Healthcare is Hostage to Rx Pricing

By: Michael Weinstein, President, AIDS Healthcare Foundation

The impossible has happened. Harvoni, a pill that cures Hepatitis C made by Gilead, is selling for $1044 per pill. Decades ago we were outraged at the high price of AZT which was the first anti-retroviral HIV medication to come to market. Now the price of drugs threatens the long term viability of the entire U.S. healthcare system.

Gilead did not discover Harvoni. It bought the primary compound from a company named Pharmasset for $11 billion. That money came almost entirely from huge profits made by Gilead from the sale of grossly over-priced HIV medications. Pharmasset had planned to charge $36,000 for their drug. But, Gilead was not satisfied with that price and decided to push the envelope all the way up to $94,000 for a three month cure for Hepatitis C. During the same year, John Martin the CEO of Gilead, had total compensation of $206 million.

Michael Weinstein, AHF President, leading a protest.

Anger over drug prices has made this the number one healthcare issue by far among the American people. Presidential candidates Hillary Clinton, Bernie Sanders, and Marco Rubio are condemning Pharma on the campaign trail. Senators Charles Grassley and Ron Wyden are denouncing Gilead and other companies and conducting investigations. Yet, not a single piece of significant legislation is likely to be passed at the national or local level. A simple bill that would have required a little more transparency by drug companies was squashed twice in the last year in the dark blue state of California. Pharma's contributions to candidates on both sides of the aisle combined with vast lobbying budgets make passing legislation impossible.

Citizen ballot initiatives are one of the few avenues available to start to change the system. In fact, ballot initiatives were created to allow citizens to directly enact legislation when their elected officials refuse to act. Which brings us to the California and Ohio Drug Drug Relief Acts that will appear on their respective ballots in November. Pharma is so threatened by these initiatives that they have already contributed $40 million to defeat it in California and are trying every legal trick in the book to keep it off the Ohio ballot.

Pharma is working very hard to try to confuse the issue and pick apart the initiative because polling shows that 78% of California voters would support the initiative. First, to be clear this initiative is only a start to reining in drug prices. It is a very simple concept. The state will pay no more than the Veterans Administration for any drug. Critics, many of whom are directly funded by Pharma, say that the initiative can't be implemented and want us to address every hypothetical implementation issue. That is not our job. That will be the state's job after the initiative passes.

You don't have to believe us about how important these initiatives are in giving voice to the anger over drug prices. Here is what PharmExec.com had to say on December 8, 2015:

"If the voters of California approve this proposition it would establish an incredibly deep, mandatory discount - in essence a "price control" - for the public purchase of prescription drugs in American's largest state. Such an action would not doubt cause an immediate demand for the same VA discount rate to be made available to other states, the federal government, and likely private entities as well. In short, adoption of VA pricing by the State of California would be a pricing disaster for the entire U.S. drug industry."

The California and Ohio Drug Price Relief initiatives can be a catalyst for a movement to stop the rampant greed of drug companies with your support. Please don't be distracted by all the dust the industry will try to throw up to try to divert attention from the real issue - an out-of-control system that is victimizing our country.

Editor's Note: This blog was submitted in response to our previous blog, "Is Ohio the Frontline in the War on Rising Drug Prices?"

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Disclaimer: Guest blogs do not necessarily reflect the views of the ADAP Advocacy Association, but rather they provide a neutral platform whereby the author serves to promote open, honest discussion about public health-related issues and updates. 

Is Ohio the Frontline in the War on Rising Drug Prices?

By: Brandon M. Macsata, CEO, ADAP Advocacy Association

Ohio, which is the 7th most populous state in the United States, is quickly shaping up to be the battleground over the rising cost of prescription drugs. The Ohio Drug Price Relief Act is a voter initiated statute spearheaded by the Ohioans for Fair Drug Prices and the AIDS Healthcare Foundation (AHF). The ballot initiative attempts to bring state prescription drug costs -- such as medications covered under the AIDS Drug Assistance Program (ADAP) -- in the Buckeye State in line with the lowest price made available to the U.S. Department of Veterans Affairs.

