Click here to read a letter from the Arthritis Foundation on patient protections in the federal health exchanges.
2014 Advocacy News & Letters
The Arthritis Foundation with the American College of Rheumatology sent a letter to the Center for Drug Evaluation and Research regarding their shared position on biosimilar guidance. Please click here to read the letter.
A few weeks ago we reported that the Food and Drug Administration (FDA) wants to find ways to include patients in its medical product discussions. We polled some of our advocates and got some great responses about how you want to engage with the FDA. Click here for the letter we sent to the FDA last week that incorporates your suggestions. We will keep you updated about what comes next.
Twenty-two leading patient advocacy organizations today announced the launch of Patients for Biologics Safety & Access (PBSA), a coalition dedicated to protecting patient access to safe and effective biologic medicines. PBSA members, who represent millions of patients living with serious, life-threatening and difficult-to-treat conditions, plan to ensure that there are adequate patient safety protections in place as FDA creates the regulatory pathway for so-called biosimilar medications. PBSA is the only coalition of patient advocacy organizations speaking solely from the patient perspective.
Beginning in 2015, major insurers in Montana will be required to treat all prescription drugs equally.
This new requirement was brought about by Monica Lindeen, Montana's Commissioner of Securities and Insurance, and not only brings fairness and lower prices to expensive prescription drugs and ends discriminatory practices, but it is also serves as a major milestone in overcoming the unique barriers to care faced by people with arthritis: high cost of treatment, difficulty accessing medications and “specialty tiers,” which cover essential drugs at only 50 percent or less. This groundbreaking development in Montana will have an important impact on the one in every four adults suffering from arthritis in the state.
California Governor Jerry Brown has signed into law Senate Bill 1052 to create formulary transparency in health insurance plans that will make it easier for people with arthritis to make sure the health insurance plan they choose covers the prescription drugs they need.
Many specialty drugs can be extremely expensive and individuals living with arthritis cannot obtain the information they need to confirm the cost sharing, prior authorization and step therapy requirements or coverage for their medications. Formulary transparency in health insurance plans will be used to create a “window-shopping” feature on websites to allow consumers to search for coverage by prescription drug or by condition.
The Arthritis Foundation was heavily involved in the passage of this important transparency legislation including presenting advocate witness testimony during hearings, amendment language, letters from Ambassadors and op-eds.
By Ann M. Palmer, President and CEO, Arthritis Foundation National Office
Issues of advocacy and access have long been a priority of the Arthritis Foundation. But there is a renewed sense of urgency as we shape our expanded vision of what it means to be an effective and powerful patient advocacy organization and a successful voice on issues of importance to our constituents—the more than 50 million Americans living with arthritis.
Patients and physicians are raising increasingly urgent concerns regarding timely access to a full range of treatment options and we are a strong voice in fighting against overly restrictive pharmacy plans and processes that can delay or even prevent a patient from receiving life-changing medication.
A couple of months ago, I wrote a letter to the medical director of Medical Mutual of Ohio, expressing concern and requesting a change to the company’s new Recommended Authorization Criteria requiring the use of a Preferred Drug, i.e., the injectable TNF antagonist medications, prior to the use of an infusible TNF antagonist agent.
I explained that the Arthritis Foundation advocates for:
- Access to the full range of treatment for all people with all types of arthritis, including inflammatory types such a rheumatoid arthritis;
- Supports access to a full range of treatment options, including various forms of administration; and
- Supports the physician’s right to choose the appropriate therapy for his or her patients, and we are opposed to any policy that interferes with the medical decision-making process of the doctor-patient relationship. The choice of therapy is complex and should be determined by the physician based on a number of variables, both medical and patient-centric. These variables include the diagnosis, disease characteristics, prognosis and physician’s clinical judgment and experience, as well as factors such as the patient’s proximity to the physician’s office, mobility and functional limitations.
