Blog - Page 2 of 3 - Day-Storms, LLC

Weekly Guideline Update for 3/5/2025

Searching library for journals containing weekly guidelines

Each Wednesday, I bring you news concerning updates to guidelines and recommendations by professional societies. This list is not all-inclusive, of course, but the following recent updates caught my attention.

If there are any guidelines I have missed this week that you would like to see possibly included in future updates, please email me at jerm@day-storms.com.

National Cancer Comprehensive Network (NCCN)

The NCCN guidelines can be found at www.nccn.org.

Bladder Cancer Version 7.2024

The updated guidelines now endorse perioperative/sandwich immunotherapy with neoadjuvant cisplatin-based chemotherapy followed by radical or partial cystectomy in select cases. Additionally, a new adjuvant recommendation specifies that patients receiving preoperative gemcitabine + cisplatin + durvalumab should continue durvalumab postoperatively. The guidelines also integrate a new perioperative regimen table, categorizing gemcitabine + cisplatin + durvalumab pre-cystectomy, followed by durvalumab post-cystectomy as a Category 1 recommendation.

Bone Cancer Version 2.2025

The latest version of the NCCN guidelines includes updates to the discussion section to reflect algorithm changes.

Esophageal and Esophagogastric Junction Cancers Version 1.2025

The latest NCCN guidelines introduce several key updates. Preoperative chemoradiation is now the preferred approach for medically fit patients with high-risk cT2, N0 and cT1b–cT2, N+ tumors, while perioperative chemotherapy is now the preferred recommendation over preoperative chemoradiation for adenocarcinoma. Additionally, postoperative checkpoint inhibitor therapy is recommended in select cases following preoperative chemoradiation. Regarding NGS testing, the NCCN states that IHC/ISH/targeted PCR is preferred, but NGS testing may be considered if enough tissue is available for testing. The verbiage regarding liquid biopsy for disease surveillance has been modified to include the possibility when limited tissue is available or for patients who are not able to undergo a traditional biopsy.

Gastric Cancer Version 1.2025

The new NCCN guidelines include has removed preoperative chemoradiation as a primary treatment option for locoregional disease, with perioperative chemotherapy now preferred (category 1). Systemic therapy regimens have been updated, including clarifying dosing schedule for oxaliplatin. Liquid biopsy is recommended for patients when limited tissue is available or who are unable to undergo traditional biopsy.

Vaginal Cancer Version 5.2025

The latest version of the NCCN guidelines includes updates to the discussion section to reflect algorithm changes.

American College of Cardiology (ACC)/American Heart Association (AHA)

The 2025 ACC/AHA Guidelines for Acute Coronary Syndromes (ACS) introduce updates in antithrombotic therapy, lipid management, revascularization strategies, and procedural considerations. Ticagrelor or prasugrel is now preferred over clopidogrel in patients undergoing PCI, and ticagrelor monotherapy may be considered after one month in select patients to reduce bleeding risk. High-intensity statins remain the standard, with earlier integration of ezetimibe or PCSK9 inhibitors for LDL-C levels ≥70 mg/dL. The guidelines now recommend routine radial artery access over femoral access for PCI and emphasize intracoronary imaging for complex lesions. In STEMI, a strategy of complete revascularization is advised over culprit-only PCI. Additionally, microaxial flow pump use in cardiogenic shock is conditionally recommended, balancing reduced mortality with increased bleeding risk. Post-discharge, the guidelines reinforce early lipid reassessment and cardiac rehabilitation, including home-based options.

Department of Veterans Affairs (VA)/Department of Defense (DoD)

The VA/DoD Clinical Practice Guideline Version 3.0 for Rehabilitation of Individuals with Lower Limb Amputation introduces emphasizes a multidisciplinary, patient-centered approach and evidence-based rehabilitation strategies. It is interesting to note that all recommendations are either neutral or “weak for”, meaning that there are no “strong” recommendations. Recommendations include the expanded role of osseointegration for transfemoral amputees meeting eligibility criteria and the use of intraoperative perineural catheters to reduce post-amputation pain. The guideline also reinforces structured rehabilitation in inpatient settings over home-based care, promotes peer support programs to improve psychosocial outcomes, and highlights the importance of cognitive assessment in determining prosthetic candidacy. Additionally, mirror therapy is now recommended for managing phantom limb pain, and updated prosthetic recommendations favor microprocessor knee units for prosthetic ambulators to reduce falls and enhance mobility. These updates reflect a stronger emphasis on personalized rehabilitation pathways, pain management strategies, and advanced prosthetic technologies to optimize long-term function and quality of life.

