Showing posts with label Bio-similars. Show all posts
Showing posts with label Bio-similars. Show all posts

Thursday, January 5, 2017

Notebook Page 21, December 2016

Snow and the coming holidays didn't keep the legislature away from finalizing the work of Michigan’s 98th legislature. Two major issues that ACS CAN was working on surrounded access to drugs; regulations for biosimilar drugs and oral chemotherapy fairness. Both issues at the start of December seemed to have some life but would they be able to make it across the finish line.

Earlier in the year House Bill 4812, the bill that provides the needed regulations for the substitution and dispensing of biosimilar drugs in Michigan took a major turn for the worse in the Senate Health Policy committee just before the summer recess. Groups in favor of the legislation, as it came out of the House, were found scrambling and trying to find ways to amend the legislation back to the version that had passed the House and included the critical language that required notification to physicians of substitution. The Fall brought very little activity around the legislation but rather conversations with Senators about a possible amendment on the Senate floor back to the House version and then passage during the end of the year.

Amendments were drafted and a key Senator was named as a champion for the amendment. Lame duck started; the time in the legislature when at segments all right and reason seem to escape people and deals begin to develop to get legislation moving and passed before the end of the session. This legislation was no different and rather than having productive discussions around the legislation the opposite happened. Discussions by groups with Senators about the amendment started a destructive movement against the legislation. Finally, the chairman of the Senate Health Policy committee said enough was enough and the legislation was dead for the year, leaving groups that had worked on the legislation at the doorstep with nowhere to go and lawmakers frustrated over the issue.

We have documented throughout the year that oral chemotherapy fairness was a key issue for ACS CAN. In May of this past year, the Michigan Senate passed Senate Bill 625 with all but one vote. The legislation had huge bipartisan support in the Senate, which usually sends a message to those working in or with the legislature that it should have the same support in the House. We learned this term that the House and Senate, although controlled by the same party, were the furthest philosophically from each other then they have been in years. Several large key issues made their way from the Senate with worked out compromises, only to have the House completely tear it up and write their own deals. 

Oral fairness was no different. The Senate worked hard with all of the stakeholders to ensure that the legislation that would move was a compromise. Groups like ACS CAN and the Leukemia and Lymphoma Society (LLS) took some concessions but so did groups like Blue Cross / Blue Shield (BC/BS) and the Michigan Association of Health Plans (MAHP) The legislation was finally in a place that it had never been, where the major health plan in Michigan (BC/BS) was not supportive but would not stand in the way of it moving through the legislature and patient groups were in support. Then the wall appeared in the House and MAHP worked with the House leadership to have the legislation sent to a committee that shuttered at the slight notion of anything that is a "mandate". Just the slightest notion of having a prescribed function in the legislation left the committee wanting to know more, slowing down the process considerably.

Summer came and went with ACS CAN volunteers spending time in local coffee shops, on their phones calling into their lawmaker's office, sending quick e-mails to their lawmakers asking for support, and even dusting off stationary and pen sets to send the hand written letters. Lawmakers knew what oral chemotherapy fairness was by the end of the Summer, leaving now just action from the committee. No hearings came and lawmakers came and went, off to finish their campaigns. So ACS CAN ran a campaign of our own.

Volunteers all around Michigan took a poster to bring around to their activities having people sign them to show their support for oral fairness. A mobile petition you could say; twenty posters were created. After Thanksgiving, we received eighteen posters back and started to put a plan in motion to make a final run at getting oral fairness passed. The first full week in December ACS CAN hosted a two-day drop in lobby day where we took volunteers to the House chamber doors and sent in notes for their lawmakers to come out and discuss oral fairness. This started on a Tuesday morning and by the afternoon of that Tuesday, the answers from lawmakers were becoming consistent, oral fairness will not move without drug price transparency. We knew that lawmakers were talking with each other about the issue, which raised its visibility and caught the attention of the Capitol news corp. We also brought those posters to the Capitol and displayed them for everyone to see. The posters and our activities were noticed by the media and were featured in two news stories and several interviews on radio and television.

Tuesday night our coalition created an amendment to counter the problem that the price transparency ask was attempting to address. Volunteers continued to come on Wednesday and continued to talk about the issue with their lawmakers and included that ACS CAN and others had an amendment to solve the problem that price transparency was addressing. Lawmakers took that information back to their colleagues, but still, the House leadership was convinced that the need for transparency was too great.  Thursday came and went and lead us into the last week of the session. The first day of the last week was Tuesday and leadership was still not willing to move, which left us dead in the water, having to wait until next term to finally get the fairness patients deserve. 

