there, why market a third one? They already got some 70% of the HIV-ARV market, whos shares theyre gonna snatch?

[LM]

Ann, you still owe us a thread, talking about your decision (and experience) of taking meds. I mean, 14 years of waiting deserves a thread talking about it. 

[Ann]

Ann, you still owe us a thread, talking about your decision (and experience) of taking meds. I mean, 14 years of waiting deserves a thread talking about it. 

Heh, yeah, it's been so anti-climatic and boring that I haven't gotten around to it. If I'm honest, I think part of me is afraid of jinxing things by saying how well it's going prematurely. I know, I know, I'm being silly. Humour me. 

I had my first blood draw after starting on Tuesday, Aug 21st (six weeks in), and I'm tempted to wait now until I can ring and get my results in two weeks. I have a feeling I'll be UD, but I won't be disappointed if I'm not as long as there's been a good drop.

I should probably put it in my blog as well. My poor, neglected blog! 

[Jeff G]

Heh, yeah, it's been so anti-climatic and boring that I haven't gotten around to it. If I'm honest, I think part of me is afraid of jinxing things by saying how well it's going prematurely. I know, I know, I'm being silly. Humour me. 

I had my first blood draw after starting on Tuesday, Aug 21st (six weeks in), and I'm tempted to wait now until I can ring and get my results in two weeks. I have a feeling I'll be UD, but I won't be disappointed if I'm not as long as there's been a good drop.

I should probably put it in my blog as well. My poor, neglected blog! 

Six weeks in ? , you should be posting about facial wasting , lipo with liver and kidney failure by now , get with the program !  .

[Ann]

Six weeks in ? , you should be posting about facial wasting , lipo with liver and kidney failure by now , get with the program !  .

Don't think I haven't been tempted!

[LM]

Heh, yeah, it's been so anti-climatic and boring that I haven't gotten around to it. If I'm honest, I think part of me is afraid of jinxing things by saying how well it's going prematurely. I know, I know, I'm being silly. Humour me. 

I had my first blood draw after starting on Tuesday, Aug 21st (six weeks in), and I'm tempted to wait now until I can ring and get my results in two weeks. I have a feeling I'll be UD, but I won't be disappointed if I'm not as long as there's been a good drop.

I should probably put it in my blog as well. My poor, neglected blog! 

Haha, nah, I totally get you. I'm kinda superstitious with those things as well. I don't like to pop the champagne before it's clear that all is well. 

Hope it comes UD!