March-April 2011 PAN

PATIENT ADVOCATE NEWS Dear Patient Advocates,

EDITOR’S NOTE

MAR APR 2011

News and information about patient assistance programs and other health care

I consider myself youthful, but even I am astounded by the speed at which social media and mobile communication technologies have permeated and reconfigured our social fabric. According to some polls, more than 95% of the American population owns a cell phone. What this figure means for the potential to communicate and conduct health care in this country should be considered. A recent Kaiser Family Foundation issue brief examined the use of mobile technology to increase health coverage participation among the underserved; with increased and improved access to the Internet through apps, text messaging and social networking sites, can we reach and expand health care coverage to all? If there is a means, then there should be a way.

Vikki Sloviter Editor

Wendy Owens, advocacy coordinator for the New England Hemophilia Association (NEHA), contacted us recently because she wanted our readers to learn more about a new organization, the New England Coalition for Affordable Prescription Drugs (NECAPD). Since its focus is similar to ours, how could we not oblige?

Vikki: Thanks so much for contacting us.

You are the advocacy coordinator for the NEHA, but you’d like to talk about a new initiative, the NECAPD. What was the impetus for starting this new project, and what is its mission?

Wendy: NEHA is a small non-profit organization serving a relatively small population of people in New England with bleeding disorders. Though NEHA serves its members well and with the commitment to doing all that we can to meet their needs, we do not have the resources that larger nonprofits have. The cost of medication is one of a leading concern for people with bleeding disorders. The annual cost of their medication can run from $250,000 to over $1 million annually.

Since starting at NEHA in February 2010, I have become increasingly frustrated by learning at the last minute about a bill, or public hearing on a bill, that had been introduced in a New England state that could have tremendous impact on our members.

As I made increasingly more contact with others at other New England non-profits in similar positions as mine, I was able to share with them and they shared with me information they had on legislation. Even contacts from large organizations and industry lacked all the information they needed about legislation to perform optimally. I saw the need for communication among groups for whom the cost of prescription drugs is an issue, the need for information sharing among these groups, and the vital need for transparency as to (Continued on next page)

PATIENT ADVOCATE NEWS|MAR APR 2011

(NECAPD continued from page one) what bills were going to be introduced and by whom. It seemed that forming a coalition might be the best solution to the problem of knowing about legislation and having the right information to act in the best interest of consumers to support or oppose this legislation.

NECAPD is about information sharing and collaboration among NECAPD members, elected officials, government agencies, the insurance industry and other major stakeholders to solve problems related to the high and rising cost of medication with workable solutions.

Vikki: At the risk of sounding naïve, I’m surprised there already isn’t a coalition, or consortium, whose mission is to try to curb rising prescription medicine costs.

How does the NECAPD differ from other similar organizations?

Wendy: NECAPD is focused strictly on raising awareness of the rising cost of prescription drugs and promoting workable solutions for how to keep prescription drug costs down and assure access to affordable prescription drugs by New England residents. NECAPD’s members are critical to it achieving its mission. Through communication and information sharing among members, NECAPD as a coalition can become the go-to resource for issues related to the rising cost of prescription drugs. Where one chronic disease community may endure rising costs when banded together there is power in numbers. For NECAPD as a coalition it can be one voice for many more than just a nonprofit focused on a single disease/condition.

The pooling of resources raises all ships with the large members of NECAPD supporting and being supported by its smaller members.

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Vikki: The coalition is essentially a consortium of member organizations committed to affordable medicine for all.

NeedyMeds recently joined. As a member organization, what do we do now?

Wendy: NECAPD members:

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Share information and knowledge about issues related to prescription drug costs and pricing Participate in educational webinars about NECAPD’s goals and activities Contribute examples of how specific bills in the various New England states impact your members

There is no obligation by any member to support NECAPD’s position on each bill on which the Coalition produces a position statement.

Vikki: The NECAPD’s primary initiative is to prevent the establishment of specialty drug tiers among NE health insurers.