Throughout that second to last week of the 98th session, we had over twenty volunteers make the drive to Lansing to discuss oral fairness with just a couple weeks notice. We had over 250 calls go into the Speaker of the House's office asking for action. We had amendments to solve problems, we had over 2000 signatures from people all around Michigan, several hundred emails were sent from volunteers, but MAHP won the day. MAHP did find out though that the patient groups are a passionate force and will win this battle one day.


As we move forward in 2017, we just want to say thank you for all of your efforts in 2016. We won't let those efforts go to waste and use them to build on a great 2017. As always if you have any questions please contact Andrew (andrew.schepers@cancer.org) and Matt (matt.phelan@cancer.org) and Happy New Year!

Monday, February 8, 2016

Notebook Page 12 February 2016

February signals the start of budget season in Michigan with the governor scheduled to present his budget to the Legislature on Wednesday, February 10 at 11:00 a.m. You can watch the hearing here.  

 In addition to the budget, there are several other issues we’ve been focused on.
Oral chemotherapy parity, or “fairness,” has finally started to see some action in the Senate. Last month, a coalition, including ACS CAN, worked with Senator Goeff Hansen to have Senate Bill 625 introduced and brought up for a hearing in the Senate Insurance Committee. Senate Bill 625 ensures that patients facing cancer won’t have to pay a higher price for chemotherapy taken orally, as opposed to intravenously. ACS CAN presented a letter to the committee, outlining the need for access to these critical treatment options for patients facing cancer. Our coalition hopes to have the legislation sent to the House before the start of summer recess.

The Senate Health Policy Committee took up House Bill 4812, which would provide regulations for the use of biosimilar medications in Michigan. These are drugs that are almost identical to an original product manufactured by a different company. But unlike generic drugs, they are not exact copies. We continue to support interchanging biosimilar drugs with prescribed medications, as long as the patient’s health care provider is notified.  Because biosimilars are somewhat different from the originally prescribed drug, it’s important to notify a prescribing physician of the switch. This legislation is expected to make it out of the Senate before summer recess. 

Medication synchronization is another issue that the House will take up later this month. Senate Bill 150 would allow patients schedule their medications to be filled on the same day.  This ensures that patients and their caregivers won’t be running back and forth to the pharmacy to constantly refill prescriptions.  The bill has moved from the Senate to the House for further consideration.


February is a busy month for ACS CAN in Michigan. For more information,  go to our website at http://www.acscan.org/action/mi. 

Monday, December 7, 2015

Notebook Page 10 December 2016

The legislature begins its final three weeks of session for 2016 this article we want to take a look back at what 2015 meant for CAN in Michigan.

January:

Governor veto's legislation to regulate E-Cigarettes. The Governor says in his veto statement:

"I believe the preferred way to ensure that e-cigarettes are regulated in the interest of public health is to revise the existing definition of a tobacco product to make clear that e-cigarettes (and other novel nicotine-containing vapor products) are tobacco products subject to any restrictions generally applied to tobacco products under the Youth Tobacco Act, including the minimum age law."

Efforts have been made to reintroduce the legislation that is similar to what passed and was vetoed last session, We continue to work with the legislature to create common sense legislation and regulations surrounding E-Cigarettes.

February:

Governor presented budget to the legislature, restores funding for cancer prevention and included a $100k increase for tobacco prevention.

April:

Over 90 plus cancer advocates take over the Michigan Capitol to ask that cancer and tobacco prevention be a funding priority in the state's budget. With the over 70 volunteers that joined staff at the State Capitol, almost every volunteer met with their lawmakers. Jennifer Varner received CAN's Michigan Volunteer of the Year award and Governor Snyder received Michigan's Distinguished Advocate Award with his efforts around E-Cigarettes and the Healthy Michigan Plan. Lieutenant Governor Brian Calley spoke to the crowd at the end of our busy lobby day!

June:

Legislature finalizes the budget, includes $500k for cancer prevention and $1.6 Million for tobacco prevention. Attempts were made by the Senate to move the cancer prevention line to the Health Endowment Fund; a privately controlled fund set up by the legislature and Blue Cross. If those efforts would have been successful it would've meant that the State would not fund any cancer prevention programs. This was a huge victory for us and other groups that were afraid of losing their program funding.

