Standards of Care Introduced in Minnesota

A growing number of people living with primary immune deficiencies, alpha1-antitrypsin deficiency, hemophilia and von Willebrand disease are experiencing problems accessing their medically appropriate therapies and services. This is due in large part to cost-containment measures by state Medicaid and other public programs and private insurers. These patients and their families have learned that politicsis not a spectator sport. They have made advocacy a primary focus. The patient organizations have joined forces with providers and industry to tackle the complex legislative and regulatory policy issues that affect quality of care and provide access to their lifesaving therapies so they can lead productive lives. Standards of Care legislation offers protection to people living with these rare genetic disorders.

CSL Behring Public Affairs has made it a priority to join with patient advocacy organizations across the United States to pursue state-based Standards of Care legislation ensuring access to all plasma-derived therapies and recombinant analogs, including necessary ancillary services. The drive for Standards of Care began with the passage of model legislation in the state of New Jersey in 2005. Pennsylvania and Minnesota followed with bills introduced in 2007. In 2008, the number of states pursuing Standards of Care grew to include California. In 2009, more states intend to continue this trend. Alabama, Missouri and Texas are in discussions with legislative leaders; California and Indiana are exploring regulatory implementation; and Pennsylvania, Massachusetts, Connecticut and Minnesota are introducing legislation.

Elected and appointed officials, lobbyists and historians often warn that changing public policy takes commitment, hard work, patience, persistence, perseverance, diligence and even luck. Pursuing Standards of Care legislation is no exception.

Of course, momentum can help as well. In Minnesota last spring, Standards of Care initiatives were infused with new energy when a coalition of patient advocates from across the state attended a legislative day in St. Paul, Minnesota. Minnesotans who rely on plasma protein therapies, their families and representatives from industry joined forces to educate lawmakers about rare chronic diseases. They shared their personal stories with legislators and educated them on the importance of access. Every participant played a vital role in advancing Standards of Care.

As legislators listened to their stories, the participants were empowered to continue to reach out and build awareness. Some of the participants even visited their legislators and contacted candidates during the summer months.

Patient advocates had become a resource to their elected officials on issues of health care, rare genetic diseases and access. The Senate and House authors were pleased to introduce newly drafted Standards of Care in 2009 because of the persistence and hard work of patient advocates from the Immune Deficiency Foundation and the Alpha1 Association.

Working together, patients, families, providers and representatives from industry can influence the policy issues affecting quality of care.

Learn more about Standards of Care legislation by reading the “Key Issues Dialogue: Standards of Care Legislation.”

This dialogue features Minnesota resident, Kathy Antilla,Director of volunteer programs at the Immune Deficiency Foundation, who leads advocacy for this legislation in her state. Also featured are Ann Rogers, Executive Director of the Delaware Valley Chapter of the National Hemophilia Foundation (NHF), Val Bias, Executive Director of NHF and Jerry Powell, M.D., Director of the hemophilia treatment center at the University of California, Davis Medical Center.

Volunteers from the Minnesota immune deficient, alpha1 and bleeding disorders communities pose with the Minnesota bill sponsors, Senator Kathy Sheran and Representative Kim Norton at the 2008 legislative day in support of Minnesota Standards of Care

Certain RA Medications Associated With Increased Risk for Herpes Zoster

CHICAGO — February 17, 2009 — Use of monoclonal anti-tumor necrosis factor alpha (TNF-alpha) antibodies for the treatment of rheumatoid arthritis appears to be associated with an increased risk for herpes zoster, according to a study in the February 18 issue of JAMA.
There has been evidence from some studies that patients treated with anti-TNF-alpha agents are at an increased risk of bacterial infections, but little is known about the risk of viral infections in patients with rheumatoid arthritis receiving these types of medications.
Anja Strangfeld, MD, German Rheumatism Research Center, Berlin, Germany, and colleagues investigated the association of various rheumatoid arthritis treatments, including anti-TNF-alpha therapy, with the risk of herpes zoster.
The researchers analyzed data from patients who began treatment with adalimumab or infliximab, etanercept, anakinra, or when patients changed conventional disease-modifying anti-rheumatic drug (DMARD).
Treatment, clinical status, and adverse events were assessed by rheumatologists at fixed points during follow-up (of up to 3 years). A total of 5,040 patients were included in the analysis.
There were 86 cases of herpes zoster among 82 patients. Of the cases, 39 could be attributed to treatment with anti-TNF-alpha antibodies (23 to etanercept, 24 to conventional DMARDs).
The researchers found a significant association between herpes zoster and treatment with infliximab and adalimumab, although this risk was lower than the threshold for clinical significance. There was no significant association between herpes zoster and treatment with etanercept, or anti-TNF-alpha treatment as a class.
A significantly higher risk of developing herpes zoster was found for patients of older age and for treatment with glucocorticoids.
“Based on our data, we recommend careful monitoring of patients treated with monoclonal anti-TNF-alpha antibodies for early signs and symptoms of herpes zoster,” the authors concluded.
SOURCE: JAMA

It’s going to be hard some days to tell the patient from the caregiver.   I had gotten so used to being the patient, and my husband had been the caregiver, that I had not realized how many things- chores, activities, etc he had taken over for me.

Now, 2 weeks after he came home from the hospital, and is still learning his new ‘dance’, I realize how much I have to step up to the plate- even while exhausted.

He needs so much rest, and yet- the daily grind of keeping up a home must go on.   That leaves me doing the grocery shopping (which he had taken over), the cleaning, the laundry, the meals and clean-up, etc.   I had really gotten spoiled over the past few years.   He would not let me do anything if I got fatigued, as he would worry that I would end up sick.

Now, I’m very fatigued, and yet, I’ve found a way to carry on.

Is it adrenal that is keeping me going?   Am I a lot stronger than I realized?   Have I learned to care for myself, and stay healthy so well, that now, when it’s my turn to bat- I can easily step up to the plate?

I hope that all PIDD patients reading this, will make sure to take very good care of yourselves- eat right, exercise, rest, sleep hard and always stay compliant with your meds, as some day- you will also be asked to step up to the plate in some fashion- and it’s best to be prepared.

It’s actually a very good thing that I stayed in Girl Scouts for so many years – I learned the art of always being prepared.

It was our motto then – and it should be our motto now as well.