KLSC to Senate: Pass House Bill 330 to Combat Prescription Drug Abuse in Kentucky

Access to innovative medicines critical to curbing improper opioid use and addiction

Frankfort, Ky. (March 24, 2016) – Today the Kentucky Life Sciences Council (KLSC), the Commonwealth’s leader in developing the life sciences industry, called on the State Senate to bring House Bill 330 to passage this session.

“Innovations in the health care industry have provided patients and providers with new medicines to treat pain more effectively,” said Dr. Kyle Keeney, president and CEO of the Kentucky Life Sciences Council. “Unfortunately, people have found ways to misuse and abuse these medicines. In Kentucky, we now face a very serious prescription drug abuse epidemic that is taking lives and hurting our communities.”

House Bill 330 seeks to address this epidemic by increasing access to a new type of prescription medicine that has entered the market in recent years, thanks to advances in science in and medicine. Abuse-deterrent opioids—commonly referred to as ADOs—are reformulated versions of common opioids, such as hydrocodone, oxycodone and morphine. ADOs have built-in technology that prevents potential abusers from crushing, injecting or smoking the medication, while still providing pain relief to patients with legitimate medical needs.

“ADOs could significantly lower abuse and addiction rates throughout Kentucky, but patients must be able to access them through their health plans. Despite the many proven benefits of ADOs, many Kentucky insurers currently refuse to cover them because they are, in some cases, more expensive than the non-abuse-deterrent formulations,” said Keeney. “In reality, this difference in cost is a small price to pay if it means saving lives and stopping prescription drug abuse in the Commonwealth.”

House Bill 330 passed the House last week with a 94 to 1 vote. Despite broad bipartisan support, the legislation has still not been called in the Senate.

“There have been many efforts over the years to curb prescription drug abuse and addiction—some of them more effective than others,” said Keeney. “Abuse-deterrent opioids represent an innovative approach, built on scientific research, to truly help Kentucky reverse this longstanding and dangerous trend once and for all. I strongly encourage our senators to bring House Bill 330 to the floor and pass this critical legislation in 2016.”

About KLSC
The Kentucky Life Sciences Council (KLSC) is a statewide association focused on developing the life science industry in Kentucky. KLSC works to educate both state and federal policymakers, the media, and the public about how legislative policies will affect the growth and development of the life sciences industry.


BIO & Kentucky Life Sciences Council Support Bill Ensuring Patient Access to Interchangeable Biologic Medicines

BIO & Kentucky Life Sciences Council Support Bill Ensuring Patient Access to Interchangeable Biologic Medicines

Frankfort, KY (March 17, 2016) – The Biotechnology Innovation Organization (BIO) and Kentucky Life Sciences Council (KLSC) today voiced support for Kentucky Senate Bill 134, legislation that properly preserves patient and physician access to accurate prescription information, while promoting a competitive market for complex biologic medicines.

This important piece of legislation gives pharmacists the ability to substitute lower cost interchangeable biologic medicines while safeguarding the primacy of the physician-patient relationship and maintaining communication between patients and their treatment teams.

The policies outlined in the bill align with BIO’s principles on biologic substitution, therefore BIO and KLSC support this legislation and are grateful for bipartisan support and leadership on this issue.

Following today’s House Health and Welfare Committee hearing, BIO and KLSC highlight four key points pertaining to biosimilars:

  • The full spectrum of biologic medicines are safe and effective: Similar to innovator biologics, interchangeable biologics will provide patients opportunities to address their unmet medical needs
  • Substitution should occur only when the FDA has designated a biologic product as interchangeable
  • Biosimilars and interchangeable biologics are not generics: interchangeable biologics will be highly similar to the innovator biologic medicines they seek to replicate but not exactly the same. Therefore the policy issues surrounding these medicines are different than those associated with generic medications
  • Communication between physicians, patients and pharmacists, as well as all appropriate parties in the patients care continuum, is imperative so that any immunogenicity issues or adverse reactions from innovator biologics, biosimilars or interchangeable biosimilars can be documented and appropriately addressed

“We are pleased to see Kentucky legislators leading the way in adopting policies that not only support a growing industry in our state, but more importantly allow patients access to safe and effective therapies to treat chronic conditions,” said Kyle Keeney, Executive Director of the Kentucky Life Science Council. “We encourage the House of Representatives to pass this legislation that will allow for more treatment options with potential cost savings and will also improve patient safety by ensuring that the prescribing physician is always notified of the exact medication dispensed.”

