OBAMA ADMINISTRATION GUIDANCE WILL INCREASE ACCESS TO HEPATITIS C CURE DRUGS Urges State Medicaid Programs to Lift Restrictions for the Nation’s Most Vulnerable

National Policy Office - Washington, DC: 202-835-8373

Program and Administrative Office - Tampa, FL: 813-258-5929

For Immediate Release: 11.05.15   

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Media Contact: Carl Schmid: (202) 669-8267 cschmid@theaidsinstitute.org

                                                                                    

OBAMA ADMINISTRATION GUIDANCE WILL INCREASE ACCESS TO HEPATITIS C CURE DRUGS

Urges State Medicaid Programs to Lift Restrictions for the Nation’s Most Vulnerable  

Washington, DC – The AIDS Institute praises the Obama Administration for their letter sent today to State Medicaid Directors that suggests states lift their onerous restrictions that have prevented people living with hepatitis C access to medications that can cure them.  “Denying drugs that can cure people of a deadly infectious disease is just bad public health policy. This announcement demonstrates that Medicaid beneficiaries with hepatitis C, who represent some of the Nation’s most vulnerable, deserve access to a cost-effective cure just like anyone else,” commented Carl Schmid, Deputy Executive Director of The AIDS Institute.

The AIDS Institute, a national public policy and advocacy organization dedicated to ensuring people living with HIV and hepatitis have access to quality and affordable health care, along with others, have urged the Centers for Medicare and Medicaid Services (CMS) to take this corrective action.  Most state Medicaid programs have instituted barriers to accessing hepatitis C cure drugs by limiting them to only individuals with advanced liver disease.  States have also used a number of other restrictions which have no scientific basis such as limits on who can obtain and prescribe the drugs. In one recent study, 46 percent of Medicaid beneficiaries were denied access to hepatitis C drugs. 

Medicaid is a joint federal-state funded program.  States must cover all medications produced by pharmaceutical manufactures that participate in the Medicaid Drug Rebate Program.  While states may be putting the hepatitis C drugs on their formularies, many are making it extremely difficult for patients in need of the drugs to access them. Today’s announcement makes it clear that this is wrong and states need to remove restrictions that have no clinical or scientific basis. 

Nationwide, an estimated 3.2 million people are living with hepatitis C; however, up to 75 percent have not yet been diagnosed.  There are approximately 20,000 deaths attributed to hepatitis C annually in the U.S. and it is the leading cause of costly liver cancer and liver transplants. 

Clinical experts at the American Association for the Study for Liver Diseases (AASLD) and the Infectious Diseases Society of America (IDSA) have recently updated their guidance on the treatment of hepatitis C virus.  They have concluded that treatment would benefit nearly all of those who are chronically infected and the goal should be to treat all patients as promptly as feasible to improve their health and to reduce HCV transmission.

Since many Medicaid beneficiaries are now being served by Medicaid Managed Care Organizations (MCOs), the directive announced today makes it clear that MCOs cannot impose restrictions on patient access that are more restrictive than the state’s fee-for-service program.  In some states, Medicaid MCOs have instituted even far wider restrictions than the state run programs.

“Now, we call on all state Medicaid programs to remove patient barriers to hepatitis C treatment that the federal government has called to be eliminated,” said Michael Ruppal, Executive Director of The AIDS Institute.  “In the long run, it will save the health care system billions of dollars, save the lives of hundreds of thousands of people, and help eradicate a deadly infectious disease.” 

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The AIDS Institute is a bipartisan, national nonprofit organization that promotes action for social change through public policy, research, advocacy and education.

For more information and to become involved, visit www.TheAIDSInstitute.org or write to us at Info@theaidsinstitute.org, and follow The AIDS Institute on Twitter @AIDSAdvocacy and Facebook at www.facebook.com/The-AIDS-Institute.