Currently, New England health insurers do not have specialty tiers, so why is there a concern now?

Wendy: Actually, Vermont does have specialty tiers though the out-of-pocket costs are not yet onerous. Eliminating specialty tiers in Vermont and precluding the creation of specialty tiers in the remaining New England states is our initial priority. By precluding the creation of specialty tiers we can prevent people from ever having to face extreme out-of-pocket costs for medication.

Legislation to preclude specialty tiers is currently before the Connecticut, Massachusetts, Rhode Island and Vermont legislatures, respectively. The legislation was introduced as preemptive strikes against the implementation of specialty tiers. Should we (Continued on next page)

PATIENT ADVOCATE NEWS|MAR APR 2011

(NECAPD continued from page two) allow specialty tiers to be enacted in New England there is the possibility for a long fight to pass legislation to halt the use of specialty tiers. During this fight, people’s lives could change dramatically due to having to make decisions regarding compliance with their prescription drug regime, paying for medication versus paying for essentials, and making substantial changes to their employment status in order to afford their medication.

included some of the following major findings:

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Vikki: Tell us how a drug’s specialty tier status affects a beneficiary’s reaching the donut hole, and then catastrophic coverage level.

Wendy: The impact on Medicare beneficiaries is constrained because many long-term users of specialty tier drugs reach the out-of-pocket limit and qualify for catastrophic coverage. At this point, federal reinsurance limits the impact on plan costs by paying 80% of costs once plan enrollees qualify for catastrophic coverage.

Nonetheless, having to pay specialty tier rates until you reach the catastrophic coverage threshold can still have a severe impact on the lives of those reaching the donut hole.

There is hope for people on Medicare Part D who take specialty drugs. Medicare Part D allows a beneficiary to establish that the non-preferred drug is medically necessary and no preferred drug would be as effective, thus they pay the lower cost that applies to the preferred drug.

Vikki: You’ve probably read the GAO’s 2010 report that evaluated Medicare Part D spending, beneficiary cost sharing, and cost containment for specialty-tiereligible drugs. What were some of their major findings?

Wendy: The GAO January 2010 report entitled “Medicare Part D: Spending, Beneficiary Cost Sharing, and CostContainment Efforts for High-Cost Drugs Eligible for a Specialty Tier (GAO-10-242)”

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Specialty-tier drugs accounted for 10%, or $5.6 billion, of the $54.4 billion spending in total prescription drug spending under Medicare Part D plans in 2007.

Medicare beneficiaries who received a low-income subsidy (LIS) accounted for most of the spending on specialty tier-eligible drugs—$4.0 billion, or 70%, of the total.

Among all beneficiaries who used at least one specialty tier-eligible drug in 2007, 55% reached the catastrophic coverage threshold, after which Medicare pays at least 80% of all drug costs.

In contrast, only 8% of all Part D beneficiaries who filed claims but did not use any specialty-tier-eligible drugs reached this threshold in 2007.

Vikki: According to a September 2010 Kaiser Family Foundation report on Medicare Part D, the CMS allows insurance plans to put a drug on a specialty tier if it costs more than $600 per month. One example is Tracleer, used to treat pulmonary arterial hypertension.

According to the report, because Tracleer is usually a specialty drug, and not a preferred drug, an enrollee’s average monthly cost for Tracleer is $1,566, with some enrollees paying an astronomical $3,477 per month. How can anyone afford that?

Wendy: It is unlikely that most people could afford this out-of-pocket expense and be able to meet their other fundamental needs.

Specialty tiers violate the basic principal of insurance whereby individuals and employers purchase health insurance plans to preclude the risk of needing to pay for highly expensive medical treatments.