If the Ohio Secretary of State's Office certifies the signatures -- in which 91,677 valid signatures of registered voters are needed -- then the next step in the process would be the Ohio General Assembly taking up the legislative measure. If state lawmakers failed to approve the legislation within four months, then the petitioners could attempt to place the initiative on a statewide ballot for referendum.

According to Ballotpedia:

“The Act would enact Section 194.01 of the Ohio Revised Code to require that notwithstanding any other provision of law and in so far as permissible under federal law, the State of Ohio shall not enter into any agreement for the purchase of prescription drugs or agree to pay, directly or indirectly, for prescription drugs, including where the state is the ultimate payer, unless the net cost is the same or less than the lowest price paid for the same drug by the U.S. Department of Veterans Affairs."[1]

Among other provisions, the Act also:

• Sets forth the title of the Act as "The Ohio Drug Price Relief Act."
• Sets forth Findings and Declarations and Purposes and Intent of the Act.
• Sets forth factors in determining "net cost."
• Authorizes state departments, agencies and other state entities to adopt administrative rules to implement the provisions of the Act.
• Provide that the Act shall liberally construed to effectuate its purpose.
• Provide that if any provision of the Act is held to be invalid, the remaining provisions shall remain in effect.
• Provide that if the Act is challenged in court, it shall be defended by the Attorney General.
• Declare that the committee of individuals responsible for circulation of the petition ("the proponents") have a direct and personal stake in defending the Act and any one or more of them may do so in court if challenged. Provide that the proponents shall be indemnified by the state for their reasonable attorney's fees and expenses in defending against a legal challenge to the Act. Provide that the proponents shall be jointly and severally liable to pay a civil fine of $10,000 to the state if the Act or any of its provisions are held by a court to be unenforceable, but shall have no other personal liability.
• Provide that in the event that the Act and another law are adopted by the voters at the same election and contain conflicting provisions and the Act received less votes, the non-conflicting provisions of the Act shall take effect.
• Require the General Assembly to enact any additional laws and the Governor to take any additional actions required to promptly implement the Act.[2]

The fight over the ballot initiative has pitted familiar foes against one another, with AHF leading the charge in favor of it, and the Pharmaceutical Research and Manufacturers of America (PhRMA) -- which is the pharmaceutical industry trade association -- trying to squash the measure. The main criticism of the measure is the lack of specifics, including over how it would be enforced.

Upon announcing that the signatures had been submitted to the Ohio Secretary of State, said AHF's president Michael Weinstein, “While we’ve seen ample evidence that there is seemingly no limit to the corporate greed of pharmaceutical companies, we also know that Americans are tired of feeling afraid every time they go to the doctor or it’s time to get a prescription filled. Astronomical prescription drug prices hurt everyone—except the drug makers’ bottom lines. This has got to stop.”[3]

There remains considerable uncertainty over the outcome of the petition effort, as well as what lies ahead with this ongoing debate in Ohio.

“As I had testified to the Ohio Ballot Board, this well-intentioned but sloppily written ballot measure will have no real effect on drug prices due to trade secrets and lack of a verifiable reference source," argued long-time Ohio resident Eddie Hamilton, Director of the ADAP Educational Initiative. "What it will guarantee is lawsuits whose legal fees will be borne by Ohio taxpayers."

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[1] Ohio Secretary of State,"2015-07-21 petition," July 21, 2015; Last viewed online at http://www.sos.state.oh.us/sos/upload/ballotboard/2015/2015-07-21-petition.pdf. 

[2] Ohio Secretary of State,"2015-07-21 petition," July 21, 2015; Last viewed online at http://www.sos.state.oh.us/sos/upload/ballotboard/2015/2015-07-21-petition.pdf. 

[3] BusinessWire, "AHF: Advocates Submit 171,205 Signatures for 2016 Drug Pricing Ballot Measure in Ohio," December 22, 2015. Last viewed online at http://www.businesswire.com/news/home/20151222006046/en.

