NEED YOUR HELP NOW TO PASS CRITICAL LEGISLATION

Ok folks – I need your help.  Yes – all of you.   Particularly you Californians…..  But honestly – I need everyone to engage.

So – this is the situation.  There is a crazy debate in the California State legislature over whether a doctor should be notified about what’s going into their patients.  I need your help to make it clear to legislators that it is important that physicians know what their patients are taking – particularly because the drugs that we’re talking about are for maladies like cancer, rheumatoid arthritis, Crohn’s disease and many many others.

Now – this is going to sound complicated, but just hang with me, or, if you’d prefer, just go directly to the end of this and get your marching orders….

I need your support on Senate Bill 598 (Hill), which outlines how pharmacists can substitute biologic medicines with a new and more affordable class of FDA-approved treatments called biosimilars.

Biologic medicines are the next generation of innovative medical treatments.  They are providing therapeutic options for illnesses that were once considered untreatable such as cancer, Parkinson’s disease, multiple sclerosis and Alzheimer’s disease. Biologic medicines are vastly different from traditional prescription drugs because they are made from living cells – not chemical compounds. These biologically-based treatments are highly specialized and they can also be extremely sensitive.

In the next couple of years, biosimilar medications are expected to enter the U.S. healthcare market. They are copies of an original biologic medicine (these medicines are either delivered via infusion or taken via syringe) and hold the promise of providing similar results as the original biologic at a lower price.  However, unlike generic pills, biosimilars are not structurally identical to the biologic products they seek to copy; thus the name biosimilar. Due to the sensitive nature of biologics, the slightest variation from the original biologic medicine can result in an immune response or other patient side effects.

Specifically SB 598 would:

·      Update California law to allow for greater patient access to life-saving, less costly, FDA-approved biosimilar medicines.

·      Allow pharmacists to substitute a biosimilar for a brand biologic when the biosimilar is deemed interchangeable by the FDA.

·      Require that a patient’s physician is notified when a biosimilar medicine is substituted for a medication the doctor originally prescribed.

·      Require pharmacists to keep a biosimilar substitution record on file for a period of 3 years

As the next generation of biologic treatments is introduced, SB 598 ensures that patients will have access to these innovative, lower cost medications and recognizes the importance of tracking and tracing the use of sensitive medicines in the event of an adverse patient reaction.

There is another competing bill AB 1139 (Lowenthal), which does virtually the same thing except for one significant difference – AB 1139 does not require a pharmacist to notify the physician when they switch out the biologic medicine.

The problem is that unlike pills, these biologic medicines can have an immune reaction months after taking the drug. 

Given the severity of the diseases being treated with biologics and the vulnerability of the patients, physicians should be given every opportunity to monitor their patients taking these medications, and patients should have the benefit of their physicians having all relevant information.

Notifying the doctor can be a valuable tool for both the physician and the pharmacist, and can be done within the existing system of communication without disrupting the clinical and financial opportunities associated with substitution.

Below you will find a sample support letter for you to use.  If you’d like a fact sheet, just e-mail me and I’ll send it to you.

Why do I need your help?  There is a huge effort by a bunch of lobbyists in Sacramento to confuse the issues and convince legislators not to support physician notification of a biologic drug switch by a pharmacist.  At this point – it’s mainly pharmaceutical companies that are battling this out and so legislators are reluctant to vote on the legislation.  We need more patients and people that care about patients to engage.  My oncologists feel like what we’re doing is very important.  In fact, the fabulous Dr. Holbrook Kohrt actually wrote an oped for the LA Times because he is so incensed that there’s an effort to keep doctors from being told about the drugs going into their body.

Enough is enough.  This silly debate must end.  Please help me educate the legislators.  Sit down and scrawl out a letter today.  Heck – I don’t care if you just cut and paste the draft letter onto a piece of paper and sign it.  Ask all of your friends, family and random contacts to send a letter.  I need a mega grass roots campaign to go up against the thousands of dollars being spent by the opponents of doctor notification.

We need the letters to hit by the end of this week.  Can you do it?  Will you do it?  Please, please, please help.  Lives are dependent on this.  Someday, it could be mine….

SAMPLE LETTER

DATE

Senator Jerry Hill                                           SUPPORT SB 598 (HILL) –

State Capitol, Room 5064                               PATIENT ACCESS TO BIOSIMILARS

Sacramento, CA 95814

Dear Senator Hill,

I am writing in support of SB 598 which would update current law and allow pharmacists to substitute biologic medicines with a new and more affordable class of FDA-approved treatments called biosimilars.

For patients who suffer from one or more chronic illnesses, biologic medicines represent life-changing, and often lifesaving, therapies. They have improved quality of life, alleviated symptoms and reduced both disability and mortality rates. This new generation of treatments has transformed the health and lives of patients and has given them hope for recovery.

In the next couple of years, biosimilar medications are expected to enter the U.S. healthcare market. They are copies of an original biologic medicine and hold the promise of providing similar results as the original biologic at a lower price.  However, unlike generic drugs, biosimilars are not structurally identical to the biologic products they seek to copy; thus the name biosimilar. Due to the sensitive nature of biologics, the slightest variation from the original biologic medicine can result in an immune response or other patient side effects.

As important as these new therapies are to patients in California, it is just as important that public policy ensures the safety of the patients who rely upon them. That is why we are in strong support of SB 598. Specifically the bill would: 

·      Update California law to allow for greater patient access to life-saving, less costly, FDA-approved biosimilar medicines.

·      Allow pharmacists to substitute a biosimilar for a brand biologic when the biosimilar is deemed interchangeable by the FDA.

·      Require that a patient’s physician is notified when a biosimilar medicine is substituted for a medication the doctor originally prescribed.

·      Require pharmacists to keep a biosimilar substitution record on file for a period of 3 years

SB 598 is a common sense bill that will ensure that patients have access to life-saving, lower cost, FDA-approved biosimilars and also recognizes the importance of tracking and tracing the use of sensitive medicines in the event of an adverse patient reaction.

On behalf of patients who depend upon safe, affordable, effective medications for their health and well-being, I urge passage of SB 598.

Sincerely,

FIRST NAME, LAST NAME

TITLE (if relevant)

ORGANIZATION (if relevant)