Using the right tools to improve the formulary review process

Hurdles with data collection 

Sources of background information can include national guidelines, informed expert opinion, and tertiary resources. While many of the sources may be useful for background information, no single source should be relied on for concluding a treatment is effective without a thorough evaluation of the research literature. 

Another common obstacle that HCDMs face is when biopharma companies have not published all clinical trials for their product, leading to a gap in available data for review.³ When this issue arises, they often must reach out to the biopharma company to request access to the data.  

 Furthermore, HCDMs often spend significant time and resources to locate and gain access to information.  Critical information exists across many sites, making it challenging for HCDMs to locate and consolidate pieces of information. Additionally, there is a lack of easily accessible resources.⁴ HCDMs may have limitations within their organization as to which resources are available for use (e.g., subscription services covered by the org). Costly access to published articles can be prohibitive for some organizations and may not provide information that will impact the formulary decision.  

Finally, there may be questions or concerns with the quality of data available at time of review. Clinical trials are not always designed with an active comparator.⁵ A lack of active comparator results in time spent drawing indirect comparisons to available treatment options and pushes toward an economic review if products are considered equal. Determining the clinical significance is also a common topic for Pharmacy & Therapeutics (P&T) discussions, but the minimal clinically important differences in the outcomes are not always available as clinical trials endpoints.⁶   

How to improve efficiency in formulary review process 

It's important for a HCDM to evaluate clinical and economic resources thoughtfully, while leveraging resources which provide high-quality, unbiased, comprehensive data. FormularyDecisions, an online platform for HCDMs houses many useful tools and pieces of information in one place, saving time by creating efficiencies.  

The top four ways HCDMs are using FormularyDecisions to create efficiencies in their formulary process: 

1. Access pharmacy and medical coverage data for products 
2. Stay up to date on biosimilars through a dynamic repository of current state substitution laws and curated biosimilar resources 
3. Seamlessly request dossiers, clinical, and economic information from numerous biopharma companies
4. Information on  Academy of Managed Care Pharmacy (AMCP) Pre-approval Information Exchange (PIE) webinars 

eDossier’s hosted on FormularyDecisions can be a resource for comprehensive clinical and economic information that can act as a starting point for understanding the available data that support the research as part of the drug review process. eDossiers are digitized by the FormularyDecisions team to html format, making it easier to search or toggle to the content of interest. Rather than requesting dossiers individually from each biopharma company, the FormularyDecisions eRequest tool can be used to request dossiers from numerous manufactures, all from one place. The eDossier can also be used to facilitate directed discussions with the biopharma company to gain access to information that would be beneficial in the formulary review process.  

In addition to the eDossier provided by biopharma companies, there are many curated tools and resources. FormularyDecisions allows HCDMs to gather information from many resources in one place and can be used in concert with other proprietary HCDM resources (e.g., claims data).  

One exclusive tool is Product Snapshots, which are developed by clinical pharmacists and offer intel to help address some pain points in the decision-making process. Creation of the drug monograph to prep for P&T can be a drain on organizational resources. Product Snapshots are in an AMCP monograph format to include information on competitive product landscape, disease epidemiology, relevant ICD-10-CM codes, clinical trial results, and factors that could potentially impact patient uptake. FormularyDecisions has over 400 Product Snapshots available that can be leveraged to provide key product information, comparators, clinical trial summaries, and P&T Considerations (eg, suggestions on utilization management, prior authorization criteria, and opportunities for value-based contracting). 

FormularyDecisions also provides metasearch results to quickly link eligible users to credible primary and secondary resources (eg, ClinicalTrials.gov, PubMed, JAMA, etc.) with access to full-text articles including Pharmacist's Letter and The Medical Letter. These links can help HCDMs identify potentially useful scientific evidence,7,8 create a focused clinical question,⁹ and critically appraise the evidence and evaluating the results. Such resources can identify gaps that HCDMs can raise to biopharma and/or internal decision-making committees (P&T, value committee, etc.)  

 Formulary Coverage Insights is a feature that allows users to see how other organizations are managing a product, including whether a product was added to formulary and if utilization management strategies (prior authorization, step therapy, quantity limits) were deployed.  The data is updated weekly and sourced from Managed Markets Insights and Technology (MMIT). This information which can be helpful for the organization that wants to ensure they are on the right path with their decision. 

In addition to dossiers and Product Snapshots, FormularyDecisions is a resource for AMCP PIE webinars. AMCP PIE webinars are hosted by product and/or therapeutic area experts to inform HCDMs of hot topic pipeline products that may be of interest to their organization.  

In addition to the features listed, there is a survey option available to provide feedback on the quality of evidence available and report issues/gaps that had an impact on the overall formulary decision. Responses provided in surveys are blinded and collated before sending that feedback on to the biopharma company.   

Other features available on FormularyDecisions include: 

• The Biosimilars Resource Hub for gathering the latest pipeline and approval information for biosimilars  
• A repository of Institute for Clinical and Economic Review (ICER) reports to quickly gather the latest ICER positions on product value
• A Drug Class Review tool to compare products within the same therapeutic class 

FormularyDecisions helps create efficiencies in the formulary review process and it’s a complimentary resource for eligible HCDMs.  

References 
1. Roberts, M.H., Ferguson, G.T. Real-World Evidence: Bridging Gaps in Evidence to Guide Payer Decisions. PharmacoEconomics Open 5, 3–11 (2021). https://doi.org/10.1007/s41669-020-00221-y 
2.Wang A, Halbert RJ, Baerwaldt T, Nordyke RJ. US payer perspectives on evidence for formulary decision making. Am J Manag Care. 2012;18(5 Spec No. 2):Sp71–6. 
3. Lundh A, Barbateskovic M, Hróbjartsson A, Gøtzsche PC (2011) Correction: Conflicts of Interest at Medical Journals: The Influence of Industry-Supported Randomised Trials on Journal Impact Factors and Revenue – Cohort Study. PLOS Medicine 8(2): 10.1371/annotation/7e5c299c-2db7-4ddf-8eff-ab793511ec 
4. Mongeon, P.. “Big Publishers, Bigger Profits: How the Scholarly Community Lost the Control of its Journals." MediaTropes 5 (2015): 102-110. 
5. Sorscher S, AbuDagga A, Almashat S, Carome MA, Wolfe SM. Placebo-only-controlled versus active-controlled trials of new drugs for nine common life-threatening diseases. Open Access Journal of Clinical Trials. 2018;10:19-28 https://doi.org/10.2147/OAJCT.S156054 
6. Draak THP, de Greef BTA, Faber CG, Merkies ISJ; PeriNomS study group. The minimum clinically important difference: which direction to take. Eur J Neurol. 2019 Jun;26(6):850-855. doi: 10.1111/ene.13941. Epub 2019 Mar 25. PMID: 30793428; PMCID: PMC6593833. 
7. Strite SA, Stuart ME, Urban S. Process steps and suggestions for creating drug monographs and drug class reviews in an evidence-based formulary system. Formulary. April 2008;43:135–145. 
8.Strite SA, Stuart ME. The Pharmacy & Therapeutics Committee Evidence-Based Decision-Making Handbook: Practical Guidance, Advice, Strategies, Tips and Efficiencies (Delfini Group Evidence-based Practice) ‎ CreateSpace Independent Publishing Platform, 2015.
9. Riva JJ, Malik KMP, Burnie SJ, Endicott AR, Busse JW. What is your research question? An introduction to the PICOT format for clinicians.J J Can Chiropr Assoc