Florida Solution: Prescription Freedom Act of 2016

By: David W. Poole, Director of Legislative Affairs, Southern Bureau, AIDS Healthcare Foundation

Mandate, Mitigate, and Manage, perhaps the 3 M’s are the most overused verbs tossed around regularly and often throughout our vast and complex healthcare systems, all in the spirit of optimal outcomes for the patient, right?  Perhaps some of the time. Hopefully patient outcomes are core to all parts of our healthcare universe – which includes hospitals, pharmacies/specialty pharmacies, outpatient surgery centers, home health care,  rehabilitation centers, manufacturers, insurers, wholesalers, and the list goes on and on. Patient outcome language was certainly integrated into the Patient Protection and Affordable Care Act, “PPACA” or the often shortened “ACA.” And the Ryan White legislation throughout its now 25 year history has long since included patient health outcomes as an expectation for grantees managing this very important safety net for person living with HIV disease.

Photo Source: optimistically pessimistic

But what about the “C” word, CHOICE or the “F” word, FREEDOM. Choice and the freedom to choose should be at the real heart of our continuum of care – choice or options that facilitate optimal health care outcomes. And if you have optimal health outcomes shouldn’t the economic benefits follow. Choice is the enemy of barriers to access (which can include the 3 M’s),  both purposeful and unintentional. Choice and freedom are the best friends to individualism – what works for one patient doesn’t work for the next patient, thus having choice and the freedom to choose what works - serves the patient and all health care stakeholders in the best possible way.

You may be surprised to learn that your health care systems deprive you of the freedom to choose the option that serves you best and none is more glaring than many insurer mandated mail order policies. These policies can take many different forms with nuances too numerous to cite; however, two lawmakers in Florida have filed legislation for 2016 that will hopefully reverse this trend with persons living with HIV, Epilepsy, Diabetes and Hypertension. Senator Rene Garcia (R-Hialeah) and Representative Debbie Mayfield (R-Vero Beach) have filed Senate Bill 780 and House Bill 583, "The Prescription Freedom Act." These bills simply provide for patient choice of receiving their medications through a brick and mortar pharmacy or a mail order program – the insurer must not mandate that a patient access their medications from only one or the other and there cannot be financial advantage or leverage assigned to one over the other for the patient or for the insurer. Let freedom ring in health care choices and may options be abundant!


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Disclaimer: Guest blogs do not necessarily reflect the views of the ADAP Advocacy Association, but rather they provide a neutral platform whereby the author serves to promote open, honest discussion about public health-related issues and updates. 

It's Time to End Bad HIV Laws!

By: Brandon M. Macsata, CEO, ADAP Advocacy Association

The ADAP Advocacy Association applauds the efforts of the Human Rights Campaign (HRC) to combat HIV-related criminalization laws with the launch of their new national public education campaign, "It's Time to End Bad HIV Laws!" A new microsite, http://www.endbadhivlaws.org, is headlined by an informative and passionate video showcasing Marvell Terry II. Terry makes the compelling case against these outdated and unfair laws targeting people simply for their HIV status.

The HRC national public education campaign was launched in partnership with the National Center for Lesbian Rights (NCLR) and the Center for HIV Law and Policy (CHLP). Whereas the video addresses the 30 states with outdated HIV-related criminalization laws, its messages applies to the stigma experienced by people living with HIV/AIDS nationwide.

It's Time to End Bad HIV Laws

On YouTube, there have been nearly 30,000 views in just a few short days. To watch the video on YouTube, go to https://www.youtube.com/watch?v=48Sf39k0_xo.

The Human Rights Campaign's Senior Specialist for HIV Prevention & Health Equity, Noël Gordon summarized: "We are closer than we've ever been to turning the page on the domestic HIV & AIDS epidemic. But HIV criminalization laws continue to undermine that progress, especially among LGBTQ communities of color. HRC launched this campaign - in collaboration with the Center for HIV Law & Policy and the National Center for Lesbian Rights - to shine a spotlight on these outdated laws and to build public support for addressing them once and for all."

