How do we devise an optimal strategy to ensure patient access to our treatments in an age of value and affordability? How do we incorporate the impact of payers, medical communities, providers, prescribers and patients in a framework that helps us make trade-offs for development and commercialization decisions? It’s time to start the “access journey.”Consider the access journey as a sequence of hurdles that need to be addressed to optimize the commercial success of a drug through broad and extended use at an attractive net price. Each of these steps can be considered a financial risk equivalent to a dangerous curve on a mountain road. Every “miss” results in loss of patients and revenue from what’s formally authorized through the approved label, as illustrated here:
For each of the access journey steps, we need to consider a different decision maker with different values and preferences. The impact of imperfect value demonstration is a penalty in net revenues as patients are withheld from your drug. While it’s not realistic for a drug class or treatment to be used in all patients within label, minimizing losses from the narrowing of the funnel is essential. Each of the access journey steps may influence each other, and decisions aren’t necessarily taken in a sequential order.
How do we best shape our development program so that each of these steps in the access journey are considered—with respect to their impact on the funnel—so that we limit restrictions and ultimately retain a large share of eligible patients? How do we ensure a proper trade-off between results and the underlying investments, clinical risk, and impact on timeline with the forecasted revenue? Doing so requires a structural evaluation of each of the steps on the access journey.
List and Net Pricing
Differences between official list price and actual net price can be substantial, particularly in highly competitive therapy areas. In the United States, PBMs and MCOs can extract significant rebates when choices are deemed sufficiently interchangeable by the medical community, knowing that exclusion lists and co-payment differences can substantially shift prescribing behaviors. U.S. pharma companies spend well over $100 billion on rebates annually—more than twice all other selling, general and administrative expenses. As rebates are confidential between manufacturer and payer, it’s hard to provide exact insights by drug or therapy area, but we know that many rebates in diabetes and hepatitis C exceed 50%. In other areas, where there are few similar options, rebates may be very small or non-existent. In other countries, discounts can be agreed upon, usually on a basis of confidentiality. For example, in France, periodic negotiations between the French government and pharmaceutical companies often include confidential rebates and contractually agreed upon further rebates when, for example, certain sales revenues are exceeded. In Germany, the government insists on transparency of net prices. The future will tell how this debate will further evolve in the United States.
Formulary adoption by public and private payers is obviously a critical step in reaching a patient. In price-controlled markets, this is essentially an all-or-nothing event, where the outcome is largely driven by the provided evidence of benefit over the existing treatment standard at the time of negotiation. Criteria for approval are different by country, but the critical issue is usually whether the demonstrated patient benefit is deemed significant by payer-accepted standards. Approval criteria have gradually become more stringent over time, particularly in terms of head-to-head comparisons with standard of care and demonstrated benefit across the label population.
In the United States, the stakes have increased as payers are no longer routinely putting new drugs on a third formulary tier with a higher co-payment. Large PBMs and many MCOs often exclude new drugs from formulary until closer review or on a more permanent basis when it’s placed on an exclusion list, favoring similar drugs with better rebate terms.
Provider Formularies and Treatment Pathways
Provider organizations include a large range of integrated healthcare systems, specialty clinicals, hospitals and physician groups that put policies in place that influence treatment and prescribing behaviors of its associated physicians in varying degrees. Payment mechanisms and performance metrics are important drivers of provider organization preferences and related decisions.
Provider performance metrics are increasingly visible to the public and can influence the ability to attract patients, as well as directly impact reimbursement rates. Hospitalization rates, re-hospitalization rates and cardiovascular outcomes metrics are among the most commonly
monitored metrics, but more detailed Healthcare Effectiveness Data and Information Set (HEDIS), ACO and other metrics are increasingly used in payment decisions. Broader public awareness of health outcomes of provider organizations and their individual physicians is likely to further evolve. In the age of TripAdvisor, it may soon only require a few clicks to access specific statistics such as hospitalization rates and cardiovascular event rates, and direct patient feedback on each institution and physician.