In locations where the practice of specialty tiering is allowed, researchers find that the out-of-pocket costs for medications are high enough to prohibit people from (Continued on next page)

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PATIENT ADVOCATE NEWS|MAR APR 2011

(NECAPD continued from page three) complying with the treatment prescribed by their doctors. Severely ill people are four to five times as likely to delay or avoid medical care when faced with financial problems because of their medical bills. Numerous studies demonstrate that high out-of-pocket costs lead to decreases in compliance to medical treatment, especially for lowerincome groups who are more likely to experience chronic illness. Decreased compliance with medical treatments leads to increased medical costs for employers and insurers as patients need emergency care and other high-cost treatments due to noncompliance.

For a patient with the bleeding disorder hemophilia, annual cost for medication alone can range anywhere from $250,000 to over $1 million annually. Should a person with hemophilia (without inhibitors) have to pay specialty-tier co-insurance rates of 20%-33%, their out-of-pocket cost of medication would range from $80,000 to $120,000 per year. Such a scenario is well beyond the means of most people with hemophilia.

Having to face such expenses would be devastating for any individual or family. For people and families with children who have bleeding disorders, for example, the economic, physical, and emotional tolls would be nearly incomprehensible. Imagine parents of children with chronic diseases having to say to their children, “We are sorry we cannot afford your medication so you are going to be physically disabled and live with chronic pain for the remainder of your life.”

Unfortunately this is not an exaggeration but potential reality should insurers in New England states adopt specialty tiers and the associated high coinsurance rates.

Vikki: Another GAO finding was that many insurers claimed they had difficulty negotiating prices for specialty-tier drugs from the manufacturers. Why and how do you think that is?

Wendy: According to the GAO report cited earlier, supply and demand had the most to

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do with the negotiation of prices for specialty-tier drugs. Essentially, most specialty drugs have few other competitors in the marketplace. According to the GAO, Medicare “plan sponsors were more often able to negotiate price concessions for drugs with more competitors on the market.”

The GAO cited two additional reasons for limited leverage in negotiating pricing for specialty drugs. Specifically, (1) “CMS requirements that plans include all or most drugs from certain therapeutic classes on their formularies, limiting sponsors' ability to exclude drugs from their formularies in favor of competing drugs;” and (2) “that the relatively limited share of total prescription drug utilization among Part D beneficiaries for some specialty-tier-eligible drugs was insufficient to entice manufacturers to offer price concessions.”

Vikki: What role do doctors have directly in prescribing drugs—especially specialty-tier drugs—and indirectly in lowering overall drug costs?

Wendy: The challenges doctors and patients with chronic diseases face is that certain drugs, in particular specialty drugs (e.g., biologics), have no generic equivalent.

Consequently, doctors are limited to what they can prescribe, and patients what they can take, to have the necessary impact for a patient to live a “normal” life.

Doctors and patients will struggle with specialty tiers since insurers can change specialty-tier coinsurance rates unpredictably. This makes it impossible for patients to anticipate and budget for health care costs. It also impedes them from having informed discussions with their doctors about containing the cost of their treatment.

More factors than doctors alone can affect the price of overall drug costs, so though they have a role to play, the responsibility and burden of indirectly lowering overall drug costs is not doctors’ to bear alone.

Vikki: Specialty-tier drugs are so expensive because they treat less (Continued on next page)

PATIENT ADVOCATE NEWS|MAR APR 2011

(NECAPD continued from page four) common, often chronic, illnesses and there is less supply and demand for them.

What research and development is going on to help make more equivalents for these types of drugs, or to create drugs that aren’t so expensive to make and administer?

Wendy: Drug companies are developing drugs that are extremely similar, though not exact replica of, specialty drugs. These similar drugs are known as biosimilars or follow-on biologics. Biosimilars are medicines that are similar to, but not the same as, innovator biologics because they do not have the same molecular make-up as the specialty drug often brand name drug.