← Back

Thank you for your response. ✨

This is for informational purposes only. Publication does not constitute endorsement by Day-Storms, LLC or its employees of any particular product or service offered by a company, association, or society listed within the publication. To learn more about Day-Storms, LLC, please check out our Services Provided.

Jerm Day-Storms, PhD, MWC

Contact me: jerm@day-storms.com | (863) 279-7910

Weekly Guideline Update for 2/26/2025

If there are any guidelines I have missed this week that you would like to see possibly included in future updates, please email me at jerm@day-storms.com.

National Cancer Comprehensive Network (NCCN)

The NCCN guidelines can be found at www.nccn.org.

Breast Cancer Risk Reduction Version 2.2025

In the most recent update, the NCCN has updated the discussion section to better align with algorithm changes.

Melanoma: Uveal Version 1.2025

The updated NCCN include changes in risk stratification, metastasis surveillance, and systemic therapy. The classification of distant metastasis risk has been revised, emphasizing PRAME expression as a modifier, with Class 1B tumors or PRAME+ status now categorized as medium risk. Surveillance recommendations specify contrast-enhanced MRI as the most sensitive imaging modality for liver metastases, with alternative imaging options based on institutional expertise. Terminology updates distinguish “hepatic-dominant” versus “non–hepatic-dominant” metastatic disease. Systemic therapy updates include guidance on nivolumab and hyaluronidase-nvhy, now an option for subcutaneous administration in place of IV nivolumab, though not for concurrent use with ipilimumab.

Myeloid/Lymphoid Neoplasms with Eosinophilia and Tyrosine Kinase Gene Fusions Version 1.2025

The updated guidelines expand the recognized clinical presentations of PDGFRB-rearranged neoplasms to include CMML, atypical CML, and MDS/MPN-unclassifiable cases. Diagnostic criteria have been refined to incorporate immunohistochemistry (IHC) for tryptase/CD117/CD25/CD30 and/or flow cytometry for CD117/CD25/CD30/CD2, along with KIT D816V molecular testing. In cases where standard testing does not detect PDGFRA or PDGFRB rearrangements, but the clinical phenotype strongly suggests their presence, the guidelines now support considering imatinib as a treatment option. Additionally, quizartinib has been added as a recommended tyrosine kinase inhibitor for FLT3-mutated disease. The language regarding the use of NGS has been modified to include RNA fusion panels and comparative genomic hybridization to identify gene fusion events that may not be detected by conventional testing methods.

Myeloproliferative Neoplasms Version 1.2025

The NCCN Guidelines Version 1.2025 for Myeloproliferative Neoplasms (MPNs) introduce several updates in diagnostic criteria, risk stratification, and treatment strategies. Notable changes include revisions to bone marrow cytogenetics, now allowing FISH in cases where bone marrow aspiration is not feasible. Updates to risk stratification models for myelofibrosis (MF) incorporate the myelofibrosis transplant scoring system (MTSS) to refine patient selection for allogeneic hematopoietic cell transplant (HCT). The guidelines also redefine anemia management in MF, adjusting ruxolitinib combination strategies and incorporating momelotinib as a preferred regimen in symptomatic patients. In polycythemia vera (PV) and essential thrombocythemia (ET), the role of pegylated interferons has been expanded, with ropeginterferon alfa-2b now a frontline option.

Systemic Mastocytosis Version 1.2025

The latest version of the guidelines includes revised criteria to align with the WHO 5th Edition and International Consensus Classification (ICC), refining diagnostic thresholds, including the REMA score for bone marrow biopsy necessity. The recommendation regarding cladribine as consideration for therapy has been relaxed. Additionally, the NCCN has updated the language regarding DEXA scanning for osteopenia/osteoporosis by removing the language indicating a prior diagnosis of osteoporosis/osteopenia was required for DEXA scanning.

American Heart Association (AHA) and American College of Cardiology (ACC)

The 2025 AHA/ACC Scientific Statement on competitive sports participation for athletes with cardiovascular abnormalities shifts from a paternalistic restriction model to a shared decision-making (SDM) approach, emphasizing individualized risk assessment.