“Ensuring access to these potentially life-saving medications is a shared goal with patient groups and both innovator biologic and biosimilar manufacturing companies,” said Patrick Plues, Senior Director, State Government Affairs, BIO. “Due to the complexities of biologic medications, existing Kentucky laws governing generic substitution cannot be applied to biosimilars and we must address this issue prior to interchangeable biologics coming to market.”

While the U.S.  Food and Drug Administration (FDA) oversees approval of biologic medicines and designation of interchangeability, policies governing whether one product may be substituted in place of a doctor’s prescription and whether a pharmacist must inform patients and doctors are covered by state law.

Patients and physicians managing chronic conditions are generally aware of which biologic treatments work best in their unique circumstances. Communicating with patients and physicians allows everyone involved the opportunity to discuss past treatment experiences so that any possible unexpected issues can be better understood and avoided.

As the Kentucky Legislature continues to address issues related to biologic medicines, BIO and KLSC encourage policy makers to continue to put patients first.

About KLSC

The Kentucky Life Sciences Council (KLSC) is a statewide association focused on developing the life science industry in Kentucky. KLSC works to educate both state and federal policymakers, the media, and the public about how legislative policies will affect the growth and development of the life sciences industry.

About BIO

BIO is the world’s largest trade association representing biotechnology companies, academic institutions, state biotechnology centers and related organizations across the United States and in more than 30 other nations. BIO members are involved in the research and development of innovative healthcare, agricultural, industrial and environmental biotechnology products. BIO also produces the BIO International Convention, the world’s largest gathering of the biotechnology industry, along with industry-leading investor and partnering meetings held around the world. BIOtechNOW is BIO’s blog chronicling “innovations transforming our world” and the BIO Newsletter is the organization’s bi-weekly email newsletter. Subscribe to the BIO Newsletter.

PhRMA Releases New Policy Solutions for Delivering Innovative Treatments to Patients

Washington, D.C. (March 10, 2016) — Today, at the Pharmaceutical Research and Manufacturers of America (PhRMA) 2016 Annual Meeting, PhRMA president and CEO Stephen J. Ubl announced the association’s policy solutions for delivering innovative treatments to patients.

“I am a passionate believer in the power of biomedical innovation to save and improve lives,” Ubl said. “We are on the cusp of a golden era in medical discovery and have the potential to revolutionize the treatment of costly and debilitating diseases. But we can’t take this progress for granted.

“Now is the time for PhRMA to play a leadership role in advancing pragmatic, pro-consumer policies that enhance the private market and address costs holistically.”

The proposals in the policy framework are aimed at modernizing the drug discovery and development process, promoting value-driven health care, engaging and empowering consumers and addressing market distortions.

“We need to improve on the competitive market to build a sustainable, health care system that stems the growth of chronic disease and fosters the development of tomorrow’s cures.”

The policy solutions for delivering innovative treatments to patients include:

