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The committee met to take up and consider bills. This report focuses only on the bills listed below.
 
 
HB 1282 – Zerwas, Relating to a human papillomavirus-associated cancer strategic plan developed by the Department of State Health Services.

  • Directs DSHS to gather information and does not grant the agency any authority to take any further action
  • The legislature can take action, if desired, after reading the report
  • DSHS is planning to address HPV cancers in their next biennial budget so this will help them to develop their LAR
  • DSHS will be required to study ways to reduce morbidity and mortality from HPV associated cancers
  • Also includes a list of medical schools that will be available to assist the work group
  • Crownover asked if Zerwas is absolutely positive that this bill does not mandate anything
    • Absolutely
  • There is no more effective way to prevent cancers than the uptake of this HPV vaccine
  • Coleman commended Zerwas for including CPRIT in this effort

 
Bill left pending
 
HB 751 – Zerwas, Relating to the prescription and pharmaceutical substitution of biological products.

  • Bill has gone through a couple of iterations and there is a committee substitute
  • Committee sub laid out
  • Biologics are an emerging class of medicine; they can treat a person by directing cells in their body to act in a particular way
  • Biologics have proven to effectively treat multiple diseases
  • Congress has created an expedited licensure pathway for follow on biologics or biosimilars
  • FDA has approved a biosimilar already and there are four other applications pending
  • Texas regulates dispensation and substitutions but current law does not contemplate the existence of biosimilars
  • Gay Dodson has testified that legislation is necessary to authorize substitution of biosimilars
  • Biosimilars offer a lower cost method for treatment of these diseases
  • HB 751 updates substitution laws for generic drugs so that patients have access to biosimilars
  • Similar legislation has passed in 10 states and is on the way to being passed in 12 other states
  • The bill limits substitution to only those biosimilars that are determined to be interchangeable by the FDA
  • Existing laws for generics already requires patient notification and allows doctors to indicate “brand medically necessary” to prevent substitutions; same protections are offered in the bill
  • Bill requires communication between the pharmacist and the prescribing specialist to show the specific product dispensed
  • The committee substitute includes a provision to Sunset the required communication after 4 years
  • Various patient groups asked for definition of a reasonable time to notify the prescribing specialist; defined as 5 business days
  • Adds a requirement that the Board of Pharmacy provide a link on their website to FDA approved biosimilars
  • Reference to “practitioner” has been changed to the plural form and “pharmacist’s designee” has been included as an authorized person to make the notice to the prescribing practitioner
  • Committee sub includes “information submitted for the payment of claims” to the list of acceptable means with which the communication to the prescribing specialist can be made
  • The recent biosimilar that was approved was a substitute for Neupogen; Zerwas provided this drug to his wife when she was going through cancer treatment
  • Drugs will be entering into the marketplace to provide safe, cost-effective care for patients in the US
  • Naishtat asked if there are side effects associated with biological products
    • Yes; like any medication, side effects vary depending on the patient and the rate of infusion in this case
  • Naishtat noted in recent session the legislature determined they should wait for FDA regulation on this issue  
    • The FDA has now approved the first biosimilar product which will be used in cancer centers and other places; there are several others on the way to FDA approval; need to have a body of law in the state to authorize these substitutions

 
Chase Bearden, Coalition of Texans With Disabilities

  • In support of the bill
  • The disability community is very excited about the progression of these biologic medications
  • In support of the communication piece that requires the physician notification in order to form a complete medical record

 
Tom Kowalski, Texas Healthcare and Bioscience Institute

  • In support of the bill
  • The 41 new medicines approved in 2014 alone show the rate at which new medications are being developed
  • The bill reflects good policy and will improve access to lower-cost medications

 
Cindy Brannum, Global Healthy Living Foundation

  • In support of the bill
  • Because of biologics the witness has been able to live past her expected lifespan
  • Very supportive of the communication and notification aspects of the bill because of the complexities of the diseases they treat
  • Excited to see what the future has in store in medical advances to help treat these diseases including biologics and biosimilars

 
Joe DeSilva, Texas Pharmacy Association

  • Testifying on the bill
  • Representing a coalition of multiple pharmacy groups including independents and large pharmacies
  • There is still an issue with the bill being worked out and that is the reason not testifying for the bill
  • Thought the legislation was premature last session and now it is time to pass it
  • The purpose of the bill is to allow pharmacists to substitute the drugs when appropriate
  • The requirement for pharmacists to notify physicians even if biologics are dispensed as prescribed creates a hurdle for pharmacies; it is always the goal to dispense as prescribed and if not, then have the discussion with the prescriber
  • Appreciate the inclusion of many of the revisions brought up with the committee substitute
  • Look forward to supporting the bill when the final version is out
  • Naishtat asked if the witness has a problem with the notification requirement
    • Do not have a problem with the notification of dispensing a substitute; that aspect is appropriate; working on the aspect related to notification when a prescription is filled based on what they prescribe
  • Crownover reiterated that the pharmacies have an issue with notification when dispensed as prescribed
  • Naishtat asked if the problem is the expense or the work
    • The workload; as biosimilars continue to come onto the market there could be quite a bit of work

 
Jim McKay, Sandoz – Generic Pharmaceuticals Division of Novartis

  • In support of the bill
  • World leader in developing biosimilars
  • First company to have a biosimilar approved in the US
  • FDA reported there are another 4 applications for biosimilars pending and another 2 for interchangeable biosimilars
  • The bill will pave the way for substitution biosimilars deemed to be interchangeable by the FDA
  • A recent study estimated $42 billion in cost savings over the next ten years due to substitution of biologic products; an important aspect of these cost-savings is automatic substitution
  • Sandoz opposed 2013 legislation because it did not provide a level playing field for all biologics and biosimilars
  • Proposal establishes communication on the specific product dispensed
  • Object to the plural form of “prescribers” which removes specificity

 
Thomas Felix, Amgen Inc.