Key updates include:

removal of universal sports disqualifications, particularly for genetic cardiomyopathies like HCM and ARVC, with data supporting lower-than-expected risks;
a more nuanced classification of sports based on endurance, strength, and collision risks rather than rigid categories;
incorporation of new data on myocarditis, allowing return to play sooner than the traditional 3-month restriction if cardiac inflammation resolves;
expanded inclusion of masters athletes (≥35 years old), given increased coronary artery disease risks; and
greater focus on race-related disparities in ECG interpretation and access to care.

Alzheimer’s Association

The Alzheimer’s Association recently published guidelines on the diagnosis, evaluation, and disclosure of Alzheimer disease (AD) and related dementias (ADRD) in primary care and general clinical practice settings, addressing prior gaps in standardized evaluation outside of specialty care. The guidelines emphasize patient-centered communication and a triadic clinician–patient–care partner model to improve disclosure and care planning. Integration of validated cognitive assessments and routine use of biomarker-supported diagnostics, including CSF and PET imaging, are recommended when standard evaluations yield uncertainty. The association also discusses a new risk-stratified diagnostic framework, shifting away from a binary diagnosis toward a probabilistic, syndrome-based approach. They have also enhanced recommendations for evaluating cognitive impairment in diverse populations.

The American Thoracic Society (ATS), U.S. Centers for Disease Control and Prevention (CDC), European Respiratory Society (ERS), and Infectious Diseases Society of America (IDSA)

The updated ATS/CDC/ERS/IDSA guidelines for tuberculosis (TB) treatment emphasize shorter and all-oral regimens for drug-susceptible and drug-resistant TB. For drug-susceptible pulmonary TB, a novel 4-month regimen with isoniazid, rifapentine, pyrazinamide, and moxifloxacin is conditionally recommended for patients aged 12 and older, offering an alternative to the standard 6-month regimen. Children and adolescents (ages 3 months to 16 years) with nonsevere TB can now be treated with a 4-month regimen instead of 6 months. For drug-resistant TB, new recommendations support the use of 6-month all-oral regimens containing bedaquiline, pretomanid, and linezolid (BPaL) or with the addition of moxifloxacin (BPaLM) as alternatives to conventional 15-month regimens.

American Society of Clinical Oncology (ASCO)

The 2025 ASCO guideline update on neoadjuvant chemotherapy (NACT) for newly diagnosed advanced ovarian cancer reinforces patient selection criteria and treatment sequencing to optimize outcomes.

Recommendations include:

refined selection criteria for NACT, recommending it for patients with high perioperative risk or low likelihood of complete cytoreduction, while primary cytoreductive surgery (PCS) remains preferred for fit patients with resectable disease;
histologic confirmation of invasive ovarian cancer before initiating NACT, with core biopsies preferred over cytology alone;
NACT regimen recommendations, with platinum-taxane doublet therapy remaining standard, and bevacizumab considered in select cases;
revised recommendations on interval cytoreductive surgery (ICS), emphasizing surgery after ≤4 NACT cycles in responsive or stable disease;
consideration of hyperthermic intraperitoneal chemotherapy (HIPEC) during ICS for stage III, good performance status patients; and
genetic and molecular testing at diagnosis to inform treatment, including FDA-approved maintenance therapies post-NACT.

BMJ Rapid Recommendations

The international expert panel of BMJ Rapid Recommendations strongly recommend against spine injections or joint radiofrequency ablation for non-cancer chronic back pain since such interventions provide little to no pain relief as compared with sham injections.

← Back

Thank you for your response. ✨

Jerm Day-Storms, PhD, MWC

Contact me: jerm@day-storms.com | (863) 279-7910

Weekly Guideline Update for 2/19/2025

If there are any guidelines I have missed this week that you would like to see possibly included in future updates, please email me at jerm@day-storms.com.

National Cancer Comprehensive Network (NCCN)

The NCCN guidelines can be found at www.nccn.org.

