Thursday, January 31, 2019

New Research Shows Changes to the Six Protected Classes Would Harm Most Vulnerable Patients and Are Unnecessary

By: Juliet Johnson, Deputy Vice President of Public Affairs, PhRMA

Reprinted with Permission from the Pharmaceutical Research and Manufacturers of America


In Medicare Part D, the six protected classes policy protects vulnerable seniors and low-income beneficiaries with serious and complex health conditions, while also allowing Part D insurance plans to use the tools they need to control costs. Medicines for some of the sickest patients in Part D are covered within the six protected classes, including those for cancer, epilepsy, HIV/AIDS and mental illness.  Many of these conditions require patients to attempt a variety of therapies before they and their doctor settle on the most appropriate treatment, so there is no one-size fits all medicine for these conditions.

Unfortunately, the Centers for Medicare & Medicaid Services (CMS) has issued a proposed rule that would weaken the six protected classes by allowing Part D plans to restrict access to medicines by: using prior authorization or step therapy for patients already stable on a six protected classes medicine, including patients who are taking HIV/AIDS medicines; excluding a protected class drug if the drug is simply a new formulation regardless of whether the old formulation is still on the market; and excluding a drug from the protected classes if its list price increased more than general inflation.

New data from IQVIA’s US Market Access Strategy Consulting team highlights how plan sponsors are already using the tools they currently have to manage costs and how devastating these changes could be to many seniors and low-income beneficiaries who rely on the six protected classes for their treatment.

Currently, plans have ample opportunity to use utilization management tools to contain costs and influence the medicines new patients begin their treatment with in the protected classes, with the exception of HIV patients. For HIV, CMS historically has not permitted plans to use utilization management for patients new to therapy because “utilization management tools such as prior authorization and step therapy are generally not employed in widely used, best practice formulary models” for HIV (CMS, 2010). Analysis of IQVIA’s longitudinal patient claims data finds that, depending on the class, between 27 percent and 48 percent of patients taking a medicine in one of the five non-HIV protected classes are new to treatment in a given year.

Changes to the six protected classes impact Low Income Subsidy (LIS) patients heavily as they make up a substantial portion of beneficiaries within the six protected classes, particularly within the mental health and HIV/AIDS classes. LIS beneficiaries have limited income and resources so they are eligible for extra help to access their medicines. For example, in 2019, for beneficiaries to be eligible for LIS their annual income is limited to $18,210 for an individual, or $24,690 for a married couple living together. That means for LIS patients it is that much more important that the six protected classes provide access to required medicines for their complex condition because they do not have the disposable income to pay for them without coverage.

IQVIA found that LIS patients represent more than one in four beneficiaries across the protected classes; and for certain classes it can be as high as 65 percent of patients. Therefore, if the changes proposed by CMS were implemented, jeopardizing access to the drugs in the six protected classes, it could have devastating consequences for literally the most vulnerable of the most vulnerable Part D beneficiaries.

Enabling plans to limit access to the medicines that patients rely on would weaken the six protected classes to such an extent that the classes could no longer be considered truly “protected.” Plans are already effectively using the tools they have, making it unnecessary to enact changes that would jeopardize access for the most vulnerable of the sickest patients in Part D.

References:
  • CMS, Medicare Prescription Drug Benefit Manual, Ch. 6, 30.2.5 (Feb. 19, 2010)

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.


Thursday, January 24, 2019

Pharmacists' Hands No Longer Tied by Pharmacy 'Gag Orders'

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

In healthcare the relationship between patients and their pharmacists is extremely important, similar to the one that exists between patients and their physicians. Thanks to bipartisan legislation that was signed into law late last year the patient-pharmacist relationship is even stronger. Gone are the ridiculous pharmacy “gag orders” that prohibited pharmacists from sharing with patients that they could save money by paying cash for prescription medications rather than using their health plan.

According to Kaiser Health News, both bills — one for Medicare and Medicare Advantage beneficiaries (S.2553) and another for commercial employer-based and individual policies (S.2554) — passed Congress with little dissent. The legislation was endorsed by the National Community Pharmacists Association (NCPA), American Medical Association, Alliance for Transparent and Affordable Prescriptions, ERISA Industry Committee, Pharmaceutical Care Management Association, and America’s Health Insurance Plans (Jaffe, 2018). Most patient advocacy groups also supported the effort to lift the gag orders.

Trump signs bills lifting pharmacist 'gag clauses' on drug prices
Photo Source: NBC News | Saul Loeb / AFP - Getty Images
Senators Susan Collins (R-Maine), Claire McCaskill (D-Missouri), and Debbie Stabenow (D-Michigan) introduced the bipartisan legislation in the U.S. Senate. It passed 98-2. Representative Earl L. “Buddy” Carter — who is a pharmacist by trade — introduced the companion legislation in the U.S. House of Representatives.

"As a pharmacist for more than 30 years, I can say firsthand that I was prohibited many times from telling my patients that there was a cheaper option available to them because of a gag clause," Rep. Carter said in a statement upon introducing . "Pharmacists must be able to tell patients what is in their best interest and this legislation works to make that happen. Patients need and deserve the most affordable options" (Carter, 2018).