Medical Mutual of Ohio responded quickly and favorably to my inquiry, agreeing to broaden the range of treatments and, as a result, beginning September 1, 2014, the medical benefit requirement that a trial of a self-administered anti-tumor necrosis factor-alpha agent be attempted prior to treatment with Remicade® was eliminated.
This expansion of treatment options is a win for the millions of people with an inflammatory form of arthritis in Ohio. However, it is not a complete victory, as many viable treatment options are still not included. As we know, people respond differently to the different treatments for inflammatory arthritis and need to have their options open so that they can find the right medication for them.
Because of this, I am continuing the dialogue with Medical Mutual of Ohio to request that they consider broadening their coverage to ensure that there is a complete access to appropriate treatments for all people with inflammatory arthritis in Ohio. I will keep you posted on the results.
Ann M. Palmer
President and CEO, Arthritis Foundation
Illinois Governor Pat Quinn has signed into law House Bill 3638 that was actively supported by the Arthritis Foundation. The new law, which takes effect on January 1, 2015, will provide better access to medications and better information about health insurance coverage of medications for people with arthritis
The law will streamline the prior authorization approval time to no more than 72 hours or 24 hours in cases of an expedited coverage determination. It will also require health insurers to provide information on their websites to allow consumers to compare the treatment of medications. Consumers would be provided information about the covered prescription drugs, tiering and the cost-sharing structure for each tier and information about how a consumer can obtain specific copayment amounts or coinsurance percentages for a specific plan before enrolling in that plan.
Click here to read the letter sent by Arthritis Foundation President and CEO, Ann M. Palmer, to the U.S. Food and Drug Administration on the biosimilar naming issue.
The comments stated, “This rule allowing pharmacists to unilaterally substitute a biosimilar therapy for a prescribed reference biologic disrupts the patient-physician relationship, undermines physician judgment and clinical experience and, more importantly, puts patient outcomes and safety at risk. The proposal also does not require a pharmacist to notify the prescriber of any substitution.
Click here to read an article from HartfordBusiness.com, a publication by the Hartford Business Journal.
When the Arthritis Foundation learned that CMS was making decisions about which medications they would reimburse for based on the method of administration, Ann Palmer the AF CEO wrote this letter outlining the importance of having all forms of a drug available to arthritis patients.
The Pennsylvania Senate passed Senate Bill 405 by a vote of 44-6 to allow the substitution of biosimilars for biologic medicines. Arthritis Foundation representatives visited the legislature the day before the Senate vote to help secure the bill’s passage. A great victory for our Ambassadors and Advocates!
The Arthritis Foundation thanked Massachusetts Governor Deval Patrick for his enactment of House Bill 3734 that permits the use of biosimilar medications. The Arthritis Foundation has been a critical part of the consideration of this legislation by providing testimony, written position statements and a letter of support urging the Governor to sign the bill.
Arthritis Foundation President and CEO, Ann M. Palmer, sent a letter to Medical Mutual of Ohio to ensure access to vital medications for people with arthritis. To read the letter, please click here.
Connecticut Governor Dannel P. Malloy (center) signs legislation (Senate Bill 394) regulating “Insurers’ Use of Step Therapy” into law in front of patient advocates, including Arthritis Foundation Regional Advocacy Committee Chair Paula Haney (third from left).
The Arthritis Foundation has been working to ensure that people with arthritis have access to vital, life-improving treatments.
Because of our efforts including written and in-person testimony before the Senate Insurance Committee and an Op-Ed in the Connecticut Mirror, Connecticut Governor Dannel Malloy signed Senate Bill 394 into law to bar health insurers that use step therapy protocols from requiring their use for more than 60 days and providing doctors with a method to override the protocol.
The act requires insurers to establish and disclose to their providers a process by which the provider may request, at any time, an override of any step therapy regimen. The override process must be convenient for providers to use. At the end of the step therapy period, the act allows an insured's treating health care provider to determine that the step therapy regimen is clinically ineffective for the insured. At that point, the insurer must authorize dispensation of and coverage for the drug prescribed by the provider, if it is covered under the insurance policy or contract.