Cervical Cancer Version 3.2025 — The NCCN guidelines include significant updates for stage III-IVA disease, particularly regarding the use of pembrolizumab in combination with chemoradiation. For FIGO 2014 stage III–IVA (IIIA, IIIB, IVA), the addition of pembrolizumab to cisplatin-based or carboplatin-based concurrent chemoradiation is a category 1 recommendation. For select cases of FIGO 2018 stage IIIC with nodal metastasis but without defining tumor characteristics of FIGO 2014 IIIA–IIIB, pembrolizumab is a category 2B option. The guidelines clarify that when FIGO 2018 stage III aligns with FIGO 2014 IIIA/IIIB criteria, pembrolizumab + cisplatin (or carboplatin) should be considered a category 1 recommendation.

American Academy of Pediatrics (AAP)

The updated AAP guidelines on newborn screening for critical congenital heart disease (CCHD) now specify that screening should be performed only on newborns not receiving respiratory support, including those in the NICU, to reduce false-negative results. A screening “pass” now requires both pre- and postductal oxygen saturations to be ≥95%, eliminating the prior allowance for ≥95% in either measurement, which previously led to misclassification. Additionally, the new protocol reduces the number of screening attempts from three to one or two, enhancing sensitivity and ensuring earlier detection of CCHD.

National Institute for Health and Care Excellence (NICE)

The updated NICE guidelines on endometriosis include strengthening the recommendation for transvaginal ultrasound from a weak “consider” to a strong “offer” in primary care to detect ovarian endometriomas and deep endometriosis. Additionally, pelvic MRI is now recommended alongside transvaginal ultrasound in secondary care for diagnosing and assessing deep endometriosis. Referral criteria have been updated, with stronger recommendations to refer suspected or confirmed cases of endometrioma and deep endometriosis to specialist services. Notably, the guidelines now highlight a positive family history in first-degree relatives as a risk factor.

American Association of Clinical Endocrinology (AACE)

The updated AACE guidelines on the pharmacologic management of dyslipidemia include a conditional recommendation for the use of PCSK9 inhibitors (alirocumab, evolocumab) or bempedoic acid in patients with ASCVD or high-risk features who are not at LDL-C targets despite maximally tolerated statin therapy, while discouraging their use in lower-risk populations. Eicosapentaenoic acid (EPA) monotherapy is suggested for hypertriglyceridemia in high-risk individuals, whereas combination EPA/DHA and niacin are strongly recommended against. The LDL-C treatment goal remains <70 mg/dL for high-risk patients, with insufficient evidence to support more aggressive targets.

← Back

Thank you for your response. ✨

Jerm Day-Storms, PhD, MWC

Contact me: jerm@day-storms.com | (863) 279-7910

Weekly Guideline Update Archives

Below, you can find PDFs of weekly guideline updates prior to February 18, 2025.

20250212 GL update Download

20250205 GL update Download

20241106 GL update Download

20240918 GL update Download

20240911 GL update Download

20240814 GL update Download

20240807 GL update Download

20240619 GL update Download

20240626 GL update Download

20240612 GL update Download

20240605 GL update Download

20240529 GL update Download

20240522 GL update Download

20240515 GL update Download

20240508 GL update Download

20240424 GL update Download

20240417 GL update Download

20240327 GL update Download

20240320 GL update Download

20240313 GL update Download

20240306 GL update Download

20240228 GL update Download

20240221 GL update Download

20240214 GL update Download

20240207 GL update (1)Download

← Back

Thank you for your response. ✨

Pricing Transparency in Dossiers Increases Committee Trust

The Power of Pricing Transparency in Early Communication

Even if your product or test has not yet been approved by the FDA, transparency in pricing strategies stands out as a key differentiator when you ask a formulary committee or review board for a review.

The Format Executive Committee of the AMCP strongly advocates for pharmaceutical manufacturers to provide extensive product pricing information ahead of FDA approval. This approach is not just a regulatory requirement; it’s a strategic tool in healthcare decision-making processes. Manufacturers who do not supply a pricing strategy within Section 4.0 Economic Information (of AMCP Format 4.1) will be at a disadvantage.

Strategic Planning for Healthcare Decision Makers

Healthcare Decision Makers (HCDMs), including formulary committees and review boards, play a pivotal role in the integration of new pharmaceutical products into the health system. Early access to pricing information, presented as ranges or comparative figures, enables HCDMs to make informed decisions about drug coverage and reimbursement. Such proactive planning is essential in an industry where financial and clinical considerations are deeply intertwined. By aligning pricing strategies with market expectations and budgetary constraints, pharmaceutical companies can facilitate smoother market entry for new products.