In recent years, states had already started to remove such restrictions. According to a detailed report by the National Conference of State Legislatures, between 2016 and 2018, at least 30 states enacted laws among at least 41 state legislatures that considered prohibiting “gag clauses” in contracts that restrict pharmacists (Cauchi, 2018). It has long been said that the states are the laboratories of democracy, and on this issue they proved to be right.

State legislation to prohibit "gag clauses" applying to pharmacists
Photo Source: NCSL
It remains to be seen whether removing pharmacy gag orders will alleviate the high cost of prescription medications, but it is a good start. SpendingTracker.org estimates S. 2554 will save $88 million through 2028. There is no good, ethical reason why patients should be denied access to any information that might save them money. Pharmacists are an under-utilized community resource and the patient-pharmacist relationship is often under-appreciated but the new laws could change both.

References:



Thursday, January 17, 2019

Safe Medicines in the United States aren't a Guarantee

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

In 2019, prescriptions medicines in the United States are not immune from the increasing dangers associated with counterfeit drugs. In fact, it can be a serious issue. Dating back to the start of the HIV/AIDS epidemic in the United States, it is an issue that has also resulted in Black Market HIV/AIDS prescription medicines falling into the unknowing hands of HIV-positive consumers. Therefore, raising awareness about counterfeit drugs and the dangers associated with drug importation is an issue the ADAP Advocacy Association takes very seriously.

On January 31st, we are proud to sponsor a series of Congressional Briefings on counterfeit medications  which are being hosted by The Partnership for Safe Medicines ("PSM"). It is an issue that has impacted me, personally, and why I penned an Op-Ed in the Washington Blade last year on the inherent dangers (Drug importation policy is a hard pill to swallow).

I ordered medications from an online Canadian pharmacy. To this day, I have no way of knowing where the drugs were made or if they contained the active ingredients I needed to effectively treat my condition.

Counterfeit medications affect all patients: patients with acute diagnoses, patients with chronic conditions, and patients with immunodeficiency. A patient who has an acute bacterial infection needs a legitimate antibiotic with a proper dose to kill the bacteria and is endangered by the rebounding infection caused by a counterfeit that is beneath sufficient dosage. A patient with a chronic condition who needs maintenance medications may weaken and worsen if their maintenance meds are substandard in dosage. Patients with immunodeficiency may end up with serious additional infections if medications they take have not been sourced and stored in sterile conditions.

HIV patients may suffer all of these things at the hands of unscrupulous drug counterfeiters. Come to PSM's Congressional Briefings to hear the stories of counterfeit medicine victims, including an HIV patient, who received counterfeit drugs that impacted his health. Upcoming legislation proposals to bypass the U.S. Food and Drug Administration's safety protocols and import medicine from foreign sources that can neither be verified nor regulated will have profound affect upon all of the populations of patients who depend upon safe, accurate medicine to maintain their health.

HIV red ribbon next to spoon filled with Rx medicines
Photo Source: Community Access National Network

Black Market HIV/AIDS prescription drugs have been in the news for many years. In fact, several years ago PSM published an important report in collaboration with the Community Access National Network ("CANN"). The PSM-CANN report outlined numerous instances of counterfeit drugs in the HIV/AIDS drug supply change between 2006 and 2013. Download the report online.

Register today to attend either the free House breakfast event at 9 a.m., or the free Senate lunch event at 12 p.m., on January 31, 2019 in Washington, DC.

Friday, January 11, 2019

Sometimes Circumstances Dictate 'Positive' Change

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

Happy New Year! With a new year comes new beginnings and very often it dictates needed change. The ADAP Advocacy Association is seeking to make some 'positive' (pun intended) changes to its HIV/AIDS advocacy agenda this year, especially in light of the current political environment.

Positive Change Ahead
Photo Source: pha-media.com

The current occupant residing at 1600 Pennsylvania Avenue has turned HIV/AIDS advocacy on its head, some of which impacted the AIDS Drug Assistance Program. Federal public policy is undergoing a lot of upheaval so many of the planned changes being implemented by our organization reflect the need to better engage local advocates at the community level. These changes will be periodically announced throughout the year, but this week's blog will highlight a few of them.

Our ADAP Blog will feature a monthly guest blog by advocates living with HIV/AIDS, whereby they will share their personal advocacy journey fighting the epidemic. Two such guest blogs were shared last year, by Wanda Brendle-Moss and Michael Zee Zalnasky. The guest blogs seek to share some valuable lessons learned by advocates.

Our Annual ADAP Conference will be replaced by numerous HIV/AIDS Fireside Chat Retreats, convened across the country. Two such Fireside Chats were held last year in Tampa, Florida and Boston, Massachusetts. Our Fireside Chats convene key stakeholder groups to discuss pertinent issues facing people living with HIV/AIDS and/or viral hepatitis. Patient advocates will continue to play a central role during these important discussions (with advocacy scholarships offered).

We will be re-convening our ADAP Advocacy Council (details forthcoming). Additionally, we will seek to leverage existing community partnerships with AIDS Service Organizations to better engage local advocates on Federal public policy issues. We anticipate 2019 being another challenging year for the HIV/AIDS community, but we're taking steps to ensure our advocacy remains relevant and effective.