Unlike generic drugs, which are exact copies of prescription drugs often marketed under specific brand names, biosimilars are not exact copies of chemical drugs; they are vastly more complex. Due to the fact that many specialty drugs are biologically derived and have a unique molecular composition, to produce an exact duplicate of an existing specialty drug is not possible with today’s science. Instead a biosimilar can be developed once the patent for the brand name specialty drug has expired. However, companies that produce biosimilars will not have access to the exact molecular composition of the original brand name drug.

As part of the Patient Protection and Affordable Care Act signed by President Obama March 23, 2010, the FDA has the authority to approve biosimilars. Though many biosimilars are in the drug pipeline, none have yet been approved. Biosimilars face fewer regulatory hurdles, including less rigorous testing, to get to market than new specialty drugs. For this reason, some watchdog groups are concerned that patients could suffer unintended harm or side effects from biosimilars that lack the exact same molecular structure of the original specialty drug.

The hope is that once biosimilars are approved by the FDA and available to

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patients through prescriptions this will drive the overall costs of specialty drugs down dramatically. Again, this is a supply and demand issue.

Vikki: Finally, what advice do you have for folks who are insured and need a specialty-tier drug but can’t afford their plan’s typical 25-33% coinsurance? And how can our readers learn more about NECAPD? Wendy: There are a number of options for patients with chronic diseases whose prescription drugs are on a specialty tier.

Patients should investigate if they can demonstrate that there is no lower-cost and/or generic alternative to their medication available that can properly treat their disease so they can pay the nonspecialty drug price for their medication instead of the specialty-tier prices. Medicare Part D allows for a beneficiary to establish that the non-preferred drug is medically necessary and no preferred drug would be as effective, thus they pay the lower cost that applies to the preferred drug.

Further, patients should contact the specialty-drug manufacturer to see if it offers a coupon or voucher program that they can use to pay for their medication.

Manufacturers of specialty drugs do not like the idea of specialty tier. They recognize that cost prohibitions associated with higherthan-normal out-of-pocket costs lead to failure to comply with a prescribed medication regime (e.g., people stop taking their medication because it is too expensive), which leads to less of the manufacturer’s specialty drug being sold.

Patients should look to NeedyMeds as a resource for finding assistance with the cost of their medication. In addition, patients should also contact the local chapter of the national organizations for their specific disease for guidance on what additional options exist specific to their disease group.

Your readers can learn more about NECAPD from the NECAPD web site, www.necapd.org or by contacting me directly at wowens@necapd.org or 781-326-7645.

PATIENT ADVOCATE NEWS|MAR APR 2011

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Camp s Upda & Scholar te ships • We n ow ha ve 1,1 camp 41 s childr listed for en a n d with s pecifi adults c dise • We h av ases. schol e 186 arshi p pro gram s

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Check the m out!

PATIENT ADVOCATE NEWS|MAR APR 2011

Vikki: Hi Elizabeth. Thanks for letting our readers learn more about you.

Tell us who you are and what you do at NeedyMeds.

Elizabeth: Hi Vikki. I’ve been working here at NeedyMeds since December 2010, and recently began my new position as Research and Outreach Coordinator. This means that on a daily basis, I keep all the information about the Patient Assistance Programs listed on our website up to date. We like to update these programs every few months, so I contact the pharmaceutical companies and foundations that run the programs to make sure the information we have is accurate. In addition to that part of the website, I also work on our Disease Resource Page section. I’ve been adding more diseases in the past few months to make sure that we are covering most of the major conditions that people may have.

Separately from the work on the website, I’ve also started to focus on expanding our outreach efforts. We’re really trying to get the word out there about NeedyMeds and in my new position, I’m going to start reaching out to different advocacy groups, non-profit organizations and clinics. We want our website to reach anyone who needs it and for more people to be aware of the resources we offer. We are also focusing our efforts on getting the drug discount card out to as many people as we can. The more people who know about NeedyMeds, the more people will get the help they need.

Vikki: Your professional background has been working for nonprofit organizations, including Make-A-Wish Foundation and Doctors Without Borders. What is it about nonprofits that appeals to you?