Assessing Economic Impact Pre-Approval

The preliminary assessment of a pharmaceutical product’s economic impact is a critical step in the pre-approval phase. Manufacturers who share early pricing information provide HCDMs with crucial data to evaluate the cost versus benefit ratio of new drugs. This transparency helps in creating a more robust and strategic market introduction plan, ensuring that when a product is approved, it can be integrated into the healthcare system with a clearer understanding of its economic implications.

Navigating Uncertainties with Prudence

In the complex landscape of drug approval, where budget impact and cost-effectiveness models are often incomplete, initial pricing strategies offer a glimpse into the potential market dynamics. This pricing transparency approach allows pharmaceutical companies to present a preliminary economic perspective without making unsubstantiated claims about a product’s efficacy or safety. It’s a strategic balancing act that involves sharing enough information for informed decision-making while adhering to regulatory guidelines.

Building Trust through Confidentiality

In an industry where sensitive data is the norm, confidentiality is paramount. Implementing nondisclosure agreements allows for the secure sharing of sensitive pricing information. This practice not only protects proprietary information but also establishes a foundation of trust between manufacturers and HCDMs. It demonstrates a commitment to ethical practices and respect for the confidentiality of business information.

Rationalizing the Pricing Strategy

Explaining the rationale behind a product’s pricing strategy is crucial for creating a transparent narrative. This explanation helps HCDMs understand the value proposition of a product. By articulating factors like research and development costs, market positioning, and anticipated therapeutic benefits, pharmaceutical companies can provide a comprehensive view of their pricing decisions. This level of clarity is instrumental in building long-term partnerships and facilitating informed decision-making among HCDMs, but it does not mean that a manufacturer must give away their proverbial “secret sauce”.

Leading the Way in Pharmaceutical Transparency

Pricing transparency indicated by image of a magnifying glass with a medicine bottle and a dollar sign

As leaders in the pharmaceutical industry, there is a significant responsibility to pioneer transparency and foresight. Early and clear communication of pricing strategies not only facilitates strategic healthcare planning but also sets a standard for how pharmaceutical companies can positively impact patient care and health outcomes.

Embracing transparent pricing practices is more than adhering to regulations. By leading with transparency, pharmaceutical executives can contribute to a more informed, efficient, and ethical healthcare ecosystem. This is a strategic decision that enhances healthcare planning and ultimately patient care.

Do you have a dossier that you would like reviewed? Feel free to set up a time for a quick chat.

You can also check out our full list of Services Provided.

Securing Healthcare Payor Coverage: A Comprehensive Guide to Success

In the ever-evolving landscape of healthcare, securing favorable coverage from payors is more critical than ever. For healthcare innovators and product developers, understanding the nuances of payor dynamics is key to success. These essential strategies are needed to navigate and master the complexities of healthcare payor coverage.

Elevating Value Demonstration in Healthcare Products

business person entering in maze to secure coverage

The first and most critical step in securing payor coverage is to transcend beyond traditional product features and emphasize the overall value demonstration. This goes beyond just showcasing what the product does; it’s about illustrating how it can lead to significant improvements in patient outcomes and reduce overall healthcare costs.

In this context, demonstrating the clinical utility of your product is paramount. Clinical utility refers to the ability of your product to not only provide meaningful health outcomes but also to positively impact the decision-making process in clinical settings. This involves showing how your product can lead to better diagnostic accuracy, inform treatment choices, and ultimately improve patient care.

Highlighting the clinical utility of your product is essential because it directly correlates with the value proposition for healthcare payors. Payors are increasingly focused on not just the efficacy and safety of healthcare products but also on how they contribute to the effectiveness and efficiency of patient care. Demonstrating the clinical utility provides concrete evidence that your product is not only innovative but also practical and beneficial in real-world healthcare scenarios.

Developing a robust narrative that includes data and real-life examples of the clinical utility of your product can make a compelling case for payor coverage. It’s about presenting a complete picture that shows how your product can enhance the quality of healthcare delivery in a tangible, measurable way. By effectively communicating this, you stand a much better chance of securing the approval and support of healthcare payors.

The Power of Data-Driven Insights in Healthcare

In today’s data-centric world, relying on anecdotes or incomplete data is a strategy doomed to fail. Payors are seeking solutions backed by solid, evidence-based data. This means leveraging findings from well-designed clinical trials, real-world studies, and comprehensive health economic analyses.

