TKG PACT Executive Briefings - 3-Minute Market Insights

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Introduction to Gene-Editing Therapy: CRISPR

CRISPR is a relatively new medical advancement that was inspired by the natural defense mechanism found in some microbes, such as bacteria. To protect themselves against invaders like viruses, these microbes capture snippets of the intruder’s DNA and store them away as segments called CRISPRs, or Clustered Regularly Interspersed Short Palindromic Repeats. If the same germ tries to attack again, those DNA segments (turned into short pieces of RNA) help an enzyme called Cas find and slice up the invader’s DNA. 

In the laboratory, the CRISPR process consists of two main components: a DNA-cutting enzyme called “Cas9” modified with an added guide RNA. The guide RNA is engineered to mirror the target DNA of the gene to be edited. The guide RNA seeks for and locates, the target DNA. When the guide RNA finds an exact match, the Cas9 enzyme cuts, or modifies the target DNA. 

Need more information? As always, if you need a deeper dive into any of these topics, please don’t hesitate to reach out. 

Check out @The Kinetix Group‘s growing library of TKG PACT Executive Briefings where you can listen and download the companion PDF infographics.

https://tkgpact.com/executive-briefings/

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Introduction to Targeted Therapies: CAR T-cell Therapy 

T-cell Transfer Therapy is a special type of immunotherapy that takes a person’s own T-cells (a type of immune cell), adds specific antigens to the T-cells that can identify the cancer cells,  and puts them back into the person’s body. Cancer cells express unique antigens (signaling proteins). T-cells are programmed in the lab to find those signals and deliver a cancer stopping treatment right to the individual cancer cell. There are two main types of T-cell transfer therapy: tumor-infiltrating lymphocytes (TIL) and CAR T-cell Therapy. 

Targeted therapies are evolving rapidly and are increasingly more patient specific, as well as significantly more complex to manufacture and deliver. With any of these therapies, life science companies may need to thoughtfully consider strategies for addressing market access needs, patient journey issues, and the complexities of clinical care delivery protocols. 

Need more information? Please email us at [email protected]

Check out @The Kinetix Group‘s growing library of TKG PACT Executive Briefings where you can listen and download the companion PDF infographics.

https://tkgpact.com/executive-briefings/

Send us a text

Provider Insights on the Impact of 340B Pricing.

We frequently get asked for insights on how the 340B Drug Pricing Program may... or may not... be impacting the prescribing choices of participating covered entities. The Health Resources and Services Administration (HRSA) administers this federal program which is intended to help safety-net providers carry out their missions to serve their communities. 

The Kinetix Group (TKG) recently conducted a market access research study to gain insights from healthcare providers on how the 340B program is impacting care delivery in covered entities. You can reach out to us for the full study, but a few of the highlights from our study are included in this briefing

You can download the full Executive Briefing at:  https://tkgpact.com/executive-briefings/

Or, feel free to email us at [email protected] 

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Today’s topic is the The Federal NOPAIN Act.

The Federal “Non-Opioids Prevent Addiction In the Nation Act” (or, the “NOPAIN Act”), Senate bill S.586, was signed into law in December 2022. It takes effect this coming January as part of the Centers for Medicare and Medicaid Services 2025 OPPS proposed rule. 

The NOPAIN Act directs CMS to reimburse hospital and surgical centers separately for non-opioid, post-surgical pain control, in hopes of reducing or replacing opioid consumption. By separating, or “unbundling,” payment for non-opioid pain control, hospitals and surgical centers may receive additional reimbursement for non-opioid alternatives, encouraging the use of substitute means of pain control. This helps to ensure that non-opioid options are more widely available to individuals as a post-surgical treatment option.

You can download the full Executive Briefing at:  https://tkgpact.com/executive-briefings/

Or, feel free to email us at [email protected]

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The High-Value Pharmacy Enterprise Framework.

The High-Value Pharmacy Enterprise Framework is a collection of evidence-based and expert recommended best practices designed to enhance health system pharmacy operations by ensuring safe, effective, and patient-centered medication management throughout the health-system pharmacy enterprise. It is gaining in popularity due to the many patient safety, operational, and cost efficiencies it brings to health systems that embrace the model. 