Elizabeth: When I started college, I really had no idea what I wanted to do.

However, I always knew that I wanted to help people in some way. After completing my first internship at Make-A-Wish my sophomore year of college, I decided that this was the type of work I wanted to do after I graduated. I think that non-profit work is both interesting and challenging, and is also a way I can effect positive change.

Elizabeth Messenger

Get to Know

Vikki: How did you learn about NeedyMeds, and what do you enjoy most about working here?

Elizabeth: I only first learned about it when I saw the job posting and applied.

As my first job out of college, I’m really thrilled to be working at an organization like NeedyMeds! It is a very comfortable and welcoming work environment. Everyone is extremely supportive and helpful. I also am glad that I get to have a hand in a lot of different projects.

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PATIENT ADVOCATE NEWS|MAR APR 2011

(Elizabeth continued from page seven) Vikki: Is there anything that has surprised you about the world of the under- and uninsured since working at NeedyMeds?

Elizabeth: I think what actually most surprised me was the depth of assistance programs there are out there to help people. I’ve always been aware of the many people in need, but I had no idea how many programs there were out there. That’s something that we are trying to work on here at NeedyMeds with the increase in outreach work. It is important to get the word out there about not just our organization, but all of the different ways people can access assistance in paying for their healthcare costs.

Vikki: How important do you think Internet technology is in helping people gain access to health care? Do you think social networking sites like Twitter and Facebook make a difference?

Elizabeth: I think that these sites certainly do make a difference to an extent.

Especially, for the younger population of uninsured and underinsured people, this is a good way to get information out there. However, I’ve certainly learned from working on our helpline, that many people do not have access to the Internet, especially the low-income, uninsured population. This is why it’s also important to reach out to advocates and other organizations that help these populations and let them know about NeedyMeds.

One way we are making use of Internet technology is our new Webinar Initiative. We have always done webinars upon request, but we thought it might be helpful to advocates to have a more fixed schedule. As we increase our outreach efforts, we now offer several webinars a month, and may increase the number if there is demand. During these sessions, I will explain the different components of our website and how to use the website most efficiently. Make sure to check our website to view the most updated schedule.

Vikki: If NeedyMeds were to get a $10 million grant to use however it saw fit, in what ways do you think we could have the most direct impact? (Do you know anyone who wants to give us $10 million?)

Elizabeth: I wish I did know someone! It’s hard to imagine what we could do with that kind of money. I’d love to say we could use that money to pay for all those people’s medications that cannot afford it, but $10 million probably still wouldn’t be enough. So more practically, I’d say we could use that kind of money to make every single person in the country aware of our website and all the assistance that is out there. I’d also love to get our drug discount card in the hands of everyone who has prescriptions they cannot afford.

(Continued on next page)

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PATIENT ADVOCATE NEWS|MAR APR 2011

(Elizabeth continued from page eight) Vikki: Finally, in your free time you like to cook and try new restaurants.

What’s one of your favorite restaurants (anywhere), and what one kitchen gadget should every home cook have?

Elizabeth: Wow, picking one restaurant is pretty tough. In college, I spent a semester abroad in Florence, so honestly I left my favorite restaurants back in Italy. Here in the North Shore of Boston, the Blue Ox in Lynn, MA is very good.

They try to use local ingredients whenever possible, so the food is always fresh and also unique at the same time.

For me, my go-to gadget is a food processor. I know that true chefs are expert choppers, but I certainly can’t recreate the knife skills I see on food shows. So I’m often using my food processor. It’s especially great for chopping onions.

That can really hurt!

NeedyMeds and Merck Pharmaceuticals are pleased to announce funding to underwrite up to 100% of the cost of PAPTracker software for 12 months.

PAPTracker software automates the PAP application process and automatically creates refill reminders.

If you are a nonprofit organization and currently complete PAP applications by hand, then you may qualify.

The grant application is simple and straight forward and you'll be notified about eligibility within 10 days after submission.