Concrete, data-driven insights serve as powerful tools in negotiating coverage terms. They provide payors with the assurance that your product is not only effective but also backed by rigorous scientific research and real-world applicability.

Prioritizing Patient Access and Experience

A critical aspect often overlooked is the focus on patient access and experience. While securing payor coverage is essential, ensuring that the product is accessible, affordable, and convenient for patients is equally important.

Strategies aimed at enhancing patient access involve addressing not just the cost but also the ease of use, education, and support surrounding your product. By developing a patient-centric approach, you not only make your product more appealing to payors but also improve its overall market acceptance.

Engaging in Continuous Stakeholder Dialogue

The fourth and perhaps most dynamic strategy is the continuous engagement with stakeholders. This includes payors, patients, healthcare providers, and other key players in the healthcare ecosystem.

Establishing ongoing communication channels helps in understanding and adapting to the changing needs and feedback from these groups. It also allows for the identification of potential barriers to access and the opportunity to adapt your strategy accordingly. This continuous dialogue ensures that your product remains aligned with the evolving demands of the healthcare market.

The Path to Securing Coverage

Navigating the path to positive healthcare payor coverage requires a synergy of strategies focusing on value demonstration, evidence-based solutions, patient-centricity, and ongoing stakeholder engagement. By adopting these approaches, healthcare innovators can significantly increase their chances of securing favorable coverage, ultimately leading to the delivery of effective and evidence-based care to patients.

Incorporate these strategies into your healthcare product development and marketing plans to ensure your innovations receive the attention and endorsement they deserve from healthcare payors.

Contact me today to discuss how I can help you with your product!

Check out the services we offer!

Clear Objectives in Medical Writing Provides Precision and Clarity

Medical writing, with its intricate details, demands precision and clarity. Whether you’re drafting a research paper, a patient information leaflet, or a clinical trial report, establishing clear objectives is the cornerstone of a successful project. Here’s how to ensure your objectives are crystal clear:

Clear objectives are SMART

Outline of SMART goals: Specific, Measurable, Achievable, Relevant, and Time-based.

In the realm of medical writing, the stakes are high. Ambiguity can lead to misinterpretation, which can have serious consequences. Adopting the SMART criteria (Specific, Measurable, Achievable, Relevant, and Time-based) ensures that your objectives are not only clear but also actionable and trackable. For instance, instead of stating “We aim to study the effects of the drug,” a SMART objective would be “We aim to study the drug’s effects on 200 adult male patients over six months, measuring blood pressure changes weekly.” This specificity reduces ambiguity and sets the stage for success.

Use a three-step framework to align your project with broader goals

Medical writing projects often involve multiple stakeholders, from researchers to clinicians to patients. The writing project itself is typically part of a larger business goal. To ensure everyone is aligned, start by defining the desired outcome. For a clinical trial, this could be “determining the efficacy of drug X in reducing blood pressure.” Next, list the steps or actions needed, such as patient recruitment, drug administration, and data collection. Lastly, determine the metrics or indicators of success, like a 10% reduction in blood pressure. This structured approach ensures that your objectives resonate with the broader goals of the project and are actionable. (For more on the three-step framework, check out the blog post “A 3-Step Framework for Writing Better Project Objectives“.)

Use clear language with examples to inform and engage your audience

The medical field is rife with jargon. While these terms are second nature to professionals, they can be confusing to others. For example, a company may use specific acronyms that are not industry standards. This can result in confusion for an external audience. When setting objectives, use straightforward language. Providing examples can further clarify your intent. This ensures that all stakeholders, from seasoned clinicians to laypersons, have a clear understanding of the objectives and can work towards a shared goal.

In conclusion, clear objectives are the backbone of any successful medical writing project. They provide direction, foster alignment among stakeholders, and set the stage for meaningful outcomes. By implementing the above strategies, you can ensure that your medical writing project not only starts on a solid foundation but also achieves its intended impact. So, as you embark on your next writing journey in the medical field, remember these strategies and set yourself up for success. Happy writing!

Do you have an interest in medical writing? Check out our other medical writing posts!

Do you have a medical communications project you need help with?

Contact me at jerm@day-storms.com today!