HRC is encouraging people to raise awareness about these bad laws by Tweeting using hashtag #EndBadHIVLaws!

HIV-related criminalization laws indirectly impact the delivery of supports and services under the AIDS Drug Assistance Programs (ADAPs), as well as all other programs designed to help people living with HIV/AIDS. These bad laws undermine ADAPs and the successful treatment options afforded to patients, which have resulted in better health outcomes, fewer new infections, and lower community viral load rates across the country.

Together, let's help the HRC end bad HIV laws!

CLICK HERE to read "Personal Perspective: Impact of HIV Criminalization," a 2013 blog by Robert Suttle, Assistant Director at the SERO Project and ADAP Advocacy Association board member.

Attention Case Managers: A Conference with You in Mind

By: Vincent Lynch, MSW, Ph.D., Founder and Chair, The Annual National Conference on Social Work and HIV/AIDS

On World AIDS Day 2015, as we consider this year’s theme of “Getting to Zero,” please take the opportunity to read here about a four-day annual national conference on psychosocial issues which may very well interest you, your colleagues and possibly your clients. The Annual National Conference on Social Work and HIV/AIDS was founded by me at Boston College in 1988 in response to the growing need expressed by case managers, social workers, client advocates and mental health professionals to develop a major annual conference where these psychosocial AIDS care providers could network and learn from each other regarding new developments in the psychological and social aspects of HIV/AIDS care. Now in its 28th year, the conference moves around the country to a different city each year and consistently draws 400-500 attendees. We typically offer over 100 presentations each year. Here are examples of just a few of the topics we address: new approaches to case management service delivery, updates on ADAP policy/program issues, other HIV policy issues including the changes in the Ryan White Program, effective strategies for treatment adherence, advocacy skill building, self-care for providers, techniques for interdisciplinary collaboration, improving services to communities of color and current medical updates.

Panelists in Photo: (left to right): Russell Bennett, MSW, Ph.D.- conference co-chair; Vincent Lynch, MSW, Ph.D.- conference founder and present chair;  Gina Brown, MSW- Planning Council Coordinator, New Orleans Regional AIDS Planning Council; Randall Russell, MSW- Board Chair, Professional Association of Social Workers in HIV/AIDS.

A high proportion of attendees each year have the MSW degree, but by no means is that degree necessary to participate in the conference (either as a general attendee, presenter or exhibitor). Our next conference will be at the Hyatt Regency Minneapolis during May 26-29, 2016.  At present we are receiving abstracts of proposed conference presentation proposals from colleagues. I’d like to invite you to consider sending me a conference presentation abstract if you have a topic that you might wish to discuss. The official deadline for submission of presentation abstracts is December 4, 2015; however, we are willing to extend the deadline until December 21 for readers of this blogpost.

We have four presentation categories at the conference: a 90-minute poster session, 75-minute workshops; 50-minute “conversations on best practices” and 20-minute brief reports.  If you wish to submit an abstract please email it directly to me as a Word document at lynchv@bc.edu. Just send me your title, the name(s) of the presenter(s), a 250 word summary of your topic, email address(es) for presenter(s) and your preference for what presentation category you’d like it to be considered. We’ll get it in review right away and should have a decision for you in 10-14 days as to where it might fit in the conference schedule.

We also have a special “Early-Bird” discount conference registration fee available until January 25, 2016 whereby you can save $100 on the standard conference registration fee if you register by that date. Please note: we can also waive the conference registration fee in full for persons living with HIV/AIDS and also for a limited number of colleagues who wish to serve as conference volunteers. For more details please contact me directly as my email address (noted above).

To obtain a copy of our latest flier which will provide all the information you need about our conference please go to:

www.bc.edu/swhivconf

We have a loyal following… many of our attendees have attended our conference multiple times. Please consider participating with your brother and sister providers of HIV/AIDS psychosocial services. I can guarantee you will meet some fascinating colleagues from around the country (and around the world!). In addition to the valuable learning you’ll be exposed to at the conference sessions, you’ll also have the chance to participate in receptions and other informal “Meet-And-Greet” opportunities. The only way we can “Get to Zero” is for all of in HIV/AIDS to unite our efforts and work together more collaboratively. I do hope to see you in Minneapolis in May where you can meet and collaborate with many others doing the same important work as you. Thank you for all the important service you provide in our common goal of fighting the epidemic. All the best.  