For more information about this terrific opportunity please contact Roberta at paptracker@neeymeds.org.

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PATIENT ADVOCATE NEWS|MAR APR 2011

Feel free to make copies and distribute our card to your patients.

Card Front

Card Back

THERE’S AN IPHONE APP FOR THE DISCOUNT DRUG CARD! Not all needy patients are the same. While many of those that we assist may barely meet the federal poverty level and don’t know how they’re going to feed their families, others may be more comfortable but have recently lost their jobs and can’t pay for their costly prescriptions out of pocket. For the gadget-loving patients who, though they may have lost their employer-sponsored health insurance still have their iPhones, we have an app for them. NeedyMeds’ drug discount card is available as a free iTunes application. With the iTunes app, patients can show the pharmacist the app on their iPhone or iTouch (just like showing them the actual card) and receive discounts on their prescription medications. Click here to download the free NeedyMeds drug discount card app. (For a printable paper copy of our card, see the top of this page or visit our website, www.needymeds.org.) As always, the card and app are free to download and use.

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PATIENT ADVOCATE NEWS|MAR APR 2011

PAP UPDATES Here are a few programs for which there are recently updated applications: Actavis Eurand Pharmaceuticals Qualaquin CephalonCares Foundation PAP for Treanda and Trisenox Repaflo Abbott PAP for Zemplar J&J Hospital Access J&J PAF, Inc. PAP Ampyra Patient and Co-Pay Assistance Programs Graceway Pharmaceuticals Pfizer Maintain Express Pain for Info Center (EPIC) for Prialt Validus Pharmaceuticals has a new PAP for Marplan. Application is on our website.

As of June 1, 2011, the following medications will be removed from the Bridges to Access and GSK Access PAPs: Amerge®

NM STAFF RICHARD SAGALL, MD President richsagall@needymeds.org

JAYE VANDUSSEN Vice President jaye@needymeds.org

BILL KYROUZ Research Associate bkyrouz@needymeds.org

ROBERTA DOWNEY Software Sales Manager roberta@needymeds.org

ABBY MARSH Call Center Representative abby@needymeds.org

VIKKI SLOVITER PAN Editor vikki@needymeds.org

DAMARIS MERCEDES Call Center Representative damaris@needymeds.org

CYNTHIA FOOTE Call Center Supervisor cynthia@needymeds.org

ELIZABETH MESSENGER

KAREN GRENHAM Call Center Assistant karen@needymeds.org

SAMUEL RULON-MILLER Research Associate samuel@needymeds.org

ROBIN HOFFMAN Database Manager robin@needymeds.org

TONYA WHITE Research Associate tonya@needymeds.org

Research & Outreach Coordinator

elizabeth@needymeds.org

Coreg® (IR) Flonase® Imitrex® (all formulations except Nasal Spray) Requip® Rythmol® Valtrex® Wellbutrin® (IR and SR) Zovirax® (all formulations) Zofran has also been removed from the Commitment to Access and GSK Access programs.

Bristol-Myers Squibb Destination Access Oncology is a new program that combines three previous BMS Destination Access programs for Erbitux, Ixempra and Sprycel.

YERVOY was also added to this new program.

A new application is used for Erbitux, Ixempra and YERVOY. The application for Sprycel has not been changed.

We have many more PAP application and program updates on our website. Keep checking!

For a one-stop place to see PAP updates, join NeedyMeds Forums for free at forums.needymeds.com.

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Needy INFO@NEEDYMEDS.ORG CALL US 978-281-6666 FAX US 419-858-7221 WRITE US PO Box 219 Gloucester, MA 01931

NeedyMeds, Inc. is a 501(c)(3) nonprofit with the mission of helping people who cannot afford medicine or health care costs. The information at NeedyMeds is available anonymously and free of charge. NeedyMeds does not discriminate on the basis of race, ethnicity, religious affiliation, gender or sexual orientation.