Mastering Committee Presentations with Clarity and Evidence

man in black suit and blue denim pants standing beside projector screen

In the medical and pharmaceutical sectors, committee presentations are a pivotal aspect of the decision-making process. Whether it’s a formulary committee, a med review board, or a new tech evaluation committee, the importance of a well-structured and evidence-backed presentation cannot be overstated.

Here’s a comprehensive guide to mastering your presentations:

Understanding the Importance of Critical Thinking

Critical thinking is not just about presenting facts but about constructing compelling arguments. It is essential to maintain productive communication, even when disagreements arise. Committee members might come with their biases, and the presenter has the responsibility to navigate these biases. Using logic and reason, combined with a deep understanding of the subject matter, can help present a clear and persuasive case.

The Power of Simplicity in Communication

Complex ideas need to be distilled into easily digestible information. Overloading professionals with jargon can lead to disengagement. While being thorough is essential, being clear is more important. Remember, simplicity does not mean diluting the content; it means making it accessible and understandable. Even though the committee members are professionals within their respective fields, their eyes will glaze over when inundated by acronyms, jargon, and legalese.

Engaging Stakeholders: Building Trust and Alignment

Stakeholder engagement goes beyond merely stating facts in committee presentations. It’s about fostering trust, aligning goals, and understanding the needs and concerns of the committee members and who they represent. Setting clear boundaries and managing expectations can pave the way for more productive discussions and outcomes. If possible, research the members of the committee to see what their goals and interests are.

The Art of Setting Clear Objectives

Every presentation should start with a clear objective. What do you aim to achieve with this presentation? Knowing the end goal ensures that the presentation remains focused, relevant, and impactful. Tailoring the message to meet the audience’s needs is crucial for engagement and understanding.

For example, the roles of P&T (pharmacy and therapeutics) committees have been expanding to include a broader range of considerations, including access, affordability, and quality. This means you may need to touch upon topics other than safety and efficacy within the presentation.

Evidence-Based Claims: The Cornerstone of Credibility

In the medical and pharmaceutical sectors, evidence-based claims are the gold standard. This cannot be stressed enough. Any claim or argument should be rooted in solid evidence. Backing up statements with credible sources and empirical data not only enhances credibility but also reinforces the strength of the argument. Determine the decision you want to influence and use your communication skills to guide the committee towards it.

For example, you are wanting to gain positive coverage by a major payor for a diagnostic genetic panel your company has developed for a specific condition. Your goal should be getting positive coverage for diagnostic genetic panel tests for that specific condition…NOT asking for positive coverage for your company’s test at the expense of a potential competitor’s test.

The Essence of Effective Committee Presentations

Mastering presentations in the medical and pharmaceutical sectors is a blend of art and science. It is communicating with clarity, backing arguments with solid evidence, and understanding the audience’s needs and biases. In this field, credibility is the most valuable asset. With the right approach, you can make a lasting impact and drive decisions in your favor.

By following the above guidelines and structuring your content effectively, you can ensure that your presentations are not only informative but also persuasive and impactful.

If you need help with getting payor coverage for your product, just email me at jerm@day-storms.com.

Day-Storms, LLC provides full medical writing and consultation services. For more information, check out our Services page.

Working with Ambiguity in Medical Policy Guidelines

yelling formal man watching news on laptop

Ambiguity within medical policy guidelines can be a challenging hurdle for healthcare professionals… not to mention medical writers. These guidelines, intended to provide direction for coverage decisions and appropriate patient care, can sometimes leave room for interpretation. Navigating such ambiguity requires a strategic and thoughtful approach to ensure accurate coverage decisions for the health plan as well as providing evidence-based patient care. The following key strategies can help effectively tackle ambiguity in medical policy guidelines.

Collaborative Expert Insights

When ambiguity arises, collaboration becomes a powerful tool. Engage in discussions with colleagues, subject matter experts, and even guideline creators themselves, if possible. Collaboration may seem a “no-brainer”, but I have seen issues arise when a well-meaning person has made assumptions from ambiguous guidelines.

By pooling diverse perspectives, you can gain a more comprehensive understanding of the guideline’s intent. I have had the pleasure of working with one group that proactively brought together team members from different departments and specialties to discuss these issues. Collaborative sessions can uncover nuances that might have been overlooked individually. Additionally, seeking expert opinions can provide valuable insights into potential interpretations and considerations.