Treatment pathways have emerged to encourage the efficient use of resources in the treatment of patients. Pathways have been primarily used to optimize treatment and thus improve outcomes efficiently in cancer care. Treating physicians get a payment depending on the degree of adherence with the treatment options that are specified in the pathway guidelines. Some pathways, such as AIM (part of Anthem), select specific drugs within a recommended class. The actual impact of pathways on physician prescribing still isn’t fully clear. However, we expect that payers and providers may seek economic opportunities to make choices between options where they are deemed medically interchangeable.
Clinical Guidelines and Value Frameworks
Medical communities have provided clinical guidelines to the physician community for many years. In recent history, these guidelines were purely clinically oriented and rarely included treatment and drug cost considerations. As an illustrative example, the American College of Cardiology and the American Heart Association published the ACC/AHA Statement on Cost/Value Methodology in Clinical Practice Guidelines and Performance Measures. It states, “The need for greater transparency and utility in addressing resource issues has become acute enough that the time has come to include cost-effectiveness/value assessments and recommendations in practice guidelines and performance measures.”
Oncologists have been the most vocal on the impact of cost and affordability on patients. Various value frameworks by the American Society of Clinical Oncology, the European Society for Medical Oncology and the National Comprehensive Cancer Network, as well as the Drug Pricing Lab by Memorial Sloan Kettering Cancer Center’s Dr. Peter Koch, have attempted to measure and communicate the benefits of drugs, or lack thereof, in relation to its cost.
In heath-economics-driven markets, such as the U.K., Canada and Australia, health technology evaluations provide a basis for price or reimbursement. These cost-effectiveness-based guidelines provide payers significant control through direct linkage to price or reimbursement decision-making. The Institute for Clinical and Economic Review (ICER) is using a similar method to communicate cost-effectiveness of drug treatments in the United States. However, both the methodology and financial perspectives are not well aligned with U.S. PBM and MCO decision-making. The question is whether and how ICER cost-effectiveness reviews will be adopted by payers, and whether these initiatives will be endorsed by the medical community and patients.
The actual physician prescribing decision will continue to be the central factor in the market adoption of any drug. No drug will perform well without the physician’s endorsement of its value in treating individual patients. As such, the prescribing decision is the resulting transaction under the influence of decisions and communications provided by medical communities, payers, provider organizations, and other potential stakeholders and influencers.
A lack of demonstrated value can have a strong negative impact on prescribing due to payer-imposed restrictions in addition to the direct impact of a less compelling message to prescribers. Commercial success may not be achieved by merely passing minimum hurdles to gain market access. In the United States, we may gain FDA approval for an undifferentiated drug with a placebo-controlled study. However, we will subsequently be forced to offer either significant rebates or intensive co-pay offset programs in the commercial market to overcome patient co-payment hurdles and related hesitance of physicians to prescribe.
A key question is whether we adequately represent the impact of demonstrated value, or lack thereof, on the forecasted physician prescribing. Forecasts are only as good as the options that we consider in predicting performance. Unless we explicitly consider the impact of multiple value proposition options on peak market share and forecasted revenues, decision-making teams will typically favor adhering to the minimum FDA requirements.
What happens when the patient leaves the doctor’s office? Will the patient go to the pharmacy to pick up the prescription? What if there is a substantial co-payment? If so, was the patient made aware of any coupons that may offset the co-payment? As co-payments have been rising in the United States and some other markets, prescription fulfillment is an increasing area of concern.
Pharmaceutical companies have been offering an array of patient support services to help eliminate paperwork, cost and co-pay hurdles that payers have instituted to limit access to high-cost prescription drugs. Payer adoption of new management strategies such as drug exclusion lists and recent co-pay accumulators require adjustments in brand strategies.
Does the patient adhere to the drug treatment over time, and how is this different across patient populations? Adherence is strongly dependent on efficacy and the safety/tolerability profile and can also be impacted by patient co-payment and the associated financial burden. Particularly for non-symptomatic chronic conditions, adherence can be a major challenge.
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