  • Modernizing the Drug Discovery and Development Process –Pro-patient, pro-science, pro-market reforms at the Food and Drug Administration would enhance the competitive market for biopharmaceuticals, drive greater efficiency in drug development and discovery and help hold down costs for payers and consumers.
  • Promoting Value-Driven Health Care – Payers face challenges in paying for the value of prescription medicines because regulatory barriers impede open communication by manufacturers, predictability regarding the biopharmaceutical pipeline, and innovative contracting. Value-driven payment for prescription medicines can promote efficiency and affordability by ensuring that more patients receive the best treatment for them, the first time around. We need to remove the hurdles making it difficult for innovative, sensible payer/manufacturer arrangements to emerge.
  • Engaging and Empowering Consumers – A well-informed consumer is an engaged and empowered patient. We need to make more information on health care out-of-pocket costs and quality available to patients. In addition, vulnerable patients should have the protection of enforceable, common sense rules that prevent discrimination and remove barriers to access. These steps will improve coverage and access and help make medicines more affordable to patients.
  • Addressing Market Distortions – The market-based U.S. health care system has worked well over time, but more can be done to help the market work even better. Addressing distortions in the market – like the rapidly growing 340B program, or the risk adjuster for commercial insurance that does not account for prescription drug costs – would help preserve the safety net, revive the health care market and improve affordable access to medicines for patients.

The platform can be viewed online here: http://phrma.org/sites/default/files/policy-solutions.pdf.

About PhRMA

The Pharmaceutical Research and Manufacturers of America (PhRMA) represents the country’s leading innovative biopharmaceutical research companies, which are devoted to discovering and developing medicines that enable patients to live longer, healthier, and more productive lives. Since 2000, PhRMA member companies have invested more than $600 billion in the search for new treatments and cures, including an estimated $51.2 billion in 2014 alone.

340B Hospital Savings Come at the Expense of Oncology Practices

By Kyle Keeney

Are hospitals fueling drug spending as they buy up oncology practices? This important question is the focus of a recent Modern Healthcare article. A new analysis of private insurance claims indicates that the answer is yes.

What is missing from the article is context around why so many oncology practices are being bought out by hospitals in the first place. The federal 340B drug pricing program is one of the primary drivers behind this industry-wide shift.

Under 340B, drug manufacturers are required to provide outpatient medicines to eligible health care facilities at significantly discounted rates. Hospital systems can participate in the program, while oncology practices cannot.

Access to 340B gives hospitals a critical advantage over the independent and community-based oncology practices that have no choice but to pay market prices for the prescription medicines their patients need to survive.

The cost-savings and profits that hospitals reap from 340B come at the expense of cash-strapped oncology practices, which are increasingly being forced to shut their doors or be bought out by large hospital systems.

This is not to say that we should throw out 340B. It serves an important purpose, and has helped many patients access the medications they need to be healthy. But the negative impacts it is having on oncology practices and the cost of health care nationwide warrant a closer look at the program.

Kyle Keeney is executive director of the Kentucky Life Sciences Council.

A generic approach to biosimilar substitution won’t do

This piece originally appeared on Medical News.

In Kentucky you don’t have to look far to find the positive impacts of health care innovation.

From preventative medicines to new cures, advances in medical technology have been the driving force behind significant improvements in patient health. But as new treatment options are introduced to the market, protecting patient safety has never been so important.

This year, the General Assembly is considering legislation that would establish a much-needed framework of regulations for biologics and biosimilars – breakthrough treatments that could help many people living with chronic diseases.

Unlike oral pills or tablets, which are made from chemically derived ingredients, biologics are complex treatments manufactured from living organisms – cells programmed to produce a desired therapeutic substance in a highly controlled, sterile environment.

While drug manufacturers are able to create chemically identical copies of pharmaceutical medicines such as oral pills – think generic versions of brand name drugs – the same isn’t true for biologics because they are made from living materials that cannot be perfectly duplicated.

Drug manufacturers can, however, create a version of a biologic that is so close to the original medicine it may be deemed a biosimilar. This could benefit many patients with chronic diseases, as biosimilars are expected to cost significantly less than biologics.

SB 134, in its originally intended form, would establish much-needed guidelines for substituting an interchangeable biosimilar to ensure patient safety. This includes ensuring that substitution would occur only when the FDA has designated a biosimilar as interchangeable; that the prescribing physician would be able to prevent substitution if he or she feels it is not in the patient’s best interest; that pharmacists would be required to communicate what product was dispensed with the prescribing physician; that the patient, or the patient’s authorized representative, would, at a minimum, be notified of the substitution; and that the pharmacist and the physician would keep records of the substitution.