Example:

Consider a scenario where a medical policy guideline provides limited guidance on the coverage of a new diagnostic tool. By gathering a team of radiologists, clinicians, and health economists, you can jointly analyze the guideline’s implications from different angles. This collaborative effort can lead to a holistic interpretation that considers the clinical, economic, and patient-centered aspects.

Evidence-Based Reasoning

In the face of ambiguity, evidence-based reasoning serves as “true North”. Thoroughly examine the available clinical studies, real-world data, and scientific literature related to the topic at hand. By aligning your interpretation with existing evidence, you can bolster the validity of your coverage decision. Analyze how the available data correlates with the guideline’s broader goals and objectives. Finally, clearly document your rationale because this can save many future headaches.

Example:

Suppose a medical policy guideline offers vague recommendations for the coverage of a novel immunotherapy drug. By conducting a systematic review of clinical trials and presenting data on the drug’s efficacy, safety, and long-term outcomes, you can craft a compelling case for coverage. Connecting the dots between the evidence and the guideline’s overarching goals can guide decision-making and may sway an indecisive P&T formulary committee member.

Contextual Analysis and Stakeholder Engagement

Understanding the broader context is essential when dealing with ambiguity in medical policy guidelines. Consider the patient population, the treatment landscape, and the healthcare system’s priorities. Engage with various stakeholders, including patient advocacy groups and healthcare administrators, to gain insights into the real-world implications of different interpretations.

Example:

Imagine a medical policy guideline that lacks clarity on the coverage of a rare disease treatment. By consulting patient advocacy groups and discussing the potential impact on patient outcomes, quality of life, and the healthcare budget, you can enrich your interpretation. Understanding the broader context enables you to make decisions that align with the healthcare ecosystem’s values.

Cracking the code of ambiguity in medical policy guidelines requires a multifaceted approach. Collaborative discussions with experts, evidence-based reasoning, and contextual analysis are powerful tools that empower healthcare professionals and medical writers to make accurate coverage decisions to help patients get appropriate care. By embracing these strategies, you can navigate the complexities of ambiguous guidelines and ensure that your decisions reflect the best interests of patients and the healthcare system.

If you need help with getting payor coverage for your product, just email me at jerm@day-storms.com.

Day-Storms, LLC provides full medical writing and consultation services. For more information, check out our Services page.

Top 3 Mistakes to Dodge When Navigating Positive Healthcare Payor Coverage

a healthcare worker measuring a patient s blood pressure using a sphygmomanometer

Securing favorable coverage from healthcare payors for your product demands a strategic approach. While working within the medical policy field, I have seen my share of products not covered by payors even though the manufacturer felt confident the evidence supported it.

Here are three pitfalls to evade:

Underestimating Value Demonstration

Convincing healthcare payors goes beyond highlighting product features. Neglecting to showcase how YOUR product significantly improves patient outcomes, reduces costs, or enhances overall healthcare quality can hinder success. Construct a robust case demonstrating the tangible value your product brings to the table.

Focusing on how your product is better than a competitor’s does NOT guarantee positive coverage by health plans and hospital systems. Instead, you can come across like a used car salesperson.

Disregarding Data-Driven Insights

Relying solely on anecdotes or incomplete data won’t cut it. Payors seek evidence-based solutions. Avoid the mistake of overlooking comprehensive data from well-designed clinical trials, real-world studies, and health economic analyses. Concrete data is a persuasive tool in negotiating coverage terms.

In another post, I will cover this point in greater detail–it is THAT important to securing positive payor coverage.

Overlooking Patient Access

While engaging with payors is crucial, don’t forget about the patients. Failing to address affordability, convenience, and availability can undermine coverage efforts. Develop strategies to ensure your product is accessible and beneficial for patients, enhancing its appeal to payors.

Remember, the path to positive payor coverage involves a synergy of value, evidence, and patient-centricity. Focus on those rather than delving into a diatribe against a competitor or than throwing every piece of data at the reviewer.

By steering clear of these missteps, your product can garner the attention and endorsement it deserves from healthcare payors. The ultimate goal is to provide the patient with appropriate, evidence-based care. 💼

If you need help with getting payor coverage for your product, just email me at jerm@day-storms.com.

Day-Storms, LLC provides full medical writing and consultation services. For more information, check out our Services page.