Under the Gun: Mandated Mail-Order Pharmacies

By: Brandon M. Macsata, CEO, ADAP Advocacy Association

At the heart of any successful disease management is informed consumer choice; without it, access to timely and appropriate health care services, and adherence to treatment options will likely suffer. HIV/AIDS disease management is certainly no exception. People living with HIV/AIDS must play a central role in determining their care and treatment options, which may -- or may not -- include the use of mail order pharmacy programs.

Mail-order pharmacy programs can serve an important resource for some people living with HIV/AIDS, including prescriptions delivered under the AIDS Drug Assistance Programs (ADAPs). Mandating such programs, as often is the case with some ADAPs and insurance carriers, can present numerous obstacles. Many patients and their advocates view these services as counterproductive, too.

Photo Source: MichRx Pharmacist Consulting Services, Inc

It is an issue that has routinely raised cautionary flags. So was argued in an earlier blog by Michelle J. Sherman, RPh, FASCP, AAHIVP, MichRx Pharmacist Consulting Services, Inc., "Many of these mail order pharmacies are owned and operated by the insurance company themselves. There are so many conflicts of interest in this behavior you would think the FTC [Federal Trade Commission] would put a stop to it, but instead they seem to turn a blind eye and is encouraged. In recent weeks, we have seen major insurance company mergers. Aetna spent $37 billion to buy its rival Humana; Centene spent $6.3 billion to buy Health Net and Anthem is close to a $47 billion deal to buy Cigna."

Mandating the care and treatment of any chronic disease posses numerous challenges. Among some of the most common challenges faced by patients include the potential breach of privacy, lack of oversight on negative drug interactions, lost/late shipments, and loss of face-to-face consultations with pharmacists. These challenges, as well as others, have led to several states banning, or attempting to ban the use of mandated mail order pharmacies—including Maryland, New York and Pennsylvania.

Now, Florida can be added to the mix of states aggressively tackling mandated mail-order pharmacy programs. Last week, Senator Rene Garcia (R, 38th District - Miami) and Representative Debbie Mayfield (R, 80th District - Vero Beach) filed legislation in the Florida Senate (S.B. 780) and Florida House (H.B. 583), respectively. The news was welcomed by advocates in the community.

In a statement issued by the AIDS Healthcare Foundation (AHF), David Poole, AHF’s Director of Legislative Affairs, argued, "...[T]he problem is these arrangements are often more focused on minimizing financial risk for the insurers and not focused on providing the patient or beneficiary with options that work best for the individual patient’s situation."

Bill Arnold, President & CEO of the Community Access National Network (CANN), echoed those sentiments when he summarized mandated mail-order pharmacies violate the right of every patient to choose how they wish to receive medications. He said, "The process over rules free choice for the patient, potentially exposes private health information to other present at the mail deliver site, and subverts the relationship of a patient with their local pharmacist. This relationship is  virtually important to many seniors and to many patients with life threatening and chronic diseases. The requirement fails the basic test of treating patients as American consumers.”

Most organizations, including the ADAP Advocacy Association, are not necessary opposed to mail-order pharmacy programs, but mandating that patients use these programs can pose significant barriers to care and treatment. It is paramount that patients, advocates, social workers and other stakeholders continue to monitor damaging policies, such as mandated mail-order pharmacies.

To that end, there is a free webinar being held on Wednesday, November 18th. The webinar - hosted by the ADAP Advocacy Association, and held in partnership with the Great Lakes ADA Center and the Community Access National Network - will focus on the challenges associated with mandated mail-order pharmacies. It will review three case studies, each presenting different obstacles presented by mandated mail order pharmacy programs and how best to overcome them. To register, go to http://www.adapadvocacyassociation.org/events.html.

When Shit Hits the Fan...Daraprim Style!

