Market Access & Market Analytics
At Avalon, our staff specializes in helping our clients obtain expedient market access and market penetration as “treatments of choice” for bio-pharmaceutical products and medical devices. Our experience includes providing market access support and life cycle management solutions for over 30 products across a wide range of therapy areas.
We provide ongoing market access support to our clients through:
- Strategic plans for life cycle management and line extensions
- Presentations to payers and regulators
- Continued information dissemination through poster presentations and peer-reviewed manuscripts
Click a Subject Below:
Retrospective Database Analyses
Retrospective database analyses are an invaluable tool for understanding a myriad of facets related to healthcare delivery in clinical practice or the “real world.”
Comprising of a longitudinal record of care delivered in pharmacy, inpatient, and outpatient settings, retrospective databases are a wealth of information on a large number of patients. Studies utilizing these databases are a relatively inexpensive alternative to randomized controlled trials (RCTs) for answering ongoing questions about the effectiveness and safety of healthcare interventions. Such studies are also vital in informing the clinical development program through obtaining insights into the natural history of medical conditions and existing/recommended treatment patterns and treatment gaps. During the commercialization phase, or post-launch, retrospective database studies are used to profile factors related to the effective adoption of new treatments or technologies by patients and physicians.
Our staff has extensive experience working with a wide array of databases encompassing:
- Various available commercial medical and pharmacy claims databases in the US including LifeLink Health Plan Claims Database provided by IMS, Thompson Reuters Commercial Claims and Encounters and Health and Productivity Management databases, Protocare Sciences, and others
- Government databases in the US including Medicare and Medicaid claims databases, Surveillance, Epidemiology and End Results (SEER) cancer registries, National Health and Nutrition Examination Surveys (NHANES), Medical Expenditure Panel Survey (MEPS), National Health Interview Survey (NHIS), National Hospital Discharge Survey (NHDS), National Ambulatory Medical Care Survey (NAMCS), National Medical Expenditure Survey (NMES), Healthcare Cost and Utilization Project (HCUP), National Comorbidity Survey (NCS), and others
- General practitioner and specialist medical records databases in Europe including IMS Disease Analyzer databases, The Health Improvement Network (THIN) database, General Practice Research Database (GPRD), and others
- Disease-specific or product-specific private industry sponsored or medical association registries in the US, Europe, and Asia
At Avalon, our retrospective database studies have been instrumental in answering critical questions, and empowering our clients in making strategic business decisions at different stages during drug development.
Below are examples of some questions related to the use of healthcare interventions in clinical practice our studies have answered for our clients. Our studies supported our clients in facilitating and maintaining formulary access for their products:
- What are the pre and post treatment health resource utilization and costs associated with initiating treatment with a new medication?
- Does the use of a newly launched product result in lower use of other expensive medications? i.e., does the new product effectively replace more expensive therapies?
- Are there product attributes such as easier dosing schedules, or reduced adverse events that would make treatment A more attractive to sub-groups of patients (e.g., elderly, patients with impaired renal functions) compared to other available treatments?
- What is the market share of competing treatments and which treatment is a newly launched product most likely to replace?
- Does the market share of competing products vary by geographic region? and are there access barriers in some regions?
- What are the market uptake rates for a specific product post-launch, and do they vary by region?
- Are there favorite competitors in certain regions of the country? and what are the reasons? tier status?
- What are the prescribing patterns by region & physician specialty?
- Is there any association between co-payments and prescribing patterns for various drugs?
- Can any detailing gaps be identified based on profiling the use of all marketed drugs in a particular therapeutic class?
- Can any competitive niches be identified based on untreated or undertreated patient sub-groups?
- What are the effects of channeling or selection bias on overall costs attributable to a particular treatment?
- Is the newly launched drug being dosed at its clinically effective and recommended dose?
- What are the costs of alternative treatment strategies in usual care?
- What physician specialties are early adopters of a specific treatment?
- What are the adherence and persistence rates for competing treatments?
- What are the patterns of therapy switching, augmentation, and discontinuation for newly launched treatments and do they differ from other therapies?
- How are product uptake rates related to formulary tier status? and what have been the historical sales trends after change in formulary status for medications in a particular therapeutic class?
- What is likely to be the potential impact on market share due to anticipated line extensions for specific competitors?
Global Value Dossiers, NICE (UK) & AMCP (US) Submissions
Our experience includes development of dossiers for 15 products across several different therapeutic areas. Dossiers were required as a part of regulatory or reimbursement submissions or were developed to communicate critical product information to internal and external stakeholders.