Carl Schmid

Deputy Executive Director

The AIDS Institute

Washington DC

202/462-3042-office
202/669-8267-cell
202/328-0467-faxcschmid@theaidsinstitute.org

Medicaid officials want to expand access to pricey hepatitis C drug

Health care officials in Washington state thought thousands of Medicaid patients would line up to receive a breakthrough hepatitis C treatment that went on the market late last year.

Yet by June, the state had treated only a third as many hepatitis C patients as it had planned for — about 1,200 people.

Now, the state’s Medicaid authority wants to use the $44 million it didn’t spend over the past year to start covering the drug for a wider range of patients, instead of just the sickest ones.

State officials estimate about 75,000 to 100,000 people in Washington have hepatitis C, a blood-borne virus that can cause liver failure or liver cancer if left untreated. Nationwide, many people living with the disease are low-income patients who are eligible for Medicaid, officials said.

Read more....

Emotional Issues When Leaving Work on Disability —By Jacques Chambers, CLU, September 2015

QUOTE: There is frequently a feeling of loss of control over not only the direction of your life, but also a sense of losing control over your very own body. Likewise, the medical condition is now dictating your future.

For persons dealing with HCV, the recent introduction of the new medications that appear to provide the complete annihilation of the virus truly is miraculous. Access to the medications is another story, however. Insurance companies want to protect their profits; Medicaid programs are scrambling to find a way to budget the enormous cost of providing these medications to those who need them.

Also, as marvelous as the medications are at killing the virus, they are unable to repair the damage to the body that the virus has already caused, up to and including cirrhosis. While dealing with the physical and medical issues is vital, there are emotional issues as well that need to be at least acknowledged and dealt with should you find yourself in the position that you are no longer able to work and stay healthy.

The emotional impact of such an event may seem like one of those issues that is too basic to spend much time thinking about. Of course, there’s an emotional impact on leaving work for disability. Who wouldn’t be depressed? However, there is usually more to it than that, and not being prepared for it can put you into a tailspin that can affect your mental well being as well as your physical health.

In my years of working with clients, I have found that making the transition from work to disability is a major life event, right up there with getting married or moving, and it can have broad repercussions on actions as well as feelings and emotions. It can also have a dramatic effect on your ability to make decisions objectively and rationally. Clients who recognize this impact and know to expect such feelings are better prepared to deal with them and minimize them when they occur.

What, emotionally, will happen to me?
Don’t worry, you won’t “totally lose it.” As with medical symptoms the emotional impact will vary from person to person. The emotional repercussions of leaving work on disability often take the form of depression, lack of concentration, inability to focus on a goal and achieve it, as well as general feelings of malaise,  helplessness, and fear of the future. It can also interfere with your ability to think objectively and react rationally. There may be other symptoms both emotional and physical. The important thing to remember is that, uncomfortable as these symptoms are, they are a natural part of this change you are making, and they will pass. Everyone in a similar situation goes through a similar process.

Why does this happen?
Part of it is obvious. You are moving from active work to inactive disability; that’s a major life event and would upset anyone. There are other factors as well, primarily the sense of loss of control and having to battle old messages drilled into you by society since childhood. In many cases, a person self-identifies with the work they do.

There is frequently a feeling of loss of control over not only the direction of your life, but also a sense of losing control over your very own body. Likewise, the medical condition is now dictating your future. You may feel like you no longer have the power to decide what direction to take or what to do next. Such a feeling of helplessness can be devastating emotionally and can create all sorts of symptoms.

Finally, there are all those good work ethic messages you learned growing up and which you are probably still replaying from the early stages of your condition till now. Many people feel that stopping work is “giving up” or “surrendering” to the medical condition; that the disease is now in control of his or her body and all he or she can do is watch helplessly. Who wouldn’t have emotional issues if, in the back of their mind, they keep thinking things like:

• You’re giving up by stopping work. You’re a quitter.
• You’re surrendering to the disease.
• You’re no longer a contributing member of society.
• You’re taking a giant step closer to “The End.”
• You’re going to “milk the system.”
• You’re weak, needy, plus many other not-so-nice adjectives.

