Happy New Year! As we are now three weeks into 2016, many of us have been dusting off our failed resolutions and hitting the gym. Eating more beans and green, trying to sleep more and manage that stress.
As little as a decade ago, we would have never thought of discussing lifestyle interventions with leading therapy companies. That has changed with the realization that prevention and management of disease requires a multi-faceted solution, not only a therapy. Chemicals and biologics form only a segment of the equation. A multitude of studies have cited the value of exercise, dietary modification and stress relief in conditions such as cardiovascular disease, diabetes, GI problems. Even patients with cancer and inflammatory-driven diseases can benefit from incorporating non-therapeutic solutions. Therefore, for industry to strengthen its offerings and provide more value to the market, it makes sense for the industry to take the initiative to build commercialization efforts that blend the non-therapeutic with the therapeutic. For example, we worked on a commercialization program that blended a lifestyle program (diet) and tools (blood pressure cuff) with a blood pressure lowering drug. The idea was to support the patient and clinician, and improve overall compliance and increase product satisfaction.
To be successfully incorporated into a disease management solution the evaluation and planning process needs to be of a similar level of scrutiny and rigor as the therapy they accompany. The same type of systematic analysis used for evaluating therapeutic agents should be the basis for a decision to incorporate a non-pharmacologic product or service. This approach is carried out in the following steps.
Establish overall goals for the solution.
This is essentially the most critical and the toughest part of the process. For a blended solution including lifestyle modification or any other non-therapeutic offering to work, it has to have a purpose besides just supporting the therapeutic agent. It should give the customer a reason for doing business with the company. Additionally, this is the time to be clear on how the intervention will be provided – is it a value-add, out of pocket offering, or even covered through insurance (lofty goals are just fine at this point). This is where a workshop-type of format is useful here as it allows all internal stakeholders to sort out their thoughts concerning this offering and to allow for prioritizing amongst the team.
Extensively search the literature to determine any evidence for the use of lifestyle changes in the prevention or management of the given condition.
Be clear on what the non-therapeutic intervention needs to be. This may appear intuitive when in fact it is not clear until after a lot of digging is done. This means a comprehensive literature review which should not be limited to the peer-reviewed articles but also rounded out with lay sources. A systematic approach utilizing specific search terms will help to (1) understand evidence for broad categories of non-therapeutic approaches and objectives and (2) begin to pinpoint the specific interventions which accomplish them. For example, increasing activity can be achieved through structured exercise programs, counseling, increasing daily activity measured through a fitness tracker, maintaining accountability for exercise using a digital app or even finding ways to leverage resources already available. In the case of dietary modifications, there are many opportunities for synergistic effects of diet with therapy. Case in point is the recent focus on the microbiome and how it may impact multiple conditions ranging from obesity to inflammation. Could there be a particular dietary intervention that targets the ideal balance of the microbiome which can effectively augment a therapy and how could it be implemented?
Do a competitive assessment to understand the options, their benefits and challenges.
It is guaranteed that the first step in this process will yield an endless number of potentials which must be whittled down to something manageable. This is the time to do an in-depth analysis of the options and compare and contrast according to various factors such as cost, ease of use, available evidence, and how suitable it is to the particular disease state and companion therapy. This is also the ideal time to determine the unmet needs of the market and explore the use of existing products or services versus creating one from scratch. For example, according a recent article in Fortune, the weight loss industry in the US alone was $64 Billion in sales in 2014, however over one third of the population is considered obese and another third overweight. It is fruitless to offer the same programs that are currently failing the population. Additionally, while fitness apps and wearables are all the rage, surveys have shown that around 50% of us lose interest in them, thus rendering them valueless to a significant portion of the population.
Engage clinicians, patients, and other stakeholders, particularly payers.
As often non-therapeutic approaches clearly take more time and effort than prescribing a drug or inserting a device, it “takes a village” to make sure that they are as effective as possible. It is also critical that they meet an unmet need. The virtual trash is full of impractical initiatives and digital solutions that have quickly lost their luster due to their being too arduous or not to maintain. Such offerings are in fact, detrimental to the therapy and risk the adoption of the overall solution by the patient and clinician and potential reimbursement by a payer. For example, a world renowned expert in preventive medicine indicated that even though diet and exercise is the number one remedy for vascular inflammation it won’t work “because patients won’t do it”. He obviously had not been exposed to a solution that he feels provides value. Even if clinicians are on board, according to a 2014 article in the Washington Post, the majority would not know the first thing to tell a patient about diet or exercise. On the other hand, payers are already offering multiple programs and apps which are designed to encourage increased activity, more healthful diet, stress reduction and psychological wellness. It is imperative to understand their hot buttons and how a particular non-therapeutic modality will serve their interests while augmenting their efforts.
The trend is undeniably moving toward an integrated approach to disease management and industry should be a leader with the evolution to solutions that combine therapy with other components such as behavioral modifications, services and digital applications rather than drug or device on its own. While the development time and investment is nothing close to what is necessary for an FDA-approved therapy, it is still imperative that only the most effective and synergistic lifestyle interventions are identified, developed and integrated as inability to do this will negatively impact the overall solution offering. The idea is to support the patient, physician, and improve overall compliance and increase product satisfaction. By producing better results an integrated program will ultimately build product differentiation in an often crowded market.
If you are contemplating a non-therapeutic component for your own therapy-based disease management solution, Snowfish is happy to help. Our years of experience in commercial analytics have helped multiple companies to develop integrated disease management solutions which include non-pharmacologic/device components. Please reach out to us at www.snowfish.net or +1-703-759-6100.
Melissa Hammond, MSN, GNP is Managing Director at Snowfish a commercial insights firm.