- Integrated documents summarizing relevant epidemiological, clinical efficacy and safety, health economics, and PRO data
- Communicate product value to key decision makers
- Developed in compliance with submission formats specified by NICE, AMCP, and EMEA, to support reimbursement or regulatory submission in US and Ex-US markets
- Compendiums or repositories of all health economics or PRO data, “one-stop source,” for a specific product for internal use to prepare staff for new product/indication launch or to support reimbursement negotiations
- Developed using proprietary formats for visual appeal, or developed to be end-user friendly depending on client preference
- Accompanying slide decks to facilitate presentation to payers and regulators
- External expert or key opinion leader (KOL) input based on client preference
Our “objection handlers” are essentially training manuals that are developed to inform and assist our clients in achieving a positive outcome during their reimbursement negotiations, particularly in Ex-US markets. These documents include:
- A comprehensive list of potential objections, questions, or concerns payers may raise during pricing and reimbursement negotiations
- Concise arguments with the best available product data (efficacy, safety, health economics, PROs) that should be used to address or refute these objections
Disease & Drug Registries
Our experienced researchers have been successful in developing and implementing patient registries in Ex-US markets. Our registries have been a powerful source of reliable and valuable information for internal and external stakeholders. Examples of the types of questions our registries have been able to answer include:
- What is the long-term efficacy, tolerability, and safety profile of a newly launched therapy in usual care or clinical practice?
- Are there any additional clinical benefits in terms of efficacy or PROs not uncovered in pivotal studies?
- What are the early versus late adopter profiles of patients & physicians for specific treatments?
- What are the most commonly prescribed treatments in clinical practice?
- What combination therapies are most likely to be prescribed in clinical practice?
- What are the primary cost drivers for managing a specific disease? and what portion of the costs of treatment are attributable to pharmacological therapies?
- To what extent are patients on a specific treatment using alternative treatment strategies including acupuncture, massage therapy, chiropractic care?
- What are the costs of a disease purely from a patient perspective? out-of-pocket expenses for over-the-counter medications, co-pays for prescription medications, costs of alternative treatments?
- What are the compliance and persistence rates for specific treatments?
- What are the rates of patient satisfaction with specific treatments?
- Is a particular therapy being dosed at its clinically effective dose? and how does sub-therapeutic dosing affect treatment effectiveness in clinical practice?
- What are the comorbidity profiles of patients with specific diseases?
- What is the quality of life impact of specific medical conditions or treatments?
- How do specific medical conditions or treatments affect patient functional status, physical functioning, social functioning, etc?
- What is the effect of certain diseases on patients’ ability to work? and do some treatments affect work productivity differently than others?
- What are the most commonly cited reasons for discontinuation or switching off different therapies?
- Do some side-effects of therapies bother patients more than others?
Our payer, patient, and provider research studies have been instrumental in shaping product strategy, generating target product profiles (TPPs), informing clinical development, and generating value messages. Studies were conducted using surveys (mail or web-based), focus groups, or advisory panels and we undertook all aspects of these studies including questionnaire development, administration/moderation, transcription, analyses and message extraction.
Our payer, patient, and physician research has provided answers to the following types of questions:
- What are payer information needs, attitudes towards, and factors influencing the adoption of new treatments and/or existing treatments for new indications?
- What is payer price sensitivity and potential impact of new treatments on payer budgets?
- Depending upon the potential efficacy and safety profile of a new treatment, are payers likely to restrict access to only a sub-set of patients, for example, patients with the most severe disease, and those who are refractory to other available treatments?
- Given a set of target product profiles and corresponding hypothetical prices, which ones are most likely to obtain preferred formulary status?
- What efficacy versus safety versus cost trade-offs are most acceptable to payers?
- What efficacy versus safety trade-offs are acceptable to patients?
- What are the most important product attributes for a new treatment from the patient’s perspective?
- What specific PROs are important to patients?
- How much are patients willing to pay “out-of-pocket” for a new treatment given a hypothetical set of efficacy and safety attributes?
- What specific product attributes will influence physician prescribing of new treatments?
- Which current treatment do physicians consider as the “benchmark” and what attributes should a new treatment have in order to become the “standard of care”?
- What efficacy versus safety trade-offs are acceptable to patients?
- Do physicians perceive there to be critical “treatment gaps” for a particular medical condition?
At Avalon, our staff have numerous years of experience in developing effective and successful pricing strategies for products in many different therapeutic areas. We are acutely aware that pricing issues vary significantly based on country-specific regulations, market size, and competitor/reference pricing and we pay the utmost attention to all these parameters in developing our pricing strategies and recommendations.
Our work has encompassed both the generation of “early price recommendations” for compounds in clinical development, and development of “launch price” recommendations for US and Ex-US markets.
Critical inputs that inform our price recommendations include:
- Modeling and assessment of potential price/volume trade-offs based on the price, market share, and efficacy/safety attributes of competing treatments, sequence of market introduction (launch sequence) in individual countries and country-specific market characteristics
- Analysis of retrospective databases to evaluate uptake of competitor products at various price points
- Country-specific primary payer research
- Review and analysis of government and third party reimbursement policies
- Economic models to identify break-even or “budget neutral” price
- Analysis of competitor pricing at market entry and later
- Country specific barriers to ceiling prices
Reimbursement Reviews & Analyses
- Over the years, we have assisted our clients with critical appraisals and reviews of government and third party reimbursement policies
- Our reviews have been therapy area-specific or product-specific (bio-pharmaceutical products or medical devices)
- Our reviews have informed the development of strategies to ensure maximum coverage from all payers for bio-pharmaceutical products and medical devices
We have routinely assisted our clients in complying with requests from their customers, predominantly health plans, for studies/data specifically applicable to their plan population.
- Customization of Budget Impact Models
- Retrospective database studies using the health plan’s medical and pharmacy claims databases
- Membership surveys (patients and physicians)