Of course, none of these are true or even rational, but our emotions aren’t based on reason.

Those messages even may get communicated from friends and family. People who haven’t been disabled do not understand the price you must pay for stopping work. I have heard some refer to their disabled friend as “retired” or “taking it easy.” There may even be “jokes” about “envy you.”

Also, do not forget that disability benefits are not always easy to obtain, whether from a private insurance company or Social Security. A denial, which should always be appealed, can cause those messages to replay even louder.

Family dynamics as well as your social relationships will be changing. Your family and friends have known you as one person. Now, even though it is not true, they may perceive you as someone different. This can cause a strain in these relationships that you need to be ready to recognize and work through.

What can I do about it?
Fortunately, there’s a lot you can do about it, and all of the suggestions below would come under the overall title of “Take back control of your life.”

• Control how and when you leave work – Know what you are doing. Make your plans; do your research; create your own timetable for stopping work.
• Take one step at a time to avoid being overwhelmed – You can do this by breaking down your tasks into smaller steps. First, work with your doctor on the process of leaving work, and then apply for the employer’s sick leave and short-term disability. Then decide whether to continue the employer’s health insurance to COBRA or switch to a health plan under the Affordable Care Act (Obamacare). Next you should apply for your employer’s Long Term Disability coverage, if available, then for Social Security Disability (SSD). A list or timeline will help you focus your attention on the next small step without being overwhelmed by the entire process.
• Build, activate and use your support network – Your family, friends, and caregivers can give you emotional support as well as practical assistance, but you may need to ask for it.
• Consider short-term therapy – Perhaps your support network is strong enough that they will give you all the help you need to get through this time. Many clients have also found that a few months with a therapist trained in the emotional issues of the disabled can be of great help as well.
• Speak up, politely but firmly – Do not hesitate to tell those who don’t understand what you are going through that this is not a vacation and you wish you could return to work and understand any snide or “comic” remarks are coming from ignorance.
• Be a little selfish – Finally, it is time, for at least a while, to take care of yourself first. You have been accommodating to others and have been putting their needs and wants ahead of yours. It is time to take a break from that. Let them know as much as you love them that you need to focus on yourself right now, and deeply appreciate their support through this period.

But what will I do once I go on disability?
Many people worry that after they leave work, they will have nothing to do. Some people have an image of themselves lying in bed, face to the wall, doing nothing but waiting. That’s not the way it is. More than one of my clients has worried that they will have too much time on their hands only to return after leaving work to tell me they are so busy, they have no idea how they were able to work full-time.
Initially at least, there’s a lot to do, applications and claims to file, health insurance to adjust, government benefits to apply for. I have heard complaints that, initially, they are busier with those than when they were working; an exaggeration perhaps, but it may seem so.
If you are the type of personality that was always busy before, trust me, you will be as busy as you want and are able to be once you leave work on disability. Depending on how you feel and your interests, there are classes to be taken, family to be enjoyed, other people or agencies that you could volunteer to assist.
Be aware that you can expect some emotional upheaval when leaving work. Recognize it as a natural part of the process and don’t let it scare you into believing that it is more than just a passing reaction to what’s going on with your life at the moment. It will pass; you will move on. Life will continue; you will be healthier and happier for it.

QUOTE: It can also have a dramatic effect on your ability to make decisions objectively and rationally. Clients who recognize this impact and know to expect such feelings are better prepared to deal with them and minimize them when they occur.

The True Cost of an Expensive Medication

It was supposed to be a miracle, but now it’s what keeps Laura Bush, a nurse-practitioner near Albuquerque, awake at night.

There’s a drug called Sovaldi that works astonishingly well to cure people with the liver disease Hepatitis C. The rub? It costs $1,000 per day for all 12 weeks of treatment.