The law also expands the prohibition on insurer requirements to obtain prescription drugs from a mail order pharmacy. The law extends the scope of the law to cover (1) all other types of insurance entities covering prescription drugs; (2) insurance contracts as well as policies; and (3) policies and contracts that are delivered, renewed, amended, or continued.
The law will become effective on January 1, 2015.
Under a new law advocated by the Arthritis Foundation and signed by Louisiana Governor Bobby Jindal, the maximum co-payment or coinsurance for up to a 30-day supply of any single drug may not exceed $150 per month beginning January 1, 2015.
The co-pay limit will become effective once any applicable deductible is reached and until the individual's maximum out-of-pocket limit has been reached.
New law also provides a method for physicians, at the request of patients, to have specialty tier medications included the covered formulary. Under such a request, a non-formulary specialty drug could be deemed covered under the formulary if the prescribing physician determines that the formulary drug for treatment of the same condition either would not be as effective for the individual, would have adverse effects for the individual, or both.
Delaware Governor Jack Markell signed into law the Arthritis Foundation supported Senate bill 118 that allows pharmacists to substitute interchangeable biosimilars. The hope is that bio-similars will provide patients with lower cost alternatives to biologic drugs.
The Arthritis Foundation helped enact a new law in Maryland that caps out-of-pocket drug costs. House Bill 761 – which limits co-pays and co-insurance on “Specialty Drugs” to a maximum of $150 per 30-day supply, will benefit many of the state’s 1.08 million patients with arthritis. The bill was signed into law by Governor O’Malley and applies to all insurance policies, contracts and health benefit plans issued, delivered, or renewed in Maryland on or after January 1, 2016.
Through the work of our dedicated Ambassadors and E-Advocates, 33 new co-sponsors have been added to H.R. 460, the “Patients' Access to Treatments Act” since the 2014 Advocacy Summit. The new co-sponsors bring the total to 127 members of the US House of Representatives.
This is an important milestone because H.R. 460 is now co-sponsored by more than one-quarter of the entire U.S. House of Representatives (109 were needed to hit one-quarter). The bill would limit co-payments for specialty tier drugs.
The list of co-sponsors on H.R. 1827, the “Pediatric Subspecialty and Mental Health Workforce Reauthorization Act”, has also increased by 12 (a 35% increase since the Summit) bringing the current roster to 46. The bill seeks to address the nationwide shortage of pediatric subspecialists including rheumatologists.
If your member of the U.S. House of Representatives has not yet signed on as a co-sponsor of these bills, please contact and encourage them to take a stand for patients with arthritis. Your member of Congress may be reached (even if you don’t know who it is) through the Capitol switchboard at (202) 224-3121.
A list of the co-sponsors of H.R. 460 may be found here.
A list of the co-sponsors of H.R. 1827 may be found here.
The Department of Defense announced that “post traumatic osteoarthritis” and “rheumatoid arthritis” will be included in the Department of Defense Peer Reviewed Medical Research Program for FY2014. This program awards grants to researchers to look at various diseases affecting our soldiers. This year, over $200 million will be available to the diseases listed in the provision.
Active duty soldiers and veterans have twice the rate of OA when compared to non-military populations, thus the need for research at the Department of Defense is vital. Not only will this benefit our service members, but a breakthrough in research will benefit all with arthritis. Thank you to all of our advocates who called on their Members of Congress to include this important provision in the appropriations bill!
The Arthritis Foundation is continuing to monitor changes to health plans and pharmacy formularies that impact your access to the treatments you need. We need to hear from you too!
Discussions at the end of the year between Arthritis Foundation CEO Ann M. Palmer and Express Scripts, a leading pharmacy benefit management company, led to clarification of the company’s general formulary policies.