By: Brandon M. Macsata, CEO, ADAP Advocacy Association

Earlier this month, relatively few people within the healthcare community, patient advocacy movement and frankly the general public probably knew much about the drug Daraprim (pyrimethamine). Not anymore! The drug, along with the pharmaceutical company that recently purchased the rights to sell it, Turing Pharmaceuticals, was transformed into a household name overnight. A 5000% price increase can have that sort of effect.

Turing Pharmaceutical's young CEO, Martin Shkreli, didn't help his new company's PR nightmare with some of his initial comments. But it is Mr. Shkreli who will most likely be responsible for the increased scrutiny over pharmaceutical drug pricing, and the process behind it. Stakeholders -- including physicians, pharmacists, healthcare professionals, pharmaceutical companies, patients -- can have honest disagreements over the issue of drug pricing, and each side has very valid merits behind their respective arguments. What happened with the Daraprim price hike is something entirely different, and even more troubling.

Source: Business Insider

The reaction to the 5000% price hike speaks volumes, too.

The National Alliance of State & Territorial AIDS Directors (NASTAD) immediately pounced on the decision, writing a letter to the Health Resources and Services Administration's Office of Pharmacy Affairs. The NASTAD letter sounded the alarm on behalf of patients living with HIV/AIDS across the country, since the drug is commonly prescribed under the AIDS Drug Assistance Programs (ADAPs). Several ADAPs have reportedly experienced difficulty in acquiring Daraprim at the discounted 340B price.

"It is apparent that Turing has violated HRSA’s non-discrimination requirements for the 340B program, and NASTAD believes that this discriminatory restriction on purchasing at the 340B price is ongoing. NASTAD requests that HRSA investigates Turing’s violations of the non-discrimination requirement and imposes appropriate penalties," argued NASTAD's Executive Director, Murray Penner. [1]

A full version of the letter can be read here.

The Human Rights Campaign's CEO,  condemned Mr. Shkreli and Turing Pharmaceuticals. The HRC statement read, "Your greed in raising the single-pill price from less than $15 to more than $750 is unconscionable. It immediately puts at risk scores of medically vulnerable people, including those living with HIV, and women who are pregnant. Medical organizations have estimated that this predatory move could increase the average cost per year for an adult patient reliant on the drug to more than $630,000." [2]

A full version of the letter can be read here.

The news media smelled blood, and they too focused their attention on the issue. "PRICE GOUGING CEO NOW TARGETING AIDS DRUG ASSISTANCE PROGRAMS," read the headline by the popular online news magazine, HIVEqual. Even business-oriented news outlets couldn't resist raising the red flag, evidenced by "Drug companies are reeling after the Martin Shkreli incident — and it could shake up the entire industry," published by Business Insider.

And of course, Twitter lit up like a Christmas tree. The following are just a few of the hundreds of thousands of the Tweets screaming about the 5000% price increase:

Ironically, there are only approximately 8,000 Daraprim prescriptions filled annually. [3] But that shouldn't matter, and it most certainly doesn't matter to the patients who rely on those prescriptions.

Turing Pharmaceuticals has already back-tracked from its absurd price hike, but the damage is done and lawmakers from both political parties will surely seek to tame the 800-pound gorilla in the room. The egregious example set by Mr. Shkreli must lead to an open, honest dialogue about the cost of health care in this country -- including drug pricing, insurance companies gouging patients, and even the shortcomings of the publicaly-financed health programs in this country. It should be a conversation that the advocacy community can come together with one, unified voice!

[1] National Alliance of State & Territorial AIDS Directors, "NASTAD ASKS FOR FEDERAL INVESTIGATION IN RESPONSE TO DARAPRIM PRICING AND ACCESS," September 22, 2015.
[2] Human Rights Campaign, "HRC President Chad Griffin Calls on Drug Manufacturer to Roll Back Unconscionable 5000 percent Price Hike On Life-Saving Treatment," September 22, 2015.
[3] The New York Times, "Drug Goes From $13.50 a Tablet to $750, Overnight," September 20, 2015.