Bush’s clinic, First Choice Community Healthcare, is a federally qualified health center in the rural town of Los Lunas, New Mexico, which means she sees a disproportionate number of patients who are uninsured, underinsured, and on Medicaid, the government insurance program for the poor. In other words, they can’t afford Sovaldi.

Read more....

What We Talk About When We Talk About Hepatitis C

Since 2007, more people have died every year from hepatitis C than from HIV. Fortunately, the latest hepatitis C medications can cure nearly everyone in a relatively quick, easy fashion. So, if it is so easy to cure hepatitis C, why haven't we?

Ostensibly, it is because of the cost. At $1125 a pill for Gilead Sciences' drug Harvoni, a 12-week course of hepatitis C treatment would amount to $94,500. Trying to manage these costs, many state Medicaid programs and insurance companies have severely restricted access to treatment. You save money if you deny treatment to people, and dead people cost nothing.

This means that although we can cure hepatitis C, we aren't. Under many insurance plans, patients have to prove that they have cirrhosis. In short, treatment is approved when liver damage has progressed to its worst stage. It is like refusing to pay for diabetes drugs until the patient is blind or minus a few toes.

Read more....

State Moves To Make Costly Hepatitis C Drugs More Accessible To Medicaid Patients

HARTFORD — Connecticut is poised to make a new class of costly hepatitis C drugs more accessible to the state's poorest patients.

The state Department of Social Services will classify Sovaldi, Harvoni and Viekira Pak as preferred drugs in its Medicaid program, which means they will be "readily available to our clients,'' said department spokesman David Dearborn.

The department is also simplifying its prior authorization process, which had been criticized by advocates for hepatitis C patients as a tactic designed to limit access to the expensive but highly effective treatments.

Read more...

Advocates Urge Easier Access To Expensive Drug For Medicaid Patients

Advocates for those living with Hepatitis C are urging the state Department of Social Services to ease new criteria patients must meet in order to have an expensive medication covered by Medicaid.

DSS has issued a bulletin to medical care providers, notifying them that patients with Hepatitis C who are enrolled in HUSKY A, HUSKY C or HUSKY D — parts of the state’s Medicaid program — must have “prior authorization” in order for prescriptions for the medication Sovaldi to be covered.

Prior authorization typically is required by insurers when they want to make sure certain prescription drugs are appropriately used. In essence, it requires enrollees to meet a higher threshold of criteria before insurers will agree to cover the medication’s expense.

Read more....

David E. Miller: New hepatitis C treatments save lives, reduce expensive complications

"If Illinois expands access to new hepatitis C medicines, it not only will save lives and relieve untold patient suffering, it dramatically will reduce long-term health care costs resulting from this awful disease."

After decades of research and clinical trials, we have new cures for hepatitis C, the most prevalent and deadliest blood-borne viral disease in the United States.

Until now, hepatitis C treatments have been long, painful and even life-threatening, with low cure rates of 40 to 65 percent. Consequently, up to 85 percent of patients discontinue treatment before they finish.

Still, the Illinois Department of Healthcare and Family Services set tight restrictions on innovative hepatitis C treatments. Only patients with the highest degree of liver damage who meet a set of 25 criteria can have access.

- See more at: http://www.sj-r.com/article/20150305/OPINION/150309693/2011/OPINION#sthash.e3ELmAZa.dpuf

State OKs new Hep C drug for Medicaid patients

Two drugs now available, but cost difference unclear

During the latter portion of 2014, Oregon officials and Hepatitis C patient advocates debated who would be able to receive a new, highly effective yet prohibitively expensive drug under the state’s Medicaid program.

Officials approved criteria that restricted the drug, Sovaldi, to very sick patients, with the caveat that they’d take up the issue again once new, perhaps more affordable drugs hit the market.

That appears to have happened sooner than expected. The director of the Oregon Health Authority, which oversees the state’s Medicaid program, the Oregon Health Plan, approved new criteria this month that permits some OHP beneficiaries with Hepatitis C to access a new drug: Harvoni. Hepatitis C is a disease that causes inflammation of the liver and can lead to liver failure or liver cancer.  