Given the complex nature of biologics and the challenging medical conditions they treat, these are commonsense guidelines to ensure that doctors, patients and pharmacists are all informed about the medications that are prescribed and ultimately dispensed to the patient.

Biologic medicines are an important new tool in treating and curing disease. Biosimilars are also important for providing different and sometimes less expensive options for treatment.

But let’s be clear. Patient safety and ensuring physician involvement is far more important than helping the insurance company’s bottom line.

Legislators should pass SB 134 as it was originally intended. Common sense dictates that we make sure physicians are informed about what products their patients are using to treat their life threatening and chronic illnesses.

Kyle Keeney is the Founder and Executive Director of the Kentucky Life Sciences Council.

Biosimilars: A Cost-Effective Treatment Option for Kentuckians with Chronic Diseases

In Kentucky, you don’t have to look far to see medical innovation in action. Innovation in the health care industry has helped to discover new cures and treatments, and ultimately, save lives.

As new and improved medicines are introduced to the market, patient safety has never been so critical.

This year, Kentucky’s General Assembly is poised to consider legislation that would establish a much-needed framework of regulations for biosimilars to ensure patient safety as these new medicines become available.

A biosimilar is a biologic that, as the name suggests, is highly similar to another biologic drug already approved by the FDA.

Biologics are medicines made by or from living cells though highly complex manufacturing processes. They are used to prevent, treat, diagnosis or cure a variety of serious illnesses including cancer, chronic kidney disease and rheumatoid arthritis.

The interchangeable biosimilars are sometimes a much more cost-effective treatment option than biologics for Kentuckians living with chronic diseases. However, Kentucky does not currently have sufficient measures in place to protect patient safety when a pharmacist feels that dispensing a biosimilar is in a patient’s best interest.

Kentucky should consider legislation that would allow for substitution of interchangeable biosimilars but also require communication between the pharmacist and prescribing physician on which product is dispensed. This will ensure patient safety, transparency and accurate patient records are maintained.

Kyle Keeney, Executive Director of the Kentucky Life Sciences Council

2016 Cap the Copay Bill Will Ensure Kentuckians Have Access to Life-Saving Medications

Access to coverage has expanded under the Affordable Care Act, but many Kentuckians are still struggling to afford the treatments they need to stay healthy.

This year’s Cap the Copay bill will be updated to address fiscal concerns raised by some health plans and other organizations. But the original intent of the legislation remains the same: creating coverage options that better meet the needs of Kentuckians who depend on prescription medications.

Under the current setup, insurers often place some life-saving medications on specialty tiers – a practice called “co-insurance.” Doing so can unfairly burdens patients with excessive and unexpected out-of-pocket costs which may put medications financially out of reach.

The new Cap the Copay legislation would provide Kentuckians a much needed choice when picking their health so that they are offered more reasonable copays for the medications prescribed by their doctors.

Additionally, the 2016 bill will:

  • Require 25 percent of plans per metal tier (Silver, Gold and Platinum) – or the equivalent tiers for a private/employer plan – to offer only copays for prescription medications and to cap these copays at one-twelfth of the plan’s annual out-of-pocket maximum cost. This means the cap would be one-twelfth of the annual out-of-pocket maximum per prescription.
  • Require at least one plan per metal tier to offer only copays for prescription medications. These copays would be capped at one-twelfth of the plan’s out-of-pocket maximum. Prescription medications will not be subject to a deductible.
  • Exclude all Bronze plans from these requirements. The legislation only impacts Silver-tier plans and above.

Kentuckians living with chronic diseases should not have to choose between paying for a life-saving medication and having enough money to cover groceries, gas and bills each month.

People purchase insurance with the assumption that it will provide reasonable coverage for the treatments they need. If passed, the 2016 Cap the Copay bill will ensure that this is really the case.

Kyle Keeney, Executive Director of the Kentucky Life Sciences Council