The HVPE framework is built around 8 Domains of essential pharmacy practice elements that are established best practices for health-system pharmacies. The framework contains a total of 94 operational statements and 336 performance measures within these 8 domains.

You can download the full Executive Briefing at:  https://tkgpact.com/executive-briefings/

Or, feel free to email us at [email protected]

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Introduction to Targeted Therapies: Monoclonal Antibodies

Targeted Therapy is the foundation of Precision Medicine. Targeted therapy is a type of personalized treatment that targets specific proteins that control how cells grow, divide, and spread. 

Antibodies are produced naturally by our body and help the immune system recognize cells that cause disease, such as bacteria and viruses, and mark them for destruction. Antibodies can be engineered in the laboratory to find and attach themselves to specific targets, called antigens, found on cancer cells. They are made to recognize and bind only to a very specific antigen target. 

This week's episode highlights three important terms you may be hearing: Antibody-Drug Conjugates, Monoclonal Antibodies, and Bispecific Antibodies.

You can download the full Executive Briefing at:  https://tkgpact.com/executive-briefings/

Or, feel free to email us at [email protected]

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All 50 states now allow pharmacists and physicians to enter into Collaborative Practice Agreements (CPAs) in which one or more pharmacists establish a formal relationship with a prescriber, in which the prescriber can delegate specific tasks to a pharmacist under negotiated conditions, which would not otherwise be permitted under the pharmacist’s normal scope of practice

Although state laws vary, generally, CPAs allow prescribers to delegate specific patient care tasks to pharmacists. The pharmacist’s scope of practice under a CPA is generally defined by established protocols that are condition or disease specific. For example, under a CPA, pharmacists many be empowered to perform patient assessments, order laboratory tests, prescribe drugs, counsel patients,  and make referrals for related care. They may also be permitted to select, initiate, monitor, continue, discontinue, adjust, and refill therapy regimens.

You can download the full Executive Briefing at:  https://tkgpact.com/executive-briefings/

Or, feel free to email us at [email protected]

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When a physician prescribes an expensive specialty medication for a patient, the traditional distribution process was for the provider to purchase the medication, administer it to the patient, and then bill the insurance company for the drug. This “buy-and-bill” process has been utilized for many years. 

In recent years, and to help control costs, third-party payers have mandated that the medications come from their own pharmacies where they have more control over the acquisition price of the drugs. This is especially prevalent for expensive, specialty pharmaceuticals. 

Various alternatives of this approach have been referred to as “bagging”. In this episode, we define the different types of "bagging" that you may be hearing about.

You can download the full Executive Briefing at:  https://tkgpact.com/executive-briefings/

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Laboratory Benefit Managers have emerged over the past decade to fill the need to manage complex and expensive laboratory testing for payers. They have become the new Precision Medicine Gatekeepers. 

Results from over 14 billion diagnostic tests are estimated to influence 70% of today’s clinical decisions. It’s estimated that there is both overutilization of testing in approximately 20% of cases, and underutilization of testing in approximately 45% of cases. Laboratory Benefit Managers have improved Next Generation Sequencing test payment turnaround times, but also have increased denial rates. 

You can download the full Executive Briefing at:  https://tkgpact.com/executive-briefings/

Or, feel free to email us at [email protected]

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The term therapeutic inertia describes the failure of health care providers to initiate or intensify therapy when it is clearly indicated by established guidelines. The term has largely been applied to the management of blood pressure, blood sugar, and cholesterol, by primary care physicians who recognize the need for their patients to control these conditions but fail to act sufficiently to achieve the guideline recommended therapeutic targets. Despite clearly articulated, evidence-based, clinical guidelines, some physicians fail to translate this knowledge into practice. We believe that therapeutic inertia plays a significant role in delaying the adoption of many new treatments. 

Most practitioners function within a “personal comfort zone” of prescribing behavior, being reluctant to take unnecessary risks with new drugs. There is a natural “learning curve,” where clinicians need to learn the side effect profiles and characteristics of new drugs, as well as to be assured that the drugs perform as promised.

You can download the full Executive Briefing at:  https://tkgpact.com/executive-briefings/

Or, feel free to email us at [email protected]