  • In support of the bill
  • Amgen has 9 biosimilars in development; need to ensure there is confidence in the marketplace
  • There is a total of 5 biosimilars that are on the verge of approval so the time is right to pass this bill
  • There is almost complete consensus within the industry in support of the bill
  •  In the realm of biosimilars the FDA has made it clear there is a need to track the dispensing of these products which is a departure from the normal realm of generics
  • The industry is held accountable by ensuring when something goes wrong with a product the manufacturer is made aware of it
  • Coleman noted there was a similar fear regarding Coumadin and its generic which some people believed would not have the same effect; has that been resolved regarding narrow therapeutic index drugs
    • The greater generics experience has been successful; there has been concern about that narrow field of drugs; not sure if that has been resolved; the FDA has communicated that closely following these products is important
  • Coleman asked if the FDA has required it
    • They cannot require that
  • There is a balance in responsibility regarding traceability of products in the US; the FDA only has certain things they consider regarding traceability; states have the ability to improve traceability
  • Coleman noted he is for the bill and asked if Amgen was for the bill last session
    • Yes
  • Coleman noted the bill is very different today
  • The differences are the details related to pharmacist-physician communication; allowing a full spectrum of methods of communication
  • Coleman noted it required communication of a biosimilar prior to dispensing
    • That is incorrect; the 2013 bill asked for communication after the substitution
  • Coleman noted it is still different in a lot of ways
    • Working with pharmacies to see how that communication can occur; physicians and pharmacists do not always have an open line of electronic communication
  • Coleman asked why there was opposition from people who are now supportive
    • There was a concern in 2013 that communicating after the substitution would cause a dampening of the biosimilar marketplace
  • Coleman asked if the witness would be for the same communication regarding dispensing substitutes of narrow therapeutic index drugs if there was a chance of harm
    • Amgen does not produce narrow therapeutic generics; not an expert in legislation on generics in general
  • All medications have side effects; since biologics have the ability to react with the immune system there can be an immune response; a different concept than traditional pharmaceuticals and generics, a reason why there have to be clear records in place
  • There has been federal legislation that the FDA does not need to release guidance in order to progress the biosimilars pathway; the industry receives direct guidance from the FDA in meetings
  • The use of “prescribers” does not ensure there will be a direct communication between the physician and the pharmacy; it broadens the definition of the availability of information but decreases the specificity that ensure a patient and their physician are in the loop
    • The use of the “s” has not been passed in any other state’s legislation

 
Mark Godfrey, Eli Lilly and Company

  • In support of the bill
  • Echoes most comments made in support of the bill today especially those by Zerwas
  • Have good experience with biologics so far; need to be careful as new waters are delved into regarding biosimilars

 
Chris Nieto, Arthritis Foundation

  • In support of the bill
  • Described his experiences as a father of a child with juvenile arthritis
  • Child reacted positively to biologics which have helped her lead a better life
  • Naishtat asked about the notification and communication piece
  • Families need to have access to medicines to treat their children; want to look at all options and a lot of that has to do with cost; families best operate by having all the information possible in order to make the best decisions

 
Shannon Garrett, Self

  • In support of the bill
  • Suffers from rheumatoid arthritis
  • Important that patients are given access to biologics as soon as possible
  • Even with insurance, biologics are very expensive so access to biosimilars is important
  • Biologics are not normally dispensed by a neighborhood pharmacy
  • It is important to know what is going into your body and with similar drugs that are not identical it is even more important

 
Cam Scott, American Cancer Society Cancer Action Network

  • In support of the committee substitute
  • Interchangeable biosimilars have the ability to lower cost burdens on cancer patients
  • State pharmacy laws have to be amended to allow for substitution of biologics at pharmacies
  • Policies must ensure access and affordability of biosimilars for cancer patients
  • Physicians should have the ability to withhold consent for substitution
  • Prescribing physicians should be notified of substitution of biologics to create an accurate medical record
  • Patients need a safe, transparent process to access interchangeable biologics; creating a new pathway in Texas enhances patient access to new and potentially less costly medications

 
Chuck Clayton, Friends of International Cancer Advocacy Network (ICAN)

  • In support of the bill
  • Communication is a very important piece of this bill
  • It is wise to control costs but that needs to be done properly to ensure patients are receiving the best treatments
  • This bill is extremely important

 
Zerwas closed

  • There is a sense of urgency because biosimilars are entering the marketplace
  • There are only minor issues left to deal with on this bill

 
Bill left pending