June-August:

Summer recess! Volunteers made in district meetings and drop by's with state and federal lawmakers, working hard to get our messages to the lawmakers. 

As a result, U.S. Senators Gary Peters and Debbie Stabenow signed on as co-sponsors to S 624, the Removing Barriers to Colorectal Screening bill.

Members of Michigan’s Congressional delegation were targeted for co-sponsorship and support of the 21st Century Cures Act. Michigan ended up with 11 members signing onto the act and all but one member of Congress voted in support.

September:

The State and Federal legislatures got back to work. In Michigan regulations for Bio-Similar products was a hot topic for the state. Creating regulations for these products could allow them to come to market in Michigan and make them available, creating lower cost options for biological products. This debate would go through until the end of October.

More than 700 volunteers and staff took part in the annual Leadership Summit and Lobby Day in Washington DC. Michigan's delegation represented the state extremely well gaining co-sponsors on critical legislation around polyp removal coverage legislation and legislation supporting palliative care training. Michigan Governor Rick Snyder was recognized at the event with the National Distinguished Advocacy Award.

October - November:

October and November saw bio-similar products at the forefront of the legislative activity. Additionally, the foundation was being set to start a large campaign issue for 2016. ACS CAN started the Prevention Michigan coalition. The coalition’s goal is to raise the tobacco taxes and use the funding to support prevention efforts in cancer and tobacco and to support the state's trauma system. We kicked off our activities with a poll and release the week of the Great American Smoke Out. The poll found 6 out of 10 Michiganders support an increase in the cigarette tax and 6 out of 10 provide more support when they know the new funding would go towards health initiatives. This shows clear support from the State for an increase in the tax and support for health in Michigan. We continue to grow our coalition to gain more support throughout the health community.

December:

December looks as if it might be quiet for our issues in Michigan. We will continue our work on Bio-Similar products, support the newly introduced oral parity legislation and continue our work around the tobacco taxes. Petitions for the Prevention Michigan campaign are being collected with a goal of 5,000 petitions collected in 2016.


We also want to take a moment to say thank you. Our volunteers, ACT Leads, State Lead Ambassador, Community Ambassadors, and others give so much of their time to help support our efforts. Without your voice, the voice of cancer would go away. Thank you for all that you do and we hope you have a great 2016.

Monday, November 2, 2015

Notebook Page 9 November 2015

October found the state in full gear working on trying to find a solution to the road situation in Michigan.  This left a lot of the health issues and others on the back burner for many different groups including ACS CAN. The House Health Policy Committee did consider one issue that ACS CAN has some interest in; Bio-similars.

Biologic drugs are a classification of drugs that are made through a process that involved a living organism. The process uses that living organism to create the active ingredient in the drug that will be used to fight whatever the drug has been approved for. Biological drugs have been used to treat breast cancer and other cancers  so access to these critical medications is crucial. Today, the science is evolving and how biologic drugs are being made is changing. Many manufactures are creating what’s called a Bio-similar medication. That drug is similar to the biologic that it is trying to replicate but not quite the same thing. 

The US Food and Drug Administration (FDA) has created regulations that govern these bio-similar products creating two classifications, bio-similars and interchangeable bio-similars, which are even closer in resemblance to the primary biological drug.  These drugs are usually less costly to the patients, making access to them extremely important. Michigan does not have any regulations that would allow these drugs to come to market and the first bio-similar is about to hit store shelves here in the next couple months, therefore regulation of these products is needed. 

House Bill 4812 was introduced by Representative John Bizon, a physician from Battle Creek, to provide regulations around bio-similars. A critical part of his legislation provided an avenue for physicians and pharmacists to communicate when an interchangeable bio-similar is changed out for a biologic. For safety reasons physicians have the knowledge if there is a switch and the patient has an adverse reaction. For the patient it can provide a piece of mind that the physician knows what is happening with their care. Another piece of legislation was introduced, House Bill 4437, which we oppose that does not provide the communication piece in the legislation.

The House Health Policy Committee took testimony on House Bill 4437 with the majority of the testimony being against the legislation. ACS CAN provided written testimony explaining our support for communication for safety and peace of mind. We expect the House committee to take up HB 4812 since there is a lack of support for HB 4437. 