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Pa. considering moving away from costly Hepatitis C treatment

(Harrisburg) -- Pennsylvania might move away from a stunningly expensive prescription drug treatment for Medicaid patients with Hepatitis C, but the Commonwealth won't save as much as other states.

Missouri is one of the first states to move away from Sovaldi, which costs $1,000 a pill.

Pennsylvania might do the same, but the state's Medicaid program is waiting on final offers from two competitors that provide other drugs recently approved by the FDA for Hepatitis C treatment.

Read more...

NAMD Statement on Supplemental Rebates for Hepatitis C Therapies

FOR IMMEDIATE RELEASE
February 2, 2015

Statement of the National Association of Medicaid Directors

Washington, DC - NAMD is pleased to learn that manufacturers of Hepatitis C therapies have finally come to the table to acknowledge and discuss the unsustainable pricing of their products. We believe this is an important first step in achieving the goal of making their products more affordable and accessible for Medicaid consumers and should produce significant savings for federal and state taxpayers.

However, we believe it is important to clarify several aspects of the current status of these discussions. While in some states the price negotiations have been completed, the process is at different stages in most other states. By their nature these agreements often take significant time to finalize. This is due to a variety of factors, including the time that it will take states and their contractors to fully analyze these proposals and then ultimately finalize agreements according to their respective state policies and procedures.

Irrespective of these early rebate agreements emerging for some states, Medicaid Directors remain concerned with regards to the overall sustainability and pricing levels. Directors take very seriously their role as stewards of the both the taxpayer dollar and the public trust. It is therefore important to ensure that these conversations continue in the evolving field of Hepatitis C treatments, as well as when new specialty pharmacy products become publicly available.

Source: http://www.medicaiddirectors.org/node/1136

The White House signals a fight on high drug prices

On Monday, the Obama administration proposed taking a major step towards bringing prices down for expensive specialty medications.

In its budget, the White House calls for Medicare's prescription drug program to negotiate on prices for "high-cost drugs" and biologics, a complex and expensive class of drugs that is just starting to get competition from generics in the United States. "The administration is is deeply concerned with the rapidly growing prices of specialty and brand name drugs," the budget reads.

The Department of Veterans Affairs and state Medicaid programs get mandated discounts on these drugs, but Medicare was forbidden by the 2003 law creating its prescription drug program to negotiate on price. For years, liberals have been pushing to give Medicare that authority, which would make the United States more like the rest of the world.

It's not clear how hard the administration will fight for this idea, but you can add this to the list of budget requests that probably aren't going anywhere. Drug companies and Republican lawmakers have regularly pushed back against the idea of price controls in Medicare Part D.

Read more....

Expensive Hepatitis C Cure ─ Georgia Decides Who Gets It, Who Doesn't

There’s a new drug on the market that’s up to 99 percent effective at curing hepatitis C, an often deadly liver virus. The drug is known as “V-pak.”

Some Georgians will get it.

But thousands of HIV-positive Georgians, who also have hepatitis C, won't.

The reason? Cost.


Read more and listen to the podcast here....

Hepatitis C Drug Discount Deals Still Miss Many Patients

Of the estimated three million Americans estimated to have Hepatitis C, about one-third are covered by Medicaid, according to industry reports. About 70 percent of Medicaid recipients are covered by managed care plans, according to Medicaid Health Plans of America, a trade group representing private health plans that contract with health insurance programs for the poor to administer their medical benefits.

Jeff Myers, chief executive officer for Medicaid Health Plans of America called the CVS Health and Express Scripts deals a “fantastic first step in bringing pricing rationality for this population.”

“But unfortunately the prices we’re starting from are at such a ridiculously high level because of the pharmaceutical companies’ pricing model that states still will find it difficult to manage these treatment costs,” Myers said in a statement to Forbes.

Read more...