This past month we also had our second meeting of the Michigan Palliative Care Summit. Health leaders from around the state met in Lansing and began work on a road map to quality palliative care in Michigan. Close to twenty health care professionals and patient advocates participated in the great work that was done. We are hopeful that with all of the great notes that were taken by each work group a draft document can be created to provide the road map that Michigan needs.


Lastly, Michigan has leveraged Breast Cancer Awareness month to push Governor Snyder to increase funding for the Cancer Prevention Program.  Michigan’s Cancer Prevention Program houses the Breast and Cervical Cancer Control Navigation Program.  This program is vital to making sure all women have access to the screenings and follow-up care necessary to make an accurate cancer diagnoses and secure the proper treatment.  Volunteers from around the state have been collecting postcards throughout the month asking the Governor to increase funding by $2 million in his next budget.  Over 2,000 postcards have been sent to the Governor so far.

Monday, October 12, 2015

Notebook Page 8 October 2015

September was a full month for ACS CAN in Michigan. The Michigan legislature made it's way back from its summer recess and the with national Leadership Summit and Lobby Day ahead, the ACS CAN team from Michigan was in full swing legislatively on both state and federal fronts.

In Michigan legislation was introduced to regulate bio-similar pharmaceuticals. Biologics are a classification of drugs that are commonly used for the treatment of cancer along with arthritis and other conditions. These drugs are created through a completely different process from your common pharmaceuticals like aspirin. Biologics use biologic materials to create the drug which leaves it extremely hard to recreate into a generic form. They have created drugs called bio-similars which gets extremely close to the original biologic composition but not quite.

These drugs are so new that regulations from state to state have not been created yet. ACSCAN is working with other interested parties to create legislation and regulations that would allow for the switching out of the biologic to a bio-similar but require that the pharmacist contact physician to notify them that switch has been made. The House Health Policy committee will be taking testimony on two bills dealing with the issue. We support House Bill 4812 from Representative John Bizon, a physician from Battle Creek.

Also in September ACSCAN made it's way to Washington D.C. for it's annual Leadership Summit and Lobby Day.

The Michigan delegation to the national Leadership Summit and Lobby Day was very successful this year.  We held 12 meetings with congressional offices along with meetings with Senator Gary Peters and Senator Debbie Stabenow.

Accomplishments on the Hill

After excellent meetings with our Congressional members, we were able to get verbal commitments from Rep. Dave Trott and Rep. Debbie Dingell to co-sponsor H.R. 1220, the Removing Barriers to Colorectal Screenings Act, and H.R. 3119, the Palliative Care & Hospice Education Act. Additionally, we were able to thank Senators Stabenow and Peters for co-sponsoring S. 624, the Removing Barriers to Colorectal Screenings Act.  The Senators signed onto the bills earlier this year after meeting with our volunteers in Michigan.

Advocacy Awards
Michigan was well represented at the annual national advocacy awards dinner.   Michigan ACT Lead Jennifer Varner was awarded the national ACT Lead of the Year Award for her outstanding work over the last year, and over the last few years, with advocacy and program integration.
Jennifer’s Award was highlighted in a recent news article in Midland.

Michigan Governor Rick Snyder won the National Distinguished Advocacy Award for his support of ACS CAN priorities over the past few years.  Governor Snyder spearheaded the charge to expand Medicaid in Michigan with his Healthy Michigan Plan.  Over 600,000 Michigan workers now have access to health insurance and life-saving cancer screenings through this plan.  Additionally, Governor Snyder took a firm, and very public, stand against e-cigarettes by heeding the call of ACS CAN volunteers to veto misleading e-cigarette legislation.  This legislation would create a special class for these products and possibly prevent them from all tobacco control laws.  Governor Snyder was not able to attend but did record a video accepting the award which was played during the Leadership Summit.

Finally, Matt Phelan was awarded the Grassroots Professional of the Year award.

Lights of Hope
This year’s Lights of Hope ceremony saw significant rain, but that only showed the vigilance of cancer advocates as they ventured out into the weather to honor those that are battling cancer or have lost their battle.  There were a record 22,000 bags around the Capitol Reflecting Pool this year and thanks to some fantastic volunteers, Michigan collected around $12,000 in Lights of Hope donations!  The Lakeshore Division ranked second in Lights of Hope donations and Michigan ranked 4th among the states.  We only trailed the mega-states, Texas, California and Florida.    Michigan volunteer Jennifer Belaire was the top online fundraiser in the nation this year for Lights of Hope collecting over $2,000 in online contributions.